chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced paresthesis and achiness of feet, then legs, then hands, and arms progressing over 9 days.  Today, on day 10 hips and shoulders also painful.  Weakness and pain worse on exertion.  Numbness and tingling most concentrated in hands and feet, lower arms and legs.  12/1/09 Medical records received, service dates 11/24/09 to 12/1/09. Assessment: Muscle weakness, fatigue, paresthesias, and aching. Patient complains of body aches, presents with tingling, numbness, and migratory paresthesias. Worried re Guillain Barre. Numbness and tingling soles of feet, aching in feet. Weakness of dorsiflexion of left big toe. Numbness progessed to thighs, tingling numbness in hands, forearms. Feels cold all over. Weakness, fatigue. Choked on food, liquid, dysphagia. Clonus (L) foot. Decreased pinprick perception (L) lower extremity. Hyperreflexia. Caffeinated beverages. Continues to have pain in feet and legs, also shoulders and hips.
Received Tdap at 445 pm awoke at 900 pm with swollen eye, lips, difficulty breathing pain at site of injection with skin rash at site.
Patient has memory loss issues.  He had forgotten that he received his third dose at his doctors office along with a flu shot so patient actually received 4 doses.  No adverse effects were reported.
This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (POSSIBLE AE receiving a full dose instead of a booster dose by mistake) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (POSSIBLE AE receiving a full dose instead of a booster dose by mistake). At the time of the report, ACCIDENTAL OVERDOSE (POSSIBLE AE receiving a full dose instead of a booster dose by mistake) had resolved.  Concomitant product use was not provided by the reporter.  No treatment information provided. Caller mentioned following vaccination with the booster dose he got a new vaccination card saying he needed to receive a second dose. Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Non significant followup received on 16-Nov -2021.
beginning the following morning: hot flash followed by chills followed by vomiting.  Hot flashes, Chills, Nausea, Vomiting, Diarrhea continued for 48 hours
Patient received the vaccine while seated, got up and walked a few feet, returned to room, fainted then fell to floor hitting head; picked up by mother, placed on cart, O2 administered, head tilt/chin lift  done; HR and pulse ox monitors applied; pt responded within a minute or so, crying/confused, c/o headache, with contusion and abrasion to chin, c/o jaw pain and no stated "Am I done yet mommy?"; pt bit tongue on both sides with minimal bleeding noted, resolved quickly; pt given 150mg Ibuprofen at request of mother and po sips of water; pt rested on cart for approximatley 30-45 minutes, then left, carried by mother where pt was taken to see ED physician who is family friend for evaulation; no further recommendations from ED physician; pt taken home, ate dinner without difficulty although con't to c/o chin and jaw pain; rested; bed by 830 pm after medicated with acetaminophen; patient woke up a couple of times in night, appeared restless, returned to sleep after briefly being consoled by mother. Woke up next am without difficulty, worried about eating breakfast and hurting jaw; medicated with acetaminophen and ibuprofen; appeared to act normally except for being scared about previous events.
My period started over 11 days too early. My period usually starts on the 22nd and I am never this early.
Information has been received from a consumer referring to his/her mother, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provide. On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot number and expiration date were unknown) for prophylaxis. The reporter was not sure which pneumococcal vaccine the patient received but the reporter would find out. On an unknown date, the patient was in hospital with cellulitis. The outcome of the event was unknown. The reporter considered the patient was in the hospital with cellulitis to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Upon internal review, cellulitis was considered to be medically significant. Additional information has been requested.
After the second vaccination on April 3, 2021, I started having a low-grade fever on Tuesday, April 6. The fever was oscillating between 97 and 99.8°. On April 10 the fever got worse and went as high as 101.8°, and I started to develop a cough. I called my local general practitioner for advice on Monday, April 12. Should recommended A Covid test. Over the course of the week I continue to have symptoms of fever oscillating between high and low temperatures (chills and fever) and an increasing development of the cough. Over the course of the illness mornings seem to be better and the temperature with spike in the afternoon. Sleeping was difficult because of the persistent cough. It is currently April 19, 2021 and I still have the persistent cough and intermittent low-grade fever. I had an appointment with my my doctor Dr., she indicated that although the duration is longer than a normal lease see that this would appear to be an adverse effect two of the Covid vaccination. She requested that I report the symptoms that I was having.
