chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure; crashed my car.; don't remember 45 minutes of my life; This is a spontaneous report from a Contactable Consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 13:15 (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation at a vaccine facility, at 26 years old. Medical history included known allergies: Penicillin from an unknown date. No other vaccine in four weeks. Patient did not COVID prior vaccination and has not been tested for COVID post vaccination. Concomitant medication included bupropion; and venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported. Patient waited 15 minutes and felt normal. Patient stopped for gas and soda and then patient stated to be honest he woke up surprised with EMT, police and fire just telling him he started having a seizure and crashed his car on 17Apr2021 13:30. Patient stated "that's craziest laser I don't remember 45 minutes of my life (onset 17Apr2021). Thought I would be like 140. It was 3 pm which leave a large gap. This is really scary for me and my family". The events resulted in emergency room visit for seizure and crashed his car. The patient was hospitalized for seizure and for crashed his car for 1 day. Therapeutic measures were taken as a result of seizure and crashed my car (Some things to regulate my heart rhythm). Outcome of the events seizure and crashed his car was not recovered while unknown for don't remember 45 minutes of his life.
Pt called 2/13/13 & said she developed HA shortly after receiving vaccine, now feeling nauseated, tired & tearful. Instructed to call her personal dr to inform & get further instructions.
high fever; cough; sore throat; a lot of cold-like symptoms; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves an unknown age male patient who experienced high fever, cough, sore throat and a lot of cold-like symptoms while receiving vaccines influenza vaccine and COVID-19 VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer and COVID-19 vaccine not produced by Sanofi Pasteur both at an unknown dose (lot number, expiry date: not reported) for immunization.  On an unknown date the patient developed a non-serious high fever (pyrexia), cough, sore throat (oropharyngeal pain), a lot of cold-like symptoms (nasopharyngitis) (unknown latency)  2 days following the administration of influenza vaccine and (unknown latency) following the administration of COVID-19 vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.
Pt presented to health center for Covid-19 vaccine #1. During check-in, verbalized an allergy to PCN- anaphylaxis reaction and current back pain. Due to prior allergy, determined we will watch her for 30 min post injection. Injection given without incidence and patient brought to recovery area. Approximately 5 mins later, RN came and asked for assistance. States patient was exhibiting stridor breathing. Epi-Pen injected at 9:04am to left thigh, BP=173/109 by electronic BP machine. 9:06am- O2 at 10L paced via non-rebreather mask and 911 called. 9:08am BP=166/83. P=120. Pt remained alert and oriented. Reclined to approximately 45 degree angle due to complaints of back pain. 9:09am IV line started in L antecubital, normal saline wide open. 9:11am PB=171/97. 9:16am BP=105/79 P=119. rescue arrived. Pt ambulated with minimal assistance to gurney for hospital transfer for evaluation.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown dates in February 2017 the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot numbers M022085, expiration date: 09-OCT-2017 and M038359, expiration date: 13-MAY-2018 (doses, routes and sites of administrations were not reported). The PNEUMOVAX 23 doses were stored in the temperature of 35 Fahrenheit for 9 days. No other temperature excursions were reported. No adverse events were reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA006308: US-009507513-1703USA006309: US-009507513-1703USA006310.
temperarily lost sight in left eye; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS TRANSIENT (temperarily lost sight in left eye) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Right knee replacement surgery) in 2017. Concurrent medical conditions included Blood pressure high since 2014 and Benign prostatic hypertrophy since 2000. Concomitant products included TAMSULOSIN, LOSARTAN and NIFEDIPINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021 at 2:30 AM, the patient experienced BLINDNESS TRANSIENT (temperarily lost sight in left eye) (seriousness criterion medically significant). On 12-Jun-2021, BLINDNESS TRANSIENT (temperarily lost sight in left eye) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2021, Computerised tomogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BLINDNESS TRANSIENT (temperarily lost sight in left eye) to be possibly related.    Patient's treatment product details not provided. It was ambiguously reported that outcome of the event was resolved on 12-Jun-2021 and unknown.  The first event occurred the day after the first vaccine shot the left toe swelled and the swelling and pain worked its way into the lower leg.  Required a doctor visit, ultra sound and xray did not show any damage to the toe, foot or leg.  Blood tests showed uric acid levels in the high end of the normal range.  After treatment in office with an injection the pain and swelling subsided.  No long term effects from this event. The second event occurred after the second vaccine shot.  Two weeks after the second shot was administered (Saturday 6/12/21), temporarily lost sight in my left eye while driving. Went to the ER for treatment. Assement showed no retinal detachment. On Monday visited family doctor and she recommended that patient see by an eye doctor and ordered some additional blood tests blood tests.  Family doctor appointment for follow up visit scheduled for 7/28/21. Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-040178, MOD-2021-245133 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
At day 4 increase large local reaction, felt to be cellulitis due to late onset and increasing size, but in retrospect likely a delayed hypersensitivity reaction (have photo images)
I woke up blind in both eyes. My sight slowly came back over the next few weeks. I went to an ophthalmologist, who sent me to a neuro ophthalmologist, who sent me for MRI scans and was then send to a neurologist. I went to a second neurologist who after many, many tests diagnosed me with MS.
