chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 41 year old male. 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 not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210953012 and 20210953327.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-MAY-2016, the patient was vaccinated with M-M-R II (lot # L024268, expiry date: 18-JUL-2017) (route of administration: subcutaneous) and VARIVAX (lot # L048467, expiry date: 02-DEC-2017) (route of administration: subcutaneous) that were improperly stored. The vaccines were stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
PATIENT AWOKE AFTER SLEEPING NEAR SPACE HEATER WITH MACULAR RASH AND THREE VESICLES ON LEFT LATERAL ELBOW (SAME ARM AS SMALLPOX VACCINE), POSSIBLE AUTOINOCULATION VS THERMAL BURN, PATTERN OF RASH NOT CONSISTENT WITH MOST THERMAL BURN SO TREATING AS AN AUTOINOCULATION.
Hives and itching 2 Benadryl  (25mg tablets) Hives were gone in the morning but still some slight itching
pt states that she woke up and tried to get up but when she put weight on her left leg that she had a severe sciatic pain from her butt down to the bottom of her leg.  She has been having to use a walker to get around. Pt   is taking Tylenol for her pain and says the pain is getting better every day.   She says she is 85% better at this time and has not contacted her PCP at this time.
Warmness and tingling moving from injection site across upper body (compared to sensation after receiving contrast dye).  Denies shortness of breath, chest pain and respiratory symptoms.
Patient and mother arrived for 2nd dose Pediatric Pfizer today. Mother admitted she lied about patient's age when getting first dose due to father having heart transplant. Patient was age 4 years and 10 months when receiving first dose at Pharmacy. Mother reported to Pharmacy patients date of birth  was 03/10/2016 for 1st dose. Patient did not have any reactions/adverse events. Patient received 2nd dose Pediatric Pfizer today per CDC Guidelines. Mother informed this will be report to VAERS due to patient receiving unauthorized dose prior to age 5 for eligibility.
Patient had received 1 dose of Moderna vaccine on 4/11/21, Pfizer on 7/29/21, and another Pfizer today on 9/17/21.  Essentially, he received an extra dose of a COVID vaccine.  He was observed in the waiting room for 15 minutes with no adverse effects noted.
12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transported to EMS area of observation area; in wheelchair lost consciousness and had brief 15-20 second seizure 13:10 Repeated bouts of emesis.  Patient had marked pallor and diaphoresis 13:35 EMS transport arrived, placed IV, gave phenergan, and transported via ambulance to  Hospital Center
Around 9:30 am on Wednesday 11/18/2020, patient was getting a drink from the fridge. She turned around and dropped her cup. She stumbled into a corner of the kitchen, stood up, fell over again landing on the microwave stand. As tried to stand up, I (her mother) and her father, realized someone was not right. She looked glassy-eyed and dazed and she was swaying. She couldn't stand up on her own. My husband held her and her eyes began to roll back and her head and body went limp. Then she passed out completely. She woke up in a few minutes and then within about 5 minutes the EMS came and she stood up.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Approximately in 2010, (reported as "five years ago"), the patient was vaccinated with the first dose of ZOSTAVAX site and route of administration, lot#, expiry date and dose were not reported. On an unknown date, the patient was vaccinated with a ZOSTAVAX, dose, lot#, expiry date, route and site of administration were not reported. On unknown dates, the patient experienced shingles six times. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX, lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. 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 has been requested.
Headache, Myalgia, Fever, Body aches, chills, headaches, weak; all resolved as yesterday Narrative:  Other Relevant History:
Patient was mistakenly given a 2nd dose of Moderna when his first dose was Pfizer.
Tightening of the Chest; Harder to breath; sensitive to lights and sounds; for 2 years Iv'e been hearing voices; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 33130BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Erb's Palsy" (unspecified if ongoing), notes: Erb's Palsy due to Birth Trauma. There were no concomitant medications. Past drug history included: Bnt162b2, start date: 02Apr2021, stop date: 02Apr2021, for COVID-19 immunization, notes: DOSE 1, SINGLE, Batch/Lot No: Pfizer ER8730, Location of injection: Arm Left; Bnt162b2, start date: 29Apr2021, stop date: 29Apr2021, for COVID-19 immunization, notes: DOSE 2, SINGLE, Batch/Lot No: Pfizer ER8735, Location of injection: Arm Left. The following information was reported: CHEST DISCOMFORT (disability, medically significant, life threatening), outcome "not recovered", described as "Tightening of the Chest"; DYSPNOEA (disability, medically significant, life threatening), outcome "not recovered", described as "Harder to breath"; PHOTOPHOBIA (disability, medically significant, life threatening), outcome "not recovered", described as "sensitive to lights and sounds"; TINNITUS (disability, medically significant, life threatening), outcome "not recovered", described as "for 2 years Iv'e been hearing voices". Therapeutic measures were taken as a result of chest discomfort, dyspnoea, photophobia, tinnitus.  Clinical Course: No Other medication in 2weeks. Today was 16Mar2023 and I am still having really bad symptoms. Tightening of the Chest, Harder to breath, Became more sensitive to lights and sounds and now for 2 years Iv'e been hearing voices and want to kill myself so Screw Pfizer for what they did to me. I'm serious these symptoms are not going away and now I just got prescribe Quetiapine ER (150 MG Tablets) to get ride of the voices. I mean it that lost shot messed my life up but this better not last even though it's 2 years in. Adverse event start date was 19Jan2021.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events chest discomfort, dyspnoea, photophobia, tinnitus and suspect BNT162B2 cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300118031 same patient, different dose/AE;
Pt was given 2nd dose Pfizer vaccine 0.3ml dose approved for 12 yrs and up instead of the pediatric pfizer 0.2ml dose approved for ages 5-11. Mistake not noticed until reporter went to document vaccine, which was not in real time. Once mistake was noticed, reported and incident report completed as well.  Advised pt parent would be contacted in regards to error.d
Patient has sx consistent with TIA.  Taken to hospital, confirmed. No TPA, just ASA & plavix. D/C on Lipitor. advised to stop HRT & diclofenac.
