chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/6/2021 and 2/27/2021. Patient presented to physician office on 12/29/2021 complaining of shortness of breath, congestion, cough, body aches, headaches, fatigue and sinus pain x4-5 days. Rapid influenza screen was positive for Influenza B, and patient prescribed oseltamivir, while awaiting COVID PCR results which later resulted as positive as well. Patient presented to ED on 1/2/2022 with increased weakness, dyspnea, and decreased appetite with an SpO2 of 80%. Patient admitted, and continued to decompensate requiring intubation on 1/4/2022.  Patient status was DNAR/COT and patient expired.
pt recv vax 6SEP96 & 9SEP96 pt devel 100 chickenpox lesions over the entire body w/a fever of 101;tx w/Bactroban;MD stated that a possible secondary infect was developing d/t the lesions;@ time of report pt still being treated;
Feeling sick/doesn't feel very well; hives (on neck and shoulder); Feverish; Achy; cannot move; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included "coronavirus" and allergies. The patient's concomitant medications were not reported. On an unspecified date, the patient was feeling sick and developed hives (on neck and shoulder). She wanted to know if she needs to get the second dose since she is afraid to have the side effects again. Patient was feeling feverish and achy, cannot move and doesn't feel very well on an unspecified date. She stated that the place where she received the vaccine had several sites set up. She got the first at one site. She is scheduled for her second dose at another site, but she read or heard it should be done at the same site. She wanted to know if it is safe to have the second shot. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Day 2,  arm soreness, fatigue, chills half day, metallic taste in mouth, exhaustion, lethargy. Day 3, slight nausea half day, metallic taste in mouth, tiredness.
10/24/13 pt received PNEUMOVAX vaccine and flu vaccine. 5 hours later developed pruritic vesicular rash on extremities and face. Treated with prednisone 11/7 - will follow up with dermatology.
She experienced body aches, vomiting, diarrhea, tinnitus and headache. The headache lasted several days. She continues to have tinnitus, which is the only symptom that persists.
body aches; joint pain; headache; tiredness; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches) in a 41-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 01-Apr-2023.    On 29-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 30-Oct-2023, the patient experienced ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tiredness). On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches) outcome was unknown.            No concomitant medications were reported. The patient did not experience any additional symptoms/events. No medicines were taken in response to the event.
Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. original expiration was 2Mar2021 states the expiration was changed to 2Oct2021. Nurse states she wrote expired on the box but the doses were accidentally administered .   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: significant follow up appended : Reporter / Lot no / Expiration Date Updated .
No adverse reactions reported.  To whom it may concern: In November 2022 our state immunization program did our every-other-year audits in both our offices. It was discovered at that time, that some covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.) The state program directed us to fill out VAERS forms and send them to you. The state also counseled us that it was our providers & parents joint decision as to whether to re-vaccinate pats or not. We only use Pfizer vaccines for Covid and the listed lot #'s given outside the expiration date are listed below.  Lot #s FM0369 (orange top)       FM0698 (purple) FM0698 (purple top)        FP4554 (purple) FL8095 (orange top)        FL8094 (orange) FL8094 (orange top)        FL8095 (orange) FM7553 (purple)              FT1551 (orange) Please see the attached VAERS forms, and feel free to contact the office for further questions or concerns.
Booster dose given. During observation, patient reported feeling dizzy and then vomited x3.  EMS called and pt was transferred to ED for further evaluation.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested.
1545 Pt reported feeling sharp pain when breathing in. 1600 Pt reported tingling bilateral arms and back of neck. 1615 Pt reported sharp pain upon breathing had resolved. Tingling sensation beginning to go away.
pt had school physical showed physician arm while there-had low grade temp-given APAP;bruise, red, swollen 4" diameter-placed on ATB;
Had to call doctor on call due to my lips swelling, full body rash.... Lumpy, red and itchy. Asthma flared up also.  Doctor put me in a week of steroid tablets, I'm still taking 3 anti hestamines a day to control the rash.
Itchy rash all over face and body, occurred for 5+ days. Little red bumps.
Face flushed, complained of tightness to throat, complained of difficulty breathing, BP 182/82, pulse 66, O2 sat 98% on room air, hoarseness and weakness.  Maculopapular rash on neck and back.  Patient transferred to ER and received diphenhydramine 50mg IM at 1640.  Patient to take diphenydramine 50mg by mouth every 6 hours if needed for itching.  (Note: pateint has recieved influenza vaccination annually for many years).
Pt died p/recvd vax w/Hep B; @ time of report casue of death was unk; No further details were provided;
Exhaustion; Fever 101.8 Fahrenheit; body aches; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Exhaustion), PYREXIA (Fever 101.8 Fahrenheit) and MYALGIA (body aches) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021 at 7:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (Exhaustion), PYREXIA (Fever 101.8 Fahrenheit) and MYALGIA (body aches). At the time of the report, FATIGUE (Exhaustion), PYREXIA (Fever 101.8 Fahrenheit) and MYALGIA (body aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 101.8 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Case number PHEH2016US029290, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 65 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX Quadrivalent at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 20 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Description: SM developed, N&V, HA, diarrhea about 72 hrs post anthrax vaccination #1, which recurred with second anthrax in Sept. Symptom: Fatigue, Malaise >60 Days Start: 07/08/2007. Symptom: Diarrhea Start: 07/08/2007 Comment: lasted 4 days first shot, 2 days second shot. Symptom: Nausea w/ vomiting Start: 07/08/2007 Comment : only nauseated with anthrax#2. Symptom: Headache, general Start: 07/08/2007 Comment: 8/10 first time, 3/10 second time.
