chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over his body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Had a rash started on both of his arms.) since 18-Feb-2021.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (Rash all over his body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH (Rash all over his body) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.  Patient reported that the rash took one year to disappear. Patient took the second dose without any issues.     Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: Additional information received on 27-Feb-2021 contain no significant information. On 09-Jul-2021: Follow up document received on 09-Jul-2021 contain significant information, outcome of the event updated and information regarding the second dose.
7MAY fever max temp 104ax; 6MAY low grade fever lethargic, poor apetite; 8MAY reported fever of 104 again;
Pt was seen at our clinic on 10/06/2023 for Tdap vaccination. Tdap was ordered by provider. Medication assistant mistakenly administered Tdap as a TB test intradermally in left forearm. Immediate swelling of forearm that worsened over the weekend iwith swelling of her lymph nodes under her arm. Pt was seen in emergency room on 10/07/2023 related to error. Ibuprofen prescribed. PT returned to our clinic on 10/24/2023 to notify us of mistake and follow up of arm pain. This is when we were notified of error. Per MD note  evidence of 1cm nodule in mid-forearm  that is the residual effect of the inflammation and is moderately tender. No evidence of long term damage.
Like had the flu; Felt sick; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about one year before the date of reporting, did not have any symptoms).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and malaise. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the influenza-like symptoms and malaise to be related to Shingrix.  Additional details were provided as follows: The patient might be 74 or 75 year of age at the time of vaccination. The patient felt sick like he had the flu after the 2nd dose. It was unknown if the reporter consented to follow-up. This case was linked to case US2019205793 and US2019205795 reported by same reporter.  Following a correction performed, 'Drug Not Administered' was unchecked.
Severe fatigue, body aches, and appetite loss- onset 4/9; still ongoing 4/12  Fever/chills - onset 4/9; ended 4/11  Sore throat- onset 4/11; ongoing 4/12
blacked out; scraped his face; light headaches; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 17Feb2021 03:00 (batch/lot number was not reported) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus from 2008 and ongoing and reported that it's under control. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. The patient was calling because he got his shot through the (facility name withheld) on the 17Feb2021 around 3:00. The caller goes for walks, and one week later he had a blackout, about the same time he got the shot 3:00 or 3:15 on 24Feb2021. The caller blacked out and he broke his glasses, scraped his face, all that stuff. All the scrapes were healing. The weirdest thing was it happened almost exactly a week later. The caller asked was it possible that this could be related to the vaccine. For the following two days after the vaccine the caller had 2 light headaches on 18Feb2021 and then they were gone on 19Feb2021. This blackout event happened one time. Caller mentioned the headaches were nothing to be concerned about. The caller was not given a vaccination card at the (facility name withheld) and does not know the lot number, NDC number, or expiration date. This was the caller's first dose of the vaccine. The caller mentioned that 11Mar2021 was his next appointment for the second dose of the vaccine. The caller has never had a black out episode or dizziness before. The caller said he licked his wounds and will be okay. No visit to the emergency room and physician's office required. No prior vaccinations (within 4 weeks). No relevant tests done. The outcome was recovered on 19Feb2021 for the event Headache; and recovering for the other events.   Information about lot/batch number has been requested.
The day after receiving my second Pfizer dose I developed significant GI symptoms (nausea, vomiting, diarrhea) that lasted about 12 hours.
nausea; muscle aches; extreme fatigue; felt flushed; shaky; Always lightheaded/dizzy; Slept almost constantly for 4 straight days; Barely able to stay awake or get out of bed for over 2 weeks; vomiting; increased headaches; brain fog; loss of motor skills in my hands; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 12Apr2021 16:15 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation. Medical history included migraines due to traumatic brain injury (TBI) in 2014 unknown if ongoing and hypertention from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included valproate semisodium (DEPAKOTE), lamotrigine (LAMICTAL), oxybutynin (OXYTROL), lisinopril (LISINOPRIL) and varenicline tartrate (CHANTIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 12Apr2021 17:30, an hour after 1st dose, the patient felt flushed, shaky, and dizzy an hour after first dose. On 13Apr2021, about 12 hours after injection, patient had nausea, muscle aches and extreme fatigue. On unspecified date in 2021, patient slept almost constantly for 4 straight days and barely able to stay awake or get out of bed for over 2 weeks, always lightheaded, with bouts of nausea and vomiting, increased headaches, brain fog and loss of motor skills in her hands on unspecified date in 2021. Currently still battling fatigue and functioning for more than a few hours without falling back to sleep. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. At the time of this report, the outcome of event slept almost constantly for 4 straight days and barely able to stay awake or get out of bed for over 2 weeks were recovering and all other events were not recovered.  No follow-up attempts are required. No further information is expected.
