chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event: I had anaphylaxis on 2/12/21 that required transport via ambulance to the nearest emergency room for life saving treatment.  Background information. I took a 7 day course of celebrex (200mg orally once daily) on 1/25/21, prescribed by my primary physician for a flare up of low back pain.  A 14 day course was prescribed; I stopped taking it after 7 days because my stomach was getting upset and I didn't want to take it close to my 2nd covid moderna booster. I got my 2nd moderna covid vaccine booster on 2/8/21.  For 1-2 days, my left arm (injection site) was sore and I was mildly fatigued.   I took over the counter advil  (200mg twice daily) and tylenol (500mg twice daily); the day I took advil, I was sneezing and developed signs of allergic rhinitis (congestion/runny eyes and nose). I did not have any other immediate adverse reaction and by Thursday, 2/11, the arm soreness and fatigue resolved.   My low back pain began to bother me again, so I took a 200mg oral dose of celebrex at 7:30a on 2/12/21. I went to work (I am a veterinary neurologist. While at work, at 9:30a on 2/12/21, I had a severe anaphylactic reaction and had to be taken via ambulance to Medical Center.  I developed hives/welts/burning/itching all over my body,  within 5 minutes my throat closed up, I couldn't breathe, I became hypotensive/collapsed; in the ambulance, I was given IM epinephrine; then at the ER, I was given IV steroids (solumedrol), benedryl, famotidine, zofran (due to abdominal pain/nausea) and IV fluids. This stabilized my signs within 1 hour and I improved and was going to be discharged at 2pm. However,  the hives returned at that time, so I was given additional IV benedryl, famotidine, fluids and oral prednisone and kept in the hospital overnight for monitoring; I was discharged to go home on 2/13/21 on a 4 day course of oral famotidine, benedryl and prednisone; I remained itchy and continued sneezing at home on 2/13/21. Today, 2/14/21, all signs of this reaction have resolved.    The ER doctors and myself believe the 2nd moderna covid booster on 2/8/21 stimulated my innate immune system, leading to this anaphylactic reaction to celebrex (a medication I had taken 2 weeks prior with no problem).   The doctors feel the celebrex is what set off the anaphylactic shock, but that my immune system was primed to do so after the vaccine.  In hindsight, I realized that I was having allergic rhinitis symptoms after taking oral advil on 2/9 the day after my booster (which has never happened to me before either). I am a person with no pre-existing allergies of any kind. There was nothing different at all in my routine including food or potential environmental exposures) on 2/12, the day of my anaphylactic reaction, other than my taking a 200mg dose of oral celebrex.  I am not allowed to take NSAIDs until I see an allergist for testing now.   I am reporting this adverse event as I believe the moderna booster caused an anaphylaxis to the celebrex medication.
Swelling, redness and tenderness @ injection site - (L) arm 20cm x 20 cm; (R) arm 10cm x 10cm.
Breakthrough case admission after 3 vaccines Moderna 4/21/21 Lot# 045B21A;  Moderna 5/19/21 Lot# 033B21A;  Moderna 1/13/22 Lot# 041J21A
Pt recvd 2-1cc injects of Recombivax 1DEC90 & 1JAN91; 4JUN91 recvd Engerix-B; pt "did not develop immunity";
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received BOOSTRIX (batch number P39AZ, expiry date 15th February 2015). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
The next day after the vaccine, 02/19/2021 at 2:00 AM: shakes, chills, I was really cold and body aches. Bedridden due to fatigue and feeling horrible and high fever, 103.8 until Sunday afternoon, 02/21/2021. On Sunday morning, my fever dropped down to 100. On Saturday, I spoke to NP, and prescribed: to take 4 Advil's every 8 hours.
The Varicella vaccine ( would have been the patients 2nd dose) was given subcut in the Right arm that had expired 4 days earlier
Patient complained of delayed adverse reaction after Shingrix vaccine.  3-4 days after vaccine the patient developed constant stabbing Cervical & Thoracic back pain for 3 weeks. Patient also complained of lightheadedness on some of those days.
2 to 3 events of Acute pain experience in elbows while doing normal exercising.  Acute morning pain in thumb joints, knees and feet.
On 09/10/2022 I received my Covid-19 vaccine. On 02/02/2023 I started having very painful earache and could not swallow having a sore throat. I was very tired as well. After reaching out to my doctor I was diagnosed with Covid-19 and was prescribed PAXLOVID. Symptoms lasted approx. 11 days.
