chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea 3-4 times; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (144508).  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation, reaction(s): "diarrhea", "sore arm". The following information was reported: DIARRHOEA (non-serious) with onset 27Feb2021, outcome "recovered" (28Feb2021), described as "diarrhea 3-4 times".  Additional information: It was reported that the patient could barely get out of bed and the event stopped the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer and described the occurrence of stiffness in a 75-year-old patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 2nd dose of SHINGRIX. On 26th October 2018, 2 days after receiving SHINGRIX, the patient experienced stiffness and general body pain. On an unknown date, the outcome of the stiffness and general body pain were unknown. It was unknown if the reporter considered the stiffness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient had the extremely stiff and whole body was just aches and pains that, the patient just sat all day and did absolutely nothing. This case has been linked to the case US2018GSK196601.
Patient was given Hep A # 2 6 days to soon. It will be repeated 7/24/2022 or after
Immunization given AM 4/30/02. On 5/1/02, developed shaking all over then had periods of unresponsiveness. Drooled but no respiratory distress. Seen 5/1/02 Med. exam. 2 further episodes over next couple days, rechecked 5/7, Referred to neurologist, Probable seizures, Normal head CT & EEG, No medication, No further seizures.
Pt had 2nd dose on 2/18. Had fall on 2/19 from weakness resulting in rhabdomyolysis.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 12:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Initial misuse report received from a healthcare professional on 01 August 2013. A child was administered only the DTaP/IPV component from PENTACEL vaccine without the ACTHIB component. No adverse event was reported. List of documents held by sender: none.
Skin turned bright red from neck to groin, complete abdomen and both arms down to elbow, mild itching
Muscle where medication administered very sore and tender.  Date 11/21/2014 currently and still exhibiting pain and tenderness.
1st flu shot ever, never had flu before and got symptoms approx. 8 hrs after receiving flu shot included, high fever 103 degrees, near syncope, dizziness, nausea, body aches, headache.  Tylenol taken with onset of fever, decreased through the night to 101 degrees.
body pain, skin sensitive to touch, redness at site, swelling at site, headache, stomach pain, tiredness, chills, fever, dizzy
03Jan2022 PCR positive for COVID after exposure to sister on 24Dec2021 NO SYMPTOMS; 03Jan2022 PCR positive for COVID after exposure to sister on 24Dec2021 NO SYMPTOMS; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP(nurse)) from product quality group.  An adult male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FF2589) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "positive for COVID after exposure to sister", start date: 24Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" and all described as "03Jan2022 PCR positive for COVID after exposure to sister on 24Dec2021 NO SYMPTOMS". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, asymptomatic covid-19. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and asymptomatic COVID-19 cannot be ruled out.
pt recvd vax & in 1985 failed to seroconvert; No further details were provided;
Severe Nerve pain right side upper and lower teeth. Sharp shocking pain when any liquids, even water, touch mid to back right side teeth. Nerve pain also noted when sustaining open mouth and breathing. Touch of breath on teeth causes pain.  Dentist evaluation 02/06/22. An experienced dentist reviewed x-rays of teeth and assessed mouth. He reported that he did not see any problems that would cause that pain.
tested positive for covid after receiving the vaccine; A spontaneous report was received from a physician concerning five patients of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID after receiving the vaccine.   The patients' medical history was not provided. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the event, the patients received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the physician called in stating he knew of 5 other people that tested positive after receiving the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, tested positive for COVID after receiving the vaccine, was not reported.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of a Covid-19 positive test after vaccination, this event is assessed as unlikely related to mRNA-1273.
Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/25/2021: 7:45 AM extreme fatigue,  loss of appetite,  taste buds off Treatment: naps, fluids  02/25/2021 9:00PM mild muscle aches and joint pain
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information provided. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) (batch number- 011L20A). No treatment information provided. This case was linked to MOD-2021-395985 (Patient Link).
About an hour and a half after I got the vaccine I started feeling very nauseous and started to get a slight headache. A few hours went by and the nausea increased. I layed down for a while and then my body started to ache intensely. Once I finally fell asleep and woke up from my name the body aches were horrible and then I suddenly had the chills. I almost threw up three times and I had the chills so bad that my body aches more and more.
