chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 10:00 (Lot number: ER8730) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "Her arm was sore".  Additional information: The first dose her arm was sore but it got better pretty quickly. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No family Medical History Relevant to AE(s). No relevant tests was done.  No follow-up attempts are possible. No further information is expected.
Gave high dose flu shot to someone who was not yet 65 years old. Patient did not report any adverse effects or reactions as of this time.
11/13/09 "felt exhausted" approx 2 hours post vaccination.  11/14/09 Able to work around house but extremely tired - early to be 11/15/09 Awake ~0900 drank coffee, then back to sleep, Aroused for dinner, then back to bed. 11/16/09 Up at 0500. To work at 0700, noticed slurred speech and exhaustion left work at 1400 to go home to bed. 11/17/09 Aroused at 0500.  "Too weak to go to work"  Requested coffee from housemate.  Within 10 minutes back to sleep and unable to remember calling work.  Phone checked by housemate.  Patient did call work, but also tried to call a relative and misdialed the number. Fine rash noted on Face. Slurred speech, urinary incontinence, mispelled words, stumbling noted by roommate. 11/17/09 pm taken to ED where she was admitted to ICU following. 11/18/09 Transferred to another Medical Center ICU. 11/23/09 Medical records received for DOS 11/17/09- Final DX: Altered mental status, confusion, UTI, dehydration, encephalitis  C/O extreme somnolence S/P vaccine. Incontinence x1. Confusion. Unsteady gait.   L sided weakness. Head CT and CXR WNL. CMP WNL.   12/4/2009 MR and DC summary for 11/18-11/24/2009. Patient with c/o's fatigue, excessive sleep, mental confusion, urinary incontinence, LUE and LLE weakness and slurred speech. Neuro exam + for weakness lt side. Tx: initially with IV depakote which was changed to trazadone due to side effects, ABX for UTI, LP with S/P headache which was not relieved per blood patch, PT and OT Dc Dx: Complex migraine, UTI, Post LP headache    12/4/2009 MR and DC summary for 11/25-11/27/2009. Patient with c/o's seizure-like activity and continued LUE and LLE weakness. DC Dx: Probable pseudo-seizures vs conversion disorder, LUE and LLE weakness  12/8/2009 MR, H&P and Admission note for 11/18/2009 12/11/2009 PCP visit for 12/1/2009, f/up visit , neuro exam still notes decreased strength RUE, RLE and LLE, mild lt foot drop. referred to PT/OT, has f/up appt with Neurologist. Dx post vaccine encephalitis vs MS  12/23, 24 and 12/28/2009 Neurology f/up visit post hospitalization, patient currently on Keppra but having c/o's increased somnolence, confusion and headaches, denies any new seizure activity. Dc'd Keppra and started on Lamictal XL, to f/up in 2 months unless new problems
Patient noticed at site of vaccination it looked red or she said it appeared bruised to her. She did not come to pharmacy until 6 days after she initially saw the area. I encouraged the patient to go on to physician and let us know immediately what the doctor said. I also encouraged patient to always contact pharmacy as soon as anything like that happens with a vaccine or any medication. The importance of prompt assistance is crucial.
chest pain an hour after the vaccine that is still persisting and associated with sensation of radiating heat from the chest
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 15-month-old male patient. The patient's illness at vaccination was reported as none. The patient was allergy to peanuts, strawberries, tomatoes, lactose. The birth weight was 8 lbs and 12 oz. The patient had 1 sister and 1 brother. Concomitant therapy included sterile diluent (manufacturer unknown) and hib vaccine conj (tet tox) (HIBERIX).    On 26-MAY-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U025790, expiration date: 19-AUG-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. The vaccine was purchased with public funds. No adverse event was reported (no adverse event). The vaccine was no longer in office and no longer available for return or evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007513: US-009507513-2206USA001254:
-progression to Atrial fibrillation and NSTEMI. As well as acute on chronic CHF -monitored and discharged on Eliquis and increase in metoprolol tartrate 50 mg BID and increase in furosemide 40 mg daily
High fever; Chills; Nausea; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's mother) via medical information team. A 22-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 04May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Reporter stated that she got an email stating that there was a recall on sterile solution/water. Her daughter and she got the second dose of the Pfizer covid vaccine yesterday (04May2021). Reporter wanted to know was that what they put in the vaccine. On 04May2021, her daughter had a high fever, chills and nausea. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 54 years old female patient with diabetes, hypercholesterolaemia and hypothyroidism and penicillin allergy (rash). The patient was vaccinated with a dose, 0.65 ml ZOSTAVAX (lot # not reported) on 30-JUL-2012. Concomitant medications included insulin, SYNTHROID and statin (unspecified). The pharmacist stated that the patient who received a dose of ZOSTAVAX on 30-JUL-2012, returned to the pharmacist on 01-AUG-2012 to report that her arm was red, warm, and itchy. Pharmacist noted that a roughly 3 inch oval near the injection site was red and warm to the touch. Pharmacist reported that she called the patient on Friday, 03-AUG-2012 to follow up and that the patient reported that the area was painful and felt like there was a knot under the skin. Treatment for the adverse event included BENADRYL and ice. At the time of the report all the patient's events persisted. Additional information has been requested.
