chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. received dose of Moderna from a vial that was outside the discard timeframe. Vial was still stored at proper storage temp. Moderna manuf. notified. Due to, proper storage & no other negative factors, per Moderna vaccine dose "Maintained activity against COVID-19". Dose valid Per Moderna. Doses increased risk for microbial infection the father outside the discard window as it is for MDV. No known injury to patient.
Patient noted on awakening right arm swollen, red and with decreased range of motion and pain, tender - day after injection. Patient is noted to have a temperature today.
Sinus congestion/sore throat/cough/headache/fatigue/lightheadedness 2 hrs post vaccine. Given supportive medication to manage symptoms
My eyes were really dry, bloodshot, watery. I was treating it like it was allergies, I made an appointment to go in to see my doctor, who was not available, I had to see an associate. I was told it did not look like pink eye; I was not given any medication. I have been using warm compresses on it to soothe the pain and help to open my eyes. I called back to let the doctor know that my eye was now clear but very dry and irritated. I was advised that I could use eye drops for dry eyes.
Vaccinated with Pfizer in April 2021. Experiencing only loss of sense of smell and some cold.
Received a TD on 8/20/02. Initially, no swelling or soreness but 7 days later, on 8/27/02, noticed arm feeling warm with itching and also some swelling. Today, C/O pain in lower rib cage (Evaluated by NP on 8/27/02. NP recommended Benadryl 25mg po; warm wet compresses but no improvement or worsening to see per PMD).
Itching; Skin burning sensation; red welts; About 3-4 hours afterward her 1st COVID-19 Vaccine, she had a rash start on the back of her left leg that then spread allover her body on 18Apr2021; bad back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0153, Expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 17Apr2021 16:00 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included prednisone (PREDNISONE) (60mg tablet per day) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. The reporter reported that she had her first dose of the Pfizer COVID-19 Vaccine on Saturday, 17Apr2021. She said about 3-4 hours afterwards, she had a rash start on the back of her (left) leg. She said at the time, she didn't think anything of the rash because she had received her COVID-19 Vaccine in her in right arm. She said the rash was on the back of her left leg, behind her left knee. She said by the next day (Sunday, 18Apr2021), the rash had spread all over her body. She said the rash was itching and burning with red welts. She said she went to immediate Care (an urgent care) yesterday (18Apr2021), when the rash started to spread up to her neck. She said she was concerned when the rash started to spread to her neck because she was told if she had a reaction to the COVID-19 Vaccine, the reaction could close off her breathing. As a treatment patient has received steroid injection at the urgent care, and told to start Benadryl, and to take the Benadryl 25mg tablet, every 4-5 hours. She said she was also given a steroid prescription to take for the next 5 days. The outcome for the events Rash starts on the back of her left leg that then spread all over her body, itching, skin burning sensation, red welts was not recovered. And for the event bad back was unknown.  No follow-up attempts are needed. No further information is expected.
had a rash all over; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient had a rash all over. It was unknown if therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The clinical outcome of the event, rash all over was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had extreme redness and some swelling on the bottom half of arm between injection site and elbow. Her fever declined after 2 days but the redness and swelling occurred all over bottom of arm above the elbow. She said it wasn't itchy but a little painful. She did receive the PNEUMOVAX vaccine at the same time in the same arm.
patient had rashes after they received the vaccine; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to cases 2023SA314994 and 2023SA315554.  This case involves an unknown age and unknown gender patient who had rashes after they received the vaccine after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (with an unknown formulation, strength, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient had rashes after they received the vaccine (rash) (unknown latency).  It was reported, Caller does not have patient information as well as lot number and expiration as the reporter stated nurses just informed her with regards to the AE but no specific details provided. The reporter consented to follow up.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the reported events.  At time of reporting, the outcome was Unknown for the event patient had rashes after they received the vaccine.
expired ActHIB was administered to a patient today with no adverse event; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.   This case involves 12 month old male patient who was vaccinated with an expired dose of  HIB (PRP/T) VACCINE 0.5 ml (lot number UI921AAA, Expiry date 09-NOV-2019) once via intramuscular route in the left thigh on 12-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Expired vaccine used.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
neurological syptoms; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (neurological syptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 NEUROLOGICAL SYMPTOM (neurological syptoms). At the time of the report, NEUROLOGICAL SYMPTOM (neurological syptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up attached on 21-Oct-2021 contains no new information
My first two doses of COVID-19 vaccine were Moderna and my booster was Pfizer. After receiving my booster shot I experienced 3 deep bouts of depression. I already have a therapist that I speak to on a regular basis.
