chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had 2 doses of Pfizer Moderna vaccine on 10/4/21 and 9/9/21, and was hospitalized on 12/21/21 for COVID.  Patient remains hospitalized at this time (12/22/21)
Woke up with headache the morning after the shot.  By noon, had chills and body aches.  By 2 pm had a temp of 102, terrible headache and body aches.  It felt just like the first day I had Covid back in December.  Next day still had all symptoms, but fever was down to 100.  By 7 pm fever had broken.  Next morning just had a little headache left but mostly better.
Extreme fatigue, body aches, localized pain at injection site, mild disorientation, all symptoms continued  for 48 hours.
1645- Patient gave vague reports strange taste in her mouth and shortly after that began, strange sensation of tongue and heaviness in chest. VS 118/64, pulse74, SaO1 97, Resp 16.  1655- no change in symptoms. Ambulated around clinic with no change in symptoms.  1710- Patient reported some numbness and itching of her face and arms along with the heaviness in the chest. Denies lightheaded/dizzy. Benedryl given per allergic reaction protocol.  1730- patient report itching of face and arms continues.  1735- patient ambulating in clinic with steady gait.  1745- patient reports slight improvement of itching and chest heaviness resolved. Dismissed to home.  12/21/2020 Asymptomatic.
SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TALK; HIT HEAD; HIT HAND; HIT ELBOW; BUMP ON HEAD, ELBOW, AND HAND; HEADACHE; This spontaneous report received from a patient concerned a 61 year old Hispanic or Latino female. 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: 2076A21A, and expiry: unknown) dose was not reported, frequency 1 total, administered on 07-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-JUL-2021, after receiving vaccine, the patient felt dizzy and could not talk. The patient fell down and hit her head, hand, and elbow. Paramedics were called to help the patient and she was taken to emergency room (ER). The patient was informed that her blood pressure was very down, she was hyperventilated and was trembling. On the same day, the patient felt fine and experienced headache after going home and noted bump on her head, hand, and elbow because of the fall. The patient was diagnosed with syncope/collapsed. Laboratory data included: Blood pressure (NR: not provided) Decreased, and Laboratory test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from syncope/collapsed, trembling, hyperventilated, blood pressure was very down, and could not talk, and the outcome of fell down, hit head, hit hand, hit elbow, headache and bump on head, elbow, and hand was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- 20210718537- covid-19 vaccine ad26.cov2.s-syncope/collapsed. 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).
Left arm was very sore for 7 days, it was swollen and  had welts then turned into a bruise for a week.  I woke up the next morning and hurt all over, felt very fatigued, my joints hurt, had headache, and just felt bad. This lasted for 7 days!
SHIVERS; FEVER; 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 (suspension for injection, route of admin not reported, batch number: Unk) 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 shivers, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from shivers, and fever. This report was non-serious.
Lymphedema of right armpit, redness, swelling, heat at injection site, severe itching and pain in the right armpit and down towards the right lateral breast.
Moderate to severe body muscle and joint pain Headache Fever Irregular Heartbeat Arm Pain at injection site Uncontrolled shivering / night sweats
This is a spontaneous report from a contactable Nurse. A 39-year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number: EL9269, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:15 as DOSE 1 SINGLE for covid-19 immunisation. The patient medical history included ibs-c, allergies: Shellfish. The patient's concomitant medications included diphenhydramine hydrochloride (BENADRYL), ranitidine hydrochloride (ZANTAC) reported. No other vaccine was received in four weeks. Covid prior vaccination was No and Covid tested post vaccination: No. It was reported that about 50 minutes after the vaccine. I developed severe itching of the lips and tongue as well as dizziness all. It lasted approximately one hour all on 10Feb2021 at 10.15. No Treatment was received for the events. The outcome of the events were recovered on an unspecified date.  No Follow-up attempts completed. No further information expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Other medical history: Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: began testing positive; Negative, notes: I tested negative for 10 days after completing the Paxlovid 5-day dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 15Jan2023 the patient took Paxlovid for the treatment of event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
start with red  rash then following week blister on my hands  arms and feets neck.
Pt. went to sleep and woke up with stiff/painful right arm, which radiate to neck/jaw/and down to the rest of the arm. Pt. took CLARITIN and it helping to relieve the symptom. Lasted 2 days.
Stiff, sore arm starting first day, runny nose/cold symptoms next day, stomach pain and nausea 2 days after shot.
