chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got COVID; got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 42 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (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 04Feb2023, outcome "not recovered" and all described as "got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Feb2023) Negative, notes: Nasal Swab; (04Feb2023) Positive, notes: Nasal Swab; (05Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported event drug ineffective and COVID-19 cannot be ruled out.
Atrial fibrillation "AFib" - Heart Rate of 150 BPM; A spontaneous report was received from an 87-year-old male patient, who experienced Atrial fibrillation - Heart Rate of 150 BPM.  The patient's medical history included Atrial fibrillation (Afib). Relevant concomitant medication included amiodarone.  The consumer received the first of the two planned doses of mRNA-1273 on 03-FEB-2021 intramuscularly for prophylaxis of COVID-19 infection. On the same day, he experienced Atrial fibrillation - Heart Rate of 150 BPM.  No treatment information was provided.  On 04-MAR-2021, the patient received the second of the two planned doses of the mRNA-1273 in an unknown route.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event Atrial fibrillation "AFib" - Heart Rate of 150 BPM was resolved.  The report's causality assessment was not provided for the event.  Follow-up received on 05-MAR-2021 included Atrial fibrillation (Afib) as the consumer's historical condition. Consumer reported that he was in Afib for about 9 days. Doctors changed some of his medications that has helped with his condition. Consumer had his second dose of the vaccine on 04-MAR-2021 and has had no issues with AFib.; Reporter'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.
red spot on arm 2 inches below injection site. Hot to the touch, sore and somewhat hard. Appeared ~48 h after vaccination and resolved within 24h.
Upon receiving the first dose of the HPV vaccine, I fainted in the doctor's waiting room.  I fell straight backwards and hit my back/neck on a couch in the waiting room.  I have since had problems with my neck and back.
Fever flu-like symptoms Narrative:  employee states: she experienced flu-like sx which  started about 24 hours later including a low grade fever. she took ibuprofen to control sx
were overdue for dose two of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis  Previously administered products included Shingrix (1st dose received more than 6 months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this case. The reporter stated that, several patients (at least 4 last week of reporting) were overdue for dose two of Shingrix. Till the time of reporting, these patients did not receive second dose, which led to incomplete course of vaccination. No more details about these patients were available at the moment of the report. The reporter consented to follow up. This is one of the three cases, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238462:same reporter US-GLAXOSMITHKLINE-US2021238463:same reporter
After waiting 15 minutes  after administration of vaccine., the patient and mother came back to pharmacy window . The mother state the son complained of pain in his throat while walking towards their car.  I had them sit for additional 20 minutes and having some water. Child stated he felt better.  Child could breathe well . no itchiness.
Information has been received from a consumer concerning her now 4 year old son with an intolerance to gluten and a history of "GI Issues" who "when he was 15 months old" in approximately January 2006, was vaccinated with MMR II. There was no concomitant medication. "Within 48 hours after vaccination" in approximately January 2006, the patient started "losing skills" (not further specified). The patient had sought unspecified medical attention. At the time of reporting the patient was recovering from the adverse event. No further information is available. No further information is expected.
Information has been received from a pharmacist referring to a 65 or older age group female patient. The patient's concurrent condition and concomitant therapies were not provided. On 15-APR-2017, the patient was inadvertently provided an unknown dose of PREVNAR by an unknown route today. The pharmacist stated that the patient was supposed to receive PREVNAR (dose, frequency, route, lot# and expiration date were unknown), which was not provided. The pharmacist also reported that the patient had received PREVNAR previously within 2 years of the accidental administration today. Additional information has been requested.
aches; fever; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her most recent COVID-19 vaccine in a hospital. The patient experienced aches and fever on 07Jan2021 22:00. The outcome of the events was recovered in Jan2021. The reporter considered the events as non-serious. The patient received ibuprofen as treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  Information on Lot/Batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of axillary pain in a 53-year-old female patient who received SHINGRIX (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th August 2018, 1 days after receiving SHINGRIX, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain was unchanged. It was unknown if the reporter considered the axillary pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The pharmacist stated that the patient experienced tenderness and pain under the left armpit closer to the breast area. The patient described tenderness as bruise like feeling. No further details were provided by the pharmacist.
Dizziness, headache, nausea, severe body aches, was sent to the Emergency Department right away. Patient had LP and head CT which were both negative.
