chrisvoncsefalvay/vaers-outcomes huggingface dataset:
teeth hurt; bad headache; chills; tired; achy; temperature 103F; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired) and MYALGIA (achy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported.  Concomitant products included PAROXETINE for Depression, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3), VITAMIN D3, BIOTIN, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), FISH OIL and CALCIUM for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired), MYALGIA (achy) and PYREXIA (temperature 103F). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired), MYALGIA (achy) and PYREXIA (temperature 103F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 High.         Concomitant medications - Vitamin calcium D3 zinc magnesium, Vitamin D3, Biotin, Probiotic are taken as supplements by the patient. It was reported that patient height was 5'5.   This case was linked to MOD-2021-170043 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up document received on 08-JULY-2021 contain information of added concomitant products. And patient demographics were added.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=24Jul2022, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shoulder injury related to vaccine administration. Continuing limitation in range of motion with significant pain if moved in certain way.
Nausea, stomach cramps, diarrhea, Went on Brat diet. Bismuth . Cleared up in 4 days
Experienced a reaction to Shingrix; This case was reported by a physician via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The physician stated that, the patient's friend experienced a reaction to Shingrix and as a result got a lower dose, which led to underdose. No further details were provided, since it was reporter's patient's friend.
Narrative:  Patient reports blisters on the tops of both feet after receiving vaccines (influenza and pneumovax 23) on 9/14/2020. States blisters were ~1.5 inches wide. He treated wound at home. Patient denies any other potential causes for his blister. He had received prior vaccines of influenza and pneumovax. Symptoms:  & blisters Treatment:
flu; This is a spontaneous report from a  Support, from a contactable consumer (Patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Feb2021, the patient experienced flu. Caller asked if it is still okay to get the vaccine tomorrow as scheduled appointment for a second dose. The outcome of the event was unknown.   Information of batch/lot number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Itching; Burns started appearing; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), THERMAL BURN (Burns started appearing) and SWELLING (Swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRURITUS (Itching), THERMAL BURN (Burns started appearing) and SWELLING (Swollen). At the time of the report, PRURITUS (Itching), THERMAL BURN (Burns started appearing) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.; Sender'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.
pt recv vax & devel a fever of 102;no further details known as of the date of this report;this is one of three patients from this site who exp above rxn;
Patient was given booster by local Care Center staff too early. 2nd dose was administered 3/11/22 and booster given 5/27/22
severe headache; fatigue; This is a spontaneous report from a contactable healthcare professional via Pfizer sales professional. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization and meningococcal vaccine conj (MENINGOCOCCAL VACCINE) via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe headache and fatigue within an hour of vaccination with meningococcal group b rlp2086 and a MCV4 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained
Generalized skin eruption red rash patches trunk/arms - started after shot, progressively worse until today 6/21/18 (expected Tx, Rx Prednisone).
I had 1 prevnar 13 shot around 2014. I have had pneumonia a couple of times; I had 1 prevnar 13 shot around 2014. I have had pneumonia a couple of times; I had 1 prevnar 13 shot around 2014. I have had pneumonia a couple of times; COPD on oxygen and use inhalers; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2014 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "I had 1 prevnar 13 shot around 2014. I have had pneumonia a couple of times"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (medically significant), outcome "unknown", described as "COPD on oxygen and use inhalers". Therapeutic measures were taken as a result of chronic obstructive pulmonary disease.  Additional information: Patient had 1 Prevnar 13 shot around 2014. Patient had pneumonia a couple of times and had COPD. Patient was on oxygen and use inhalers. Patient asked her PCP and her pulmonary doctor if she should have the pregnancy 20 shot (as reported) but neither of them could give an answer. Patient was asking what would be the recommendation.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 21-FEB-2011, patient received improperly stored VARIVAX dose 2, from batch/lot # 666869/0469Z (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Open wound at injection site that left flesh exposed, burning and itching.    Anaphylactic shock on September 30th
On 02/04/2001 the patient developed chicken pox with a fever of 101F. Additional information has been requested. FOLLOW-UP information has been received from a health professional that states the patient recovered. FOLLOW-UP information has been received from a physician who is the mother of the patient. She reported that the patient broke out with the chicken pox on 02/03/00. It was reported that she had about five pox on her face, multiple across her chest, abdomen, back and down in her vulvar area and some scattered on her arms and legs. It was reported that she would "judge to be mild to moderate case". Unspecified medical attention sought. No further information is expected.
peripheral neuropathy; Still cannot move hands / cannot write anything,cannot type or sign anything; postural orthostatic tachycardia syndrome; Feel dizziness / dizzy all the time; Can't sleep at night; Hands freeze; daily migraines; Still have headache; Fatigue all the time/chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (Auto immune disorder .) and Hypotension (low blood pressure).   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, 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 experienced NEUROPATHY PERIPHERAL (peripheral neuropathy) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Still cannot move hands / cannot write anything,cannot type or sign anything), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome), DIZZINESS (Feel dizziness / dizzy all the time), INSOMNIA (Can't sleep at night), PERIPHERAL COLDNESS (Hands freeze), MIGRAINE (daily migraines), HEADACHE (Still have headache) and FATIGUE (Fatigue all the time/chronic fatigue). At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy), DIZZINESS (Feel dizziness / dizzy all the time), INSOMNIA (Can't sleep at night), PERIPHERAL COLDNESS (Hands freeze), MIGRAINE (daily migraines), HEADACHE (Still have headache) and FATIGUE (Fatigue all the time/chronic fatigue) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Still cannot move hands / cannot write anything,cannot type or sign anything) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome) had not resolved.            Concomitant medications were not provided.  Treatment medications were not reported.  Company comment: 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.   This case was linked to MOD-2021-127566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received contains significant information ; event  outcome updated as not recovered not resolved for stiffness, Events migraine, peripheral neuropathy added.; Sender'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.
