chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiration date not reported), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history included 'Blood pressure'. Concomitant medication included doxorubicin hydrochloride (LIPISOL) for blood pressure. The patient reported that on 08Jan2021 (Friday), she had the COVID vaccine. On 09Jan2021 (Saturday), her arm hurt, she had body aches, and weakness. She also had a headache Saturday night. On 10Jan2021, she started getting chest congestion and her throat was hurting. When she was spitting out it felt like her throat was scratchy. Patient further reported that her arm does not hurt now. It still bothers her a little if she touches it, but doesn't if she doesn't touch it. Patient also reported that she does not have too much body aches now. She had a good dinner and took two of the 600mg Ibuprofen. It helped her. It still hurts a little. Patient reported that her weakness feels a little better. No fever and she has been checking her temperature. Patient clarified that her throat wasn't bothering her last night, but today it was bothering her. It was the bottom of her throat. She was supposed to go back on the 29th to get the other part. The patient was recovering from arm hurt, body aches, and weakness; has not recovered from chest congestion; and unknown outcome for the remaining events.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, COVID-19, Chest discomfort, Cough, SARS-CoV-2 test positive
Clinical narrative: chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiration date not reported), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history included 'Blood pressure'. Concomitant medication included doxorubicin hydrochloride (LIPISOL) for blood pressure. The patient reported that on 08Jan2021 (Friday), she had the COVID vaccine. On 09Jan2021 (Saturday), her arm hurt, she had body aches, and weakness. She also had a headache Saturday night. On 10Jan2021, she started getting chest congestion and her throat was hurting. When she was spitting out it felt like her throat was scratchy. Patient further reported that her arm does not hurt now. It still bothers her a little if she touches it, but doesn't if she doesn't touch it. Patient also reported that she does not have too much body aches now. She had a good dinner and took two of the 600mg Ibuprofen. It helped her. It still hurts a little. Patient reported that her weakness feels a little better. No fever and she has been checking her temperature. Patient clarified that her throat wasn't bothering her last night, but today it was bothering her. It was the bottom of her throat. She was supposed to go back on the 29th to get the other part. The patient was recovering from arm hurt, body aches, and weakness; has not recovered from chest congestion; and unknown outcome for the remaining events.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; Temp of 100.4; This is a spontaneous report from a non-contactable healthcare professional. An elderly male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. Medical history included Covid-19 (patient was diagnosed with COVID-19 prior to vaccination). The patient's concomitant medications were not reported. The patient experienced nausea, vomiting, and a temp of 100.4 on 07Jan2021. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Itching; Rash/all over the body, face, neck and back; Fever; This is a spontaneous report from a contactable consumer reported for himself. A 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included diabetes. Concomitant medication included varicella zoster vaccine (VARICELLA VACCINE).  He noticed a rash on Saturday 09Jan2021 all over the body, face, neck and back; and he had fever. Did not take his temperature. Now today the rash is itching and getting worse. He is planning to get the next injection in 21 days. Mentions he showed the rash to the nurse who gave him this number to call. Information on the Lot/Batch number has been requested. Outcome of event fever was recovered, of others was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Reddening and itching at injection site; Reddening and itching at injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 18Dec2020 in the left arm at a single dose for COVID-19 immunization. The patient's medical history included shellfish allergy. The patient is not pregnant at the time of vaccination. Concomitant medication included spironolactone (ALDACTONE), dextrin (BENEFIBER), folic acid, atorvastatin (LIPITOR), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC), famotidine (PEPCID), and estradiol (VIVELLE DOT); patient also received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Dec2020, the patient experienced reddening and itching at injection site and fatigue at 2 days post-inoculation. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovered. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; chills; muscle aches; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscularly on 06Jan2021 at 18:30 at a single dose on the left arm for COVID-19 immunization in the hospital. The patient's medical history and concomitant medications were not reported.  The patient previously took spironolactone and had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 07Jan2021 at 05:00, the patient experienced fever, chills, and muscle aches. No treatment was given to the patient. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date in Jan2021. The events were considered non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; myalgia; fatigue; This is a spontaneous report from a contactable nurse. A 53-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK923), intramuscular on 08Jan2021 16:15 (reported as "04:15 PM") at single dose on the left arm for COVID-19 immunisation. There were no medical history and concomitant medications. