chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light headedness/headedness/still feeling light headedness; woken up through the night; wasn't feeling well; my energy levels totally just gone; I have to take irregular naps; chills started to being hot; felling really tired/fatigue was still there/still feeling tired/really fatigue; arm still sore; Second day also had body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness/headedness/still feeling light headedness), INSOMNIA (woken up through the night), MALAISE (wasn't feeling well), ASTHENIA (my energy levels totally just gone) and IRREGULAR SLEEP PHASE (I have to take irregular naps) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DIZZINESS (light headedness/headedness/still feeling light headedness), INSOMNIA (woken up through the night), MALAISE (wasn't feeling well), ASTHENIA (my energy levels totally just gone), IRREGULAR SLEEP PHASE (I have to take irregular naps), FEELING HOT (chills started to being hot), FATIGUE (felling really tired/fatigue was still there/still feeling tired/really fatigue), VACCINATION SITE PAIN (arm still sore), MYALGIA (Second day also had body ache) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. In November 2021, FEELING HOT (chills started to being hot) and CHILLS (Chills) had resolved. At the time of the report, DIZZINESS (light headedness/headedness/still feeling light headedness) and FATIGUE (felling really tired/fatigue was still there/still feeling tired/really fatigue) had not resolved and INSOMNIA (woken up through the night), MALAISE (wasn't feeling well), ASTHENIA (my energy levels totally just gone), IRREGULAR SLEEP PHASE (I have to take irregular naps), VACCINATION SITE PAIN (arm still sore) and MYALGIA (Second day also had body ache) outcome was unknown.            No Concomitant Medications details were provided.  It was reported the caller was on his 60s, maybe the year was 1958 and the month was march.   This case was linked to MOD-2021-400044, MOD-2021-400048 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Significant follow up appended( batch No updated)
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown. It was unknown if the reporter considered the fever and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced fever and a headache. No additional information was provided. The pharmacist left the chat without providing adverse event details.
Patient did not actually have any adverse events.  However, this patient received the "21st" dose from a 14dose Moderna vial.  Our tally marks on our bottle were one off, so we unintentionally punctured the vial 21 times, and this patient received that 21st dose.  She did not have any adverse events reported to us.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 16-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, dosage and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
hives; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3RN95, expiry date 6th December 2021) for prophylaxis.   On 10th December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2019, less than a week after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional case details were reported as follows: The patient developed hives sometime after vaccination with Shingrix. The patient did visit her doctor as a result of the hives. Caller did not have any further details regarding the event.
Patient was given 0.5ml of flu vaccine. Wronf dose-over dosage.
This week I got COVID; This week I got 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 male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 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), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "recovering" and all described as "This week I got COVID". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional Information: Patient took 2 Pfizer COVID vaccine shots in Feb2021 then 2 boosters later. Patient was taking Paxlovid and doing better.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt says she has joint pain, body aches and pain.   She says her entire body has a itching sensation like her skin is crawling.  Pt will contact her PCP for medical advice.
tremors have gotten very much worse; To the point of not being able to feed himself; Difficulty with walking (now needs the aid of a walker).; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in right arm on 21Mar2021 13:30 (at the age of 69-years-old) as single dose for COVID-19 immunization. Medical history included Parkinson's with mild to moderate tremors (ongoing) and diabetes. Concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) dose 1 via an unspecified route of administration, administered in right arm on 28Feb2021 02:00PM (at the age of 69-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed for COVID-19 prior vaccination. On 22Mar2021 at 04:00 PM, within 12 hrs of receiving his 2nd dose of the Pfizer vaccine his tremors have gotten very much worse, to the point of not being able to feed himself and difficulty with walking (now needs the aid of a walker). No treatment was received for the reported events. The patient had not tested for COVID-19 since vaccination. The outcome of the events was reported as not recovered.