Information has been received from a nurse concerning a 42 month old male patient who in July 2001 (also reported as July 2008 by the nurse) was vaccinated with a 0.5 ml first dose of VARIVAX (Merck) (Lot #, expire date and route not reported). The patient recently presented with a zoster like rash. On an unspecified date, either the patient was taken to the health department or a culture was sent to the health department. The results from laboratory confirmation for zoster came back positive for shingles and the Health Department believed that it was from the vaccine. The patient had not received any dose of VARIVAX (Merck) after the first one. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Fever (36 hours), swollen hand/arm (2 days), headache (4 days), fatigue (4 days), nausea (3 days), dizziness (3 days), loss of taste (6 days), joint ache (4 days), injection site soreness (7 days)
Red area approx 30cm x 30cm. Warm to touch pt. given 1 tsp. BENADRYL at 1620. Complains area itches.
Raised skin bumps resembling measles on neck, back, arms, breast and "butt"....none lower. Itching. No fever. Very fatigued.
Initial report was received from a consumer, who was also the patient's mother, on 01 July 2013. This reporter also reported another adverse event which was captured in case number 2013-07467. A 2-month-old male patient had received an an injection of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (manufacturer, lot number, route and site not reported) on 10 June 2013 and the same day experienced spitting up "like with bad reflux" and dry skin around the wrists, ankles, legs, face and cheeks. Then started experiencing wheezing and stuffy nose. The patient's medical history was not reported. The patient's mother had a history of severe nickel allergy. Outcome was not recovered. Documents held by sender: none.
Swelling, redness, hot to touch, swelling under arm (lymph gland), temp 99-100. General malaise. Pain in arm, itchy at sight.
moderna arm; rash all over both hands; skin is blistering; fingers are red/not going away and spreading more; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (moderna arm), RASH (rash all over both hands), BLISTER (skin is blistering) and ERYTHEMA (fingers are red/not going away and spreading more) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (moderna arm), RASH (rash all over both hands), BLISTER (skin is blistering) and ERYTHEMA (fingers are red/not going away and spreading more). At the time of the report, VACCINATION SITE REACTION (moderna arm), RASH (rash all over both hands), BLISTER (skin is blistering) and ERYTHEMA (fingers are red/not going away and spreading more) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment took an antihistamine and used Benadryl cream.
This spontaneous report as received from a female consumer reporting on herself who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that on an unknown date she had experienced a rash and fever lasting for 10 days after receiving ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The relatedness for rash and fever and ZOSTAVAX was unknown. Additional information is not expected.
On 1/23/2021 I started feeling nauseas, had headaches, & muscle pain. It lasted all Saturday, all Sunday. On Monday 1/25/2021 I  vomited 12 times within 1 hour. I called where I got the vaccine the nurse advise me to go to the ER. I went to the ER I got there with abdominal pain from the vomiting. They said I was dehydrated & they right away started me with IV fluids. They did blood work, abdominal CT scan, & a chest x-ray, My white blood count came back elevated. They said to follow up with my doctor.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/28/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Left messages on 5-9,5-10, and 5-11 for patient to return our calls.
Dizziness, nausea, vomiting. Evaluated by EMS-Cleared.
After intern gave the vaccine , she  stood up , within 30 seconds to 1 minute the patient fainted,  the intern and the mom held on to her but she still fell to the ground  . After talking to her she did not eat that morning, she did not have reactions to medicine or vaccines in past but she did faint in the past from a blood draw . As I was calling 911 patient came to.  She was alert.  Fire department  paramedics checked her out and she was ok when she left . Patient was counseled to follow up with doctor.
THE PATIENT RECEIVED EXPIRED VACCINE ( OVER ROOM TEMP AFTER 6 HOURS).
