chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
Narrative: Patient hospitalized at Hospital and diagnosed with COVID post full vaccination. Department of Health notified facility that patient reported deceased due to Covid post vaccination. No other records available at this time.
This case was reported by a healthcare professional (nurse) and described the occurrence of international normalized ratio increased in "about 5" male subjects of unspecified age who were vaccinated with FLULAVAL. Concurrent medications included warfarin. The nurse documented that reactions experienced with previous flu shots as "last year was Sanofi." It was unclear from the report what this statement meant. On an unspecified date (s) the subject's received a dose of FLULAVAL (.5 ml, unknown details). The nurse documented the following as dates of administration for FLULAVAL: 1 October 2013, 3 October 2013 and August 2013. In 2013, at an unspecified time after vaccination with FLULAVAL, the subjects experienced international normalized ration increased. At the time of reporting the event was unresolved. The nurse reported another case with FLULAVAL. See case A1045977A for details on the other case.
The next morning the patient experienced a large red, swollen, knotted, itchy, hot crescent moon shaped rash near the injection site.  She also had some shortness of breath as well.  The patient iced it, applied topical benadryl and also took oral benadryl and saw her medical doctor.  The doctor prescribed an antibiotic for a suspected skin infection.
Vaccine administration error.  Event: Patient had 2nd Pfizer dose today (on 5/5/2021). Vaccine syringe malfunctioned during administration. Some vaccine leaked out around syringe during injection, and more vaccine leaked out of the arm after the needle was withdrawn. Vaccine administrator noted that some vaccine was visible remaining in the syringe after it was withdrawn. Administrator estimates that more than half of the 0.3mL dose leaked out of the patient, but is unsure on quantifying the amount.  Pt contact information was collected, and she left the facility before CDC guidelines specific to this issue were reviewed.   Treatment: After reviewing CDC guidelines specific to this issue regarding how much vaccine was administered after some leaked out, I spoke to pt over phone (at about 11:45 on 5/5/2021), explaining the CDC guideline to return for additional dose in opposite arm today, since it is estimated that less than half of dose remained in patient's arm during administration earlier today. Pt stated she would like to think about it, review guidelines herself, and consult her mother who is in the healthcare field before making decision. I emailed the link and screenshot about the CDC guidelines to the patient. Patient states that she would "probably" come back in as walk-in for repeat dose today or tomorrow.  I informed the patient of our hours for walk-ins, and that the CDC recommendation is to receive another dose today.  Outcome: patient was counseled that guideline recommendation was to return immediately for repeat dose of Pfizer in the opposite arm. As of time of this writing (12:50pm on 5/5/20201, patient has not returned to the facility for a repeat dose. She was provided with my contact information to address any questions or concerns about returning for a repeat dose. Health director was also notified of this incident and agreed with recommendation per CDC guideline for the patient to return today for repeat dose.
tingling in the left leg and numbness, as well as pedal edema only to the left leg, since the vaccine.
crying, fever increased T 103 starting 2Feb91 (crying X 3 days) Rt. otitis media-Augmentin TX
Barrel on the Syringe was broken upon adminstartion of the vaccine. No vaccine was adminstered intramuscullarly. A second vaccine was then adminstered sucessfully.
8/26/21 PMH Anxiety disorder, CKD, CHF, Diabetes mellitus type II , Diverticulitis, Hypercholesteremia, Hypertension, Hypothyroidism, Osteoporosis presented to emergency with concerns for cough and nausea
Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2020, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm and experienced flu like symptoms that resolved the next day. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2021AMR102990, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102990:Same reporter
FOR 3 DAYS  KNOW I HAVE SEVERE HEAD ACHE  ,  NAUSEA  AND LOST APETITE
Pt recv vax on 3/5/99; post vax pt exp fever, headache, crying, vax site & arms (w/ swelling) pain
t104.2 48 hrs p/vax; LP-clear; CBC-white cell count 32,300; UA neg; CXR neg; Claforan;
fever; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) 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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098288 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098288:Reporter case
Patient received 1st dose of moderna and week and a half ago caught COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID). At the time of the report, COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that tested positive for COVID and that not contagious. The reporter mentions the children were eligible to get their second dose.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a 4-year-old male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred 22 days after receiving the first dose of mRNA-1273.  The clinical presentation, clinical course and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-637093, US-MODERNATX, INC.-MOD-2022-637095, US-MODERNATX, INC.-MOD-2022-637089 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 4-year-old male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred 22 days after receiving the first dose of mRNA-1273.  The clinical presentation, clinical course and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-637093:Patient 1 US-MODERNATX, INC.-MOD-2022-637095:Patient 3 US-MODERNATX, INC.-MOD-2022-637089:Reporter's case
Pt was brought to the ER from nursing facility due to increased weakness for 2 days.   Patient was also reportedly diagnosed with pneumonia at hospital and was started on Levaquin.   In the ER his vitals were stable.  Workup showed unremarkable CBC and CMP except for pancytopenia, COVID-19 PCR came back positive.  Chest x-ray did not show any focal infiltrates.  CT head unremarkable, UA negative.   Patient was started on decadron and  gentle IV fluids and was admitted to hospitalist service. He remained on 4-6 L home oxygen.    Had reach call on 1/11 due to acute change in mental status, bradycardia and concern for aspiration.  He was switched to NPO, repeat CT was unremarkable.  Was started on empiric IV Zosyn.
