chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menorrhagia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 06May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Prev dose administration date: 05May2021, prev dose dose number:  1/Prev dose administration date: 06May2021, prev dose dose number: 2"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 05May2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 22Dec2021, outcome "recovered with sequelae" (Jan2022), described as "Menorrhagia". The event "menorrhagia" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient did not receive any other vaccines within 4weeks prior to COVID vaccine and since the vaccination patient has not been tested for COVID 19. Device date:28Feb2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
bright red face & itching p/5th dose in series;was given DPH 30min a/inj & 20min post;
During immunization of ANTHRAX/HEP B/H1N1-pt passed out-sent to ER-observed-released.
Moderna LOT# 061B22A expired 11/27/2022. Pt. received doe on 11/30/2022. Moderna was contacted to determine stability, and determined that the vaccine maintained the activity necessary to protect against COVID-19 virus at the time of administration.
pt stated about 4 hours after taking the vax she had a terrible headache.  pt laid down but when she got up she had very sharp pains shooting from her toes up to her legs.  pt said she had a stabbing pain in her left mid thigh.  This episode lasted about 15 minutes.  the next day she went to a routine exam but her PCP did not seem to think there was anything to worry about.  pt had to have blood test 10 days later.  She stated she was so tired she could barely get to the lab to get the test.  The following weekend on 5/17/2021 she started having SOB and a coughing spell. On 5/19/21 she called to make an appt w/ PCP on 5/21/21.  She saw a different physician and she was ordered a D-Dimer test. On 5/22/21 the pt got a phone call stating she needed to get to an Emergency Room since the lab test proved she had a blood clot.  She went to ER.  They did a US Doppler and CT of lungs.  She had 2 pulmonary thrombosis. One in left lung and one in right lung.  She had one DVT in left calf.  Pt was admitted. She was given heparin IV for 3 days.  She was then put on Xarelto and discharged on 5/25/2021.  she has to take Xarelto for 90 days and scheduled to have another US on 7/19/2021 to see if the clots are dissolved.
Prolonged febrile seizure lasting 8 minutes in duration. Required EMS transport to hospital. Versed adm x 4 in route by EMS. Observation in ER and discharged home.
Tested positive for COVID; took paxlovid for 5 days; did not experience any symptoms.
Apparent seizure on 2-14-2008.  Taken to medical facility emergency room and was held in the hospital overnight for observation.  Patient was transferred to Hospital.  She was seen in the emergency room by Dr., pediatric neurologist, started on phenobarbital and will return to see him on 4-14-2008.  04/18/2008 MR received for DOS 2/15-16/2008 with D/C DX: Complex Partial Seizure.  Otitis media. Pt transfered to facility after being found in crib limp, pale and cyanotic with open eyes.  Infant had been crying previous to the event and suddenly stopped.  Admitted for w/u. PE (+) for R TM redness. Neuro exam WNL.
Started feeling achy, throat was sore, neck ached, temp was 99.2, had trouble sleeping that night but then slept most of the day on 10/14/11.
he reported that his girlfriend just tested positive on a home test kit; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he reported that his girlfriend just tested positive on a home test kit) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he reported that his girlfriend just tested positive on a home test kit). At the time of the report, COVID-19 (he reported that his girlfriend just tested positive on a home test kit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) tested positive on a home test kit, but the home kit is expired..   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747075 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747075:
24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild  chills.  While trying to get blankets, turning up heat, preparing dinner, had abnormal muscle and joint pain upon any movement.  No muscle or joint pain while sitting still.. 6 hours after symptoms took acetaminophen 500mg and diphenhydramine 25mg .  9 hrs after onset of symptoms felt fine with no symptoms and slept through the night fine.  48 hrs after vaccine feel completely normal.
No adverse event; administered dose one ofGARDASlL 9 in 2/2019 and will be in the ofT1ce today, 11/5/2019 to receive the second dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date in February 2019, patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose (dose, frequency, route, lot# and expiry date were not reported) for prophylaxis. On 05-NOV-2019, patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose (dose, frequency, route, lot# and expiry date were not reported) for prophylaxis. On 05-NOV-2019, longer than recommended interval between dose one and two (inappropriate schedule of product administration). No adverse event was reported. No additional information was reported. No product quality complaint (PQC) was reported.
Pt reported redness, swelling and warmth at the site. Arm soreness and Temp of 102 and body aches.  2 pts reported the same symptoms in similar time period.
