chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:32 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 66.75.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 08:00 AM . This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour. No treatment medications were reported.
Pt has an erythematous maculopapular rash according to the ER report. She was treated with diphenhydramine 6.25mg once, prednisolone 3mg/mL (6mg once), and ranitidine 15mg once. She was discharged with Rx for BENADRYL and ORAPRED.
Day after the shot i had a fever (100.6) and chills, achy, headache. A few days later i developed a skin rash on mostly my left arm but also my right arm
Around Feb 1st or about 10d after his first dose of the moderna covid-19 vaccine (which was 1/20/21) he developed a small faint pruritic rash above the gluteal cleft mostly midline with two small areas that over the next few days became more raised, almost vesicular in two circular patterns. Was told it looks like ring worm tried lotrimin OTC, no help. but persisted and over the next few weeks flattened some what but was pruritic throughout. Was treated with topical steroid triacinolone which helped the pruritus but the rash was mostly staying the same until the second dose of the vaccine. After the second dose of the moderna vaccine which was 2/17/21 the rash expanded laterally along the upper glute and down the posterior thigh mostly along the S1 dermatome. No pain was noted, only pruritus. Was seen in clinic today and was initiated on valtrex 1000mg BID x10d, and refill of topical triamcinolone
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 28-AUG-2015, the patient was vaccinated with VAQTA (lot # L))1445 and expiration date 15-FEB-2016) (dose and route were not reported) which were improperly exposed to the following conditions. 25-AUG-2015: 30.2F for 4 hours 30 minutes. 26-AUG-2015: 31.6F for 5 hours. 27-AUG-2015: 33.4F for 2 hours 45 minutes. 28-AUG-2015: 33.8F for 1 hour. It was also reported that VAQTA was improperly exposed on the following dates to the following conditions that had been administered to unspecified patients. 29-AUG-2015: 32.9F for 1 hour 30 minutes. 30-AUG-2015: 33.0F for 2 hours 15 minutes. 31-AUG-2015: 33.6F for 4 hours. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
coughing; low fever 99 up to 100.3 ° F; single episode of nausea and vomiting; single episode of nausea and vomiting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PYREXIA (low fever 99 up to 100.3 ° F), NAUSEA (single episode of nausea and vomiting), VOMITING (single episode of nausea and vomiting) and FATIGUE (fatigue) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COUGH (coughing), PYREXIA (low fever 99 up to 100.3 ° F), NAUSEA (single episode of nausea and vomiting), VOMITING (single episode of nausea and vomiting) and FATIGUE (fatigue). On 15-Jan-2021, NAUSEA (single episode of nausea and vomiting), VOMITING (single episode of nausea and vomiting) and FATIGUE (fatigue) had resolved. On 17-Jan-2021, PYREXIA (low fever 99 up to 100.3 ° F) had resolved. At the time of the report, COUGH (coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: low 99 upto 100.3 (Inconclusive) Low 99 upto 100.3. On 15-Jan-2021, SARS-CoV-2 test:. On 18-Jan-2021, SARS-CoV-2 test: (Positive) Test was conducted on 16-Jan-2021.  Result was positive on 18-Jan-2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included epilepsy medication. Treatment included ibuprofen.
I had an upset stomach that felt very gassy and swollen around 4:00 PM, then I began to throw -up about 2:00 AM .  After I threw -up a lot, diarrhea set in.  My stomach is still upset today, but have not thrown up.  The last loose bowel movement was  around  4:00 AM. this morning.
non-hodgkins lymphoma,; a little fever this morning; pretty severe joint pain, from her jaw to her ankles; This is a spontaneous report from a non-contactable nurse (patient) via Medical Information Team. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine and had been fine. On 05Feb2021, mid afternoon, she went to an urgent care and tested negative for COVID and the flu. On 06Feb2021, she was fine, had a little fever in the morning, but about 3 in the afternoon, she started with pretty severe joint pain from her jaw to her ankles. She was recently diagnosed with non-Hodgkins Lymphoma and they put her on a chemo and a monoclonal antibody. One of the oncologists thinks it was a reaction to the vaccine. Outcome of the events was unknown.    No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Based on the limited information currently available, a causal relationship between event non-Hodgkins Lymphoma and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Myalgia, Arthralgia, NauseaVomiting, fatigue, weakness Narrative:
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, interval and route of administration were not reported) lot number: K022265 with expiration date of 22-OCT-2016 and lot number: K010216 with expiration date of: 17-SEP-2016. No adverse events or product quality complaints (PQC) were reported. Additional information has been requested.
