chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case previously recorded as MA2009-3458. Initial case report received from a registered nurse via MedCom on 30 OCT 2009. A 15-month-old female patient was vaccinated i.m. with 0.25 ml S-OIV FLUVIRIN (batch no. 1007393P). The patient, under 4 years, was inadvertently given Novartis H1N1 vaccine. No adverse event was reported. Reference no.: NA09-007320.
15 minutes after vaccination the patient was by the reception area and started to feel feint. A nurse nearby guided her to a chair. Patient lost consciousness for a few seconds. EMS was called. Patient's breathing remained normal and pulse was at 60 normal quality. Patient stated she was going to vomit, but did not. Patient stated she has feinted 4 or 5 times related to blood draws. EMS arrived at approx. 2:50PM. Patient refused transport and stayed for approximately 40 minutes. She stated she was now feeling fine and left.
Patient described swelling and was not able to use her arm for a few days. After checking on 1/14, patient reported improved symptoms but still had muscle spasms Treatment: doctor recommended flexeril as needed
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # not reported) that were exposed to 47 F for 168 hours. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Vial of vaccine was not diluted prior to administration.  Patient had no adverse affects from dose.  Did report mild sore arm
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Pustular, pruritic rash primarily on legs and arms beginning 2 wks after smallpox vaccination.  Symtoms resolving after 3 days.  No systemic sx.  Sx improved with antihistamines.  No autoinnoculation, BUT very robust take on right arm.
Constant generalized headache, intermittent episodes of aphasia.  Patient is ex smoker, quit 1 year ago.  Neurology is consulted.  Patient is diagnosed with TIA involving left internal carotid artery.  Clopidogrel 300mg and aspririn 162mg given in ER.   Patient is given prescriptions for clopidogrel 75 mg daily. Patient is to follow up with PCP.  Appointment made while patient in ER.
Stiffness in neck and shoulders, loss of strength in hands and forearms. Numbness in hands. pain in lower back and hips.
Sore arm, body aches, chills, 100 degree temperature, dizziness, weakness in legs, shortness of breath, head congestion, fatigue, loss of appetite.
patient reported rash on left forearm but not other symptoms. Also rash was small and not very obvious and not bright or raised. There were several other bright spots which were on both forearms. patient refused to have Bp taken and was given 50mg of oral benadryl and told to take additional doses at 6 to 8 hours apart if needed for rash. Patient left home alone
Patient received immunization on 6/17/2017 and began to have headaches once she got home. She went to the primary care physician on 6/21/2017 at around 9:00am and then the Primary Care Dr sent patient to ER around 10:30am. The radiologist evaluated patient and wrote her a prescription FIORICET for her HA's. She only took 1 tab due to it causing her heart to race. She went to see a neurosurgeon on 6/29/2017 still complaining of HA's.
Fever; Fatigue; Muscle pain/Weakness; Muscle pain/Weakness; Sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).  A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 05Feb2021 14:30 (at the age of 36 years) as dose 2, single for covid-19 immunisation at workplace clinic. The patient medical history was reported as none. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication from Sep2018 and ongoing; probiotics (PROBIOTICS) taken for an unspecified indication from 16Jan2021 and ongoing; lecithin (LECITHIN) taken for an unspecified indication from Jun2019 and ongoing. It was reported that, the patient followed standard vaccine schedule only vaccine taken in the past year was flu shot. Also she has previously received Hep A/B combo shot and multiple previous Flu vaccinations over the course of the previous decades. There were no AE following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. On 05Feb2021 18:30 the patient experienced sore arm. On 06Feb2021, the patient experienced fever (at 10:00), muscle pain, weakness and fatigue (at 7:00). It was reported that, no relevant tests were done, no culture was performed, there were no predisposing factors and no antipyretic was used. It was reported that the vaccine was not administered at military facility. The Adverse events did not require any visits to the emergency room or physician office. The patient did not receive any treatment for the events. Patient was not admitted to the hospital due to the events. The outcome of the events was recovered in on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
AST 916; ALT 1865; TB peaked at 5.5; AP 134; jaundice; headache; chills; acholic stools; dark urine; This is a spontaneous report from a contactable physician on behalf of patient. A 59-year-old male patient of received bnt162b2 (Pfizer COVID 19, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome. The patient had no allergies. Concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. The clinical course of the events was reported as: on an unknown date in Feb2021, the patient experienced jaundice and went to the physician. The reporter stated that first saw him on 25Feb2021. His initial presentation included headache and chills. He completed the second Phizer COVID vaccination on 08 Feb2021. He never had abdominal pain but he did develop icteric sclera, jaundice, acholic stools and dark urine. A workup included a negative viral hep panel including two HAV IgM (anti Hepatitis A virus immunoglobulin M), negative ANA (Antinuclear antibody), A1AT (Alpha-1 anti-trypsin) and a normal CT (Computerised tomogram) with normal GB (Generalised bullous) and bile ducts. TB (Tuberculosis) peaked at 5.5 with AST (aspartate transaminase) 916, ALT (alanine transaminase) 1865. He began to feel better the last week of Feb 2021 and repeat labs on 10Mar2021 showed TB 1.3 AST 29 ALT 102 ap 134. It was unclear if this was an infectious process that was not captured but the reporter worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report. Since the vaccination the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment. The outcome of the events was recovering.  Information regarding the lot/ batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event increased AST, ALT and TB test positive and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities,  Committees, and Investigators, as appropriate.