CHICKENPOX lesions (>25) on the extremities, trunk, feet and groin/ Tested positive for varicella zoster using the PCR test; This spontaneous report was received from a lab manager concerning a 2-year-old female patient.   The patient had a healthy past medical history however it was reported that she was allergic to spinach. Information regarding the patient's historical drug was not provided. Concomitant therapies included daily vitamins with fluoride.  On 27-JUN-2021, the patient was exposed to shingles because of her grandmother for an unknown timeframe.  On 28-JUN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters on the left arm, lot number T035398 expiration date 16-OCT-2022 (route of administration was not provided) as prophylaxis.  On 08-JUL-2021, the patient presented chickenpox lesions (>25) on the extremities, trunk, feet and groin; the patient tested positive for varicella zoster via Polymerase chain reaction (PCR) test.   The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 12-JUL-2021, a sample was obtained from a skin lesion (papule). It was unknown if the patient was on antiviral therapy; results from the PCR test were still pending.  At the time of the report the rash was still present. The causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the chickenpox was not reported.
REALLY BAD CHILLS; FELT A BIT RUN DOWN; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose, start therapy date were not reported 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 an unspecified date, the subject experienced really bad chills, and felt a bit run down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really bad chills, and felt a bit run down. This report was non-serious.
cough; stuffy nose; headache; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASAL CONGESTION (stuffy nose), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough), NASAL CONGESTION (stuffy nose), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (fever). At the time of the report, COUGH (cough), NASAL CONGESTION (stuffy nose), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown.            Reporter did not allow further contact
Information has been received from a nurse midwife concerning an 18 year old female patient with no pertinent medical history who approximately in "mid-June", was vaccinated with the first dose of GARDASIL (lot number not reported). On 17-AUG-2009 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot number 660618/0572X). There was no concomitant medication. The patient fainted after receiving the second dose of vaccine and recovered a few minutes later. Unspecified medical attention was sought. It was unknown if there were lab studies performed. Additional information has been requested.
67-year-old female employee (pediatric surgery office practice nurse) with history of migraine headache, no significant episodes after menopause, who received a 1st COVID vaccine dose 12/22/2020 here with a 3rd episode of migraine headache, nausea, and dizziness since vaccination.
Patients Left arm was swollen- red at injection site, Site measured to be a 4cm X 6cm.
Since patient received the 1st booster (3rd shot) of Pfizer she cannot make a fist with her hands and she lost feeling in her feet - Her doctor told her that this is not the first time he has witnessed this happening with his patients after receiving the vaccine and that he has seen this happen to many of his patients
Allergic reactions as swelling of lips, tongue, face, and throat, and rash and itching on face and lips
Right Arm swelling, lump and severe pain.  Persisting 2 mos later.  Weakness.  Pain has now migrated up into neck and then moved to left arm and then feet.
While at school, the patient complained of painful/swollen lymph nodes of his right neck at approximately 8:15AM the morning after being given the meningococcal vaccine. He went to the school nurse who took his temperature (which was normal at that time). The patient had no other complaints of not feeling well. The school nurse administered IB profin to the patient. The patient returned to class. Approximately 90 minutes later, the patient returned to the school nurse with complaints of feeling dizzy, light headed and "weird." The patient also complained of a bad headache and also felt his throat hurt. The nurse took his temperature which at that point was 100.7, even after being give the fever reducing meds 90 minutes prior. The patient was brought home from school. Patient has been given alternating doses every three hours of IB profin and acetaminophen. Patient complained of continuous headache throughout the day. Patient was seen by Dr. at his primary care. Dr. explained symptoms were "normal". Patient's mother explained her concern for the dizziness/lightheadedness and fever.  Dr. said she would not report as an allergic reaction. Dr. wanted to test for flu and strep which patient's mother declined, the patient having just been at the dr 14 hours before with no symptoms and the symptoms came on quite suddenly. Dr. suggested fluids and meds.
left sided chest pain x1 week. Pericarditis on EKG. Troponin negative
February 4, 2021 Patient woke up from nap at 2:10pm very lethargic, starting to turn purple, respiratory failure,  muscle weakness, eventual paralysis in upper and lower extremities.  We are still in the hospital and not looking to leave anytime soon.
