chrisvoncsefalvay/vaers-outcomes huggingface dataset:
yesterday severe pain on her shoulder; This is a spontaneous report from a Pfizer-sponsored program via a contactable female consumer.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot/Batch number: unknown), via an unspecified route of administration on an unspecified date in Jan2021 (a week ago) as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced severe pain on her shoulder on 04Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): 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.
Anxious; Not sleeping well; Feels off; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxious), INSOMNIA (Not sleeping well), MYALGIA (Sore arm) and FATIGUE (Feels off) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Patient medication history was not provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MYALGIA (Sore arm). On an unknown date, the patient experienced ANXIETY (Anxious), INSOMNIA (Not sleeping well) and FATIGUE (Feels off). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Inflammation, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Sore arm, at an unspecified dose and frequency. On 15-Mar-2021, MYALGIA (Sore arm) had resolved. At the time of the report, ANXIETY (Anxious), INSOMNIA (Not sleeping well) and FATIGUE (Feels off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: heart beats per minute (High) Elevated heart rate, 150 heart beats per minute (High) Heart rate of 150, heart beats per minute (High) High resting heart rate, heart beats per minute (abnormal) Fluctuations in heart rate and heart beats per minute (abnormal) Irregular heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported
The patient has had left shoulder pain and has been unable to have full range of motion. Patient was seen by his primary care physician and an orthopedic physician. The shoulder pain may be due to a possible bone spur in the shoulder. The patient will be followed up by the orthopedic physician, who also was treating a hamstring issue of the patient. The physicians are not sure if the shoulder pain was due to the vaccination, but the pain did not start till after the initial shot was given.
Patient reported a total paralysis from arm to toes with unbearable pain for a week. Cannot walk when in pain.
Headache, chills, Fatigue, Muscle Pain, Pain at injection site . SIQ 24 hours
Swelling, redness, hot to the touch, knot under the skin and pain if touched
Nine days after first shot left arm non functioning- COVID ARM Second shot...next day very ill with headache, chills, fever, sweating. The most extreme is the double vision in left eye
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: En6203), in right arm, on 26Mar2021 as dose 2, single (Lot number: Er8730), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: Ew0175) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT; OMEPRAZOLE; LOSARTIN. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine? Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Additional Information: anti-viral details: COVID 19 Treatment (Paxlovid). treatment start date: 04May2022 and 08May2022. Indication is used for treatment of COVID-19. adverse event: Rebound infection following course of paxlovid. Completed course 08May Tested negative 10May. Experienced new symptoms and positive test starting 15May. adverse event start date: 15May2022. if patient not recovered. if the patient was not received treatment. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Event: Rebound infection following course of paxlovid. Completed course 08May. Tested negative May 10th. Experienced new symptoms and positive test starting May 15th.  Amendment: This follow-up report is being submitted to amend previous information: To amend to update Vaccination date for dose 2, event coding for Covid recoded with Suspected COVID-19 and date format in narrative.
