chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding the patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, 40 unspecified patients were vaccinated with improperly stored doses of M-M-R II (albumin status of recombinant human albumin (rHA)) lot # M042846, expiration date 21-OCT-2018 and lot # M045392, expiration date: 14-NOV-2018 (dose and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursion was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007367: US-009507513-1708USA008139: US-009507513-1708USA008140: US-009507513-1708USA008141.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, current conditions and drug reactions/allergies were not provided. On 15-DEC-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX for prophylaxis; route of administration was not reported (lot # N016090, expiration date: 23-AUG-2018). Concomitant therapies included properly stored sterile diluent used for reconstitution. The vaccine underwent a temperature of 6 Fahrenheit degrees (°F) to 14 °F (10.6 °F) for 2 hours 55 minutes. Previous temperature excursions included 6°F to 14°F for 1 hour and 15°F to 46°F (31.9°F) for 14 hours. Digital data logger was involved. No adverse effects were reported
After vaccination given, Pt. began to seize, eyes rolled back, limbs shook for aprox. 30 sec.  Pt. was in padded wheelchair, monitored by RN, clerk, mother.  Mother wanted to take Pt. home.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2021-313106 (Patient Link).
Moderna COVID-19 Vaccine EUA dose given 1 day after the BUD for refrigeration
Pt had a fever of 104-106 after testing positive for about 48hrs. On his 8th day of infection, he had diarrhea. And he had stomach pains and vomiting until day 14.
ITCHING, REDNESS AND SWELLING OF INJECTION SITE; FEVER, CHILLS.
stomach ache; excessive urination; Body Chills; Debilitating Headache/headache was sensitive to light; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21 and 038C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PROGESTERONE and ESTRADIOL for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light). On 27-Jun-2021, ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light) had resolved.            No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-239147 (Patient Link).
pruritic erythematous rash at injection site one week after injection.  The involved area measured  7 cm x 10 cm.  The rash resolved spontaneously after 72 hours.
Low grade fever of 100 x 1wk p/vax; w/questionable hypotonic episode approx 24 hrs p/shot; Also some question of diminished interactiveness & muscle tone subsequently has had neurological consult feels there is some gross motor delay;
Tingling, pain in nails of feet and nails. Pain travels up the side of both legs, radiating to both of my thighs causing thyme to become hot and swollen.  Soreness and redness of both my thighs which continues to radiate up my back. Pain can be felt in my groin, buttocks and chest.
Fever with associated chills and shivering; Fever with associated chills and shivering; Fever with associated chills and shivering; Soreness at injection site; Headache; Fatigue; This is a spontaneous report from a contactable consumer (Age: 50; Units: Unknown) reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number was not reported) via an unspecified route of administration on 04Feb2021 13:45 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (first dose) for covid-19 immunisation. On 05Feb2021, the patient experienced soreness at injection site, headache, fatigue 24 hours after administration, fever with associated chills and shivering 36 hours after administration. The clinical outcome of the all the events on 06Feb2021 was resolved.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Large area of induration, redness and swelling on (R) shoulder at site of shot.
INSOMNIA; MINOR MUSCLE SORENESS FROM THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included: The patient was mostly in bed by midnight. The patient had 2 monsters drink at 8-9 PM so that might had a little to do with insomnia. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced insomnia, and minor muscle soreness from the injection site. The action taken with covid-19 vaccine was not applicable. The outcome of the insomnia and minor muscle soreness from the injection site was not reported. This report was non-serious.
Narrative:  COVID infection following COVID vaccine series 03/09, Pfizer, dose #1 03/31, Pfizer, dose #2 12/22 COVID swab, result: detected 12/18 pt cc: cough, chills, nausea, sore throat, fatigue, exposure: son 12/28 Clinically resolved
Near syncopal episode, revived with smelling salts. Patient has history of fainting with needles. Patient given food and water and recovered. Reported feeling better. Walked out without any additional complaints.