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on 18Dec2020 04:30 PM on left arm. COVID-19 vaccine was administered in the hospital. The patient experienced headache, myalgia and fatigue on 09Jan2021 at 8:00 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: unilateral cervical lymphadenopathy; seemed to start developing within 24-48 hours after the shot, more noticeable at 72 hours with the pain already improving; myalgia; headache; chills; This is a spontaneous report from a non-contactable physician. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The healthy female patient complained about a unilateral cervical lymphadenopathy (self-examined) on the left side (the same side as the 2nd vaccine shot on Friday 08Jan2021), yesterday evening (Sunday, 10Jan2021). It seemed to start developing within 24-48 hours after the shot, more noticeable at 72 hours with the pain (Jan2021) already improving. She also developed myalgia, headache and chills 12-18 (Jan2021) after the shot. All the other symptoms were somewhat anticipated, but the lymphadenopathy was not. She doesn't have any other conditions. The outcome of lymph node pain was recovering, while the outcome of the remaining events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild pain at the injection site; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received first dose of BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration on Dec2020 12:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID 19 vaccine three weeks ago at 12:00 noon in the left arm. After the first dose there was mild pain at the injection site which lasted two days and then was gone. The patient did not receive any other vaccines within four weeks prior to the vaccination. The outcome of the event was recovered on Dec2020. The reporter assessed the event as non-serious.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: cut to the hand; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient cut his/her hand on an unspecified date with outcome of unknown. The patient received tetanus shot on 07Jan2021, for cut to the hand on an unspecified date. He was due to get 2nd dose of COVID vaccine tomorrow and queried if the patient can receive 2nd dose.  Information on Lot/Batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Tremor
Clinical narrative: Heart rate of 136; chills; shaking uncontrollably; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced heart rate of 136, chills and shaking uncontrollably on an unspecified date. The events took place after use of product. The patient went to the ER and was treated. Therapeutic measures were taken as a result of heart rate of 136, chills and shaking uncontrollably. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: she had a fever; runny nose; This is a spontaneous report from a contactable consumer (patient's parent) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. 3 weeks after the first dose, the patient had a fever and runny nose. The reporter would like to know if the patient can take the second dose of the Pfizer COVID vaccine. The outcome of the events was unknown.  information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Breath odour, Taste disorder
Clinical narrative: ODOR. I am constantly smelling smoke. As if I am holding a cigarette ashtray against my nose when taking deep breath/After the second injection it has intensify; ODOR. I am constantly smelling smoke. As if I am holding a cigarette ashtray against my nose when taking deep breath/After the second injection it has intensify. I now can taste it; This is a spontaneous report from a contactable nurse. A 50-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL1284; expiration date: not known), via an unspecified route of administration on right arm on 06Jan2021 at single dose for covid-19 immunization, administered in hospital. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 16Dec2020 13:30, the patient administered first dose covid vaccine (Lot number: EH9899). On 23Dec2020 13:00, the patient experienced "ODOR". He was constantly smelling smoke. As if he was holding a cigarette ashtray against his nose when taking deep breath. This started a week after the first injection. After the second injection it had intensified. He now could taste it and he felt it went down his throat when he took deep breath. He was hesitated taking deep breath afraid of having an asthma attack or suffocating. The reported events were non-serious. No treatment was received for the events. The outcome of the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This is a spontaneous report from a contactable Nurse. 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EKS730), intramuscular (IM) on 18Dec2020 at single dose on left upper arm once for COVID-19 immunisation. There were no medical history and concomitant medications. The patient stated that she did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it was sore. The event was considered as non-serious. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Pain, Pain in extremity
Clinical narrative: arm hurts; body ache; heavy headedness; more tired; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 on an unspecified date at single dose for COVID-19 immunization and experienced injection site pain, feeling more tired than usual the day off and after and headache. After receiving the second dose, the patient experienced arm hurts way more than last time, a lot more body ache, heavy headedness and just feeling more tired on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Off label use, Pain in extremity, Product use issue