Patient has covid19 per positive test 4/24/21, post 2 dose series of vaccine.
SICK; CHEST PAINS; HURTING ALL OVER; NO ENERGY; This spontaneous report received from a consumer via social media (Facebook) concerned a male of unspecified age, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No adverse events reported after vaccination.  The patient received non-company suspect booster vaccine included: BNT 162 (Pfizer) (form of admin, route of admin, and batch number were not reported), dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On an unspecified date following BNT 162 (Pfizer) vaccination, the patient got really sick. The patient had chest pains within 10 minutes and within half hour it was hurting all over and had no energy (dose number in series 2).   It was reported that "my husband and I took the Pfizer (however it is spelled) booster after we had the J&J and we both got really sick. My husband had chest pains within 10 minutes and within half hour was hurting all over and no energy. Mine started the next day and I was in bed for 7 days with joint pain, nausea, dizziness and no appetite. I will never take another vaccine"  The action taken withcovid-19 vaccine ad26.cov2.s  was not applicable.  The outcome of the sick, chest pains, hurting all over and no energy was not reported.  This report was non-serious.  This case, from the same reporter is linked to 20211229790.
Approximately 30 minutes after receiving HPV 9 vaccine c/o lightheadedness followed by syncopal episode w/LOC approximately 10 sec associated w/diaphoresis. Rapid recovery over the course of supine position for approximately 15 min. Monitored for 40 minutes before discharging home.
PROBABLE ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY AIDP / GUILLAIN  BARRE SYNDROME DIAGNOSED 12/6/11 BY NEUROLOGIST. HOSPITALIZED ON 12/8/11. SYMPTOMS STARTED 11/19/11.  VERTIGO 11/28/11.
Patient fainted for about 20 seconds in waiting room as she walked out, father was able to break fall, no injuries reported by patient or visible injuries, patient was brought back to treatment room, vitals were obtained and normal, patient was released and self ambulated to vehicle.
Patient  received the COVID and Flu vaccien on the same day (mom thinks around November 1st,2022. He had nausea the next day and has had  intermittent nausea since then  no other symptoms
There were more than 50 red dots on the left shoulder, armpit, chest, and back, and the tickling and tingling phenomenon has been going on for 3 weeks.
Stomach pain,   Diarrhea,  no treatment,  both subsided during the night.
Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events.   Information on the lot/batch number has been requested.
PATIENT REPORTED SORENESS OF JOINTS, NODE BESIDE LEFT EAR 4 DAYS AFTER RECEIVING TDAP, HEP B, MMR AND HEP A.  SHE THOUGHT PROBLEM WAS DUE TO MMR RECEIVED.  RESOLVED IN ONE WEEK 9/8/08.  STATED HER DR FRIEND SAID IT WAS OKAY TO GET A 2ND DOSE.
Case number PHEH2012US015830 is an initial spontaneous report received from a physician on 06 Aug 2012. This case refers to a patient of unspecified age and gender. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unspecified date. The patient was also vaccinated with HPV vaccine (other manufacturer, batch number: not reported) on the same day. On an unknown date after vaccination the patient developed rashes. The outcome, causality and seriousness of the vent were not reported. No other information was available at the time of this report.