Body aches where like flu; Body aches in shoulders, back and legs; Nauseous; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Body aches where like flu), NAUSEA (Nauseous) and PAIN (Body aches in shoulders, back and legs) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included LISINOPRIL and ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizzy) and NAUSEA (Nauseous). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Body aches where like flu) and PAIN (Body aches in shoulders, back and legs). At the time of the report, DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Body aches where like flu), NAUSEA (Nauseous) and PAIN (Body aches in shoulders, back and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
No additional AE reported.; ROTATEQ was improperly stored and administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.       On 14-OCT-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S040076, expiration date 15-JUN-2021 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 11.35 degree Celsius (°C) for 40 hours as recorded by a data logger. There were previous temperature excursions of 9.45 °C for 1 hour and 30 minutes on 07-OCT-2020; 11.86 °C  for 11 hours and 15 minutes on 09-OCT-2020 and 10.23 °C  for 1 hour and 45 minutes on 10-OCT-2020.
Couldn't stay awake; Swelling all over her body and all the way to her feet; Slept a lot; Had no energy; Lost her sense of taste; Lost her sense of smell; Pain; Still gets tired easily; Body ache; Headache; A fever; Coughing; Brain fog and can't think straight; COVID; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), FEELING ABNORMAL (Brain fog and can't think straight), COVID-19 (COVID), SOMNOLENCE (Couldn't stay awake) and SWELLING (Swelling all over her body and all the way to her feet) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Aug-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 COUGH (Coughing), FEELING ABNORMAL (Brain fog and can't think straight), COVID-19 (COVID), SOMNOLENCE (Couldn't stay awake), SWELLING (Swelling all over her body and all the way to her feet), HYPERSOMNIA (Slept a lot), ASTHENIA (Had no energy), AGEUSIA (Lost her sense of taste), ANOSMIA (Lost her sense of smell), PAIN (Pain), FATIGUE (Still gets tired easily), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (A fever). The patient was treated with MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency; FISH OIL (OMEGA 3 [FISH OIL]) at an unspecified dose and frequency; VITAMIN A [RETINOL] at an unspecified dose and frequency; VITAMIN B NOS at an unspecified dose and frequency; ASCORBIC ACID (VIT C) at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency; VITAMIN E NOS at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Pain and Fever, at an unspecified dose and frequency; AZITHROMYCIN at a dose of 250 mg and BENZONATATE for Cough, at a dose of 200 mg once a day. At the time of the report, COUGH (Coughing), FEELING ABNORMAL (Brain fog and can't think straight) and FATIGUE (Still gets tired easily) had not resolved and COVID-19 (COVID), SOMNOLENCE (Couldn't stay awake), SWELLING (Swelling all over her body and all the way to her feet), HYPERSOMNIA (Slept a lot), ASTHENIA (Had no energy), AGEUSIA (Lost her sense of taste), ANOSMIA (Lost her sense of smell), PAIN (Pain), MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (A fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. On 25-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. The patient took a higher doses of multivitamins and omega 3, including vitamin A, B, C, D, and E. The patient also took airborne, elderberry, a cold remedy that's high in zinc. The patient drank a lot of water and Gatorade.
Sudden pulsatile tinnitus and loss of hearing in left ear within a week or so after 2nd shot.; Sudden pulsatile tinnitus and loss of hearing in left ear within a week or so after 2nd shot.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Er8727, on unknown date at single dose in right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested covid post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 Lot number En6202, on 28Feb2021 and had a blot clot discovered in lung within 2 weeks of first shot. The patient had sudden pulsatile tinnitus and loss of hearing in left ear within a week or so after 2nd shot. The patient went for ENT Dr for hear. Treatment was received for the events. The outcome of the event was unknown. The event is serious with hospitalization and disability.