Clinical narrative: Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous report from a non-contactable nurse. This patient reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. For the first dose the patient only had a sore arm and maybe fatigue. No treatment received for the adverse event. She was also breast feeding. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Increasing mild to moderate local tenderness at the deltoid of the injection arm; This is a spontaneous report from a contactable physician. A 53-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) (lot# EH9899), via an unspecified route of administration in right deltoid, on 15Dec2020 at 07:45 AM, at single dose, for COVID-19 immunisation. Medical history included reactive airway disease, Blood pressure abnormal, kidney stones, no sense of taste or smell (Between Dec2019 and Jan2020 or Feb2020), migraine, ongoing obesity (250 to 255 pounds). Family history included migraine (family members). Previously the patient was immunized with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (booster) in Aug2020, varicella zoster vaccine rge (cho) (SHINGRIX) on 10Aug2020, influenza vaccine (unknown  manufacturer) on 12Oct2020, tetanus vaccine (unknown  manufacturer) and experienced mild arm soreness. Previously the patient received fluticasone propionate, salmeterol xinafoate (ADVAIR) from Dec2020 and experienced dry mouth and lost sense of taste. Concomitant medications included multivitamin (unknown manufacturer), fluticasone propionate, salmeterol xinafoate (ADVAIR DISKUS INHALER) from 2020 for reactive airway disease, allopurinol (unknown manufacturer) for kidney stones, atorvastatin (unknown manufacturer), potassium (unknown manufacturer); hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) for blood pressure abnormal, colecalciferol (VITAMIN D). The patient experienced increasing mild to moderate local tenderness at the deltoid of the injection arm on 15Dec2020 with outcome of recovered in Dec2020 (in 36 hours). On unspecified dates the patient underwent lab tests and procedures which included COVID-19 antibody test, COVID-19 PCR test, salivary test: all negative.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Tilt table test positive
Clinical narrative: postural orthostatic tachycardia syndrome; experienced symptoms of syncope; Collapse; Heart palpitations; Dizziness; Initial information regarding an unsolicited valid serious case received from the other healthcare professional via phone at call center (Reference number: US-SANOFI-00426245) on 12-Jan-2021.  This case involved a 19-year old female patient who experienced postural orthostatic tachycardia syndrome, after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient received no concomitant medications.  On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED 0.5 mL multi-dose vial (lot number: UJ477AB, expiry date: 30-Jun-2021) via an unknown route in the right deltoid for prophylactic vaccination.  On 22-Oct-2020, 3 days following the suspect product vaccinations, the patient experienced symptoms of syncope, collapse (Fall), heart palpitations (Palpitations), and dizziness. Reporter that the patient had visited the emergency room. After being symptomatic for a while, the patient was seen at the reporting primary care practice on 12-Nov-2020, where an electrocardiogram was performed, which was abnormal. Patient was referred to a neurologist on 11-Dec-2020, Doctor who suspected postural orthostatic tachycardia syndrome (POTS), and the patient was referred to Genetics on 21-Dec-2020.   On 21-Dec-2020, 2 months 2 days following the suspect product vaccinations, at genetics, patient underwent a tilt table test, which confirmed postural orthostatic tachycardia syndrome (POTS). Patient had a follow-up appointment with neurologist on 28-Dec-2020.   Final diagnosis was postural orthostatic tachycardia syndrome.  The event of postural orthostatic tachycardia syndrome associated with accompanying symptoms of syncope, palpitations, dizziness and fall were assessed as important medical event as the accompanying symptom of syncope was assessed as medically significant as per important medical event list.  It was not reported if the patient received a corrective treatment.  Outcome of the event of postural orthostatic tachycardia syndrome with its accompanying symptoms was unknown.  The neurologist and other members of the patient's healthcare team believe that the patients POTS was related to the Fluzone vaccine the patient received.; Sender's Comments: This case involved a 19-year old female patient who presented with postural orthostatic tachycardia syndrome (POTS) accompanied with symptoms of fall, dizziness, syncope and palpitations three days (although  diagnosed on a later date) following INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE). Time to onset is compatible. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No other AE reported; We have a patient 64 years old who received VARlVAX instead of Shingrix; This spontaneous report was received from a medical assistant and refers to a 64-year-old male patient. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 21-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot # T002846, expiration date: 23-JAN-2022 (injection site, route of administration were not provided) for prophylaxis instead of zoster rgE vaccine (mammalian) (SHINGRIX). The doctor knew it was not harmful to the patient that he received the varicella virus vaccine live (oka/merck) (VARIVAX) but he asked when was it safe to revaccinate the patient with zoster rgE vaccine (mammalian) (SHINGRIX) after getting varicella virus vaccine live (oka/merck) (VARIVAX). No other adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; Improperly Stored PROQUAD was administered to patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) lot # S021326, expiration date 05-JAN-2021 (dose, route of administration and anatomical location were not reported). Administered dose of vaccine was stored in an unknown improper temperature for unknown period of time.  It was unknown by the reporter if there were any previous temperature excursions reported or if digital data logger was involved. There was no additional adverse event reported.
