chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; excruciating headache; runny nose; congestion; shortness of breath when she started talking; having aches and pains; lightheaded, experienced dizziness; tied; This is a spontaneous report from a contactable consumer(patient).  The 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, intramuscular injection ), intramuscularly in left arm on 23Dec2020 at single dose for COVID-19 vaccination in nursing home. Medical history included she had a right knee injury so she had some inflammation, She had stomach issues in the past- Barrett's syndrome, H. pylori(Helicobacter infection), GERD(Gastrooesophageal reflux disease), so, Pantoprazole is just a maintenance medicine, she was stable right now. She had a Vitamin D deficiency at one point.  Ongoing concomitant medication included meloxicam for inflammation, thyroid for thyroid(Thyroid disorder), pantoprazole for stomach issues, colecalciferol (VITAMIN D 3) for supplementation therapy. There was no vaccination within 4 weeks. She received her first vaccine on 23Dec2020. There no other vaccine received in the same day. By 26Dec2020, she started with symptoms and then she tested positive for COVID-19 on 29Dec2020. She felt horrible with an excruciating headache and was wondering if she was going to die now. She can really feel for the residents she works with who get it. Right now, she was hopefully going back to work next week, but she was wondering about the second vaccine. People are saying she got COVID-19 because of receiving the first vaccine and she was hoping it was not the case. Is it going to be an issue getting the second vaccine after testing positive? The caller declines to include her healthcare professional for this report, stating she has been talking with her doctors over the week. Her symptoms included runny nose, congestion, and what seemed like shortness of breath when she started talking. She started having aches and pains over the weekend. By Monday, 28Dec2020, there was loss of taste and smell, it was totally gone. She also was lightheaded, experienced dizziness, was tied. She went through a lot of symptoms which was shocking to her. She clarified these symptoms first began the morning of the 26Dec2020. Christmas she was fine, and then she to go out to get snow off of her car and do some running around on 26Dec2020 and she noticed she started having symptoms. When probed for outcome, the caller state she was most definitely feeling better. She was having some excruciating headaches and she has worked with her doctor on what they needed to do. She is still working with the doctor on her lightheadedness. She has set up a follow-up appointment, but she was feeling better. There was no emergency room nor physician office. Relevant test was none. It was also reported lot number was either EJ1685 or EJ1085, she can't tell. Outcome of loss of taste and smell was recovered, of dizziness was not recovered, of other events was recovering.
Narrative: Erythema Multiform inj red, warm, itchy, firm to touch. Inj red, warm, itchy, firm to touch; 5-6cm diameter area on left deltoid
flu like for two days but then 5-7 days later, I broke out in a rash & hives that went all over my body. The hives burned like fire
Numbness and tingling starting in left wrist and arm on Sunday, spread to left knee and left side of face.
First symptom was mild headache. That evening I had a cough, clear nasal discharge, muscle aches. In the morning the headache and cough were worse. I had a home test, and it came back positive. I was able to check my oxygen and it was still at 96. I had a telemedicine appointment with my doctor.
Arthralgia LEFT AXILLAE LYMPHADENOPATHY, FATIGUE Narrative:
Increased and erratic heart rate.  Sometimes even when I'm at rest it can go up to as high as 120. When I'm doing anything strenuous (exercise, climbing stairs, brisk walking), it goes up to 140.  My blood pressure does not seem to have been affected. I started taking OTC Magnesium and saw my PCP.  She sent me to a Cardiologist, and I have that appointment scheduled but it has not happened yet.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004091: US-009507513-1702USA004090: US-009507513-1701USA014195: US-009507513-1702USA004089.
Same dizzy feeling, but not as bad as the 1st one; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Same dizzy feeling, but not as bad as the 1st one) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M21A) for COVID-19 vaccination.     The patient's past medical history included Cessation of smoking (couple years ago). Concurrent medical conditions included Drug allergy (Allergy to amoxicillin 12 months ago). Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Same dizzy feeling, but not as bad as the 1st one). The patient was treated with IBUPROFEN for Dizzy, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Same dizzy feeling, but not as bad as the 1st one) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient asked whether dizziness was one of an allergic reactions because the patient had allergy to amoxicillin 12 months ago, which she never had before and was wondering if the allergy caused hypersensitivity to the vaccine.   This case was linked to MOD-2022-452546, MOD-2022-452562 (Patient Link).
Information has been received from a pharmacy technician concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored unspecified doses of with (Oka/Merck) VARIVAX (lot number L018001 with an expiration date of 19-MAY-2017) (strength, dosage schedule, route and anatomical location were not reported). It was also reported that other multiple unspecified patients were vaccinated with ZOSTAVAX (Captured in MARRS# 1610USA004091). No other suspect and concomitant medications were provided. There was no adverse effect reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
pt recvd vax & 11 days p/dose 2 exp elevated liver function tests & abdo pain;
Swelling, redness, itching R arm x2 days.  Multiple bumps from shoulder to wrist L arm - mom used oral and topical Benadryl.  No fever.