Symptoms started approximately 24 hours after the injection.  It has been over a week and the symptoms are not getting any better and since Saturday the 3rd, one week since the first injection, they are increasingly getting worse.  Was told to give it time and they would reside however that is not happening
Neurological Parasthesis in all extremities, numbness, pain, burning, weakness, cranial neuropathy, falling, itching Fatigue These symptoms have NOT resolved
This spontaneous report was received from a healthcare worker refers to a patient unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 02-AUG-2016, the patient was vaccinated with improperly stored (wistar ra 27-3) M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
Severe headache, muscle fatigue, chills.  Fever of 102.  Side effects lasted 24 hours.  Next 24 hours were fatigue, low grade fever 99+ and  general lethargy
itching around site of injection followed by diffuse skin scaly itchy skin with peeling of ski of both upper extremities
Pfizer Bivalent (adult 12y+ gray cap) was administered after the beyond use date.  Manufacturer was contacted, with no further vaccine stability information.  Patient was contacted regarding incident and opted to not revaccinate at this time.  Patient will discuss with provider at upcoming appointment.  No adverse symptoms noted.
The morning after pt. received immunizations mom noticed an "episode" that "looked" like a seizure. No fever - episode lasted less than 10 sec. and mom had dad witness the episode - it happened 2 more times that day. Mom did not call to report.
After my vaccine I experienced sweats, fever body aches and had stomach pain for three days.  I had arm pain for about three weeks as well. On Monday afternoon, I still had stomach pains, fever and leg cramps. I went to see my doctor and he performed exams on me and was told I had swelling of my intestine. My digestive tract has been profusely slow since receiving the J&J vaccine. They also ran some tests to check if I had any blood clots.  I still experiencing full digestive tract issues and slowness.
he notes that he work up around 7-7:15am and 10 minutes later, developed a mild burning pain in the center of his chest that radiated up into his throat, jaw and neck. He also endorses feeling discomfort in his shoulders and arms bilaterally. The pain resolved with ibuprofen but he still presented the ED given the similar nature to his prior myocarditis.
This spontaneous report as received from a physician refers to a patient of unknown age. On 04-NOV-2014, the patient was vaccinated with two doses of LIQUID PEDVAXHIB, two 0.5 ml doses, intramuscular (lot number not reported) instead of a dose of LIQUID PEDVAXHIB and RECOMBIVAX HB. The reporter stated that and the packaging LIQUID PEDVAXHIB and RECOMBIVAX HB was identical and hence led to the confusion. No adverse effect reported. Additional information has been requested.
30 hours post second dose of Pfizers- Biontech COVID-19  vaccination EUA  I noted left arm tingling /altered sensation down to fingers.  Headache,  Left foot/heel pain/ weak knees, fatigue/temp 100 , left flank pain and bladder incontinence over night.   Headache continued during the day and evening of 2/10/21,   I also did have some transient pins/needles to both hands after dose 1 but thought it was related to sleeping position....then this developed after 2nd dose and I started becoming concerned this was a neurological/nerve related side effect of vaccination.
Severe heart pain and nausea that started a  about 36 hrs after booster shot. Ongoing heart pain a week later.
Pt recvd Hep B vax & exp unspecified allergic reaction; No further details were provided;
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.
PATIENT REPORTS LUMP AND UNDER ARM ON THE INJECTION SITE, LUMB IN THE BACK OF NECK. PATIENT REPORTS IT HAPPENED NEXT DAY AFTER VACCINE. NO SHORTNESS OF BREATH, MILD PAIN
Injection site became painful; injection site red/blotchy; Injection site swollen; Injectio site warm to the touch; injection site red/blotchy; Blotchiness around the injection site has gotten larger; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 6th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy to be related to Shingrix.     Additional Information: GSK receipt date :12 July 2022 Reporters comment: This case was reported by the patient. The patient received first Shingrix vaccine in his left arm and soon after the injection, the injection site became painful, red/blotchy, swollen, and warm to the touch. The patient stated that the symptoms had not resolved and the blotchiness around the injection site has gotten larger in area. The reporter did not consent to follow-up.
Headache, nausea, fatigue, diarrhea, vomiting, fever of 102, chills,
About 19 hours after injection, my body broke out in hives and the hives have lasted 5 days and slowly spread
ST, COUGH, HA, BODY ACHES, N/V, CONGESTION
Patient experienced rash at injection site that appeared 9 days after first Moderna vaccination. In clinic, the rash measures 5x6 cm and is not raised. It is not painful. Similar in appearance to delayed cutaneous hypersensitivity. She does not require treatment for this as it is not bothersome to her. Presented 2/24, and on day 4, the rash had already begun to fade.
Sore left injection site arm; Greater than 35 days between primary doses of the Moderna covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between primary doses of the Moderna covid-19 vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A, 007B21A and 066K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between primary doses of the Moderna covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between primary doses of the Moderna covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received his second dose in his left arm shoulder muscle. The patient received his first Moderna Covid-19 vaccine booster dose on 13Apr2022.  Treatment information was unknown.   This case was linked to MOD-2022-539737 (Patient Link).