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No other AE details available; temperature excursion; This spontaneous report was received from a registered nurse referring to a 11 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 04-DEC-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported, lot # T017688, expiration date was 21-MAY-2022) 0.5 ml for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 13.3 degree Celsius for a time frame of 4 hours and 15 minutes, as recorded by the digital data logger. There were no previous temperature excursions. No further adverse event (AE) information was provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2012USA013093: US-009507513-2012USA013095: US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013539: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013598: US-009507513-2012USA013601: US-009507513-2101USA000121: US-009507513-2101USA000122: US-009507513-2101USA000144: US-009507513-2101USA000266:
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to an 8-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided.  On 16-DEC-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (lot # T002845, expiration date 23-JAN-2022; strength and route were not reported) for prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of -14 degree Celsius to -10 degree Celsius (-12 degree Celsius) for 2 hours and 30 minutes recorded by a data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA002097: US-009507513-2101USA004102: US-009507513-2101USA004159:
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated muscle pain with Shingrix.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Pain, Pyrexia
Clinical narrative: pain at the injection site; sweating; shivering; fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of hyperhidrosis (1st dose received in December 2019 and he had body aches, pain at the injection site, shivering and fever of 101.9 degrees,refer case US2020244465).   In March 2020, the patient received the 2nd dose of Shingrix (intramuscular). In March 2020, 6 hrs after receiving Shingrix, the patient experienced injection site pain, sweating, shivering, fever and general body pain. Rechallenge with Shingrix was positive. In March 2020, the outcome of the injection site pain, sweating, shivering, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sweating, shivering, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm. After receiving 2nd dose of Shingrix, the patient experienced fever, body aches, pain at the injection site, shivering, and sweating which lasted about 7 hours. The patient reported the events did not seem as bad with the second dose compared to the first. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244471:same reporter US-GLAXOSMITHKLINE-US2020244465:same reporter
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: pain at the injection site; sweating; shivering; fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of hyperhidrosis (1st dose received in December 2019 and he had body aches, pain at the injection site, shivering and fever of 101.9 degrees,refer case US2020244465).   In March 2020, the patient received the 2nd dose of Shingrix (intramuscular). In March 2020, 6 hrs after receiving Shingrix, the patient experienced injection site pain, sweating, shivering, fever and general body pain. Rechallenge with Shingrix was positive. In March 2020, the outcome of the injection site pain, sweating, shivering, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sweating, shivering, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm. After receiving 2nd dose of Shingrix, the patient experienced fever, body aches, pain at the injection site, shivering, and sweating which lasted about 7 hours. The patient reported the events did not seem as bad with the second dose compared to the first. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244471:same reporter US-GLAXOSMITHKLINE-US2020244465:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: very sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th August 2020, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The age at vaccination was not reported. The patient had a very sore arm for 2-3 days after receiving first dose of Shingrix. The reporter consented to follow up. For tolerance of 2nd dose refer case US2020253858.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020253858:2nd dose, same reporter
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe headache, no breathing difficulty, no rash, no swelling of tongue or throat, was able to walk, now feeling much better- after 2 days.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Slight fever. Severe left arm pain with arm pit swollen gland.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Dyspnoea, Full blood count, Laboratory test, Lymphocyte count
