chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced swelling, redness, & warmth at injection site approximately 10.5cm x 14cm.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored vaccine was administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in July 2019 (reported as between 03-JUL-2019 and 29-JUL-2019), the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002393, expiration date 31-JAN-2021 and lot # R035225, expiration date 04-DEC-2020 (dose and route of administration were not reported) for prophylaxis and improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003178, expiration date reported as 31-JUL-2020, but upon internal validation established as 30-JUL-2020 and lot # S008577, expiration date reported as 30-SEP-2020, but upon internal validation established as 16-SEP-2020 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of total time in range -14 degrees Celsius to -10 degrees Celsius (-12.8 degrees Celsius) for 12 hours 3 minutes. There were no previous excursions reported. The data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA000192:
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Vomiting
Clinical narrative: syncope; vomiting; Information has been received from a registered nurse referring to a 13-year-old male patient via the field employee. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapy were not reported.      On 07-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. It was unknown which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series was administered.        After administered the vaccine, on the same day, the patient had syncope which lasted longer than usual. The patient also had vomiting and was treated with crackers and water. These events occurred during office visits and the patient sought for medical attention. The syncope and vomiting were resolved on the same day.   The reporter did not provide causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Upon internal review, the event syncope was considered as medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but it was selected as an adult as per the vaccine indication. The nurse stated that the other patients have reported flu like symptoms after Shingrix, just not to the same severity. The nurse granted permission for safety to follow up. This case has been linked with US2019142314, reported by same reporter.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Chills, Confusional state, Dyspnoea
Clinical narrative: SEVERE SHIVERS (CONVULSIONS), SHORTENED BREATH, CONFUSION
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Middle insomnia
Clinical narrative: extreme tiredness leading to joint pain about 5 hours after injection...patient went to bed and woke up in the middle of the night with a terrible headache
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Muscle spasms, Nausea, Vomiting
Clinical narrative: Initiated vaccine series on 7/25/19, completing on 7/31/19. On 8/5/19 vomited once, felt better afterwards.  On 8/10/19 experienced several hours of stomach ache, nausea and cramps; vomited 8/11/19 at 0200 hrs; followed by several hours of stomach ache. No further symptoms. Denies fever or diarrhea, nor additional possible causative factors. Did not seek medical treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Impaired work ability, Injection site pain, Injection site warmth
Clinical narrative: Chills, feverish feeling but no fever,  severe body aches, joint pain. Upper left arm hot to touch and extremely sore. Arm still sore next day and feeling achy and nauseated. Stayed home from work.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Chills, feverish feeling but no fever,  severe body aches, joint pain. Upper left arm hot to touch and extremely sore. Arm still sore next day and feeling achy and nauseated. Stayed home from work.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Client given 1st dose of Pentacel (ACT-HIB) portion of vaccine mixed with sterile water instead of the Dtap-IPV portion of Pentacel. This would have been her second dose of Dtap-IPV-HIB.  No adverse signs and symptoms noted.  Mother informed of need for client to be re-vaccinated.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Pyrexia, Rash
Clinical narrative: Fever started 10 days after shots. Injection site got red. Fever lasted two day then bumps started to appear 11 days after shots , all over her body. Face, torso, back, arms and legs. Bumps lasted 3-4 days.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Face injury, Fall, Skin abrasion, Skin discolouration, Vomiting
Clinical narrative: Patient was fine in room after vaccines were given He went to bathroom then went to waiting room. He was sitting on table then fell to floor; he hit his face on the rug and had an abrasion on R cheek. He was walked back to exam room. He vomited into trash barrel and immediately said he was feeling better. He laid down on exam table for 15 minutes. His color improved after taking water & crackers. He was discharged to go home.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: body aches, extreme soreness at injection site, chills....lasted for approx 12 hrs
Age: 13.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none anticipated
Age: 10.0
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a 10 year old patient was administered a MMR II vaccine that was reconstituted with expired DILUENT; This spontaneous report as received from a pharmacist refers to a 10-year-old patient of unknown gender.  On 02-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) that was reconstituted with expired sterile diluent(STERILE DILUENT) injection,  lot # N015479, expiration date 23-JUL-2019. There was no adverse effects.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for prevention of shingles and zoster-related conditions by a healthcare provider at medical center. Pt was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. Pt claimed damages as a result of: injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the events was unknown.