Dizzy; Fever 101 degrees Fahrenheit; Nausea; Body aches; Seizure; Symptoms like the flu; Felt like she was going to faint; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Symptoms like the flu), DIZZINESS (Dizzy), PYREXIA (Fever 101 degrees Fahrenheit), NAUSEA (Nausea) and MYALGIA (Body aches). On an unknown date, the patient experienced PRESYNCOPE (Felt like she was going to faint). At the time of the report, SEIZURE (Seizure), INFLUENZA LIKE ILLNESS (Symptoms like the flu), PRESYNCOPE (Felt like she was going to faint), DIZZINESS (Dizzy), PYREXIA (Fever 101 degrees Fahrenheit), NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-054366 (E2B Linked Report). This case was linked to MOD-2021-077998, MOD-2021-077998 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-054366:
broken out in hives on his arm below the injection site; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982; expiry date: not known), via an unspecified route of administration in the left arm  on 14Jan2021 11:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. No history of previous immunization with the vaccine. On Friday morning (15Jan2021), he noticed he broken out in hives on his arm below the injection site; he had been putting some Benadryl cream on it. He stated that he still had 2 red marks on his arm, but the swelling had gone down. The patient did not require emergency room or physician office visit. The outcome of the event was recovering.
Hives, body rash , still comes and goes after Prednisone treatment . Pt has an allergist appointment on 6/17/2021.
After administering the last vaccine, which was HPV, the patient had fixed vision, turned his eyes, turned an ash color, began to hyperventilate until he stopped breathing and convulsed. When he finished convulsing, ventilation was given with an Ambu, he began to breathe slowly on his own, he begins to regain consciousness, and he begins to scream. He was disoriented in time, space or place. Patient continued to regain consciousness and stability. The ambulance was called to take him to the emergency room to stabilize him better. R / O syncope, vasovagal
exposed to lowest temperature 32.1-33.4 F to highest temperature 35.2 F for 14 days in total from 28Dec2021 to 10Jan2022 and has been administered to patient with no reported adverse event; Initial information was received on 22-Feb-2022 regarding an unsolicited non-valid non-serious case received from other health professional via call center.  This case involves an 8years old male patient who received a dose of vaccine which was exposed to lowest temperature 32.1-33.4 F to highest temperature 35.2 F for 14 days in total from 28-Dec-2021 to 10-Jan-2022 and had received post excursive vaccine with no reported adverse event while receiving Poliomyelitis vaccine (inactivated) (Ipol).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Jan-2022, the patient received a dose of suspect Poliomyelitis vaccine (inactivated) (Lot: T1D482M, expiration: 25-Jul-2022; Lot: U1A452M, expiration: 20-Feb-2023) (formulation, strength, dose: unknown) for prophylactic vaccination.  On 11-Jan-2022, the patient received a dose of vaccine which was exposed to lowest temperature 32.1-33.4 F to highest temperature 35.2 F for 14 days in total from 28-Dec-2021 to 10-Jan-2022 and had received post excursive vaccine with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of Poliomyelitis vaccine (inactivated).  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event (product temperature excursion issue).  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  Additional information was received on 22-Feb-2022: Case was updated from non-valid to Valid with no AE, patient's details were added, event verbatim was updated and narrative was amended accordingly.
Information has been received from a physician via Pfizer referring to a patient of unknown age and gender who was immunocompromised. Concomitant medication was not reported. On an unknown date the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot # and expiration date were unknown). It was reported that the patient had no reaction to the first dose. Subsequently on an unknown date the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) manufacturer unknown) (dose, route, lot# and expiration date were unknown). On an unknown date the patient experienced severe localized allergic reaction (non anaphylactic). Outcome of the event was unknown. The reporter considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 09:53 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023219 and expiration date on 03-MAR-2022 at a dose of 0.5 mL intramuscularly (IM) on the right tight (RT) and with an improperly stored dose of diphtheria toxoid, and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # J947T for prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008889: US-009507513-2008USA008883: US-009507513-2008USA008884: US-009507513-2008USA008882: US-009507513-2003USA002275: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008875: US-009507513-2008USA008890: US-009507513-2008USA008877: US-009507513-2008USA008903: US-009507513-2008USA008913: US-009507513-2008USA008912: US-009507513-2008USA008931: US-009507513-2008USA008930: US-009507513-2008USA008901: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008929: US-009507513-2008USA008928: US-009507513-2008USA008898: US-009507513-2008USA008927: US-009507513-2008USA008925: US-009507513-2008USA008896: US-009507513-2008USA008923: US-009507513-2008USA008911: US-009507513-2008USA008910: US-009507513-2008USA008922: US-009507513-2008USA008922: US-009507513-2008USA008887: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008906: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008907: US-009507513-2008USA008909: US-009507513-2008USA008890: US-009507513-2008USA008932: US-009507513-2008USA008920: US-009507513-2008USA008904: US-009507513-2008USA008904: US-009507513-2008USA008886:
Chills, fever, achey, migraine type headache, nausea, dehydration
Severe arm pain, fever, body aches, nausea, hallucinogenic dreams, thirst, inability to sleep
A total of 8 pts had local reactions following immunization; 6 of these 8 pts exp inject site reactions which included erythema, hot to touch, pain & swelling w/in 15 mins of immunization; dx allergic topical reaction;
Pain Lt arm (site), fever 102 degrees F, headache, neck stiffness, nausea.