Clinical narrative: Dose #1 ER5730  12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulation - worse than with #1. RR 36+ O2 sat stayed at 93 or above with ambulation. HR in supine position 70 w/in 10-15 seconds of ambulation greater than 105. On day 6 post injection, with bagging up a bag of garbage (bending over and picking things up with a spilt can) I had to sit down I was that SOB. HR 130 on pulse ox - O2 sat. 94-95.  Day 7 post injection - ER work up for PE - negative, chf evaluation - negative. no pneumonia or cardiomegaly on CTA. CBC all w/in normal limits except on diff - lymph 0.5 above normal range only. CMP ok as well. BMP and trops normal. Day 9 diffuse itchy rash has developed, even worse now on day 10. Raised, blanching, papules - no pustules/vesicles noted. Trunk presentation spreading to extremities.  leg signifiant more populated than arms. Rash now on tops and bottoms of feet.  Minimal spots on dorsal hands and none on palms. Extremely itchy.   + Celiac patient (Dx- genetically 7-8 years ago, symptoms for over 10) and + Hashimotos patient (29 years). No recent gluten exposure resulting in GI response. (I can get bowel incontinence with cross contamination. ) I'm taking Synthroid as prescribed.  Since I'm in the CD8 peak days (9-11)- can this just be some type of autoimmune storm since it was a viral vaccine? No history of any problems with my yearly influenza vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Pallor, Rash papular, Rash pruritic, Troponin
Clinical narrative: Dose #1 ER5730  12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulation - worse than with #1. RR 36+ O2 sat stayed at 93 or above with ambulation. HR in supine position 70 w/in 10-15 seconds of ambulation greater than 105. On day 6 post injection, with bagging up a bag of garbage (bending over and picking things up with a spilt can) I had to sit down I was that SOB. HR 130 on pulse ox - O2 sat. 94-95.  Day 7 post injection - ER work up for PE - negative, chf evaluation - negative. no pneumonia or cardiomegaly on CTA. CBC all w/in normal limits except on diff - lymph 0.5 above normal range only. CMP ok as well. BMP and trops normal. Day 9 diffuse itchy rash has developed, even worse now on day 10. Raised, blanching, papules - no pustules/vesicles noted. Trunk presentation spreading to extremities.  leg signifiant more populated than arms. Rash now on tops and bottoms of feet.  Minimal spots on dorsal hands and none on palms. Extremely itchy.   + Celiac patient (Dx- genetically 7-8 years ago, symptoms for over 10) and + Hashimotos patient (29 years). No recent gluten exposure resulting in GI response. (I can get bowel incontinence with cross contamination. ) I'm taking Synthroid as prescribed.  Since I'm in the CD8 peak days (9-11)- can this just be some type of autoimmune storm since it was a viral vaccine? No history of any problems with my yearly influenza vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Full blood count, Metabolic function test, Paraesthesia oral
Clinical narrative: 30-40 minutes after receiving the vaccine, it became more difficult to swallow. Shortly after, my tongue and lips were tingling. I was dizzy. I went to the Emergency Department and got Prednisone, Pepcid, and Benadryl.  The next day, I started to experience tremors, mostly in my right hand.   Two days later, I was so dizzy that the room was spinning and I could hardly stand up. Did not receive treatment for it.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thyroid function test, Tremor, Vertigo
Clinical narrative: 30-40 minutes after receiving the vaccine, it became more difficult to swallow. Shortly after, my tongue and lips were tingling. I was dizzy. I went to the Emergency Department and got Prednisone, Pepcid, and Benadryl.  The next day, I started to experience tremors, mostly in my right hand.   Two days later, I was so dizzy that the room was spinning and I could hardly stand up. Did not receive treatment for it.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash maculo-papular
Clinical narrative: 2 days after vaccine, pt developed a maculopapular rash. Rash started on right thigh, then both arms, then chest, abdomen, and back. Finally rash spread to neck, face, hands & feet (including palms & soles). Pt first seen for rash on 1/12/21, 4 days after the vaccine. Then seen again for follow-up on 1/14/21 after the rash continued to spread and get more red and diffuse on oral antihistamines and topical mild steroids. When seen 6 days after the vaccine, pt given oral steroids for 5 days. Has not been seen for follow-up to know outcome but did not go to the hospital over the following 4-day weekend.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Headache, pain at injection site, muscle soreness, nausea, vomiting, fatigue, and decrease in appetite. Headache, pain, and soreness occurred and increased the day of the vaccine into the following day. Decreased by second day after injection. Appetite decreased day following vaccination and maintained decrease into second day after injection.  Fatigue occurred day of and day following vaccination. Nausea and vomiting appeared on second day following vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Headache, pain at injection site, muscle soreness, nausea, vomiting, fatigue, and decrease in appetite. Headache, pain, and soreness occurred and increased the day of the vaccine into the following day. Decreased by second day after injection. Appetite decreased day following vaccination and maintained decrease into second day after injection.  Fatigue occurred day of and day following vaccination. Nausea and vomiting appeared on second day following vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site, 15 cm x 7 cm.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Pain in extremity
Clinical narrative: headache, dry mouth, and arm pain
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching, mild redness on arms, legs, and torso
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bone pain, Chills, Diarrhoea, Laboratory test
