chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstruation started 01Oct21 (vaccination #1 date) and 13Oct21, 2 weeks apart; Severe headache; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 08Nov2021, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 01Oct2021 (Batch/Lot Number: EW0217) (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Oct2021, 6 days after vaccination, patient experienced severe headache. Patient also reported that menstruation started on 01Oct2021 then on 13Oct2021, 2 weeks apart. After patient's first shot on 01Oct2021, patient started feeling debilitating headaches on the left side of her head starting on 07Oct2021. Patient never had headaches, so this adverse effect was a significant disruption to her life. Patient started her period on 01Oct2021 which was a little early, but the next period occurred on 13Oct2021 and lasted 2 days longer than usual. The patient took ibuprofen (ADVIL) for the headache. On 20Oct2021, patient started acupuncture treatments to balance her body and avoid adverse effects after second shot of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EW0217) on 22Oct2021 administered intramuscularly in the left arm. Patient had no adverse effects experienced after second shot. The reporter assessed the events as serious, medically significant. Outcome of headache was recovered on 10Oct2021 while remaining event was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Two days after my first covid shot I experienced in my right eye - eye heaviness, double vision, numbness around the eye socket, my eyeball was twitching. After the secondd injection my eye was worse, I had pain in my eye., blurriness.
Blister formed at the injection site 24 hrs after the second vaccine off Pfizer Covid Vaccine.  Resolving when presented
presents to the ED for RLQ abdominal pain that started today. Pt claims that the pain started this morning at 6AM. She also claims that the pain has gotten better but she now feels sore.
Initial misuse case was received from a healthcare professional on 26 NOV 2013. Cases were received on 21 March 2014. A patient over age of 65 years whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE HD on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an expired dose from last year. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Narrative:  Patient received 2nd dose Pfizer COVID-19 vaccination during dialysis session. 20 minutes after the vaccination, he reported feeling confused and was found to have altered mental status. This reportedly has happened to him after dialysis sessions in the past, and was felt to be unrelated to his vaccination. However, he then reported having itching in both his hands. Because of this, he was given diphenhydramine and methylprednisolone. He was then sent to the nearest Emergency Room for further evaluation, and ultimately discharged home.  Other Relevant Hx: Symptoms:  Confusion & UrticariaPruritus Treatment:  DIPHENHYDRAMINE 25 MG ONCE
Body aches; itching eyes & body; itching eyes & body; chills; headache; This is a spontaneous report from a contactable other health professional (Patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, Right arm on 05Feb2021 at single dose for covid-19 immunisation (Age at vaccination 44 years) at hospital. Patient was not pregnant at the time of vaccination. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications received within 2 weeks of vaccination. Medical history included ehlers-danlos syndrome (EDS), mast cell activation syndrome (MCAS), postural orthostatic tachycardia syndrome (POTS). Allergies to medications, food, or other products included Latex allergy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COVID 19, Pfizer, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration, Right arm on 15Jan2021 at single dose for covid-19 immunization (Age at vaccination 44 years). On 06Feb2021, the patient experienced body aches, chills, headache, itching eyes & body. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No treatment was received for the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Reported symptoms like those of "serum sickness" after administration of H1N1 in 2009. "Abdomen swollen".
the patient was inadvertenlty administered a dose of ZOSTAVAX instead of the scheduled second dose of VARIVAX.; Dose/Frequency: 0.5 ml/ once; No adverse effects were reported; Information has been received from a nurse referring to a 28 years old female patient. Information of drug reactions/allergies was not reported. Concomitant therapy included sterile diluent. On an unspecified date, the patient received her first dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, frequency, route, lot# and expiration date were unknown) for prophylaxis.   On 29-MAR-2019, the patient was inadvertenlty administered a dose of zoster vaccine live (ZOSTAVAX)(0.5 ml, once, subcutaneous, lot # R023356, expiration date: 28-JUN-2019) for prophylaxis instead of the scheduled second dose of varicella virus vaccine live (oka/merck)(VARIVAX)(wrong vaccine administered, inappropriate dose of vaccine administered). Properly stored sterile diluent was used to reconstitute the zoster vaccine live(ZOSTAVAX). No adverse effects were reported.
Developed chronic hives.  Completely random/sporadic outbreaks usually daily.  Different parts of the body affected:  forearms, scalp, stomach, back, legs.  Itchy beyond words.  I take a OTC Zyrtec at night to curb them from coming on.  They flare for no reason.  Usually itch for about 30mins to an hour and then calm down and go away on their own.
