chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For employer vaccine compliance or termination by 10/31/21 patient received Covid19 vaccine on 9/14/21.  On 9/14/21 initial symptoms of adverse reaction displayed in 4-6 hours of injection (6pm). Symptoms included tachycardia (132bpm), difficulty breathing (labored), body hives, vertigo, and severe tinnitus. Pt. treated with Epinephrine 0.3mg auto inject (self administered). Outcome of injection successful in treatment of tachycardia, DOB and hives. After several days of continued remaining symptoms Pt received urgent care consultation 9/27/2021, Pt was prescribed Hydroxychloroquine 200 mg, Azithromycin 500 mg, Dexamethasone 2 mg, Zinc 50 mg.  Full recovery.
On 03/29 I had my vaccine and a week and a half later about 04/07/21 I went to the ER with trouble breathing and I do have COPD so occasionally I have that problem. I was admitted and was diagnosed with atrial fibrillation, and they had to treat me, and I received various medications for that and when I was released from the hospital I had oxygen ordered for me, so I currently am on oxygen level 1 for the COPD. Meds were added and I?ve been taking those that have been taking care of the atrial fibrillation. I was in the hospital for 7 days. I did not have any symptoms of atrial fibrillation such as heart flutters before going to the hospital.
Died 4 days after shot from blood clots in my lungs. No history of clotting before this. Did have Covid asyptomatic back in January. So not sure whether having had Covid caused the clotting. Having the vaccine or being out of work with torn meniscus. They think clots started in my legs and ended up in my lungs. I was brought back after coding for 6 minutes. They seem to think Covid caused it. Not sure if vaccine contributed or not. But it did happen 4 days after the shot.
Nausea and vomiting for 24 hours, severe bone and joint pain, sore throat, not able to keep food down for 5 days. Returned to normal on 8th day.
p/vax CBC revealed a low neutrophil count;CBC repeated on 5/17/99 & again revealed a low neutrophil level;MD felt there is no relationship between vax & neutropenia;
Child went back to classroom after vaccination and was sitting at desk and fell over backwards and passed out.  Classroom teacher immediately responded to child and she was awake and conscious. School nurse and vaccine administrator were notified and responded.  Child was pale but alert and awake.  Child was taken to nurses office and rested -- was incontinent while resting.  Very sleepy.  Parents were called and child went home.  Reported by parents that she slept much of the remainder of the day and evening but by next morning was well.
No additional adverse event; Vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided.  On 14-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), (Lot number [U022726] is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)) and expiration date: 16-JAN-2023, directed as to prevent measles, mumps, rubella and varicella.  The reporter mentioned that, there was a temperature excursion involving administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) vaccines (product storage error). No additional adverse event reported.
Getting up 2 days after the shot I began experiencing facial and hand tremors, As the day progressed, they became more frequent and overt.  This continued for several days, eventually reducing severity after 5-6 days.  I was winking with both eyes involuntary, face twitching, hand and fingers twitching and jerking
Severe chills, fever reaching 102, severe, very severe, headache. Body aches. Recovered in less than 12 hours.
Severe pain in my back/hips/upper legs area.  Difficulty walking with severe pain down the back of my legs to my feet.  About three and a half months after an MRI, I was given a Cortisone injection in my back.  I am still having pain down the back of my legs, though not severe.
Arm extremely sore, tingling in fingers, feeling of heat rushing down to my hand.  Today is 11/23/09 and there has been no relief in the pain.  I am visiting my physician today for the pain.
severe dizziness; horrible nausea and vomiting; horrible nausea and vomiting; muscle soreness; headache; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female nurse received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route in left lower deltoid on 17Dec2020 10 am, single dose for COVID-19 immunization at 40-year-old. Medical history included: surgery and lipoma removed from upper deltoid in Nov2020. Family medical history included: Her mother had colorectal cancer at age 40. When the patient turned 40, she had colonoscopy earlier this year (2020) and it was negative. Concomitant medication included: levothyroxine 100ug daily from 2001. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had pretty severe muscle soreness Thursday night (17Dec2020) and the next two days. On 19Dec2020 it was not as severe. It was mild and it started to dissipate on 19Dec2020. The only thing she had been taking was acetaminophen 650mg that night for the muscle soreness. The patient awoke at 3:00 am on 20Dec2020 out of a dream with severe dizziness that turned into horrible nausea and vomiting. She had vomiting for a little while the third night (20Dec2020) into the fourth day. The patient (nurse) considered the muscle soreness and dizziness was non-serious and not medically significant. She didn't feel the need to go to the hospital because it did improve. After she threw up, the dizziness kind of went way. Even today (21Dec2020) she felt fine and no more nausea, but still felt kind of off and dizziness, lingering dizziness. It wasn't extreme dizziness but when texting she could feel, and it was hard to focus. She was not one hundred percent her normal self. She was not sure if it was related to the vaccine. She was eating and drinking normally. The night that she received the vaccine, she had one beer and one margarita at dinner. She did have alcoholic beverages, a beer and a margarita. It was nothing excessive with dinner. She was not overly drunk. She didn't know if alcohol could have contributed. She had never had that kind of reaction before from drinking. That was very odd. She just wouldn't drink any alcohol. She took acetaminophen for a headache (in Dec2020) that she was experiencing. She was pretty healthy. All of this was so new with the COVID vaccine. That night into this morning she started her menstrual period as well. She had never had any horrible side effects like migraines or cramping when getting her menstrual cycle. It could have been the alcohol or her period. No visit to emergency room or physician office. Action taken for BNT162B2 was not applicable. Outcome of the event muscle soreness was resolved on 19Dec2020; outcome of the event severe dizziness was resolving; outcome of the other events was unknown. Causality assessment between the event muscle soreness and the suspect product BNT162B2 per the patient was reported as related.