Clinical narrative: Diarrhea, fever, chills, nausea, vomiting, body aches, bone pain, abdominal pain.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Diarrhea, fever, chills, nausea, vomiting, body aches, bone pain, abdominal pain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus
Clinical narrative: Day 9, 10,  11: Red bite? Rash below injection site, right arm. Itchy.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Illness
Clinical narrative: At 3:30 in morning after receiving shot I became violently ill.  I began having severe chills that made my entire body shake.  Despite 4 blankets, a heating blanket and two corn bags I could not get warm.  The chills brought on unbearable muscle and joint pain. It was excruciating.  My fever fluctuated from 100 to 102. This lasted 24hrs. I had and continue to have a headache, on and off fever and extreme fatigue.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: At 3:30 in morning after receiving shot I became violently ill.  I began having severe chills that made my entire body shake.  Despite 4 blankets, a heating blanket and two corn bags I could not get warm.  The chills brought on unbearable muscle and joint pain. It was excruciating.  My fever fluctuated from 100 to 102. This lasted 24hrs. I had and continue to have a headache, on and off fever and extreme fatigue.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Developed fever and chills 12 hours after receiving dose. Had extreme fatigue x 24hrs and significant Headache.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Rash erythematous
Clinical narrative: I had the Vaccine Monday but the rash did not start till Friday. I have a red rash all over my body, Light headed , weak,
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: Moderna COVID-19 Vaccine EUA. Hives on chest, arms & back with Red blotches all over face.  Took Benedryl q4 hrs until gone.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hours after vaccination.  Treated with acetaminophen and ibuprofen.  On 1/14/2021, forty-eight (48) hours after the vaccine administration,  rash appeared on trunk and neck.  Rash was red, warm not itchy and was treated with diphenhydramine oral and topical hydrocortisone.   Rash persisted for 24-36 hours.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hours after vaccination.  Treated with acetaminophen and ibuprofen.  On 1/14/2021, forty-eight (48) hours after the vaccine administration,  rash appeared on trunk and neck.  Rash was red, warm not itchy and was treated with diphenhydramine oral and topical hydrocortisone.   Rash persisted for 24-36 hours.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Lymphadenopathy
Clinical narrative: 8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection site. Exam notable for 7cm region of erythema, with central induration. region is warm, mildly tender to palpation. no severe swelling. also tender Left axillary adenopathy. no fever, chills. no systemic systems. Pt very well appearing. presentation concerning for cellulitis.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: 8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection site. Exam notable for 7cm region of erythema, with central induration. region is warm, mildly tender to palpation. no severe swelling. also tender Left axillary adenopathy. no fever, chills. no systemic systems. Pt very well appearing. presentation concerning for cellulitis.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Fatigue, Feeling of body temperature change, Headache, Myalgia
Clinical narrative: Headache, muscle/body aches, hot and cold flashes, fatigue, and low grade fever.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, muscle/body aches, hot and cold flashes, fatigue, and low grade fever.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site discolouration, Injection site induration, Injection site rash, Injection site scar
Clinical narrative: Rash; injection site was hard; injection site was swollen; The injection site was hard and swollen, and had raised redness about 2 inches wide; injection left her with a purple scar; injection left her with a purple scar; itching on the chest, neck and stomach; skin all over felt like pins and needles; joint pain in ankles, knees, and legs; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site inflammation (1st dose received in August 2020).   On 17th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, less than an hour after receiving Shingrix, the patient experienced injection site induration, injection site swelling, injection site erythema, injection site scar, injection site discoloration, pruritus, pins and needles and joint pain. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the injection site induration and injection site erythema were unknown and the outcome of the injection site swelling, pruritus, pins and needles, joint pain and rash were recovered/resolved and the outcome of the injection site scar and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site induration, injection site swelling, injection site erythema, injection site scar, injection site discoloration, pruritus, pins and needles, joint pain and rash to be related to Shingrix.  Additional details were provided as follows: On 17th November 2020, within an hour, the patient experienced itching on the chest, neck and stomach, skin all over felt like pins and needles. The patient experienced joint pain in ankles, knees, and legs, the injection site was hard and swollen, and had raised redness about 2 inches.  The injection left the patient with a purple scar.  The reporter consented to follow up.