chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain
Clinical narrative: redness; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and erythema. On an unknown date, the outcome of the injection site pain and erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination with Shingrix, the patient experienced  pain at injection site and large bright red spot 2 inches wide and 2 and half inches long. The injection site pain was lasted for 4 days and erythema was lasted for more than a week. The patient did not consent to follow up. No further details were provided.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient reported 5 days of fever after Prevnar 13 shot.; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported 5 days of fever after pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) shot. The patient recovered from the fever on an unspecified date. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Injection site reaction
Clinical narrative: Redness at injection site which persisted for 4 days; flu like symptoms on day after; diarrhea
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Diagnosis: shingles. Treatment : acyclovir 800 mg  every 8 hours for 10 days  Symptoms: multiple lesions on trunk
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Nausea, Paraesthesia, Throat tightness
Clinical narrative: Patient experienced tightness in throat, but did not lose conciousness and could breathe. as time passed she felt some tingling in fingers, nausea and headache. Administered Benadryl 50mg waited per patient's request about 30 min them administered Epipen and called 911. Patient taken via EMS to ER.
Age: 30.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Approximately 5 minutes after vaccine administration, patient fell and hit her head, had loss of consciousness for about 15 seconds.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Induration, Mass, Pain, Pruritus
Clinical narrative: Redness(2X4 inches), soreness, swelling, itching and hard lump in center.  Started feeling itchy 6/19/19 evening then redness started and began to spread 6/20/19  morning. She states it is now (6/21/19) approx 2x4 inches and has hard lump in the center. She denies any lesions or chickenpox-like rash. She states it "looks like a huge mosquito bite" She denies scratchy/itchy/tight throat or difficulty breathing.  Reported over the phone by patient, no physical exam  or treatment done.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: Redness(2X4 inches), soreness, swelling, itching and hard lump in center.  Started feeling itchy 6/19/19 evening then redness started and began to spread 6/20/19  morning. She states it is now (6/21/19) approx 2x4 inches and has hard lump in the center. She denies any lesions or chickenpox-like rash. She states it "looks like a huge mosquito bite" She denies scratchy/itchy/tight throat or difficulty breathing.  Reported over the phone by patient, no physical exam  or treatment done.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Rash erythematous, Rash pruritic, Somnolence
Clinical narrative: Red hot, itchy rash on entire neck, ears, and two spots on the forehead, extreme body fatigue and muscle pain, extreme sleepiness until Monday at 2 p.m.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Rash
Clinical narrative: Grandmother left voice mail on 6/19/19 to report episodes of diarrhea alternating with formed stool on 6/9/19, day two post vaccination, followed by a rash on 6/19/19 day 12 post vaccination. Child had  poor appetite and low energy, though continued to eat and drink. Temporal temps read 99 F. A once daily dose of Tylenol was given next 4-5 days to treat.  On 6/19/19  a mild rash was noted over his back and neck. This lasted for about 2 days, spread to the chest and toward his face. Benadryl was given once daily. Child did not complain of itching. Once the rash erupted, the child's energy returned to normal, as well as his appetite. The rash faded within two days. The nurse was able to reach the grandmother for details on Monday June 24 2019. At that time the child was fully back to normal.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Received one dose of improperly stored RECOMBIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 19-JUN-2019, the patient was vaccinated with one dose of improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot # R021372 (expiry date: 25-MAY-2021) for prophylaxis (strength, anatomical location and route were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009509: US-009507513-1906USA009510: US-009507513-1906USA009514: US-009507513-1906USA009522:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No adverse effects; inadvertently administered an expired dose of RECOMBIVAX; This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 21-JUN-2019, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) Thimerosal Free (RECOMBIVAX HB) intramuscularly, # M036156, expiration date 23-FEB-2019 (exact dose was not reported) for prophylaxis (Expired product administered).