Vaccine Exposure During Pregnancy; soreness at the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine Exposure During Pregnancy) and VACCINATION SITE PAIN (soreness at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-20A) for COVID-19 vaccination.     The patient's past medical history included Childhood asthma (Last attack occurred between 8 and 9 years-old).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. The patient's last menstrual period was on 16-Oct-2020 and the estimated date of delivery was 23-Jul-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine Exposure During Pregnancy) and VACCINATION SITE PAIN (soreness at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 16-Jan-2021, VACCINATION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine Exposure During Pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prenatal screening test: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is history if subfertility - husband's side Unremarkable prenatal course to date She's on Prenatal Multivitamins.   Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during pregnancy Vaccination Site Pain for this 29-year-old female patient. Based on the current available information and temporal association between the use of the product and the start date of the other event (Vaccination Site Pain), a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Muscle soreness to right arm that ascends to the right neck and is painful to the touch. Pain severe enough to prevent patient from using full ROM. Patient is able to use full ROM when she forces through the pain. States that soreness started almost immediately after the injection and has not improved. States that she was required to do push ups in PE class on 1/11/08 that might have made the pain worsen. Patient has been using a heating pad and ibuprofen for treatment.
Day of vaccine-12/29/20-at about 3-4 pm started having headache, body aches, fever 101.2, chills. Day 2-12/30/20-severe body aches, difficulty walking, joint pain and soreness, fever 102.6, chills, took Tylenol Q 4-6 hours with no relief. Day 3-12/31/20-all same symptoms as above with right shoulder soreness and pain and warmth at the injection site. Day 4-1/1/2021-warmth at injection site, no other symptoms.
Low fever, Chills, Body aches, Sore arm, Mild head ach
Menstrual cycle issues, heavy bleeding for 5+ days, blood clots in period blood, spotting and bleeding between periods, ovarian cysts
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 36-year-old male patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# FG3527), at the age of 36, on Nov 11, 2021, single dose, for COVID-19 immunisation. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot# unknown) for immunisation. Medical history not reported. Concomitant medication included: Nyquil, start date: May 6, 2022 and Tylenol, start date: May 7, 2022. The patient experienced suspected COVID-19 (medically significant) and ineffective drug/treatment of COVID-19 (medically significant), onset 2022, with outcome of unknown. Therapeutic measures were taken as a result of suspected COVID-19 and ineffective drug. Clinical course: Antiviral details: Product: COVID-19 treatment, Brand: Paxlovid, Treatment start date: May 7, 2022, batch/lot# GA3567; Indication: Treatment of COVID-19. Device date: May 9, 2022. No follow-up attempts possible. No further information expected.
TEMP EXCURSION- ROOM TEMP (68*) FOR >12HOURS. PT REPORTS SORE ARM/FLU-LIKE SYMPTOMS FOR 2 DAYS
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex and unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) 1 total, dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-SEP-2021, the patient was tested positive for covid (suspected clinical vaccination failure and suspected covid-19 infection). The patient had all the symptoms but the worst was the cough and the symptom was like having a bad cold. The patient was feeling better after 10 days.  Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000196265.; Sender's Comments: V0: 20211011774-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild
Aphasia, paraesthesia, (L) eye not blinking on closing. Intermittent flushing of face and feeling of warmth. Unstable B/P; rapid pulse
Needle became partially unscrewed resulting in a partial dose administered. Unable to determine how much vaccine was administered compared to how much was lost on the patient's arm. Following CDC guidelines, we administered a full dose in the opposite arm immediately. The patient was notified.
Achy  Feverish Cough Sneezing Runny nose Stuffy nose
Severe fatigue and body aches the following day, 2 days following: body aches, fatigue, and swollen lymph node on right arm
1. Complex febrile seizure, about 15 hours after shots. 2. Acute otitis media
Patients came in with her parents to get her pfizer shot for covid-19.  The shot was administered by RPh into the left deltoid with a 5/8 inch needle for a dose of 0. 2 ml of NDC. The dose was given at 2:35 PM and within 5 minutes, pts mother got the pharmacist's attention to say that she was not feeling well. This occurred immediately after the father, got his moderna shot. The child indicated that there was something in her throat and that she had trouble breathing. Pt looked pale but her airway was unobstructed the entire time. She was given two doses of ammonia inhalant to keep her from fainting. I counseled the parents on the possible need for an epipen in the event that she starts have physical signs of hypoxia or an obstructed airway. No epipen was given since there was not airway obstruction or signs of hypoxia. The parents ask if we could give her some water but I advised against it due to choking risk. No hives we observed. Paramedics arrived at about 2:50 PM and did an assessment, which her Oxygen levels were above 98 and indicated that they were within normal limits and confirmed that no hives were present. The patient remained alert and orientated the entire time and was speaking normally. The mom did indicate that the child had a heart murmur after the child started to have symptoms post vaccination; however, this was not indicated on the PCQF. The parents called after patient was taken to the hospital to ask about how much vaccine was given (the dose) and asked us to email them the copy. I sent the copy to them as requested and also pointed out that the information was also on the white covid vaccination card that we gave them along with the sheet for Pfizer.
