chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states the next day she had tiny swelling at the injection site.; has a 2.5 inch circle around injection site.; little pain at the injection site; redness that has gotten bigger; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program COVAX US SUPPORT.  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 19Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 20Mar2021, the next day after vaccination she had tiny swelling at the injection site. Caller states yesterday the area was not swollen or raised. Caller states today it is flat and has a 2.5-inch circle around injection site. On an unspecified date, she had a little pain at the injection site that has went away. Had a raised mark; redness that has gotten bigger and not gone away after two weeks now. Caller would like to know if this is normal or something she should be concerned about or report. Caller would like to know if she should send or upload picture. Is scheduled for her second shot next Friday. Outcome of the event vaccination site pain was recovered, vaccination site swelling, and vaccination site erythema was not recovered, vaccination injury was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained
On December 23, 2020 she had the Pfizer COVID-19 vaccination at 7:30 p.m. She then worked her shift as a dialysis nurse and went home the following morning. She did not have any symptoms until 5:00 p.m. the following afternoon when she woke up. She developed itching of her back and a mild erythematous rash across her chest.  That evening around 7:00 p.m. she noticed a rash on her arms that was itching.  At 7:30 p.m. she had tightness in her chest and a nonproductive cough.  She attributed the symptoms to her asthma. Her symptoms improved throughout the night. She went home on Christmas morning and went to bed.  She woke up at around 5:00 p.m. She had swelling of her eyelids and an urticarial rash across her face and chest. She did have some mild throat itching. She reported to work at 7:00 p.m. but continued to have symptoms with increasing shortness of breath. She reported to the emergency department and was evaluated. She was given famotidine, Methylprednisolone, and hydroxyzine.  She was also given ipratropium/albuterol nebulized.  Her respiratory symptoms did improve, and she was discharged around midnight. She continued to have a slight erythematous rash that was present until she went to bed the following morning. When she woke up it had resolved.
Fever, chills, body achy, headache, neck stiffness, diarrhea, soreness of injection site
Dizziness; Bodyaches; Ringing in ears; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 28Jul2021 at 11:45 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. 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 COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 28Jul2021 at 22:00, the patient experienced dizziness, ringing in ears, fever, headache, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, ringing in ears, fever, headache, body aches was not recovered at the time of this report.
Information has been received from a pharmacist concerning her daughter who on approximately 25-JUL-2006 was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast).  On approximately 25-JUL-2006 the patient experienced soreness at the injection site that lasted approximately one week and at the time of this report had not resolved.  Additional information has been requested.
3-4 hours after shots face was very pale and baby was limp, the mother thought the hands were cold.
Accelerated menstrual cycle by one week; This is a spontaneous report from a non-contactable consumer. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication received within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced accelerated menstrual cycle by one week. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event accelerated menstrual cycle by one week was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired vaccine. No temperature excursions occurred. Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration." No adverse reactions reported.
Onset of discrete papular lesions over lower extremities plus hives within 2 hours, post vax, culminating in Henoch-Schonlein Purpura. Pt was hospitalized.
Patient is 35 who is not  immunocompromised but doctors allowed to get it; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's comment: The Shingrix had been approved for those who were immunocompromised less than 50. The reporter asked if someone who had shingles and was 35 and they did not qualify if this information was correct. They were not immunocompromised, but their doctors told them they were allowed to get it. The reporter consented to follow up. Additional supportive information: The patient of 35-year age to whom doctor told them they were allowed to get Shingrix, which led to inappropriate age at vaccine administration.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 48-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
This case was considered medically important (OMIC). Information regarding poliovirus vaccine live oral trivalent solution was received from an attorney regarding a female patient who developed a brain tumor. The patient received a dose of polio vaccine on an unspecified date in the 1960's. Relevant medical history was not provided. Indication for Orimune vaccine was immunization. Product was administered on an unspecified date in the 1960's. Dose regimen was not provided. Concomitant medications were not reported. It is alleged that the patient suffers from a brain tumor, as a result of exposure to Simian virus 40 contained within the polio vaccine. No additional information was available at the time of this report.
He started getting a rash on his forehad, ears and neck, spared his nose and perioral area, also rash on lower extremities.