Information has been received from a registered nurse, via a company representative, concerning a 12 year old female patient, who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, of Gardasil (Lot # 655205/1426F).  There was no concomitant medication.  Subsequently the patient developed diabetes, sometime "after 03-APR-2007."  At the time of this report, the outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Patient felt unwell following vaccination.  He was dry heaving and looked pale.  We applied ice pack to his neck  and kept his feet elevated.  He was feeling better within 5 minutes.  Follow up phone call to mother resulted in her stating that he was feeling fine
UPSET STOMACH; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart issues, and blood issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood issues, and heart issues, clopidogrel bisulfate for blood issues, and heart issues, and apixaban for heart issues, and blood issues. On 02-APR-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upset stomach on 02-APR-2021. This report was non-serious.
Pale and started to faint .  Put in a lying position.  B /p 87/55 lying down, up to 128/75 prior to discharge.  Drank some water and feeling better.  Discharged home
Information has been received from a physician concerning a patient who was vaccinated with a dose of Rotateq. Subsequently the patient experienced hematochezia. It was noted that the hematochezia lasted about a week. The outcome was recovered. Upon internal review, hematochezia was considered to be an other important medical event. Additional information has been requested.
Fever, chills, weakness, fatigue, diarrhea, nausea, headache, joint pains, muscle pain.
Pt. showed an injection site reaction; red, swollen, itchy, warm to touch. Pt. has been putting ice on it.
chest pain; loose bowel movements; Symptoms have gotten progressively worse; muscle pain / new muscle pains; Joint pain three weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), MYALGIA (muscle pain / new muscle pains), DIARRHOEA (loose bowel movements), ARTHRALGIA (Joint pain three weeks after first dose) and POST PROCEDURAL COMPLICATION (Symptoms have gotten progressively worse) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ARTHRALGIA (Joint pain three weeks after first dose). On 08-Jun-2021, the patient experienced MYALGIA (muscle pain / new muscle pains). On an unknown date, the patient experienced CHEST PAIN (chest pain), DIARRHOEA (loose bowel movements) and POST PROCEDURAL COMPLICATION (Symptoms have gotten progressively worse). The patient was treated with PREDNISONE ongoing from 02-Jun-2021 at a dose of 20 mg. At the time of the report, CHEST PAIN (chest pain), MYALGIA (muscle pain / new muscle pains), DIARRHOEA (loose bowel movements), ARTHRALGIA (Joint pain three weeks after first dose) and POST PROCEDURAL COMPLICATION (Symptoms have gotten progressively worse) outcome was unknown.
6/1/99 after vax pt began to itch at 9pm he develop rash on 6/2/99 used over the counter Benadryl to control itching
Fatigue initially, subsided after 24 hours. Approximately 48 hours after the vaccinations vertigo began and is not consistent. Vertigo happens when laying down, getting up too quickly, or excessive movement.
numbness on the right arm where she was vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (numbness on the right arm where she was vaccinated) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (numbness on the right arm where she was vaccinated). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) on 01-Feb-2021 for Vaccination site hypoaesthesia, at a dose of UNK dosage form. On 01-Feb-2021, VACCINATION SITE HYPOAESTHESIA (numbness on the right arm where she was vaccinated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was reported as Lasix.