Lump on LT thigh where KINRIX (DTAP/IPV) was given. Patient was seen in clinic for lump on 4/14/16. Mom was advised to monitor for any pain, fever, redness, or drainage and to call with any concerns.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4356269-00. A 44-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years intramuscular for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: Unknown, Route of administration: Intra-muscular), administration date: 23Aug2021, when the patient was 43-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Lot number: Unknown, Route of administration: Intra-muscular), administration date: 15Apr2021, when the patient was 43-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 1, SINGLE, Lot number: Unknown, Route of administration: Intra-muscular.), administration date: 16Mar2021, when the patient was 43-year-old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 07Feb2022, outcome "unknown" and all described as "Fourth dose"; ARTHRALGIA (non-serious) with onset 07Feb2022, outcome "recovered" (07Feb2022), described as "sore shoulder". Additional Information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. other relevant history was Not Reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (07Jul2022): This is a follow-up solicited report based on information received by Pfizer [Mfr Control No.: 22K-163-4356269-00]. A contactable consumer (patient) reported that: Updated information: Event information (Event added). Follow-up attempts are completed. No further information is expected.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001687 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns *37-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Fever, leg spasms/cramps within a few hours and daily/hourly for the next 18 months approximately, then about monthly to every 2 months since; rash, screaming & abdominal pain within a few hours then on and off over the next 18 months; hives began a few weeks later, which is on and off with no apparent cause since injection; extreme skin sensitivity to any soaps, chemicals, sun etc, including severe eczema which never occurred prior, monthly to every few months since injection. Medical doctors claimed it was unrelated, even up through facility's legal dept.  I finally found a nutritionist/chiropractor about 18 months after the injection who was able to detect toxins in his body, which we treated with organically bound minerals and organic detox vitamins/minerals.  Within a few days symptoms subsided significantly and he was able to sleep through the night for the first time in 18 months.  Now the symptoms are very rare, but his skin sensitivities and rashes persist.
Patient developed hives about 2 hours after receiving the vaccine.  She also reported dry  throat and some difficulty in breathing.  She later checked herself into an Urgent Care clinic for medical help.  The hives on her whole body persisted for some 2-3 weeks before going away.
Pain in right breast. Very painful. I went to have a mammogram. They found a mass ( benign). They want to see me back in July to be sure.   Ozempic 1 mg is no longer repressing my appetite.
Day 1: 4:30pm received injection, 8:30pm headache and chills began,  extreme chills all night, could not stand up to do dizziness, took 2 Tylenol around 3pm,  Day 2: woke up around 6:00am, fever was 100 again, headache persisted, took 2 more Tylenol,  12:00pm - extreme chills returned to the point where my teeth were chattering uncontrollably, fever persisted, took 2 more Tylenol, 4:30pm took a nap for about 15 minutes, 8:00 fever was 101.4, 8:30 went to bed and slept all night Day 3: Mild headache persisting, 7:00am, fever 99.7, took 2 more Tylenol, 7:40am filing this report  General malaise, aches, and fatigue throughout and still continuing  FYI - my base temperature is usually around 98, rather than the general 98.6.
Redness; Hot to the touch; Swelling; second dose on 06Jul2020 and a first dose on 19Dec2019.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix administered on 19th December 2019.).   On 6th July 2020, the patient received the 2nd dose of Shingrix. On 6th July 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site swelling and drug dose administration interval too long. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: After receiving the 2nd dose if Shingrix the patient experienced, redness, swelling and hot to the touch sensation at the site of injection. The events had persisted over 3 days. On 6th July 2020, the patient received 2nd dose of Shingrix, which led to which led to lengthening of the vaccination schedule. The reporter consent to follow up.
Narrative: Patient reported to ED on 4/15/21 stating that he received 2nd dose of covid-19 vaccination about 2 weeks ago and within 2 hours of receiving that dose, began experiencing flu-like symptoms including nausea/vomiting/diarrhea to the point of unable to keep Heart Failure medications down. As of 4/15 presentation to ED and quick progression to admission to ICU was in cardiogenic shock, elevated LFTs, and possible acute renal failure. ICU team treated with pressors initially. During course of evenign on 4/15, patient experienced 3-4 seizures while in CCU. Keppra was administered. After final seizure, Code was called with ACLS algorithm followed. Coded on 4/16 and was pronounced dead at 4 a.m. It is unknown where or which Covid vaccine that patient received as is not in our records.
retrospective review shows pt was not 18 at the time of immunization.  Parent contacted.  Father said nothing out of the ordinary in the way of side effects occurred, the pt was +200 lbs and the father said the pt would and has been fine.
Starting at 2 am, very high temp, splitting headache, vomiting at 2 am and again at 8 am (although at that time it was dry heaves), aches, fatigue, chills.  It was all I could do to make it to the bathroom (just a few steps away), and I could not bring myself to take my temp.  Around 8 am the worst was over, and the the temp was 100.8, so it was much higher during the worst.  I am a fit person and am not generally sick, and this was the worst event of my life.  I would still get the shot, but this did seem to be more difficult than usual, so wanted to report it.  I was wiped out the rest of the day, but I had expected that.
