chrisvoncsefalvay/vaers-outcomes huggingface dataset:
is not feeling well; feeling quite ill today; fever; chills; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Not Provided, Expiry Date: not Provided), dose 2 via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, patient was not feeling well, feeling quite ill today, reported fever, chills and headache after second dose of the vaccine. Reporter mentioned that patient wanted to know if Tylenol or Motrin can be taken as she read conflicting information, that it was not advisable to take pain relivers such as Motrin or Tylenol. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
After the vaccine, I had a slight sore arm that lasted for one day. I started feeling symptoms on 10/13/2022 of a sore throat and headache. On 10/14/2022 I took a home test for COVID-19 and it was positive. I contacted my doctor's office, and they have a COVID-19 team that I talked to about my symptoms and the positive test. They sent in a prescription for PAXLOVID. I tested negative on 10/19/2022.
started feeling sick; This is a spontaneous report from a contactable consumer (patient who is retired teacher). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL9264, expiration date unknown) 2nd dose, via an unspecified route of administration on 04Feb2021, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number EL3246, expiration date unknown), via an unspecified route of administration on 14Jan2021, as single dose for COVID-19 immunization. The worst part was she thinks she has a UTI and it makes her feel sick. She was so mixed up with days. She had the vaccine on Thursday. She started feeling sick on Sunday, 07Feb2021. She has an appointment to see the doctor in the morning. She was starting to feel sick like she has a urinary tract infection. She doesn't think the Estring was working. She doesn't have lubrication that she normally would. She think she has a defective one. She has and appointment with her doctor tomorrow morning. She had COVID19 Vaccine on Thursday. She started feeling sick on Sunday, 07Feb2021. The outcome of the events was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  Pharmacist reported administration of expired vaccine were given as booster shot to patients around 490 to 500 people on the date last 20-Oct-2021 to 29-Nov-2021.  The vaccines were stored in freezer, they take out one or two vials and place it in fridge each day as needed.  No treatment given on the patient.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 09-JUN-2015 to 07-JUL-2015, the patients received RECOMBIVAX HB (lot # K0214444 and expiry date of 17-SEP-2016) (unknown strength, route and dose), which was improperly exposed to 10.9 degrees centigrade for 494 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Lump felt in arm pit days after receiving first dose; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0182) via an unspecified route of administration in the left arm on 21May2021 at 16:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient experienced lump felt in arm pit days after receiving first dose. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lump felt in arm pit was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient received Moderna vaccine on 3/16.  Developed myalgias prompting hospitalization at Hospital 3/18-3/24.  He was subsequently transferred to ER for management of anemia/bleeding and found to have Factor VIII inhibitor.  It is not clear if the Moderna vaccine was associated with the Factor VIII inhibitor, but given the possibility, we are filing the VAER.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042BA1A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.         No concomitant medications provided. Treatment information was not provided.
No adverse reactions were reported; inadvertently received PROQUAD. and VARIVAX instead of M-M-R II and VARIVAX; inadvertently received PROQUAD. and VARIVAX instead of M-M-R II and VARIVAX; inadvertently received PROQUAD. and VARIVAX; Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. Concomitant medication included sterile diluent (lot numbers and expiration dates were not known)  On25-JUN-2019, the patient received Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number, expiration date, dose/frequency, route were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX), (lot number, expiration date, dose/frequency, route were not reported) for prophylaxis (Inappropriate schedule of vaccine administered and overdose). Nurse reported the patient was inadvertently received Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX)due to product confusion(Wrong vaccine administered). No adverse reactions were reported.
This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient was allergic to corn. On 07-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 dose 1, intramuscular in the right arm. Other suspect therapies included MENACTRA (dose, route and frequency were not reported) which was administered on 07-JUL-2016. On an unknown date in July 2016 (reported as after 07-JUL-2016) the patient experienced localized reaction to the vaccination that involved his entire right arm. The primary reporter states the mother did not bring her son back to the office, so the primary reporter never saw the right arm reaction. The primary reporter stated the patient does have a history of an unspecified allergic reaction to corn. It was reported that the patient did not sought medical attention and did not receive any treatment for the event. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Got shot / then got a second batch of shingles just not as bad/Suspected vaccination failure; got a second batch of shingles just not as bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingles vaccine year later and then got a second batch of shingles just not as bad. The patient stated that he wished they would stop making it sound false, like if you get the shot you would not get shingles.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR106601, reported by same reporter.
Nerve damage  Pain at time of injection  by nurse.  Currently experiencing pain and phantom shot replication.
