chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Culture, Sinus disorder, Weight
Clinical narrative: I have never had such anxiety, I could not sit down and I was pacing back and forth; I was so wired; Severe sinus issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EN6202) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious) with onset Feb2021, outcome "recovering", described as "Severe sinus issues"; ANXIETY (non-serious), outcome "unknown", described as "I have never had such anxiety, I could not sit down and I was pacing back and forth; I was so wired". The events "severe sinus issues" and "i have never had such anxiety, i could not sit down and i was pacing back and forth; i was so wired" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinus disorder, anxiety.  Additional information: The consumer stated, "I had the Pfizer shot (Covid Vaccine) on 24Feb (not clarified) and when I went in, I was feeling good, no issues. Probably, that evening and the next day and up until now, I have severe sinus issues and they have ease some. I went to ENT and primary care; they didn't inform anything. It was reported that consumer stated, "As well as one other side effects which was anxiety and I have never had such anxiety, I could not sit down and I was pacing back and forth." Consumer stated that, "I am about 165 pounds weight." Consumer stated, "I got it from super market chain, that was (name withheld) was details of prescribing healthcare professional. Consumer stated, "I have no idea regarding dose." Consumer stated that regarding treatment, "Well they told me to take Flonase and they told me to take Saline, they tried to clear it up, they told me to drink lots of water. There was no infection, there is nothing like that. They tried to give me something to relax because he was so wired." Consumer stated, "They did a culture which was normal." (not clarified further) on lab test. Consumer stated, "I am due for the second shot. I don't know whether he should have taken it or not now because was this a common side effect or have you seen a lot of this. Consumer was informed about Pfizer Medical Information department and provided with the number "He guess that was like an emergency number for Pfizer or something." Consumer was informed that Pfizer medical information was the concerned department for all queries and suggested to call on the number provided and if there is any emergency than advised to call 911.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: extreme dizziness; Vertigo; This is a spontaneous report received from a contactable reporter (Consumer - patient's sibling) from medical information team.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "extreme dizziness"; VERTIGO (non-serious), outcome "unknown", described as "Vertigo". Therapeutic measures were taken as a result of dizziness.  Additional information: Reporter states, she was on hold for so long yesterday, just trying to get an answer. She kept being told she was next in line for over an hour and a half. She finally hung up and was very, very frustrated. Spoke to caller from the fact sheet for patients and caregivers. Referred the reporter and provided the CDC phone number and website. Reporter states she spoke a weeks ago and filed a safety report and has not received any follow up. Reporter received her 1st Pfizer vaccine dose on 13Mar2021 and was due for her 2nd dose on 03Apr2021. Her HCP recommended she had not took the 2nd dose due to her significant side effects. Since her 1st dose she had extreme dizziness and vertigo, which continues today. She also mentioned her "sister had the same problem after her first Pfizer vaccine. The reporter states she had some relief from the dizziness by taking meclizine. Spoke to the reporter from the attached document. Spoke to the reporter from the attached document. Referred to Inquiry Management (Off-Label or No Info) (v14.0) Referred to section- "no information found" regarding medical question. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Injection site pain; Extreme Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 10:15 (Lot number: EW0150) at the age of 44 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: SLYND; ALLEGRA 24 HOUR; IBUPROFEN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 31Mar2021 14:00, outcome "recovered" (2021), described as "Injection site pain"; FATIGUE (non-serious) with onset 31Mar2021 14:00, outcome "recovered" (2021), described as "Extreme Exhaustion". Therapeutic measures were taken as a result of vaccination site pain, fatigue.  Additional information: Patient occupation: None of the above. If other vaccine in four weeks: no. Other medications in two weeks: Slynd 4 MG, Allegra 24 HR, Ibuprofen as needed. Adverse event country:  resulted in: None of the above. If treatment  No.  treatment: Tylenol and ice. If Covid prior vaccination: No. If Covid tested post vaccination: No.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-2021529341 Same patient/product, different dose/event
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Fatigue
Clinical narrative: feeling extremely dry eye symptoms; feeling extremely fatigued; This is a spontaneous report received from contactable Consumer or other non HCP. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: ER 8729) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]; ATORVASTATIN. Past drug history included: Asprin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER2613, Anatomical site: Right arm), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 20Mar2021, outcome "not recovered", described as "feeling extremely fatigued"; DRY EYE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "feeling extremely dry eye symptoms". The events "feeling extremely fatigued" and "feeling extremely dry eye symptoms" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dry eye as  Eye drops issued but ineffective.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Two weeks after my second dosage of the Pfizer COVID 19 vaccination, I've started feeling extremely dry eye symptoms. This has never occurred prior to the shot series. I'm also feeling extremely fatigued, which occurred the next day after the second shot. The patient received Refresh eye drops within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Bed rest