81 year old male with h/o M. Abscessus infection, glaucoma, HTN, HLD, BPH, TIA, who presents with 3-4 days of severe weakness and SOB found to have new bilateral upper lobe ground glass infiltrates;RPP negative,  BAL gram stain negative . Per outpatient note: Started imipenem/cilastatin and tigecycline on 10/10/20 and on Arikayce and clofazimine 10/23/20. He was transitioned to omdacycline/clofazamine/arikayce 12/20/2020. Initially on the floor but now txf'ed to ICU for worsening respiratory distress. Relevant labs: His smears and cx have been negative since 11/23/2020 including 12/10/20, 12/11/20  2/8/2021. He was found to have new bilateral UL ground glass changes by CTA and underwent BAL 3/10 for possible atypical infection versus drug induced pneumonitis;  covid 19 neg PCR  What was used to treat this reaction? Held Arikayce. Gave Solumedrol. Unsure if his pneumonitis was caused by Arikayce or the Covid vaccine.  ADR Prior to admission? Yes Severity: Severe Probability: Possible  ADR Preventable: not preventable
positive for covid; two shots in may; This case was reported by a consumer via interactive digital media and described the occurrence of COVID-19 in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   In May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, unknown after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On 24th September 2021, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, received 2 shots in May 2021 and on the day of reporting was positive for COVID. The patient received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. This case was linked with case US2021AMR202764 and US2021AMR202899, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202764:same reporter US-GLAXOSMITHKLINE-US2021AMR202899:same reporter
ED note by Dr. 10/16/22: "Chief Complaint Patient presents with ? Numbness     HISTORY OF PRESENT ILLNESS   Patient, is a 82 y.o.male who presents to the Emergency Department with numbness tingling his left arm hand.  He also has weakness in his left grip.  He states this started occurring around 6:00 p.m. yesterday.  He says he was watching football on could hold onto the remote causing him to have concern why he may be weak.  He had no difficulty with speech trouble walking.  He had no trauma associated with this change in sensation and grip strength.  He says entire left arm feels weak as well as somewhat on his left leg but is able to ambulate without difficulty.  Does not take any blood thinners, had a history of stroke, have any chest pain or shortness of breath.     REVIEW OF SYSTEMS   The pertinent positive and negative symptoms are as per HPI. All other systems reviewed and are negative." "CLINICAL IMPRESSION   1. Atraumatic subdural hematoma  2. Left arm weakness   DISPOSITION/PLAN   Admitted"  H&P by Dr. on 10/16/22: "PCP: MD Chief Complaint:  Left hand weakness and numbness   HPI: Patient is a 82 y.o., male with a history of essential hypertension, CKD who presents with left hand weakness and numbness that began yesterday around 6:00 p.m.; this morning when he woke up his symptoms continued.  He denies hitting his head or falling down, denies any difficulty with walking, talking.  No headaches, blurry vision, nausea/vomiting, chest pain, shortness of breath, diarrhea, dysuria.     In the ED, CT brain suggestive of mixed density subdural hematoma over right frontal and parietal convexity without midline shift.  ED physician discussed these findings with Neurosurgery, who recommended admission for observation and repeat imaging in the morning.   COVID-19 vaccination status:  Received vaccine x2 and booster x2. COVID-19 test:  Negative today." "Assessment/Plan:  Patient is a 82 y.o., male who presents with the following:   1. Subdural hematoma, nontraumatic -CT findings as above; neurosurgery consulted by ED, recommend MRI tomorrow to rule out underlying CVA as well. -hold off aspirin, neuro checks q.4 hours. -fall precautions.   2. Essential hypertension  -resume lisinopril, metoprolol with holding parameters.   3. Hyperlipidemia  -resume statin.   4. COPD without exacerbation  -resume home inhaler regimen.   5. Chronic GERD  -resume PPI.   6. CKD stage IIIA -serum creatinine currently around baseline, will continue to monitor and avoid nephrotoxic agents.     7. Normocytic anemia  -hemoglobin currently stable, will order iron panel, vitamin B12 and folate levels. "
Experienced severe vertigo and an almost hallucinating effect rendering me unaware of my surroundings even tho I was in total familiar surroundings at that moment..
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K007828, expiration date: 02-MAR-2017 (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
1 hour after IM injection, patient developed head to toe hives that resolved with oral benadryl
Fever of 102, lethargy, cough, difficulty breathing, shallow breathing, rapid and labored breathing started Monday around 4pm. Fever continued overnight. Visited doctor 12/22 at 4pm. Had chest X-Ray done, Doctor heard 'rales' in lungs, pulse ox at 97%, considered hospitalization due to age for diagnosis of pneumonia. However, I was going to be home from work so we're able to keep her out of the hospital. Started on amoxicillin 3 mL twice a day for 10 days. 1/6/2016 back to Doctor for another round of antibiotics, cefdinir 2 mL once a day for 10 days.