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Received one dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 20-JUN-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA), lot # R035227 (expiry date: 01-JAN-2020) for prophylaxis (strength, anatomical location and route were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009510: US-009507513-1906USA009082: US-009507513-1906USA009522:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Received improperly stored ROTATEQ; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 19-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R025731 (expiry date: 14-JUN-2020) for prophylaxis (strength, anatomical location, route and dosage details were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009509: US-009507513-1906USA009082: US-009507513-1906USA009513: US-009507513-1906USA009514: US-009507513-1906USA009510:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; aches; fever; tired; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain, fever and tiredness. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the pain, fever and tiredness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter did not have any specific details regarding any patients. The nurse reported that, lot of patients complained of flu like symptoms for up to 24 hours, after Shingrix administration. The reporter mentioned low grade fever, aches and feeling tired. The nurse stated that, she only reports events when they were not listed in the package insert. The reporter consented to follow up. This case has been linked with case US2018086784, reported by same reporter.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction -- sognificant swelling, tenderness of Rt LE.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister, Lip swelling, Lip ulceration
Clinical narrative: PT RECEIVED VACCINE ON 6/19/19. ON FOLLOWING DAY 6/20/2019 PT SAID SHE WOKE  UP WITH SWOLLEN LIPS AND ULCERS/BLISTERS INSIDE HER LOWER LIP AND A BLISTER/ULCER ON HER UPPER LIP.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Area became markedly swollen and red 2 days after injection.  Did not required antibiotics. or imaging.  Pt still has clinically significant induration at site of injection after 4 weeks.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Gait disturbance, Headache
Clinical narrative: Symtoms-the expected was the soreness at injection site, but at about 12 hours after the shot I experienced shivering at first was minimal and then it got to the point I could do not anything for 2 hours of massive shakes.  Then I got a slight fever, headaches, and general aches and pain.  I took aspirin which help me sleep.   The morning after, I was dizzy and weak.  I had a hard time walking around the house and I am normally an endurance runner.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in jaw, Pyrexia, Tremor
Clinical narrative: Symtoms-the expected was the soreness at injection site, but at about 12 hours after the shot I experienced shivering at first was minimal and then it got to the point I could do not anything for 2 hours of massive shakes.  Then I got a slight fever, headaches, and general aches and pain.  I took aspirin which help me sleep.   The morning after, I was dizzy and weak.  I had a hard time walking around the house and I am normally an endurance runner.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Injection site discolouration, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: Fever, Discoloration below the injection site, patient was immobilized-could not move arms and legs, could not dress herself or stand up or sit down without assistance. Patient reported overall body pain at a level of 7-8 on a pain scale. Pain and tenderness to the touch in shoulder blades, clavicles, and sternum. These symptoms persisted for 15 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Fever, Discoloration below the injection site, patient was immobilized-could not move arms and legs, could not dress herself or stand up or sit down without assistance. Patient reported overall body pain at a level of 7-8 on a pain scale. Pain and tenderness to the touch in shoulder blades, clavicles, and sternum. These symptoms persisted for 15 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction, Impaired work ability, Mobility decreased, Product complaint
Clinical narrative: Fever, Discoloration below the injection site, patient was immobilized-could not move arms and legs, could not dress herself or stand up or sit down without assistance. Patient reported overall body pain at a level of 7-8 on a pain scale. Pain and tenderness to the touch in shoulder blades, clavicles, and sternum. These symptoms persisted for 15 days.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash eruption throughout the body and light fever. Patient presents varicella with no contact with the virus during the week of vaccination
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: swollen arm; swollen arm and a painful itchy blistering rash/ diagnosed with shingles; other dermatological injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after injection, the patient suffered a swollen arm and a painful itchy blistering rash. As a result of her symptoms, she presented to a medical provider and was diagnosed with shingles, as well as, other dermatological injuries. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles and other dermatological injuries were considered to be disabling.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin injury
