chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his sister's arm was injured; His sister's arms are shaking like crazy; she can't sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (non-serious), outcome "unknown", described as "his sister's arm was injured"; TREMOR (non-serious), outcome "unknown", described as "His sister's arms are shaking like crazy"; INSOMNIA (non-serious), outcome "unknown", described as "she can't sleep at night".  Additional information: The reporter mentioned that he'd seen the Pfizer CEO talk about on a podcast that he wasn't vaccinated yet because he wouldn't endanger himself and they're plan was to reduce the population by 50 percent. Also, he stated that his sister's arm was injured because of the Pfizer vaccine. His sister's arms were shaking like crazy, and she couldn't sleep at night. It kind of scared them off. He also mentioned that Pfizer keeps getting sued for malpractice for Doller 3.5 billion or lying stuff in this and he's not happy about that. He would like to know how we can kill a person.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Soreness of arm; A spontaneous report was received from a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 026L20A) intramuscularly for prophylaxis of COVID-19.  On an unknown date, the patient experienced soreness of arm and inquired how long it would last. No treatment information provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the event, soreness of arm was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
got the flu everytime she got the shot; Initial information received on 09-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who got the flu everytime she got the shot after receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had a non-serious got the flu everytime she got the shot (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment  At time of reporting, the outcome was Unknown
About 20 minutes post vaccination, patient complained of itching all over body. No evidence of rash existed though.
Tingling in left face check..legs very weak .. congestion..very tired for 4 days
Female is experiencing bothersome pruritus at the site of injection; This Initial case was previously missing the following minimum criteria: reporter has no first hand knowledge. Upon receipt of reporter has First-hand knowledge per ID #: 2209551., this case now contains all required information to be considered valid.  This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).   A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Female is experiencing bothersome pruritus at the site of injection". Additional Information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the shot, I didn't feel good for two weeks. I was rundown and fatigued, had headaches and dizziness. I felt terrible all over. It took two weeks for it all to subside. I went to the urgent care.
This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a elderly female patient who received SHINGRIX. On 8th May 2018, the patient received the 1st dose of SHINGRIX. On 8th May 2018, less than a day after receiving SHINGRIX, the patient experienced abdominal pain, vomiting, diarrhea, fever and shivering. On an unknown date, the outcome of the abdominal pain, vomiting, diarrhea, fever and shivering were not recovered/not resolved. It was unknown if the reporter considered the abdominal pain, vomiting, diarrhea, fever and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Limited information was provided. During conversation, the patient disconnected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, drug reactions or allergies, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048849, expiry date 04-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 27 degrees Fahrenheit for 1 hour and 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician. Sender's Comments: US-009507513-1703USA007944.
started as small hive lt arm was sore waited 2 days got hot & cold flashes hive got bigger; called MD & describe area; MD instructed MD to take APAP or Ibuprofin; also DPH light pink;
TINGLING IN LEFT LEG WHICH WAS PROGRESSED TO LEFT ARM; PAIN IN THE LEFT HIP JOINT; This spontaneous report received from a patient concerned a male of unspecified age. 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: unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced tingling in left leg which was progressed to left arm, and pain in the left hip joint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the left hip joint and tingling in left leg which was progressed to left arm was not reported. This report was non-serious.
Staff vaccinated with 1st dose of Moderna on 04/14/2021. The following day 04/15/2021 the staff woke up with swelling the size of a golf ball at the injection site, and no other symptoms. On 04/20/2021 the staff said she woke up with moderate whole-body itching, no hives were present at the time. Later, that day on 04/20/2021 staff reported hives on body and SOB. Staff visited her provider and was given a Benadryl shot and prescribed PO steroids.
VACCINE ADMINISTERED WAS STORED AT FREEZER TEMPERATURE FOR TOO LONG. PATIENT IS BEING REVACCINATED.
The following morning after my second vaccine, I woke up with a very sharp headache.  I could not lift my left arm that was vaccinated.  My lower back was sore and I began to have severe menstruation-like cramps that soon turned into throbbing in my uterus and my lower back.  It felt very similar to back labor pains I had with my second child.   This lasted until 3:00 pm and decided to take 1000 mg of Tylenol.  Throughout the day I had a fever and chills.   I attempted to sleep throughout the day.   I took another 1000 mg of Tylenol at 8:00 pm.  This help with my fever.  At 11:00 pm my uterus pain subsided mostly.  The next morning, I felt weak but feel better.
