chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of Moderna COVID vaccine about 35 minutes before presentation to doctor. He started feeling scratchiness in his throat after about 10-15 minutes. He did not feel like his throat was closing off. Nor was any worse since it first started. He has had anaphylaxis with shellfish in the past and carries an EpiPen. He said it does not feel like that now. Feels like he needs some Benadryl. Patient told the pharmacy tech that he thought this might be moreso anxiety (after reading the paperwork). Did not feel like other reactions he has had in the past.
Donor stated his muscles were tense, and (L) knee had sharp pain; time of s/s to resolve 12 hours.
This spontaneous case reported by a nurse, describes the occurrence of product storage error (administered vaccine stored at temperature between -80ºF to -84ºF) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 076C21A) for COVID-19 immunization. No medical history reported. On Nov 19, 2021, at 1:06 pm, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25 milliliter. On Nov 19, 2021, patient experienced product storage error (administered vaccine stored at temperature between -80ºF to -84ºF). At the time of the report, product storage error (administered vaccine stored at temperature between -80ºF to -84ºF) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-402935 (patient link).
MASSIVE BILATERAL PULMONARY EMBOLISM; PEA  ARREST; This spontaneous report received from a health care professional concerned a 44 year old of unspecified sex, race and ethnicity. 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, and batch number: 1805018 expiry: unknown) dose was not reported, frequency once total, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the patient experienced bilateral pulmonary emboli classified as massive and was hospitalized, and experienced pulseless electrical activity (PEA) arrest in the setting. Patient was discharged on 16-MAY-2021. Patient was hospitalized for 16 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from massive bilateral pulmonary embolism on 16-MAY-2021, and PEA arrest. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210547403-covid-19 vaccine ad26.cov2.s -Massive bilateral pulmonary emboli, pulseless electrical activity arrest This event(s) is considered unassesable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Chills, fever (100.1), body aches, fatigue, headache, joint pain. nausea, injection site pain and redness. Took Tylenol every 4 hours. Lasted more then 48 hours. Improved after 72 hours.
pain in arm, sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm, sore arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in arm, sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm, sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that pain in arm stopped for 10 days and reappeared in worst state 3 days ago. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Event details updated
experienced bruising of approx 4 to 6 inches in diameter at the injection site.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation : solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bruising of approximately 4 to 6 inches in diameter at the injection site. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following 3rd shot, got COVID infection 3 weeks later; Following 3rd shot, got COVID infection 3 weeks later; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 8 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Following 3rd shot, got COVID infection 3 weeks later". Clinical course: Note, patient is 8 weeks pregnant and the doctor was recommending 4th COVID dose.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
H1N1 nasal spray given in error. Call to family 10/23/2009-no ill effects.
Fever 101F 9/29/09 in evening. Fever 102F 9/30/2009. 10/1/09 - Right arm is swollen, hot to touch and has red blotches at injection sites. Pt used ALEVE and warm compress 10/1/09. No fever 10/1/09. Improvement at site 10/2/09 - less red. 10/2/09 3:58PM - Received call from patient. She explains that her R upper arm is itching. This is a new symptom after receiving vaccine on Monday 9/28/09. See attached VAERS for information. Explained that I would contact Dr. and call her back. 7:05PM - Discussed case with Dr. 7:15PM - Returned call to patient. Advised her to call her doctor and report symptoms prior to taking any medicine, since she takes many medications. Advised to continue with compress to site. Advised to seek immediate medical care if she begins to have difficulty breathing. Also, advised against applying topical Benadryl to area as it has been warm and inflamed. She verbalized understanding of all of this. 10/5/09 7:30AM - Called to follow-up with patient. Her itching on her R arm subsided. The redness on her R arm was gone yesterday. She states that most of  the swelling is gone and she is doing much better.
pt recv vax which was reconstituted w/pancuronium bromide instead of appropriate diluent;pt died;addtl info has been requested;
encephalitis; VZV; shingles; experiencing confusion; This case was reported by a physician via sales rep and described the occurrence of encephalitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced encephalitis (serious criteria hospitalization and GSK medically significant), varicella zoster virus infection (serious criteria hospitalization), shingles and confusion. On an unknown date, the outcome of the encephalitis, varicella zoster virus infection, shingles and confusion were unknown.   It was unknown if the reporter considered the encephalitis, varicella zoster virus infection, shingles and confusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient developed shingles. The patient was experiencing confusion, so she recommended pcp send patient to emergency room. The patient was hospitalized with encephalitis and confirmed varicella zoster virus infection.
