chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe right tibialis anterior muscle cramp; low level fever; This is a spontaneous report from a contactable physician (patient). This 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiry date unknown, vaccine location: left arm), intramuscular on 05Jan2021 08:00 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient has no known allergies. Concomitant medication included valsartan and loratadine (other medications in two weeks include valsartan and loratadine). The patient took the first dose of bnt162b2 on 16Dec2020 01:00 PM (lot number: EH9899) intramuscular, vaccine location: left arm. The patient experienced severe right tibialis anterior muscle cramp on 06Jan2021 12:00 PM, 30 hours after second injection (as reported) with onset of low level fever. The fever resolved within 2 hours. Muscle cramping persisted for 30 hours with complete resolution. No treatment was received. Outcome of the event low level fever was recovered on 06Jan2021 14:00 and of the event muscle severe right tibialis anterior muscle cramp was recovered on 07Jan2021 18:00. The patient had no COVID prior to vaccination. The patient was not tested for COVID post-vaccination. The patient had no other vaccine in four weeks.
I had a rash on my arm around the injection site of the COVID vaccine starting on 1/10/23. The rash got bigger on 1/11/23. I took pictures so I know the rash started on the tenth and that it had grown on the eleventh. I think it cleared up within the week, and I don't think it got worse after the eleventh, otherwise I would have taken more pictures. It might have been itchy, but it's hard to remember. Apologies for not reporting sooner.
-headache at the time of vacciene relieved totally with acetaminophen -post vacciene days 1 and 2 soreness in the muscle of the vacciene, totally relieved by tylenol and excersize -day 7 post vacciene, I woke up with right arm pain, itching and erythemia. i took tylenol and drank lots of water as well as moved my arm with daily activity -day 8 post vacciene continued symptoms same as day 7 just increased itching and redness, took benadryl 25mg and 500mg tylenol and proceeded with daily activities reporting today, day nine
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-058894 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058894:Case for patient 1
I'm a little concerned that it was given subcutaneously; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I'm a little concerned that it was given subcutaneously) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I'm a little concerned that it was given subcutaneously). On 18-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I'm a little concerned that it was given subcutaneously) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications are provided. No treatment information was provided.; Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, with no associated AEs.
Diastolic blood pressure spiked from usual 55-60 to 95.; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). An 86-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 30Sep2021 at 13:15 (at the age of 86-years-old) as dose 3, single for COVID-19 immunization. Medical history included prostate cancer, arrhythmia, myasthenia gravis, pacemaker, a fib, Sulfa allergy. Patient previously took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported) administered in left arm on 05Feb2021 12:00 AM (at the age of 86-years-old) and First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported) administered in left arm on 18Jan2021 12:00 AM (at the age of 86-years-old) for COVID-19 Immunization Batch/Lot No: Not available/provided to reporter at the time of report completion. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXIN); acetylsalicylic acid (BABY ASPIRIN); apixaban (ELIQUIS); sotalol (SOTALOL); retinol (VITA A. Patient didn't received vaccine within 4 weeks prior to the COVID vaccine. Prior and since vaccination patient was not tested and diagnosed for COVID-19. Patient didn't had prolong hospitalization. On 03Oct2021 at 04:00 AM the patient experienced diastolic blood pressure spiked from usual 55-60 to 95. The patient underwent lab tests and procedures which included Diastolic blood pressure: 95 on 03Oct2021 spiked from usual 55-60 to 95. Patient received the treatment for event. The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician concerning three children who were vaccinated with one dose of varicella vaccine, on unspecified dates. The reporter indicated that the children had been vaccinated prior to being exposed to chicken pox at school. Following the exposure, the children broke out in mild cases of chicken pox. Unspecified medical attention was sought. Additional info has been requested.
Teen son described a heart pain on the left side of his chest when he leaned forward or took a deep breath.  Pain went away when he stood upright and resolved after a few days.
Pt. had cortisone injection (L) shoulder on 3-10-20. Pneumovax, Boostrix, Shingrix given 3-13-20. On 3-15-20 Felt scratchy throat, seemed swollen, facial tingling, Took 2 Benadryl, then napped. Sx resolved. Today 3-16-20 Had facial tingling again. Advised 2 Benadryl.