He is a 68 y.o. male patient of MD with history of COPD/Emphysema, Amyloidosis, Asthma, Beta Thalassemia, PAF s/p PPM and Watchman device, DM2, HFpEF, HTN, OAB, Prostate Cancer presented to the Medical Center with shortness of breath found to have COVID-19 .   Acute Respiratory Failure with hypoxia, resolved Presented with shortness of breath Sat > 90% on room air in ER but increased work of breathing Secondary to COVID-19 Weaned to room air (3/31) Pulm followed   Covid-19 Virus Infection Date of onset of symptoms: 3/30 Symptoms present on admission: Shortness of breath Date of covid positive test: 3/31 Vaccination status: vaccinated and boosted Imaging: CXR (3/30) with mild perihilar opacities, interstitial thickening, small R pleural effusion Oxygen requirements on admission: BIPAP, for increased work of breathing, no hypoxia Current oxygen requirements: Room air Medical therapy: steroids, will discharge on 6mg dexamethasone to complete 10 day course Consultants following: Pulm Anticipated special isolation end date: 4/10/23   COPD/Emphysema Asthma No acute exacerbation Continue home Atrovent, Albuterol, Breo Ellipta, Spiriva   DM2, not on long term insulin A1C pending Holding home jardiance, linagliptan SSI Resume home meds at discharge   HTN Continue home aldactone and torsemide   Chronic HFpEF EF 60-65% per history Euvolemic on exam Continue home aldactone and torsemide PAF S/P PPM and Watchman Continue home amiodarone Continue home eliquis   Gout Continue home allopurinol Pt states not taking colchicine   BPH Continue home flomax
Patient received a janssen shot from another facility on 03-16-21. Pt did not tell the pharmacy this was her second shot and wanted to get the Johnson and Johnson. Her caregiver called us to inform pharmacy that this in fact was her second shot of Janssen. Her first shot was at ESF-8 COVID clinic on 03-16-21.
Soreness at injection site; dizziness; nausea (vomited once); nausea (vomited once); cold hands; slight chills; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9262) via an unspecified route of administration on 30Jan2021 at 14:00 in left arm as 1st dose, single dose for COVID-19 immunization. Medical history included epilepsy, elev. cholesterol (contr. By meds.). Concomitant medication included phenytoin, atorvastatin. Prior to vaccination, patient was not diagnosed COVID. Patient did not receive any other vaccine in four weeks. On 31Jan2021 at 04:30 PM, patient experienced soreness at injection site, dizziness, nausea (vomited once), cold hands, slight chills. No treatment was received for the adverse events. Patient had not been COVID tested post vaccination. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
I experienced very bad stingy in my arm for 5-10 minutes, sore to touch at the site for 2 weeks afterwards.
TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report was received from a consumer (PVX2019-235) on 24-Jan-2019. The report describes a male consumer who "took unrefrigerated Vivotif". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer finished entire course of Vivotif but the doses were unrefrigerated. He took his first dose on 17-Jan-2019.  The action taken with Vivotif with respect to the event "took unrefrigerated Vivotif" was not applicable.  The clinical outcome of the event "took unrefrigerated Vivotif" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Development of a small circle of erythema on day of vaccination, but then increased to 10x8cm area of erythema surrounding the vaccine site by day #4. Tender to palpation, but no fluctuance. Started on doxycycline for presumed cellulitis.
Wednesday Feb 24 -Started as flu like symptoms with aches, fever, chills , nausea. Thursday Feb 25-Aches and fever continued. Sharp chest pains started Friday Feb 26-Aches, fever and sharp pain continued. Blisters broke out on torso. Contacted doctor symptoms continued over the weekend Tuesday Mar 2 Saw doctor-diagnosed as shingles.Treated for shingles for the next 5 months
Received second dose of Pfizer on Saturday 3/20/2021. Conceived sometime either right before or in the week after receiving the shot. Had a strong reaction for 3 days that week most likely from the shot (fever, diarrhea, body aches, fatigue) from Wednesday-Friday.  I found out at my 9 week prenatal visit that baby was not viable and appeared to have stopped growing at 6 weeks gestation.