SUDDEN FEVER, UNRESPONSIVE, TACHYCARDIA. ER ARRIVAL 10/4/2022@ 0345. PT TRANSFERED TO ICU HOSPITAL 10/4/2022@0850. PT INTUBATED AT TIME OF TRASFER.
1pm pain slight swelling, tender to touch. Began cold compresses 1 Aleve for symptoms progressed to increased swelling, more tender, some redness continued cold compresses alternated with warm moist heat. Continued Aleve Q 6 hrs as needed.
This spontaneous report as received from a Emergency Medical Technician refers to a multiple patients of unknown ages and genders. Medical history and concurrent conditions were not reported. On an unknown dates multiple unspecified patients received doses of improperly stored VARIVAX, unspecified route, dosage, lot number and expiration date. The doses had some unspecified temperature stability issues (not data logger). No adverse effects were reported. Additional information has been requested.
hand became stiff and sore and within a week settled in index and thumb; severe pain; Swelling; A cellulitis developed in the hand of the arm that received the vaccine in; hand became stiff and sore and within a week settled in index and thumb; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration in the left arm in Jan2021 at 12:00 (at the age of 37-year-old), dose 1, single for COVID-19 immunisation. Medical history included allergy. The patient did not receive concomitant medications. The patient previously took unspecified medication and had allergy. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 19Jan2021, a cellulitis developed in the hand of the arm that the patient received the vaccine in. The hand became stiff and sore and within a week settled in the index and thumb. The patient also had swelling and severe pain. The events were reported as serious (medically significant) and resulted in doctor or other healthcare professional office/clinic visit. The patient received Augmentin and Bactrim for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at 0.3ml single injection in the left arm on 22Dec2020 09:00 for covid-19 prophylaxis. Medical history included persimmon fruit allergy from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced tingling in the left side of her tongue on 22Dec2020, the event was reported as serious per medically significant, suspect that it may be bell's palsy on an unspecified date. The adverse event was not required a visit to emergency room or physician office. Caller was an employee health nurse that reported that she had an employee that received the first dose Covid-19 vaccine on 22Dec2020 and as they were administering the vaccine, the patient developed tingling in the left side of her tongue. The caller said that the patient reported that the tingling was still there. She said that the patient was concerned that it might cause her to get bell's palsy. Caller wanted to know if this was this common and whether she could move forward with getting the 2nd dose of the vaccine. The caller said that the patient received the vaccine in her left arm. The caller said that the patient reported that the tingling in her tongue was mild and not stopping her from eating and she was not having any respiratory issues. Caller said that the only allergy that the patient has was to Persimmon fruit. The side effect mentioned is not necessarily Bell's palsy since the characteristic eye drooping is not present. The outcome of events for tingling in the left side of her tongue was not resolved, for suspect that it may be bell's palsy was unknown. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility: No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No relevant tests. Drug result was related.; Sender's Comments: The causality between the reported tingling in the left side of her tongue, which was suspected that it may be Bell's Palsy and the administration of COVID-19 vaccine, BNT162B2, cannot be denied, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
pt became ill; mom states pt recvd vax 29JAN93; mom noticed pt was fussy & warm; t101, cried off & on all evening & into next day; wouldn't eat; pt screamed when legs bent & hips; to MD 23FEB93 was told was virus; knees were stiff;
Suspected vaccination failure; got the vaccine and got shingles anyway!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself or herself. The age at vaccination was not reported. The patient developed shingles after receiving Shingles vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
I got sick as if I had the flu, or COVID itself ... raw/sore throat, stuffy head, stuffy nose, plugged up ears, sneezing, coughing (still have cough as of 04/06/2021), chills, fever, and body ache.