On 07/31/2022, I woke up with a sore scratchy throat. I just kind of generally didn't feel good and it got worse throughout the day. That night I woke up with chills and was shivering. That morning  08/01 I took a home COVID test and tested positive. I then immediately made an appointment with the urgent care to go in. I felt like I had really bad bronchitis, chest discomfort, ran a fever on and off, cough, and runny nose. I never took my temperature but I definitely felt like I had fever. They prescribed an inhaler, they put me on Paxlovid, an antibiotic, and a steroid pack. On 08/03/2022 my chest had gotten worse each day leading up to 08/06/2022. It was hurting more every day. On Saturday 08/06/2022, I called into and went into the ER. They had me start on Mucinex and increase my water. A few days after that I started feeling better every day. On 08/18 I finally tested negative.
Vaccine was administered with diluent. patient contacted once error discovered, unknown symptoms at time of report
12 wk old infant rec'd HIBTITER/OPV/DTP on 18MAR91; on 19APR91 temp 103 w/vomiting; Hosp H. Influenzae grown from spinal fluid;
After receiving the vaccine patient began complaining of numbness & swelling on upper lip. Patient immediately asked NP on site to look at lips. Erythema noted above lip. Patient stated that had an epipen. History was reviewed. Patient stated she has unknown allergies. Patient was sent to observation for evaluation and possible treatment. Verbal handoff and assistance to NP in observation. VS 126/90, P-102, 02 stat 97%. NP in observation took over care. Redness around lips and itching resolved. Benadryl was offered but she refused stating she had a history of passing out from IV Benadryl. She had personal Zrytec which she took. Patient stayed an additional 30 minutes & reported feeling 100% better. She was stable and ok to drive home.
Expired Engerix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number P4DJ5, expiry date 15th December 2022) for prophylaxis.   On 30th December 2022, the patient received Engerix B. On 30th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comments: The healthcare professional reported that a dose of Engerix-B that expired on 15th December 2022, was administered to a patient 15 days after that expiration date. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administered an Engerix-B, 15 days after expiration date, which led to expired vaccine used.
Bell's Palsy that won't go away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: EW 0164) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER 8732), administration date: 03Apr2021, when the patient was 50-year-old, for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 01May2021, outcome "not recovered", described as "Bell's Palsy that won't go away.". It was unknown if therapeutic measures were taken as a result of bell's palsy.  Clinical information:The patient was not tested with Covid19 prior and post vaccination.  No follow-up attempts are possible. No further information is expected.
Overview: Double vision and weakness starting in April and getting worse - Saw eye doctor and neurologist - tests inconclusive - referred to neuro-ophthalmologist who confirmed Myasthenia gravis in  who confirmed Myasthenia gravis in  early fall  Details: In April 2021, felt like I had a kidney / bladder infection but it was negative (history of chronic UTIs but none in years). I was in the ER in May 2021 - left wrist pain and weakness, did a CT Head scan and x-rays - discharged Saw ortho in May 2021 - thought it might be carpal tunnel syndrome or related to EDS.   June 4 - test with neuro to address numbness and tingling in both hands - tests done: MUSC test done w/n test comp and motor&/SENS 5 - 6 NRV CNDJ TST - not carpal tunnel, wore braces to help with numbness and weakness June 28: saw doctor who treats me for migraines - suspected Myasthenia gravis - bloodwork was negative RAD MRI on July 15 Referred to neuro-ophthalmologist who confirmed Myasthenia gravis
Patient receive this vaccine.  A few short seconds later patient fainted and looked to be having a seizure.  She came out of this seizure and/or fainting spell confused numbness of a part of the body, a brief loss of memory, sparkling or flashes,appeared to be confused or dazed and was not be able to respond to questions or direction  and was having  difficulty breathing; swelling  of her lips.  Her fingers where very stiff and she complain that she couldn't close her hands.  She said her muscle in her legs felt strange.   After about 15 min.  Patient sat up and her teeth started chattering.
Vomited 2x Rectal temp. 101.4 Very Cranky, given Tylenol.
Pain radiating from injection site up through shoulder and down arm, welt about 3cm X 3 cm appeared.  Next morning welt much larger and pain in arm/shoulder more intense.  Saw Dr. at 2:30 in afternoon and welt was 9.5 cm X 3.5 cm.  Pain being treated with Tylenol and ice being applied to welt.  Slight reduction in welt size and redness, and reduction in pain after Tylenol, and then back to previous level when Tylenol wears off.  Today a new symptom has appeared:  tenderness and slight swelling of the right arm pit (injection site is right arm).
Patient was given 3 immunization 10/17/2012 she had MCV4 and Tdap in left deltoid. She came in 10/19/2012 with arm swollen and rash all over her body. Patient was placed on Prednisone. Patient did recover.
(R) deltoid (posterior) atrophy, (R) tricep atrophy. (R) arm immobile - scar tissue build up. Physician visit. Physical therapy.
12-19-13; 9:45 AM - patient called asking if ZOSTAVAX could cause seizures she said she had 4 seizures on 12-12-13 and went via ambulance to hospital. She doesn't like to be heavily drugged and has pounding head.