Pt reports pain, redness and itching moving down arm.  Started around injection site along with a welt, swelling and hardness.  Injection site is now normal but still having pain surrounding it and around elbow.  Pt says it feels like there is a band wrapped around upper arm.  Also extremely itchy all the time.  Taking benadryl at night and ibuprofen and tylenol for pain.  Also has used calamine lotion and benadryl gel.  Does not have numbness, tingling or loss of sensation.
arm soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced arm soreness after receiving Shingrix. The nurse did not have any of the patient information available at the time of the report. The reporter would provide that information when the (2nd line) agent called her back. Consented to follow up was provided. This case has been linked with case  US2020009073, US2020AMR009401 and US2020009080, reported by the same reporter.
The patient called stating she received the COVID vaccine yesterday at 11:30 AM. She reported that she had the usual sore arm. She woke up at 1:00 AM with 102.0 temperature and then start excessive vomiting at 1:30 AM. She also complained of vertigo and dizziness. She reports that she lost consciousness about 3:30 AM.  Advised to go to the ER if symptoms continue.
Two days after the vaccine experienced severe chest pains for about an hour on and off. Nerve pain in the left side of my neck. Four days after the vaccine my period started and was a week-long on the heaviest flow I have ever experienced.  I wasn't due for another 2 weeks and have been regular up until the vaccine.    I'm usually healthy, very fit, rarely get sick, and have never had breathing or chest problems.
I received the GARDASIL vaccine and Passed out.  I passed out about 2 times after that. the dr. office called 911 and went to the ER and they found nothing wrong.  Said it was a Vasovagal reaction.  I went home.  Had a headache, felt nauseous and dizzy since.  Friday night I fell down the stairs because my balance is not right.  I went back to my dr on Saturday.  He said I was fine and that it was maybe because I hit my head but he said it was not a concussion.  My head still hurts and I am still not feeling right.  I am nauseous and dizzy.  I feel very weak and have a headache since receiving this vaccine.
COVID-19 like symptoms but did not get tested if it was COVID-19; Little reaction after the second shot; This spontaneous case was reported by a physician and describes the occurrence of SUSPECTED COVID-19 (COVID-19 like symptoms but did not get tested if it was COVID-19) and IMMUNISATION REACTION (Little reaction after the second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, the patient experienced SUSPECTED COVID-19 (COVID-19 like symptoms but did not get tested if it was COVID-19) and IMMUNISATION REACTION (Little reaction after the second shot). At the time of the report, SUSPECTED COVID-19 (COVID-19 like symptoms but did not get tested if it was COVID-19) and IMMUNISATION REACTION (Little reaction after the second shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had COVID-19 like symptoms but did not get tested if it was COVID-19, he just stayed home and treated himself and 24 hours after the second dose had a little reaction with the Moderna vaccine.  No Concomitant medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This is a spontaneous report from a contactable consumer (parent) via Pfizer-sponsored program (program name not reported). A 16-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection, lot#, expiration date not reported), via an unspecified route of administration, on Aug 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On a week before the time of report, patient had the vaccination. About 24 hours later, she experienced a rash in armpit. It turned out as shingles on Aug 2021. The patient visited the doctor on the day before the time of report, because the rash was not getting any better. The outcome of the events: not recovered. The lot number for the vaccine BNT162B2: not provided and will be requested during follow-up.
Discomfort in their right testicle; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (Discomfort in their right testicle) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041821A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced TESTICULAR PAIN (Discomfort in their right testicle). At the time of the report, TESTICULAR PAIN (Discomfort in their right testicle) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment details were provided.   This case was linked to MOD-2021-212091 (Patient Link).
I got the shot in the morning came home got very tired, felt like I was getting a temperature, woke up with bad fever, throat swelled had trouble breathing called primary care physician spoke with nurse, no treatment suggested she assured me I would be ok.  Went back woke up could not attended doctors appointment went back to bed.  Slept for over 24 hours and woke fever subsided and throat swelling went down.  Took the rest the next day for all symptoms to subside.