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: There were no adverse effects reported; The patient was vaccinated with a expired dose of properly stored of ROTATEQ; This spontaneous report was received from a licensed practical nurse, referring to a 4-months-old female patient. There was not concurrent conditions, medical history, concomitant medications, drug reactions or allergies reported.   On 06-AUG-2019, the patient was vaccinated with an expired dose of properly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis, orally, lot# N030174 and expiration date on 13-JUN-2019 (dose and strength were not reported). There were no adverse effects reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No adverse effect reported; The patient got out of their restraint and movement caused the needle to be dislodged; This spontaneous report was received from a medical assistant regarding a 2 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported. ]  On 09-AUG-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S004091, expiration date 11-FEB-2021 for prophylaxis (strength, dose, frequency, and route of administration was not reported), the vaccine was reconstituted with sterile diluent lot number S008567, expiration date 23-SEP-2021. On the same date, the patient got out of their restraint and the movement caused the needle to be dislodged from the site losing the vaccine on the table. It was not sure how much of the dose the patient actually received (incorrect dose administered). No adverse effect reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post herpetic Neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions or concomitant medications.   On or around 08-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, lot number and expiration date were not reported).  On an unknown date (reported as "shortly after receiving defendant's zoster vaccine live (ZOSTAVAX) vaccine), the patient experienced severe post herpetic neuralgia and severe herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not presented prior to using the product. The patient also experienced mental and emotional distress due to to resulting physical limitations and seriousness of her conditions. As a consequence of the Company´s wrongful conduct, the patient 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 the Company's conduct, the patient had suffered and incurred a damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of post herpetic neuralgia and herpes zoster was not recovered/not resolved. The reporter considered post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Herpes zoster and post herpetic neuralgia were considered to be disabling.  Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; administered VARIVAX and MMR II intramuscularly; This spontaneous report was received from a nurse regarding a 42 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported.  Concomitant medications included sterile diluent.  On 07-AUG-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # S001329, expiration date 14-JAN-2021) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # R035222, expiration date 04-DEC-2020) intramuscularly (dose, dose number and anatomical location were not reported for both vaccines). Both vaccines were administered for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of 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, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient had reported flu-like symptoms that lasted a day, after receiving Shingrix. The physician did not have patient specifics, these were patients that were just generally reporting adverse events. This case linked with US2019AMR142874, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Gait disturbance, Headache, Myalgia, Thirst
Clinical narrative: difficulty walking; sore muscles; burning feeling in spine; headache; extremely thirsty; This case was reported by a pharmacist and described the occurrence of walking difficulty in a female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced walking difficulty, muscle soreness, burning sensation, headache and thirst. On an unknown date, the outcome of the walking difficulty, muscle soreness, burning sensation, headache and thirst were unknown.   It was unknown if the reporter considered the walking difficulty, muscle soreness, burning sensation, headache and thirst to be related to Shingrix.  Additional details were provided as follows: The customer field a claim and its subsidiaries for injuries/ damages sustained resulting from an alleged product hazard arising from a Shingrix product supplied to pharmacy. The age at vaccination was not reported. After the vaccination, the patient had difficulty walking, sore muscles, burning feeling in her spine, headache and was extremely thirsty. The patient received treatment at a hospital twice and was still seeking medical treatment. Based on the above information, this claim was received for further handling and denying liability on behalf of pharmacy and it's subsidiaries. The reporter asked to notify insurer if required.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Vaccine positive rechallenge
Clinical narrative: Malaise; Having trouble getting out of bed; This case was reported by a consumer via call center representative and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on an unknown date, refer case US2019143109).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise and activities of daily living impaired. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the malaise and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the malaise and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received 2nd dose at different pharmacy than the 1st dose and experienced malaise for 3 days. Malaise described as having trouble getting out of bed. The reporter consented to follow up. This case had been linked with case US2019143112 and US2019AMR143602, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The reporter reported that the patient received experienced malaise for approximately 1 day. The reporter consented to follow up. This case was linked with US2019143112, reported by the same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: seizures / prolonged seizures; This case was reported by a other health professional via other manufacturer and described the occurrence of prolonged seizure in a child patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, less than a week after receiving DTaP vaccine, the patient experienced prolonged seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the prolonged seizure was unknown.   