rash all over her body; right axillary lymph node was swollen; shingles outbreak; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Right on 02Aug2021 (at the age of 32-year-old) as dose 1, single for covid-19 immunisation. Medical history included Shingles (Caller said this was diagnosed 5-6 years ago, maybe longer). The concomitant medications of the patient were not reported. Caller stated she broke out into a rash all over her body and her right axillary lymph node got swollen which started on 04Aug2021. She said her rash had gotten a whole lot better, she worked for an Infectious Disease doctor who prescribed her a Medrol pack, dose unknown. Caller stated the Medrol pack was like a Z-pak where one takes it for 6 days and the 6th day you take 6 pills, on the 5th day you take 5 pills, and so on. She said she was not sure about the milligrams. Caller stated she got shingles, so she also had a shingles outbreak, which it was better, and her lymph node swelling got better. The outcome of all events was recovering.   Follow-up attempts are completed. No further information is expected.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 22-months old patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT, lot UJ088AB in the left thigh on 12-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose. It was unknown if 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient developed chest pain and shortness of breath 55 days after smallpox vaccination ( revaccinee).  Hospitalized.  Patient had abnormal EKG and normal cardiac enzymes.  Echocardiogram showed akinetic inferior septum and inferior wall, LVEF =40-45%.  Cardiac cath showed normal cardiac enzymes and left ventriculogram showed LVEF =42%.  Diagnoses with mild cardiomyopathy
- 2PM feeling "off?, strange sensations in both arms, and face and right thigh. Later progressed to painful left arm (non-injection arm) and cramping of R arm and R neck. - 8P/9P while driving home symptoms began to become severe. Symptoms, severe and deteriorating, included though are not limited to: - Slow thinking and confusion approximately 5 miles from home, causing dangerous driving - Electrical sensation/pin pricks/?bursts? across the face - Tingling across the face, including the lips and tongue  - Facial fullness and swelling, throat fullness and swelling, slurred speech due to swollen tongue - Flushing in the face - Difficulty breathing - Overall tenseness  - Overall weakness - Delayed speech, and at times, inability to respond to questions - Loss of ability to speak and formulate clear thoughts  - Inability to walk due to weakness and shaking - Involuntary muscle movement (jerking of the muscles in a 2-4 second rhythmic pattern that lasted 3-4 hours) - Double vision in the right eye followed by blurred vision (with corrective contact lenses, RX unchanged for 2years) - Headache - Clamminess - Increased heart rate up to 85 from typical 50, and increased blood pressure while laying down at 30 degrees - Tearfulness, crying  - R arm soreness 9/9/21 Severe and deteriorating symptoms continued. Severe and deteriorating symptoms included, though are not limited to: - Exhaustion (slept most of the day) - Worsening headache, ongoing, constant - Migraine (800mg Ibuprofen, followed by Sumatriptan 100mg two hours later, and a second dose, never needed in the past, of Sumatriptan 100mg two hours after the first dose, resulted in a continued low-grade headache throughout the day) - Continued confusion - Continued delayed processing and response - Overall weakness - Plugged up ears (both at times, one or the other at other times) - Period came one day early, and with unusual heavy blood flow such that there was bleeding through the pad, through clothing, the bedding and into the mattress protector.  - Continued swelling and internal pressure to the face, lips, mouth, and tongue - Inability to read at any distance with the R eye given blurred vision, inability to drive given blurred vision despite regular use of corrective lenses. - Nausea  - Right arm soreness  Continued symptoms include though are not limited to: - Vision changes both near and far sight, both eyes affected. Vision ?filmy?, ?blurred?. Each eye sees something different. Regular corrective lenses no longer effective.  - Headache beyond normal occurrence and normal severity - Migraine beyond normal occurrence and normal severity (I have never lost work time for headaches nor migraines) - Nausea - Feeling ?off?, ?cloudy?, ?slow? - Confusion - Sensitivity to light - Exhaustion - Continued pressure and fullness in the head/neck beyond that normally experienced - Stomach pain
Patient originally registered for Johnson & Johnson vaccine but at the clinic site, she received Pfizer vaccine by accident. Patient was made aware and informed she had to return for a second dose after 21 days.