Narrative: 52yo male pt was found down through his window in his apartment by office manager of the apartments who called police. Police arrived and called EMS. Pt was taken to hospital. Pt was diabetic and believed to have seized related to his diabetes. Also, pt tested positive for cocaine. Pt was admitted to hospital on 3/2/22 for medical complications (DKA) and placed in ICU. On 3/3/2022 pt was in ICU on a ventilator, on insulin drip, & received dialysis, also diagnosed with pneumonia (no mention of covid infection). Pt died on 3/8/ 2022 in hospital. Pt had received a covid vaccine on 6/29/2021 (JnJ). Likely this death is not related to the vaccine given pt in ICU with DKA & other medical complications.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Additional Details: flucelvax and pfizer were given on the same day 12-16-2021
Hives on one side of her stomach; Itchy; The injection site was a red rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on one side of her stomach), PRURITUS (Itchy) and INJECTION SITE RASH (The injection site was a red rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A.) for COVID-19 vaccination.     No medical history reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PRURITUS (Itchy) and INJECTION SITE RASH (The injection site was a red rash). On 22-Feb-2021, the patient experienced URTICARIA (Hives on one side of her stomach). On 18-Feb-2021, PRURITUS (Itchy) and INJECTION SITE RASH (The injection site was a red rash) had resolved. At the time of the report, URTICARIA (Hives on one side of her stomach) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Within 10 seconds of receiving the shot, I was nauseous.  Within 20 seconds very nauseous and dizzy.  Passed out.  Woke up on pharmacy floor.  Do not know how long I was out.  Continued to be nauseous and sweaty for 10 minutes.  Had someone drive me home, nauseous and dizzy for 2 hours at home.  Headache, body aches and sweaty all night.  Nausea to a lesser degree with headache and body aches for another 24 hours.  Feel still slightly off/slight nausea currently which is 6th day after vaccine.
No Wheal on first or 2nd Intradermal administration. Full Dose given Subcutaneously.
Patient contacted our office  on 2/25/2020 to report left arm pain from receiving Pneumovax 23 vaccine on 2/20/2020.  She wanted to make us aware that she went to the emergency room for the pain.  Emergency room records were obtained.  Patient went to Hospital on 2/24/2020 with c/o achy pain in the left deltoid muscle x 3 days.  The pain was constant and exacerbated with movement, radiating to the left neck and chest. She denied any other symptoms. Patient was given prescriptions for Flexeril 10 mg, Norco 325mg-5mg, and Lidoderm 5% patches.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Additional Details: Patient fell over in chair after given vaccine.  Another customer found patient and called for pharmacy staff.  Needed 2 pharmacist to help pick up patient.  Patient was lethargic, labored breathing and was not able to sit upright in chair.  Patient was nauseated and threw up in trash can.  911 was called and patient denied treatment from them.  Patient eventually recovered and walked out of store on own.  Also had front store type up incident report
Patient received his 2nd dose of the Pfizer vaccine at on Monday, February 15. That evening, he experienced visual disturbances with slightly blurred vision. Not thinking anything of it at the time, the vision cleared, and he continued about their evening/week without telling anyone of his visual disturbances. On Sunday, February 21, he experienced additional visual disturbances including double vision and dizziness, and we had him visit a local ER for evaluation. He was discharged with a diagnosis of dehydration and vertigo. No scans were performed. The visual disturbances cleared up the following week and the only persistent symptom was a slight dizziness. An eye exam was performed on Friday, February 26 with no problems found. An MRI was performed on March 3, and he was diagnosed with the below conditions.   Impression (3/3/2021) 1. Small acute to subacute infarcts in the left splenium of the corpus callosum and parasagittal left occipital lobe. 2. Trace subarachnoid hemorrhage in the parasagittal left parietal lobe. 3. Mild chronic microvascular ischemic disease.  He was admitted to the hospital and remained there until Saturday, March 6. Follow-up scans and testing were performed with no underlying reason for the stroke being determined. Prior to the stroke, he had been a very active individual with osteoarthritis as is only health complaint. He was not on any prescription medication prior to the stroke. While in the hospital, the tests for high blood pressure, high cholesterol (LDL 92 MG/DL), sugar inadequacies (glucose 93 mg/dl, A1C 5.7%), etc. came back without major concerns. His follow-up CT scans also did not reveal the stroke shown on the MRI. No inquiry was made by any of his doctors or hospital staff as to his COVID vaccination status/dates to even consider the connection. Below are the results of the last CT scans:  Impression (3/4/2021) 1. Age-related volume loss and white matter disease similar to prior exams. 2. Small infarct seen on MRI are not well seen on CT. 3. No acute intracranial abnormality demonstrated on the CT scan.  Impression (3/5/2021) 1. No evidence of acute infarct or intracranial hemorrhage. No significant change. 2. Periventricular white matter disease is likely secondary to chronic small vessel ischemic changes.