Clinical narrative: Got mine in 94 spent week in bed never again; Initial information received on 29-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via Global Digital Media.  This case involves adult patient who had got mine in 94 spent week in bed never again (bed rest) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got mine in 94 spent week in bed never again (bed rest) (unknown latency) following the administration of INFLUENZA VACCINE.   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick; Initial information was received on 30-Nov-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had sick (illness) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I used to get the flu shot, always got sick. Stoped getting it, haven't had a cold or flu in 5 years."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case involves a patient (demographics unknown) who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered). It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical treatment(s), past vaccination(s), concomitant medications, and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE produced by Sanofi Pasteur (suspension for injection, lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency same day). It was reported "Medical Assistant calling from Health Care Professional (HCP) office to report that an expired dose of Quadracel was administered to a patient." No adverse event was reported. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: headache; Initial information received on 05-Dec-2021 regarding an unsolicited valid social media non-serious case received from a consumer.   This case involves an 80 years old male patient who experienced headache, after receiving INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2021, the patient experienced a non-serious headache (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I had flu shot past month and ended up with headache for 5 days. I am 80."  It is unknown if the patient experienced any additional symptoms/ events.   It is unknown if there were laboratory data/ results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There will be no information on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: almost died never been so sick; Initial information received on 05-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves unknown age and gender patient who had non serious event "almost died never been so sick" (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "almost died never been so sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got one almost died never been so sick in my life covid was a walk in the park compared to it."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Illness
Clinical narrative: This case involves a patient (unknown age and gender) who was sick (illness) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site prophylactic vaccination. On an unknown date, the patient was sick (illness, non-serious) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported "I got mine last week and I am still sick". It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm hurts it's sore; Initial information received on 03-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves unknown age and gender patient who had non serious event "arm hurts it's sore" (pain in extremity), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date the patient developed a non-serious arm hurts it's sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My arm hurts it's sore."  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 04-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional under reference number - US-SA-SAC20211208000921  This case involves Adult female patient who experienced flu (influenza), after receiving vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Flu Vaccine on 15-FEB-1976.  The patient's past medical history, medical treatment(s) and family history were not provided.   No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vomiting
Clinical narrative: flu shot made patient sick 20 minutes after he/ she got it, was throwing up; Initial information received on 02-Dec-2021 regarding an unsolicited valid non-serious social media case received from a consumer via social media via Digital Media.  This case involves an unknown age and gender patient who was sick for 20 minutes and was throwing up (vomiting), after receiving INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in 2020, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced a non-serious event "flu shot made patient sick 20 minutes after he/ she got it, was throwing up" (vomiting) following the administration of INFLUENZA VACCINE.  It was reported "Last year the flu shot made me sick 20 minutes after I got it was throwing up. Was sick for over two weeks."  It is unknown if the patient experienced any additional symptoms/ events.   It is unknown if there were laboratory data/ results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There will be no information on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Death, Pneumonia
Clinical narrative: This case involves three patients (unknown age and gender) who had pneumonia, after receiving INFLUENZA VACCINE. It was unknown if the patients had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patients developed serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. It was unknown if the patient experienced any additional symptoms/ events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. Three friends died in 2018 from pneumonia. It was unknown if an autopsy was done. Information on the batch number was requested.; Sender's Comments: This case involves patients who had pneumonia, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. It was unknown if an autopsy was done. Further information regarding their past medical conditions, previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a suspect vaccine cannot be assessed.; Reported Cause(s) of Death: pneumonia
Age: 0.08
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A four week old patient received Daptacel and not Adacel, Ipol, and ActHIB  with no ae; Initial information received on 30-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional. This case involves a 34 days old male patient who was administered POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (product administered to patient of inappropriate age). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL),  HIB VACCINE CONJ (TET TOX) (ACTHIB),  DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL),  ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR). On 08-Nov-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) lot number: U1A451M and expiry date not reported via intramuscular route in the left thigh for prophylactic vaccination. It was case of an actual medication error due to inappropriate age at vaccine administration (latency: same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, Medication error, Needle issue