Started having severe stabbing ache in shoulder & upper arm approximately 2-3 days after vaccine.  Began having, numbness & tingling.  Discoloration of injection site also indentation in deltoid muscle.  Severe weakness in left arm, sometimes trembling in arm.  Surgery scheduled for 4/13/09.  Nerve damage, Brachial neuritis, impingement syn.  Rotator cuff tear.4/13/09-records received-neurology consult notes for 12/31/08 with C/O pain and weakness in left shoulder. Day after receiving flu shot had intense pain and swelling in muscle and is not getting any better. past 2 months developed weakness, pain and paresthesias in shoulder area, some flattening of muscle over shoulder. PE:significant atrophy of left deltoid muscle with decrease of sensation over that particular muscle. Difficulties abducting left shoulder, deltoid muscle weak. Deep tendon reflexes preserved, sensory exam to pain and temperature normal.  Impression: most likely axonal inury to axillary nerve. office visit 2/6/09-DX: mononeuropathy of axillary nerve and continues with weakness and some paresthesias which began on 10/31/08. Now C/O strange sensation in fingers and nail changes in left hand. Recently diagnosed with focal arthritis changes in left shoulder. 6/10/09 records received from orthopedic consultant 12/17/08-5/20/09.C/O pain involving left shoulder girdle since 10/31/08-after vaccine developed acute pain lateral to injection site and atrophy. Weakness of shoulder with abduction. Sustained injury to shoulder while at work. Impression:findings consistent with possible injury to branch of axillary nerve secondary to injection.  Impingement syndrome. Surgery for rotator cuff repair on 4/27/09. Follow-up: EMG in 2/2010 shows no improvement to axillary nerve damage, still suffering from weakness in left arm and shoulder and pain.
right foot began twisting and clenching uncontrollably; right foot began twisting and clenching uncontrollably; Subtle Twitching of toes on right foot following second inj.; DX'd with Dystonia of the right foot; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 11:00 as dose 2, single (Lot number: EP7533) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Bees" (unspecified if ongoing), notes: known allergies: Bees & Custaceans; "known allergies: Custaceans" (unspecified if ongoing), notes: known allergies: Bees & Custaceans. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 18Mar2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: DYSTONIA (disability) with onset May2021, outcome "not recovered", described as "DX'd with Dystonia of the right foot"; MUSCLE SPASMS (disability) with onset May2021, outcome "not recovered", described as "Subtle Twitching of toes on right foot following second inj."; MUSCLE TWITCHING (disability), LIMB DISCOMFORT (disability) all with onset Aug2021, outcome "not recovered" and all described as "right foot began twisting and clenching uncontrollably". The events "subtle twitching of toes on right foot following second inj.", "dx'd with dystonia of the right foot" and "right foot began twisting and clenching uncontrollably" required physician office visit. BNT162b2 (Lot#: FF2590) dose 3 was received on 08Dec2021 at 12:00 AM in left arm. There was no other vaccine in four weeks. Other medications in two weeks was none. Patient had subtle twitching of toes on right foot following second inj. By Aug2021, right foot began twisting and clenching uncontrollably. Patient saw primary care followed by numerous tests and specialist consults. DXd with dystonia of the right foot. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Events treatment including Botox injections foot/leg every 3 months. There was no COVID-19 prior vaccination. COVID-19 was not tested post vaccination.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events cannot be excluded. 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
patient not returned for the 2nd and 3rd dose for Preexposure prophylaxis.; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient who was vaccinated with a first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on 15-Nov-2019 via unknown route and site of administration (The lot number and expiry date not reported) and patient did not return for the 2nd and 3rd dose for preexposure prophylaxis (missed dose).  Patient's medical history, vaccinations, treatments and concomitant therapies were not reported.  It was actual medication error due to Missed dose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
She passed out after she got home from church; so sick; could not feel my left arm, it felt like somebody else's arm; dizzy; incoherent; wheezing; trouble breathing; thought I was dying; nauseous; 103 fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She passed out after she got home from church) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced ILLNESS (so sick), HYPOAESTHESIA (could not feel my left arm, it felt like somebody else's arm), DIZZINESS (dizzy), INCOHERENT (incoherent), WHEEZING (wheezing), DYSPNOEA (trouble breathing), FEELING ABNORMAL (thought I was dying), NAUSEA (nauseous) and PYREXIA (103 fever). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She passed out after she got home from church) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (She passed out after she got home from church), ILLNESS (so sick), HYPOAESTHESIA (could not feel my left arm, it felt like somebody else's arm), DIZZINESS (dizzy), INCOHERENT (incoherent), WHEEZING (wheezing), DYSPNOEA (trouble breathing), FEELING ABNORMAL (thought I was dying), NAUSEA (nauseous) and PYREXIA (103 fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       This case concerns a 55 year-old, female subject with no known medical history who experienced the unexpected events of Loss of consciousness, Illness, Hypoaesthesia, dizziness, Incoherent and expected events of Pyrexia and Nausea 1 day after receiving the first dose of the vaccine. The rechallenge is not applicable as patient only received first dose. The event pyrexia and nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna covid 19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 55 year-old, female subject with no known medical history who experienced the unexpected events of Loss of consciousness, Illness, Hypoaesthesia, dizziness, Incoherent and expected events of Pyrexia and Nausea 1 day after receiving the first dose of the vaccine. The rechallenge is not applicable as patient only received first dose. The event pyrexia and nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna covid 19 Vaccine is not affected by this report.