pt recv vax 22JUN95 & on 13FEB97 pt exp rash w/20 lesions;
Several hours after getting the first dose of moderna my knees started feeling sore. 24 hours after the vaccine they were so swollen and painful that I couldn't walk. It has been over a week since my vaccine and I still can't walk without crutches and need to get a wheelchair. I have rheumatoid arthritis but have never had a flareup like this before. Contacted my doctor's office for help.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: EW0178) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "benign hyper-tension" (unspecified if ongoing), notes: benign hyper-tension; "cancer" (unspecified if ongoing), notes: cancer history (7 years remission). Concomitant medication(s) included: LISINOPRIL. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Bactrin, reaction(s): "Known allergies: Bactrin"; Biaxin, reaction(s): "Known allergies: Biaxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid, treatment start date=06Jul2022, treatment stop date=10Jul2022, indication=Treatment of COVID-19.
Patient presented to local Medical Center on 08/29/2021 with acute hypoxic respiratory failure d/t COVID-19. Patient was febrile, complaining of abdominal pain. KUB was unremarkable. Chest x-ray showing PNA consistent with Covid-19.  Patient received Remdesivir, Dexamethasone, Rocephin, and Zithromax. Patient progressively deteriorated and placed on BiPAP on 09/01/2021. Patient expired on 09/05/2021.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date a few years ago the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date, dose, frequency and route were unspecified. On an unknown date recently the patient developed shingles. The outcome of shingles was unknown. Additional information has been requested.
HBP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Patient received PNEUMOVAX 23 on 10/02/2023 with an expiration date of 10/01/2023. No additional AE/PQC.; HBP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Patient received PNEUMOVAX 23 on 10/02/2023 with an expiration date of 10/01/2023. No additional AE/PQC.; Information has been received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-OCT-2023, the patient was inadvertently vaccinated with an expire dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, unk, lot #W021636, expiration date: 01-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.
Within hours, Jonah became lethargic, sickly, pale, fever.  After the fever subsided 4 days later, my son was then displaying autistic symptoms like loss of eye contact, no facial expressions, and loss of language.  He was officially diagnosed with autism in July 2009. 9/11/09 Office note received dated 7/13/08.  Parents report that several days after receiving HAV, MMR and Varicella vax pt developed fever, rash emesis and decreased appetite.  Pt has developed balance problems, frequent falls and difficulty focusing the eyes.  PE WNL except faint pink macules on face and back. Assessment:  Likely viral illness 12/4/09 Medical records received for date 7/13/09 to 10/13/09.  7/13/09 DX:fever, UTI.   10/13/09 DX: burn rt. upper extremity.
got COVID and then got his second shot of COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, 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: SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "got COVID and then got his second shot of COVID-19 Vaccine". Therapeutic measures were taken as a result of suspected covid-19.  Additional information: Agent reports she has a consumer on line reporting she has been taking Paxlovid and has had the beginning of a migraine. Agent reports the caller had a drug interaction question which was addressed. She states her other grandson after one shot of the COVID-19 vaccine got COVID and then got his second shot of the COVID-19 vaccine. Caller states she does not have the details on shots.  Reporter details: Caller states she probably has the longest name in the system. She stated she was not a doctor, nurse, or pharmacist but her husband is a doctor. Caller clarifies that her area code for her phone number. Caller declined to complete report on her brother, her son, and her grandson. Full details unable to be obtained. Caller states she is glad Pfizer has these vaccines and her symptoms could have been a lot worse if she didn't have the vaccines. There was a product complaint to report. Description of Product Complaint: Description of complaint: Her other grandson after one shot of the COVID-19 vaccine got COVID and then got his second shot of the COVID-19 vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was administered 0.25 cc of the 6-11 yo Moderna vaccine, this resulted in the patient receiving half the intended dose
Unrelated to vaccine. Related to method of injection. Pt stated she felt ?like a nerve in my arm had been hit?. Medics assessed her further and she AMA?d from their care.
