chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 05May2021 as a single dose for COVID-19 immunization. Medical history included lupus, high blood pressure and severe pancreatitis wherein she had surgery all on unknown dates and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported some adverse effects after the first dose of the Pfizer COVID-19 vaccine. The patient reported stomach pain and nausea from an unknown date and fears it may be a blood clot and wants to know if these are common side effects. The patient reported having stomach pain on an unspecified date and she doesn't know if it is normal. At first she thought it was because she was so nauseous, but the nausea went away. Then she thought maybe it was like a bowel thing and she was going to have issues like diarrhea, but that was not the case. The pain is pretty bad. She is wondering if that can be a side effect. She is just wondering if she should follow up with a doctor or go to the hospital, because it hurts pretty bad in 3 different sections of her stomach. Her stomach feels like her arm felt when she got the shot. It feels like she had bruising, not exactly stabbing but it is pretty painful and she is kind of concerned. She doesn't know if her doctor would have information on the vaccine for what to do, and they would probably send her to the hospital. She hopes it's not something serious. She is worried something went wrong. Her entire family got the same shot and were fine. The pain is just like where her pancreas and gallbladder are. Since she had severe pancreatitis last summer, and it hurts where she had surgery. She wants to know if it is related to the shot or something else. The outcome of the event nausea/so nauseous was recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested. Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported blood clot 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.
Received Tdap vaccine in left deltoid at 3:30PM on 8/27/07. 5 hours later, began experiencing fatigue, hunger and pain in left deltoid. She went to bed and woke up 8/28 with very painful, swollen deltoid, but not inflamed. The hunger persisted throughout the day and she developed chills with no fever. Malaise, but no headache. "I felt like crap." Facial sinuses felt "full." "I felt twinges in my submaxillary nodes." No headache. 8/29- still fatigued. No treatment required
The day after receiving the vaccine I experienced nausea.  Following 2 days or so extreme muscle pain at injection site.  Roughly 8 days after vaccine I experienced extreme migraines, muscle pain, numbness, etc.  I felt like I was having a stroke.  Slowly symptoms have gotten better however I still experience muscle pain/weakness.  I have not gone to the doctors for these symptoms as they have slowly gotten better however it is concerning that I was completely normal and then following the vaccine I have had all of this muscle pain/weakness/numbness.
Pt received first vaccination and 10 days later began developing widespread rash. Rash identified as Pityriasis Rosea. Worsened following second vaccination on 4/28/2021 (Pfizer ER8735)
Though I suffered from macular degeneration prior, my eye site has severely gotten worse since my two doses. At first I thought it was just me then my mother got the vaccine and she is now clinically low vision and barely see anything.
Extremely tired, sore at the injection site, a headache, chills; Extremely tired, sore at the injection site, a headache, chills; Extremely tired, sore at the injection site, a headache, chills; Extremely tired, sore at the injection site, a headache, chills; This is a spontaneous report from a contactable healthcare professional.  A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9381, intramuscularly on 08Jan2021 07:30 as a single dose, right arm (age at vaccination: 57 years old) for COVID-19 immunization. Medical history included breast cancer survivor and diagnosed with COVID-19.  The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included gabapentine (GABAPENTINE).  On 08Jan2021 17:00, the patient experienced being extremely tired, sore at the injection site, a headache, and chills. Therapeutic measures were taken as a result of the events and included "Tylenol sleep." The events did not require hospitalization and were reported as non-serious. The clinical outcome of the events extremely tired, sore at the injection site, a headache, and chills was not recovered. The patient was not COVID tested post-vaccination.
Myalgia, Fever, CoughWheeze, fever; chills; excessive body aches; wheezing; sniffles; itching at injection site Narrative:  oral prednisone twice daily for 30 days  Other Relevant History:
Patient experienced redness and swelling of right arm one day after vaccine given. Patient also complained of being unable to sleep and feeling restless the night after she received the vaccine.
Patient complains of developing tingling, burning, and "prickly" sensations in bilateral hands 3 days after receiving second dose of Moderna COVID vaccine. Saw his primary care physician and was prescribed "steroids" on April 8. States symptoms subsided 7 days later, but have since returned.