Clinical narrative: swollen arm; swollen arm and a painful itchy blistering rash/ diagnosed with shingles; other dermatological injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after injection, the patient suffered a swollen arm and a painful itchy blistering rash. As a result of her symptoms, she presented to a medical provider and was diagnosed with shingles, as well as, other dermatological injuries. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles and other dermatological injuries were considered to be disabling.  Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: Wrongful death; Shingles; This initial spontaneous report was received from a lawyer and patient representative regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Shingles and she was treated by a physician for the event. On an unspecified date the patient died. It was unknown the cause of the death as well as whether an autopsy was performed. The outcome of the event herpes zoster was not reported. The reporter considered the events of shingles and wrongful death to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of death was considered to be medically significant.  Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Aphonia, Asthma, Cough, Dyspnoea
Clinical narrative: asthma attack; lost voice; problems breathing; coughing; This case was reported by a consumer via patient support programs and described the occurrence of asthmatic attack in a female patient who received umeclidinium bromide (Incruse Ellipta) inhalation powder (batch number Unknown, expiry date unknown) for product used for unknown indication.   On an unknown date, the patient started Incruse Ellipta (inhaled) 62.5 µg at an unknown dose and frequency. On an unknown date, an unknown time after starting Incruse Ellipta, the patient experienced asthmatic attack and loss of voice. The action taken with Incruse Ellipta was unknown. On an unknown date, the outcome of the asthmatic attack and loss of voice were unknown.   It was unknown if the reporter considered the asthmatic attack and loss of voice to be related to Incruse Ellipta.  Additional details: This case was reported by a consumer via GSK patient assistance programs on 7th June 2019. The patient started Incruse Ellipta about 5 years. Reporter stated that, "patient stated that she had an asthma attack and lost voice. No further details given."  On follow-up it was determined the initial receipt date was 6th June 2019 which is earlier than initial as 7th June 2019.  Backend earlier receipt date correction; significant FU flags ticked to ensure reports schedule from corrected initial receipt date. Follow-up information was received via GSK patient assistance program on 6th June 2019. Ventolin and Shingrix as suspect and breathing problems and coughing as events were added. Reporter stated that, "patient stated that she is having problems breathing and has lost her voice due to continuous coughing."
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and got shingles the next day.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included varicella zoster virus vaccine, live, oka strain (Zostavax) for shingles.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Zostavax at an unknown dose and frequency. On an unknown date, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: On an unspecified date, in August or September 2018, the patient had Shingrix vaccine and 3 weeks later had another, very mild, shingles outbreak. The emergency room visit was required. It was unknown if the reporter considered the shingles to be related to Zostavax as well. The reporter consented to health care professionals for follow-up.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The patient has an unspecified allergy to a flu vaccine. No additional details provided.  It was unknown whether non-gsk or verifiable vaccine.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Chills, Erythema, Injection site warmth, Pain
Clinical narrative: Chills and fever on 6/22 to 6/23. Pain 6/21 to present. Redness and swelling in arm continues from 6/21 to now. Stomach ache 6/21 to 6/24. Area near injection site warm from 6/22 to now.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Chills and fever on 6/22 to 6/23. Pain 6/21 to present. Redness and swelling in arm continues from 6/21 to now. Stomach ache 6/21 to 6/24. Area near injection site warm from 6/22 to now.
Age: 2.5
Sex: F
Vaccine: MMR
Symptoms: Erythema, Lymphadenitis, Mononucleosis heterophile test negative, Night sweats, Pyrexia
Clinical narrative: my daughter received the vaccine on Wednesday the 19th, on Thursday afternoon my child started with fever, She had a high fever at night , she could not breathe well and at six o'clock in the morning on Friday I realized that she  had her glands inflamed and  it looked like two lemons and she had sweated all night, she had a fever all Friday and Saturday. On Sunday she woke up with red spots on her back, chest and face
Age: 2.5
Sex: F
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: my daughter received the vaccine on Wednesday the 19th, on Thursday afternoon my child started with fever, She had a high fever at night , she could not breathe well and at six o'clock in the morning on Friday I realized that she  had her glands inflamed and  it looked like two lemons and she had sweated all night, she had a fever all Friday and Saturday. On Sunday she woke up with red spots on her back, chest and face
