chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A MILD 8 HOUR DELAYED BLAH FEELING REACTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on MAR-2021 for covid-19 prophylaxis.  The patient had no adverse events following vaccination with covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient additionally received a booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced a mild 8 hour delayed blah feeling reaction to the booster (Dose number in series 2).  The reporter stated that both them (patient) and his elderly mother had been initially vaccinated with J and J vaccine and boosted with J and J vaccine. No adverse event experienced for first dose and patient experienced 8 hour delayed blah feeling reaction to the booster. So far neither of them had a positive or symptomatic covid infection (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a mild 8 hour delayed blah feeling reaction on DEC-2021. This report was non-serious. This case, from the same reporter is linked to 20220909064.
Information was received on 20-APR-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 19-APR-2012 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-DEC-2013, the patient was treated by a physician for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Joint and muscle aches, fever, weakness; turned out to have urinary tract infection, was also treated with anti-inflammatory medication.
menstrual cycle has increased; menstrual cycle has increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), OLIGOMENORRHOEA (non-serious), outcome "unknown" and all described as "menstrual cycle has increased".  Additional information: Reporter informed that his wife expressed that her menstrual cycle has increased a few days after she got her booster shot. She also mentioned that her sister was having a similar experience.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine not was there an ADR that occurred between the observation period and the date of death. Cause of death unknown. Found deceased on the floor by suspected natural causes. Patient had lupus disease of the lung, interstitial lung disease due to collagen vascular disease and depended and supplemental oxygen. Had some complaints of fluid retention on ARNP visit on 3/3/21. Patient was homeless and had a history of cocaine dependence.
Information was received from a pharmacist via a field employee referring to a 92 year old female patient. The patient's medical history included multiple cases of shingles. The patient's concurrent condition, concomitant therapy and drug reactions were unknown. In approximately 2013 (reported as possibly 2 to 3 years ago), the patient was vaccinated with ZOSTAVAX (Lot#, expiration date, strength, dose, frequency and route unknown). Currently, the patient was experiencing a full blown case of shingles (onset date unspecified). The pharmacist was seeking information about ZOSTAVAX and shingles and would be receptive to analysis. It was unknown if patient had started any antiviral therapy. The outcome of the event was not recovered. The causality between the event and ZOSTAVAX was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
multiple bouts of tachycardia reaching a resting HR of up to 138.; profuse sweating; Gestational period at time of initial exposure was 7 Months 2nd trimester; fever; chills; muscle spasms in the legs/muscle cramping throughout my body; nausea; diarrhea; This is a spontaneous report from a contactable female consumer. This consumer reported information for both mother and fetus/baby. This is a maternal report.    A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 38-years-old, via an unspecified route of administration, administered in arm Left on 17Sep2021 13:00 (Batch/Lot Number: FF2587, expiration date: 30Dec2021) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm Left on 27Aug2021 13:00 (Batch/Lot Number: FD8448) as dose 1, single for COVID-19 immunization. Medical history included one previous pregnancy, Breech c-section delivery. The patient had no known allergies, no history of smoking, drinking and use of illicit drugs during pregnancy. Concomitant medications included ascorbic acid, calcium, folic acid, iron, nicotinamide, pyridoxine, retinol, riboflavin, thiamine, tocopherol, vitamin B12 NOS, vitamin D NOS, zinc (PRENATAL); and ferrous sulfate (IRON) both from 01Mar2021. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Gestational period at time of initial exposure was 7 Months 2nd trimester. The first night on 18Sep2021, the patient experienced fever, chills, muscle spasms in the legs, muscle cramping throughout her body. Her baby thrashed violently in her stomach most of the night. She woke with nausea and diarrhea multiple times. The second day on 19Sep2021, she had nausea and multiple bouts of tachycardia reaching a resting HR of up to 138. The second night she experienced another fever and profuse sweating. Her ob-gyn recommended fluids, rest and Tylenol. The patient has not received treatment. The outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101228216 baby case
immediately following vaccination patient reported paresthesias and numbness on right neck and arm.  Vital signs within normal ranges except blood pressure 142/94 mmHg. Patient remained awake, alerted, and oriented: no respiratory, gastrointestinal, or dematologic symptoms reported. Patient transported to emergency department where physical and neurological exam notable only for decreased sensation on right arm. Cranial nerves intact and normal strength in all extemities. Patient observed, able to ambulate without assistance, and discharged to home stable.