Vaccine dates 1/13/21, 2/9/21, 10/26/21  CHIEF COMPLAINT AMS       HISTORY OF PRESENT ILLNESS Patient is a 89 y.o. male who presents with AMS, found to COVID.    He has a medical history of BPH requiring TID self-catheterization, UTI's, hypertension, hyperlipidemia, atrial fibrillation anticoagulated on apixaban, pacemaker placement, asthma, sleep apnea on CPAP, PTSD, and history of falls.   Patient reports having hallucinations last night, seen his wife who is deceased in his room.  This was quite distressing to him.  Of note, chart review reveals he has had previous bouts of hallucinations, usually in the setting of infection, namely UTI.  In addition, he also notes subjective fevers, feeling chilled and shortness of breath.  He does not feel his shortness of breath is consistent with prior asthma exacerbations.  He has recently been treated for UTI.  His usual UTI symptoms are back pain which is not present to the degree he would expect with UTI.  He arrived to hospital via ambulance.  He lives in an assisted living facility.   In ED, labs notable for unremarkable venous blood gas, hemoglobin of 12 with an MCV of 96, platelets of 116, lymphopenia, creatinine of 1.29 with a baseline around 1.2-1.3, lactate within normal limits, troponins elevated to the 30s but flat, BNP around 2300 which is down from the 3000 range previously, urinalysis not indicative of infection, COVID testing positive and influenza testing negative.  EKG without obvious ischemic changes, unchanged from prior.  Chest x-ray without acute abnormality.  The patient was saturating well on room air and hemodynamically stable, afebrile.
Left upper arm was painful for 1-2 days. Applied ice pack to upper arm and took Acetaminophen. Symptoms were gone by Day 3.
Patient administered 2nd Moderna booster dose but did not qualify for the dose. Patient does not meet the age requirement and does not have an immunocompromising condition. No current adverse events noted at this time from the patient.
HCP had both doses of Covid vaccine and then tested positive for Covid.; HCP had both doses of Covid vaccine and then tested positive for Covid.; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Other Health Professional (HCP) reported for herself. A female patient of unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via unspecified route of administration on unspecified dates at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient had both doses of Covid vaccine and then tested positive for Covid on an unspecified date. She was wondering if there were any clinical trials going on that were studying people that tested positive after being vaccinated. The outcome of the events was unknown.  Information on the batch number/lot number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Beginning 04/06/2003 in late afternoon left deltoid became severly painful.  Over the last 2 months it has remained painful with movement but not tender to touch.  Restricts some activities of daily living, still hasn't yet sought treatment.  Using Motrin and using heat/ice.
Continue to have hives and raised pustule or Uticara on the arms almost following nerves.  It  developed to a significant level and  bruising accompanied this like swelling around 3-4 days before second injection.  Frustrating as it only now 6/2022 has begun to diminish.  People constantly talking about what caused this was of great self consciousness which was unneeded.  Additionally multiple hundreds upon thousands of dollars and unnecessary useless appointments proved purely useless.   Costly attempts by Drs who were afraid to contact you, needing four shots, and open skin sores was simply a lot.  I have dated pictures but now out of the 4th shot window?. What?s next.  Teachers were like others deemed essential and to be told that I missed the initial dates to be considered is just inequitable.  I should add many teachers are in this situation
2nd time submitting this because first submission said error; doing another report just in case. Patient got vaccine and said felt anxious then started having a seizure for 2-5 seconds pt said they had history of this prior but has been a while. I was near patient and able to slightly guide patient down but head did slightly hit floor. Patient woke up and said they were fine . Had patient stay an extra 30 minutes and gave ice pack and water and left the store after ensure they felt fine.
Two nose bleeds in two days. The first one lasted 10 minutes and there was a large coagulated chunk after 30 seconds. The second lasted one minute and was started by me merely lightly scratching the inside of my nose. I could count the number of nosebleeds I?ve had my whole life prior to getting vaccinated on one hand.