Spontaneous report received on 11/16/00, from a Medical Assistant in a Dermatologist's office, regarding an adverse event possibly related to administration of Fluvirin. On 10/6/00, this 83 year old female, shortly post vax, developed a fever of 102F, chills and general malaise. These symptoms lasted approx. 4 days. In mid-October, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of prednisone with symptom abatement. After completion of the prednisone, topical use of Orabase and Kenalog; lesions remain at the time of this report. The dx of Stevens-Johnson Syndrome has been made. The reporter stated that the Dermatologist's office has treated this pt for over 10 years. She indicates that the pt is normally very "mentally there", but that the pt "hasn't been herself". She describes pt as being "easily confused and forgetful". Additional information has been requested from the physician. The follow up received on 3/22/01 states, "vaccine reaction onset date Stevens Johnson Syndrome Oct 2000, fever and chills 10/6/00, malaise 10/6/00, forgetful October 2000, and confused October 2000."
Initial report was received from a healthcare professional through another manufacturer on 11 December 2012 under manufacturer control number 17098781. The following information was taken verbatim from the report: "This case was received from Institute (Cross Reference No: 5608). A clinical investigator reported that a 62-year-old male patient was hospitalized for nausea (grade III), vomiting (grade III) and hyponatremia (grade IV) on 26-Oct-2012, while enrolled in the study involving ipilimumab for melanoma. The patient also received acetaminophen, influenza virus vaccine, ondansetron and ibuprofen which were considered as suspect drugs. The patient was diagnosed with melanoma in Aug-2009 but had a recurrence in Apr-2012. The primary site of disease was noted in the right suprasternal area. Sites of metastatic disease included lymph node. The patient had not received any prior therapies. The patient was randomized to Arm A to receive ipilimumab. On 20-Jun-2012, the patient was initiated on study therapy with with intravenous ipilimumab 10mg/kg (over 90 minutes, once in every 3 weeks x 4 doses). The patient had received the total dose of 10mg of ipilimumab. He recently completed his induction course of ipilimumab on 22-Aug-2012. The patient had completed 4 induction courses of ipilimumab therapy. The patient had normal labs at last follow up appointment post ipilimumab on 24-Oct-2012. On the same day, the patient's baseline value of sodium was 135mmol/L. On 26-Oct-2012, the patient complained of lightheadedness and dizziness, nausea (grade III) and vomiting (grade III) and occurred almost every hour, also identified to have hyponatremia (grade IV) and hypokalemia. The patient also experienced grade I flu like symptoms. During admission patient was hydrated, CT of the brain done and did not show any acute intracranial abnormality, abdominal exam was benign. The patient presented to the emergency room on 28-Oct-2012 with resolving frontal headaches, fevers and chills. On the same day, patient's blood sodium level was 118mmol/L. Headache, hyponatremia, nausea and vomiting were resolved on 30-Oct-2012. On the same day, the patient's blood sodium level was 125mmol/L. The patient was not removed from the protocol due to the events. The patient's pre-existing condition included viral infection. Investigator reported that there were no other contributing causes for the events. According to the investigator, flu like symptoms was unrelated to ipilimumab, melanoma, acetaminophen, ibuprofen, ondansetron, but possibly related to influenza virus vaccine. The events of hyponatremia, nausea and vomiting were unrelated to melanoma. Investigator's causality assessment: Hyponatremia was unrelated to ipilimumab, acetaminophen and ibuprofen, but possibly related to influenza virus vaccine and ondansetron. Nausea was unrelated to ipilimumab and ondansetron, but possibly related to acetaminophen, influenza virus vaccine, and ibuprofen. Vomiting was unrelated to ipilimumab, acetaminophen, ibuprofen and ondansetron, but possibly related to influenza virus vaccine. Documents held by sender: None.
injection site due to a rash/ vaccination had a rash or break out around the injection site; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site due to a rash/ vaccination had a rash or break out around the injection site) and VACCINATION SITE PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (injection site due to a rash/ vaccination had a rash or break out around the injection site) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE RASH (injection site due to a rash/ vaccination had a rash or break out around the injection site) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's past medical history was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient had swollen lips and throat at around 11am. Patient was treated with liquid Benadryl around 3pm and the swelling subsided. Patient was prescribed prednisone 20 mg tablets and an EpiPen.