It was unknown if the reporter considered the prolonged seizure to be related to DTaP vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have brand name of DTap vaccine. Within 7 days after immunization, the patient experienced prolonged seizures.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Haematoma, Injection site rash, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Swelling; restless arm feeling; hematoma; blotchiness; Injection site rash; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   On 17th July 2019, the patient received Bexsero (intramuscular). On 17th July 2019, less than a day after receiving Bexsero, the patient experienced injection site swelling, restlessness, hematoma, blotchy and injection site rash. On an unknown date, the outcome of the injection site swelling and hematoma were recovering/resolving and the outcome of the restlessness was not recovered/not resolved and the outcome of the blotchy and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, restlessness, hematoma, blotchy and injection site rash to be related to Bexsero.  Additional details were reported as follows: The reporter stated that, the patient's mother informed about swelling in her daughter's arm after the injection and blotchiness at the injection site like a rash. The patient had a restless arm feeling since getting the vaccine. The patient had a hematoma about the size of a golf ball and a little under the injection site.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Restlessness
Clinical narrative: Swelling; restless arm feeling; hematoma; blotchiness; Injection site rash; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   On 17th July 2019, the patient received Bexsero (intramuscular). On 17th July 2019, less than a day after receiving Bexsero, the patient experienced injection site swelling, restlessness, hematoma, blotchy and injection site rash. On an unknown date, the outcome of the injection site swelling and hematoma were recovering/resolving and the outcome of the restlessness was not recovered/not resolved and the outcome of the blotchy and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, restlessness, hematoma, blotchy and injection site rash to be related to Bexsero.  Additional details were reported as follows: The reporter stated that, the patient's mother informed about swelling in her daughter's arm after the injection and blotchiness at the injection site like a rash. The patient had a restless arm feeling since getting the vaccine. The patient had a hematoma about the size of a golf ball and a little under the injection site.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site mass, Injection site reaction, Injection site swelling, Rash macular, Restlessness
Clinical narrative: Swelling; restless arm feeling; hematoma; blotchiness; Injection site rash; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   On 17th July 2019, the patient received Bexsero (intramuscular). On 17th July 2019, less than a day after receiving Bexsero, the patient experienced injection site swelling, restlessness, hematoma, blotchy and injection site rash. On an unknown date, the outcome of the injection site swelling and hematoma were recovering/resolving and the outcome of the restlessness was not recovered/not resolved and the outcome of the blotchy and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, restlessness, hematoma, blotchy and injection site rash to be related to Bexsero.  Additional details were reported as follows: The reporter stated that, the patient's mother informed about swelling in her daughter's arm after the injection and blotchiness at the injection site like a rash. The patient had a restless arm feeling since getting the vaccine. The patient had a hematoma about the size of a golf ball and a little under the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Nausea, Oropharyngeal pain
Clinical narrative: fever; sore throat; stomach ache; sick to the stomach; chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, sore throat, stomach pain, upset stomach and chills. On an unknown date, the outcome of the fever, sore throat, stomach pain, upset stomach and chills were unknown.   It was unknown if the reporter considered the fever, sore throat, stomach pain, upset stomach and chills to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist reporting a patient reported to him that the patient experienced fever, sore throat, stomach ache, being sick to the stomach and chills after receiving a dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; sore throat; stomach ache; sick to the stomach; chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, sore throat, stomach pain, upset stomach and chills. On an unknown date, the outcome of the fever, sore throat, stomach pain, upset stomach and chills were unknown.   It was unknown if the reporter considered the fever, sore throat, stomach pain, upset stomach and chills to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist reporting a patient reported to him that the patient experienced fever, sore throat, stomach ache, being sick to the stomach and chills after receiving a dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pain in extremity, Skin lesion
