chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient reports that she got the first Shingrix vaccine Friday Sept 13, 2019 around 2pm, and around 10pm suddenly got cold, "felt like I had the flu" - no energy, whole body ached, had a headache; she's not sure if she had a temp, did not check; the last symptom to resolve was the headache, which was gone around 5pm on Saturday the 14th. No N/V. She also had soreness at the injection site. She did have 3 allergy shots around noon that day, 2 in right arm, 1 in left; the Shingrix was given in the left deltoid.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Pt reports rash, swelling of the (L) upper arm 14 days after the 2nd vaccine. Used OTC NSAIDS + Benedryl. Feeling better now.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Drooling, Herpes zoster, Impaired work ability, Sensory loss
Clinical narrative: Later that night after patient received shingrix, she couldn't feel her face and started drooling. She woke up the next morning and couldn't feel anything. She ended up in the hospital the following day.  She also reports that she ended up with shingles, but she's not sure if this was from vaccine or if it was already in her body. She has missed 2 months of work.  2 months later she is slightly better but not 100%.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Exposure during pregnancy, Induration, Musculoskeletal stiffness, Neck pain
Clinical narrative: At the time of reaction, I was 10 weeks and 4 days pregnant, estimated deliver April 6, 2020.  Around 30 minutes after the shot, my arm became extremely swollen, red, itchy, and hard.  Around 6-7 hours later, my neck became extremely stiff and painful.  The pain was localized in my spine from between my shoulder blades up to the base of my head.  I could not move my neck or sit up because the pain and stiffness were so awful.  I continued to have these symptoms for two days.  On the third day (Monday September 18, 2019), the swelling mostly subsided and the redness disappeared.  The hardness on my arm was still present.  The stiffness in my neck went away at this point, but I am still currently experienced some pain in my neck.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling, Pruritus, Spinal pain
Clinical narrative: At the time of reaction, I was 10 weeks and 4 days pregnant, estimated deliver April 6, 2020.  Around 30 minutes after the shot, my arm became extremely swollen, red, itchy, and hard.  Around 6-7 hours later, my neck became extremely stiff and painful.  The pain was localized in my spine from between my shoulder blades up to the base of my head.  I could not move my neck or sit up because the pain and stiffness were so awful.  I continued to have these symptoms for two days.  On the third day (Monday September 18, 2019), the swelling mostly subsided and the redness disappeared.  The hardness on my arm was still present.  The stiffness in my neck went away at this point, but I am still currently experienced some pain in my neck.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Influenza like illness, Insomnia, Lethargy
Clinical narrative: ROUGHLY 8 HRS POST INJECTION, SORE SHOULDER.  12 HRS POST INJECTION ACHY FLU-LIKE SYMPTOMS BACK, LOWER BACK, BOTH SHOULDERS, CHILLS, SHAKING, NO FEVER, GENERAL MALAISE.   IBUPROFEN HELPED SOME BUT AWAKE MUCH OF THE NIGHT.  MASSAGER IN THE MORNING HELPED SOME WITH MUSCULAR SORENESS BUT STILL FEEL LETHARGIC WITH SYMPTOMS.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal pain, Tremor
Clinical narrative: ROUGHLY 8 HRS POST INJECTION, SORE SHOULDER.  12 HRS POST INJECTION ACHY FLU-LIKE SYMPTOMS BACK, LOWER BACK, BOTH SHOULDERS, CHILLS, SHAKING, NO FEVER, GENERAL MALAISE.   IBUPROFEN HELPED SOME BUT AWAKE MUCH OF THE NIGHT.  MASSAGER IN THE MORNING HELPED SOME WITH MUSCULAR SORENESS BUT STILL FEEL LETHARGIC WITH SYMPTOMS.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever, shivering, chills, unwell feeling
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Impaired work ability, Skin warm, Swelling
Clinical narrative: redness, swelling, warmth, felt bad enough to leave work, saw pcp diagnosed with cellulitis, prescribed cephalexin
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Flatulence, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: +nausea, +feeling gassy, +runny nose +left throat itchiness/irritated +dry cough, +itchy/painful left upper arm, left upper arm swelling - these symptoms started after the shot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Rhinorrhoea, Throat irritation
Clinical narrative: +nausea, +feeling gassy, +runny nose +left throat itchiness/irritated +dry cough, +itchy/painful left upper arm, left upper arm swelling - these symptoms started after the shot.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Urticaria
Clinical narrative: Hives only .  Local site reaction.  Red, swollen and warm to touch.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No known events at this time Possible fever could happen
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Dyspnoea, Vaccine positive rechallenge, Wheezing