productive cough; first dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (productive cough) and PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     The patient's past medical history included Productive cough. Concurrent medical conditions included Reaction to food colouring, COPD (Started 20 years ago, changes across the board because of the lung infection), Serratia marcescens infection (bacterial lung infection started 7 years ago, slight changes due to environmental problems), Irritable bowel syndrome (Started 10 years ago), Diarrhea (December 2020 phase change (from constipation to diarrhea).) since December 2020 and Drug allergy (some ingredients used in antibiotics called sulfa additives). Concomitant products included ALBUTEROL [SALBUTAMOL], IPRATROPIUM BROMIDE (ATROVENT), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MACROGOL 3350 (MIRALAX) and PREDNISONE for an unknown indication.    On 12-Dec-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 PRODUCTIVE COUGH (productive cough) and PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). At the time of the report, PRODUCTIVE COUGH (productive cough) had not resolved and PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was using prednisone around August-September 2021. In December 2020 phase change (from constipation to diarrhea), he was using 4 or more laxatives in high doses each night. Then he stopped using all those medications, including vitamins.  Patient reported the people who gave him the first shot told him they would  be in contact with him in 30 days to give him the second shot. However, those people stopped and another business took on their work. There was a time lapse between his first shot and then at the time of reporting.  For the adverse event productive cough  patient did not seek medical care.Treatment information was not provided by the reporter.
Initial and follow-up information has been received from a licensed practical nurse concerning an 18 year old female patient with a history of human papilloma viral infection, who on 02-FEB-2007 was vaccinated with an 0.5ml, IM dose of GARDASIL (Lot # 654535/0960F).  There was no concomitant medication.  The nurse reported that the patient "subsequently determined she is pregnant."  The date of the LMP was 15-DEC-2006, with an estimated due date of 22-OCT-2007.  The nurse added that there were "no problems reported."  Follow-up information indicated that the nurse thought the abortion was an elective termination.  Although it was also reported that "the patient wasn't truthful about many things with them."  The patient sought unspecified medical attention.  Additional information has been requested.
Swollen lymph node on left side of neck that is oblong in shape, measuring 2.5in x 1.5in; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date not reported), via an unspecified route of administration (reported: left arm), on 30Dec2020 at 20:30 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication includes unspecified multivitamins. The patient experienced swollen lymph node on left side of neck that is oblong in shape, measuring 2.5in x 1.5in, on 08Jan2021 at 5 AM. The patient has not recovered from the event.
pain in her shoulder/ shoulder hurting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient to received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 25Jan2021 at single dose in right arm (by injection once to right shoulder) for COVID-19 immunization. Medical history was none. Concomitant medications were none. Caller wanted to know if she can use Tylenol 8 hours to treat pain in her shoulder/ shoulder hurting (25Jan2021), she received the COVID-19 vaccine this morning. The patient had a COVID shot this morning, and shoulder was hurting so bad, she was going to take a Tylenol 8 hour, wanted to know if that was ok, and what about heat or ice. The Tylenol said for muscle aches, but she didn't know if she should take it, it had been hours since the vaccine, hurting a little bit, certain ways move it, was going to put heat, thought maybe ice. It was just a little sore, nothing she can stand, she didn't know whether to take a Tylenol for muscles, then heat or ice. Daughter kept vaccine card, caller had to go for the second dose, so her daughter kept the vaccine card in the car. Height: 5'6" to 5' 7". Weight: 170-180 pounds. No Investigation Assessment. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Development of a dark irregular shaped patch of skin on the upper right wrist and hand as well as smaller areas on the upper and lower left wrist. the areas are dry and flakey that do not itch, do not burn and do not hurt in any way. The patches developed two weeks after the first injection and are still present after receiving the second one. The patch on the underside of the left wrist has enlarged a bit in the last week. Some of the skin on the right wrist has fallen off revealing new pin skin beneath that is still discolored.
No adverse effects; the patient was inadvertently administered one dose of expired PNEUMOVAX 23; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.       On 07-AUG-2019, the patient was inadvertently administered one dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R012713, expiration date: 03-AUG-2019), for prophylaxis (strength, frequency and route were not reported) (expired vaccine used). No adverse effects were reported.
I had mild pain and itching in my arm the evening of the day of the vaccine (02/12). The next morning I woke up feeling awful, I had a fever of just over 100 and chills, vomiting and diarrhea, body aches and a medium headache. This lasted the full day. I couldn't eat or drink anything...kept coming back up and out... really awful. When I had Covid-19 back in March although I had a fever for 10 days, I had none of these symptoms... I just lost my sense of taste and smell for 7 months.
This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 29-NOV-2018, the patient was vaccinated with an expired PROQUAD for prophylaxis, lot #N016113 and expiration date 21-NOV-2018 (strength, dose, frequency and route of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported.
Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle pain".  Additional information: The vaccine was received on Thursday (as reported). The reporter wanted to know when the pain would subside and how long the event would last  The lot number for bnt162b2 was not provided and will be requested during follow up.
While sitting at her work desk about four hours following the vaccine, she became very nauseous, pallid and warm. She experienced severe pain in her lower right side.
Men B vaccine was given IM (R) deltoid on 9/14/17. No redness or swelling seen at injection site immediately after injection was administered. Pt returned to clinic 9/15/17 w/ c/o swelling and redness (R) arm at injection site. There was a 1 in localized area of erythema and swelling on exam. Prednisone, ATARAX and ice pack TID was advised. Pt to return to clinic for f/u in 3 days. No fever.