11 year old female was administered two pediatric Pfizer vaccines (0.2 ml), in deltoid muscle bilaterally in one clinical visit. Patient did not demonstrate any abnormal symptoms and was fully alert, conscious, and oriented during the entire interaction. Patient and parent present were informed of medical error and parent verbalized understanding of error and understood that the patient did not exhibit any symptomatic abnormalities.  Error occurred after receiving one COVID vaccine at a COVID vaccination station and then proceeded to a different vaccination station to receive a flu shot. At the second station,  patient presented a vaccination card and stated that she needed a vaccine along with her brother who stated that she needed a COVID vaccine. Patient presented no abnormal symptoms after receiving a second pediatric Pfizer dosage (0.2 ml). Patient was monitored for 15 minutes however no abnormal symptoms were noted on patient. Patient's mother and patient stated that they felt normal and w there informed to seek additional medical if symptoms presented at a later time.  Patient's mother stated to be comfortable with the outcome of the medical error.
24 hrs. local "pin prick" - swelling - red - hot 2/3/11 7:30-8pm H/A, chills, fever 101 2/4/11 slight H/A, T 100 local red, hard, hot but not worse will follow up with her PCP.
5-10 mins after injection increased heart rate to 165. Heart palpitations the next two days.
Within 14 hours of 2nd dose, a morbilliform rash occurred on the trunk of my body. Lasted 2 months. Not itchy. 2 weeks post vaccine, capillary issues present on feet that resembled COVID-19 feet and toes. Capillary issues still persist 12/18/2021.
10/12/14 - felt weak. 10/18/14 - weakness, cough, hoarseness, low grade fever, body ache, mild headache. 10/19/14 - TYLENOL 2 x 2.
Swelling at the injection site, extending approximately 2" diameter around the site. Area was hot to the touch. She was uncomfortable and fussy. Swelling and fussiness went away after several days.
pt recv vax NOV97 & lab eval revealed that the pt did not have any antibodies;
Soreness in left arm at injection site.; This is a spontaneous report from a contactable consumer via Pfizer sales/company representative, the parent. A 25-year-old-non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Mar2021 at 10:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021 at 12:00, the patient experienced soreness in left arm at injection site. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event vaccination site pain. The clinical outcome of the event vaccination site pain was recovering at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
very sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (very sore arm.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer. Concurrent medical conditions included Crohn's disease and COPD.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (very sore arm.). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (very sore arm.) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  After the first dose she had a very sore arm which was no worse than a tetanus shot.  Patient reports a recent antibody test on an unknown date that was inconclusive.   This case was linked to MOD-2021-295023 (Patient Link).
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 04-JUN-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
2.5mm red circle around injection site; Swelling on shoulder; Swelling on shoulder along with pain; Tenderness of muscles surrounding shoulder; Fatigue; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 29Mar2021 at 13:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was unknown about the allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), buspirone (MANUFACTURER UNKNOWN), cannabidiol (CBD) (MANUFACTURER UNKNOWN) and nutrients NOS (ENSURE); all from unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced 2.5mm red circle around injection site, swelling on shoulder, swelling on shoulder along with pain tenderness of muscles surrounding shoulder, severe fatigue, minor headaches and chills. The patient did not receive any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events 2.5mm red circle around injection site, swelling on shoulder, swelling on shoulder along with pain, tenderness of muscles surrounding shoulder, fatigue, headache and chills were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Pt states 2 hr after Flu shot and Pneumonia shot sore arm, chills, myalgia and some diarrhea.
pt recvd vax 23AUG94 & mom called 23AUG93 @ 1350 stating pt had hives all over body; stated they had appeared approx 3 hrs p/vax 23AUG94; no fever; pt given APAP MD advised DPH;
p/recv vax pt on 6/30 devel hives on legs & feet. treated w/benadryl  but rash continued until 7/4/99