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Headache, Hyperhidrosis
Clinical narrative: Pain, redness, and swelling at injection site; pain and redness radiated down the entire arm, including shoulder and hand; pain radiated down entire left side down to my lower calf.  Because of the severe pain on the left side of my rib cage, breathing hurt.  Those symptoms lasted three days.  I am a fit and active senior, however I needed help getting in and out of bed during that time because of the crippling pain.   High fever and listlessness lasted 40 hours, including severe nausea and stomach pain.  Shivering and sweating with the fever.  Severe to bad headache lasted three days, headache for an additional three days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Listless, Mobility decreased
Clinical narrative: Pain, redness, and swelling at injection site; pain and redness radiated down the entire arm, including shoulder and hand; pain radiated down entire left side down to my lower calf.  Because of the severe pain on the left side of my rib cage, breathing hurt.  Those symptoms lasted three days.  I am a fit and active senior, however I needed help getting in and out of bed during that time because of the crippling pain.   High fever and listlessness lasted 40 hours, including severe nausea and stomach pain.  Shivering and sweating with the fever.  Severe to bad headache lasted three days, headache for an additional three days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Nausea, Pain, Pain in extremity, Painful respiration
Clinical narrative: Pain, redness, and swelling at injection site; pain and redness radiated down the entire arm, including shoulder and hand; pain radiated down entire left side down to my lower calf.  Because of the severe pain on the left side of my rib cage, breathing hurt.  Those symptoms lasted three days.  I am a fit and active senior, however I needed help getting in and out of bed during that time because of the crippling pain.   High fever and listlessness lasted 40 hours, including severe nausea and stomach pain.  Shivering and sweating with the fever.  Severe to bad headache lasted three days, headache for an additional three days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain, redness, and swelling at injection site; pain and redness radiated down the entire arm, including shoulder and hand; pain radiated down entire left side down to my lower calf.  Because of the severe pain on the left side of my rib cage, breathing hurt.  Those symptoms lasted three days.  I am a fit and active senior, however I needed help getting in and out of bed during that time because of the crippling pain.   High fever and listlessness lasted 40 hours, including severe nausea and stomach pain.  Shivering and sweating with the fever.  Severe to bad headache lasted three days, headache for an additional three days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Faeces discoloured, Gastrointestinal haemorrhage
Clinical narrative: Patient reported that he was having stomach pain and dark stools a few days after receiving the vaccination and went to the doctor's office  and they said he had a GI bleed.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Amnesia, Fatigue, Malaise, Pain, Rash generalised
Clinical narrative: RASH OVER BODY PAIN , FEELING SICK AND RUN-DOWN SINCE VACCINE , MEMORY LOSS,
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: DEVELOPMENT OF CELLULITIS. Patient had received vaccination in the morning and called back in the afternoon because her arm was starting to feel slightly warm to the touch.  The pharmacist who had administered the vaccine instructed her to go see a doctor if symptoms persist or worsen over the next 2 days. Patient called again on 06/22/19 because her arm was warm and red. I instructed her to go to an urgent care clinic for antibiotics. Patient came in later that day for a prescription for oral antibiotics.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Differential white blood cell count normal, Enema administration, Full blood count normal, Intussusception, Irritability
Clinical narrative: Fussiness, vomiting, lethargy started in the evening of 6/21/19. Presented to hospital on 6/22/19 and admitted with a diagnosis of intussusception. Treated with an air-contrast enema. Discharged on 6/23/19.  Presented to pediatrician office on 6/25/19 with recurrence of symptoms.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Lethargy, Lipase normal, Metabolic function test normal, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Fussiness, vomiting, lethargy started in the evening of 6/21/19. Presented to hospital on 6/22/19 and admitted with a diagnosis of intussusception. Treated with an air-contrast enema. Discharged on 6/23/19.  Presented to pediatrician office on 6/25/19 with recurrence of symptoms.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Fatigue, Headache, Malaise, Nausea