Patient experienced pruritus on the face and neck anterior chest, scratchy throat. she was treated with Benadryl, Pepcid and observed in the emergency department and discharged. She has similar reaction if exposed to cats and penicillin.
Information has been received from a registered nurse (RN) concerning a 24-week-old male who on 20-MAR-2007 was vaccinated with the second dose of Rotateq (1st dose administered on 07-DEC-2006). Unspecified medical attention was sought. Additional information has been requested. No further information is available.
day of vax pt devel hives & itching on trunk et arms, resolved same day, treated w/benadryl
On the day of my vaccination I received it at around 4:30 pm -4:45PM on 9-21-21 - I did mention i had an episode of Afib in 2019 - I was asked if I had medical clearance not knowingly if I needed it - I was told no - After my injection - that night around 11-12am I experienced pain twinges in my heart - at least 2 times that night. The next day on 9-22-21, in the AM at work I noticed another set of twinges with pain briefly , later once i got home at at around 5-5:30 PM within 24hours of my vaccine I experienced my heart doing flips and fluttering pounding and decided to check my heart monitor which at that moment detected Atrial-Fibrillation along with heart pounding, heart palpitations fluttering and high heart rate readings up to 135-155. I am still experiencing heart palpitations and flutters.
Covid arm. Red, hard, slightly swollen and slightly itchy circle around the vaccine area on the left arm.
febrile sz; temp to 104.6; local erythema @ DPT site;
Tetanus and Diphtheria Vaccine given on 11/12/03.  On 11/16/03 patient reported mild fever, 3-4 inch red, hot area on right upper arm.  Prescribed antibiotic by emergency dept. physician.
This case was reported by a physician via sales rep and described the occurrence of pain in a patient who received MENVEO. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, unknown after receiving MENVEO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to MENVEO. Additional details were provided as follows: The reporter stated that, the patient had been offered a Medical Science Liaison (MSL) address safety concerns. This case has been linked to the US2017GSK132045 and US2017GSK132046 reported by the same reporter.
Near-faint episode (occasionally occurs already with this patient) at 11:30PM on 10/29/15. Low blood sugar of 70mg/dL at 12:30AM. Ate a snack. Felt cold at 1:10AM. Checked oral temperature twice at 1:30AM, with reading of 95.0 degrees F both times. Blood sugar normal of 110mg/dL at this time. Felt he had a high heart rate and nausea. He took vitamin C and his missed thyroid dose at 1:30 (missed dose earlier in day, was going to wait until normal scheduled time, but took it when he saw his temperature. Felt less cold around 2:00AM but did not recheck temperature. Upon waking, normal body temperature but still nauseous. Still slightly nauseous at time of reporting to administering pharmacist at 5:30PM on 10/30/15.
pain /achy; shivering; tired; hot; rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 30 years ago). Concomitant products included Herpes zoster (Shingrix).   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th November 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering and tiredness. In November 2019, the patient experienced red rash and skin warm. Rechallenge with Shingrix was positive. On 9th November 2019, the outcome of the pain, shivering and tiredness were recovered/resolved. On an unknown date, the outcome of the red rash and skin warm were unknown.   It was unknown if the reporter considered the red rash, pain, shivering, tiredness and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the early September 2019 in left arm and had similar side effects. The patient received dose of Shingrix in the left arm around 5 pm. In the middle of night of vaccination day, the patient had pain, shivering, tiredness and achiness and then resolved in the following day. On 10th November 2019, the patient took band aid off from arm and noticed a 3 inch red rash on left arm that was two inches below the injection site. The patient reported smaller areas of a rash beside them that was hot to the touch. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
This spontaneous report was received from a medical assistant and refers to a 65 year old female patient. There was no information about the patient's concurrent conditions or concomitant therapies. The patient was vaccinated with PREVNAR 13 in July 2018. The patient had allergy to iodine, AUGUMENTIN, BETADINE, BIAXIN, KEFLEX, vancomycin and latex. On 04-OCT-2018 (reported as today), the patient was administered with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) with only 3 months separation from the injection of PREVNAR 13. On 04-OCT-2018, reported as after the vaccine injection, the patient developed redness and was swollen at the injection site. No adverse effects were reported. The patient was seen by the physician and received treatment for the events. No lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
on 5/31/18 she woke up with a fever, was given tylenol and went back to bed. The morning of 6/1/18 she woke up and continued to fever and had a rash. Went to the pediatrician's office, confirmed it was a vaccine reaction. Asked to give tylenol to keep the fever down and it would subside in about 24-48 hours. From 6/1-6/4 she spiked fevers every 4 hours that would range from 104.5-105.1. Called the nurse line on 6/2 and we were told to continue tylenol. She went back to the pediatrician on 6/4 due to high fevers still and was diagnosed with pneumonia via chest x-ray. Given Rocephin shot, then prescribed oral amoxicillin for 10 days.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was intramuscularly administered the three doses in the GARDASIL series on 05-OCT-2011, 25-SEP-2012 and 24-OCT-2012 respectively. No lot number was provided. No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Approximately 8.5 hours post vax the pt experienced severe deep tendon muscle pain. At 7PM pt took Biox tablet for backache. At 10PM she noticed muscle cramps on the inside of thighs which was relieved with movement. Half and hour later she was awakened by severe deep tendon pain which ran from the outside calf from ankle to knee and then up inside her thighs to her groin. She states that she was screaming and crying and could not relax. Her husband, an MD, tried to massage her muscles and the report states that he couldn't feel any spasms. The pt was inconsolable and her physician husband administered and unspecified amount of IV Valium. She woke up feeling fine. No further muscle cramps or complaints of discomfort. Pt is cold by nature and experienced an unusual feeling of extreme heat during this event.