Clinical narrative: flare up on left forearm-lesions; injection site warmth; tenderness at injection site; This case was reported by a nurse via call center representative and described the occurrence of skin lesion in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced skin lesion, pain in arm and touch sensitivity increased. The patient was treated with acyclovir. On an unknown date, the outcome of the skin lesion was recovered/resolved and the outcome of the pain in arm and touch sensitivity increased were unknown.   It was unknown if the reporter considered the skin lesion, pain in arm and touch sensitivity increased to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who himself was a nurse. The age at vaccination was not reported but the age could be 63 or 64 years. In 2018 a year ago from the date of reporting, the patient received 1st dose of Shingrix in the right arm. A week or two later, there was a flare up on left forearm- lesions, sensitive to touch and painful. The reporter would like to know if he could receive the 2nd dose or could restart the series based off of the flare up. The reporter consented to follow up. This case had been linked to the case US2019142355, reported for the dose 2 of the same patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Feeling abnormal, Gastric disorder, Malaise
Clinical narrative: quite a bit of redness in arm; quite a bit of redness and swelling in arm; stomach problems; fever; malaise; felt bad; achy joint pain; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2019, the patient received the 1st dose of Shingrix. On 3rd August 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, gastric disorder, fever, malaise, feeling bad and joint pain. On an unknown date, the outcome of the erythema of extremities, swelling arm, gastric disorder, malaise, feeling bad and joint pain were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, gastric disorder, fever, malaise, feeling bad and joint pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient's physician suggested her to get the vaccine. The patient received her 1st shot on Saturday before the reporting date and had quite a bit of redness and swelling in arm, stomach problems, fever, malaise, felt bad with achy joint pain. The reporter did not consent to follow-up. The health care professional's (HCP) information was not obtained.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: quite a bit of redness in arm; quite a bit of redness and swelling in arm; stomach problems; fever; malaise; felt bad; achy joint pain; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2019, the patient received the 1st dose of Shingrix. On 3rd August 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, gastric disorder, fever, malaise, feeling bad and joint pain. On an unknown date, the outcome of the erythema of extremities, swelling arm, gastric disorder, malaise, feeling bad and joint pain were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, gastric disorder, fever, malaise, feeling bad and joint pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient's physician suggested her to get the vaccine. The patient received her 1st shot on Saturday before the reporting date and had quite a bit of redness and swelling in arm, stomach problems, fever, malaise, felt bad with achy joint pain. The reporter did not consent to follow-up. The health care professional's (HCP) information was not obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Redness in arm; Hot arm; Itching arm; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th August 2019, 7 days after receiving Shingrix, the patient experienced erythema of extremities, extremities hot feeling of and itchy upper limbs. On an unknown date, the patient experienced pain in arm. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, erythema of extremities, extremities hot feeling of and itchy upper limbs were recovering/resolving.   It was unknown if the reporter considered the pain in arm, erythema of extremities, extremities hot feeling of and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix in left arm. The patient experienced sore arm for about 5 days after receiving the 1st dose of Shingrix vaccine.  On 5th August 2019, the patient experienced red, hot and itchy arm right below the injection site.  The patient applied topical Benadryl and also took a Benadryl. It was now getting better.  The reporter did not consent to follow up. No further details were provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: Malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date. Please refer the US2019AMR143602).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The reporter reported that the patient received experienced malaise for approximately 1 day. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Mobility decreased
Clinical narrative: Malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date. Please refer the US2019AMR143602).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The reporter reported that the patient received experienced malaise for approximately 1 day. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: Malaise; Having trouble getting out of bed; This case was reported by a consumer via call center representative and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise and activities of daily living impaired. On an unknown date, the outcome of the malaise and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the malaise and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received 1st dose at different pharmacy than the 2nd dose and experienced malaise for approximately 2 days. Malaise described as having trouble getting out of bed. The reporter consented to follow up. This case had been linked with case US2019143112 and US2019AMR143602, reported by the same reporter for her husband and for tolerance of 2nd dose, refer case US2019AMR143589.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Mobility decreased
Clinical narrative: Malaise; Having trouble getting out of bed; This case was reported by a consumer via call center representative and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise and activities of daily living impaired. On an unknown date, the outcome of the malaise and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the malaise and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received 1st dose at different pharmacy than the 2nd dose and experienced malaise for approximately 2 days. Malaise described as having trouble getting out of bed. The reporter consented to follow up. This case had been linked with case US2019143112 and US2019AMR143602, reported by the same reporter for her husband and for tolerance of 2nd dose, refer case US2019AMR143589.