Clinical narrative: 06/18/2019 Went to bed with an itchy bump on left arm. Arm was sore. 06/19/2019 Woke up with a welt larger than a quarter, tired and ill feeling. Arm was even more sore. At night, welt was larger, still ill feeling, and itchy all over. Nausea and headache. Arm really hurt. Called doctor. Told to give Benadryl and ibuprofen. 06/20/2019 Woke up, the welt had grown larger still. Still felt very ill. Itchy on back of neck and left harm. Felt as though it was hard to breathe. Pain in arm. Took Benadryl and ibuprofen through the day. 06/21/2019 The welt started going down. All symptoms were beginning to lessen. Continued to take ibuprofen. 06/23/2019 All symptoms had resolved.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Peripheral swelling, Pruritus generalised, Urticaria
Clinical narrative: 06/18/2019 Went to bed with an itchy bump on left arm. Arm was sore. 06/19/2019 Woke up with a welt larger than a quarter, tired and ill feeling. Arm was even more sore. At night, welt was larger, still ill feeling, and itchy all over. Nausea and headache. Arm really hurt. Called doctor. Told to give Benadryl and ibuprofen. 06/20/2019 Woke up, the welt had grown larger still. Still felt very ill. Itchy on back of neck and left harm. Felt as though it was hard to breathe. Pain in arm. Took Benadryl and ibuprofen through the day. 06/21/2019 The welt started going down. All symptoms were beginning to lessen. Continued to take ibuprofen. 06/23/2019 All symptoms had resolved.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: nausea and vomiting, 12 hrs after,  headache, dizziness
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever of 99.9 to 100.3 for 2+ days Mild headache Stomach ache Joint stiffness Soreness around injection site Redness around injection site Injection site hot to the touch Low stamina
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Joint stiffness, Pyrexia
Clinical narrative: Fever of 99.9 to 100.3 for 2+ days Mild headache Stomach ache Joint stiffness Soreness around injection site Redness around injection site Injection site hot to the touch Low stamina
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: FEVER, FATIGUE, MUSCLE ACHES -LASTED 48 HOURS
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever of 101 degrees, headache, fatigue, pain at injection site.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: loss of appetite, nausea, head ache, muscle pain, tingling in hands.  I could not get out of bed for one full day.  I felt like I did when I had chemo.  I was able to resume my life the next day but was still very tired.  Injection site is very very soar.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Nausea, Paraesthesia
Clinical narrative: loss of appetite, nausea, head ache, muscle pain, tingling in hands.  I could not get out of bed for one full day.  I felt like I did when I had chemo.  I was able to resume my life the next day but was still very tired.  Injection site is very very soar.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 77-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 15-OCT-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from his use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: No adverse effects reported; Tested serologically and determined to have a negative titer result; This spontaneous report was received from a pharmacist refers to a currently 43 years old female patient. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 03-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) of one dosage form via subcutaneous route with lot # R036581 and expiry date: 17-DEC-2020 for prophylaxis. Therapy type of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was rHA. On an unknown date in June 2019, the patient was tested serologically and determined to have a negative titer result (Antibody test negative). No adverse effects reported (no adverse event). No treatment for the event was received. It was reported that, the patient sought for the medical attention to the pharmacy. No product quality complaint (PQC) was identified. The outcome of the event was unknown. Causality assessment for the event was not provided by the reporter.
Age: 77.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Contusion, Pruritus, Rash
Clinical narrative: pt had a rash the same day, some itching, came into pharmacy 6/25 and has a large bruise on the inside of the left arm. not near inject site.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Acne, Back pain, Diarrhoea, Headache, Pain in extremity
Clinical narrative: The client presented to the clinic on 6/24/19 complaining of having a rash that developed after her travel consult appointment Thursday June 20, 2019. I brought the client back to a clinic room and she told me after receiving the Typhoid vaccine at our clinic, the client had a "headache, diarrhea, and arm pain."  The next day she said she developed a rash on her chest and neck. It is comprised of pimple-like, red, raised bumps that she says itch. It has spread up from her neck to her face since Friday. She also had an achy back pain that she rated was a 9 out of ten on a scale of one to ten. She said she still has the pain today and it is a 4 out of ten. She denies having chills,  and did not check her temperature for a fever. She took Ibuprofen as needed. She said it "kinda helped" the pain. She did not describe having any difficulty breathing or swelling of the face or throat. I did not see any redness or swelling at the injection site.