chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report from a contactable consumer (patient's parent). Report 4 of 4. This consumer reported for a patient (kid) received BNT162B2 on an unspecific date at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Caller states that her three kids were complaining of sore arms. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433532 same reporter/drug/event, different patient;US-PFIZER INC-2021433880 same reporter/drug/event, different patient
Sore arm immediately after injection.  After 6  hrs I experienced fatigue that lasted until 11:30 the next day at which time I experienced headache, chills neck and shoulder pain, and extreme flu-like body aches and fatigue.  After 30 hours, symptoms began to subside.
they believe the cause of death was stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (they believe the cause of death was stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pneumonia vaccine. Past adverse reactions to the above products included Pneumonia with Pneumonia vaccine. Concurrent medical conditions included Egg allergy and Tuberculosis (Tuberculosis in their kidney.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (they believe the cause of death was stroke) (seriousness criteria death and medically significant). The reported cause of death was Stroke. It is unknown if an autopsy was performed.            This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (they believe the cause of death was stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pneumonia vaccine. Past adverse reactions to the above products included Pneumonia with Pneumonia vaccine. Concurrent medical conditions included Egg allergy and Tuberculosis (Tuberculosis in their kidney.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (they believe the cause of death was stroke) (seriousness criteria death and medically significant). The reported cause of death was Stroke. It is unknown if an autopsy was performed.          The patient was on blood pressure medications.  The reporter reports that two days after a family member died two days after they received their first dose of the Moderna COVID-19 vaccine and they believe the cause of death was a stroke.  No laboratory data was provided.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding this event has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Stroke
Broke out into hives; This is a spontaneous report from a contactable consumer or other non hcp. This is a spontaneous report from sponsored program SUPPORT. A male 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 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced broke out into hives on an unspecified date. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I had the chills, a bad cough, a lot of sinus drainage down the back of my throat, a low-grade fever of 101.4F, joint and body aches, I am having a hard time focusing, my gums are sore, some diarrhea. I used my home COVID-19 test, it came back positive, I waited to call my doctor since it was Sunday. We had a telehealth visit, discussed my symptoms, he prescribed the Paxlovid, a prednisone dose pack, and suggested I take Robitussin. I have noticed that since I started taking the medication my chest has started to hurt.
was administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 5H42H, expiry date 19th March 2022) for prophylaxis.   On 20th May 2022, the patient received Shingrix. On 20th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment: The reporter was the registered pharmacist. The reporter wanted to know if re-vaccination was needed if the patient was administered an expired dose of Shingrix. The number of dose given was not asked. The reporter consented to follow up. Additional Supportive Information: The patient was administered a dose of Shingrix last Friday for which the expiration date was 19th March 2022, which led to expired vaccine used.
This case was reported by a physician via sales rep and described the occurrence of fatigue in a adult female patient who received Bexsero for prophylaxis. In July 2018, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. In July 2018, 1 day after receiving Bexsero, the patient experienced fatigue, fever and nausea. On an unknown date, the outcome of the fatigue, fever and nausea were recovered/resolved. It was unknown if the reporter considered the fatigue, fever and nausea to be related to Bexsero. Additional details were provided as follows: The age at vaccination was not reported. Limited information was provided by the sales representative from the physician.
Ended up hospitalized for vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Ended up hospitalized for vertigo) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Ended up hospitalized for vertigo) (seriousness criterion hospitalization). At the time of the report, VERTIGO (Ended up hospitalized for vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported .  Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt reported Headache, feeling of lightheadedness and dizziness  20 minutes after receiving immunization.  She was monitored for 30 minutes and symptoms improved every 5 minutes and Vital signs were normal. She did not develop any rash, swelling, itching, throat discomfort or difficulty swallowing.  No cough or dyspnea. No Nausea or vomiting.  -She was placed in exam room, supine on exam table with legs bent at knee. VS were monitored continuous pulse  and pulse ox and blood pressure every 4-5 minutes.  VS remained normal.   She drank 12 oz. water after 5-10 minutes She also had came to the clinic right after  working  a night shift and did not drink much fluid that morning.  Her symptoms appear to be a vasovagal response. She left the clinic after 30 minutes in stable condition with resolution of dizziness, light headedness and headache was mild.
woke up throwing up and passed out; husband found me lying on bathroom floor after passing out; totally NOT normal for me
The patient called to see if a prescription had been called in.  Upon finding out nothing had been called in yet, I asked if the doctors office was going to call something in that day, and she said "yes, to take care of the shingles I got after the moderna shot you gave me."  I inquired when the shingles appeared and she told me it was 1 day after the shot.  She denied any problems with the first moderna shot.  She said the blisters were on the right side of her torso and migrating to the right side of her back.  She stated that Tylenol was helping with the pain.  An rx for Valtrex came in later that day for her.