1104 -Vaccine administer IM in L arm. 1110- PT states to complain of having something in her throat. Denies having any SOB, chest tightness, itching, and no hoarseness.  1115- PT is clearing her throat more and states that she feels like she has to keep clearing her throat more and started to have Hoarseness denies having SOB but states that she is having a harder time breathing when positioning her head in certain ways.  1118- Minimal  facial swelling noted clearing throat more often pt continues to talk to staff. Denies having SOB or chest tightness. Doctor notified of pt's symptoms and instructed to give Epi-Pen NOW. Epi-PEn(Lot #0FM407 exp: 02/2022) administered to Left Thigh by LPN. Pt tolerated and continues to talk to staff.   1120- Doctor in Room evaluating patient. Doctor instructed to continue monitoring in room for the remainder of 30 minute wait and advised patient that she could return back to work since pt works in the hospital. PT voiced understanding. Pt continues to deny SOB and chest tightness.  1125- PT states that she can tell her throat is starting to feel better states that she doesn't feel like she has to continue clearing throat. Continues to communicate with staff and continues denying any SOB.  1130- PT continues to states that feels like she is improving. Facial swelling has gone down. Continues to communicate and denies having and SOB and chest tightness.   1135- PT's 30 minute wait is up and Pt continues communicating with staff. Denies SOB states that she feels somewhat better. Informed patient that she could continue to be monitored by immunizations RN but pt denies  and verbalized that ''Dr. said I could go back to work''. Informed patient that if symptoms do not improve and if she starts to have SOB, difficulty swallowing, swelling in throat or tongue to seek immediate attention at the ER. Pt verbalized understanding and ambulated out of area.
Generalized urticaria, itchy, no fever, no respiratory distress after receiving JEV #2 1 week.
Pt. recieved vaccine greater than 12 hours after being drawn up. No adverse event.
urticaria (hives/itchiness starting in the scalp and moving down to the neck/arm over course of 1 or 2 hours).  General fatigue, some phleghm
Fast heart rate in the morning 5 days after vaccine administration, then patient exercised and developed hives.
Had the Shingles vaccine and I still got them/Suspected vaccination failure; Still got them (shingles); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingles vaccine and still got them. The patient stated that fortunately, no pain and Valtrex took care of them. The patient stated that ugly. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Case number PHEH2016US021633, is an initial spontaneous report received from a physician on 25 Aug 2016. This report refers to a 7 year old female patient. Medical history and concomitant medications were not reported. The patient received FLUCELVAX QUADRIVALENT (batch number: 185286) at a dose of 0.5 ml intramuscularly on 24 Aug 2016. On the same day approximately 15 minutes after receiving vaccination, the patient experienced upset stomach, tachypnea, wheezing and angioedema (the physician reported it as anaphylactic reaction to vaccine). The physician reported that, the patient experienced asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin. The physician reported that symptoms have resolved except patient was still coughing. The physician stated that steroids, albuterol and BENADRYL would be required as a treatment. The outcome of the events GI upset and cough was reported as complete recovery on 24 Aug 2016, of the event angioedema was reported as complete recovery on 25 Aug 2016, of the event wheezing reported as complete recovery on 26 Aug 2016 and outcome of other events was not reported. Seriousness of the events was not reported. The physician assessed the causality between the events and FLUCELVAX QUADRIVALENT as suspected. Seriousness of the event anaphylactic reaction was upgraded based on Novartis important medical event (NVS IME) list. Follow up report received from a physician on 10 Oct 2016: Added events (asthma, dyspnea, chest discomfort, sneezing, erythema, flushing, urticaria, rash, edema/swelling of eye, eyelids and skin). Updated event information (event end dates of the events angioedema, wheezing, GI upset and cough and outcome of event cough) and treatment information and updated the narrative accordingly.
sore arm; joint pain all over/ knee is hurting; bheadache that is a "doozy"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint pain all over/ knee is hurting) and HEADACHE (bheadache that is a "doozy") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint pain all over/ knee is hurting) and HEADACHE (bheadache that is a "doozy"). At the time of the report, PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint pain all over/ knee is hurting) and HEADACHE (bheadache that is a "doozy") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Her arm was black and blue and swollen; Her arm was black and blue and swollen; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Her arm was black and blue and swollen) and PERIPHERAL SWELLING (Her arm was black and blue and swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced SKIN DISCOLOURATION (Her arm was black and blue and swollen) and PERIPHERAL SWELLING (Her arm was black and blue and swollen). At the time of the report, SKIN DISCOLOURATION (Her arm was black and blue and swollen) and PERIPHERAL SWELLING (Her arm was black and blue and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Antibiotic was reported.  No treatment was reported in the source document.
Migraine and very drained of energy for 2 days beginning the morning after the vaccination.
Case number PHEH2013US010146, is an initial spontaneous report received from a health care professional on 03 May 2013. This report refers to a 10-year-old female patient. Her past medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: X11047, A11047) intramuscularly on an unspecified date. On 16 Jul 2012, she experienced raised, warm to touch, softball size. On an unspecified date, she developed cellulitis. She went to emergency rescue. She was treated with antibiotics for cellulitis. Outcome, seriousness and causality of event were not reported.