Clinical narrative: child another dose that day with no reported adverse event; twisted the needle onto the syringe and when administering the injection about half the vaccine came out around the luer lock no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Agency (Reference number- 00883700) and transmitted to Sanofi on 03-Dec-2021.  This case involves an 11-years-old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV], child another dose that day (extra dose administered) and twisted the needle onto the syringe and when administering the injection about half the vaccine came out around the luer lock (needle issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (PFIZER BIONTECH) for Immunisation.  On 30-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7411JA, expiry date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to extra dose administered and needle issue. (latency: same day).  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: dose 2 was not on day 7 but will be today on day 9 with no A/E; Initial information was received on 06-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist under Inquiry Number: 00886590).  This case involves an adult female patient whose scheduled second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] was not on day seven but would be today on day nine with no adverse event (wrong schedule).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On an unknown date, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a potential medication error case due to wrong schedule.  It was reported "Pharmacist states he has a pharmacy tech who is going to school and is getting pre-exposure IMOVAX but is off her schedule. Caller wants to know what day she should take her last dose since she is 2 days late for the dose 2".  At time of reporting, it was not unknown if the patient received a second dose on day nine.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Urticaria
Clinical narrative: Localized urticaria near both both injection sites; This spontaneous case was retrieved on 10-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1816326-1), reported by other health professional and concerned a 55-year-old female patient.  The patient's medical history was not reported. Patient's concomitant medications were Magnesium OTC, Align prebiotic and probiotic, and Zyrtec.  On 22-Oct-2021, the patient was vaccinated with Afluria Quad (influenza vaccine, dose: 'one' as reported, route of administration: intramuscular, anatomical location: left arm, indication: not reported). The batch number reported was P100360866.  On 22-Oct-2021, the patient was vaccinated with non-company co-suspect Pfizer BioNTech COVID-19 vaccine (dose: 'three' as reported, route of administration: intramuscular, anatomical location: right arm, indication: not reported). The batch number reported was ER8729.  On 25-Oct-2021, three days after receiving Afluria Quad and Pfizer, patient developed localized urticaria near both injection sites, radius about one inch.   At the time of this report, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  Company comment: The event 'urticaria' was assessed as related to Afluria QIV. Sender's Comments: The event 'urticaria' was assesed as related to Afluria QIV).
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid heart rate.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Migraine, Paranasal sinus discomfort, Pyrexia
Clinical narrative: My fever was so high that it caused hallucinations and the fever would not break until I took 1600mg of ibuprofen.  The vaccine also caused a migraine and sinus pain.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Diffuse urticaria, persisting >24 hours- mild improvement with cetirizine and Benadryl.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Incomplete course of vaccination, Intervertebral disc protrusion, Magnetic resonance imaging
Clinical narrative: Diagnosed with herniated disk; Heart racing 1 week after first dose, Heart racing  before & after first shot; Chest pain 1 week after first dose; She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk), PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot), CHEST PAIN (Chest pain 1 week after first dose) and INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (Heart racing and fluttering during anxiety.), Heart racing (Patient  had heart racing  after vaccination also but  thought it was related to her anxiety.) and Heart fluttering (Heart racing and fluttering during anxiety.).    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot). On 31-May-2021, the patient experienced PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot) and CHEST PAIN (Chest pain 1 week after first dose). On 14-Jun-2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk). At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk) outcome was unknown and PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot), CHEST PAIN (Chest pain 1 week after first dose) and INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) swelling in the neck that caused the disk move and press on the nerve..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter Event Pharmacist refused to give 2nd shot on 24-MAY-2021 was provided. Treatment product was not provided by the reporter. Patient went to the emergency room. MRI showed swelling in the neck that caused the disk move and press on the nerve. Diagnosed with herniated disk.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Diagnosed with herniated disk; Heart racing 1 week after first dose, Heart racing  before & after first shot; Chest pain 1 week after first dose; She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk), PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot), CHEST PAIN (Chest pain 1 week after first dose) and INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (Heart racing and fluttering during anxiety.), Heart racing (Patient  had heart racing  after vaccination also but  thought it was related to her anxiety.) and Heart fluttering (Heart racing and fluttering during anxiety.).    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot). On 31-May-2021, the patient experienced PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot) and CHEST PAIN (Chest pain 1 week after first dose). On 14-Jun-2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk). At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Diagnosed with herniated disk) outcome was unknown and PALPITATIONS (Heart racing 1 week after first dose, Heart racing  before & after first shot), CHEST PAIN (Chest pain 1 week after first dose) and INCOMPLETE COURSE OF VACCINATION (She states that some doctor's told me to get the second shot, and other doctors said not to get another COVID-19 shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) swelling in the neck that caused the disk move and press on the nerve..