ANGINA, UNSPECIFIED ACUTE ST ELEVATION MI, ANTERIOR WALL 3/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I got Johnson & Johnson ?Janssen? on May 3. For reference, I have moderate to severe ME/CFS and vestibular migraine. I had COVID in December, was bedridden for two months, and almost recovered to baseline before the jab. Here?s my V timeline:  Day 1: May 3   Several mins after J&J: Huge hot flash and vertigo spin that went away immediately   30 mins after: Felt drunk  Rest of evening: Extra sleepy  Day 2-3:  Extra dizziness and fatigue, mostly in bed. Definitely felt like I was fighting something.  Day 4: Vertigo attack.  Days 5-11: Felt better than I had since before having COVID! Less dizziness, more energy. My post-Covid symptoms such as orthostasis had greatly improved.? My resting heart rate was sometimes in the 70s!?  Day 12: ADVERSE EVENT: I felt like I got COVID all over again, but less severe. Nevertheless, my feeling of breathlessness was enough to send me to urgent care. I also had chest pain/heaviness, extra dizziness, and increased heart rate (117 resting). EKG at urgent care showed abnormalities similar to EKG I had in December when I first had Covid. So, I ended up in the emergency room. No clot or heart blockage. Doctor seemed to think either I was having a delayed reaction to the vaccine, or this was somehow Covid related.???  Day 13: Woke up feeling better until I had breakfast and had to poop. After doing that, I got so exhausted I landed back in bed all afternoon. This was another problem I had during Covid.? At least my resting heart rate was more normal, 98.  Day 14: ??Vertigo kicks in on top of everything else. Xanax is the only thing that helps my vertigo so I took that and was in bed all day.  Day 15: Didn?t sleep well but a little better.  Day 16: Chest pain and breathlessness are worse again. They got worse after I took a shower upon waking up.???  Day 51 (Today, 6/22/21): Chest pain and breathlessness are much better. Still have extra dizziness. Resting heart rate is usually between 88-100 now. Orthostasis has improved but not gone.
Pt states she woke up the morning after her injection aching all over, hurting to stand upright, and was very fatigued. 2 days later she noticed a slight rash to her left upper arm that looked like "where someone had grabbed her arm in a forceful manner". Over the next few days the reddened area became worse and reported it to us by coming by our clinic on 06/14/13 at 11:10 am.
Runny nose; Fever 101°F; Can hardly move; Body aches and pain; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), RHINORRHOEA (Runny nose), PAIN (Body aches and pain), PYREXIA (Fever 101°F) and FATIGUE (Can hardly move) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced COUGH (Coughing), PAIN (Body aches and pain) and FATIGUE (Can hardly move). On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and PYREXIA (Fever 101°F). At the time of the report, COUGH (Coughing), RHINORRHOEA (Runny nose), PAIN (Body aches and pain), PYREXIA (Fever 101°F) and FATIGUE (Can hardly move) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products was not provided/unknown.  Treatment medication was not reported/unknown.
Patient received moderna vaccin eon 4/14/21 and 5/12/21. COVID positive on 4/13/22. Presented to hospital as a transfer on 4/20/22 and admitted. Patient was transferred from the Hospital because he had a cardiac arrest needing CPR just for a couple of minutes.  He was noted to have high-grade type 2 AV block. Did not have any respiratory symptoms. Discharged on 4/27/22
Case number PHEH2013US020863, is an initial spontaneous report received from a pharmacist on 02 OCT 2013. This case refers to a multiple patients. Past medical history and concomitant medication were not reported. These patients were vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on an unspecified dates. Reporter stated that almost of her patients complain of pain upon injection of FLUCELVAX into her patient's deltoid. Reporter also stated that, this does not occur when using FLUVIRIN. No more information was provided.
Client woke up on Sunday 5/9/2021 with weakness in her legs. States she required assistance to get out of bed and go to bathroom, wobbly, dizzy, nauseated. Had a migraine headache that lasted until about 4pm. Had a salty taste in her mouth that is still current. Client states all symptoms were gone when she woke up today, Monday 5/10/2021, except for the salty taste. Still weak but independent with all movement.
Information has been received from a physician concerning a 26 year old female with no medical history or known drug allergies who on approximately 30-MAR-2007 ("last week") was vaccinated with a 0.5 mL first dose of Gardasil. There was no concomitant medications. On same day after she received the vaccination, the patient experienced arm pain. The next day, the patient started to experience flu like symptoms and developed a fever of 103 degrees. That same day, the patient had started to take MERIDIA. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. The reporter did not believe that the flu like symptoms and fever of 103 degrees were related to therapy with Gardasil. Additional information is not expected.
During night I developed flu like symptoms which included: hot then cold body, body aches, weakness, headache and loss of the whole night of sleep.
Severe anterior right shoulder pain associated with very limited ROM due to pain. No pain at injection site. No swelling or erythema at injection site. Pain is in anterior shoulder and radiates down right arm. Pain is constant but worse with movement. Pain started the night that vaccine was given 1/2/2021 and has been persistent since then making it difficult to work. Pain not relieved with tylenol or ibuprofen. Pain is more severe that what would be expected from needle trauma. Of note, vaccine was given particularly high near subdeltoid bursa.