chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US003047 is an initial spontaneous report received from a healthcare professional on 01 Feb 2013. This report refers to female patient. It was reported that on 30 Nov 2012, she received only 0.5 ml Men CYW-135 liquid conjugate component of MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly instead of being reconstituted with Men A lyophilized conjugate. No adverse reactions were reported following the administration error.
HOSPITALIZED AFTER FIRST DOSE; This spontaneous report received from a consumer via a company representative concerned a 40 year old female. 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 hospitalized after first dose, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized after first dose was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210400286-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Hospitalization. This event is considered unassessable. The event 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.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated 4 times with the Pfizer vaccine, having received vaccine on 01/14/2021, 02/03/2021, 10/27/2021, and 05/03/2022. They had a symptom onset of 08/08/2022 with nasal congestion and productive cough. They tested positive for COVID-19 on 08/09/2022. They were seen by a healthcare provider to re-certify hospice status on 08/09/2022 and  were re-certified for hospice. In addition, they were treated with Remdisivir and diagnosed with pneumonia. They were not hospitalized for this illness, but died on 08/14/2022.
Developed tachy cardia at rest and reclined with frequent PVC avg 4 a min up to 8 a min. Lasted 12 hours. Then reoccurring for 2 hour intervals for the next week.  Intermittent hyperadrenergic flares where pulse and BP went up dramatically and stayed high for 20 minutes.   Happened 2-3 times a week for six weeks, 1-2 week for the next four weeks. Seldom now once aa week or less at 11 weeks out and counting.
First it was a strong pain in the arm, from the moment of the vaccination (4/17), and 4 days later (4/20) I began a strong pain in the left leg, the pain is similar to when the leg falls asleep after sitting on the leg for a long time, but it is stronger, a tingling, as if the leg was immobile. it's a very ugly feeling.
Hives; This spontaneous case was received on 14-Sep-2021 from a physician via Regulatory Authority (reference number: SEQW21-02255) and concerned a patient of an unspecified age and gender.  The patient's medical history and concomitant medications were unknown.  On an unspecified date in 2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was P100249167.  On an unspecified date in 2020, an unknown amount of time after receiving Afluria Quadrivalent, the patient experienced hives.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The reporter assessed the event as non-serios.  Company comment: The event of hives is considered as unassessable to Afluria Quadrivalent.; Sender's Comments: The event of hives is considered as unassessable to Afluria Quadrivalent.
Mom reports fever 101.4 degrees at 6:30PM on 12/14/2005.  Also had a little swelling at injection site.  On 12/15/2005 had cough, watery eyes, and temperature 100.2 degrees.  Saw doctor on 12/19/2005.  Patient declined hospitalization and treated at home with steady improvement.
High fever of 103 for three or four days, body aches, headache, chills, rash on her face below her lips for one day - upper chin area - looked like a red bruise - was in the skin. Injection site swelled and got red, red. Never lost sense of taste or smell. Then tested positive for COVID one to two weeks later. I think I would have ended up in the hospital if we didn't take medication the day we were tested.
hot in the injection arm; sore in the injection arm; achy in the injection arm; swollen in the injection arm; Red in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot in the injection arm), VACCINATION SITE PAIN (sore in the injection arm), MYALGIA (achy in the injection arm), VACCINATION SITE SWELLING (swollen in the injection arm) and VACCINATION SITE ERYTHEMA (Red in the injection arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot in the injection arm), VACCINATION SITE PAIN (sore in the injection arm), MYALGIA (achy in the injection arm), VACCINATION SITE SWELLING (swollen in the injection arm) and VACCINATION SITE ERYTHEMA (Red in the injection arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 06-Apr-2021, VACCINATION SITE WARMTH (hot in the injection arm), VACCINATION SITE PAIN (sore in the injection arm) and VACCINATION SITE SWELLING (swollen in the injection arm) had resolved. At the time of the report, MYALGIA (achy in the injection arm) and VACCINATION SITE ERYTHEMA (Red in the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.   This case was linked to MOD-2021-142573 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-jul-2021 contains significant information. Added reporters Mail id, City, Postal code and report media updated.
Patient first received flu and covid shot in right arm and then soon after received pneumonia shot in left arm. About 15 seconds after getting the 3rd shot patient said she started to fill dizzy, short of breath, and nauseous. About 30 seconds later, patient slouched over in chair and went unconscious. At this point I called one of my technicians into the vaccine room to call EMS and close the pharmacy. I then administered 1 dose of Epi-Pen to the patients left outer thigh. EMS asked several questions over the phone and I stayed with the patient. She started to go in and out of consiousness within a couple of minutes of recieving epinephrine and I was able to communicate with her and monitored her breathing. I offered her water and 1 bendadryl tablet (25mg) to take by mouth. Event started at 3pm on 10/7/23 and EMS arrived by 3:12pm who then escorted her away. 14 year old daugher was with mother and traveled to hospital with EMS. Gave EMS all patient information and shot info possible before they left. Unknown status of patient as of submitting report but patient seemed more alert when being taken away.