This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included allergic reaction to antibiotics. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The next day she experienced a tender, red, swollen area on upper arm about an inch or more below the injection site which hurt a bit. It did not itch. The redness on the left upper arm was about 2 to 3 inches wide and about 5 inches from top to bottom. It was a little swollen. They discussed what grade 3 pain meant (defined as significant pain at rest, prevents normal everyday activities) and the patient said it was not grade 3. All events resolved after about 4 to 5 days. The caller reported these events to her physician.
Injection at 6pm 11/23/02. Next morning noticed tongue black in color and teeth stained but teeth brushed clean. Tongue could not be cleaned. no pain or swelling. By 11pm tongue back to normal.
The expired vaccine (Beyond 12 hours) was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expired vaccine (Beyond 12 hours) was administered) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expired vaccine (Beyond 12 hours) was administered). On 05-May-2021, EXPIRED PRODUCT ADMINISTERED (The expired vaccine (Beyond 12 hours) was administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6200), in right arm, on 17Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Raw fruits" (unspecified if ongoing); "Known allergies: Shell fish" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Stroke", start date: 2020 (unspecified if ongoing); "Cerebral Vasospasm" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "occasional Vertigo" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Contact Dermatitis" (unspecified if ongoing); "Hyperprolactinemia" (unspecified if ongoing); "Pituitary Microadenoma" (unspecified if ongoing); "Adrenal Insufficiency" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE; HYDROXYCHLOROQUINE; AMITRIPTYLINE HCL; VALACICLOVIR; CYCLOBENZAPRINE; GABAPENTIN; OMEPRAZOLE; DICLOFENAC SODIUM; FAMOTIDINE; ZOFRAN [ONDANSETRON]; RESTASIS; CABERGOLINE; SUCRALFATE; PSYLLIUM HUSK [PLANTAGO OVATA HUSK]; CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]; ELDERBERRY [RUBUS IDAEUS LEAF;SAMBUCUS NIGRA FLOWER;SAMBUCUS NIGRA FRUIT]; ECHINACEA; MELATONIN; SULFACLEANSE; EVENING PRIMROSE; VITAMIN D3. Past drug history included: Known allergies: triptans, reaction(s): "Allergy"; Known allergies: citric acid, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, 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: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient reported about Covid-19 treatment. Patient received other medication in 2weeks, concomitant medications reported. Anti viral details reported as patient took Paxlovid for COVID 19 treatment, from 07Jul2022 to 12Jul2022 (Lot number: 1917018A).
off and on sinus infections; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (off and on sinus infections) 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 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 SINUSITIS (off and on sinus infections). At the time of the report, SINUSITIS (off and on sinus infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment and concomitant product was reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-046530 (Patient Link).   Reporter did not allow further contact
Received second vaccine on 1/5/21 and on 1/6/21 started having chills, malaise and 102.3F fever.  Symptoms persisted appx. 24 hours and she took two days off work.  She has now returned to normal and back to work.
Fever, chills, rigors, aches within legs flu 24 hours of vaccine (H1N1), R deltoid @ injection site w/no induration, no redness, non tender.
There was no adverse event. Reporting that the client received a Pfizer vaccine 5 weeks after recieving a Janssen COVID vaccine. No adverse events to the vaccines.
COVID Vaccine breakthrough case. Pfizer 01/30/2021 EN5318, 2/20/21 EN6201 and boosted 10/23/21 PAA166261
Mother reported that child was complaining of itching all afternoon the day of immunization. Next day child woke up with diffuse edema to mouth, face and hives all over body.  Mother provided antihistamine prior to arrival
gotten the flu vaccine but had still gotten the flu; lack of efficacy; Based on information previously received on 03-Dec-2019, the following information [case classification: updated from Non-Case to Valid and updated from 04-Dec-2019 to 03-Dec-2019] have been amended.  Initial information received on 03-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case is linked to case 2020SA010875 (same reporter).  This case involves a child female patient of unknown age who experienced flu (Influenza), while she received vaccine INFLUENZA VACCINE.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was a case of vaccination failure.  Detailed laboratory examination was not provided.  Final diagnosis was influenza.   It was not reported if the patient received a corrective treatment.  The patient's outcome was not reported.  The information on the batch number was requested.  Addendum: Based on information previously received on 03-Dec-2019, the following information [case classification: updated from Non-Case to Valid and updated from 04-Dec-2019 to 03-Dec-2019] have been amended.; Sender's Comments: This case concerns a Child female patient who presented with influenza after and despite vaccination with Influenza vaccine (an Influenza containing vaccine). The time to onset is unknown. However, there is no information regarding patient's condition at time of vaccination, immune status, congenital predisposition to infections. Based upon the reported information, the role of the vaccine and a case of confirmed vaccination failure cannot be assessed.