Fever, swelling at arm, nausea, slept for 32 hrs. Still sore after two weeks. Fatigue and headache also. Redness rt arm.
TC fr mother 22AP91 pt saw MD local rxn warm to touch; Rx DPH;
Information has been received from a consumer concerning a female who on 06-SEP-2007 was vaccinated with Zostavax (Oka/Merck) (lot #"01940U").  On 06-SEP-2007 the patient experienced extreme pain from neck to toe, nausea, stomach pain and fatigue.  As of 10-SEP-2007 the patient's extreme pain from neck to toe, nausea, stomach pain and fatigue persisted.  Additional information has been requested.
This spontaneous report as received from a pharmacist refers to unspecified number of patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA000509: US-009507513-1707USA000510: US-009507513-1707USA000511: US-009507513-1705USA009596.
Redness, soreness at injection site within 2 hours; feverish, chills, muscle pain, headache  beginning 9 hours after injection and lasting for 12 hours.
Arm swollen after 2nd dose; Arm sore after 2nd dose; Couldn't sleep after 2nd dose; Eyes felt like sandpaper after 2nd dose; Felt like there was a light on in brain after 2nd dose; Upper body aches after 2nd dose; Fatigue after 2nd dose; Low grade fever after 2nd dose; Chills after 2nd dose; Low scale headache after 2nd dose; Queasy after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen after 2nd dose), PAIN IN EXTREMITY (Arm sore after 2nd dose), INSOMNIA (Couldn't sleep after 2nd dose), ABNORMAL SENSATION IN EYE (Eyes felt like sandpaper after 2nd dose) and BLOOD PRESSURE DECREASED (Felt like there was a light on in brain after 2nd dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022m20a and 046a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, 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 PERIPHERAL SWELLING (Arm swollen after 2nd dose), PAIN IN EXTREMITY (Arm sore after 2nd dose), INSOMNIA (Couldn't sleep after 2nd dose), ABNORMAL SENSATION IN EYE (Eyes felt like sandpaper after 2nd dose), BLOOD PRESSURE DECREASED (Felt like there was a light on in brain after 2nd dose), PAIN (Upper body aches after 2nd dose), FATIGUE (Fatigue after 2nd dose), PYREXIA (Low grade fever after 2nd dose), CHILLS (Chills after 2nd dose), HEADACHE (Low scale headache after 2nd dose) and NAUSEA (Queasy after 2nd dose). At the time of the report, PERIPHERAL SWELLING (Arm swollen after 2nd dose), PAIN IN EXTREMITY (Arm sore after 2nd dose), INSOMNIA (Couldn't sleep after 2nd dose), ABNORMAL SENSATION IN EYE (Eyes felt like sandpaper after 2nd dose), BLOOD PRESSURE DECREASED (Felt like there was a light on in brain after 2nd dose), PAIN (Upper body aches after 2nd dose), FATIGUE (Fatigue after 2nd dose), PYREXIA (Low grade fever after 2nd dose), CHILLS (Chills after 2nd dose), HEADACHE (Low scale headache after 2nd dose) and NAUSEA (Queasy after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Pt came to office stating that 8 days after receiving first dose of covid vaccine he has "an infection". Pt had area of erythema, 11.5cm X 7.5cm, oval shaped on his right arm, At the top of the oval, there was a more hard and reddened area, 4cm circular, and the area around it was more diffuse, lightening to the edge. Pt denies "any real itching" but did c/o tenderness when pressed on. Pt states that the first 7 days after his vaccine there was no reaction, visibly, at all. He had a "bit" of soreness after shot, like he expected, then nothing until day 8.  He did use ice on the area from the 1/20/21 through 1/28/21, when he came to our office.  Nurse initially viewed area, had PA also look. PA felt after her examination that the area was urticarial, and prescribed prednisone and Benadryl orally, and advised pt to use hydrocortisone 1% cream up to 4 times daily. Pt returned the next day, area was much less red, smaller in size, and less swollen and hard.  He was advised to use Benadryl orally and hydrocortisone 1% topically, prophylactically, after his second injection.