Clinical narrative: After both injections I developed wheezing and shortness of breath which led to chest x-rays at Urgent Care.  Doctor prescribed fluticasone HFA 110 MCG/ACT Inhaler.  I was still on the inhaler when I had the second vaccination, so symptoms did not show up until after I ran out of the prescription.  Before I got a refill (delayed in the mail) the symptoms became extremely severe.  Treatment for that visit was as follows: 2 AIRWAYINHALATION TREATMENT Procedures   ALBUTEROL SULFATE .O83% INJ Immunization/Injection,  ALBUTEROL SULFATE .O83% INJ Immunization/Injection
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Pain, Peripheral swelling, Rash
Clinical narrative: Vaccines administered 9/10/19 at 3PM. Morning of 9/11/19, inside of left arm pink, by early afternoon of 9/11/19, arm swelling, more pink & worse. Pain about 7 out of 10. Felt hard (approx 4PM) Dr visit on 9/12/19. Prescribed prednisone 20mg Q AM x 5 days, plus hydroxyzine 25mg Q12° for rash. On 9/13/19 redness swelling improved Cleared by 9/16/19
Age: 37.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Patient reported that the flu shot was given too high on the arm causing shoulder pain. She reports shoulder pain all night, numbness and tingling in the arm down to the fingers
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eyelid rash, Rash
Clinical narrative: Bumps appeared on back, chest, right ear, and right eye 09/17/2019
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Herpes zoster, Rash
Clinical narrative: mottle skin and welts; an unspecified illness; lab work done to determine immunity to chicken pox and was found to have low titers; mottle skin and welts; shingles rash; This spontaneous report was received from a nurse practitioner referring to a 3 years old male patient. The patient's drug reaction/allergies included several unspecified antibiotics and "Zith". The patient had no concomitant medications.  On an unknown date (reported as at 3 years old age), the patient received varicella virus vaccine live (oka/merck) (VARIVAX) with sterile diluent (MERCK STERILE DILUENT) (both dose, unit, lot#, and expiration date were not reported), subcutaneously for prophylaxis. A few days later, he developed a shingles rash and was treated with diphenhydramine hydrochloride (BENADRYL). The second dose of varicella virus vaccine live (oka/merck) (VARIVAX) was not given due to the shingles rash.  On an unspecified date, the patient also developed mottle skin and welts after taking azithromycin in elementary school for an unspecified illness. He had had similar skin reactions to several other unspecified antibiotics in his childhood. The reporter did not know any lot number or expiration information or the manufacturer of either product due to how long ago these reactions occurred. The patient had lab work done to determine immunity to chicken pox for his Program and was found to have low titers. In order to continue in his program, he would need another dose of varicella virus vaccine live (oka/merck) (VARIVAX). The outcome of all events was reported as recovered. The causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: She received her first dose of the GARDASIL 9 series on 10-AUG-2019, and shortly after she found out she was pregnant/she thinks he pregnancy gestation is about one week; This spontaneous prospective pregnancy report was received from a a female patient of unknown age, who was reporting on herself. The patient's concomitant therapies included an unspecified hepatitis a virus vaccine.  The patient had no pertinent medical history or drug reactions/allergies.  On 19-AUG-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1.5 milliliter for prophylaxis (route of administration, anatomical location, lot number and expiration date were not provided).   The patient's estimated date of LMP (last menstrual period) was 19-AUG-2019. On approximately 05-SEP-2019 (reported as "about one week"), the patient became pregnant with EDD (estimated date of delivery) of 28-MAY-2020. On 09-SEP-2019, she patient carried out a pregnancy test, which result was positive. No treatment was given and the patient did not seek medical attention.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: trigeminal herpes zoster; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician office for trigeminal herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Injection site vesicles
Clinical narrative: bubble at injection site; This spontaneous report was received from a pharmacist via vaccine employee regarding a patient of unknown demographics. Information on patient's pertinent medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2018 (over one year ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) in the deltoid via intramuscularly (dose, strength, lot #, expiry date unknown) for prophylaxis (the pharmacist did not remember which product it was). On an unknown date, the patient developed a bubble at the injection site (injection site reaction). The outcome of injection site reaction was unknown. Causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Vaccine positive rechallenge