Pt was bit by lab confirmed rabid fox - had traveled out of state.  Pt reported to ER in other state for tx.  Rcvd RABAVERT #1 & 2 ml HRIG on 7-31-09.  Rcvd RABAVERT #2 on 8-3-09.  Later that evening on 8-3-09, pt developed an itchy  welt - like rash all over her body.  Back in home state on 8-8-09.  Pt came to health dept.  Pt reports rash had decreased some post taking BENADRYL.  Referred to PCP for eval.  Consulted with the state - acquired IMOVAX for pt for remaining two doses vaccine.
Three days after vaccine I was extremely achey everywhere -- spent two days in bed.   No fever or headache just general malaise -- Lasted for 2 1/2 days
both times the swelling at the injection site appeared to be cellulitis, Urgent care doc gave antibiotics after the first shot, but after the second the docs were more familiar. I just iced the site and swelling decreased after 2 days.
Flu vaccination.  Developed hives at about 5 sites on body: Abdomen, buttocks, left thigh, near left and right armpits. Treated with over the counter cortisone cream. Symptoms abated after a few days.
terrible bilateral hand and joint pain; terrible bilateral hand and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "terrible bilateral hand and joint pain".  Additional information: The patient was having terrible bilateral hand and joint pain, since having Covid shot. The patient was unable to resolve this pain, and needed assistance.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Numbness in hand that will not go away; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female non-pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 29Jan2021 at 12:00 (at the age of 51-year-old) (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient received second dose of bnt162b2 via an unspecified route of administration, administered in Left arm on 12Feb2021 at 12:00 (Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history was not reported. Patient had unspecified known allergies. The patient had no covid prior vaccination. Patient had not tested for covid post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks, no other medication in two weeks. The patient experienced numbness in hand that would not go away on 01Feb2021. The patient did not receive treatment in response to event. The clinical outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
weak, old man voice. Sounds like there is a frog in his voice all ofthe time. Voice isn't as clear as it used to be.; liver enzymes shot up over 400 points. / increased liver enzymes.; very low hemoglobin.; back in 2015-had reaction to pneumonia vaccine. Had a fever for 2-3 days.; This spontaneous report was received from a consumer via other's company letter, and refers to an 88-year-old male patient. The patient's pertinent medical history, concomitant therapies, previous drug reactions, and allergies were not reported.      On an unknown date in 2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) as prophylaxis (formulation, dose, dose number, route of administration, anatomical site of vaccination, lot number, and expiration date were not provided). Additionally, the patient stated he experienced a bad reaction to it, he had fever (Pyrexia) for 2-3 days.  On an unspecified day in September 2020, the patient had a blood transfusion. Also, he stated his hemoglobin had not quite gotten to where it needed to be. It was 4 pints, but may be measured differently at the hospital. Every other time, the patient underwent to a drawing of his blood to check on his hemoglobin (also reported "Reason for drawing blood was to check on his very low hemoglobin") (haemoglobin decreased). He clarified it "was a matter of routine". Additionally, the reporter stated a doctor wanted to be preventative from getting the disease. He had a weak, old man voice and sounded like if there was a frog in his voice all of the time. Voice was not as clear as it used to be (dysphonia).  On 20-JAN-2021, the patient had a blood drawn (unknown results).     On 21-JAN-2021, the patient was vaccinated with the first shot of sars-cov-2 spike protein mrna vaccine (PFIZER) (lot number EL3247 and expiration date 01-MAR-2021), administered in the left shoulder as prophylaxis of COVID-19.  On 03-FEB-2021, the patient had another blood drawn where his liver enzymes shot up over 400 points (hepatic enzyme increased).         At the time of reporting, the outcome of haemoglobin decreased and dysphonia was reported as not recovered/not resolved. The outcome of hepatic enzyme increased was unknown. The outcome of pyrexia was reported as recovered/resolved. The causal relationship between the occurred events and the suspect vaccines was not provided.  Upon internal review, the event of haemoglobin decreased was determined to be medically significant.
Itchy, red hives suddenly appeared all over face, neck, and at vaccination site and persisted on and off for several hours (over night and into morning). Hives not present on other arm or anywhere else.
Mom called and reports patient came home from school on 2-9-18 with a red face and some face swelling at approx 4pm.
Case number PHEH2012US012630 is an initial spontaneous report received from a physician on 21 Jun 2012. This case refers to a 04-month-old male baby. The baby was vaccinated with MENVEO (batch number: unknown) on 21 Jun 2012. No adverse event was reported following vaccination.