flu terrible; Initial information received on 07-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced flu terrible after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in Oct-2022, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient got Influenza Vaccine a month ago and developed a non-serious event of flu terrible (influenza) right now (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu terrible).  At time of reporting, the outcome was Unknown for the event flu terrible.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 54th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Patient is a 32-year-old male with history of cervical disc herniation and bilateral upper extremity radiculopathy presents with complaint of left hand tightness 5 minutes after receiving a COVID-19 vaccine.  Patient was unsure if this was allergic reaction and was sent here for evaluation.  Patient denies any difficulty with breathing.
Tested positive for Covid; Scratchy throat; Was exposed to the virus; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Was exposed to the virus), THROAT IRRITATION (Scratchy throat) and COVID-19 (Tested positive for Covid) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Was exposed to the virus). On 05-Jan-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On 10-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, EXPOSURE TO SARS-COV-2 (Was exposed to the virus), THROAT IRRITATION (Scratchy throat) and COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient was exposed to the virus on Monday 04Jan2021 or Tuesday 05Jan2021 of last week after the vaccine. The patient did not receive treatment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
the patient received an unauthorized vaccine/ patient was not age 12 at the time that the vaccine was administered/incorrect birthday was given by the parent
I contracted COVID-19. I had a sore throat, headache, runny nose, joint pain, and experienced a lot of tiredness. I took a five day course of Paxlovid. I am also taking Dayquil medication.
Anaphylactic reaction; Stomach hurt; Tired; Headache; Body ache; GI issues; Shortness of breath while talking; A spontaneous report was received from a 31-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, stomach hurt, GI issues, shortness of breath while talking, fatigue, headache and body aches.  The patient's medical history includes allergy to Tylenol, Imitrex, mango, pineapple, oranges, nuts, seafood and cinnamon. No relevant concomitant medications were reported.   On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, 5 minutes after receiving the vaccine, the patient experienced an anaphylactic reaction. She experienced shortness of breath, coughing, vomiting, pulse rate dropped to 40 and she showed signs of anaphylactic reactions. She was administered Benadryl 50 mg IM at the 5-minute mark and 1 dose of the EpiPen at the 20 minute mark. This helped relieve some of the tightness around the throat. She experienced a secondary anaphylactic reaction 5 hours later and was rushed to the emergency room. She was hospitalized from 21 Jan 2021 to 24 Jan 2021. While in the hospital, she experienced two more anaphylactic reactions reported as similar to the previous reactions except that for the last two reactions, she could feel them coming on before her coughing and tightness started. She states "I felt very hot, clammy, and could feel the allergic reaction coming on for the last two reactions." During the hospitalization, she was administered Benadryl, Solumedrol, and EpiPen. On 26 Jan 2021, she has recovered from her anaphylactic reaction but she was tired, has shortness of breath while talking, headache, body aches, her stomach hurts, and its hard for her to eat without having some GI issues. She has never felt like this before and it is very unusual for her.   Action taken with the second dose of mRNA-1273 in response to the events were not reported.   The outcome for the event, anaphylactic reaction was considered Resolved/Recovered On 26 Jan 2021. The outcome for the events, stomach hurt, GI issues,shortness of breath while talking, fatigue, headache and body aches was unknown.; Reporter's Comments: This case concerns a 31-year-old female patient with medical history of multiple food and drug allergies,  who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of anaphylactic reaction, the non-serious listed events of Fatigue, Headache, and Myalgia, and the non-serious unlisted events of stomach ache, gastrointestinal issues, and shortness of breath while talking.  The event of anaphylactic reaction started within minutes after vaccination.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient).  This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Headache, bone pain, fatigue, body aches were present when I woke Sunday morning I slept 28 hours and awoke Monday morning still having a severe headache. Headache responds minimally to ibuprofen.
PFIZER COVID VACCINE #3 GIVEN 11/24/2021, LOT # NO AVAILABLE; pt had a long complicated hospital course from 4/14/22 - 71/22; admitted with valvular heart disease, colon CA; had a colon resection; stage III CKD; aortic valve valvuloplasty complicated by cardiac arrest; tested positive for COVID on 5/30/2022; experienced a seizure and required intubation; EEG showed global hypoperfusion/global hypoxia process; transitioned to DNR; pt passed away in the hospital