Clinical narrative: rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of rash erythematous (1st dose received on 10th July 2019, refer case US2019AMR166975).   On 10th September 2019, the patient received the 2nd dose of Shingrix. On 10th September 2019, less than a day after receiving Shingrix, the patient experienced red rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. within 24 hours the patient had the same exact side effect.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: numbness in right arm; tingling in right arm; Limb mobility decreased; This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced numbness of upper extremities, tingling of extremity and mobility decreased. On an unknown date, the outcome of the numbness of upper extremities, tingling of extremity and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the numbness of upper extremities, tingling of extremity and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient experienced numbness and tingling in his right arm to where he cannot raise his hand fully. The events were ongoing. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: Patient developed headache, sore throat, body aches, and significant redness of eyes a few hours after receiving the high dose flu vaccine. Patient was treated at outpatient clinic and it was recommended that patient take otc antihistamine.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient described pain as severe at the time on injection and followed up a week later with pain in arm that was only a little better
Age: 69.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Per patient - she noticed some itching of her right arm the day following her vaccine then it proceeded to get red and have some warmth to her right arm exclusively.  She said she applied some cortisone to control the affected area.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Dysstasia, Fatigue
Clinical narrative: between half hour and hour after getting first shingrix vial kit I experienced such exhaustion, weakness  and dizziness I have never felt before.  I sat down before I fell, I was that dizzy.  I also experienced slight breathlessness but that didn't last as long as the extreme weakness, exhaustion and dizziness.  It lasted a couple hours before I was able to stand up.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Loss of consciousness, Nausea
Clinical narrative: Patient received a routine blood draw (fasting) and immunization with MMR at aprox 0940 on date of incident. Patient described feeling  nauseous, sat down, and doesn't remember anything until being woken up by medical staff asking how he was doing. No difficulty breathing, normal heart rate, lungs clear to auscultation. Vitals steadily increased over time. Pt had not eaten breakfast. Pt was given water and banana, oxygen via nasal cannula. Discharged after 20 minutes to place of work, with improved symptoms.   Vitals at 0948: Pulse 59,, weak; 16 breaths per minute, shallow, BP: 98/78; Vitals at 1008: Pulse 72, Breaths 14 per minute; BP: 122/90, Temp: 97.7
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Patient broke out with rash on left torso. Rash was painful and contained blisters. Diagnosed as shingles outbreak by visit to primary care physician. Patient was given prescription for Valacyclovir 1000 mg to be taken 3 times per day for the next 7 days.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Hives and rash with pruritus. Went to ED x2 on 9/14 and 9/15 reportedly received steroid injection and prescribed prednisone, famotidine, and diphenhydramine. Came to office on 9/17/19 for f/u with ongoing sx. Steroid course extended, added cetirizine. No sx of anaphylaxis.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Decreased appetite, Hot flush, Night sweats, Pain
Clinical narrative: concerns regarding sx's of "clammy, waves of hot flashes, night sweats, achy and no appetite". She has low grade fever of 99.6.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: concerns regarding sx's of "clammy, waves of hot flashes, night sweats, achy and no appetite". She has low grade fever of 99.6.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Feeling abnormal, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Within a half an hour after injection, Patient complained that the left side of his tongue was numb and tingly and he felt off. It last an hour.   July 12, 2004 Patient had a polio, lot # O340N within several hours of injection his whole leg blew up and he was inconsolable for over an hour, with high pitch screams.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Inappropriate schedule of product administration, Nausea, Pain
Clinical narrative: Employee came in the next morning for work and stated he was feeling nausea, chills, and body aches. He states he  had not eaten this date, and was given oral fluids and crackers. VS were obtained and found to be normal for the individual. He states this made him feel some better. After speaking with Agency, employee states he has previously had the Hep B vaccination with his prior job site. These were giving to him in May 2019, and June 2019. This was not disclosed to the center at the time the employee signed his consent for immunization. Employee left early  and Medical supervisor will follow up with employee by close of business today.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Rash, Sensitive skin