Pt evaluated by local EMS for unwell feeling and dry mouth. Pt was anxious. No other signs or symptoms of allergic reaction noted on physical exam. Vitals stable including B/P and Resp rate and SPo2%. Lungs were C+E bilat. Spo2 100%. B/P 176/86. Pt administered 25mg of Benadryl IM, Lft Deltoid. ECG 4 lead showed NSR. Pt transported by local EMS to HCF.
This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's concurrent conditions included diabetes mellitus and hypertension. On 13-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot # reported as M020902, expiry date: 18-SEP-2017), at a dose of 0.65 ml, once (route: subcutaneous). Concomitant therapies included metformin, PRINIVIL, JANUVIA and glipizide. On 14-SEP-2016, at mid-day, patient's injection site was inflamed, very red and patient experienced itching. On the same day in the evening, patient experienced frequency of stools, resulting in stomach irritation and decreased urine output. The patient did not receive any treatment for the events. The outcome and causality of the events were unknown. Additional information has been requested.
extremally dizzy; all of sudden felt down; felt icky; No energy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremally dizzy), FALL (all of sudden felt down), FEELING ABNORMAL (felt icky) and ASTHENIA (No energy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     Concomitant products included CALCIUM, MAGNESIUM and ZINC for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (extremally dizzy), FALL (all of sudden felt down), FEELING ABNORMAL (felt icky) and ASTHENIA (No energy). At the time of the report, DIZZINESS (extremally dizzy) and FALL (all of sudden felt down) had resolved and FEELING ABNORMAL (felt icky) and ASTHENIA (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included Vitamin C for an unknown indication.  Follow up received on April 30 included additional events of feeling abnormal(feeling icky) and asthenia (low energy) and dose 2 events which will be reported in  a  separate report with case # MOD-2021-100848.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-100848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up was received on 30 Apr 2021 included New AE added
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with diabetes and penicillin allergy. On 13-SEP-2014 the patient was vaccinated with ZOSTAVAX (dose and route not provided). Concomitant therapies included BENADRYL. The pharmacist reported that on 13-SEP-2014, patient had a site reaction and a red marking where she received the ZOSTAVAX. Pharmacist reported patient had a small grade of shingles and broke out in blisters on the top part of her chest and shoulders and site reaction and a red "marking" where she received the ZOSTAVAX was reported as not recovered/not resolved. Relatedness between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
1 day after (3/12) - general body ache until 10am. 2 day after (3/13) - same as my Covid experience - bad sinus pressure behind eyes/pain behind eyes/eyes burned/fatigue. 3 day after (3/14) - same as 3/13, but slightly less/fatigue. 3/15 thru 3/29 - slight pressure behind eyes and went away on 3/29.
caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 days later; depression was ten times worse than it was before the second vaccination; feeling like sick; 101 fever for two days; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; Headache pounding; nausea; fatigue; swollen gums; can't eat; I'm in very bad shape; crying; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Mar2021 at 12:00 (at 44 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included bipolar, asthma, hypothyroidism, and depression; all from unspecified date. The patient had no known allergies. Concomitant medications included quetiapine fumarate (SEROQUEL), lurasidone hydrochloride (LATUDA), clonazepam (KLONOPIN), lithium, and levothyroxine sodium (LEVOTHYROXIN); all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 06Mar2021 at 13:15 (at 43 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that after her second shot (27Mar2021 at 12:00), in the middle of the night, the patient woke up feeling like sick like someone hit her with a truck. A 101 fever for two days, pain and swelling under her arms and at the injection site. Headache pounding, nausea, fatigue, all of a sudden it caused her back to be in so much pain that she still can't walk 4 days later, swollen gums, can't eat, her depression was ten times worse than it was before the second vaccination. The patient stated she was in very bad shape since this happened on 28Mar2021 (Sunday). The patient also added "I beg you to study the effects of this injection on people with a mental illness. I'm still crying." The start date of the event was on 28Mar2021 at 04:00. The events caused her back to be in so much pain that she still can't walk 4 days later, still can't walk 4 days later, and depression was ten times worse than it was before the second vaccination were considered medically significant. All events resulted in physician office visit. No treatment received for the events. Outcome of crying and still can't walk 4 days later was not recovered, while the rest of the events was recovered with sequelae on unspecified date in Mar2021.  Information on batch/lot number has been requested.
The patient received the vaccine from an expired vial.  Patient is returning on 06/03/2021 for follow up vaccination
Information has been received concerning a pt who post vaccination, had a site reaction with pain at the injection site and redness from his shoulder to his wrist.
Throwing up, headache, can't hardly breathe, diarrhea, chills... laying down in bed... slowly eating crackers and flat ginger ale