chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body is full of bumps was reported as worsened / bumps are on body from stomach to inner thighs/ It is spreading all over arms; The bumps are spreading. It is painful. She is off work. She cannot even work. She got the steroid pills; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 16Apr2021 09:00 (Lot Number: EP7534) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot number: EP6455) at 9 am on 26Mar2021, administered in arm right for COVID-19 immunization. Clinical course: After vaccination, her body was full of bumps (also reported as body is full of bumps was worsened). She had to go the emergency room, and they gave her steroid pills. It was not clearing up from the steroid pills. She had to leave work today. She went to the clinic today, and they gave her a steroid shot. The bumps were on her body from her stomach to her inner thighs. This all started on 16Apr2021 after the second vaccine. It was spreading all over her arms. The bumps were spreading. It was painful. She was off work. She could not even work. She got the steroid pills, Methylprednisolone on 18Apr2021. She started with 6 tablets and decrease by one tablet per day for 6 days. The events required to visit emergency room and physician office. No prior vaccinations received within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer. The event seriousness was provided as unspecified by reporter. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Immediately after, child stumbled and said he was dizzy. His color was pale, he was diaphoretic and "trying to go to sleep". He remained dizzy and complained of a headache. The next AM, went to school.
On 01/06/2023, I felt like I had something in the back of my throat and a terrible headache. My husband and I tested for COVID-19 and it was positive. I called my doctor's office and they later prescribed Paxlovid. My symptoms were vomiting, muscle pain, headache, dizziness, and lack of taste and smell which I still haven't recovered. After the fifth day, the vomiting and diarrhea stopped, but the fever, headache, dizziness, and chills were still there, along with fatigue and sore throat. I couldn't sleep well the whole time either. The symptoms got better gradually, but as of today, my nose is still running and I'm still experiencing dizziness. I tested myself two days ago and I was still positive.
PATIENT REPORTED TO PHARMACY WITH DROOPINESS OF RIGHT EYE ON 3-12-21 AND WAS TOLD TO PURCHASE OTC EYE DROPS FOR IT. THE NEXT DAY (3-13-21) SHE CAME TO PHARMACY WEARING EYE PATCH ON RIGHT EYE. SHE SAID SHE WENT TO HOSPITAL ON 3-12-21 AND WAS TOLD DIAGNOSED WITH BELLS PALSY, NO PREVIOUS HISTORY.
had a very rare miscarriage; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 2023NVX-US-000001229 (Novavax).  A female patient (pregnant) received bnt162b2 (BNT162B2), as dose 2, single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (dose 1 (primary series)), for Covid-19 immunization, reaction: "maternal exposure timing unspecified". The mother's vaccination history included: Pfizer biontech covid-19 vaccine (dose 1 (primary series)), for Covid-19 immunization, reaction: "maternal exposure timing unspecified". The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "had a very rare miscarriage". The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. The pregnancy resulted in spontaneous abortion. The fetal outcome is neonatal death. Clinical course: On 26Sep2023, it was reported that a (withheld) patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine primary series for COVID-19 immunisation. It was reported the patient was vaccinated with the primary series when she was pregnant and had a very rare miscarriage.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
I received my second vaccine 15Feb and the next morning 16Feb my mood increased to euphoria; This is a spontaneous report from a contactable consumer. A 59-years-old non-pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 15Feb2021 at 15:00 (at the age of 59-years-old) as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included hypothyroid, bipolar depression and hx of cancer. Patient had no known allergies. Concomitant medications included levothyroxine sodium (LEVOXYL), lamotrigine (LAMICTAL) and lithium. It was unknown if patient received any other vaccine in four weeks. Patient was not diagnosed with COVID prior to vaccination. Patient was not tested for COVID post vaccination. On 16Feb2021, patient experienced, after receiving the second dose of vaccine the next morning her mood increased to euphoria. Patient reported that she was stable on the medication for bipolar. Therapeutic measures were not taken due to the events. The outcome of the event was recovered on unspecified date in Feb2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
a really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a really bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (a really bad headache). At the time of the report, HEADACHE (a really bad headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided Treatment medication include Tylenol
After eating dinner on Monday night after 8:30 pm I did not feel well and was sitting on the couch.  I could feel my heart racing and started to monitor my heart rate on my smart watch.  Not even 10  minutes later I developed shortness of breath, heart palpitations, pulse was reading at 130 bpm and told my 8 year old son to get daddy and call 911. My whole left side of my body I could not move and experienced radiating pain behind my left shoulder/neck area through my left arm. I could not talk and my speech was impaired and slurring. I felt like my nerves were shot and was in so much pain.  EMS arrived and took me to the hospital.