Clinical narrative: Friday 9/13/19 woke up in AM torso was covered in a Rash. not itchy - PT had Fever (didn't take temp) Skin was sensitive had a bad headache. on Sunday Rash was gone. Headache gone on SAT. 9/14. Patient recovered.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient stated that she had pain, numbness and tingling of fingers and left arm, due to flu shot. Possibly given too high in the deltoid. Denies any redness, fever or chills.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray normal, Chills, Influenza virus test negative, Pyrexia, Rash
Clinical narrative: Fever, Chills and bumps and Tylenol was give at the ER
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative
Clinical narrative: Fever, Chills and bumps and Tylenol was give at the ER
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received Shingrix. On 10th September 2019, 1 hr after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovering/resolving.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The reporter stated that the patient experienced shoulder pain. On the day of reporting the reporter called for treatment recommendations but was referred to a Healthcare provider. The reporter noted that the pain had gotten worse over the night. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Too many side effect; This case was reported by a consumer and described the occurrence of adverse reaction in a adult 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. It was reported that the patient would never get the Shingrix shot again too many side effect started the moment the patient received the Shingrix shot 1.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a nurse via sales rep 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 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 received as follows: The age at vaccination was not was reported. The age group selected as per vaccine specification.  The patient reported flu like symptoms after receiving a dose of shingrix. This case was linked with cases US2019AMR165394 and US2019AMR165395, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a nurse via sales rep 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 the 1st dose of Shingrix. On an unknown date, unknown 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 received as follows: The age at vaccination was not was reported. The age group selected as per vaccine specification.  The patient reported flu like symptoms after receiving a dose of shingrix. This case was linked with cases US2019AMR165394 and US2019AMR165390, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Tiredness; Feeling Weak; This case was reported by a other health professional via interactive digital media and described the occurrence of tiredness 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, less than 2 years after receiving Shingrix, the patient experienced tiredness and feelings of weakness. On an unknown date, the outcome of the tiredness and feelings of weakness were recovered/resolved.   It was unknown if the reporter considered the tiredness and feelings of weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction to the shinrix vaccine which has lasted over 3 weeks. The patient had a reaction to shinrix in the form of tiredness feeling weak at times.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: Wrong Route of Administration; redness at injection site; tenderness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number K1T3C2 ?, expiry date 5th December 2021) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 4th September 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In September 2019, the patient experienced injection site erythema and injection site tenderness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site erythema and injection site tenderness were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The reported batch number was not available in sales data sheet, hence it was captured as  K1T3C2 ?. The pharmacist reported that a 66 year old female received the initial dose of Shingrix subcutaneously and experienced redness and tenderness at the injection site, which led to intramuscular formulation administered by other route.  The patient took Tylenol and the redness and tenderness had resolved.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats
Clinical narrative: Night Sweats; This case was reported by a consumer via call center representative and described the occurrence of night sweat in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, 1 days after receiving Shingrix, the patient experienced night sweat. On an unknown date, the outcome of the night sweat was not recovered/not resolved.   It was unknown if the reporter considered the night sweat to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient stated the day after vaccination he experienced night sweats, and he was still experiencing night sweats. No further details were provided. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2019, the patient received the 2nd dose of Shingrix. On 9th September 2019, 1 days after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on left arm. The patient received the second dose of the Shingrix vaccine and, after about 24 hours, on day of reporting she started to experienced chills. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Inappropriate schedule of product administration, Pyrexia, Rash macular