This spontaneous report was received from a nurse practitioner via company representative refers to a 2 month old male patient. On 02-APR-2013, the patient was vaccinated with a dose of ROTATEQ, (lot number J00035, expiry date was unknown and route was oral). Other suspect therapies included PENTACEL, PREVNAR 13 and HEPATITIS B VIRUS VACCINE (possibly RECOMBIVAX). On 02-APR-2013, the patient was reported to have turned pale and to have had severe diarrhea. The patient was taken to the emergency room for evaluation. The patient was not hospitalized. The patient did not get laboratory tests performed. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Got the vaccine and still got shingles/suspected vaccination failure; Shingles; Horribly painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, between 2 and 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Horribly painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine three months ago and still experienced shingles on last week. The patient stated that it was horribly painful sucks. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Night sweats; chills; This is a spontaneous report received from a contactable consumer (reporting for herself). A 89-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 23Jan2021 16:00 as single for covid-19 immunisation. The patient's medical history included diabetes, congestive heart failure and cancer from an unknown date and unknown if ongoing. The patient previously took codeine and experienced drug hypersensitivity. The patient had no covid prior vaccination. Since the vaccination, the patient not been tested for covid-19. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced night sweats and chills. Treatment was not received for events. The events were assessed as non-serious by reporter. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Pt given oral ROTATEQ vaccine inadvertently.  Pt's family notified and stated on 7/7/08 no side effects and child has been fine since vaccinations.  Mother notified IPV still needed and verbalized she would follow up.
Guillain Barre suspected Area Hospital Admitted   Admit date: 06/27/2021   Admitting Diagnosis:  Worsening generalized weakness-secondary to   possible Guillian Barré Syndrome   History of Present Illness: This is a 34-year-old female patient that presented at sells emergency department  with a medical history of recent upper respiratory infection, obesity, asthma who  stated she is short of breath.  She has generalized muscular weakness x3 days and  per mother's report, the patient was unable to get out of bed and required max  assist.  The patient had a CT of the head, influenza swab, COVID-19 swab, CBC,  CMP, magnesium level, lactic acid, venous blood gas and urinalysis.  All imaging  and diagnostic lab work were negative and within normal limits.  Due to worsening  weakness, the ED provider in hospital intubated the patient for transfer to  Hospital ICU for further evaluation and treatment.
Positive Covid Test.  recieved Paxlovid.  symptoms: very sore throat, runny nose, fever, fatigued negative at 8 days freom onset.  fatigue lasted anothe week or so.
Patient developed rash on R thigh on 11/1/2021  at  9:45 a.m.  This spread over 2 hours  to  R lower extremities, trunk, upper extremities & ears.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Initial misuse report received from a healthcare professional on 14 October 2013. The patient had received first dose of FLUZONE at one pharmacy and another dose at another pharmacy. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Pt recv vax on 11/4/98; on11/6/98 pt exp red &muscle atrophy vax site, chest pains, dizzy; progress of red line down LA, nausea, insomnia
Severe Headache 99° temp chills Body Aches. leg weakness Dizzy
Woke up at 3am with: Extreme muscle aches Severe joint aches Headache Mild nausea Fever Insomnia
Post vax, child became pale and white and unconscious for about 1 1/2 minutes, non-responsive to sound or touch. It took 45 minutes to regain normal behavior. Went to ER and admitted. Continued to have episodes that have been dx'd as seizures and he is now on phenobarbital.
no adverse event for the shingrix arm, but the pneumovax arm bled a little after the injection and an hour later, patient called and said arm swelled up and was itchy.  On day 2, patient said it's still red, but not swollen or itchy anymore
Patient received flu vaccine 11/03/2005. Telephoned 11/04 AM reporting upper left chest pain and discomfort and numbness down left arm and into fingertips. Reports symptoms have lasted "several hours".
developed blood in ejaculate (hematospermia) about 2 months after 4th vaccine. Happened again a few months after Moderna Bivalent booster (A57146B lot number)
Narrative:  Patient reported receiving the J&J COVID19 vaccine on 9/17/21. Three weeks later 10/3/21, patient was admitted to Hospital ED where they confirmed DVT of right popliteal and right posterior tibial veins.
Not Feeling great; Pain in left side of neck; No energy; Little warm; Feeling as if coming out with a flu; Pain in right arm; Drained feeling & tired; Chills; Enlarged lymph nodes on right side; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm) and FEELING COLD (Feeling as if coming out with a flu) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm), FEELING COLD (Feeling as if coming out with a flu), PAIN IN EXTREMITY (Pain in right arm), FATIGUE (Drained feeling & tired), CHILLS (Chills) and LYMPHADENOPATHY (Enlarged lymph nodes on right side). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm), FEELING COLD (Feeling as if coming out with a flu), PAIN IN EXTREMITY (Pain in right arm), FATIGUE (Drained feeling & tired), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (Enlarged lymph nodes on right side) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided by the reporter.   This case was linked to MOD-2021-228327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant follow-up containing Dose-2 details and associated events. Updated the action taken Unknown to No change
light headache; arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "light headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurt".  Additional information: It was reported that events was not that bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.