COVID-19 virus test positive; COVID-19 virus test positive; Blood pressure fluctuation; This is a spontaneous report from a contactable consumer reporting for himself and from another consumer. A 57-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), via an unspecified route of administration in the right arm, on 05Jan2021 at 14:10, at single dose, for COVID-19 immunisation. Medical history included ongoing gout and ongoing blood pressure high. Concomitant medications included allopurinol (unknown manufacturer) from 2008 to an unknown date and from an unknown date to ongoing for gout, lisinopril (unknown manufacturer) from an unspecified date and ongoing for blood pressure high at 40 mg daily, an unspecified drug for blood pressure high from Dec2020 at 5 mg and an unspecified anti-inflammatory. The patient previously took allopurinol from 2008 for gout and experienced abdominal pain upper so the drug was stopped on unknown date but his uric acid levels get high and he had to go back on it again. The patient experienced COVID-19 virus test positive (medically significant) on 16Jan2021 with outcome of unknown and blood pressure fluctuation in Jan2021 with outcome of unknown. It was reported that the only symptom he had on 13Jan2021 at first was a crash in his blood pressure. It was in the 80's over 50's. After that he had a fever of 102.2 F on 13Jan2021 for which he took two Tylenol. On 13Jan2021 at 09:30 PM his temperature was back down to 98.8 F. He has not had anymore fever. He has not had any other symptoms since. His blood pressure fluctuated but they have made some changes with his medication. The patient underwent lab tests and procedures which included blood pressure: in the 80's over 50's on 13Jan2021, blood pressure: fluctuated in Jan2021, uric acid levels: high on unspecified date, body temperature: 102.2 F on 13Jan2021, body temperature: 98.8 F on 13Jan2021, COVID-19 virus test: positive on 16Jan2021. Therapeutic measures were taken as a result of the events.
Pt. came to the clinic for mgc, ty, ppd shots at noon and around 1300 noticed rash below bilateral breast. Pt. took Benadryl to medicate. Pt. was seen today n clinic acute care w/ the same sx. w no px, no NVD, no lightheadedness, no fever or chills.
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine.  Went home early from work.  As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
SHAKY; SHIVERS/ COLD; FATIGUE; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 09:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced shaky. On 07-APR-2021, the subject experienced shivers/ cold. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, shivers/ cold, and shaky, and had not recovered from muscle aches, and headache. This report was non-serious.
Blisters in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: ORAL MUCOSAL BLISTERING (non-serious), outcome "unknown", described as "Blisters in mouth". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tiredness; slight headache; twitch in her eyelid.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitch in her eyelid.), FATIGUE (tiredness) and HEADACHE (slight headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE TWITCHING (twitch in her eyelid.). On an unknown date, the patient experienced FATIGUE (tiredness) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, MUSCLE TWITCHING (twitch in her eyelid.) had not resolved and FATIGUE (tiredness) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Inconclusive) fever of 100.         Concomitant medication was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Case number PHEH2014US022798 is an initial spontaneous report received from a consumer on 10 Nov 2014. This report refers to a 10 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that 3 days after vaccination, she was paralyzed. She was then on oxygen and was confined to a wheelchair. The event outcome was unknown. The seriousness of paralysis was not reported, but the event was upgraded as medically significant based on the information available on NVS-IME list and NVx key event list. The causality of the event was not reported.
muscle and joint soreness; muscle and joint soreness; This is a spontaneous report from contactable consumer, the patient. A 63-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: unknown), via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes. The patient was allergic to strawberries and bee stings. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: unknown), via an unspecified route of administration in the left arm on 26Feb2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 08:00, the patient experienced muscle and joint soreness. The patient took ibuprofen as a treatment for the reported events. The clinical outcome of muscle and joint soreness was resolving at this time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
For unknown reason (not documented in chart) patient received the first Pfizer COVID-19 Vaccine dose on 07/28/21 and the second dose of Pfizer COVID-19 Vaccine on 08/10/21 which is earlier than 21 days and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Patient developed right upper extremity hemiballismus within 48 hours of Moderna vaccine in his right upper extremity.
Immediately had sight, hearing and brain function issues.  Including loss of peripheral vision and hearing/ear disfunction (partially blocked, tinnitus and sound sensitivit. Very quickly developed an inability to perform normal functions at work (36 year career)  at normal levels without errors and confusion lasting until Nov. 2021. It was not until the brain fog lifted that I was able to discern the effects of the vaccination had not resolved. Several incidences of dropping blood pressure issues and dizziness and weakness    also occurred.
