chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to a 2 month old infant to an unknown gender who on 04-MAR-2014, was vaccinated with the first dose of LIQUID PEDVAXHIB (lot # not reported). The physician reported that the syringe broke during administration of a first dose of LIQUID PEDVAXHIB to a 2 month old infant. Physician stated he was not sure if the patient received any of the LIQUID PEDVAXHIB dose during administration. No adverse symptoms reported. Additional information has been requested.
Patient received injection on 12/7/12, approx 1 1/2 days later some swelling and warmth around injection site. 10 x 9 cm. Patient placed ice on area and took some MOTRIN.
Bell's Palsy in her right side afterwards; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient in her 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Bell's Palsy in her right side afterwards".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Employee received annual flu vaccine which was administered by staff RN per protocol. Within 30 seconds, employee began having difficulty breathing and turned blue. Employee carries an EPI PEN which was administered. Despite this, the employee further deteriorated and a rapid response and subsequent code blue was called. The employee was intubated and ventilated overnight in critical condition. The following morning, she was extubated and remains in the ICU.
Patient got the shingrix shot on July 23nd, 2019. Left upper arm is red and pain for 7-10 days after vaccination, lost of feeling for both hands and finger,fore arms. Both legs and feet are tingling. Head ache for 7-10 days. On August 1st, patient has been sent to the Hospital and stayed in ER overnight.
Chest pain and shortness of breath exacerbated by exertion from the first dose of vaccine lasting for 2 months. One event when the chest pain radiated to jaws Back pain starting July 10 2021 and than other joints of body become involved restricting movements and limiting physical work capability. Swelling and pain in both ankle joints August 13, 2021 progressing such that I was unable to walk or bear weight.  On and off right knee joint pain since November 2021
Had Vaccine on 12/24.  Since then she has had daily episodic full-body itchiness and rash or redness; light-headedness, migraines, irregular heartbeat.  She has also noted episodic throat tightness and SOB in the 10 days since the vaccine.  She has a history of anaphylaxis w/ morphine.  She has an autoimmune condition currently being evaluated by rheumatology.  Has Von Willibrands and Hx stroke due to BCP. Will need Allergy Consultation with MD prior to 2nd dose.
Mild sore L shoulder about three hours later. About 11 hours later felt nauseated. Uncontrollable shaking 12 hours later. Fever 13 hours later 102 and cramping in leg muscles through the night that kept me awake-despite taking a hot bathe.
Flucelvax is only approved for use in patients age 4 and up. This patient was only 3 years 6 months at the time the vaccination was given. We have contacted the manufacturer and are awaiting information on their clinical trials regarding patients under age 4. Patient's parent states no adverse reaction to the vaccine given on 10/23 nor the 70 hours since the vaccine was administered
Rash under left armpit, it started out as a random blotch and it "dried" and I was able to get it off because it was like shedding. But now the blotch is back and its like irritating my underarm now.  My memory has gotten worse, I tend to have a pretty bad memory at the moment but it hasn't been this bad before. Things that were just told to me, its been really hard to process them now.
DTAP/IPV injection site reddened, swollen to golf ball size. Facial swelling with spots. ER prescribed KEFLEX, prednisone, NAPROSYN.