5 hrs after shot I got fever and shivering and shaking uncontrollably. My hands and feet went numb, trouble walking. Next morning (today) woke up with temp of 100 and aches and pains.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff). This case involves a 13 months old female patient and reported that ACT-HIB mixed with sterile water given to a patient, while she received vaccines ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 18-Sep-2018, the patient received a 0.5 ml once dose of suspect ACT-HIB (lot number: UI817AAA and expiry date:14-Nov-2018) (dose in series and route was not reported) in the left deltoid. On 18-Sep-2018, the patient received a dose of suspect HEPATITIS A VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series and route of administration was not reported) in the right deltoid. It was a case of actual medication error due to inappropriate reconstitution technique (reported that ACTHIB mixed with Merck sterile water diluent (Lot# N014021, Exp 04-Aug-2019). It was unknown if the patient had any adverse event. 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 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. List of documents held by sender: none.
DOUBLE VISION; BLURRED VISION (HAD TROUBLE LOOKING AT THINGS); FEELING DIZZY; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: acetylsalicylic acid. On 20-MAY-2021, the subject experienced double vision. On 20-MAY-2021, the subject experienced blurred vision (had trouble looking at things). On 20-MAY-2021, the subject experienced feeling dizzy. The action taken with covid-19 vaccine  was not applicable. The outcome of the double vision, blurred vision (had trouble looking at things) and feeling dizzy was not reported. This report was non-serious.
Intense nausea and lightheadedness  Slept and took Pepto and ginger pills.
Fever ranging from 99.0 to 103.7 for 5 days Aches and nausea  for 5 days Night sweets for 2 nights
Pt called on 4/23/21 to call Center. Pt got Moderna vaccine  second dose on 4/22/21. Pt complains of right lump in the arm at the injection site, swollen, warm, size of marble and purple in color, onset 4/23/21 this morning, pain 9/10 constant. Pt also states feeling warm/feverish but no temp taken. Pt states she has moderate-severe asthma and diabetes. Pt advised to go to ED/urgent care to have the arm . Pt verbalized understanding
1 of 2 pts vaxed from the same Tetramune lot who had an adverse event;pt recvd vax 4NOV94 & was immed returned to MD office w/fever of 104.8;APAP & DPH given; w/in 45mins, t99.8;
pt recv vax 1SEP95 & was exposed to varicella @ school;MAR97 pt devel a mild case of chickenpox consisting of rash w/20-25 vesicular lesions;pt also devel ear pain;pt was taken to clinic 25APR97 & dx w/ROM;
Information has been received from a physician regarding an approximately 6 month old male patient who on 24-JUN-2010 was vaccinated with the first dose of ROTATEQ (lot #0350Z). On 14-SEP-2010 (lot # 667991/0726Z), the patient was vaccinated with his second dose of ROTATEQ, oral. That same day, on 24-Jun-2010, the patient also received DTAP, HIB and pneumococcal (unspecified). On 01Nov2010, the patient developed intussusception and was admitted to the hospital where he was given an enema for reduction. On 01-Nov-2010, the patient's outcome had recovered. On 08-Nov-2010, the patient was vaccinated with his third dose of ROTATEQ oral. Intussusception was considered a life threatening illness by the reporting physician. All available medical records will be provided upon request. Additional information has been requested.
Syncope, nausea, vomiting - one episode occurring around 8pm. Vaccine administered at 4:25 pm.