Receive the booster in the morning at 11:20 AM I have any effect in the 15 waiting time. Went home in the afternoon went to the park and rolled in the grass complained of itching after took a shower. the next morning he had the hives on both arms and below his belly button and still has them on the following days. days of reaction May 29 May 30 May 31 as of now. No other reactions Pediatrician advised me to give him Benadryl 2 teaspoons every 4 to 6 hours as of May 31. Forgot to report on vsafe check in on May 29 and May 30
WAS AT A FUNERAL 6 DAYS AGO. COUGH STARTED 7/21/21
Narrative:  86yo male on 9/7/21 was discharged from hospital admission to home hospice. Pt died at home on 9/8/21. From pt's medical records to determin cause of death: Problem list- "hcap toxic metabolic encephalopathy chronic respiratory failure dysphagia transaminitis hyponatremia chf dm foley catheter status anemia merkel cell carcinoma of ear constipation presented to e.r. w/ labored breathing and lethargy likely aspiration pna infectious w/u neg ct chest 8/25/21 bilat pleural effusions w/ associated atelectasis sats ok on 3 liters oxygen home oxygen eval completed and patient qualifies left pleural effusion felt likely parapneumonic or due to volume overload IR consulted to drain? hospital acquired pna on prolonged abx, completed course of zosyn and had vanc transitioned to doxycycline recs to finish 7-10 days of abx d/ced home w/ home hospice" Pt had received covid vaccines on 2/26/21 & 3/23/21. Pt's death is not related to covid vaccines.
Syringe malfunction while administering the second dose; A large quantity of the vaccine came out of the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe malfunction while administering the second dose) and UNDERDOSE (A large quantity of the vaccine came out of the syringe) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 12-Jun-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe malfunction while administering the second dose) and UNDERDOSE (A large quantity of the vaccine came out of the syringe). At the time of the report, DEVICE CONNECTION ISSUE (Syringe malfunction while administering the second dose) and UNDERDOSE (A large quantity of the vaccine came out of the syringe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
3 hours following vaccine, my face started itching and swelling. My eyes swelled shut and when my lips began to itch I took a Benadryl. Eyes remained swollen for one day after. Slept for 15 hours straight
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Developed Monkeypox symptoms 11/5/2022; including fever then anal lesion. He sought care and tested PCR positive for Monkeypox 11/11/2022. On interview, he reported also receiving a Monkeypox vaccine in early August.
Pt. states that after receiving the 2nd dose of Moderna 03/12/2021, started experiencing symptoms of shortness of breath. Primary visit 04/2021, diagnosed with A-Fib. Referred to Cardiologist, Procedure preformed "Watch-man" 10/26/2021.
Patient injected with larger than normal dose, monitored for 30 minutes after dose was given, follow up phone calls that night as well 24hrs post vaccine. Symptoms-none.
Rash after MMR given consistent with measles like rash (morbilliform rash).
NEEDLE STICK-NEEDLE SAFETY MECHANISM NOT ACTIVATED IN THE SHARPS CONTAINER. PHARMACIST RIGHT MIDDLE FINGER WAS STUCK BY A USED NEEDLE ATTACHED TO A FLU VACCINE
Pt recvd vax 10AUG92 & fainted immed following vax; pt recovered on the same day; No further details were provided;