lost 13 pounds; got so sick it was like she had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (not ongoing), notes: she still has side effects due to chemo treatments she was given; "chemotherapy" (not ongoing), notes: she still goes through blood work. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Lot number: unknown), for COVID-19 immunisation, reaction(s): "shingles", "very sick". The following information was reported: WEIGHT DECREASED (hospitalization), outcome "unknown", described as "lost 13 pounds"; ILLNESS (hospitalization), outcome "unknown", described as "got so sick it was like she had COVID". The patient underwent the following laboratory tests and procedures: Weight: she lost 13 pounds. Clinical course: Patient waited 8 weeks (since first vaccination) and got the 2nd one that also put her in the hospital, and she lost 13 pounds and got so sick it was like she had COVID. She has not received the booster because of her reactions. Patient stated she was hesitant about all these vaccines, they may work for people, but she did not want to put herself out there to get a problem she didn't have.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
MMR #1 given 2/6/04. 2/17/04 pt started with 102 deg F temp. 2/18/04 bright red diffuse maculopapular rash on face UE/ LE trunk (-) crust (-) vesicles (-) kopblo. Was f/u 2/19/04.
vaccines are kept frozen in fridge about1-3 days,they tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated; Administered Moderna vaccines beyound the use date/expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days,they tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days,they tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days,they tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.
This spontaneous report was received from a 66 years-old female patient, reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-APR-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # M043424 (expiration date, strength and dose were not reported), administered intramuscularly in her deltoid muscle by a physician, for prevention of pneumococcal disease. On 27-APR-2017, the patient began to experience swelling of her arm, pain and burning. Subsequently, she sought medical attention and the physician prescribed her prednisone (manufacturer unknown) as treatment. However, on 10-MAY-2017 (reported as "13 days later"), the patient had not recovered and continue to had burning and pain. The relatedness between the peripheral swelling, the pain in extremity and the burning sensation with the vaccine PNEUMOVAX 23 was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
PT REPORTED BLISTER LIKE REACTION EMANATING FROM THE EYE AND CONJUNCTIVAL SAC AREA. UPON VISITING DERMATOLOGIST, THEY SAID THE REACTION WAS RESULT OF SHINGRIX VACCINE
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported for two patients. This is the first of two reports. A male patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. The outcome of the event was unknown. The information on the batch/lot number has been requested. Sender's Comments: Linked Report(s): PFIZER INC-2018224839 Same reporter, drug, event; different patient
This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 13Sep2021 at 17:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included patient currently recovering from miscarriage. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified prenatal vitamins for an unknown indication from an unknown date and unknown if ongoing. On 14Sep2021 at 08:30, the patient experienced feelings of having a fast-beating or pounding heart. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events feelings of having a fast-beating or pounding heart was unknown at the time of this report.
Headaches. Almost everyday. Sometimes multiple times a day.  About 1-3 hours each or until Advil relieves it.
Patient stated that she had developed a rash after getting her shots on Monday. She had a rash on multiple parts of her body. She mostly described under the fold of her abdomen and her thighs. She also stated that she had tried a new fragrance of Tide and had washed her sheets and clothes in it. She stated that she took two benadryl and the rash did not go away, so it could not have been the Tide.
shingles; Information has been received on 09-APR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  In 2007, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot# and route not specified) by a healthcare provider.  On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with zoster vaccine live (ZOSTAVAX).  The outcome was not provided.   Additional information has been requested.
positive for COVID 08/09/2021, had mild symptoms. no known epi link. He got the infusion and feeling better already.
Received the booster Moderna vaccine on 12/10/2021; on 12/12/2021 noticed a red "Welt" around the injection site, warm to the touch. This area continued to get bigger over the next two days. This morning the red area (roughly oval shaped) measures 5in by 3in. It is still warm to the touch and is slightly swollen and itchy. Managing with OTC ibuprofen, ice and topical steroids (hydrocortisone) and waiting for resolution.
Strong muscle pain around the injection site.  Slight dizziness. Strong feeling of fatigue, which caused me to rest for at least 6 hours on bed. Feeling a pain around my left armpit around 30 to 40 hours after injection.
fever, fatigue, body aches, chills, chest pain and abnormally high blood pressure
Patient reports pain in arm that is "severe". Patient has not tried anything to help with it. It is listed as a side effect on the package insert.
Information has been received from a  consumer concerning her healthy 27 year old grandson who on 7/9/04 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination included hepatitis B virus vaccine and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 7/19/04, the patient developed spots. The child also had loss of appetite, a nasal discharge and a non-productive cough. The grandmother reported that he was still developing spots and was falling down more than usual. Unspecified medical attention was sought and no treatment was required. Information from the physician's office indicated that the mother of the child called and only reported that the patient had a chicken pox rash after varicella virus vaccine live vaccination. There was no product quality complaint involved. Additional information has been requested.
Developed full blown Shingles approximately 4 days following vaccination. Prescribed ACYCLOVIR, 800MG, ONE TABLET 5 TIMES A DAY FOR 10 DAYS