About a week after I received the second dose of moderne I have been experiencing heavy palpitations with pins and needles going through my entire body, hot and cold sweats and dizzy. I also experience sharp pains on the left side of my chest. I went to the emergency room three time since 4/20/21 and seen two primary care doctors. They are all unable to find out what is wrong with me. I never had health issues prior to getting vaccinated.
SEEN FOR SPE ON 11/15/10 when lump was brought to attention of MD
Havrix adult dose administered to a 9 y/o child; Havrix adult dose administered to a 9 y/o child; HPV vaccine administered at the same time; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-year-old male patient who received HAV (Havrix adult) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   On 16th July 2021, the patient received Havrix adult (intramuscular), hepatitis A vaccine pre-filled syringe device and HPV vaccine. On 16th July 2021, unknown after receiving Havrix adult and hepatitis A vaccine pre-filled syringe device and not applicable after receiving HPV vaccine, the patient experienced overdose, adult product administered to child and product use in unapproved population. On an unknown date, the outcome of the overdose, adult product administered to child and product use in unapproved population were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The healthcare professional reported administered Havrix adult dose to a child, which led to overdose and adult product administered to child and the HPV vaccine administered at the same time to male patient, which led to product use in unapproved population. The reporter consented to follow up. This case had been linked with US2021075972, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075972:Same reporter
Migraines; Explosive diarrhea; Somnolence; Headaches; This spontaneous case was reported by a health care professional and describes the occurrence of MIGRAINE (Migraines), DIARRHOEA (Explosive diarrhea), SOMNOLENCE (Somnolence) and HEADACHE (Headaches) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Cough (believes they had COVID-19 because they suffered having a bad cough back in 24Jan2020 through 15Feb2020) from 24-Jan-2020 to 15-Feb-2020. Concurrent medical conditions included Migraine. Concomitant products included FENTANYL, MORPHINE and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced MIGRAINE (Migraines), DIARRHOEA (Explosive diarrhea), SOMNOLENCE (Somnolence) and HEADACHE (Headaches). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 22-Aug-2021, MIGRAINE (Migraines), DIARRHOEA (Explosive diarrhea), SOMNOLENCE (Somnolence) and HEADACHE (Headaches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient taken migraine medications.   This case was linked to MOD-2021-294571, MOD-2021-294576 (Patient Link).
Pt recvd 3 doses of Engerix-B on 3DEC90; 10JAN91 & 10JUL91 was exposed to a potential source of Hep B; 9OCT91 HBSAB titer (Anti-HBS) was tested & reported neg; booster doses given 12OCT91 & 11NOV91;
Ears plugged. Then at 8:45 pm started severe back pain. (Lasted 3 weeks). Headaches off and on. Tired/fatigue.
Hospitalization for acute encephalopathy, COVDI19 8/15-8/19/2021. Treated with dexamethasone 6 mg IV daily and Remdesivir.
Patient reports abnormal ringing in her ears ~1 week after receiving first dose that has not gone away since.  The patient's PCP has been notified.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 20-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Initial information has been received from a pharmacist and follow-up information was received from a registered nurse concerning a 34-year-old female registered nurse who, on 12-MAR-2007 (previously reported as March 2007), was vaccinated with MMR II (manufacturer unspecified), and now has a negative mumps titer (date unspecified). Concomitant vaccines administered on 12-MAR-2007 included varicella virus vaccine live and DT (manufacturer unspecified). At the time of the report the patient's status was unknown. The patient had the following laboratory test: 25-Mar-2008: serum hepatitis C antibody test (pending). 25-Mar-2008: serum rubella immunoglobulin G antibody test (4.13). 25-Mar-2008: serum varicella zoster virus antibody test (2.05). 25-Mar-2008: serum mumps immunoglobulin G antibody test (<0.91). A product quality complaint was not reported. No further information is available.
Information has been received from a physician concerning a 26 year old female with a history of syncope when giving blood, who on 11-Jan-2007 was vaccinated with Gardasil (lot #653978/0955F). It was reported that the patient fainted 15 minutes after vaccination. The patient subsequently recovered. No further details were provided. Additional information has been requested.