Soreness to Left arm 20 and 21st, home on the 22nd however on the 23rd extremely painful, red and swollen. Tx. warm compress, Ibuprofen (OTC) 200mg tabs, 2 tabs 3 times daily for 3 to 5 days.
Pt recvd vax & passed out to floor; BP 70/; no c/o h/a-seen by MD-given exam-no adverse findings; syncope following inject;
Fever of 100 F; Soreness at injection site; Pounding headache in eye, entire top left side of head, 8/10 pain; Pounding in eye; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 10Apr2021 at 17:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included slufa drug (sulfonamide) allergy and protein s deficiency. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) from unknown dates for unspecified indications and unknown if ongoing. The patient previously received the first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 23:00, the patient experienced a fever of 100 F (Fahrenheit), soreness at injection site and pounding headache in eye, entire top left side of head, 8/10 pain. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event fever of 100 F, soreness at injection site and pounding headache in eye, entire top left side of head, 8/10 pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2015US019674, is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 27 year old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Patient (DOB 2/12/1968) received dose 1 of the Pfizer COVID vaccine (lot EH9899) from a HCF on 12/29/2020. On 9/9/2021, patient requested to receive Janssen at local public health center mass immunization POD at approximately 1815. The patient reported reaction to dose 1 of the Pfizer including feeling fatigue, low grade fever, and left-sided numbness. Patient reports that the fatigue and fever resolved within 5 days but the numbness and subsequent intermittent pain were the result of permanent peripheral nerve damage diagnosed after receiving full neurologic workup including MRI and cat scan. Patient reports no known allergies. Her medical conditions include Hashimoto's and mild mitral valve prolapse. Patient reports taking gabapentin to manage nerve pain.
Patient received vaccine on 10/05/17 and experience pain on the left arm that has not resolved till date.
This spontaneous report as received from a physician via field employee refers to a female patient of unknown age. On an unknown date the patient was vaccinated with dose 1 of VAQTA, (strength: 25/0.5 units per milliliter (U/ML)) at the dose of 0.5 milliliter (ml) as a preventative. The physician reported that the patient received second dose of VAQTA, three months after receiving the initial dose of VAQTA (date unspecified). No adverse effect was reported. No further information was provided. Additional information has been requested.
3am on 4/19/22 I woke up and thought I was upside down.  My Mom was here [she died 2 years ago]  I yelled for help but no one came. I tried to call someone but no one answered
20-30 mins p/vax rt arm @ the inject site became swollen & warm to touch; ice pack was applied PRN the rest of the day; also had numbness & tingling of rt arm & hand;
Developed HZ despite vaccination; Information has been received from the authors of the article titled as stated below, and refers to 185 male patients of unknown age. The patients' medical history, concurrent conditions, and concomitant therapies were not provided.   On unspecified dates, the patients were vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, dose number, route and anatomical location were unspecified).   On unspecified dates between 18-JAN-2012 and 26-FEB-2015, the patients developed herpes zoster despite vaccination (vaccination failure).   The outcome of the vaccination failure was unknown.  The authors considered the vaccination failure to be related to zoster vaccine live (ZOSTAVAX).   This is one of two cases received from the same source (US-009507513-1905USA006682)  A copy of the published article is attached as further documentation of the patient's experience.   Sender's Comments:  US-009507513-1905USA006682:
Headache, Myalgia, Arthralgia,  body aches Narrative:
Confirmed with caller no other AE occurred; The caller said an expired dose was administered on 11/1/2022; This spontaneous report was received from a pharmacist and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)syringe, injection, 1 dose, lot number u010533, expiration date: 29-OCT-2022, administered for prophylaxis (exact dose, strength, and route of administration were not provided) (expired product administered. No other adverse event occurred (no adverse event).
The patient received the above 2 vaccines at 10:03 AM. She felt dizzy and nauseated about 8 to 10 minutes later. Blood pressure was 112/87, pulse rate 76 at 10:13 AM. Heart rates were regular sinus rhythm with no heart murmur. She then went to the rest room where she vomited and then had diarrhea. A follow-up check at 10:26 AM showed BP 119/96, Pulse rate 85. A few minutes later she left the office to go home because she felt much better.
pt exp swelling & itching for more than a wk p/immun; no addtl info available @ time of this report;
001/03/2022:  Event occurred after 2nd vaccine.   Presents to the ED today for shortness of breath with nausea vomiting.  Patient states she has had shortness of breath x7 days, states is hard to take a deep breath and she feels worsening shortness of breath when she gets up to exert herself even taking a few steps.  Also reports that she has had nausea with vomiting over the last 7 days.  Chest x-ray consistent with bilateral pneumonias.  Course of remdesivir.  remains in hospital on 01/10/2022. History of  ESRD on hemodialysis
Two and a half to three weeks post vax, this pt began head banging with screaming especially when tired. Parent saw marked personality change. This lasted for about 3 weeks and stopped. No medical treatment sought during this time.