The vaccine given had a expiration of 3/18/22.  A stability report has been requested from Moderna.  The results of the stabilty study show the vaccine was active and provides adequate protection against COVID-19.  The patient reports zero adverse events with the booster.
11/17/20  tHE PATIENT SAID SHE EXPERIENCED PAIN ON THE FIRST DAY OF THE VACCINE 11/10/20. SHE SAID SHE EXPERIENCED FEVER AND REDNESS. SHE SAID ON 11/15/20 AND 11/16/20 THERE WAS REDNEDD AND WARMTH AT THE INJECTION SITE. SHE SAID THE REA IS INFLAMMED AND THE SIZE OF INFLAMMATION IS 3 INCHES BY 3 INCHES. SHE WAS GOING TO  CONTACT HER PHYSICIAN.
Administered shots, pt walked into waiting area and collapsed. About five minutes later she had a seizure, ambulance came and took her to medical center ER.
Pain & swelling at site, swelling in axilla area rash from site down to elbow.  Pain in collarbone are and chest with exertion
Headache, CoughWheeze, NauseaVomiting, short of breath Narrative:  diagnosis not known, covid test not reported  Other Relevant History:
Patient is under the age of 18.  Moderna should not have been administered.  Patient returned for Dose 2 Pfizer.
Pain in joint to shouler, scapula and ribs on same side as shot. 34 hours later fever, headache, muscle/joint aches, fatigue, stuffy nose, dizziness.
Syncopal episode, smelling salts, monitored for 15 min, 120ml water to drink.
itching of skin/Generalized itching; hypoglycemia; hypotension; generalized rash; This is a spontaneous report from a non-contactable other healthcare professional. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via an unspecified route of administration on an unspecified date as dose 2, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itching of skin/generalized itching, hypoglycemia, hypotension and generalized rash. It was reported that during the 15 minutes waiting period after the injection, the patient began to experience itching. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient complained of itching of skin. She was observed in the medical bay for approximately 15 minutes. She responded really well to the antihistamines. No further itching reported. No rash or other symptoms noted. She felt well to go home. Given handwritten instructions on medications received and when she can repeat if needed along with Benadryl use. The patient was treated with antihistamines pepcid and Zyrtec; and was discharge as she was stable to go home and follow up with PCP. The clinical outcome of all the events was resolved on unspecified dates.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Symptoms: cough and body aches. Symptoms increased to chills, rigors, difficulty breathing, and the following days. Throughout the week, she became dehydrated and symptoms increased but she did not take any medicaton. She sought medical attention 12/29 in the ER.
The patient was administered high dose of vaccine; This is a spontaneous case, initially received from pharmacist via Communications (reference number: SEQ19-04364) and initially received on 10-Oct-2019, concerning an adult female patient.  The patient's relevant medical history and concomitant medications were not provided.  On an unspecified date in 2018, the patient was administered unspecified flu vaccine [Influenza vaccine, dose reported as: 'high dose', anatomical location, route of administration, batch number and expiration date: not reported] (explicitly coded as 'Inappropriate dose of vaccine administered') for an unknown indication.   It was unknown if the patient experienced any adverse event after vaccination.  This case is linked to case 201905210 (the same patient).  Non-significant follow-up reported by Communications (reference number: SEQ19-05385) on 23-Oct-2019: Additional Communications reference number added. No changes in narrative.; Sender's Comments: Reportedly, incorrect dose administered occurred during vaccination with the suspect product unspecified flu vaccine. Chronology is plausible. It was not reported if the patient experienced any adverse event. Causal role of the suspect product is assessed as not related per company conventions.
I've had a mild tinnitus for about 5-6 years.  6-7 days after my first Pfizer shot, my tinnitus has become very bad. In the last week, twice I was awakened by it in the middle of the night and was not able to fall back to sleep because it is so loud. In the past, I never heard it during the day, but now it is very loud even in the daytime. This is very serious. Not being able to sleep and rest at night is very hard to cope during the day. I'm not sure what to do as there is no cure for this tinnitus.
Body aches; sleeplessness; Fever of 101 deg Farenheit; This spontaneous case was reported by a non-health professional and describes the occurrence of INSOMNIA (sleeplessness), PYREXIA (Fever of 101 deg Farenheit) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INSOMNIA (sleeplessness) and PYREXIA (Fever of 101 deg Farenheit). On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, INSOMNIA (sleeplessness), PYREXIA (Fever of 101 deg Farenheit) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
pt received 1st dose of moderna covid-19 vaccine on 06/04/21 and presented to pharmacy on 06/16/21 with complaints of soreness and swollen arm.  Pt stated that the symptoms started on 06/11/21. Per pt, she was seen by her doctor yesterday and he recommended a "heat patch" for the pain- which the pt had applied over injection site and refused to remove patch for observation of injection site. Pt also stated that the doctor already prescribed muscle relaxant medication and that she only presented to the pharmacy to report the adverse effect.