I went into the pharmacy to get my Tdap shot yet I was given a 4th COVID19 shot booster by mistake. The pharmacist administered the Tdap shot after he gave me the COVID19 booster. I felt very tired the next morning with a headache and a sore shoulder.   The mistake happened because the COVID19 shot was supposed to be given to a lady after me but for some reason the pharmacist brought both vaccines to my appointment ended up giving me both. I never asked  for a second booster.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 05-MAR-2016, the patient was inoculated with ZOSTAVAX at a pharmacy for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-APR-2016, she was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Patient complains of fever developing the night after vaccination and rash appeared around injection site 3 days later after fever has lowered.  Rash was warm to touch.  No signs of difficult breathing, severe allergy reaction or other discomfort.
Received Tdap, varicella, Hep A, MCV, and HPV. HPV was the last vaccine; fainted approx. 1 minute after HPV given. Slumped forward, eased to floor. Regained consciousness in approx. 45 seconds. Remained shakey; 1:20pm BP 138/76, AP-96; 1:30pm 130/82, AP-98; 1:45pm 120/80, AP-80; Gatorade x3 provided; Per Dad B/P runs low, fainted before. Released to Dad at 2:20pm.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with doses of GARDASIL, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported) which underwent a temperature excursion. No adverse effects were reported. Additional information has been requested.
Pain spread down side of arm to elbow; Pain in up side of neck; Arm starting hurting focalized at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain spread down side of arm to elbow), NECK PAIN (Pain in up side of neck) and VACCINATION SITE PAIN (Arm starting hurting focalized at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain spread down side of arm to elbow), NECK PAIN (Pain in up side of neck) and VACCINATION SITE PAIN (Arm starting hurting focalized at injection site). At the time of the report, PAIN IN EXTREMITY (Pain spread down side of arm to elbow), NECK PAIN (Pain in up side of neck) and VACCINATION SITE PAIN (Arm starting hurting focalized at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment included ice and ibuprofen.
Severe pain in arm, swelling/redness, fever, nausea, weakness. Disoriented for 1 week. Patient put on Tequin 400mg.
Pt experienced a fever of 103, nausea, chills & injection site erythema w/in 48 hrs p/immun; Tx included ice packs for the erythema & APAP;
Tingling sensation in arm and leg; This case was reported by a physician via other and described the occurrence of tingling of extremity in a 37-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 15th September 2022, less than a day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comments:  The reporter stated that a patient was injected with tdap (immunization), they started experiencing a tingling sensation in their arm and leg.  The reporter mentioned no initial/follow up treatment was provided as they physician was continuing to monitor the patients' health. The patient had no allergies.  The reporter stated that this was the first time it occurred.
I LOST HEARING IN BOTH EARS. I AM EXPERIENCING TINNITIS IN ONE EAR WHICH IS ABOUT HALF VOLUME W MUFFLED SOUND AND SHARP PAIN AND EVEN LESS HEARING WITH EVEN MORE MUFFLED IN LEFT EAR.
mild headache; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration in the left arm on 22Jan2021 07:15 AM (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. The medical history included Factor XI bleeding disorder from an unknown date and unknown if ongoing, left and right hip replacements on the Summer of 2003 and the summer of 2007, non-hodgkin's lymphoma from 08Jan2001 and finished the treatment in the fall of 2003 (since then, the patient have not had cancer). Concomitant medication included amphetamine (DESXTROAMP-AMPHETAMINE) taken for an unspecified indication, start and stop dates were not reported. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. The patient experienced a mild headache on 24Jan2021, two days after the first dose. It was reported that the event could have been due to any number of other things. The outcome of the event was unknown. The patient was vaccinated with the second dose of BNT162B2 on 12Feb2021 07:15.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication pertinent history and drug reactions/allergies were not reported. On 07-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was o previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, chills, diarrhea, migraine, stiff joints,  trouble catching my breath , tremors, slight confusion
11 month old scheduled to receive her first dose of Influenza Vaccine. Primary Care has Fluzone Quadrivalent prefilled 0.5ml syringes. Pt was administered 0.25mls of the prefilled syringe (therefore not a full dose). Mom has declined second flu vaccine due to concerns about getting the "full dose" now, and per guidelines, first dose was invalid and pt actually needs 2 doses to be considered vaccinated.