Age: 77.0
Sex: M
Vaccine: 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 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received the 1st dose of Shingrix. On 22nd July 2019, 3 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: This case was reported by the patient himself. The patient received the diagnosis of shingles. Emergency room visit was required. The reporter stated that the letter from safety could be mailed to his house as he was not sure if he wanted his doctor to receive it. The outcome reported for the event in the structured field is "recovering/ resolving " instead of "not recovered/ not resolved" (outcome uploaded).
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Given at 9AM DTAP to the right thigh noted small amount  of redness to the site. Called mom to check on her at 10AM and she stated more redness and swelling she came back to the clinic noted site reaction to rt leg 5 x 8 cm gave Benadryl PO & Prednisole at 2 pm mom stated much better on 8/14/2019 1 am started resolved
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Discomfort, Grip strength decreased, Impaired work ability, Injected limb mobility decreased
Clinical narrative: Patient seen on 8/14/2019 for persistent left arm pain since shortly after vaccination. Patient states around 11:45 am she started having  left upper arm pain which quickly spread up into the shoulder and down the whole arm to the fingertips. She describes it as a very severe pain, "fiery/ burning" pain.  a "complex" pain that is hard to describe. She was unable to continue working and had to be driven home.  She was unable to work the following day, and tried working the next day but could only work half the day. She had pain with any movement. Could not get comfortable sleeping . Ibuprofen did not help much. Ice / heat did not help. Intense pain started to recede from the fingers upward over that weekend (Shot was on a Wednesday). She still has pain at rest 3 weeks later above the elbow to the shoulder, and states she has some loss of range of motion of the arm , some weakness in the hand, and some left upper neck/back pain.  On exam she has normal range of motion of hands, wrists, elbow . Starting with passive range of motion abduction left shoulder was at least above 90 deg.  She then was able to do at least to 90 deg. with active ROM with some discomfort. There was never any redness, swelling, or pain to touch she states.  Nontender on exam, and no redness, swelling or skin changes. Grip strength on left was slightly decreased, otherwise had normal exam (except full range of motion left shoulder not tested.) . PT / OT offered, but she'll try stretching at home, and call in a week if not getting better.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscular weakness, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient seen on 8/14/2019 for persistent left arm pain since shortly after vaccination. Patient states around 11:45 am she started having  left upper arm pain which quickly spread up into the shoulder and down the whole arm to the fingertips. She describes it as a very severe pain, "fiery/ burning" pain.  a "complex" pain that is hard to describe. She was unable to continue working and had to be driven home.  She was unable to work the following day, and tried working the next day but could only work half the day. She had pain with any movement. Could not get comfortable sleeping . Ibuprofen did not help much. Ice / heat did not help. Intense pain started to recede from the fingers upward over that weekend (Shot was on a Wednesday). She still has pain at rest 3 weeks later above the elbow to the shoulder, and states she has some loss of range of motion of the arm , some weakness in the hand, and some left upper neck/back pain.  On exam she has normal range of motion of hands, wrists, elbow . Starting with passive range of motion abduction left shoulder was at least above 90 deg.  She then was able to do at least to 90 deg. with active ROM with some discomfort. There was never any redness, swelling, or pain to touch she states.  Nontender on exam, and no redness, swelling or skin changes. Grip strength on left was slightly decreased, otherwise had normal exam (except full range of motion left shoulder not tested.) . PT / OT offered, but she'll try stretching at home, and call in a week if not getting better.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Drug hypersensitivity, Eye swelling, Gingival swelling, Headache, Injection site erythema
Clinical narrative: Teen reported to Mother that she had a headache, and that her right eye  and right side of her lips were swelling at about 11:00am  (Mother thought this was due to nerves because of it being the first day of school), then the next morning teen  reported that  She also had a cold sore in her mouth.  Then on 08/13/2019, the school nurse called Mom reporting that the teen had a swollen left jaw and that she had swollen gums on the left side of her mouth. Was not sure if she had wisdom teeth trying to come in or a gum infection. After work (10pm) on 08/13/2019, teen reported to her Mom that her Right arm had been tingling and painful with a red swollen area over lower right deltoid and that the tingling had been happening since Monday but she forgot to tell her . This is when they went to the E.R. E.R. MD treated teen for a medication allergy and then released her to home. Client reports that she is having no symptoms at this time.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site swelling, Lip swelling, Oral herpes, Pain in extremity, Paraesthesia