After 2nd Pfizer shot, 6 days later I developed Small fiber neuropathy. Tried prednisone and didn?t help. ER gave me gabapentin today.  300mg po 3x a day
He started having some raised red itchy bumps on his trunk yesterday afternoon (9/3/22).  His mom called the on call pediatrician and they stated this is not a reaction to the shot.  He is taking Benadryl and hydrocortisone for the rash. His mom stated that he is better today- he is not itchy like yesterday.  He seems more comfortable.  He did not have this reaction after the first 2 shots- only a sore arm.
Arthralgia fatigue Narrative: Arthralgia, fatigue; self resolved 48 hours
Fever, Chills, Headache, Diarrhea, Tiredness, Injection Site Pain (minor), Feeling unwell. Tinny taste in my mouth that I still get occasionally.  Reaction began during the night after the shots on Wednesday, October 12th. I woke up with fever and chills, the tin taste in my mouth. Very tired. Ibuprofen helped with the fever. It was gone by the end of day Thursday. I continued to feel tired and draggy with headache, through Saturday. I continued to take Ibuprofen daily which helped. Sunday, October 16th I felt normal again.  I have never had a reaction when taking the flu shot.
This spontaneous report as received from a medical assistant referring to a 2 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL Lot#: M034437, expiration date on 03-FEB-2019 (strength, dose number, route and anatomical location were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. No product quality complaint was involved. The vaccines experienced the following temperature excursions during 20 minutes: 32°F (Fahrenheit), 36°F and 46°F; during 41 minutes: 77°F; during 1 hour and 20 minutes: freezer 5°F and 14°F. The aforementioned ones were identified due to a data logger. There was no previous temperature excursion. It was reported that the vaccines were supported. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided.; Sender's Comments: US-009507513-1701USA012391: US-009507513-1701USA012392:
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a registered nurse and refers to a 4-years-old male patient. The patient's pertinent medical history, concurrent conditions, , previous drug allergies or reactions and concomitant medications were not reported.    On 24-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen and route of administration were not provided), lot number T002848; expiration date 23-JAN-2022, as prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT) (Lot number S008566; expiration date 16-NOV-2021).    The improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature excursion of -14 degree Celsius (°C) to -10 °C (average temperature was -12.1 °C) degree Celsius (°C) for a period of 3 hours with multiple excursions: -9°C to 8 °C (average temperature was -7.5 °C) for 8 hours 30 minutes. It was reported that the vaccine did not had a previous temperature excursion. The call was because a digital data logger.
Patient states to have flu like symptoms.  They did not start until 5 days after shot.  Sore throat, coughing, extreme fatigue, blooding recent bloody nose(but he's not sure if it's from constant blowing).  Patient went to an urgent care and was tested for COVID.  Results came back 9/20/2021 negative.  Patient states he is starting to feel improvement.  He's not going into work and just resting.
