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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 12:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 12:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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 71.20 for dose administered on 12-Feb-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion with temperature 35 degrees Fahrenheit from 11:00 AM to 12:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. 3 vial was moved to clinic, Product moved to clinic on 12-Feb-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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Child received DTaP, MMR at 15 months of age 6/21/01-3days later-Had seizure, was taken to ER-treated.  Then 2nd seizure about 20 days after Immunizations, seen at Medical Center ER. Now is being followed by Neurology Clinic. Development normal until 2 years 18days of age- I have followed repete on EPSoT-at 3year visit DX Autism-Dx  8/02
Case number PHEH2015US025897, is an initial spontaneous report received from a consumer (also patient) on 09 Dec 2015. This report refers to a male patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient received influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced transverse myelitis. The outcome of the event was reported as condition deteriorated. Seriousness and causality was not reported. Seriousness of the event was upgraded based on Novartis Important Medical Events list. No follow up contact information was provided and there was no consent to contact the reporter.
pt reported swelling of tongue and lips 25 mins after receiving booster dose of Moderna. She called our clinic, we called EMS for her. Per follow up, EMS came and assessed her, no trip to ED. Pt had been instructed to take 50mg benadryl by our RN, she did and felt relief of symptoms by the time EMS arrived.
fever, weakness, orthostatic hypotension with syncope, headaches starting 36 hours after vaccines were given
Information has been received from a licensed practical nurse concerning a male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and "presented to office today", on 30OCT2003 with "the same local site reactions", a red, swollen and painful arm. Unspecified medical attention was sought.  There was no product quality complaint involved. Subsequently, the pt recovered. The reporter expressed concern about the particular lot of vaccine and requested a lot check on 1026M. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.
Fever 102.3, crying for 40 minutes. Given Tylenol by mom and temperature down to 99.7, calmed and slept. By 2:30 PM active, happy, eating, playing.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: PT received vaccine and then felt light headed and began to panic. She was being assisted by pharmacist and shift supervisor when she stood up to attempt to walk into the vaccination booth to calm down. She passed out, flew forward hitting her forhead on the corner of the wall, she was momentarily unconcious and she had a cut on her forehead and was bleeding. Shift supervisor called 911 while pharmacist tended to her until emts arrived.Her parents were contacted and she was taken to er
Extreme bleeding vaginally.  Uncontrollable bleeding at odd times.  Bleed every 3 weeks now.  Some days very very light then out of nowhere so heavy it feels like I am peeing.
Flu-like, pain injection site and all over body muscles, tired requiring 48 hours bed rest. Felt like higher than normal temperature but not measured. Dizzy.
ACUTE RESPIRATORY FAILURE 2/28/2023  &  1/19/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
12 year old male received Pfizer Covid 19 vaccine for 1st dose and was inadvertently administered Moderna for 2nd dose.
Nausea and diarrhea within 2 hours of shot - resolved Headache and stiff neck within 2 hours of shot - persists  Fever reaching 102.9 - 5/5 4am  Fever persists 99-100 with advil / tylenol
severe headache; slight headche; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headche) and HEADACHE (severe headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (slight headche). On 11-Mar-2021 at 3:00 AM, the patient experienced HEADACHE (severe headache). The patient was treated with MELATONIN at an unspecified dose and frequency. On 03-Mar-2021, HEADACHE (slight headche) had resolved. At the time of the report, HEADACHE (severe headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
12 days after 2nd shot, he developed gait ataxia, hand paresthesiae, upward gaze palsy and areflexia
skin reaction/delayed covid arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (skin reaction/delayed covid arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to Compazine, Bactrim DF, morphine.) and Breast cancer female.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (skin reaction/delayed covid arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) at an unspecified dose and frequency. At the time of the report, SKIN REACTION (skin reaction/delayed covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt was waiting in observation area.  1440 - reported feeling faint, escorted to stretcher - Vitals - 84/55, 71/min, feeling faint, nauseated, weak 1445 - 116/60, 73/min - feeling better, more normal 1459 - pt feels normal, all symptoms resolved, able to drink water, denies nausea, denies dizziness, denies weakness, able to sit, stand, without feeling faint. 1502 - left with husband
Migraine headache; Red and blotchy on the injection site; Sore throat; Lost his sense of smell and taste; Lost his sense of smell and taste; Fatigue; Arm is sore; Chills; A spontaneous report was received from a consumer who was a male patient who received Moderna's COVID-19 Vaccine, and who experienced chills, arm was sore, fatigue, lost his sense of smell and taste, sore throat, red and blotchy on the injection site and migraine headache.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (LOT 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The next day, on 29-Dec-2020, he began to have chills and his arm was sore.  Two days later, on 01-Jan-2021, he felt fatigued.  On 04-Jan-2020, he reported losing his sense of smell and sense of taste.  He reported a sore throat one day later on 05-Jan-2021 and stated that on 06-Jan-2021, his injection site was red and blotchy.  Finally, on 07-Jan-2021, patient said that he experienced a migraine headache.   He reported that for the migraine headache, he took six tablets of paracetamol which did not help.  He stated that he then took three, 81 mg tablets of baby aspirin which did provide some relief.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, events loss of smell and taste is unlikely related to mRNA-1273. Further information is requested.
99.8 F fever; body aches, particularly in my joints; Fatigue; Body aches; Sore arm the night of the vaccine, lasting approximately 48 hours on both shots; This is a spontaneous report from a non-contactable consumer (patient).  A 35-years old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number EW0170) via unspecified route of administration in left arm as dose 2, single on 27Apr2021 at 15.45 for covid-19 immunization. The patient age at vaccination was 35-years old. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 06Apr2021 at 16:15, as a single dose for COVID-19 immunisation and experienced sore arm. The patient experienced minimal side effects from first shot. On an unknown date in Apr2021, the patient experienced Sore arm the night of the vaccine, lasting approximately 48 hours on both shots. On 28Apr2021 at 07:00, the patient experienced 99.8 Fahrenheit fever, body aches particularly in joints and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 28Apr2021, the patient underwent lab tests and procedures which included body temperature and the result was 99.8 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events sore arm (lasting approximately 48 hours), 99.8 Fahrenheit fever, body aches particularly in joints and fatigue was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
cough; Temperature of 99.8; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.   An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration injected in the right arm on 16Jan2021 at a single dose as COVID vaccine to avoid getting the virus. Medical history included high blood pressure. The patient had no other patient history. Concomitant medications included warfarin which started maybe 10 years ago and an unspecified medication for high blood pressure. The reporter took her mother, who's 83, and herself, on Saturday morning and got the COVID vaccine. Her mother woke up Sunday with a 99.8 temperature and she has been coughing real bad (cough) on 17Jan2021. The reporter asked if this was a side effect of the vaccine. This was her mother's first dose. Her underlying question was, after all this, she heard the second dose was worse, so the reporter wanted to know,  should her mother get the second one if her mother has these symptoms, the reporter heard the second dose was worse and would give some symptoms. Investigation assessment was noted as no. The outcome of 'temperature of 99.8' was recovered on Jan2021 as she did not have it anymore and of cough was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021072457 same reporter, same product, similar events, different patient
79 with Covid, breathing problems; 79 with Covid, breathing problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 79 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "79 with Covid, breathing problems". Patient was 79 with Covid, breathing problems, but fighting hard.  The lot number for bnt162b2 was not provided and will be requested during follow up.
A nurse reported that a 51 year old female received an injection of Pnu-Imune 23 on 12/20/00. On 12/22/00, the pt developed myalgia, arthralgia, muscle weakness, loss of appetite and a pink, macular rash on the arms, back, chest and abdomen. She also developed a local reaction which the reporter did not describe. Follow-up information received from the physician on 5/30/01, indicated that the pt recovered.
Information has been received from a registered pharmacist concerning a female patient in her early 60's who on an unspecified date was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on an unspecified date, the patient was diagnosed with shingles by her physician. At the time of the report, the patient's outcome was unknown. This is one of two reports from the same source. Additional information has been requested.
Flared up drastically psoriasis after their 1st, 2nd, & booster doses; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster doses) 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 PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster doses). At the time of the report, PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2021-432423, MOD-2021-432424 (Patient Link).   Reporter did not allow further contact
Extreme Chills, fever, headache, muscle aches, injection sight extreme soreness, fatigue
no additional AE or PQC was reported; a dose of MMRlI with a labeled expiry of 6/30/2021 was administered to a patient on 7/15/2021; This spontaneous report was received from a clinical manager (also was a medical assistant) referring to a 1 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) (strength and route were not reported, lot # S020161, expiration date 30-JUN-2021) 0.5 milliliter for prophylaxis (expired product administered).         Agent utilized "Post Expiry Memo Vaccines and Biologics Administered" to evaluate the administered product and verbally provided supported disclaimer from attached article. No additional information was provided, no additional AE or PQC was reported at time of call.
Swelling on right arm with red raise area in location of injection. Advised pt to take Benadryl and Ibuprofen for swelling and pain.
Side effects to first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects to first dose) 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 VACCINATION COMPLICATION (Side effects to first dose). At the time of the report, VACCINATION COMPLICATION (Side effects to first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.   Reporter did not allow further contact
Loss of balance and dizziness when I move my head after waking up from sleep. The dizziness stops when I steady my head. The symptoms gradually abate over a few hours as the day wears on.
I was unable to sleep the entire night because of an alarming fast heart rate of 95 BPM. I used a pulse oximeter to check my heart and oxygen. My high heart rate sustained for at least 9 hours. It was pretty terrifying.
Couple hours after receiving BEXSERO vaccine, patient reported feeling "sick" with headache. ("Severe") rash and induration/swelling at the injection site. The rash spread out more the following day and muscle pain continued for over a week. Patient applied ice, massage and took Ibuprofen.
Pt received covid vaccine. Pt felt dizzy he was seeing black and white spots and dizzy. EMS provided 2 bottles of water and he instantly felt better. Vitals monitored.
Information has been received from a medical student concerning a 33 year old female patient who was vaccinated with2 doses of VARIVAX (Merck) "at an unknown time in the past". It was reported that the patient has negative varicella titer. The patient sought medical attention in the office. The outcome was reported as not recovered. Additional information has been requested.
Patient stated she had a headache for two weeks post immunization along with left arm pain and pain in left hand
Patient experienced chest pain unrelated to activity and  pericarditis and myocarditis approximately 48 hours post vaccination
N17.9 - Acute kidney failure, unspecified K37 - Unspecified appendicitis
Started that day chills and three four hours hot and shaky. I could not work a couple days feeling like very very sick, nauseous. three or four days and went away slow.  Missed  work last week, diarrhea, getting sick off and on since the covid shot feeling like the flu. But tests negative. Sometimes I am perfectly fine, sometimes very sick and very down. Happens randomly. Could not even get up from the bed. Still taking nausea pills and pills for pain, body aches.
Right radial nerve neuropathy with decreased sensation dorsum of right hand and right wrist drop.  Numbness noted the evening of the day of vaccination and wrist drop noted the next morning.  Treatment: oral prednisone, physical therapy and wrist splint.
Patient claims symptoms of leg pain and numbness that she believes may be associated with the vaccine. She asked us to file a VAERS. She notes that the symptoms began a few days before the vaccine was administered.
PAIN AT SITE OF INJECTION IN THE SHOULDER WENT TO ER MD SAID MAY HAVE NICKED A NERVE AND IT WOULD PROBABLY BE SORE FOR A COUPLE OF WEEKS PATIENT SAID PAIN WAS IN THE ARM SHE GOT HER PNEUMONIA SHOT IN
Case number PHEH2015US021287, is an initial spontaneous report from a nurse received on 18 Oct 2015. This report refers to a 27 years old patient of an unknown gender. Medical history included injured LT MCL (left medial collateral ligament). Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173991, expiry date: May 2016) on 14 Oct 2015. On the same day, two hours after vaccination the patient experienced pain in previously injured LT MCL (pain in joint involving lower leg). It was reported that the pain had increased in severity within 24 hours after the vaccination. Final outcome of the event was unknown. Seriousness and causality of the event was not reported.
Moderna 1/16/21, 3/6/21, 11/18/21. Positive on 1/24/22
After my vaccine, one day after my right arm and leg broke out little red bumps, were itchy and blistery, looked like hives. I went to clinic where I was prescribed Prednisone, Bactrim and a topical cream. My symptoms lasted two weeks then they started to go away.
Patient received shot and walked to the back of the store to get groceries with her father, She started not feeling well, lost all color in her face, her jaw locked up and dropped to the ground and lost conscious. Her father carried her to the nurse practitioner at the clinic in our store and then to the pharmacy. She could tell us her name and where she was. Her blood pressure was taken and was normal. She was given crackers and apple juice and waited in our lobby until she felt fine to walk without assistance.
I had not had my period in over 10 months and now I have had it two months in a row.
Flushing of face and rash all over chest.  Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm,  chest pressure, vomiting, and loose stools
Patient denied in writing and verbally any prior dose of COVID 19 vaccine. During data entry, on a historical view it was noted an outside clinic at a drug store had given both doses of Pfizer on 2/26/2021 and 3/19/2021.