chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection spot red the first two days. Day 7 - got an arm soreness - small little hard spot was there at injection site -  hot from shoulder to elbow. It became hot and hard and it started to spread quite a bit. Ibuprofen helped. Benadryl didn't help at all.  I drew the margins of it and go to ER (ER - but it wasn't documented visit -and they were able to see me quick)  and I was diagnosed with a cellulitis - sulpha antibiotics  (I couldn't stop vomiting - reaction to sulpha medication); felt so tired and felt the injection site got worse - body aches and injection site - because of delay in treatment with a new antibiotic and my next prescription was Clindamycin. Arm got better after I started Clindamycin. I couldn't take the whole course of the antibiotics - my gut was affected by the antibiotic - was having diarrhea and vomiting. Arm was better though so that's good. I'm just now to the point - in the last week or so that my bowel movements are better. I'm taking probiotics to introduce good bacteria. Did require treatment for vaginal yeast infection - my  normal after having antibiotics. I took two Diflucan - and taking vaginal cream for it.  Had second dose of vaccine.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-OCT-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J004159 and expiry date: 08-APR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical or concurrent conditions were reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored M-M-R II (dose, strength, dose number, route of administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) 1 total, 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 number. No concomitant medications were reported.  On an unspecified date, the patient got covid-19 (captured as suspected covid-19 infection, and suspected clinical vaccination failure). The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This reported was associated with product Quality complaint. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: covid-19 vaccine suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient came to clinic 2 days after administration of vaccine with complaint of redness, swelling warm sensation and tender. Patient was prescribed KEFLEX to take 1 capsule (500 mg) by mouth every 8 hours for 7 days.
Mild headache 1 day, tired 2 days, Premature Ventrical Contractions atarting 8 days after shot and have not gone away. PVCs increased after booster on October 29, 2021. EKG in cardiologist office on May 25, 2021 showed marked PVCs. Felt thumping in chest that increased over time. Prescribed Flecainide on September 9, 2021.
On 01/03/2001 the patient's sister was diagnosed with shingles. The sister was never vaccinated. Eight days later the patient developed a fever. On 01/13/2001 the patient developed blisters and a bloody ear. The patient was seen in the ER and had blisters in her ear canal. The patient was diagnosed with chicken pox. Approximately 7 to 10 days later the patient recovered. The hospital summary was not available. No further information is expected.
pt recv vax 22JUL96 & 24DEC96 pt devel full blown varicella;pt was seen by MD 26DEC96 & was covered w/lesions;2JAN97 pt was seen again by MD w/a high fever & bilat cervical lymphadenopathy;a strep cult was positive;tx w/Augmentin;
patient started not feeling well, shortness of breath, chest pain, dizziness, tachypnea, hypotension.  Given cetirizine and Pepcid PO tabs, pt continuous to have chest pain and shortness of breath Doctor okeyed to give epi-pen x 1 dose, BP improved but pt continuously had SOB and CP 911 called and sent to Emergency Department
Soreness at site for two weeks, dizziness, headaches, body aches, and muscle aches.
neck stiffness; This case was reported by a nurse via sales rep and described the occurrence of stiff neck in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 7th October 2020, the patient received Bexsero and FluLaval Tetra 2020-2021 season. On 10th October 2020, 3 days after receiving Bexsero and FluLaval Tetra 2020-2021 season, the patient experienced stiff neck. The patient was treated with ibuprofen. On an unknown date, the outcome of the stiff neck was recovering/resolving.   It was unknown if the reporter considered the stiff neck to be related to Bexsero and FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Bexsero in one arm and FluLaval in the other on same day. Patient experienced neck stiffness on the side that the FluLaval was given. The patient was advised to take Ibuprofen. The patient reported that event was resolving.
Received a mixed dose series.   1st dose was Pfizer Lot# EP6955 on March 17, 2021 at a different facility and missed appointment for 2nd dose. Then shows up for 2nd dose of Moderna Lot# 039B21A on April 16, 2021 at our facility, but never stated he had gotten a first dose elsewhere, as we were only giving 1st doses.
Temp of 104(R) x 4-5 days- treated w/pediatric Tylenol - site was reddened infant lethargic.
I received injection on Feb. 11, 2015 on Feb.13 I had severe pain in my left arm, Rt. Arm and back and neck and head. After 1 week I also had a bad headache. Called doctors office and was told it possibly was a muscle problem. Was given rx for baclofen. These pains continued for six weeks. I could not drive my auto during this time.