1. within 10 minutes I had increased heart rate, which went away within next 3-5 minutes than I had another episode, 10-15 min after the first episode, again it went away within 2-4 minutes 2. 04/13/21 by the evening the same day of vaccination I developed pain in the shoulder, arm, hand, neck, breast and underarm on the left side (injection side), left ear, head. Within 24 h form injection I developed ringing in the left ear.  3. Ringing got worse within next 48h. Headache was very bad in the evening/night on 13 -16 of April. Also felt tightness in my throat when swallowing.   4. 04/16/21 - ringing in the ears still there, no improvement,  very loud. Tightness in my throat when swallowing, postnasal drip  5. 04/17/21 ? ringing in the ear still there, no improvement, slight pain in the shoulder, and intermittent headache and pain in the left ear, postnasal drip. 6. 04/18 ? 05/02/21 ? constant tinnitus, no improvement, postnasal drip is lessening.
Section 3: Incident Description (what happened) The patient arrived with guardian and signed consent . The patient was administered Pfizer COVID-19 vaccine by DOD staff, with contracted staff, as the processor in the 1800 hour. The  discrepancy was identified by FEMA during reconciliation of paperwork. When both staff were questioned, staff stated he immunized patient then noticed patient was underage. Staff stated he asked staff only after immunization was  administered if it was ?ok? and Staff stated ?it should be since they only have to be 12 years of age and older to receive the vaccine.?  Neither Staff nor Staff reported the incident to Management and only offered this information once discrepancy was identified.  Operations Manager, denoted patient had already left site by the time discrepancy was identified.
Information has been received from a 34 yr old female with asthma and no allergies who on 09Sep05 was vaccinated with the third 1.0 mL dose of hepatitis B virus vaccine rHBsAg (yeast) (lot 651362/0192R). Concomitant therapy included levothyroxine Na (Synthroid) and hormonal contraceptives (unspecified). The pt reported that on 09Sep05, she experienced fever, headache and nausea. Medical attention was not sought and no lab/diagnostic tests were performed. At the time of this report, the pt was recovering from the fever, headache and nausea. No further information is available.
I received a Moderna COVID-19 booster on 11/23/2021. On 4/1/2022, in the middle of the night or very early morning, I felt like someone had kicked me in my back. The feeling subsided after a while, and then I went back to sleep. Several hours later, when I woke back up, I had a slight fever, a sore throat, and head and chest congestion. I took a home antigen test that day, and the result was positive. I later took another test that evening to confirm the result, and I again got a positive result. I isolated and treated my symptoms with OTC remedies like TYLENOL and vitamin C. My symptoms lasted for around 5 days. After the first day, the fever was gone, but I still had fatigue and cold-like symptoms. From the first day on, the symptoms just gradually improved. On about 4/5/2022 or 4/6/2022, I took another home test and got a negative result. At that point, I was still pretty fatigued and had to occasionally nap, but I otherwise felt fine.
Contracted covid four months after fully vaccinated; COVID-19; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) (age at vaccination 41-years-old) via an unspecified route of administration on an unspecified date as dose 2 single and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6199) via an unspecified route of administration, administered in Arm Left on 25Mar2021 (age at vaccination 41-years-old) as single dose for COVID-19 immunization. The patient had no known allergies. The patient had no other medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 25Jul2021 the patient experienced contracted COVID four months after fully vaccinated. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Rapid Covid-19 Antigen Test was positive on 25Jul2021 Nasal Swab (Rapid Covid-19 Antigen Test). The outcome of the events was recovering.
Allergic Reaction at testing site transported to ED via EMS from home. Throat and facial swelling , tight breathing  Treated with Benadryl and Epinephrine
During monitoring after vaccine, pt stated she was experiencing racing heart and feeling faint.  BP was taken and found to be 174/97 with pulse of approximately 104.  Pt was escorted to emergency room for eval and treatment.
11/15/2005 States felt really bad 7-73PM night of flu shot.  Cold symptoms, chills, achy, eyes blood shot and dry.  11/16/2005 at work feeling somewhat better, eyes still blood shot.  Received Advil 11/17/2005 PM feeling much improved, eyes better.  11/21/2005 recovered.
Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Eh9899), intramuscularly in left arm on 15Dec2020 16:00 at single dose for COVID-19 immunization. There was no medical history (Known allergies (Allergies to medications, food, or other products): No). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: No. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient experienced injection site pain 12 hrs post injection, myalgias, chills, fatigue at 24 hrs on 16Dec2020 07:00 with outcome of recovered. The patient received treatment ibuprofen for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. AE was not resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Serious: no.  Seriousness criteria-Results in death: no. Seriousness criteria-Life threatening: no. Seriousness criteria-Caused/prolonged hospitalization: no. Seriousness criteria-Disabling/Incapacitating: no. Seriousness criteria-Congenital anomaly/birth defect: no.
Dizziness, vertigo with generalized bodyaches and fatigue on Saturday 01/09/20 Narrative: