chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two deaths in her state from vaccine; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for two patients. This the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was concerned because there had been two deaths in her state from vaccine and thought Pfizer might be curious in how their product was being handled. The patient died on unspecified date. It was unknown if autopsy was performed. The outcome of the event was fatal.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021371688 same reporter/event, different patient; Reported Cause(s) of Death: two deaths in her state from vaccine
Itching; Had hives the same day as she had her vaccine; This is a spontaneous report received from a contactable consumer (Patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EP7533, expiration date: Jul2021) via an unspecified route of administration, administered in arm left on 04Jun2021 at a dose of 0.3 ml as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the Pfizer vaccine on 04Jun2021. She had hives the same day 04June2021. Since 04Jun2021, patient has had hives and itching. Patient was due for her second dose in one and a half weeks. She wanted to know if she should get her second dose. The outcome of events was unknown.
54 y ea rold male states he had swelling of left arm and breast and thinks he has a muscle twitch of left pectoralis muscle from vaccine. Has had sx for past four weeks . Mild but he has no other sx.
RECEIVED 1ST DOSE OF PFIZER COVID19 VACCINE ON 02/21/21. REPORTED TO ER ON 02/28/21 WITH SOA AND HEMOPTYSIS. DIAGNOSED WITH ATYPICAL PNEUMONIA, SHORTNESS OF BREATH, HYPOXIA, AND ELEVATED BNP. PLAN IS TO ADMIT TO HOSPITAL.
his mind seemed to be forgetful; 2 days fever; weakness and tiredness for 2-3 months; weakness and tiredness for 2-3 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200464133 (Pfizer).  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, for Covid-19 immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for Covid-19 immunization. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "his mind seemed to be forgetful"; PYREXIA (non-serious), outcome "unknown", described as "2 days fever"; FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "weakness and tiredness for 2-3 months".  Additional information: Patient stated that he had his 2 shots and booster last fall and had bad reactions with the Pfizer COVID vaccine. At first he did not associate it with the shot and stated that he had 2 days fever, weakness and tiredness for 2-3 months, it probably was a lingering effect of the vaccination and ell couple times and his mind seemed to be forgetful, he did not think it is dementia. Patient scared about taking another boster shot. NDC, UPC number of Covid-19 vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Patient seen at the Lindstrom clinic for her COVID-19 vaccine. She received her 1st Moderna COVID-19 vaccine. (1150) Within 10 min after injection patient complained of both arms having a blotchy red rash (size of pea and flat) and which spots were hot. Denied feeling SOB, no dysphagia, etc. VSS. 132/84, 98.2, HR 72, 98% RA. Spoke with available Dr. Got ok to give benadryl 25 mg PO. To continue to monitor patient longer. Would need to get a note cleared by her provider to get second dose.    Patient stated that her mother had similar effects but she received Pfizer injection. She had rash on upper chest and lips were tingly so patient chose to have Moderna. Her mother did get the second vaccine without any issues.    Benadryl 25 mg PO was administered NDC 00536121429 exp. 6/30/21 at 1205pm. Kept patient until 12:20 pm. With frequent monitoring every few minutes. Had a few more blotchy red spots on her abdomen. No dyspnea. Got one more set of vitals which were stable. Cleared by Dr. that she could leave with her family member. Will place in VAERS. Gave patient fax number to clinic.
Large red patch on arm lasting 3-6 days, Pain in injected arm lasting 3-6 days Significant  aches and pain all over body
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Feb2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (not ongoing), notes: but off medication due to pregnancy. Date of last menstrual period: 17Jan2022. The patient was 5 weeks pregnant at the time of exposure to BNT162b2. The patient is expected to deliver a baby(s) on 07Nov2022. Concomitant medication(s) included: NESTLE MATERNA, start date: 01May2022, stop date: 21Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Weakness; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), ASTHENIA (Weakness) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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 CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 04-Mar-2021, the patient experienced ASTHENIA (Weakness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Information has been received from a respiratory therapist concerning a 17 year old female patient with allergies who in June 2007, was vaccinated IM with a first 0.5ml dose of GARDASIL. Concomitant therapy included ZYRTEC. Within 24 hours after administration of the vaccine, the patient developed a widespread rash. Unspecified medical attention was sought. At the time of this report, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2001. Follow up information stated the patient was referred to an allergist and allergy tests were conducted. The allergist requested a sample of GARDASIL to test to see if the patient was allergic to the product. At the time of this report, the outcome of the allergy test was not known. No product quality complaint was involved. Additional information has been requested.
LEFT ARM HURT-EVENING PHLEM IN THROAT AND DRY- BODY ACHE- NEXT DAY RIGHT ARM HURT  STILL HAVE ACHY BODY AND PHLEM IN THROAT  AND PAIN IN BODY- DREAMING THROUOUT THE NIGHT
Baby woke up in the middle of the night and started crying hysterically. He was inconsolable. It took a while to calm him down and put back to sleep. The same happened the night after.
tested positive for COVID-19; rash; A spontaneous report was received from a consumer concerning herself, who is a unknown aged female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, tested positive for covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route in the unknown location for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced a rash that disappeared 2 weeks later, 8 days after vaccination on 21Jan2021, patient tested positive for COVID-19.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 27 Jan 2021 the outcome of event rash was resolved on 27 Jan 2021. The outcome of event tested positive for covid-19 was unknown.
fever, rash, swollen joints (ankles, elbows, shoulders), can't walk, sore throat, toes blue. Probable Serum sickness
Increased heart rate 160,  Arrythmia Specific  PVC, with in 6 hours of Injection. Stopped that night. arrhythmia a couple times in following  10 days.  No treatment.
A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 42-year old male.  The patient's medical history and concomitant medications were not reported.  On 05-Dec-2008, the patient was inadvertently administered expired FLUMIST;  the product was expired by 10 months (February 2008).  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 31-Mar-2009 that included the results of a Lot Investigation. Eased on the results of the investigation, the root for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 32-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment medication was not provided.
Fever and chills at 2am that continued until morning, sweating, dizzy, headache,  PASSED OUT for a minute
Itchiness; Redness; Sore Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness) and PAIN IN EXTREMITY (Sore Arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 04-Feb-2021, the patient experienced PRURITUS (Itchiness) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itchiness) and ERYTHEMA (Redness) outcome was unknown and PAIN IN EXTREMITY (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     The patient reported that following her first shot of COVID vaccine, she had a sore arm, which went away afterwards (details not provided). Six days later of her vaccine shot, she experienced redness and itchiness in her arm that still persisted. Reportedly, the patient was on cholesterol medication (details not provided). Details regarding treatment medications were not provided. The patient wanted to know, how long her side effects will last.
Menveo mixed with sterile water instead of supplied diluent. Patient to have vaccine repeated.
Case previously recorded as MA2009-3693. A health care professional reported the following information via MedCom, on 4 NOV 2009: A 52-year-old female patient was vaccinated i.m. with S-OIV FLUVIRIN (batch no. unknown) on 28 OCT 2009. She developed large raised hives on her trunk and legs on 1 NOV 2009 (as start date 28 OCT 2009 was also reported). She had not recovered at reporting date. MedCom Ref. no.: NA09-007569. Follow up report received on 26 Apr 2010: Follow-up with reporter was attempted, but no response received so far. Therefore the case was closed with consideration as lost to follow-up.
Information has been received from a medical assistant referring to unspecified number of male and female patients. No relevant medical history or current conditions were reported. For the past seven years, since an unknown date, these patients were vaccinated with GARDASIL (dose, route, lot# and expiration date not reported). On unknown dates, these patients had been getting dizzy, been very pale and "spaced out" after the vaccination of GARDASIL while lying down. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
feeling bad; arm soreness; test positive for COVID/getting the vaccine while infected with COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (test positive for COVID/getting the vaccine while infected with COVID), DRUG INEFFECTIVE (Lack of drug effect), FEELING ABNORMAL (feeling bad) and PAIN IN EXTREMITY (arm soreness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046b21a and 008b212a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced COVID-19 (test positive for COVID/getting the vaccine while infected with COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad) and PAIN IN EXTREMITY (arm soreness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (test positive for COVID/getting the vaccine while infected with COVID) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and FEELING ABNORMAL (feeling bad) and PAIN IN EXTREMITY (arm soreness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication were reported.  Patient experienced arm soreness and feeling bad with the second dose but took Tylenol and felt better.  Patient took anti inflammatory and felt better.  Company Comment: This case refers to a 35-year-old female patient with no known medical history who experienced the unexpected events of COVID-19 and Drug Ineffective approximately 9 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case refers to a 35-year-old female patient with no known medical history who experienced the unexpected events of COVID-19 and Drug Ineffective approximately 9 months after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt was lightheaded, hot, coughing, and said she is having a little trouble breathing.
Patient states she woke the morning after receiving her vaccine and felt disoriented for about 10 min, when she went to get out of bed she had severe vertigo and was unable to ambulate without holding on to furniture.  She took over the counter vertigo medication which did not resolve her symptoms.  She was unable to work. As of 01/13/21 patient continues to experience mild vertigo and now has fluid building up in left ear.  Has called PCP and is waiting for direction.
Large red rash on arm under site of injection, swelling, itching.  Lasted over a week
Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided  No treatment medication information provided  The patient was healthy before getting the vaccines.  Company comment:  This case concerns a 43-year-old male patient with no reported medical history who experienced serious unexpected event of death, that occurred after the dose of the mRNA-1273 . No further details were provided. The rechallenge was not applicable due to fatal outcome, as well as unspecified number of doses administered.  The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-445808, MOD-2022-445819.; Sender's Comments: This case concerns a 43-year-old male patient with no reported medical history who experienced serious unexpected event of death, that occurred after the dose of the mRNA-1273 . No further details were provided. The rechallenge was not applicable due to fatal outcome, as well as unspecified number of doses administered.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Doctor note-  H&P: chief complaint: recurrent dizziness and gait instability  HPI: 84 y.o. female with PMH of SSS s/p PPM, CAD, pAfib, mod MR, pul HTN and CVA who presents with nausea, vomiting, recurrent dizziness and gait stability. Patient says that since this morning she has been feeling nauseous and dizzy. When she stands up she feels extremely dizzy to the point of almost passing out. She denies chest pain or shortness of breath. She mentions she does have cramps in her lower legs which she attributes to having low sodium. She denies dizziness when she lying in bed. She denies being ill recently.  Diagnoses: recurrent dizziness, CAD/SSS s/p PPM/pAfib, Hypothyroidism   Doctor note-  HPI: female who presents to the ED with nausea. This patient woke from sleep and felt okay but then was sitting down reading the Bible at which time she developed the onset of symptoms that included blurred vision nausea as well as a dizziness that she associates with a feeling like she is going to pass out. She has not experiencing any headache or any chest pain accompanied with this only the symptoms as described. She does state that this seems to worsen with the movement and position changes. She denies being sick over last several days there has been no fever no nausea vomiting prior to this. States onset of symptoms was 7am and was with unsteady gait following. Blurred vision has cleared at time of this evaluation. No change in medications.   RN note-   Pt reports nausea with high blood pressure that starts today. Reports she is dizzy. Hx of pacemaker and cardiac stent x1. States ?i just feel sick.?   RN note-  Pt reports onset of symptoms this morning including: eyes were blurred and vision was fuzzy, BP elevated 183/90, nausea, chest pressure, weakness. Pt reports yesterday she felt normal and she raked leaves outside. She denies blurred or fuzzy vision at present. Chief complaint at this time is nausea.
caller also mentioned not feeling very well/Possible AE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (caller also mentioned not feeling very well/Possible AE) 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.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (caller also mentioned not feeling very well/Possible AE). At the time of the report, VACCINATION COMPLICATION (caller also mentioned not feeling very well/Possible AE) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  It was reported that the patient was not feeling very well and was thinking to get a flu vaccine and also a COVID test. The patient stated that there were no side effects experienced after the first two doses. It was reported that the patient may had a cold or the flu.   Reporter did not allow further contact
Patient is visiting approximately 3 weeks ago. Patient states that he had the AstraZeneca Covid vaccine approximately 3 weeks ago and since vaccine he has been feeling pain in both of his lower extremities with the left lower extremity worse than the right.  Pt started to have lower extremity pain 2 weeks ago from below the knee. Patient states he came to the point where he can only walk a few feet and he got significant pain in both of his legs and came to the hospital.  The pain has been progressively worse. He feels the pain when he is standing or when he is walking. Otherwise he has no rest pain. Denies trauma to the lower extremities. Denies atrial fibrillation.    In the ED vital signs stable initially hypertensive, labs remarkable for creatinine of 1.22 (possible AKI or CKD), Covid negative. Found on CTA to have an occluded left iliac system, occluded right femoral artery, thrombus in aorta, as well as PEs.  Admitted stat on 5/6/2021 to vascular surgery at Hospital. Overnight underwent bilateral lower extremity thrombectomies, embolectomy of aorta, bilateral fasciotomies of lower extremities with bovine repair of left common and superficial femoral arteries. As of today 5/7/2021, patient is currently intubated and sedated in the SICU.
Began having tingling in her right arm on 12/28. Numbness and tingling spread to both arms and to feet. Wakes her up at night. Pt was seen by pcp. .
Itching, hives,  50mg benardyl IM  Transfer to ED by ambulance