The 2nd Day I had swelling that was kind of large and today 10-28-2021, I broke out in a huge rash where the injection site was and intense itching started to accrue.
Due to Covid-19 lockdown the patient has not been able to receive the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 98-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, due to Covid-19 lockdown the patient had not been able to receive the second dose of Shingrix, which led to social problem.  The reporter consented to follow up. This case was 1 of 5 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199879:same reporter US-GLAXOSMITHKLINE-US2019AMR161146:same reporter US-GLAXOSMITHKLINE-US2019AMR157845:same reporter US-GLAXOSMITHKLINE-US2019157535:same reporter
Information has been received on 15-FEB-2019 regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 13-NOV-2014, the patient was administered ZOSTAVAX (lot# and route not specified) by a pharmacist. On an unspecified date the patient was treated by a healthcare provider at a hospital for pneumonia as a result of her vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Chapped, swollen upper lip 2/3 in length, lasted 5 days. RPh suggested BENADRYL to decrease swelling. AFLURIA 2014-2015 syringe NDC 33332-0014-01.
p/vax pt exp fever & swelling of the entire arm w/redness & pain;pt was seen in ER where they were not sure if it was a rxn or an infect, so they chose to put pt on ATB;@ time of report pt was improving;
mom reports splotchy, itching, hive-like rash on face, neck & upper chest the day p/2nd dose of vax;afeb;no SOB;2 doses of DPH given;no further c/o rash/NKA:
This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 27-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route and lot number were not reported) and (Oka-Merck) PROQUAD (dose, route and lot number were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. No relavant concomitant medications reported. No treatment information was provided. Action taken with mRNA-123 is not applicable. Reporter did not allow further contact.
Moving severe pain in arm from shoulder to wrist. Mostly centered at elbow with swelling of site of injection, elbow and wrist. Raised bump at injection site. Unable to perform usual daily activities.
PATIENT EXPERIENCED SWELLING OF HER UVULA, MALAISE, CHILLS, JOINT PAIN & SORENESS
Moderna COVID Vaccine EUA The injection site was size of baseball. I had chills and body aches throughout the day on 2/9/21. Became feverish around 0730PM 2/9/21, temp was 102 at that point. 2/10/21 had low grade fever 99.9 and some body aches. The infection site was still warm to touch but swelling is going down.
Evening of administered dose sore and itchy arm. Woke up the morning after injection (3/18/2021) had tired feeling of eyes, white of left eye appeared to have bleeding  across entire bottom area as well as up both sides, top area remained white in appearanceor bleeding was unresolved in three weeks AS
One week after Shot got hard bump size of egg on right arm below injection site, then a rash broke out.  use topical Benadryl. Bump gone. Some itching remains. Two days later a rash started started to break out on both of my hands. Spread from wrist area to knuckles of fingers. Itching is distracting.  Starting to treat both with Cortisone as Benadryl isn't working . Will consider systemic oral Benadryl or Zyrtec if it doesn't go away. Both make me so drowsy it would be hard to work during day.  So far the symptoms have lasted 4 days.
I stayed for an extra 20 minutes or so just to be sure I was OK. When I got home, I had a slight headache, and a slight sore arm. Advil 400 mg and an ice pack handled that well.  Friday morning, woke up and prepared for my day as normal, including a healthy fruit smoothie for breakfast
Around 24 hours after receiving second Moderna shot, the patient started experiencing shooting chest pain on left side that radiated to her back and had shortness of breath.
PT STATED SHE HAS HISTORY OF "FAINTING" EVERY TIME SHE GETS INJECTIONS.  Pt placed in reclining chair for administration. Pt experienced brief vaso-vagal response; closed eyes for less than 30 seconds. Pt regained full consciousness with no injury. Normal HR.
swollen lymph nodes under armpit clavicle and neck, Body aches, nausea, blurred vision.
This spontaneous case reported by a consumer, describes the occurrence of pain (really hurting), melanoderma (black spots under her arm), pruritus (itching real bad) and feeling abnormal (breaking-out) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 066D21A and 959902) for COVID-19 immunization. No medical history provided. On Aug 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain (really hurting), melanoderma (black spots under her arm), pruritus (itching real bad) and feeling abnormal (breaking-out). Patient treated with topical cortisone for the adverse events, at an unspecified dose and frequency. At the time of the report, pain (really hurting), melanoderma (black spots under her arm), pruritus (itching real bad) and feeling abnormal (breaking-out): not resolved. No concomitant medications provided. This case linked to MOD-2021-359249 (patient link).