Clinical narrative: Inappropriate Schedule of Vaccine; Swelling; Blotchy Extremeties; Redness/redness occurred on face downward to neck/arm redness; Fever/feeling feverish; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 21st February 2019, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema and feeling hot. On 22nd February 2019, the patient experienced swelling and blotchy. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the erythema, feeling hot, swelling and blotchy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the erythema, feeling hot, swelling and blotchy to be related to Shingrix.  Additional details were received as follows:  The patient received Shingrix in right arm . At physician's office and was debating whether or not to receive 2nd dose 2 to6 month window expired. This led to incomplete course of vaccination.  The reporter reported that, approximately 2 days following vaccination redness occurred on face downward to neck.  That evening caller reports feeling feverish, and after waking the next morning reports swelling along with redness on face that last a couple days. Lastly, caller reports extremities, mostly arms, were blotchy and red for several days. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Inappropriate Schedule of Vaccine; Swelling; Blotchy Extremeties; Redness/redness occurred on face downward to neck/arm redness; Fever/feeling feverish; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 21st February 2019, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema and feeling hot. On 22nd February 2019, the patient experienced swelling and blotchy. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the erythema, feeling hot, swelling and blotchy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the erythema, feeling hot, swelling and blotchy to be related to Shingrix.  Additional details were received as follows:  The patient received Shingrix in right arm . At physician's office and was debating whether or not to receive 2nd dose 2 to6 month window expired. This led to incomplete course of vaccination.  The reporter reported that, approximately 2 days following vaccination redness occurred on face downward to neck.  That evening caller reports feeling feverish, and after waking the next morning reports swelling along with redness on face that last a couple days. Lastly, caller reports extremities, mostly arms, were blotchy and red for several days. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Fatigue, Musculoskeletal pain
Clinical narrative: Shoulder pain; So tired and didn't want to do anything/Laid in bed; Extra doses administered; Extra doses administered; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2 doses in last year from the reporting date ).   In April 2019, the patient received the 3rd dose of Shingrix (intramuscular). In September 2019, the patient received the 4th dose of Shingrix. In April 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered. In September 2019, the patient experienced shoulder pain, tiredness and extra dose administered. On an unknown date, the outcome of the shoulder pain, tiredness, extra dose administered and extra dose administered were unknown.   It was unknown if the reporter considered the shoulder pain and tiredness to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported. The patient again received both doses of Shingrix this year, which led to extra dose administered. The reporter couldn't remember the dates of her first injections last year, however, she received one dose this past week and then five months prior she received the other dose.  When the reporter inquired if she remembered the dates of the vaccination from last year, she stated that she was losing her memory a little and couldn't remember.  She also reported that after the second dose of the Shingrix this year, she laid in bed the next day from shoulder pain and she was in bed all day and was so tired and she didn't want to do anything but then the issues resolved.   The reporter consented to follow up. The patient requested to remain anonymous.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oropharyngeal pain, Pain
Clinical narrative: Injection Site Swelling; Injection Site Redness; Heat at the Injection Site; Feel achy; Low grade fever; Sore Throat; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On 11th September 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but may be between 82 or 83 years. The reporter stated that, the patient experienced swelling, redness, and heat at the injection site. The patient also felt achy, had a low grade fever, and a sore throat. The reporter stated that, the patient at the time of reporting was having these symptoms. The reporter was unable to obtain additional details because her mother was not with her at the time of reporting. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection Site Swelling; Injection Site Redness; Heat at the Injection Site; Feel achy; Low grade fever; Sore Throat; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On 11th September 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but may be between 82 or 83 years. The reporter stated that, the patient experienced swelling, redness, and heat at the injection site. The patient also felt achy, had a low grade fever, and a sore throat. The reporter stated that, the patient at the time of reporting was having these symptoms. The reporter was unable to obtain additional details because her mother was not with her at the time of reporting. This case is 1 of the 2 linked cases, reported by the same reporter.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reports persistent radiating pain down left arm to fingers starting 09/13/19 after receiving vaccine on 09/10/2019