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter Event Pharmacist refused to give 2nd shot on 24-MAY-2021 was provided. Treatment product was not provided by the reporter. Patient went to the emergency room. MRI showed swelling in the neck that caused the disk move and press on the nerve. Diagnosed with herniated disk.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and nerve pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the nerve pain was not recovered/not resolved. It was unknown if the reporter considered the shingles and nerve pain to be related to Shingles vaccine. Additional details provided were as follows: The case was reported by patient herself. The age at vaccination was not provided. The patient received a dose of Shingles vaccine. The patient stated that, he/she got over shingles and gradually felt back to normal but still got some nerve pain, but it was tolerable. Follow-up would not be possible as no contact details available.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: Lost the hearing completely; This case was reported by a consumer via interactive digital media and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   The reporter considered the hearing loss to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported for reporter's sister. The age at vaccination was not reported. The patient lost the hearing completely in one ear after taking the vaccine. The reporter reported that there was hearing loss associated with the vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Gait disturbance, Limb discomfort
Clinical narrative: ATRIAL FIBRILLATION; HARDLY WALK ANYMORE; LEGS ARE SO HEAVY; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. (Dose Number In Series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient stated that "My goodness is all this stuff everyone has really related to the vaccine? I have AFIB (atrial fibrillation) all of a sudden and my legs are so heavy I can hardly walk anymore! I couldn't figure out where all that came from!!". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the atrial fibrillation, heavy legs and can hardly walk anymore was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211222396-covid-19 vaccine ad26.cov2.s-atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Muscle swelling, Paralysis
Clinical narrative: PARALYZED; MUSCLE SWELLING; This spontaneous report received from a social media through a patient via a company representative concerned patient of an unspecified age, and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose,01 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Reporter stated that, "My son-in-laws friend has been paralyzed for a week from J and J vaccine. The doctors are saying it is muscle swelling. They refuse to admit it is from the vaccine." On an unspecified date, the patient experienced paralyzed, and muscle swelling. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralyzed and muscle swelling was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211223119.; Sender's Comments: V0:20211223490-COVID-19 VACCINE AD26.COV2.S-Paralyzed. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN EARS; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ringing in ears was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: SUDDEN ONSLAUGHT OF CANCER; This spontaneous report received from a consumer concerned a female of unspecified age and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total (dose series 1), for prophylactic vaccination (date unspecified). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died 6 weeks after her injection from sudden onslaught of cancer. As per reporter they stated that "there's my stepdaughter who died 6 weeks after her injection from sudden onslaught of cancer" On an unspecified date, the patient died from sudden onslaught of cancer. It was unknown if autopsy were performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20211225989-COVID-19 VACCINE AD26.COV2.S-Sudden onslaught of cancer. This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.; Reported Cause(s) of Death: SUDDEN ONSLAUGHT OF CANCER
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose was not reported, administered on JUL-2021 for prophylactic vaccination. Dose series was 1. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient had no side effects after vaccination. But, on an unspecified date in NOV-2021, the patient got covid (suspected covid-19 infection, suspected clinical vaccination failure) with very little symptoms. The consumer reported as "The patient got Johnson and Johnson shot in July no side effects but got Covid in November with very little symptoms Thank (a higher power)". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000206658.; Sender's Comments: V0 20211227545-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON HAND; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rash on hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on hand. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Influenza like illness, Neck pain, Paraesthesia
Clinical narrative: feels flushing; tingling on her legs / extremities; very sore neck on the same side (left) she had shot/pain on her neck on the same side she had her shot; flu like symptom; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (feels flushing), PARAESTHESIA (tingling on her legs / extremities), NECK PAIN (very sore neck on the same side (left) she had shot/pain on her neck on the same side she had her shot) and INFLUENZA LIKE ILLNESS (flu like symptom) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced FLUSHING (feels flushing), PARAESTHESIA (tingling on her legs / extremities) and INFLUENZA LIKE ILLNESS (flu like symptom). 09-Dec-2021, the patient experienced NECK PAIN (very sore neck on the same side (left) she had shot/pain on her neck on the same side she had her shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FLUSHING (feels flushing), PARAESTHESIA (tingling on her legs / extremities), NECK PAIN (very sore neck on the same side (left) she had shot/pain on her neck on the same side she had her shot) and INFLUENZA LIKE ILLNESS (flu like symptom) outcome was unknown.            patient Took an Advil 15-20 mins prior shot. Patient was  on Thyroid and blood pressure medications and taking supplements.   This case was linked to MOD-2021-028351 (Patient Link).