about 4 weeks after my second shot I started to notice unusual things in my body. I was waking up every day with severe cramps in my calfs.  I did not change my exercise routine and never have had that problem before in my life. Then I noticed that both of my knees were very sore- that has never happened to me before. Then yesterday I got alarmed when I found myself getting VERY dizzy every time I bent or stooped and then stood- I almost fell over- that NEVER happened to me before.  Today I feel a bit like "brain fog" and that is also a new experience for me.  I am hoping I have not had a brain blood clot or other adverse reaction to the shot. These are strange symptoms but so unusual for me that I felt I had to report them.`
very uncomfortable; Headache; Chills; Fatigue; Coughing; sore throat; No appetite; A spontaneous report  was received from a consumer, concerning a 42 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced headache, chills, very uncomfortable, coughing, fatigue, no appetite, and sore throat.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 29 Dec 2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number: 025L20A) intramuscularly for COVID-19 infection prophylaxis.   On an unknown date, the patient started having a headache, chills, and was very uncomfortable. The reporter stated that as days went by, the patient had more and more symptoms.   On 31 Dec 2020, the patient was coughing, had fatigue, no appetite, and had a sore throat. Treatment for the events included acetaminophen/doxylamine succinate/dextromethorphan and ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: This case concerns a 42-year-old, male patient. The patient's medical history was not provided. The patient experienced unexpected event of cough, sore throat, malaise, decreased appetite and expected event of chills, fatigue and headache. The event of headache, chills, malaise occurred on unspecified date and event of cough, fatigue, decreased appetite and sore throat occurred 3 days after the first dose of mRNA-1273 (batch number: 025L20A) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Within 24 hrs /p immunization, child experienced swelling @ the inject site & a T of 105.2 . Treatment included Tylenol for T the following day, the child asymptomatic.
Flu like symptoms that started early Saturday morning 4/10/2021. Fever no higher than 100.6 Then around 7 PM small nodules appear all over body. (Like bug bites) None around the injection sight.  All vitals are good no respiratory issues.
COMA; FITTING; SEVERE HEADACHES (WORSEN NEXT DAY); DIED; This spontaneous report received from a patient social media via a company representative concerned a male of unspecified age, race and ethnic origin. 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 not reported, batch number: Unknown, expiry: Unknown) dose was not reported, frequency time 1 total administered on 27-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 27-AUG-2021, after vaccination the patient instantly got severe headaches, even worst next day (28-AUG-2021). On 29-AUG-2021, patient started fitting in hospital and on 30-AUG-2021, she was in coma and was hospitalized (days unspecified). On 31-AUG-2021, the patient died from unknown cause of death. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died on 31-AUG-2021, and had not recovered from severe headaches (worsen next day), coma, and fitting. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210902754.; Sender's Comments: V0: 20210902775-covid-19 vaccine ad26.cov2.s-died, coma, fitting. 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). 20210902775-Covid-19 vaccine ad26.cov2.s-severe headache. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Information has been received from an office administrator concerning a 19 year old male patient who on unspecified date was vaccinated with a dose of 5 mcg/ 0.5 ml RECOMBIVAX HB (Lot number not reported). On an unspecified date the patient had no detectable hepatitis B titers. The patient had visited the office. At the time of reporting, the patient had not recovered. Follow-up information has been received from a physician reporting that they had re-vaccinated the patient on an unspecified date. No further information is available.
Narrative:  COVID infection following COVID vaccine series 02/18, Pfizer, dose #1 03.11, Pfizer, dose #2 09/24, Pfizer, dose #3 08/26 COVID swab, result: detected 08/26 pt cc: no symptoms exposure: unknown 08/26 DDIMER result: 0.27 08/26 BNP result: 92.8 08/26 SARS-COV-2 Variant Sequencing result:  pending 08/26 CXR impression: no acute cardio-pulmonary finding 09/28 CXR impression: lung hyperinflation may be secondary to vigorous inspiratory effort versus air trapping. 2. Progressive left basilar opacities may represent residual atelectasis/scarring from reported pneumonia. Similar right basilar atelectasis/scar. Correlation with clinical symptomatology is needed. Consider follow-up imaging to confirm resolution or stability.
Janssen COVID-19 Vaccine EUA Soreness immediately after injection.  Chills, dizziness, ringing in ears, nausea lasting from about 9pm to 3am.