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity, Local reaction, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: Local Allergic Reaction. 3" diameter circle rash with stiffness, swelling, and pain.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: Local Allergic Reaction. 3" diameter circle rash with stiffness, swelling, and pain.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient was injected into left bursa and has ongoing pain since injection
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Right arm of patient where she received the pneumovax 23 showing erythema and swelling of the lower arm near elbow. No redness or swelling at the injection site. Per patient, the swelling has gone down in the past 2 days.  I advised patient to keep monitoring the symptoms and see her primary care provider. I will also check with patient in the next couple of days to monitor her symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm of patient where she received the pneumovax 23 showing erythema and swelling of the lower arm near elbow. No redness or swelling at the injection site. Per patient, the swelling has gone down in the past 2 days.  I advised patient to keep monitoring the symptoms and see her primary care provider. I will also check with patient in the next couple of days to monitor her symptoms.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: patient developed fevers, chills myalgia headache fatigue
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Erythema, Feeling cold, Feeling hot, Pruritus
Clinical narrative: Patient was very cold, couldn't get warm.  Around midnight felt like she had a very high fever.  Blood pressure went to around 198/108 with HR of 100.  Patient cycled through hot and cold.  Next day the upper part of her arm was red.  Two days later the redness has subsided but remains itchy. Contacted medical doctor who said that was a normal reaction and that she would be fine.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient was very cold, couldn't get warm.  Around midnight felt like she had a very high fever.  Blood pressure went to around 198/108 with HR of 100.  Patient cycled through hot and cold.  Next day the upper part of her arm was red.  Two days later the redness has subsided but remains itchy. Contacted medical doctor who said that was a normal reaction and that she would be fine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Skin red esa and inflamation
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pallor, Injection site swelling
Clinical narrative: Patient state she had a white color bump 1cm away from injection site.  She states over the weekend there was red swelling with a white hard bump in the middle of the swollen area.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Induration, Skin discolouration, Swelling
Clinical narrative: Patient state she had a white color bump 1cm away from injection site.  She states over the weekend there was red swelling with a white hard bump in the middle of the swollen area.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Palpitations
Clinical narrative: Constant palpitations
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Suspected Localized Cellulitis Of Upper Left Extremity 14cm X 14.5cm - Patient placed on Augmentin
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: Event started with chills and fever, progressed to nausea, loss of appetite, and exhaustion. I slept for 11 hours and woke with a headache and brain fog. Appetite did not return until early afternoon. Continue to be tired on 2nd day.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Event started with chills and fever, progressed to nausea, loss of appetite, and exhaustion. I slept for 11 hours and woke with a headache and brain fog. Appetite did not return until early afternoon. Continue to be tired on 2nd day.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: Patient received trumenba vaccination on 09/12/2019 and said soon after vaccination she developed a headache and low grade fever.  ER on Monday 9/16 with a headache with a pain 10/10 unrelieved with acetaminophen, ibuprofen as well as a family members oxycodone. In the ED  medication received was  diphenhydrAMINE (BENADRYL) tablet 25 mg,metoclopramide (REGLAN) tablet 10 mg , naproxen (NAPROSYN) tablet 500 mg and butalbital-acetaminophen-caffeine (FIORICET,ESGIC) 50-325-40 mg per tablet 1 tablet. Discharge home with rx for naproxen and to follow up with PCP. Fever has resolved she came back to the office on 09/18/2019 and said she still has a consistent headache.