Shortly after receiving the 2nd covid vaccine, I began to experience numbness and tingling in the left hand middle finger and left foot. Nothing seems to alleviate the symptoms and it is a daily occurrence.  I find myself shaking and rubbing my hand and tapping my foot to improve the sensation. I have a doctors appointment scheduled.
Day of vaccine: fatigue, lethargy, severe chills, severe arm soreness that travelled from armpit to right trunk, headache. 2nd day: same as above with severe weakness and fatigue, pt slept most of the day.
Reports ate a few peanut butter pretzels today. Reported lightheadedness that resolved within about 1 minute, followed by seeing spots for about 2 minutes resolved, momentary tightness on inspiration that resolved, and ringing in ears for about 3 minutes resolved. Later reported nausea on ambulation post vaccination to seat in observation area that resolved upon sitting down. Also, reported has history of similar s/sx with flu vaccination. Denies chest pain and other s/sx. Nurses responded with emergency cart. 01:47pm LUE 96/70 pulse regular R20, lungs clear, lips noted to be dusky/purplish. Benadryl 50mg PO x1 administered. Lips color reassessed and after few minutes returned to usual pink color. Reports nausea, lightheadedness, visual spots, and ringing in ears resolved, all s/sx resolved, stated "I feel normal". Counseled follow up with pediatrician, urgent care or emergency department for any return s/sx, Mom verbalized understanding.  Observed for 30 minutes. Ambulated with steady gait off floor with his parent and sibling.
Low grade headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Low grade headaches) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Low grade headaches). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Low grade headaches) outcome was unknown.        No Concomitant medication was reported.
1st dose Dec2020, 2nd shot this week; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in December 2020) and Covid vaccine (received in January 2021).   In January 2023, the patient received the 2nd dose of Shingles vaccine. In January 2023, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comments: The reporter was a patient. The reporter asked, what happened if the second shot was not given in the 2 to 6 month window. The patient failed to get his/her second shot in that window. The doctor just gave patient 2nd shot this week (from the reporting date). The patient was doubting the effectiveness after such a long period and asked for a advise. Additional Supportive Information: The patient received the 2nd dose of Shingles vaccine delayed than the recommended schedule, which led to lengthening of the vaccination schedule. Note: The suspect vaccine captured as Shingles vaccine instead of Shingrix, based upon clarification received from intake hub.
Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
The MMR went out of tempature to 55/4F and the manufacturer said to not give it and we did before knowing it was n't usable.
Soreness at injection site now on third day.   Headache within two hours of injection along with mild fatigue for several hours.
(L) arm, swollen, with redness, hot (R) arm swollen with slight redness.
Patient developed severe pain in both arms and both legs, was unable to sleep due to the pain which then caused spasms in legs; following morning patient felt weak and lightheaded and fainted.
This spontaneous report as received from a nurse refers to a 6 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Pt developed full body erythema around 2 minutes after receiving vaccine and reported dizziness.  Pt denied SOB, chest tightness, wheezing, itching . After around 5 minutes, the erythema resolved, but pt developed prominent lower back spasms.   After remaining seated for around 15 minutes and stating the dizziness had subsided , pt slowly stood up . Upon standing pt denied dizziness. She reported after walking around a little that the back spasms were improving.
6pm - Fever &  chills started  and continued to become wores as the night went on 10pm - Fever and extrem chills 1am- dizzy, Fever was about 101 at the highest, elevated HR (80-130bpm) chills with sweats, having trouble getting enough air 3am -was able to finally sleep 6am- Fever 100, swollen lymph nodes, body aches, headache, and dizzy (HR was under control) still having trouble getting enough air. 4pm-Fever 99.5 swollen lymph nodes, body aches, headache, and dizzy (HR was under control) still having trouble getting enough air. 10pm-Fever 99.1 swollen lymph nodes, body aches, headache, and dizzy (HR was under control) still having trouble getting enough air. 5:30am-No fever, felt almost normal 5:30am -next day dizzy and poops
HYPOTENSION 10/27/2022 GENERALIZED ANXIETY DISORDER  HYPOTENSION 10/27/2022 SEPTIC SHOCK  HYPOTENSION 10/27/2022 UTI (URINARY TRACT INFECTION)
Pt was admitted on 4/15/21 to hospital  for pneumothorax after biopsy, after receiving the vaccine on 4/12/21. Per guidelines, all hospitalizations are reported
On Wed, June 9 at approximately 7 pm, pt. noticed her arm was feeling sore, muscles sore and arm was weak. By Fri, June 11, her right hand was swollen enough that she could not remove her rings. She also had temp of 99.3 that day. Today June 14, she complains of her right hand feels "tight" and arm remain sore.