Pt developed ecchymotic area (about 3in x 5 in) with surrounding warm, erythematous patch (total size 5 1/2 in x 7 in) just inferior to IPV injection site.
This spontaneous report as received from a pharmacist via a company representative refers to a non pregnant female of unknown age. The patient's relevant medical history was not reported. On an unknown date, the patient was vaccinated subcutaneously with one dose of ZOSTAVAX (0.65 ml, lot# and expiration date were not reported). Information about the patient's concomitant medication was not reported. On an unknown date, the patient experienced shingles after receiving ZOSTAVAX. The patient was examined by her physician who prescribed CYCLOVIR (date unspecified). The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Pt recvd vax & 1 day later exp itching on arms & torso & large raised white areas;
Today at 230 pm, fever 101, decreased by 3 pm. Slightly fussy, vomited yesterday.
Information has been received from a RN concerning a 5 year old female with no past medical history and no known drug allergies who on 01Sep99 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 20Feb2004 the pt developed breakthrough chickenpox. The pt was described as having 20-30 blisters and a headache on the first two days of therapy. The pt was reported to have been slowed down the first two days after onset but has been fine since. The reporter indicated that she is unaware of the rash status. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sore upper arm; A spontaneous report was received from a consumer concerning a 74-years-old male patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore upper arm/pain in extremity.  The patient's medical history included allergy to ibuprofen. Concomitant medications reported were men`s multivitamin, vitamin D3, cholesterol pill, medicine for liver and acid reflux pill.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.On 19 Feb 2021, the patient experienced sore in upper arm.No treatment was taken by the patient.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event sore upper arm was unknown.
On 10-9 patient received her flu vaccine. The evening of 10-10 patient took 25 mg of Benadryl po for c/o localized pain, swelling and redness to her left arm. No c/o Sob. On the morning of 10-11 the patient noted that she had increased localized  pain, swelling and redness  to her left arm. No c/o Sob.  During the day she took additional two Benadryl. On  10-12 patient reported to Dr. that her arm has much improved with little redness, swelling  and not much pain.
pt recvd MMR vax 11JUN90 & lab eval on 2JUL90 revealed a pos preg test; 23AUG90 pt underwent a therapeutic abortion; no further details were provided;
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was given the bivalent booster before recieving a primary series.  No symptoms or signs of adverse event just a mistake on administration.
Fever, chills, aches, tired. Felt like poo poo -- lasted 24 hours.
Fever X 2days (101F) w/ joint aches, which was listed as possible reaction, but also severe vomiting x 1 days.
Pt was given her Annual Advocate employee Influenza vaccine yesterday afternoon at ~2:05 pm. Approximately 1 hour later, she was feeling very hot and the left side of her mouth started to become numb, This progressed over about 30 min to numbness in the cheek area and slight left eyelid droop. Barely noticeable droop but fairly significant delay when blinking. Right blink faster than left. Denied HA. No noticeable mouth droop but very slight delay or slur in her speech. Pt had a stroke in March of this year with some left-sided residual weakness that had been almost completely resolved prior to this episode. She does state that sometimes when she is very stressed she will feel the slight numbness/tingling in her face, but this is more pronounced. Strongly encouraged to go to ED. Cannot go to the ED (where we were at the time) due to her insurance. Informed we did not want her to drive. Pt preferred to wait and see if it would go away or progress any further. Had a full staff of 3 RN's 2 Dr's an NP and several MA's here in the office monitoring her. It did not get any worse than as described above, but she was very tired.  After about 45 min, she stated the numbness on the lips was getting better, still tired and left eye blink lagging a little bit. No limb numbness or weakness At ~8pm last night, contacted pt and she stated she was feeling better. Resting now. No mouth numbness. Still a little numbness around left eye and cheek. Had gone to her Chiropractor who worked with her ~1 hour and suggested NO MORE FLU SHOTS. She will also contact her Neurologist. When asked this morning how she was doing, it was about the same- very slight improvement. Eye still sl droopy. No more mouth/cheek tingling. However, she states she had to use her Albuterol inhaler last night and again this morning for some wheezing
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications was reported.No treatment medications details was reported.This case was linked to MOD-2021-395701 (Patient Link).
Leg and body aches, recurrent rashes, "cap" headaches, dizziness or weakness, eyesight deterioration (rapid), eye pain, diarrhea, nausea All symptoms worse after this immunization
Patient recieved moderna . Patient accidently received  pfizer booser. Patient was informed and is it ok with it
A report received from a health professional on 10/29/2002, concerning a female vaccinee who received Fluvirin on 10/29/2002. On 10/29/2002, the vaccinee was inadvertently administered 2001-2002 Fluvirin.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment.