Red [and swollen] arm; [Red and] swollen arm; Arm went numb not even 20 seconds after the shot; This is a spontaneous case, initially received from other non-health professional via Agency (reference number: SEQ19-04752) on 15-Oct-2019 concerning a 9-year-old female patient.  The patients medical history and concomitant medications were not provided.  On 14-Oct-2019, around 4:30 pm, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: deltoid, dose, batch number and expiration date: not reported] for prevention of seasonal influenza. On the same day, not even 20 seconds after vaccination, the patients arm went numb. Around bedtime, at 9:00 pm, the patient's arm was red and swollen.   On 15-Oct-2019, one day after vaccination, at 6:30 am, it spread in a circle about two inches around and red also raised. Over the next few days it continued to spread wider and got darker in color.  On 19-Oct-2019, it was noted that the swelling had gone down and the redness had turned into what looked like a bruise.  On 25-Oct-2019, it could no longer be noticed.   The outcome for the event numbness in arm was unknown.  The case was assessed as non-serious and the reporter did not provide causality assessment.  Follow up received from other non-health professional on 13-Nov-2019: patient's initials, date of birth, age and the outcome of the events swollen arm and red arm were updated. The narrative was updated accordingly.  Company comment: The patient experienced hypoaesthesia, erythema and peripheral swelling after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced hypoaesthesia, erythema and peripheral swelling after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
respiratory distress (new), audible wheezing, shortness of breath, sensation of throat swelling or closure
Got the 1st COVID vaccine on 4/13/2021. Had a headache on 4/14/2021 for just one day.  No other symptoms  until 4/17/2021. Since that day I began to  have mild menstrual pain everyday from 4/17/2021 - 5/4/2021. (about 3 weeks) The pain level is about 2-3 and I experience a peak on  5/3 and 5/4  then it suddenly stops. My period should start on 5/3 however still didnt have it.(Have been late for 5 days and no signs that it will come at all). Had multiple pregnancy tests, all negative.
The first Shingrix shot was given on 10/22/2018 and caused muscle soreness that lasted about 7 weeks. A few days after the soreness went away, I went back to get the second Shingrix shot on 12/30/2018, but this time the same type of soreness has persisted to this day, i.e., for over 6 months. The pain is mild for most activities but is moderate for a few things like a workout on an elliptical trainer. The soreness is severe when I try to reach behind my back or if I must suddenly use my arm to steady myself on the bus.  The first shot on 12/22/2018 had lot number N79Z5.
Starting 06/16/2022, I started getting a headache, body aches and pains, and felt like I was getting a cold but it was worsening. I had an upset stomach causing me to lose my appetite. Also, I had a mild temperature. It got worse and the next day I tested myself with an at home COVID-19 test (06/17/2022) and it was positive. I went to see the doctor on 06/18/2022 and had a test done in office and a PCR which came back positive. I was told to take any over the counter medications that I would take normally to alleviate cold symptoms. I was instructed to go to the ER if I have trouble breathing. I am feeling a little better but I am still having lots of mucous and feel like I have a bad cold. I tested negative this morning but still am experiencing symptoms.
Sick office visit 11-1-14. Vaccines - PENTACEL, ROTATEQ, PREVNAR given 10-23-14. Patient projectile vomited 2x 10-31-14. both times soon after eating. Spitting up since then but not more then usual. Happy, not fussy. No fever.
This spontaneous report as received from a medical assistant refers to a unspecified patients of unknown age and gender. The reporter stated that VAQTA 50/1.0 U/ML were exposed to 5 hours each day with a lowest temperature of 28 F from 03-JAN-2014 to 17-JAN-2014. The reporter also stated that during this time period, there were approximately 15 to 20 patients who received this vaccine. No adverse experiences reported. The outcome of the events were unknown. This is one of several reports from the same source. Additional information has been requested.
10/15/2008 Contacted office-ask to return call. 10/16/08 Return call -received vaccine ZOSTAVAX 10/30/08 and noted rash on (R) leg. Saw PCP-confirmed shingles-10/10/08 started on VALTREX and steroids per PCP. Pt states pain (R) leg shin area with rash (+) pain fine.
Severe itchy skin red & hot, severe headache couldn?t even open my eyes, extreme fatigue
This spontaneous report as received from a registered nurse refers to a 8 week old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored PEDVAXHIB from lot # N000236 (dose, route and expiry date were not reported) for prophylaxis. The administered vaccine had underwent a temperature excursion (details not specified). This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1710USA014890.
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (concentration, route, dose, frequency and anatomical place of vaccination were not reported) which had a lot # of M008551, an expiration date of 02-JUN-2018, for prophylaxis. The doses were exposed to a temperature of 35F, for a time frame of 2 hours and it was reported because a data logger. No adverse effects reported. This is one of several reports from the same reporter Additional information has been requested.; Sender's Comments:  US-009507513-1612USA009486: US-009507513-1612USA009487: US-009507513-1612USA003458:
no adverse event occured, Dtap given instead of adult tetanus - notified on call immunization branch nurse. not necessary to revaccinate patient
Chills, fever (100.4 F), body aches, headache, and extreme hunger beginning roughly 12-13 hours post administration which lasted approximately 18 hours. Symptoms were partially (~70%) mitigated by using max daily dose of acetaminophen (4g) and intermittent ibuprofen (800mg in total).