pt recv vax & was found to be a nonresponder 1mo p/2nd dose;
Deafness unilateral; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Deafness unilateral) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DEAFNESS UNILATERAL (Deafness unilateral) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Deafness unilateral) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included steroids; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Vaccine given@ 11AM on 04/10/2021. At 8PM on 04/10/2021 developed headache, temp of 99.2, started having chills, temp went up to 102.5. Took tylenol, went to bed. On 4/11/2021 Temp broke about 10 AM. Had a red rash 1hr after vaccine & became itchy. Took some benadryl and HCTZ cream to area. Redness & itch stopped. On Tues 4/13/21 felt faint % HR? 160 with exertion. After sitting down & resting X 10minutes HR? to normal. Wednesday 4/13/21 rested most of day. Contacted PCP but unable to get appt. Did not go to ER. No resp problems
flu like symptoms; very high fever (103°F); body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (very high fever (103°F)) and MYALGIA (body aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (very high fever (103°F)) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (very high fever (103°F)) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. Patient received the 1st dose on 03/11/2021 on her left arm at the Hospital On Friday 03/12/21 late evening she experienced a very high fever (103°F), body aches and flu like symptoms Patient went to the ER where they gave her Tylenol The symptoms are ongoing yes but the patient said "very minimal"
Low-grade fever (100 degrees), thirst, body/muscle aches and pains, moderate chills, pounding headache, loss of appetite, fatigue, sleepiness.  Injection site on arm was  swollen, warm, and tender.  These side effects began about 9:00 pm Central time on the day of the injection, and lasted about 48 hours, with severity beginning to lessen at about 36 hours post-injection.
Patient given booster of moderna 0.25ml on 11/12/21 on chart review noted patient received  moderna full dose on  01/07/2021-02/04/21- and on 4/30/21. Extra dose given on 4/30/21.
This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 78-year-old female patient who received SHINGRIX. On 22nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced fatigue (serious criteria disability), muscle pain (serious criteria disability) and injection site pain (serious criteria disability). On an unknown date, the outcome of the fatigue and muscle pain were recovered/resolved and the outcome of the injection site pain was unknown. The reporter considered the fatigue and muscle pain to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporting nurse was the patient. The healthcare professional (HCP) stated that she experienced severe fatigue and muscle pain that lasted about 10 to 14 days. The HCP also stated that less than a year after vaccination, she experienced soreness at injection site. The HCP reported this adverse event to her primary care physician. The HCP did not want to provide her address. This case was linked with US2018080686, reported by the same reporter.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis.       On 31-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage.  On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.
After getting the second dose of Moderna, numbness from my left elbow to my left hand became pronounced and noticeable constantly. Previously numbness existing but barely noticeable in day-to-day routine activity. Contacted my primary care provider, who stated if it becomes worse to contact him. The numbness continues to present without infrequent episodes of worsening then subsiding back to the level noted after the second does of Moderna.
Within 2-4 days of receiveing menactra vaccine he had little pus filled bumps all over the top of his head in his hair.  The vaccine is the only thing I can think of that caused it because we did not change any soaps, shampoos, etc.  We did not go to the doctor with it, it went away within a few days time.
Temperature  103 starting 11 hr after injection lasting 24 hours. Temperature of 100 for following 48 hours Low blood pressure 97/67 starting 11 hr after injection lasting 48 hours.   Extreme chest pain starting 11 hr after injection lasting 24 hours.  Shooting pains throughout the body starting 11 hr after injection lasting 24 hours. Extreme nausea starting 11 hr after injection lasting 48 hours Continued malaise ongoing
Since my second dose my menstrual cycle has been heavier and with severe cramps.; Since my second dose my menstrual cycle has been heavier and with severe cramps.; Since my second dose my menstrual cycle has been heavier and with severe cramps.; Also, for the past 15 years I had acne related to my cycle under control, but now it back with full force. I just can't; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot unknown=True,, lot unknown reason=Unable to locate, or read the details,, administration date=14May2021,, dose number=1,, vaccine location=Left arm}]), administration date: 14May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 20Jun2021, outcome "not recovered", described as "Since my second dose my menstrual cycle has been heavier and with severe cramps. "; MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious) all with onset 20Jun2021, outcome "not recovered" and all described as "Since my second dose my menstrual cycle has been heavier and with severe cramps."; ACNE (non-serious) with onset 20Jun2021, outcome "not recovered", described as "Also, for the past 15 years I had acne related to my cycle under control, but now it back with full force. I just can't". The events "since my second dose my menstrual cycle has been heavier and with severe cramps. ", "since my second dose my menstrual cycle has been heavier and with severe cramps.", "since my second dose my menstrual cycle has been heavier and with severe cramps." and "also, for the past 15 years i had acne related to my cycle under control, but now it back with full force. i just can't" were evaluated at the physician office visit. Therapeutic measures were taken as a result of heavy menstrual bleeding, menstrual disorder, dysmenorrhoea, acne.  Additional information: Other medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Covid was not tested prior and post vaccination. Vaccine Facility type was Hospital. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. Adverse event treatment included: Topical treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient).  This  54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30  for covid-19 immunisation.  Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Additional information: Antiviral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=22Jun2022, Treatment stop date=26Jun2022, Lot number=GA3581 and Indication=Treatment of COVID-19. Patient not received other medication in 2weeks. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
A report received from a health care professional on 04Nov02 concerning an unk number of vaccinees who inadvertently received frozen Fluvirin on an unk date. On an unk date, an unk number of vaccinees were inadvertently administered frozen Fluvirin. The reporter was not aware of any adverse reactions experienced by the vaccinees. There was insufficient information to determine the reporter's causality assessment.