chills; It's joint pain; it seems to be getting worse, it seems to be in my left hand; my left hand up to my it's about up to my wrist; it hurts my hand and part of my wrist; shortness of breath; Pain in my hand is way much; now it's like, I can't hold anything in it; a few muscle chills pain; cold; asthma; This is a spontaneous report received from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, at first, after the second, patient just had chills and a few muscle chills pain, whatever chills, when awake just exactly cold of could been that and then think because patient got the shot and now it's joint pain. It seems to be getting worse, it's not in my body, and it seems to be in my left hand. patient don't know if that should be because getting old or turns 60. Patient don't know, just to know but it's only concentrated, left hand up to it's about up to wrist. patient was just saying it hurts hand and part of wrist. patient just don't wanted to call the emergency room because that doesn't seem like something patient should be going to the emergency for. patient just want to call and make sure if that's not one of the symptoms of it. Patient had shortness of breath and patient had asthma and they gave wrong asthma spray (Unspecified Medication) and that was causing the air, pain in hand was way much and now it's like, patient can't hold anything in it." Therapeutic measures were taken as a result of shortness of breath. The outcome of events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt experienced a 33cm x 10 cm indurated erythematous lesion. Warm and tender to touch. Received Anthrax #6 on 4/29/00.
SHINGLES; The area started to itch; Red patch on her right shoulder that was itchy and red; Right shoulder began to hurt; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included shingles (first time was below her elbow on her right side, second time was on the left side of her stomach, 3rd time was on her left arm and fourth time was on her left hand). Concurrent medical conditions included arthritis.   On 16th October 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than a month after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced shoulder pain. On 28th October 2019, the patient experienced shingles, pruritus and localized erythema. The patient was treated with gabapentin and valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the shoulder pain, pruritus and localized erythema were unknown.   It was unknown if the reporter considered the shingles, shoulder pain, pruritus and localized erythema to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: 2 weeks ago from the reporting daste, the patient received Shingrix on left arm. On the same day, the patient received flu shot in her right arm at the same time. At the end of week before the reporting date, on thursday or friday, the patient's right shoulder began to hurt. The night before last from the reporting date, 12 days after receiving Shingrix and Flu vaccine, the area started to itch. The patient then noticed a red patch on her right shoulder that was itchy and red. The patches presented on the top of the shoulder, to the back of the shoulder, across her chest to the upper part of the right breast and down her right arm to just above the elbow. Her doctor diagnosed it as shingles and yesterday she started gabapentin and valacyclovir. The patient has a history of shingles and this is the fifth time she has experienced it.  The reporter consented to follow up.
She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them; pink all the way down arm, not just in the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (pink all the way down arm, not just in the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product POVIDONE-IODINE (COVIDON) for an unknown indication.    No Medical History information was reported.   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. and POVIDONE-IODINE (COVIDON) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (pink all the way down arm, not just in the injection site). At the time of the report, VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (pink all the way down arm, not just in the injection site) had resolved.            Concomitant medication and treatment were not provided.  Patient has an appointment to receive the new Spikevax vaccine. She received three Moderna covid-19 vaccines in the past and she got Covid arm with all of them. Maybe with the last one it was not as bad. She didn´t have any other reactions. Now she is scared with receiving the new vaccine and she is asking some questions. She didn´t check this with her doctor since she thought it was just a regular thing. It took a while to get over it, but it went away. It was pink all the way down her arm, not just in the injection site. It was something normal with Moderna Last dose: October 2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-747018 (Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2023-747380 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747018:Patient 2
Left arm has been sore and hurting for the past 4 months in area of injection.; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 31-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 01Jul2021 at 12:00 (Lot number: unknown) at the age of 31 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reactions: "Drug allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN; Anatomical Location: Left arm; Administration time: 12:00), administration date: 10Jun2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Oct2021 at 14:00, outcome "not recovered", described as "Left arm has been sore and hurting for the past 4 months in area of injection". It was unknown whether any therapeutic measures were taken as a result of vaccination site pain.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild
I have lost 3 friends in Spain; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified routed of administration on unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend in Spain. The cause of death was unknown. It was unknown whether an autopsy was done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100059 same reporter/drug/event, different patient; Reported Cause(s) of Death: I have lost 3 friends in Spain