Pt recvd 3 doses of Engerix-B 22JAN91, 21FEB91, 22JUL91 & on 22JUL91 exp severe sore arm, nausea, h/a & dizziness; no tx given other than APAP; 48 hrs later sx abated; additionally p/completion of 3 doses pt only achieved a titer of 1.8;
On 07/06/2001, mother stated thigh became red and tender to touch and her daughter was having difficulty walking, fever, crying, decreased appetite and slept poorly on the night of 07/05/2001.
Minor - headache, whole body muscular pain Acute - swollen lymph node, left armpit, big (~4")  and very painful
Within 4 hours, post vax, employee states she experienced hives, welts, achy feeling all over, headache, nasal congestion and runny eyes.
pt recv vax 26OCT95 & w/in 24hrs throat felt like it was closing up;addtl info recv 20DEC95;pt was fully recovered as of 28NOV95;this is one of four patients from this site to report adverse rxn
Severe pain in the upper left arm (especially around injection site)began within hours.  I had difficulty moving my left arm without serious pain, bruising began next morning and was not totally gone for three weeks.  Took Advil for pain relief with only minimal results.  It is now nearly 10 weeks later and I still have serious disability in the left arm.  It is marginally better than in the first 2 days after the injection, but only marginally.  I still cannot lift my arm over my head without pain, can't sleep on my left side, can't carry things with my left hand without either serious discomfort or outright pain.
I began to have discomfort on the right side of my body, both front and back, about 3 inches above my waist. Sometimes it is fairly intense itchy sensation and other times there is a pricking sensation. The degree of redness varies and there are some tiny blisters like spots.
3hr p/vax pt found to be very limp, no energy & w/a very weak cry;saw PMD gave Ibuprofen;kept pt in office for 1 1/2hr;pt alert & active p/that time;
ITCHING AND REDNESS WITH ELEVATION, TREATED BY PATIENT WITH ZYRTEC AND BENADRYL. PERSISTENT UP TO 10 DAYS THEN SHE HAD TO GO TO THE EMERGENCY ROOM (APRIL 1-2). THEY GAVE HER PREDNISONE IN THE EMERGENCY ROOM. WITH PARTIAL RECOVERY.
Got vaccines 1-27-11. On 2-3-11 had elevated temp; on 2-4-11 woke during the night screaming & hallucinating (seeing & feeling worms & spiders crawling on himself); as of 2-8-11 still said could feel bugs crawling on himself; in general does not feel well & is napping - this is unusual; appt 2-10-11 with PCP; per history mom had hx of drug use; per foster mom following shots 4/2008 pt cried x 3 wks - was not reported by foster parent; saw pcp 2-10-11 & is scheduled for EEG.
Chills; did vomit a little bit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she got her vaccine on Monday and by Wednesday (Feb2021), she woke up and she had bad chills and that she did vomit a little bit. Patient said that she had no fever. She will get the next shot on the 15Mar2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
tired and not feeling like herself; tired and not feeling like herself; This is a spontaneous report from a Non-contactable consumer.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 23Feb2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 23Feb2021 the patient experienced tired and not feeling like herself. At the time of the reporting events outcome was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
7/12/99 3PM c/o feeling tired-later that evening c/o nausea, diarrhea x 1, vomited x 2 that evening;7/13/99 no more vomiting nor diarrhea;stomach a little upset;
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other company  concerned a 2 decade old adult female of an unspecified race and ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and other pre-existing medical conditions included: The patient had no known allergies or no relevant medical history. The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, 1 total administered on 31-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 2). The drug was associated with Off label use. Age at time of vaccination 2 decade old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) for rheumatoid arthritis (subcutaneous). On an unspecified date, the patient received booster dose with Covid-19 Vaccine (unspecified manufacturer), (Dose number in series 3), (intramuscular, form of admin, batch number and expiry date were not reported) dose was not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
EXTREME WEAKNESS, FATIGUE, NAUSEA AND VOMITING. I SPOKE TO PATIENT AND LET HER KNOW THAT THESE EFFECTS ARE IN THE VIS THAT SHE RECIEVED. SHE WAS GREATLY CONCERNED BECAUSE SHE FELT REALLY BAD FOR 1 DAY AFTER THE VACCINATION.  SHE ALSO SAID THAT THE SAME THING HAPPENED WITH THE FIRST DOSE BUT SHE ONLY CALLED ME TO REPORT AFTER THE SECOND DOSE.