Age: 16.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Dyskinesia, Headache, Malaise, Moaning, Muscle twitching
Clinical narrative: Mom reports in the early afternoon following his morning vaccines listed above, patient began complaining of headache, nausea and malaise so he went to his room to lay down.  She heard him making strange noises, so she went to check on him.   He was laying on his bed moaning with b/l arms flexing and extending at elbows and shoulders shrugging - she spoke to him and he was awake and able to respond, so she went to him and held him and his arms stopped moving.  She reports his arms were moving for ~1 minute while she was there but was unsure how long they'd been moving prior to her entering the room.  She asked him if he was moving his arms because his head hurt, and he denied moving his arms intentionally.  He complained it felt like someone was "kicking him in the head," and indicated his forehead.  She noted his temperature was 100.8 at this time.  She reports she gave him ibuprofen prior to the episode listed above, but timing is not quite clear.  Mom put a cool cloth on his forehead, his fever came down and he was able to sleep a bit throughout the night.  He continues to have b/l upper arm and shoulder twitching that is involuntary.  He still has headache this morning, but it is less severe.    Patient reports headache last night was 8/10, today is 4/10.
Age: 16.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Nausea, Pyrexia
Clinical narrative: Mom reports in the early afternoon following his morning vaccines listed above, patient began complaining of headache, nausea and malaise so he went to his room to lay down.  She heard him making strange noises, so she went to check on him.   He was laying on his bed moaning with b/l arms flexing and extending at elbows and shoulders shrugging - she spoke to him and he was awake and able to respond, so she went to him and held him and his arms stopped moving.  She reports his arms were moving for ~1 minute while she was there but was unsure how long they'd been moving prior to her entering the room.  She asked him if he was moving his arms because his head hurt, and he denied moving his arms intentionally.  He complained it felt like someone was "kicking him in the head," and indicated his forehead.  She noted his temperature was 100.8 at this time.  She reports she gave him ibuprofen prior to the episode listed above, but timing is not quite clear.  Mom put a cool cloth on his forehead, his fever came down and he was able to sleep a bit throughout the night.  He continues to have b/l upper arm and shoulder twitching that is involuntary.  He still has headache this morning, but it is less severe.    Patient reports headache last night was 8/10, today is 4/10.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Influenza like illness, Oropharyngeal pain, Pain in extremity
Clinical narrative: L arm sore and swollen,  flu-like symptoms, fever, chills, sore throat, runny nose, sinus pain. Missed 2 days of  work after vaccination.  Feeling better by 5 days after vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Rhinorrhoea, Sinus pain
Clinical narrative: L arm sore and swollen,  flu-like symptoms, fever, chills, sore throat, runny nose, sinus pain. Missed 2 days of  work after vaccination.  Feeling better by 5 days after vaccination.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Decreased eye contact, Dysuria
Clinical narrative: 1. Baby stopped making eye contact with people 2. Stopped smiling 3. Erections ceased 4.  Stopped reacting to things such as toys, peek-a-boo, tv 5. Didn't urinate for over 12 hours (this happened 2 times in in the 2 days following the vaccination)
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea
Clinical narrative: Nausea and headache within 5 minutes of vaccine administration.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Anal incontinence, Aphonia, Dermatitis diaper, Dysphagia, Eczema
Clinical narrative: 1. Cease of cooing/screaming/"talking"  2. Cries no longer a strong vocals; instead it's now a low grunt 3. Constantly has feces in diaper from the pressure of the low grunts  4. Extreme diaper rash; raw skin 5. Loss of fine motor skills 6. Loss of erections 7. No longer able to swallow solid foods.  Now pushes food out with tongue instead of swallowing. 8. Eczema rash all over torso
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Erectile dysfunction, Fine motor skill dysfunction, Grunting, Rash, Skin erosion
Clinical narrative: 1. Cease of cooing/screaming/"talking"  2. Cries no longer a strong vocals; instead it's now a low grunt 3. Constantly has feces in diaper from the pressure of the low grunts  4. Extreme diaper rash; raw skin 5. Loss of fine motor skills 6. Loss of erections 7. No longer able to swallow solid foods.  Now pushes food out with tongue instead of swallowing. 8. Eczema rash all over torso
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Rash papular
Clinical narrative: raise 3-4 cm papular rash about 10 minutes after injection MMR vaccine, didn't get any larger after 30 minutes, no other symptoms
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Patient called pharmacy complaining of pain at site of vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient called pharmacy complaining of pain at site of vaccination.