Case number PHEH2017US006979, is an initial spontaneous report received from a nurse (who is also the patient) on 06 Mar 2017. Report refers to a female patient of unspecified age. Prior vaccination history included vaccination with unspecified flu vaccine (manufacturer unknown) in 1974. It was reported that about in 1983 patient developed Stevens-Johnson syndrome from a sulfa drug and it took a month to recover. Current condition and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 169305) at a dose of 0.5 ml, intramuscularly on 10 Nov 2016. After vaccination on 13 Nov 2016 (reported as 3 days after the injection was received), the patient developed pain in her left arm. It was reported that patient had declined the flu vaccine every year at work until it was mandatory and she never had the flu. It was reported that patient works in nights as nurse. The outcome of the event pain in extremity was reported as unknown. The case was assessed as non serious by the nurse and causality was not reported.
ADMINISTERED 2ND MODERNA VACCINE 23 DAYS AFTER 1ST MODERNA VACCINE INSTEAD OF 28 DAYS OR LATER, NO SIGNS OR SYMPTOMS REPORTED AND THEREFORE NO TREATMENT REQUIRED
Symptoms began with all over achiness and tired, pain at inject site.  Next day, sluggish with headache and then a fever, nausea, vomitting, diarrhea, night sweats and swollen glands in the neck and tonsils.  Virus two later.
cold chills, headache, body aches, nausea, fatigue, nothing tasted good - now still tired and weak
Pt developed numbness, tingling, weakness - mainly fingers, face, legs/feet - Guillain-Barre. Tx - IVIG.
About one hour after vaccine administration, patient felt like the entire right upper side of his body was dipped in gasoline and lit on fire. This is how he described the pain and burning sensation. For the next two days he had body aches, and he could not stand up straight on 07/03/19. As of 7/10/2019, all affects have resolved.
Patient was scheduled for their second dose of Moderna but was administered the Janssen vaccine instead. The patient did not report any side effects
mild muscle pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from Agency.  A 74-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Jan2023 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "mild muscle pain".  Additional Information: An consumer who received a dose of the Prevnar 20 0.5mL yesterday and experienced mild muscle pain as a side effect has a question. He wanted to know when a patient can get the Shingrix shot after getting the Prevnar 20 injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 10 minutes into his 15 minute monitoring period, the patient became syncopal and rolled onto the floor from his chair. He was responsive within 10 seconds. Patient  was monitored for a longer period of time and fully recovered.
12-16 I was nauseous, I received the vaccine and walked to my department, I ate a graham cracker and didn't subside the rest of my shift at 130pm and went home and ate lunch took Tylenol laid down, at that time my arm started to hurt at the injection site. And when I woke up later that night around 5pm and was feeling better kind of tired but good. Coworkers could tell I didn't feel good. I felt like I needed to have a Bowl movement and urinate more than usual
Systemic: Exhaustion / Lethargy-Severe, Additional Details: got J and J from another location as first dose and did not feel well.  moderna as a booster and continues to not feel well almost 2 months after.  has seen provider and they recommended to call us
Needle or syringe popped off; Incomplete dose administered; Splashed into my face splashed into my eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (needle or syringe popped off), INCORRECT DOSE ADMINISTERED (Incomplete dose administered) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face splashed into my eyes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (needle or syringe popped off), INCORRECT DOSE ADMINISTERED (Incomplete dose administered) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face splashed into my eyes). At the time of the report, DEVICE CONNECTION ISSUE (needle or syringe popped off), INCORRECT DOSE ADMINISTERED (Incomplete dose administered) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face splashed into my eyes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
SYMPTOMS: ONSET STARTING AT 0100 12/30/2020 --STIFF/SORE NECK -- DISCOMFORT WHEN TRYING TO SWALLOW --TENSION/SORE BILATERAL SHOULDERS --SEVERE HEADACHE-LIGHT SENSITIVE --HARD TO TURN HEAD LEFT OR RIGHT-VERY TIGHT AND FEELS LIKE THERE'S A KINK THAT WON'T RELEASE --MID BACK PAIN THAT SHOOTS TO MY LEFT SHOULDER, DOWN MY LEFT ARM. TOOK TYLENOL-500MG TABLET PO AT 0105, NO RELIEF. TOOK IBUPROFEN-600MG PO AT 0600, SOME RELIEF WITH BACK PAIN, TENSION IN SHOULDERS, AND HEADACHE