This case was reported by a healthcare professional and described the occurrence of last elevated out of range in a 26-year-old female subject who was vaccinated with TWINRIX adult, (GlaxoSmithKline). Concurrent vaccination included TWINRIX, (GlaxoSmithKline); 1st dose given on 4 June 2014. On 18 June 2014, the subject received 2nd dose of TWINRIX adult (unknown route and injection site) which was administered at only 14 days after the first dose which led to a drug dose administration interval too short. Less than 1 month, after the 2nd vaccination with TWINRIX adult, the subject experienced last elevated out of range, her's level of 52 (normal range 5-35). At the time of reporting, the outcome of the events was unspecified.
Patient vomited and had diarrhea at approximately 0800. I do not believe that this was due to the flu but from his vaccine. He only vomited and had diarrhea once at 0800 and then did not have any more spells after the one.
Information was received from the parent of a 5 year old male patient with no pertinent medical history. On 11-MAR-2011, the patient received route vaccinations with MMR II (dose and route of administration not provided) and (Merck) VARIVAX (dose and route of administration not provided). There were no concomitant medications. The parents explained that their son had adverse reactions after receipt of the MMR II and (Merck) VARIVAX with specific symptoms reported as: developing a fever of up to 104F, "yellowey" runny stools, pain in his joints, and irritability that lasted several days after receiving the vaccinations. The parents had experienced the same symptoms after receiving multiple doses of RECOMBIVAX HB (WAES#1504USA024423). The pateitn has not had any further vacciantions with any of these products since 2011. The physician's office was called and treatment was reported as MOTRIN and a tepid bath. The patient recovered about 1 week after the vaccinations. No further information was provided. Additional information has been requested.
Redness at injection site larger than a quarter size. Pain. No fever, no loss of motion, no sickness.
Reported that on Thursday evening after receiving her vaccine she had a HA that lasted until Friday that resembled her Covid HA. On Friday evening around 9 pm she had a temp of 99.0. She took ibuprofen. She also reported body aches. After taking the ibupofen, the HA, temp, and body aches resolved and she felt fine.
Arm is swollen; Red hot going down the arm and spreading; Red hot going down the arm; Arm sore; The swelling limits its (arm) use; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Red hot going down the arm and spreading), FEELING HOT (Red hot going down the arm), PAIN IN EXTREMITY (Arm sore) and INJECTED LIMB MOBILITY DECREASED (The swelling limits its (arm) use) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Red hot going down the arm and spreading), FEELING HOT (Red hot going down the arm), PAIN IN EXTREMITY (Arm sore) and INJECTED LIMB MOBILITY DECREASED (The swelling limits its (arm) use). At the time of the report, PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Red hot going down the arm and spreading), FEELING HOT (Red hot going down the arm), PAIN IN EXTREMITY (Arm sore) and INJECTED LIMB MOBILITY DECREASED (The swelling limits its (arm) use) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment medications were reported
This spontaneous report was received from a medical assistant and refers to a female patient of unknown age with drug hypersensitivity to sulfa drugs. Pertinent medical history was not reported. On 08-OCT-2015, the patient was vaccinated with ZOSTAVAX, (lot number, dose and strength were not reported), subcutaneous in the left arm. There was no concomitant medication reported. On an unspecified date in October 2015, the patient developed swelling at the injection site and redness at the injection site (injection site erythema) (injection site reaction). The patient visited an unspecified emergency room on 11-OCT-2015, and was diagnosed with cellulitis. She was treated with unspecified intravenous antibiotics and KEFLEX, and the patient was not admitted to the unspecified hospital. On 12-OCT-2015, the patient visited a new physician and it was reported that she developed approximately 6 vesicles around the injection site (injection site vesicles). The injection site erythema had dissipated, however "the vesicles were painful to touch" according to the patient. They physician prescribed VALTREX for treatment of the chicken pox-like rash around the injection site (injection site rash). At the reporting time, the outcome of cellulitis, injection site rash, injection site swelling, injection site reaction and injection site vesicles was reported as not recovered and the outcome of injection site erythema was reported as recovered on an unspecified date in October 2015. Additional information has been requested.