Patient received the 2nd dose of the Pfizer COVID19 vaccine on 1/28/21. Patient began COVID symptoms on 5/9/21 and tested COVID positive on 5/13/21 via saliva test
First dose received more than 35 days ago and second dose yet to be received; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose received more than 35 days ago and second dose yet to be received) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Physical therapy and Occupational therapy.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose received more than 35 days ago and second dose yet to be received). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose received more than 35 days ago and second dose yet to be received) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Lockjaw; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Jun2021 11:30 (Lot number: EW0187) at the age of 36 years as dose 1, single and administered in arm right, administration date 22Jun2021 (Lot number: EW0169) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: She just took over the counter medicine for it as she needs to. The patient's concomitant medications were not reported. Vaccination history included: Tetanus vaccine (Verbatim: Injections site swollen and tender), for Immunisation, reaction(s): "Injection site swollen"; Tetanus vaccine (Verbatim: Injection site swollen and tender), for Immunisation, reaction(s): "Injection site tender". The following information was reported: TRISMUS (non-serious) with onset 01Jun2021, outcome "recovered" (02Jun2021), described as "Lockjaw".  Additional information: Caller states that she was calling about the Covid Vaccine. States she has been a (Privacy) for 12 years so she tends to minimize a lot of her sickness. States the two times that she had the Covid Vaccine she experienced lockjaw and thought it was something that she should report. She declines to provide HCP information. States she never sees her primary care provider. States she just goes in when she needs to and sees whatever doctor was available. Caller states that the lockjaw she was having yesterday and today seems to have gone away. States it stopped about a half an hour ago. States she doesn't know that it won't come back; but for now it is gone. Caller denies any medical conditions, medications, labs, testing or treatments relevant to these events. States she gets migraines at times and just takes over the counter medicine for it as she needs to. No other information provided by the caller. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect were reported as None. Patient did not visit emergency room and physician office visit for the events. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as None  Follow-up attempts are completed. No further information is expected.
Patient presents today with an injection site reaction.; Redness have increased over the past couple of days.; welling have increased over the past couple of days.; States it hurt immediately after receiving it.; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 62-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14Dec2022 at 09:00 as dose 1, single (Lot number: GF7610) at the age of 62 years, in left deltoid for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Dec2022, outcome "unknown", described as "States it hurt immediately after receiving it."; VACCINATION SITE REACTION (non-serious) with onset 15Dec2022, outcome "unknown", described as "Patient presents today with an injection site reaction."; VACCINATION SITE ERYTHEMA (non-serious) with onset 15Dec2022, outcome "unknown", described as "Redness have increased over the past couple of days."; VACCINATION SITE SWELLING (non-serious) with onset 15Dec2022, outcome "unknown", described as "welling have increased over the past couple of days.". Therapeutic measures were taken as a result of vaccination site reaction, vaccination site pain, vaccination site erythema, vaccination site swelling.  Clinical course: Patient presents today with an injection site reaction. She was given Prevnar-20 two days ago in-office. States it hurt immediately after receiving it. Site continues to be painful. Redness and swelling have increased over the past couple of days. She has tried ice packs and Tylenol at home for relief. Took one dose of ibuprofen. Denies any fever or drainage from the site. Facility where vaccine was administered: Doctor's office/urgent care. Patient did not received any other vaccines on the same date as the vaccine(s). It was unknown that patient received any other vaccines within 4 weeks Prior to the vaccine(s) and any other medications within 2 weeks of the event starting. Prednisone (Deltasone) 20 MG tablet, taken 3 tablets by mouth daily for 3 days, Then 2 tablet as treatment received.