Clinical narrative: Teen reported to Mother that she had a headache, and that her right eye  and right side of her lips were swelling at about 11:00am  (Mother thought this was due to nerves because of it being the first day of school), then the next morning teen  reported that  She also had a cold sore in her mouth.  Then on 08/13/2019, the school nurse called Mom reporting that the teen had a swollen left jaw and that she had swollen gums on the left side of her mouth. Was not sure if she had wisdom teeth trying to come in or a gum infection. After work (10pm) on 08/13/2019, teen reported to her Mom that her Right arm had been tingling and painful with a red swollen area over lower right deltoid and that the tingling had been happening since Monday but she forgot to tell her . This is when they went to the E.R. E.R. MD treated teen for a medication allergy and then released her to home. Client reports that she is having no symptoms at this time.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Swelling face
Clinical narrative: Teen reported to Mother that she had a headache, and that her right eye  and right side of her lips were swelling at about 11:00am  (Mother thought this was due to nerves because of it being the first day of school), then the next morning teen  reported that  She also had a cold sore in her mouth.  Then on 08/13/2019, the school nurse called Mom reporting that the teen had a swollen left jaw and that she had swollen gums on the left side of her mouth. Was not sure if she had wisdom teeth trying to come in or a gum infection. After work (10pm) on 08/13/2019, teen reported to her Mom that her Right arm had been tingling and painful with a red swollen area over lower right deltoid and that the tingling had been happening since Monday but she forgot to tell her . This is when they went to the E.R. E.R. MD treated teen for a medication allergy and then released her to home. Client reports that she is having no symptoms at this time.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient's mother, notified Health Services on 8/14/19 at 10:00 am regarding adverse reaction to immunization.  Patient's daughter complains of Left Arm hurting  after shots, but Mother did not notice redness and swelling to left upper arm until 8/14/19. Mother reports symptoms of red, hot, knot on left arm.  Provider explained to mother that child is most likely having a localized adverse reaction .  Mother denies child having fever, shortness of breath, or any other acute/emergency symptoms. Provider recommended to mother to  take her daughter to a doctor for further evaluation if symptoms become worse or that she may follow up with clinic with further concerns as needed.  Mother was able to verbalize understanding to all the above and denies further concerns at this time. Provider informed mother that the injection given into the left arm was the Kinrix, a combo vaccine for Dtap and IPV.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Pain in extremity
Clinical narrative: Patient's mother, notified Health Services on 8/14/19 at 10:00 am regarding adverse reaction to immunization.  Patient's daughter complains of Left Arm hurting  after shots, but Mother did not notice redness and swelling to left upper arm until 8/14/19. Mother reports symptoms of red, hot, knot on left arm.  Provider explained to mother that child is most likely having a localized adverse reaction .  Mother denies child having fever, shortness of breath, or any other acute/emergency symptoms. Provider recommended to mother to  take her daughter to a doctor for further evaluation if symptoms become worse or that she may follow up with clinic with further concerns as needed.  Mother was able to verbalize understanding to all the above and denies further concerns at this time. Provider informed mother that the injection given into the left arm was the Kinrix, a combo vaccine for Dtap and IPV.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Patient vomited after vaccination, he was fully alert the entire time.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; This spontaneous report as received from a physician via a company representative refers to a 75-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-JUL-2019, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot number: S00258, expiration date: 10-AUG-2020, dose and route of administration were not reported) in the left arm.  On 12-JUL-2019 (reported as on the same day), the patient developed redness, swelling and pain from the elbow to her upper arm. She sought medical attention. Lab diagnostics and studies were not performed. The patient was treated with diphenhydramine (BENADRYL), loratadine (CLARITIN) 10 mg and prednisone ice for pain. She recovered on an unknown day in 2019.  The relatedness between the events and the vaccine was not reported.