Pt yelled loudly upon cleaning of area for vaccine before needle went in; then after complained of burning, big lump in throat, heaving but no vomit, anxiety,  was laid on ground (911 called) and given epinephrine injection then complained of right side chest pai n, numbness in both hands, extreme anxiety.  wanted to refuse paramedic treatment but eventually went to hospital.  Pt called later to thank staff and said was feeling better but continuing right side pain after having been given benadryl and steroid in hospital.
Discharge Provider: DO Primary Care Physician at Discharge: MD   Admission Date: 11/18/2022 COVID positive Date 11/18/2022 Date of Death: 11/23/22 Time of Death: 11:21 AM PRESENTING PROBLEM: Acute respiratory failure with hypoxia  [J96.01] Multifocal pneumonia [J18.9] Acute on chronic congestive heart failure, unspecified heart failure type [I50.9]   HOSPITAL COURSE: Patient is an 82 y/o male with CAD, chronic systolic and diastolic CHF and stage IV CKD who presented with syncope.  It was unclear on presentation whether this was due to cardiac vs. neurologic cause. Work-up revealed bilateral CVAs as well as acute CHF with elevated troponin. He was noted to be COVID positive, but family reported that he had symptoms and positive test 2 weeks prior.  Neurology and cardiology were consulted, echo was ordered, lasix was started. Echo showed new EF reduction. Neurology started apixaban and stopped ASA as well as plavix. He was started on IV Lasix, and doses were increased due to poor response. With increasing dose of Lasix, he continued to have low urine output and developed acute kidney injury with hyperphosphatemia, increased edema and hypoxia.  By 11/22, he was essentially anuric. Nephro was consulted and felt dialysis could be considered should his renal function continue to worsen and volume status not improve with diuresis.  This was discussed with patient and family, and patient was clear that he did not wish to proceed with dialysis.  He underwent right heart cath on 11/22, which showed elevated PCWP and borderline low cardiac index, for which continued diuresis/fluid removal was recommended.  He had continued worsening of his respiratory status in the early morning of 11/23, requiring high flow nasal cannula.  After further discussions with family, decision was made to proceed with comfort care.  Hospice was consulted, and comfort measures were instituted with prn Ativan and Fentanyl drip.  He expired on 11/23/22 at 11:21 AM.
Severe pain in right arm, can't lift it due to pain. Hard to sleep. 24 hrs later getting better but still hurst alot. I can lift arm about half way today. Very tired and lethargic.
This is a spontaneous report from a contactable physician via Pfizer sales Representative. This physician reported same event for two patients. This is the first of two reports. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date for immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced vomiting on an unspecified date. Event outcome was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017362248 same reporter/drug/event, different patient.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. The reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional reported that at least one other patient experienced soreness after receiving the SHINGRIX. The health care professional did not know number of patients, product and patient information, they were unavailable at the time of the report. This case has been linked to the case US2018059361 and US2018059365 reported by the same reporter.
Chills, muscle aches, diarrhea, fatigue,headache, joint pain, congestion, sneezing. Flu like symptoms.
The arm where I was vaccinated was totally paralyzed for an entire week.  It felt a little better the fourth day but I could not even raise my arm. I had to sleep into my shirt.  It was extremely painful.  I was unable to drive cook or hold anything with that arm.   I had our son come and spend time with me since I was alone.  I also had to take pain killer to survive.  I wasted a week plus sleeping was difficult because every time I turned around on my arm I would awake.  I was unprepared for such pain and frankly furious of getting such reaction. I deserve compensation. Thanks
Irregular heartbeat, speed of heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat, speed of heartbeat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat, speed of heartbeat). The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of 5 mg twice a day and METOPROLOL at a dose of 25 mg. At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat, speed of heartbeat) outcome was unknown.            Concomitant medications were not reported .
Fever ranging from 99.8 to 100.8. Vomited 4 times in a 24 hour time period.
Red, swollen patch around injection site. Itchy   Now one and a half weeks since its start which was 7 days after the shot
The day after the injection, I woke up will all of the common complaints along with pain in the soles of my feet. I also experienced it the second time as well. The 5th day, I had chest tightness and developed a bad cough, which resulted in full asthma flair. I then had to seek care. I was tested for COVID and the flu, both negative. It took about 3 weeks to settle down, which is normal for me.