Temp of 103 F body aches and fatigue  for 24-36 hours
Information has been received from a 60 year old female with an allergy to PENICILLIN, NEOMYCIN, SULFONAMIDE and no other medical history who on 02-JUN-2008 was vaccinated with ZOSTER (Oka/Merck) (Lot # was not provided), injection in her left arm.  Concomitant therapy included CRESTOR and AVISTA.  Two weeks after receiving the vaccine, the patient experienced hives, and has had them non stop since then.  Her face has also swelled up twice in that time period.  The patient went to see a physician and a dermatologist.  And she also has basic blood test and urinalysis (results not reported).  The patient's hives and swelled face persisted.  The patient declined to provide physician's information.  No further information was given.  No further information is available.
Pt recvd 2 doses of Engerix-B 18OCT91 & 20NOV91 & exp no event following 1st vax; 2 days following 2nd dose of vax lymph node above lt clavicle was swollen, enlarged to a length of 1 1/2 inches & a width of 1 in & raised about 1/2 inch;
About 5 minutes after injection had itching and tingling in mouth and throat.  Waited 15 minutes and it started clearing up so I did not tell Provider of injection.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction with the first dose of the vaccine and was told that she could not get the second dose. The reporter did not provide the healthcare provider's information. She did not go into detail of what the reaction was, just stated she had a reaction to the first dose. The reporter did not consent to follow-up.
This spontaneous report as received from health care worker refers to unspecified patients of unknown age and gender. Patients' current conditions and pertinent medical history was not provided. On unknown dates, unspecified patients have been was vaccinated with ROTATEQ lot # K016261 and expiration date; 23-JUN-2016, (dose, strength, vaccination site was not provided) which have been exposed to temperatures outside of the recommended range since the excursion on 17-09-2015. Concomitant medication was not reported. No adverse experience has been reported. The outcome of the event reported was unknown. There was no product quality complaint involved. No additional information was provided. Additional information has been requested.
warm to touch at the injection site, it is not painful.; has a little rash around the injection site; little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch at the injection site, it is not painful.), VACCINATION SITE RASH (has a little rash around the injection site) and VACCINATION SITE ERYTHEMA (little red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch at the injection site, it is not painful.), VACCINATION SITE RASH (has a little rash around the injection site) and VACCINATION SITE ERYTHEMA (little red). At the time of the report, VACCINATION SITE WARMTH (warm to touch at the injection site, it is not painful.), VACCINATION SITE RASH (has a little rash around the injection site) and VACCINATION SITE ERYTHEMA (little red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
20mins p/vax pt started feeling dizzy, had abd cramping on 20DEC;pt had diarrhea x 14, dehydration, fevers from 101-103, neck pain, nausea, chills; was taken off of work for 7 days
Narrative:  COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/10, Pfizer, dose #2 10/15, Pfizer, dose #3 11/05 COVID swab, result: detected 11/05 pt cc: cough, diarrhea exposure: unknown
This spontaneous report as received from the patient's grandmother refers to a 15 month old female patient. On 05-FEB-2015 the patient was vaccinated with M-M-R II (lot number not reported, circular # uspi-v205c-i-1406r004). On 07-FEB-2015, 3 days after onset of therapy the patient experienced rash. It was also reported that since the patient was vaccinated with M-M-R II, whenever she eats watermelon, yogurt, dairy, egg, cheese and pickles she becomes red all over her body and face. The patient did seek medical attention with office visit. Treatment included corn starch on her body and oatmeal bath. It was reported blood work was done for allergies (results not reported). The outcome of rash is unknown. Additional information has been requested.
The onset of this started 10 days after my first vaccine dose of Moderna. With no other factors at play, my upper back and arms (fully straight across my body from where I received the shot) became almost paralyzed where I could not lift my arms or move my upper body at all for a period of about 3 full days. I have been diagnosed with neck/back arthritis in the past but this specific reactive circumstance has never come up previously before.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 13:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Gerd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treatment with Paxlovid from 01Mar2023 till 05Mar2023. Patient had no allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110169 Same reporter/patient, different drug/AE.;
Extreme and unbearable pain in all muscles, veins, joints, organs. Stomach ache. Diarrhea. Headache. Nausea. Inability to sleep. Loss of consciousness.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 13 month old patient. On 08-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.