Fever, chills, shortness of breath with an elderly patient, who reported calling 911 because of these symptoms. Symptoms have resolved, but patient reports feeling fatigued recovering from these symptoms.
Severe vertigo, dizziness, faintness. Many occurrences. Went to Emergency Room and examined, all tests negative as to cause. Meclizine 25mg prescribed.
Itchy rash covering entire face.  01/04/10 OB notes received for DOS 11/02/09 and 11/30/09.  Pt presented for routine visit.  Pt reported flutter fetal movement on 11/30/09.
CHILLS; HEAD ACHE; FEVER LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 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 MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced head ache. On MAR-2021, the subject experienced fever like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head ache, chills and fever like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210328755.
PT STATED HAD FEVER HEADACHE SWELLING OF THE ARM AND REDNESS NEAR INJECTION ONE DAY AFTER INJECTION, AND PT HAD FEVER TIRED AND WEAKNESS.
Numbness with tingling in face and arm within fifteen minutes vaccine being given. This was the of second shot in the series of three. The numbness lasted a total of thirty to sixty minutes.  02/18/2015 6:00 PM Sudden severe fit of uncontrollable laughing and crying. During the fit unable to stop even to breathe, eyes bugged out, threw himself backwards, his face was red and swollen. The fit lasted a between five and ten minutes, as soon as the fit stopped his face became numb with tingling sensation.
The following two days I had a low grade fever, extreme fatigue, dizziness, and light headedness. This was intermittent throughout the two days. By day three it was done.  I also have noticed (three weeks later) that there?s still swelling at the injection site, similar to a boil
Numbness.  It started in my arms, then by 4pm I was feeling numbness in my feet.  I went to the doctor on 10/18/3013.  I took a 6 day steroid treatment and still have the symptoms.  My doctor diagnosed this as Peripheral Neuropathy.
Per mom on 10-06-08 : Stated child developed fever of 105.2 within 24hrs of vaccines. Took in ER 3 days later with 5x of URI, cough, runny node, conjunctive excudate, UTI R/O. No site Reaction  .
I was exposed to COVID-19 and tested positive for COVID-19 on 01/26/2023. I then reached out to my provider and got prescribed PAXLOVID. I felt better for 5 days. On 02/05/2023 I tested negative for COVID-19. Then experienced fatigue, sneezing and coughing. I tested positive again on 02/07/2023 for COVID-19. I had access to at home testing.
patient states they felt pain and burning during vaccine, had fever for several days after, and that he still has pain in his arm and cannot move his arm.
Headache, Fever, Diarrhea, NauseaVomiting, INJECTION SITE PAIN Narrative:
Red, swollen, itchy arm surrounding injection site. Started 7 days after receiving vaccine. Improving after 4 days but not completely resolved
Pt reports on the evening of 5/5/21 her bottom lip started to swell. Pt reports taking Benadryl w/ some effect.  Pt stated the next morning - 5/6/21 - she noticed both her top & bottom lips were swollen
Patient presented to the ED and was subsequently hospitalized for seizure disorder within 6 weeks of receiving covid vaccination.
Pt came to flu ped at 340 pm stating persistent cough, flushed, nausea. Pt vomitted shortly after receiving oral Benadryl. Pt was referred to nearest ED - coworker dropped her there.
AWFUL!!!!!   FEVER, hurt from head to toe, Dizzy, Severe Fatigue, chest tightness X 3 days
The next day, fatigue and headache. On the second day, flare up and become numb on the right side of the head. Dizziness and vertigo after 7 days. Bell's Palsy after 8 days.
Information has been received from two healthcare workers referring to a child patient of unknown age and gender. The patient's medical history was not reported. On 22-APR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown) via vaccines for children (VFC) program. Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Asthma; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (21Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received BNT162B2 for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced asthma. It was reported that Had 2nd dose, Thursday (18Feb2021). Began Prednisone for his Asthma after the 2nd dose. The outcome of the event was unknown. Therapeutic measures were taken as a result of asthma.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.