I went in to the clinic for my second dose of the moderna vaccine for COVID-19. I was advised by my OBGYN to get the vaccine as i am 26 weeks pregnant (EDD 12/01/21). Later that day when i got home i got very sick and it followed into the next day. I have a very bad cough, chest pain, and dizzy spells. The injection site is also extremely swollen and irritated.
Numbness to left side of face (eye socket and upper cheek) post vaccination. Started after returning home from vaccine appointment. Patient reported temporary numbness improvement with diphenhydramine.
This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA and HEADACHE in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-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 NAUSEA and HEADACHE. At the time of the report, NAUSEA and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Case previously recorded as MA2009-4394.  Initial case report received from a nurse via agency on 16 NOV 2009.  A 3-year-old female patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m., on 14 NOV 2009.  Administration to a child under 4-year-old is unexpected with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
I contracted COVID-19 on 07/28/2022 with symptoms of dizziness, chest tightness, cough, difficulty breathing, headache, congestion, pressure and burning in eyes, senses of smell and taste diminished, bloody nose, and fatigue. I was not prescribed any medications. I was ill for 5 days before my symptoms began to improve. I have not recovered as of yet.
On the day after vaccination I had extreme dizziness and faintheadedness, and heavy brain fog. I could not drive or stand up for long periods of time. I was having issues expressing thoughts and having my normal conversations. This was accompanied by strong headache on right side of my head and slightly stuffed sinuses. The day afterwards all symptoms disappeared. However, they reappeared at milder levels intermittently through the next several days. I am now at day 14 with the dizziness and brain fog still occurring intermittently and last night had short episode of abdominal pain. I decided to call the doctor's office this morning when the dizziness started again, for advice and to schedule a brief exam. They told me to go straight to the ER instead, so I went and had blood drawn. Blood came back normal and likelihood of clot very low, so was released but referred to my primary doctor and a neurologist for follow up over the next week. The intermittent dizziness and brain fog persist ever since my shot 2 weeks ago. Additional symptoms that I believe to be normal are dull leg pain behind the knees, slight tightness in chest sometimes, and recurring mild headache.
Very sore arm and armpit, swollen lymph nodes all over, temperature of 100.0-100.3, headaches
redness from her shoulder to her elbow; Redness was hot to the touch; This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had redness from her shoulder to her elbow. Redness was hot to the touch and lasted for about a week.
pt recvd vax & w/in a few hrs, pt presented to ER w/an allerg react characterized by urticaria & rash (face, extremetries, & trunk); fullness in head; chest tightness; mild dyspnea; c/o sore throat & palpitations, rash, h/a given Claritin
area redness size half dollar maybe sl larger around site inj;rash noted in redness-no rash else where visible;c/o intense itching where inj given;also c/o nausea, lightheadedness;DPH given;BP 150/80;arms from shoulder down to elbow mottled
Hallucinations; This is a spontaneous report from a contactable consumer, reporting for herself. A 65-year-old non-pregnant female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration in Apr2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (Lot Number: ER8729) at 65 years of age on 06Apr2021 at 9:30AM for covid-19 immunization and experienced slurred speech and confusion for a week starting 07Apr2021 12:00AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, the patient experienced hallucinations. Prior to and since the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of the event was unknown.    The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
his friend died 2 weeks after receiving Pfizer Vaccine; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date at unknown dose number, single for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Reporter stated that his friend died 2 weeks after receiving pfizer vaccine. Reporter wanted to know if vaccine was agency approved. Also wanted to know what the threshold was for number of people dying before Vaccine was pulled from market. It was not reported if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Clarified caller knows his friend died 2 weeks after receiving Pfizer Vaccine
FEVER, CHILLS, JOINT PAIN; MUSCULAR PAIN; HEADACHE; VOMIT. TOOK ACETAMINOPHEN 500MG 2 TABS EVERY 4 HRS
This spontaneous report as received from a consumer refers to her 63 year old mother. The patient had no pertinent medical history and no drug allergy. On 06-JUN-2013 the patient was vaccinated with ZOSTAVAX, 1 time vaccine, lot# reported as carpmpd A8135577911691, subcutaneous. There was no concomitant therapy. On 06-JUN-2013, the patient experienced multiple myeloma, which was diagnosed on 30-AUG-2013. The daughter stated that since the patient received the vaccine she had flu type symptoms, and generally not feeling well. Since July 2013 the patient had had pain in her right wrist. She stated an X-ray was performed and patient had a bone lesion in her right wrist. No treatment was given. Blood and urine test was done. No lab result was provided. At reporting time, the patient was not recovered from multiple myeloma. The patient sought unspecified medical attention. Upon internal review, multiple myeloma was determined to be medically significant event. Additional information has been requested.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot number and injection site not reported). Subsequently the patient developed chickenpox. It was unknown if the patient sought any medical attention. The outcome was unspecified. This is one of several reports from the same source. Additional information has been requested.