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: The client presented to the clinic on 6/24/19 complaining of having a rash that developed after her travel consult appointment Thursday June 20, 2019. I brought the client back to a clinic room and she told me after receiving the Typhoid vaccine at our clinic, the client had a "headache, diarrhea, and arm pain."  The next day she said she developed a rash on her chest and neck. It is comprised of pimple-like, red, raised bumps that she says itch. It has spread up from her neck to her face since Friday. She also had an achy back pain that she rated was a 9 out of ten on a scale of one to ten. She said she still has the pain today and it is a 4 out of ten. She denies having chills,  and did not check her temperature for a fever. She took Ibuprofen as needed. She said it "kinda helped" the pain. She did not describe having any difficulty breathing or swelling of the face or throat. I did not see any redness or swelling at the injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: development of shingles few days after shingrix vaccination
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling hot, Hyperhidrosis, Pallor, Peripheral coldness, Pulse abnormal
Clinical narrative: After receiving the vaccine patient stated that he was hot. He then proceeded to get very pale and sweaty. When the doctor went in the room his pulse was thread.  He was cold, sweaty and he fainted. It took him about 7 min to recover from the episode.  He ate a sucker and was given lemonade as well.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: After receiving the vaccine patient stated that he was hot. He then proceeded to get very pale and sweaty. When the doctor went in the room his pulse was thread.  He was cold, sweaty and he fainted. It took him about 7 min to recover from the episode.  He ate a sucker and was given lemonade as well.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Chills, Discomfort, Fatigue
Clinical narrative: I awakened at 2 am 6.22.19 following the 4 pm injection on 6.21.19.  I was aware of achiness and sweating at that point.  I slept much later than usual and awoke feeling as though I had the flu:  chilling, sweating, body aches, joints hurt, fatigue and lethargy.  This lasted for another 48 hours, with the first 24 hrs by far the worst with fever, etc.  By 6.23.19 at 4 pm, those signs had resolved. I noted prickling, burning, itching and tingling on left scapular area starting 6.23.19 at 12 noon.  This progressed into the evening, making it difficult to sleep for the discomfort.  This continued into today 6.24.19 but to a lesser degree.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypersomnia, Influenza like illness, Insomnia, Lethargy
Clinical narrative: I awakened at 2 am 6.22.19 following the 4 pm injection on 6.21.19.  I was aware of achiness and sweating at that point.  I slept much later than usual and awoke feeling as though I had the flu:  chilling, sweating, body aches, joints hurt, fatigue and lethargy.  This lasted for another 48 hours, with the first 24 hrs by far the worst with fever, etc.  By 6.23.19 at 4 pm, those signs had resolved. I noted prickling, burning, itching and tingling on left scapular area starting 6.23.19 at 12 noon.  This progressed into the evening, making it difficult to sleep for the discomfort.  This continued into today 6.24.19 but to a lesser degree.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: I awakened at 2 am 6.22.19 following the 4 pm injection on 6.21.19.  I was aware of achiness and sweating at that point.  I slept much later than usual and awoke feeling as though I had the flu:  chilling, sweating, body aches, joints hurt, fatigue and lethargy.  This lasted for another 48 hours, with the first 24 hrs by far the worst with fever, etc.  By 6.23.19 at 4 pm, those signs had resolved. I noted prickling, burning, itching and tingling on left scapular area starting 6.23.19 at 12 noon.  This progressed into the evening, making it difficult to sleep for the discomfort.  This continued into today 6.24.19 but to a lesser degree.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Conjunctivitis, Eye pain, Injection site erythema, Pyrexia
Clinical narrative: Slight fever, joint pain 23rd & 24th - subsided late on the 24th Redness at injection site 23, 24, 25 - Tenderness through the 25th.  Left eye is tender (like I was poked) noticed June 24th 2019 approx 3pm Left eye tenderness worsens throughout the day on the 25th and now resembles conjunctivitis but without the itching.  (I have have one case of conjunctivitis in 1985)  I do not recall having any eye infections since then.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Slight fever, joint pain 23rd & 24th - subsided late on the 24th Redness at injection site 23, 24, 25 - Tenderness through the 25th.  Left eye is tender (like I was poked) noticed June 24th 2019 approx 3pm Left eye tenderness worsens throughout the day on the 25th and now resembles conjunctivitis but without the itching.  (I have have one case of conjunctivitis in 1985)  I do not recall having any eye infections since then.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received Shingrix on 6/13/19 she stated that 8 days later a rash appeared  now is beginning to self resolve.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain
Clinical narrative: SEVERE PAIN IN LOWER LEFT BACK AND HIP AREA, PATIENT WENT TO PRIMARY CARE PHYSICIAN FOR TREATMENT
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness
Clinical narrative: Patient described tightening to the throat. Went to the hospital and they gave him a Benadryl. Condition was then reversed. Patient is now fine and no further treatment was needed.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Injection site pain, Mouth swelling
Clinical narrative: Patient described tightening to the throat. Went to the hospital and they gave him a Benadryl. Condition was then reversed. Patient is now fine and no further treatment was needed.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Chest X-ray normal, Febrile convulsion, Respiratory syncytial virus test negative, Urine analysis normal
Clinical narrative: Pt with febrile seizure < 24h post vaccination, TMAX 104.9. No other symptoms at the time of seizure. No cough, no congestion, no emesis, no diarrhea. No clear etiology for high fever.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Pt came in with a large area on deltoid that is red and itchy.  States it didn't appear until a few days after the vaccine.  No mass.  No fever.  No pain.  Advised to watch area and see physician if it doesn't resolve in a couple days or gets worse.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Per patient - She developed a round like quarter size of redness around the injection site 2 days after the shot but no fever nor pain. Today patient happened to shop at our location and just wanted to show us the  reaction. Her right arm has a large patch of redness with  size of  about 6-8 inches x 4-6 inches, running from below the injection site close to her elbow. She said there's no pain and no fever, just feeling warm in the red area. Patient was instructed to take Claritin for allergy and to contact her PCP if the redness changes color or fever.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Fatigue, Headache, Pain, Swollen tongue
Clinical narrative: Patient's main symptom was swelling of the tongue and difficulty swallowing. The patient went to the emergency room for treatment and she was kept overnight for observation. The patient also had head ache, body aches, and was very tired. She stated her tongue swelling had decreased and after about 24 hours, but she was still feeling achy and tired feeling 4 days after vaccination.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Gait disturbance, Joint stiffness, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: First symptoms were typical soreness in affected arm (left). The next day, she experienced stiffness and pain in the left arm and left hip. She stated that she was unable to extend her shoulder past a certain point. Hip pain was also painful to the extent where couldn't walk properly. Went to urgent care and the practitioner had found this was also an adverse effect previously reported by the vaccination. Patient had visited the pharmacy 6/24/19 and states that she is doing better and symptoms are resolving.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: First symptoms were typical soreness in affected arm (left). The next day, she experienced stiffness and pain in the left arm and left hip. She stated that she was unable to extend her shoulder past a certain point. Hip pain was also painful to the extent where couldn't walk properly. Went to urgent care and the practitioner had found this was also an adverse effect previously reported by the vaccination. Patient had visited the pharmacy 6/24/19 and states that she is doing better and symptoms are resolving.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccination site discolouration
Clinical narrative: PATIENT IS STILL  HAVING MINOR MUSCLE PAIN IN AREA OF VACCINATION ALONG WITH SLIGHT DISCOLORATION AROUND THE AREA.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Lymphadenopathy, Muscle tightness
Clinical narrative: DONOR REPORTED JOINT PAIN IN JAW AND SWOLLEN LYMPH GLANDS IN NECK. TIGHTNESS IN NECK AREA. WITH IN 1.5 HRS OF INJECTION.  TRANSPORTED BY EMS TO EMERGENCY ROOM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Night sweats, Pyrexia
Clinical narrative: Patient received vaccination in upper left deltoid on 6/20 at around 3:30pm, evening of 6/21 patient had soreness at injection site and night sweats. 6/22 in the morning patient had a low grade fever, continued regular activities and went for a walk during the day. By the evening patient had a red, hot, sore patch about 2 inches below injection site. Came into pharmacy to report and on 6/25 the patch is about 4x3 inches in size patient said it is still warm to the touch but not as hot as when it first appeared.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Peripheral swelling, Swelling
Clinical narrative: patient reported swelling in the injection arm, located more specially in the bicep region and swelling down the trunk of his torso. patient reported no redness but swelling. patient to this day (06-25-2019) is still experiencing swelling in his arm.