Arm began  to hurt within 4hrs after receiving my 1st dose. Within 48hrs I was congested. Three days later noticed loss  of smell. During breakfast.
pt recv flu vax in both arms in error;should have recv flu & pneumococcal vax;No adverse event;
sore arm; This spontaneous case was reported by a physical therapist and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Allergy nos). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, MONASCUS PURPUREUS (RED YEAST RICE) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). On 05-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 antibody test: positive (Positive) result came back positive on (18Mar2021).     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information were not provided. Patient experienced nasal congestion as symptoms of COVID-19.   This case was linked to US-MODERNATX, INC.-MOD-2021-049944 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Non-Significant follow up received. Added symptoms of COVID-19 in narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049944:crosslink, seperate case for 2 nd dose of vaccine
Unresponsive to stimuli; Loss of consciousness; Irregular breathing; Nausea; Snoring; Staring; This is a spontaneous report from a non contactable  consumer.  A 46-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 28Dec2020 at single dose  for Covid-19 immunisation. Medical history included exercise induced asthma, penicillin hypersensitivity. Previously the patient received flu vaccine and TDAP vaccine  and experienced nausea and body aches about 2010.   The patient's concomitant medications were not reported.  The patient was unresponsive to stimuli  on 29Dec2020 with outcome of recovered , experienced  loss of consciousness on 29Dec2020 with outcome of recovered , had irregular breathing on 29Dec2020 with outcome of recovered , nausea  on 29Dec2020 with outcome of recovered , snoring on 29Dec2020 with outcome of recovered , staring  on 29Dec2020 with outcome of recovered.   The events loss of consciousness and unresponsive to stimuli were considered Important Medical Events.  It was reported that the patient  woke up in the night, walked downstairs to get water, walked back upstairs and became nauseous, laid down and became unresponsive. Eyes were open but not focused, breathing was irregular and snoring-like. This lasted less than a minute and he regained consciousness.  No follow up attempts are possible. No further information is expected.
patient was nauseous; but did not vomit , looked pale  and weak , patient denied bp check and 911. administered water to the patient and monitored the patient for 20 minutes. after that amount of time patient was fine. pharmacist followed up and called her . told patient to stay hydrated and rest. patient was called at 115pm was home and is fine .
developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21H, 041L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced URTICARIA (developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw). At the time of the report, URTICARIA (developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw) outcome was unknown.            After second dose a day and a half after developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw. It did not itch. No concomitant and treatment medications were reported.   This case was linked to MOD-2021-409888, MOD-2021-409905 (Patient Link).
Stinging, itching, red/swollen area about 2 inches by 3 inches in size, no limitation in range of motion, only 4 days since vaccine was administered.
Janssen COVID-19 Vaccine EUA.  Shot at 11am.on Friday morning.    At 6 pm, started feeling dizzy & lightheaded.  Within 30 minutes, chills started & then fever.  ( 100 -101 degrees)Chills, fever & lightheadedness continued through the night & into the next day.  These symptoms  continued through the day (Saturday) along with a headache.    Symptoms subsided by Sunday morning.
Severe Injection Site Reaction: worsening -creeping erythema, induration, swelling, cellulitis, pain.  Sought medical care--- prescribed antibiotic (Clindamycin), cold packs, acetaminophen alternating with ibuprofen.
2 inch lump, itching, hot to the touch. - Warm compress, gentle massage, BENADRYL if needed for itching.