Information has been received from a physician concerning a patient who received a single oral dose of Rotateq. The physician reported that while they were giving the dose to the baby, he stopped breathing for a few seconds and the baby's face turned red. He was seen by the physician in the office. It was reported that he improved "after stopping therapy". At the time of this report, it was reported that the patient recovered. A product quality complaint was not reported. No further information was available. Upon internal review it was determined that respiratory arrest was an other important medical event. Additional information has been requested.
diagnosed with 'RSV'; Sinus infection; This is a spontaneous report from a contactable consumer  reporting for himself.    A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient was  diagnosed with 'RSV' (respiratory syncytial virus infection) on 2021 with outcome of unknown , had a sinus infection on 2021 with outcome of unknown.  The patient was hospitalized because RSV infection.  Follow-up attempts are completed. No further information is expected.
Patient's wife called to report that the patient had "jumbled" speech this morning (02/22/2023).  She stated that it was getting better throughout the day.  I recommended that the patient seek medical attention from their doctor for stroke signs.  The patient's wife reported no other signs of stroke and that she will continue to monitor her husband at home.
arm was swollen and turned different colors. For treatment patient went to multiple appts with her allergist to assist with reaction and watch it.
17 y.o. patient given Moderna for first dose in error on 3/22/21.  Given second dose Moderna on 4/19/21 as per CDC guidance.  No AE.
Patient began to get dizzy, shaky and sweaty within 1 minute of vaccine. He was given orange juice and immediately started to get better. He declined medical care. He asked for cold water and continued to improve. In about 10 minutes he was able to walk over to Blood pressure machine and he measured 102/86. He was given 100 mg of Benadryl. He had a companion to drive him.
Developed stomach pain requiring ER visit on 4/2/2021.  Treated for gastritis and scheduled future endoscopy.  Diagnosed with Diffuse Large B Cell Lymphoma, Type ABC.  Currently being treated with chemotherapy.
body ache; headache; This is a spontaneous report from a non-contactable healthcare professional (nurse). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body ache and headache on an unspecified date. The outcome of events was unknown. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation and experienced leg cramp, body ache, headache and she was not feeling good at all.  No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Over night on the night following the vaccination, I had headache, body aches, malaise and insomnia.  Throughout the next day (1/13/21), I continued to have headache, body aches, and malaise as well as objective fever (up to about 101.5 degrees F), fatigue, dyspnea on exertion and lightheadedness.  Later in the day (about 5:00pm) I developed significant shortness of breath at rest and chest pain.  Later that evening I went to the Emergency Department because of concern over my extreme and persistent shortness of breath and chest pain.  In the E.D. they did the following tests:  EKG (normal), oximetry (normal), Portable Chest Xray (normal), rapid COVID test (normal), cardiac enzymes (normal), D-DIMER (ELEVATED), other bloodwork (normal).  Because of the elevated D-dimer, a CT angiogram of the chest was performed to rule-out pulmonary embolism.  The CT showed enlarged lymph nodes, but no evidence of pulmonary embolism.  I was discharged home.  By the next morning (1/14/21) I was feeling much better.  And by the afternoon of 1/14/21 I was feeling completely back to normal without any symptoms.
I had a delayed reaction (typical of Alpha-Gal), which started about 1:30 AM on Saturday. Anaphylaxis related symptoms began with severe diarrhea and a drop in blood pressure. When I felt I might be able to make it to the cabinet to get benadryl (diphenhydramine antihistamine) to control my syptoms, I got up and tried to get to the cabinet. My drop in blood pressure became severe, I dropped the pill bottle, fell down, and continued to have severe diarrhea. When I was able to get up long enough to take some benadryl, I took three of them (which will usually knock back the symptoms), and got back on the toilet, where I continued to have diarrhea for some time longer before the benadryl took effect. Following research into the vaccinations given, Pfizer's website indicates bovine ingredients in the manufacturing process of Prevnar 20. I was unable to determine if Fluzone HD contained mammal products.