chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DOWN AND OUT FOR 3 DAYS; MAJOR MIGRAINE; NAUSEA; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced down and out for 3 days, major migraine, nausea, and extreme fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of the down and out for 3 days, major migraine, nausea and extreme fatigue was not reported. This report was non-serious.
Injection on 11-14-2011 - pain & nausea - same day. Office visit 2 days later - extreme local reaction with pain - warmth, local urticaria at injection site only - pain radiated to forearm - nausea without vomiting. Treatment - ondansetron & Prednisone & loratadine.
Extreme fatigue,  lethargic, migraine, extreme all over body aches /joint aches.  Symptoms began the next morning after receiving the first dose of the Moderna  vaccine. Symptoms lasted for 72 hours. I took 1,000 mg Tylenol once symptoms developed on 03/27/2021. Tylenol did not help so I discontinued taking Tylenol. I also take 20 mg. of Mobic daily. Mobic did not help with pain relief.  My symptoms made me feel like I had COVID again  (I tested positive for COVID in July 2020) which was horrible. On day 3, I developed fever/chills which lasted around 8 hours.
The patient had an ischemic stroke (confirmed by MRI) on Friday, 4/2, approximately 24 hours after the 2nd dose of the Moderna vaccine given on 4/1.  The symptoms of the stroke began in the evening on 4/2 and consisted of left face, arm, and leg weakness.
Diverticulitis acted up; bumps breaking out all over her body; itched; welts; fever of 100 degrees Fahrenheit; achiness; pain in toe nails and finger nails; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis acted up) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diverticulitis.  Concomitant products included DULAGLUTIDE (TRULICITY), SIMVASTATIN, LOSARTAN, ESCITALOPRAM, ROPINIROLE HYDROCHLORIDE (REQUIP), GABAPENTIN, MELOXICAM, LEVOTHYROXINE, CANAGLIFLOZIN HEMIHYDRATE, METFORMIN HYDROCHLORIDE (INVOKANA DUO), METFORMIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR), CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3), CENTRUM SILVER +50, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and TRAMADOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 10-Mar-2021, the patient experienced PAIN (achiness), ONYCHALGIA (pain in toe nails and finger nails) and PYREXIA (fever of 100 degrees Fahrenheit). On 20-Mar-2021, the patient experienced SKIN MASS (bumps breaking out all over her body), PRURITUS (itched) and URTICARIA (welts). On 21-Mar-2021, the patient experienced DIVERTICULITIS (Diverticulitis acted up) (seriousness criterion medically significant). On 23-Mar-2021, DIVERTICULITIS (Diverticulitis acted up), SKIN MASS (bumps breaking out all over her body), PRURITUS (itched) and URTICARIA (welts) outcome was unknown. At the time of the report, PAIN (achiness), ONYCHALGIA (pain in toe nails and finger nails) and PYREXIA (fever of 100 degrees Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included prednisone and benadryl.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Fever is consistent with the known safety profile of mRNA-1273
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 31-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt presented with shortness of breath and was diagnosed to have acute hypoxic respiratory failure secondary to Covid pneumonia and was admitted for further evaluation and management under Hospital Medicine Service.  Given the patient's acute hypoxic respiratory failure with high oxygen dependence on high-flow nasal cannula the patient has an extended hospital course and was seen by multiple subspecialists during this hospital stay including Pulmonary Medicine, Hospital Medicine, Psychiatry as well.    Critical care team/pulmonary medicine have followed with him for management of his acute hypoxic respiratory failure.  Patient finished Baricitinib, dexamethasone, antibiotics including Rocephin and doxycycline, Remdesivir and was on high-flow nasal cannula for an extended duration of time but gradually improved and is down to nasal cannula oxygen support and has been holding stable with his respiratory status at discharge.
LIGHTHEADED/DIZZY/FELT HOT SWEATING  (LASTED 3 DAYS) RIGHT AFTER IMMUNIZATION (ICE PACK APPLIED AND DRANK WATER).  A VERBERATION WITH SPEECH (STOPED DAY OF THE SHOT).  VERY SHAKY.  DIFFACULT TO WALK DUE TO DIZZYNESS. OUT OF BREATH.
emergency room HPI 73 y.o. female who presents with dizziness and loss of consciousness. Patient reports that she was sitting outside in the sun this afternoon and became hot, she then went inside and came back outside to sit in the shade. She reports that she became "dizzy," lightheaded, nauseous, and that her vision began to go black. Reports that she awoke to her sister shaking her in the chair and calling EMS. Unsure of LOC time, but believes it to be short-lived. She then had one episode of vomiting. Denies vertigo, hitting head, trauma, headache, chest pain, palpitations, shortness of breath, and edema. Denies recent illness or sick contacts. Denies h/o similar episodes.