constipation continued and worsened 4 days after second Pfizer shot; tinnitus; dry mouth; the top of my tongue has turned white; a serious taste distortion in my mouth; This is a spontaneous report from a contactable consumer (the patient). A 53-year-old male patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included autoimmune autonomic disorder, Sjogren's disease, Crohn's (in remission 3 decades), COVID, known allergies: Ototoxic reaction to clarithromycin (BIAXIN), also skin rash to levofloxacin (LEVAQUIN) and ciprofloxacin (CIPRO). Concomitant medication included doxycycline taken for an unspecified indication from an unspecified date. No other vaccine was used in four weeks. No COVID tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) via an unspecified route of administration in right arm on 01Mar2021 06:45 PM at age of 53-year-old for COVID-19 immunisation. Approximately 4 days after the first COVID shot (05Mar2021), the patient developed constipation. This constipation continued and worsened 4 days after his second Pfizer shot (27Mar2021). On 23Mar2021, the patient developed tinnitus and a very dry mouth. Coincident with the dry mouth, the top of his tongue had turned white and he have developed a serious taste distortion in his mouth. The constipation initially partially responded to laxatives between the first and second vaccinations, but starting 4 after the second vaccination, the laxatives have stopped working. The events were resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient underwent lab tests and procedures which included abdominal CT, blood tests, hearing test, all with unknown results. The outcome of the events was not recovered.  Information about the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361319 same patient/drug, different events after first dose
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FEELING HOT (Hot), HEADACHE (Bad headache) and FATIGUE (Feels tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), FEELING HOT (Hot), HEADACHE (Bad headache) and FATIGUE (Feels tired). At the time of the report, MALAISE (Not feeling well), FEELING HOT (Hot), HEADACHE (Bad headache) and FATIGUE (Feels tired) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact.
Felt like I had food poisoning.  Intense diarrhea, intense cramps, nauseous (thought I was going to throw up), body temperature kept going up and down (cold one minute and hot the next minute) - Started at 10:00 p.m. and lasted close to an hour.  After that, felt extremely light headed
female child received her M-M-R II on 6/30/2014 and less than 28 days later her VARIVAX; No adverse effects reported; This spontaneous report was received from a registered nurse and  refers to a female patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.          On 30-JUN-2014, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported).    On 14-JUL-2014, less than 28 days later the patient was vaccinated varicella virus vaccine live (oka/merck)(VARIVAX)(inappropriate schedule of product administration) (dosage schedule, route, anatomical location, lot number and expiration date were not reported).   No adverse effects reported.   The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Developed red, raised area (approx3-4CM) on rt deltoid, previous inject site of MMR; No edema no generalized hives noted; No resp distress noted; given Epinephrine; child developed similar type rxn @ site of HIB & Epinephrine;
Omicron BA.1/BA.2 coinfection; Omicron BA.1/BA.2 coinfection; This is a literature report.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Omicron BA.1/BA.2 coinfection". The patient underwent the following laboratory tests and procedures: Multiple fragment analysis: COVID-19 cases caused by coinfection with, notes: different SARS-CoV-2 variants (Delta/Omicron BA.1 and Omicron BA.1/BA.2); SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. The patients had a mild course and overcame their symptoms within 2 weeks.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events "Drug ineffective" and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201307874 Same article, drug, event and different patient;
Erythema on 8/21, 30cm x 20cm, increasing to 105cm x 90cm on 8/22. Patient was prescribed prednisone and  kenalog cream.
my ears built up tremendous pressure behind them; my eustachian tubes collapsed; Tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient received the first dose of BNT162B2 and within 7 hours ears built up tremendous pressure behind them, eustachian tubes collapsed and patient had to continually try to pop ears for 2 weeks. Patient's ears were sensitive to the slightest pressure change. Patient had to pop ears frequently. Shortly after eustachian tubes collapsed, patient developed tinnitus in both ears. It had not gone away. Patient had never had any problems with ears prior to receiving this vaccine so patient had made the assumption this was the result of the vaccine. Patient decided not to take the second dose. For fear, the side effects would worsen. Outcome of tinnitus was not resolved. Outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
6 hours after booster, sore arm. Tylenol taken.  12 hours after booster, fever of 101.1. Tylenol taken.  18 hours after booster, fever of 101.5, heart palpitations, chest feeling "squeezed" Tylenol taken. 24 hours after booster, fever of 102.5, heart palpitations, difficulty breathing,  Tylenol taken 30 hours after booster, fever is broken, heart and chest is back to normal, hives across left arm, left side of chest and back.   I had no serious reactions to the first moderna shot, and while I had a strong immune reaction to the second shot, I had no concerning side effects like I did for my booster.
04/05/2022 I noticed hives on my left arm and little finger on the left arm.