libs and throat were closing; libs and throat were closing; Swelling on the face; This case was reported by a physician via call center representative and described the occurrence of throat constriction in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced throat constriction (serious criteria life threatening), lip swelling (serious criteria life threatening) and facial swelling (serious criteria life threatening). The patient was treated with steroids nos (Steroids) and antihistamine (Anti Histamine). On an unknown date, the outcome of the throat constriction, lip swelling and facial swelling were recovered/resolved.   It was unknown if the reporter considered the throat constriction, lip swelling and facial swelling to be related to Shingrix.  Additional details were provided as follows: It was reported that the 24 hours after receiving a the first dose of Shingrix the patient experienced swelling on the face, lips and throat were closing, had to go to emergency and received medications steroids and anti-histamines.  The patient was now recovered. The reporter consented to follow up.
After administration of vaccine within 5 minutes I became extremely dizzy and had a near syncope episode. I have been experiencing dizziness, headaches/migraines, and nausea ever since my first dose but it has severely worsened since receiving my second dose after my near syncopal episode. I have NO prior history of dizziness, headaches, or any other neurological or medical illness/condition.
This is a spontaneous report from a contactable nurse via a sales representative. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. Concomitant medication included HPV vaccine (HPV) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP). The patient experienced fatigue for 3 days, hard pain on arm, body and head although iced administration at the site of the shot and fever. Therapeutic measures were given on hard pain on arm, body and head. The outcome of the events was unknown. Information on the batch number has been requested.
This spontaneous report as received from a nurse refers to a 16 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 21-MAY-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 2, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Hives starting 4 days after 2nd  injection.  Scattered locations, bilateral , upper and lower extremities comng and going x 4 weeks, Additional burning, itching, erythematous maculopapular rash on neck and shins bilaterally starting  6 days after 2nd injection   persisting x 4 wks.  Treated with intermittant topical hydrocortisone and oral benadryl.
Patient arrived to observation room and approximately 25 minutes after receiving vaccine dose, patient with c/o pain in his right shoulder and back, which was the opposite side vaccine dose was given.  Patient developed rash after first vaccine dose, 2 hours later. No treatment for first dose or hives per moms report.   Patient given 25 mg benadryl at 1238.  No visible rash when checked at 1240 and no other symptoms.  At 1250, patient reported same symptoms. At 1303, patient reported pain much better.  Patient left with mother shortly after and reported will take Tylenol as needed for any continued pain.
Pt received a COVID Vaccine at the Health Dept on 09/13/2022 then came to our facility to see a provider on 11/15/2022 for arm and shoulder pain.  Pt requested that we report the incident due to she continues to have Pain in that arm and shoulder.    She stated that the swelling and redness are gone but she believed that is the  cause of her shoulder pain.  Provider is treating pt for shoulder pain.
Had a gout flare up 2 - 3 days after vaccine. Have not changed diet and am on medicine for.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via media concerned an 80 year old of unspecified sex. Initial information was processed along with additional information on 29-NOV-2022. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. 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 patient got covid-19 infection (suspected covid-19 infection) and was sick about for two weeks (dose number in series 2). The reporter stated "I'm 80 years old and had all the pre shots. I got COVID, and was sicker than I've ever been for two weeks, but guess what?? I'm still here. I know I wouldn't have made it without the shots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious. This report was associated with a product quality complaint: 90000260986. The suspected product quality complaint has been confirmed to be void (there is no product quality issue described in the information reported as there is no timeline for date of vaccination to contracting covid, no brand of vaccination mentioned and no positive confirmatory test reported) based on the PQC evaluation/investigation performed.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 19:59, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Dizzy on first day of vaccine Red painful bump/lump to arm about 2 inches in diameter, still present as of day 3
Arm pain/soreness Exhaustion Difficulty sleeping Body aches Fever (temperature of 101) Sharp pain in bottom of left foot Headache
12-27-2020 first dose of moderna - No reactions 1-26-2021 second dose of moderna - on 1-27-2021 side effects were present with fever, body aches, chills, headache, weakness, slight nausea, slight diarrhea - symptoms lasting ten hours.
Breakthrough Case of COVID-Loss my voice, I was coughing up some phlegm, I often get that in the spring, but it turned out that I had COVID.
About 8 hours after receiving the flu shot, I began to have a headache and body aches. Later on in the evening, I developed a fever which ranged from 99.1-101.1.  I had chills and severe body aches and a headache all night and most of the following day. I felt like I had the full blown flu.  I also had a sore arm.  The shot really hurt and stung bad when they jabbed me,
Patient came to pharmacy on 10/4 after receiving vaccine to complain of severe arm pain with a picture of supposed location of immunization taken by patient. I had a conversation with him about the staff member who administered the vaccine and asked about his present symptoms. Reassured patient that staff member would immediately be re-trained and patient asked to be updated after.