product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2022 as dose 1, single (Batch/Lot number: unknown) and on 05Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Sep2016, stop date: May2022; HYDROCHLOROTHIAZIDE, start date: Sep2014, stop date: May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) positive, notes: with a test on 25May that was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies. The patient took other medication in 2 weeks. Patient was exposed to COVID-19 on 21May2022 and developed symptoms on 22May2022, with a test on 25May2022 that was positive. Her symptoms were dizziness, diarrhea, mild cough and minimal SOB. She was prescribed Paxlovid on 27May2022 and subsequently developed nausea, vomiting, and lower leg muscle cramps. She presented to the ER in the evening on 28May2022 where her sodium was found to be 109. All home medications, including Paxlovid, were discontinued and she was admitted to the ICU. Her hyponatremia was slowly corrected with her transferring to acute care on 31May2022 (sodium 122). Her sodium was slowly corrected to 129 with her discharging on 2Jun2022. She never required in hospital treatment for COVID-19, nor did she develop oxygen requirement.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Information has been received from a Nurse Practitioner concerning a female patient who on 27-Oct-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient fainted in the office, hit her head on the floor and required stitches. Medical attention was sought. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving. Treatment dugs:
Pt recvd MMR vax on 3FEB92 & recvd 2nd dose 4MAR92 & on 7MAR92 pt exp sore throat, myalgias & devel rash; pt went to ER:
Metallic taste and vomiting 13 hours after. Extreme gas since injection so far lasting 2 weeks bad pains
Soft tissue pain in arches of feet and calves; fatigue; Hand and arm soreness; Leg shaking; Swollen glands; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand and arm soreness), TREMOR (Leg shaking), SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves), LYMPHADENOPATHY (Swollen glands) and FATIGUE (fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MIRTAZAPINE (REMERON) and ALPRAZOLAM (XANAX) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) and CHILLS (Chills). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Hand and arm soreness) and TREMOR (Leg shaking). On 01-Feb-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Soreness of joint, at an unspecified dose and frequency. On 27-Jan-2021, LYMPHADENOPATHY (Swollen glands) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Hand and arm soreness), TREMOR (Leg shaking), SOFT TISSUE DISORDER (Soft tissue pain in arches of feet and calves) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative and results pending (Inconclusive) results pending.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-021419 (Patient Link).
Information has been received regarding a case in litigation, from a lawyer, regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In 2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the pharmacist. On unknown date, the patient experienced shingles (herpes zoster) and in 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (quality of life decreased and condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Client noted "large bumps" of a two inch diameter around injection site 3-4 days after administration.  These bumps itched and did become smaller until disappearing approximately 8 days after administration.  Client states no redness at sight and no other symptoms.  Client checked with doctor who stated not to get third vaccine and to have titre drawn in one year.
Red circle around the injection site and warm to the touch; A red circle around the injection site; A spontaneous report was received from a Consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a red circle around the injection site, warm to the touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the events of a red circle around the injection site and warm to the touch.  No treatment information was provided  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, a red circle around the injection site and warm to the touch was not reported..; Reporter'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. Further information has been requested.
Numbness, pain right arm and hand weakness. Began night after vaccine. increased symptoms. DX Acute Brachial Neuritis.
it is starting to swell under their armpit; arm has been extremely painful, they cannot move it, it has blew up, swollen up; sore arm; sore arm arm has been extremely painful; This spontaneous case was reported by an other health care professional and describes the occurrence of AXILLARY PAIN (sore arm arm has been extremely painful), LYMPHADENOPATHY (it is starting to swell under their armpit), VACCINATION SITE MOVEMENT IMPAIRMENT (arm has been extremely painful, they cannot move it, it has blew up, swollen up) and PAIN IN EXTREMITY (sore arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AXILLARY PAIN (sore arm arm has been extremely painful). On an unknown date, the patient experienced LYMPHADENOPATHY (it is starting to swell under their armpit), VACCINATION SITE MOVEMENT IMPAIRMENT (arm has been extremely painful, they cannot move it, it has blew up, swollen up) and PAIN IN EXTREMITY (sore arm). At the time of the report, AXILLARY PAIN (sore arm arm has been extremely painful), LYMPHADENOPATHY (it is starting to swell under their armpit), VACCINATION SITE MOVEMENT IMPAIRMENT (arm has been extremely painful, they cannot move it, it has blew up, swollen up) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included icing, pain medication and elevating the arm No concomitant medications reported by reporter.
Headache started 2/20/2022 at or around 11:00. Reminds me of the headache I experienced during covid.
Mother of patient came to Health Department on 03/31/2011. Stating her son had numbness in legs progressing to belly button, cramps in legs and legs giving out 4-6 wks after H1N1 vaccine was given. Mother stated she felt like it was growing pains. She took child to see physician 01/2011. Then seen specialist 02/2011. Mother states physician feels like it is Charcot Marie Tooth Disease. EMG being done 05/16/11. Mother wonders if it could be GBS.
Lips tingling and burning, top and bottom. no visual effect. no redness or swelling
Cellulitis at inj site AUGMENTIN 875 1 BID #20.
Sat 1/15 began to experience eruptions on scalp, painful, reddened, raised, 2-3 mm diameter, posterior and R side of scalp. Area of vaccination became swollen and reddened. Red streaking toward R axilla began Sunday 1/16. Noted scattered pustules appearing on lower anterior neck and upper chest on Tuesday 1/18. One pustule on R upper anterior thigh, one on lateral dorsal L hand. Redness of lower lid L eye noted Tuesday 1/18 - pt states site is painful.
Rash from scalp neck and chest began 3-4 hours after injection. Itching and redness would subside with 25 mg of Benadryl but would come back with a vengeance as soon as Benadryl wore off. I also used hydrocortisone cream to release itching. Rash continued to spread to my thighs after 3 days. I had large red welts all over, itching, nausea, and redness.   Massive headache began about 12 hours after injection and lasted for about 24 hours.   Injection site pain and soreness began about 2-3 hours after injection and has been subsiding since then.
mom reports high pitched crying 1-2times for a couple of seconds long 24hr p/vax;then mild hives 48hr p/vax throat swelling;mom drove pt to ER;pt given pred;f/u w/MD p/pred rx was completed;
Chills the day and night after shot Flu like symptoms for next 2 days: headache, dizziness, lethargy and fatigue after sleeping 16 hours, loss of appetite
Received flu vaccination on 9/23/16 at 4:45 pm. Left arm became sore and unmovable for the next two days. Any movement caused severe pain and was unable to attend work that weekend. Treatment consisted of two rounds of Prednisone and four FLECTOR patches to no avail.
34 days post vax, the pt was seen by a physician for facial pain and facial drooping. Physician initially thought that pt had a sinus infection and prescribed antibiotics. Pt returned to physician's office for follow-up because he still in pain. Physical exam revealed facial drooping and disconnected gaze. Dx with facial palsy. Physician stated that the pt's symptoms completely resolved approximately two weeks after they initiated.
Pt recvd 1st dose of Hep B 10SEP91 & exp elevated bilirubin & jaundice wk of 27SEP91;
This spontaneous report as received from a other health professional refers to a 11 years old female patient with no illness at time of vaccination, no adverse events following prior vaccination and no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (668051/1262AA) dose 3 GARDASIL, IM, left deltoid on 28-DEC-2011 at 10:16 AM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. There was no labs diagnostic performed. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to 7 unspecified patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medications were not reported. No previous drug reactions/ allergies were reported. On an unknown date in 2016 these patients were vaccinated with improperly stored doses of GARDASIL (lot # L040459 and expiry date 06-APR-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 26-APR-2016, the vaccines were exposed to a temperature of 34 degree Fahrenheit for 15 hours. On 26-JUL-2016, the vaccines were exposed to a temperature of 35 degree Fahrenheit for 23 hours 30 minutes. On 27-JUL-2016, the vaccines were exposed to the temperature of 34 degree Fahrenheit for 17 hours 15 minutes. On 28-JUL-2016, the vaccines were exposed to the temperature of 33 degree Fahrenheit for 15 hours 30 minutes. The temperature excursion was detected by a data logger. No previous temperature excursion were reported. No product quality complaint was involved. This is one of the 3 reports received from the same reporter source. Additional information has been requested.
Client in clinic for check up on STD's. Patient denied having had Hepatitis vaccine in high school and requested them now. Pt underage but was given TWINRIX vaccine before realizing he was under 18.
Throat swelled until hardly able to swallow. I immediately took Benadryl. Sweling down within an hour.