pain goes from my arm to across my shoulder; Injection site was warm to the touch; injection site hard; my arm, where they gave me the shot, was really sore; my arm, where they gave me the shot, red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain goes from my arm to across my shoulder), VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (my arm, where they gave me the shot, was really sore) and VACCINATION SITE ERYTHEMA (my arm, where they gave me the shot, red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain goes from my arm to across my shoulder), VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (my arm, where they gave me the shot, was really sore) and VACCINATION SITE ERYTHEMA (my arm, where they gave me the shot, red). At the time of the report, PAIN IN EXTREMITY (pain goes from my arm to across my shoulder) had not resolved and VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (my arm, where they gave me the shot, was really sore) and VACCINATION SITE ERYTHEMA (my arm, where they gave me the shot, red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided Throbbing pain in the patient's right arm, is not continuous but comes and goes at least once each day. The patient is thinking of taking an X-ray or something as this should not still be bothering her. The patient's second shot caused no problems.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event verbatim; throbbing pain in my right arm was added to pain at injection site that traveled across her shoulder, outcome for this event changed to not recovered/not resolved.
After the vaccine I had a red bump on my left arm. I went to my doctor and he gave me antibiotic and after 6 days of taking medication it went away. It started in the morning. The redness was continuing to spread.
pt had/has severe fatigue, SOB, chest pain, headaches, feeling tired and weak. This has been going on for months and started after first COVID moderna vaccine
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tremor of hands (right hand) and arthritis. On 27th June 2018, the patient received the 2nd dose of SHINGRIX. On 28th June 2018, 1 days after receiving SHINGRIX, the patient experienced erythema, pain, pain in arm, tenderness and mobility decreased. In July 2018, the outcome of the tenderness was recovered/resolved. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the pain, pain in arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the erythema, pain, pain in arm, tenderness and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient developed redness, extreme tenderness and soreness the day after receiving the SHINGRIX. The tenderness and redness resolved within a week, but the soreness had persisted. The patient could not lift his arm above his shoulder without experiencing pain.
This case was reported by a consumer and described the occurrence of redness of eyes in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. On 26 October 2010 at 10:00 the subject received a dose of FLULAVAL (unknown). In October 2010 (dates not specified), less than one month after vaccination with FLULAVAL, the subject experienced redness of eyes, swollen eyes, dry eyes and dry lips. The subject was seen by an allergist on 06 January 2011 and had a skin allergy test that showed she was allergic to thimerosal. The subject was never allergic to thimerosal before. At the time of reporting the events were unresolved.
he and his wife were diagnosed with COVID-19. Caller later mentioned being vaccinated and having a booster from the Pfizer CVOID-19 Vaccine; he and his wife were diagnosed with COVID-19. Caller later mentioned being vaccinated and having a booster from the Pfizer CVOID-19 Vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. Regulatory number: US-PFIZERINC-GRACE00614852.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he and his wife were diagnosed with COVID-19. Caller later mentioned being vaccinated and having a booster from the Pfizer CVOID-19 Vaccine".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In a two month period following this accidental second DTaP shot (received in May and then July of 2006), patient suffered from recurrent otitis media, diarrhea, and bronchitis.  He received multiple courses of antibiotics and steroidal antiinflammatory medicine for the bronchitis.  He then moved deeper into a developmental delay later diagnosed as autism.  8/28/07 Received vax records & medical records from outpatient clinic which reveal patient received flu vax on 1/18/06, 2/22/06 & 11/7/06.  Medical records received for 6/05-8/07.  7/14/06 visit indicates well patient but no speech or communication w/family.  Referred for Speech & Audiology evaluation for delayed milestones.  Testing indicated  hearing WNL.  On 11/7/06 seen only for vax, no indication of medical status.  1/07 note indicates language & socialization issues.  1/07 seen for full developmental eval & Dx w/PDD & Autism including PICA.8/07 Having heavy metal testing done & receiving developmental services. FINAL DX: Autism.
Developed probable shingles on leg. No hx of natural chicken pox. History of receiving Varivax.