During observation period, patient displayed at the time syncope type symptoms (nausea, dizzy, clammy skin). Patient said she should be fine and left after 30 minutes. On 7/13/21 patient was in the store and said when she went home her heart felt racey. She said her doctor thought she may have had an allergic reaction to the moderna vaccine. Therefore I'm filing the VAERS.
Pt recvd MMR vax as a child; pt currently exhibited a lack of response to mumps; no further details were provided;
Patient had a warm red area where shot was given. She went to MD and they gave her an antibiotic.
Soreness on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the left arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on the left arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  No treatment information was provided.
had five Pfizer COVID vaccinations most recent on Sept/tested positive for COVID; had five Pfizer COVID vaccinations most recent on Sept/tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "had five Pfizer COVID vaccinations most recent on Sept/tested positive for COVID". It was reported that patient has had 5 Pfizer vaccinations and the most recent was the Bivalent in Sep2022. He tested positive for COVID on an unspecified date in Nov2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptomatic on 9/13/2021: subjective fever, cough, Pneumonia, difficulty breathing
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/5/2023 Discharge Date: 6/8/2023   Clinical Narrative:   The patient is a 58-year-old gentleman whose mother law was in a local skilled nursing facility where she was exposed to in developed COVID pneumonia.  The patient's wife was visiting her mother and did not mask.  She promptly developed COVID pneumonia and subsequently exposed this chronically immunosuppressed patient.  He developed COVID pneumonia was admitted through the emergency room with hypoxemia.  He was treated with IV Decadron given the hypoxia and received remdesivir given the symptomatic nature of his presentation, his need for hospitalization, and for the purposes of preventing progression to worsening disease or potential intensive care unit care or ventilator need.  He responded quite quickly and was stable on room air the following evening.  Remdesivir and Decadron continued.  He was significantly hyperglycemic and Decadron was subsequently decrease, somewhat.  The patient has had 4 days of remdesivir today.  Should he does meet criteria for a three-day the discharge but we were still working with better blood sugar control and electrolyte management yesterday.  He prefers to go home today rather than extending his stay through the 5th day of remdesivir therapy, again, given his candidacy for early termination of the remdesivir therapy.  Pneumonia due to COVID-19 virus Assessment & Plan   COVID-19 pneumonia with hypoxemia.  His result of the hypoxemia, Decadron 6 mg IV daily has been added.  As result the dyspnea and hypoxia, he will be treated with remdesivir per protocol.  Hope to avoid progression by so doing.   Serial CRP and D-dimers.  A perfusion lung scan was ordered.  Lower extremity venous Doppler study ordered and pending.  Will consider concurrent treatment with azithromycin and empiric coverage for community-acquired pneumonia, though suspect his hypoxia at present, is COVID related.   06/06/2023   - bilateral lower extremity venous Doppler study negative.  Nuclear medicine perfusion/pulmonary study pending this a.m.   06/07/2023   - oxygenation improved.  Off of supplemental O2.  Repeat chest x-ray quite stable.  Infiltrates have resolved.  Had considered stopping remdesivir at day 3. His CRP and D dimer however remain high.  He is fully anticoagulated at present.  Will proceed with nuclear medicine perfusion lung scan.   06/08/2023   - doing well. O2 needs at baseline for several days now and on room air. Will discuss whether to finish the Remdesivir or stop at day 3-4... risk/benefit with patient...                         - discussed with the patient.  He is doing well.  He has no shortness of breath.  He has no cough.  He is ambulating well without difficulty.  He would like to be discharged home and this should be safe at this juncture.  Impression like to limit his duration of corticosteroid exposure and the duration of remdesivir exposure given his immunosuppressed state with his renal transplant and cyclosporine.
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 14-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 17-MAY-2023, the patient started was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, and route of administration were not provided), lot #U039722, expiration date: 15-DEC-2023 (discrepancy: lot# reported also as U0397722 and this lot# is not valid for varicella virus vaccine live [oka/merck] [VARIVAX]) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
approx 6-8 hours after shot, I started having tachycardia with minimal exertion
Patient developed a sore on her arm that expanded into a possible cellulitis. She complained of itching and was seen at the ER. She was prescribed BACTRIM DS and BENADRYL.