Patient reports 8 inch by 3 inch swelling near injection side 3 days after the injection. The area was reported as hot and sore.
Pt reports that within hours of receiving the vaccine, he experienced swelling and rawness of the tongue such as if he drunk something that was too hot, a rash that extended to his upper torso and groin, and pain and swelling in the injection site that persists 10 days after injection.  Syptoms were reported 10 days after shot.
Abnormal bleeding in mouth and gums. Should I be seen by someone for this adverse reaction?  Please contact asap. Thank you  Wm. Bisceglia
Episode of angioedema; A spontaneous report was received from a healthcare professional concerning two patient's who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an episode of angioedema.  The patients' medical histories included both patients receiving dermatological fillers. No relevant concomitant medications were reported.  On unknown date, prior to the event , both patients received their first of two planned doses of mRNA-1273 intramuscularly of prophylaxis of COVID-19 infection.  On an unknown date, after vaccine administration, both patients experienced an episode of angioedema.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, episode of angioedema, was unknown.; Reporter's Comments: Based on the 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.  The Patient's history of having dermatological fillers could be a contributing factor. Further information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukemia (CLL)" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Augmentin, reaction(s): "Drug Allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Jun2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on days 3-5 of treatment with Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid, start date as 02Jun2023 and stop date as 07Jun2023. Clinical course: Patient received COMIRNATY (2023-2024 Formula) as dose 1, single on 19Sep2023 for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300351144 same reporter/patient, different product/events;
Migraine, body aches, chills, weak, muscle fatigue, arm tender with swelling and redness
Initially had fullness in right ear and tinnitus. Approximately 2 weeks after TDAP, I had vertigo with vomiting.
Pain and numbness in shoulder, arm, elbow and hand; Pain and numbness in shoulder, arm, elbow and hand; Swelling in hands, face and feet; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 10:00 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunization at pharmacy or drug store. The patient was not pregnant at time of vaccination. Patient denied for any medical history. Patient concomitant medication(s) received within 2 weeks of vaccination included iron, multivitamins [vitamins NOS] (MULTIVITAMINS [VITAMINS NOS]), calcium, biotin, cyanocobalamin (B12 [CYANOCOBALAMIN]), all were taken for an unspecified indication, from an unknown start and stop date were not reported for any. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 07:30, the patient experienced pain and numbness in shoulder, arm, elbow and hand (could not use or feel her hand at all) and had swelling in hands, face and feet. It was reported that AE resulted in doctor or other healthcare professional office/clinic visit. The reporter considered the event as non-serious. The patient did not receive any treatment for the events. The outcome of events was resolving.  Follow-up attempts are completed. No further information is expected.
Local swelling, redness, some pain. Recommended TYLENOL or Ibuprofen.
Headache; congestion; tiredness; swollen armpit lymph node on arm injection received.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2022 14:00 (Lot number: FK9895) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypothyrodism" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "GERDS" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; EZETIMIBE; VIT D3; VIT B12; VIT E [TOCOPHEROL]. Past drug history included: Hydrocodone, reaction(s): "Known Allergies: Hydrocodone". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FD8448, Location of injection: Arm Right), administration date: 06Sep2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Right), administration date: 06Aug2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Mar2022 15:00, outcome "recovering", described as "Headache"; NASAL CONGESTION (non-serious) with onset 08Mar2022 15:00, outcome "recovering", described as "congestion"; FATIGUE (non-serious) with onset 08Mar2022 15:00, outcome "recovering", described as "tiredness"; LYMPHADENOPATHY (non-serious) with onset 08Mar2022 15:00, outcome "recovering", described as "swollen armpit lymph node on arm injection received.". Therapeutic measures were not taken as a result of headache, nasal congestion, fatigue, lymphadenopathy.  Additional information: Patient did not receive other vaccine in four weeks. Facility type vaccine was Pharmacy or Drug Store. Patient received other medications in two weeks were Estradiol, Ezetimibe, Vit D3, Vit B12, Vit E. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient experienced 10-15 minutes of intense muscle spasms around torso area approximately 30 hours after her covid vaccine
Patient given Tdap and Menactra vaccine.Patient left and returned 15-20 minutes later complaining of shortness of breath, welts and rash present on face and upper body. Patient taken into exam room, vitals taken and a dose of Benadryl given ,per doctors instruction. Patient kept in exam room resting, vitals taken every 15-30 minutes.Patient also complaining of nausea and vomiting x 2.Patient began showing mild improvement After being evaluated by Dr., patient also given Solumedrol 125mg, IM.Patient kept resting. Vitals rechecked, patients redness and rash had decreased, vomiting decreased, no shortness of breath present.After patient was examined again by Dr. and mother talked with at length, patient was prescribed Hydroxyzine 25mg and left facility.