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with the dose GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I started getting congested and a low-grade fever; the fever felt more achy and lethargic more than feeling cold. A couple of days later, I developed a small cough and congestion with a headache that only lasted for a day or so. I took an at-home COVID-19 on 01/28/2023 which came back positive. I went to urgent care as recommended by my physician to get it confirmed; I went to urgent care on 01/30/2023 where they tested with a rapid test and confirmed I was positive for COVID-19. The physician prescribed me Paxlovid and rest for treatment. By day 8, I tested negative and again 48 hours later. As of today, I feel much better and well now.
Bad runny noses/constant blowing the nose; Sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose number unknown (bivalent; booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer, Had little to no side effects), for COVID-19 immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 28Sep2022, outcome "not recovered", described as "Bad runny noses/constant blowing the nose"; SNEEZING (non-serious) with onset 28Sep2022, outcome "not recovered".  Additional information: Called about the most newest booster Pfizer COVID vaccine and he and his wife both got the shot a little less than two days ago within 24 hours with him worse than his wife, they had a bad runny nose and sneezing and he happens to be the worst and today is no better or maybe slightly better than yesterday. Had no fever or anything like that but it was constant blowing the nose and sneezing and was wondering if that was one of the symptoms to be expected and how long it will last; did not experience this when they got the original shots and had little to no side effects from those and this was the result of the shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197573 Same reporter/vaccine/event, different patients;
Vaccine exposure via breast milk; Rash all over the neck; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk), NASAL CONGESTION (Congestion) and RASH (Rash all over the neck) in a 29-day-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): No medical history was reported.     On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced NASAL CONGESTION (Congestion). On 10-Mar-2021, the patient experienced RASH (Rash all over the neck). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk), NASAL CONGESTION (Congestion) and RASH (Rash all over the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Breastfeeding mom called on behalf of her son. She reported that she received her first dose Moderna Vaccine on 19 Feb 2021.On 5March 2021 her baby developed congestion. On 10 March the baby developed rashes all over his neck. No treatment taken so far
By Tuesday (03/30/21) evening, I felt ill. I had a mild headache, felt nauseous and a low grade fever. On Wednesday (03/31/21) , my headache became worse, nausea increased and my low grade temp had also gone up. It was still low grade, but it was higher than my normal body temp and higher than the night before. Thursday (04/01/2021), I had not been eating breakfast and I decided that I needed to bring in morning calories. After 30 minutes of drinking a shake, my throat started to close up and I was losing my voice. My throat felt very tight and it was scratchy. My husband came and picked me up, and took me to urgent care, who turned me away to go to the ER. I went to the ER and I was told that I was having an anaphylactic shock and I was given a shot of something and was given an EpiPen. I was told to follow up with an allergist. I followed up with an allergist, who tested me to make sure I hadn't developed a tree nut allergy. I have not developed a tree nut allergy. In my follow up with the allergist, she told me that she suspects that this is indirectly from the vaccine. I do not have an allergy to almond milk. Even since my episode, I have had other types of nuts and have not had any reaction. Overall, I was allergic to the shot, but the vaccine caused an allergic reaction to occur.
felt feverish and illx2 dys immed after vaccine then morbilliform rash (B) forelegs and forearms (none on face or trunk)
Muscle pain, headache, fever 101 degrees, nausea, tired, pain in arm at injection site.  Onset next day following the vaccine.  Mostly resolved after 3 days (i.e. today Monday, following Friday afternoon shot).
Started with a fever that got up to 101.7, chronic coughing, then body aches the following day and then hives and welts (all over the body) days after the vaccination.
the patient, who is taking ENBREL (Etanercept), was vaccinated with M-M-R II; no adverse symptoms reported; Information has been received from a physician assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient, who was taking etanercept (ENBREL), was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot# and expiration date unknown) for prophylaxis (product use issue). No adverse symptoms were reported.
fever; having allergic reaction; having stuffy, congestion; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 19-Feb-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 PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 19-Feb-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 PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.