Improperly stored vaccine administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 26-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0,5 ml, lot# S036635, expiration date 14-NOV-2021, for prophylaxis (strength, route and frequency were not reported).  The temperature excursion was of -16.07 Fahrenheit degrees (°F) for 25 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Blisters in my mouth.  Upper gum front, under upper denture.  Irritated by new denture. Lower gum front irritated by new dental bridge.  Am unable to wear bridge, but I must wear upper denture
i had flashing lights in my right eye on March31.  i saw doc on april 1.  he sent me to see P.A. on April 2nd.  I had a clump of cells behind my retina in my right eye.  I had lost most of my vision.   i am still getting treatment and still have the eye sight loss.   I have had 5 shots in my eye.  the swelling behind the retina is in control but it has damaged my flow of blood to my right eye causing loss of vision.  I am concerned that the moderna shot might have been involved.  I hope you will consider my investigation..
Hashimoto's Thyroiditis. No prior history. Also diagnosed with EBV.
19Feb90 pt vax;  07Mar90 seen by MD w/ complaints of rash, swollen tesicles, swollen legs, & conjunctivitis.  Md felt he had resolving otitis media, fever, conjunctivitis, & headaches.  05May90 seen by MD for sore throat. No swollen testicl
Received 2nd dose April 29. On May 26 in the evening began to find skin rash on lower back and arms. May 27 found a folliculitis type rash on arms and lower back. Contacted my dermatologist and saw him at 2 pm. He was unable to diagnose the condition which had spread to belly and left knee. Biopsy was taken for pathology. Since that time, has spread to both legs above knees, buttocks and upper chest. Some painful areas on stomach and back, both near the waistline that responds to massage. Triamcinolone 0.1% cream prescribed that does help some. Cold packs on affected areas helps. See improvement in the two mornings since start, but worsens during day. I can only think of two possible causes: 4 week delay from last vaccination or ammonium lactate topical for lower back.
about 6 hours after getting a flu shot I experienced a rapid heart beat for about 5 min. I take metoprolol but it didn't help this episode to quit
This spontaneous report as received from a physician via company representative refers to a 6 year old male patient. The patient's medical history included chicken pox. The patient was adopted from another country at 22 months of age. On an unknown date at the age of 24 months age, the patient was vaccinated with VARIVAX (merck) (strength, dose unit, lot# and expiry date unknown). On an unknown date at the age of 4 years, patient received additional vaccination with VARIVAX (merck). On an unknown date in 2014 at the age of 6 years, patient experienced shingles rash. On 17-FEB-2014, patient visited the doctor office with shingles rash. It was reported that medical papers that came in with the child from another country stated that the child had chickenpox prior to coming to this country, the papers do not clarify if this statement refers to the patient receiving a previous vaccination against chicken pox or if they are referring to the patient having had the chickenpox condition. The outcome of shingles rash was unknown. No further AE information was provided. Additional information has been requested.
Low grade fever; headache; body aches; chills; nausea; Swollen lymph nodes; injection site pain; swelling 12 hours after injection; patient administered first dose on 03Feb2021 and second dose on 20Feb2021; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 20Feb2021 09:30 (at the age of 19-year-old) as dose 2, single for covid-19 immunisation. Medical history included Lichens Sclerosis and supraventricular tachycardia from an unknown date. Patient reported having known allergies from amoxicillin. Concomitant medications in two weeks included CLOBETASOL PROPIONATE and Paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration, administered in left arm on 03Feb2021 09:30 (at the age of 19-year-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Feb2021 21:45 (same day of vaccination), the patient experienced low grade fever, headache, body aches, chills, nausea, swollen lymph nodes, injection site pain and swelling 12 hrs after injection, patient administered first dose on 03Feb2021 and second dose on 20Feb2021 was considered as Inappropriate schedule of vaccine administered. All symptoms subsided within 26 hrs. No treatment was given for the events. Outcome of the event Inappropriate schedule of vaccine administered was unknown and on an unspecified date in 2021, outcome of low grade fever, headache, body aches, chills, nausea, swollen lymph nodes, injection site pain and swelling 12 hrs after injection was recovered.  No follow-up attempts are possible. No further information is expected.