Two days later I was very sick.; When was tested and come to find out I had the virus, the Covid- 19 virus.; This is a spontaneous report from a contactable male consumer reported for himself and his wife, this is first of 2 cases, for the reporter self. A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. In May2021, the patient felt that he was very sick and when the patient was tested and had the virus, the COVID- 19 virus together his wife and he was in quarantine for 14 days which ended this Saturday on 29May2021. He wanted to know whether they could take the second vaccination, since they tested positive after receiving the first vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in May2021.The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.
pain in left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm) and HEADACHE (headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in left arm) and HEADACHE (headache). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 UNK. On 28-Feb-2021, PAIN IN EXTREMITY (pain in left arm) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
half hour after given vaccine I began getting angioedema and was given Benadryl by the paramedic and was taking it every 6 hours but woke up with throat swelling and increasing tongue swelling and I went to ER and was given steroids and epi
stool turned black; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (stool turned black) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Migraine and Depression. Concomitant products included VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced FAECES DISCOLOURED (stool turned black). At the time of the report, FAECES DISCOLOURED (stool turned black) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included HRD medicine, depression medicine, migraine medicine and hemapoex vitamin. No treatment information was reported.
Uveitis about a month after 2nd dose.  Saw ophthalmology.
Patient states that she experienced chills, slight body ache, and a swollen arm. This occurred 2 days after vaccination.
GI effects (Nausea/Vomiting)  Starting the day after immunization and continuing  for 5 days.  (Lost 7 lbs in 3 days) Treated for vomiting at Emergency Department per recommendation of primary care physician. Dizziness and lightheadedness. Headache Symptoms resolved after 5 days.
Starting  the day following the vaccine, I had shooting pain (nerve pain) in all of my limbs? both arms and legs. It has been more severe in my legs. The only time I experienced any similar pain was several years ago when I had shingles, except that pain was isolated to one side of my body and only in my arm. This pain is exactly like that except it is bilateral and is happening in arms and legs. I did also have the standard muscle ache post-vaccine, but this shooting pain is in addition to it. The nerve pain peaked about 32 hours post-vaccine and has persisted in my legs through today, which is 4 days post-vaccine. I have only self-medicated with ibuprofen or acedomenophen, which reduces but does not eliminate the pain. No signs of this pre-vaccine. Was feeling totally healthy? to the extent that I exercise daily and ran a half marathon a month ago.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 608 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Local reaction: Pain-discomfort, General Symptoms: joint pains, muscle pains, fatigue, stomach pain.  Narrative:
48 hours after administration of varicella vaccine (booster), pt seen in office for ~5cm area of erythema, warmth, swelling at site of injection
This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration in the left arm on 19Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 27Feb2021 at 16:30 as a single dose for COVID-19 immunisation. On 19Mar2021 at 23:00, the patient had little soreness in the injection spot. She went to bed around 21:30, but she was awoken around 23:00 because she was feeling extremely cold, even after putting on layers, her electric heating blanket at the highest temperature, and She was under a down comforter. Then the scary part was her organs started to feel heavy and sore. Her lungs, liver, heart, kidneys were weighing down inside. It was difficult for her to get up and walk because she felt like she would damage an organ(s). On 20Mar2021, the patient had a fever for most of the day, and her kidneys were in so much pain. The patient tried stretching, and sleeping it off. Did not work. She drank turmeric tea and a tall glass of water with sodium chloride, himalayan pink salt, and baking soda. The pain started to subside by evening. On 21Mar2021, the patient felt much better, but had a migraine all day and felt very weak. Her kidneys were sore. The patient did not receive any treatment for events. The clinical outcome of the events Feeling extremely cold, Organs started to feel heavy and sore, Liver pain, Organs started to feel heavy and sore, Lungs pain, Organs started to feel heavy and sore, Heart pain, Difficult to get up and walk, Kidneys pain, Migraine all day, felt very weak, Soreness in the injection spot and Fever were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.