It's led to diverticulosis inflammation in my large and small intestine extreme constipation; Gastrointestinal issues, I have GERD now; I have extreme constipation; My stomach swelled up; My stomach is not digesting food properly; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old male patient received bnt162b2 (PFIZER-BIOTNECH COVID-19 VACCINE, lot number EW0191), administered in right arm on 08Jun2021 12:00 PM (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. Vaccine facility type was reported as pharmacy or drug store. The patient's medical history included epilepsy, and hernia from unspecified date. The patient had not COVID prior vaccination. No known allergies were reported. The patient's concomitant medications included lamotrigine and zonisamide, both from unspecified date. It was unknown if patient received other vaccine within four weeks. Patient experienced gastrointestinal issues. He had GERD now (as reported). He had extreme constipation. A lot of people reporting gastrointestinal issues after vaccination. His stomach swelled up. He had to go to the emergency room. His stomach was not digesting food properly. Anything he ate seemed to hurt his stomach now (as reported). He had taken his prescribed medications for years this only occurred after this vaccine was taken. It was led to diverticulosis inflammation in his large and small intestine extreme constipation, and it seemed like there was no end in sight. He was going to wither away because eating only made things worse, or his stomach was going to rupture because no matter how much fiber or polyethylene glycol (MIRALAX) ingest his stomach was not doing what it was supposed to do. The adverse events onset date was reported as 21Jun2021 at 02:30 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received due to the events included pregabalin (LYRICA), MIRALAX and ibuprofen. Patient was not tested for COVID since vaccination. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
I had a frozen shoulder in my right shoulder, it was extremely stiff, and I could not raise my arm. There was intense pain radiating from the shoulder down the arm. It's been three months, it much better but still and going to physical therapy.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 20-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a patient with no reported medical history, who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included interferon (unspecified). The physician reported that in 2005, the patient experienced neuropathy after receiving pneumococcal 23v polysaccharide vaccine for the second time. The physician reports the patient was given a dose of pneumococcal 23v polysaccharide vaccine and then another dose was given 18 months later. No reaction was reported after the first dose, but the neuropathy occurred after the second dose that was given inadvertently. Unspecified medical attention was sought. At the time of this report the event has not recovered. No product quality complaint was involved. Additional information is not expected.
Eyes burning and blood red. Uncontrollable shaking. Coughing. Tthroat swelling, not enough to cut off air.
Subsequent to receiving one dose of varicella virus vaccine live, pt developed chickenpox.  Pts two siblings also had similar experiences.
Consistent traveling  body pain (forearms, triceps, quads, hamstrings, lower breasts, shins, calves, some feet/tips of fingers). Tightness in chest since 5/2.
patient received a dose of Moderna from a vial that had been punctured for more than 12 hours; vial stored post puncture in R/T FRIDGE and it was never really left out at room temp; adverse event; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (adverse event), EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (vial stored post puncture in R/T FRIDGE and it was never really left out at room temp) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 013F21A, 014M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022 at 1:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced IMMUNISATION REACTION (adverse event) and PRODUCT STORAGE ERROR (vial stored post puncture in R/T FRIDGE and it was never really left out at room temp). On 18-May-2022 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours). At the time of the report, IMMUNISATION REACTION (adverse event), EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (vial stored post puncture in R/T FRIDGE and it was never really left out at room temp) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 12-May-2022, the vial was initially stored in the refrigerator. On 17-May-2022, at 2.16 pm, the vial was first punctured.   The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2022-571179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Live Significant Follow up information received, Patient information and reporter information was updated.
Patient's spouse reported at approximately 1710 the pt had a sudden onset of shaking, chills, HA and fever of 101F. She reported that night the fever broke and the next day all S/S resolved but pt. had malaise. She reported all S/S resolved in 48 hours.
Three minutes after the vaccine occurred the patient started having itchy throat, throat tightness, also dizziness and SOB. Patient escorted to stretcher to lay down. No change in symptoms. RRT called. 17:11 no change in throat s/s, decreased SOB and dizziness. No CP noted. At 17:17 patient complained of itchy injection site. Patient than taken to ED.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old female patient who received SHINGRIX. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX. Concurrent medical conditions included allergic reaction to antibiotics (allergic reaction to Clindamycin) and drug allergy (lisinopril allergy: severe cough). Concomitant products ZOCOR, Losartan, melatonin, Vitamin C, vitamin D, and SYNTHROID. On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching and injection site erythema were recovering/resolving. The reporter considered the injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. All the events experienced by the patient after vaccination with SHINGRIX were specific to injection site and redness size was described as 50 cent coin. The patient had denied permission to contact her physician.
123 onset of itching/swelling of site of various injection. 8 cm x 8 cm erythema with smaller area of induration.
15 minutes: severe headache, cold thru body, tremors 25 minutes: faint, low blood pressure 3 hrs:  nausea for 4 days  18hrs:  99.8 fever (2 degrees higher than normal  for 48 hours  extreme fatigue for 4 days and tremors increased
Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet have hives. Have headache since receiving vaccination. Swollen, painful axillary lymph nodes on side of injection from Monday and still sore today on Saturday.
Client vaccinated at call bank at flu clinic at 8:50am. Approx. 25 mins later fellow employee came up to where nurses were given shots and told us above was having trouble breathing-went down to clients office-had head down on desk, c/o dizziness, anxious, pale. Epi given 911 called-ambulance responded in 6 mins-taken to hosp for monitoring. Was discharged at 10:40am.
Disorientation, dizziness, nausea, diarreah. Was prescribed Antivert by healthcare professional.