Stiffness in arm and neck. Pt has had tetanus vaccine previously with no side effects.
No adverse reactions. Patient received 1st dose of Moderna at a different location and is under 18 years old. Patient received 2nd dose at pharmacy and is under 18 years old.
1st effect was migraine with left side numbness, woke up at 4 am and was unable to walk correctly.  Went to ER 1 and was transferred due to lack of CT Scan, hospital then admitted for stroke. Can also still feel injection site
My left thumb became sensitive and extremely painful--like an arthritic flare-up.  The last time my thumb had so much pain was in 2010 when I had a job that involved a lot of repetitive movements.  My bunions on my large toes were also more painful than usual.  All symptoms have greatly improved, although not completely.  I can not use my hand the way that I used to and it has been more than 3 months.
Maculopapular rash time 5 on left deltoid (same site of Varivax) and times 1 on abdomen.
diarrhea; headache; bodyache; no appetite; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported, expiration date: Mar2021), via an unspecified route of administration on the left arm, from 05Jan2021 at a single dose for Covid-19 immunisation. Medical history included blood pressure (abnormal).  Concomitant medication included ongoing hydrochlorothiazide for blood pressure. On 06Jan2021, the patient has had body aches, headache and no appetite. On 08Jan2021, she had diarrhea. She was going to work today but was unable to because she had to run to the bathroom. She has gone to the bathroom 6 times. She called her doctor at 7:30am but has not heard back. She is unsure what to do. She is asking if these are side effects of the vaccine. She is unsure if the lot number on the card is SK4176 or PK4176. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
I noticed when I woke up 9 days after my first Moderna shot that my arm was red, warmer to the touch and itchy about six inches across in the area of the injection site. It?s still the same three days later.
Developed rash and swelling at injection site approximately 6 days after injection. Redness, itching, swelling approximately 3" x 3".  No other effects at this time.
I got J&J vaccine 6 months ago and received Pfizer shot recently. After 10 days, I developed tinnitus in my right ear.
Tinnitus started after second dose.  Was told it was not a side effect.  Symptoms got worse after recent Moderna booster shot.
Pt devel full body rash. Another pt devel similar rxn (WAES98022272). No further information available.PharmD noted they vax pt p they deliver and before pt goes home;
Patient received Pfizer booster at a vaccination event at her building and developed hives <2 days later.  She had previously received Moderna for her primary 2-dose series and did not have any adverse reactions.
Very dry mouth; eyes seem drier too; This case was received via another Manufacturer (Reference number: 202200765415) on 27-May-2022 and was forwarded to Moderna on 27-May-2022. This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (Very dry mouth) and DRY EYE (eyes seem drier too) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EN6207) on 26-Mar-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EW0176 Location of injection: Arm Left) on 26-Apr-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: EW0187 Location of injection: Arm Left) on 31-Aug-2021; for Drug use for unknown indication: Lamisil. Past adverse reactions to the above products included Allergy with Lamisil; and No adverse reaction with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Sjogren's syndrome. Concomitant products included LIFITEGRAST (XIIDRA) from 03-Jan-2022 to an unknown date for an unknown indication.   On 20-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 26-May-2022, the patient experienced DRY MOUTH (Very dry mouth) and DRY EYE (eyes seem drier too). At the time of the report, DRY MOUTH (Very dry mouth) and DRY EYE (eyes seem drier too) had not resolved.            The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Active Drug substance names for Paxlovid reported as COVID 19 Treatment.  It was reported that very dry mouth, & eyes seem drier too. Patient have Sjogrens Syndrome & already suffer from dry eyes & mouth, but patient think the Paxlovid made the dryness much worse. Patient had been drinking lots of water, about 10 -12 oz glasses per day.  Device Date was reported as 26-May-2022.
Sore arm; Fluad was given to under the age of 65; This is a non-serious spontaneous case, initially received from pharmacist on 05-Dec-2018, concerning a 62-year-old adult female patient.  On 25-Oct-2018, the patient (under 65 years) was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] for active immunization against influenza (explicitly coded as inappropriate age at vaccine administration).  On the same day, after vaccination, the patient experienced sore arm for 2 days. It was reported that no treatment was required.  The outcome of the event was recovered on 27-Oct-2018.  This case is linked to 201804954 due to same reporter.  Non-significant follow-up received from the pharmacist on 07-Jan-2019: The reporter's county (Bristol) was updated in the reporter tab. The reporter did not give permission to contact the patient. No changes were made in the narrative. Med info number (SEQ19-00121) was updated in the additional information section.; Reporter's Comments: A 62-year-old female patient (under 65 years) was administered Fluad (TIV) (as inappropriate age at vaccine administration) and developed painful arm on the same day after vaccination. The company assessed the causality of the event (painful arm) as related to suspect vaccine due to plausible temporal relationship between the event and suspect vaccine and the causality of the event (inappropriate age at vaccine administration) as not related to suspect vaccine due to accidental nature of the event.