pt recvd MMR vax 27NOV92 & on 3DEC92 exp severe abdo pain & was adm to the hosp; dx lower lobe pneumonia w/effusion; also cough;
Paresthesia in right hand (received covid-19 vaccine in right arm); Numbness; "pins and needles"; This is a spontaneous report from a non-contactable nurse, who is also the patient. This 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 23Dec2020 at 13:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included allergy to latex, mango and naproxen. Concomitant medication included unspecified oral contraceptive pill. On 23Dec2020 at 13:30, the patient experienced paresthesia in right hand (received COVID-19 vaccine in right arm), numbness and "pins and needles" which continued on and off for 48 hours. The patient did not receive corrective treatments for the reported events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient recovered from the events in Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
All over muscle pain, disrupting my normal activity- not quite 24 since vaccination, but still feeling quite a bit of pain; headache; slight nausea
pt recv vax & exp fever which may have been as high as 104 to 105 & which lasted for more than 24hr;pt also exp infrequent rash
Patient seen three days after vaccination for swelling of his right upper arm with redness and rash up to his elbow. Swelling started the day after receiving vaccination. Patient was started on cephalexin and prednisone for reaction. Prednisolone 5 mg other, Ibuprofen 600 mg TID.
very strong pain in his lower parts (in the testicles); pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain; could not breathe; he could not stand; changed the color of the skin on his face (half white and purple from the pain); dizziness; pain in his arm after the first injection; high fever; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand) and SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand), SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)), DIZZINESS (dizziness), MYALGIA (pain in his arm after the first injection) and PYREXIA (high fever). At the time of the report, TESTICULAR PAIN (very strong pain in his lower parts (in the testicles)), PAIN (pain as strong as if he had been hit /  20 minutes without being able to get up because of the pain), DYSPNOEA (could not breathe), DYSSTASIA (he could not stand), SKIN DISCOLOURATION (changed the color of the skin on his face (half white and purple from the pain)), DIZZINESS (dizziness), MYALGIA (pain in his arm after the first injection) and PYREXIA (high fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-107332 (Patient Link).
Patient received 2nd dose of Pfizer COVID19 vaccine on 1/12/21. Patient reports COVID symptom onset starting 4/21/21. Patient reports testing COVID positive on 4/27/21 via PCR NP swab.
Patient received his 2nd covid vaccine 3 days before grace period.   Patient came to clinic after receiving a call for a covid vaccine.  One employee try to figure out who had call him.    After checking with a second employee, and due to having same name of another patient coming to receive covid vaccine, patient was placed on the schedule to receive vaccine.   RN saw patient on the schedule and asked patient if this was his first dose.  Patient stated this was his second dose.  RN proceed to  vaccinate patient after asking him if he had received any vaccines in the last 2 weeks.   After that the mistake was discovered and patient was told he wouldn't need a third vaccine.  We
Extreme tiredness; Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced tiredness and dizziness. On an unknown date, the outcome of the tiredness and dizziness were unknown.   It was unknown if the reporter considered the tiredness and dizziness 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 selected as an adult as per vaccine indication. The patient inquired that was it normal to had extreme tiredness and dizziness 4 days after the Shingles shot. No other information was available.
I did have a headache and slight fever not to long after I got the shot. The next day my arm was super painful. Several days after the shot my arm where the injection site is was red. It then started going back to normal color. Two days ago it itched a little then the redness appeared back again and now it is hot to the touch.
Information has been received from a registered nurse concerning a female who was vaccinated with a dose of VARIVAX (Oka/Merck) subcutaneously. The patient experienced redness and extreme swelling of 5-6 inches in diameter at injection site after administration of vaccine. It was also painful to touch. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), " TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 80 hours (Lowest recorded temperature was 30 F (-1.111111111 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); 168 hours (Highest 49 F(9.44444444 Celsius); 24 hours (Highest recorded temperature was 48 F (8.888888889 Celsius), 416 hours (Highest recorded temperature was 47 F (8.333333333 Celsius) and 336 hours (Highest recorded temperature was 59 F (15 Celsius). No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender, possibly a newborn. The patient's medical history, past drug history, and concomitant medications were unknown. Approximately on 05-MAY-2016 (reported as on either 05-MAY-2016 or 06-MAY-2016), the patient was vaccinated with the first dose of RECOMBIVAX HB via injection (lot # L039660, expiry date 04-FEB-2018) (dose, route, anatomical location were not provided) which had previously undergone a supported temperature excursion. It was unknown if there was any relevant laboratory data. As of a time of this report, it was unknown if the patient had continued to take RECOMBIVAX HB and the outcome of receiving a vaccine that had undergone a temperature excursion was unknown. This is a one of the several reports from the same reporter. Additional information has been requested.
Presented  to ED 4/18 with severe L sided chest pain since 4/17.  Arm weakness and numbness 4/18 that lasted a few hours but resolved. No vision changes. O2 sat was 100% on room air. Diagnosed with PE. No recent mobilization. Does not smoke or use illicit drugs. Was admitted to the hospital telemetry unit 4/18-4/20. Discharged on apixaban.  I do not have any information on the vaccine Lot number received.
Itchy skin all the time Hives, blisters, flares up Has been continuing since I got the shot Tried Prednisone, and steroid shot, and Benedryl, and Claritin Nothing is helping