He had a horrible headache that came on and lasted past the site of injection pain and achy feeling.
pt recv vax & about 3 days p/vax pt exp a 6 inch area of erythema across the inj site;
Patient with 2 Moderna COVID vaccinations, last dose 05/22/21, who admitted to hospital for complications of COVID.  Provider discharge note below:  "Vaccinated smoker with history of controlled lung cancer and COPD not previously on nebulized treatments or oxygen presents with dyspnea and is found to have hypoxemia and COVID-19.  CXR and CTA chest negative for COVID pneumonitis and PE.  Patient had been ordered a nebulizer for home from her PCP office but it never arrived.  Patient admitted and treated with steroids, nebulized bronchodilators and oxygen and improved.  She was educated on the importance of smoking cessation and dust and dander avoidance.  Arrangements were made for home oxygen and a home nebulizing was dispensed.  She is to follow up with her PCP and referred to pulmonary medicine clinic"
Information has been received from a nurse referring to a patient of unknown age and gender. On 10-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown).    No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009387:
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and ASTHENIA (weakness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In February 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 DIZZINESS (dizziness) and ASTHENIA (weakness). At the time of the report, DIZZINESS (dizziness) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
hot around injection site; redness, red around injection site; injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Case comment: This case concerns a female of unknown age who experienced NS events of unexpected injection site warmth and expected injection site pain, injection site erythema.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of unexpected injection site warmth and expected injection site pain, injection site erythema.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
BODY ACHES, CHILLS (DAY 5 & 6 AFTER), BODY ACHES, CHILLS, HEADACHES, MOUTH FULL OF SORES (DAY 7-9), DR VISIT ON DAY 9, FLU TEST & STREP TEST NEGATIVE, CBC NORMAL, TERRADOL INJECTION, LIDOCAINE MOUTHWASH, CONTINUE IBUPROPHEN & TYLENOL, STILL HAVING BODY ACHES AND SORE MOUTH FROM DAY 10-14, BODY ACHES LIGHTENING UP, MOUTH SORES STARTED SUBSIDING ON DAY 18, STILL HAVE SOME SORE GLANDS CAUSING EAR PAIN IN BOTH EARS AND MUCH REDUCED MOUTH ON DAY 20 AS I WRITE THIS.
Shoulder pain; heavy arm; Muscle tightness; Spasms; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration, administered in the left arm on 03May2021 at 10:15 (at the age of 48-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included thyroidectomy in 2014, thyroid cancer from Nov2014 to an unknown date and tonsillectomy in Feb2005. No investigation assessment was present. Concomitant medication was not reported. No other vaccinations administered on the same day as her Pfizer COVID-19 vaccine or during the four weeks prior. Reporter stated that she had started no new medications recently. On May2021, the patient experienced shoulder pain, heavy arm, muscle tightness, spasms. Therapeutic measures were taken as a result of events and included treatment with Tylenol and it did not seem to help, and had tried hot and cold compresses, and muscle rubs. Reporter stated that she received the first dose of the vaccine 03May2021 and was scheduled for the next one in 10 days from today. She said she had no symptoms whatsoever until 5 days later, which was shoulder pain and a heavy arm which seems to be progressing. Reporter stated that she took Tylenol, and it did not seem to help. She clarified that she took generic Tylenol UPC/LOT/EXP: Unknown, she did not have this with her at this time. She said it was off brand, that was all she knows, it was 500mg and she takes two of them. She said she took it more than once, every 4-6 hours by mouth. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information on medical history and drug reactions or allergies. On 12-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 dose .5 ml (milliliter), strength, route not reported, product lot # J004080 that expired on 22-AUG-2014 inadvertently. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
I just was tired and I have allergies, it seemed to be more than that. It was way more serious than my allergy symptoms. I had a lot of sneezing and sinus drainage. I called my doctor and suggested I just quarantine, since I didn't have serious breathing issues. I just rested and I was ill probably for a good week. I tested after 5 days and got a negative COVID-19 test. I tend to feel I have breathing related issues. I also have some brain fogginess. I am seeing a neurologist. I started having some vertigo issues since January of 2023.
Can I take medicine for side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Can I take medicine for side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Can I take medicine for side effects). At the time of the report, VACCINATION COMPLICATION (Can I take medicine for side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Patient receives two doses of vaccine  Engerix-B pediatric.  The first dose administered was not documented by the nurse on duty.  The next day, the nurse in charge of the patient re-requests the vaccine and another dose of Engerix-B pediatric is administered to the patient prior to discharge.
13NOV92, 1 hr p/recvd a 1st dose of vax devel dizziness & loss of balance dx as myasthenic synd; An electromyogram was performed & showed loss of muscular strength;
Information has been received from a medical assistant concerning her mother (a 63 year old female) with diabetes who had a shingles outbreak "under her right breast and was given a dose of ZOSTAVAX (Merck) 2 years ago (approximately 2007) to decrease the swelling and pain from shingles". The medical assistant stated that the patient's "pain improved and the rash went away faster from the ZOSTAVAX (Merck)". It was reported the patient's "rash lasted for a total of 4-5 days". The ZOSTAVAX (Merck) was given on the second day of the rash when her pain level was 10/10. 4 days after the vaccine was given the patient's pain was 6/10. It was also reported there was no pain or rash 14 days after vaccine was given. Additional information has been requested.