Received vaccine on 09-12-13 around 11:45AM. A couple hours later patient began to experience a "severe lump in throat", she was hot, hoarse, her eyes watered and she reported having troubles breathing. She went home and to bed and reported feeling better in a few hours.
A patient received 2 doses of Fluzone High Dose in one day /No adverse event; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a patient of unknown demographic who received two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in one day lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination on an unknown date.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to extra dose administered.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: 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.
I developed a raised, red, rash-like spot at the injection site. It got better over three days and then the fourth day (today) it seems to be a bit worse again.
Extremely heavy menstrual period right after vaccine.; Fast heart rate; Warm body temperature; Nausea; Bloated; Left arm pain; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported. The patient did not have COVID prior to vaccination. Concomitant medication(s) included ibuprofen taken for an unspecified indication, start and stop date were not reported; benzylpenicillin (PENICILLINE [BENZYLPENICILLIN]) taken for an unspecified indication, start and stop date were not reported.  It was reported that patient experienced "extremely heavy menstrual period right after vaccine, same day of given shot, heavy clotting, non-stop bleeding for hours", fast heart rate, warm body temperature, nausea, bloated and left arm pain on 12Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature was warm and heart rate was fast on 12Apr2021. The patient was not tested for COVID post vaccination.  Information on the lot/ batch number has been requested.
Severe neck pain, arm pain, dizziness (fainted at 3 am), nausea, headache, stomach cramps,
This spontaneous report as received from a pharmacist refers to a currently 54 year old male patient with drug reaction/allergy to codeine. Concomitant therapy and pertinent medical history were not reported. On an unspecified date in 2013, the patient was vaccinated with a dose of Hepatitis A vaccine (manufacturer unknown) (dose, lot#, indication, route of administration not reported). On an unknown date, the patient was diagnosed with ulcerative colitis. The pharmacist was unsure, if the patient was diagnosed prior to vaccination with Hepatitis A vaccine (manufacturer unknown) or after the vaccination). The pharmacist reported that, on an unspecified date, the patient was started on REMICADE "every 6-8 weeks" for the treatment of ulcerative colitis and the patient was still being treated with the REMICADE, at the time of the report. The patient sought medical attention in an unspecified way. The outcome of ulcerative colitis was unknown. The relatedness between ulcerative colitis and Hepatitis A vaccine (manufacturer unknown) was unknown. Additional information has been requested.
hurting in my arms back and shoulder, sore body; coldness, feeling cold; feels sweaty; voice is jittery; feel horrible; soughing; dark green mucus; feels fatigued; sick everyday ever since getting the vaccine; shivering; her ears and eyes are stopped up and full; Flu; temperature of 100.3 degree F; fever of 130 degrees F; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old female patient who experienced hurting in my arms back and shoulder, sore body (pain), coldness, feeling cold (feeling cold), feels sweaty (hyperhidrosis), voice is jittery (dysphonia), feel horrible (feeling abnormal), soughing (breath sounds abnormal), dark green mucus (sputum discoloured), feels fatigued (fatigue), sick everyday ever since getting the vaccine (malaise), shivering (chills), her ears and eyes are stopped up and full (unevaluable event), flu (influenza like illness), temperature of 100.3 degree f (body temperature increased) and fever of 130 degrees f (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included FLUZONE HD. The patient's past medical history, medical treatment(s) and family history were not provided.   On 18-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient experienced a non-serious hurting in my arms back and shoulder, sore body (pain), coldness, feeling cold (feeling cold), feels sweaty (hyperhidrosis), voice is jittery (dysphonia), feel horrible (feeling abnormal), soughing (breath sounds abnormal), dark green mucus (sputum discoloured), feels fatigued (fatigue), sick everyday ever since getting the vaccine (malaise), shivering (chills), her ears and eyes are stopped up and full (unevaluable event), flu (influenza like illness), temperature of 100.3 degree f (body temperature increased) and fever of 130 degrees f (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was fever of 130 degrees f, temperature of 100.3 degree f, flu, her ears and eyes are stopped up and full, shivering, sick everyday ever since getting the vaccine, feels fatigued, dark green mucus, soughing, feel horrible, voice is jittery, feels sweaty, coldness, feeling cold and hurting in my arms back and shoulder, sore body.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for the events.  Information on the batch number was requested.
Mom tells PNN small amount of edema on 01/08/02 but has increased largely since yesterday per mom. On 1-9-02 left arm red and edematous 3 quarters way to elbow . PHN learned on 1-10-02 that MD ordered Motrin and cold compresses
Patient described a red spot on arm where he received injection about 4cm wide.  It was hot to touch and raised.  Patient was treated for reaction.
Complaining that he is unable to move right leg on awakening in the morning (day after vaccination). Having trouble walking and limping complaining that the right knee hurts.