chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vax, the pt has experienced lack of normal eye movements in her left eye and a staring right eye. It was also reported that the pt has experienced drooping of both eyelids. The pt has been evaluated by a physician and is receiving treatment with eye drops of unknown name or dosage. Attempts have been initiated to obtain further information.
H/A,vomiting,diarrhea.  PT presents with chills, n/v, diarrhea and bodyaches x 0100. received JJ vaccine yesterday. has not yet taken tylenol/motrin.
Patient received second shot in Shingrix vaccination series on 2/21/20. Presented to outpatient facility as an Walk- in. Patient had erythema and swelling in left deltoid area . Size of area described as "hand size" and very slight swelling in wrist. Patient was told to ice the area, take Benadryl for itching and ibuprofen.
swelling 4 days later spreading beyond injection site,, itchiness, redness, soreness, headache, blurry vision
Tested negative for COVID-19 test; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and SARS-COV-1 TEST NEGATIVE (Tested negative for COVID-19 test) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On 23-Feb-2021, the patient experienced SARS-COV-1 TEST NEGATIVE (Tested negative for COVID-19 test). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and SARS-COV-1 TEST NEGATIVE (Tested negative for COVID-19 test) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided no treatment given patient has taken antibody treatment
PATIENT SAYS HE IS EXPERIENCING A RASH, THAT IS NOT LOCALIZED TO THE INJECTION SITE. I INSTRUCTED HIM TO USE BENADRYL TO HELP TREAT THE SYMPTOMS IN CASE IT WERE AN ALLER
Stones in his Kidney; Badly dehydrated; Urine has been dark; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Stones in his Kidney) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DEHYDRATION (Badly dehydrated) and CHROMATURIA (Urine has been dark). On an unknown date, the patient experienced NEPHROLITHIASIS (Stones in his Kidney) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Stones in his Kidney), DEHYDRATION (Badly dehydrated) and CHROMATURIA (Urine has been dark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient states that these events were not related to vaccine and declined further follow up.  This case concerns a 60-year-old male with a serious unexpected event of nephrolithiasis, and nonserious unexpected dehydration and chromaturia. Event latency 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow-up was received on 23-may-2021. New event "Kidney stone" was added.; Sender's Comments: This case concerns a 60-year-old male with a serious unexpected event of nephrolithiasis, and nonserious unexpected dehydration and chromaturia. Event latency 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Case previously recorded as MA2009-4213. Initial case report received from a registered nurse via MedCom on 11 NOV 2009. It was reported that 13 children under the age of four were accidentally vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008010.
5/16 50yo male no significant pmhx presenting with AMS. +COVID 4 days ago. Reports of fatigue, SOB. Pt found minimally reponsive by coworkers this PM.
Fever 102.0F for roughly 24 hours.  Two large red welts about 2x2 inches in diameter on the upper arm where the vaccine was administered (hot and painful) lasting about one week. Lower extremity joint pain in bilateral knees and ankles lasting about three months.
A physician reported the occurrence of an injection site reaction in a 4-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history included possible "mild" nasal allergies and "moderate" nasal congestion. The pt had no adverse experiences following receipt of prior immunizations. There were no concurrent medications. On 07/22/2002 the pt received his 5th injection of Infanrix into his left leg. On the same date, post-immunization, the pt developed an injection site reaction characterized by swelling, redness, tenderness and warmth. The pt was seen by a physician, who noted the swelling and redness measuring 4" in diameter. By 07/25/2002 the injection site swelling was slowly decreasing, injection site redness was increasing, and injection site tenderness persisted. Outcome of the injection site warmth was not reported.
Her daughter is experiencing headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown.), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 29Apr2021, outcome "unknown", described as "Her daughter is experiencing headache". Therapeutic measures were taken as a result of headache.  Additional information: Patient got the second dose yesterday which was the 28April2021 and now was experiencing headache and she wants to know if she can provide Tylenol for her daughter's headache, that's the reason for the call. Reporter stated, Yes, is that okay if I give her Tylenol over the counter medicine. I just gave her some Tylenol (Treatment), so hopefully she will be better. Reporter stated, regarding lot number It is EWO169, that O could be zero, I can't tell.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feeling like she has a cold; Sinus congestion; standard side effects; Achy; Tired; Chills; Fever of 100.1; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feeling like she has a cold), SINUS CONGESTION (Sinus congestion), ADVERSE REACTION (standard side effects), PAIN (Achy) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ADVERSE REACTION (standard side effects), PAIN (Achy), FATIGUE (Tired), CHILLS (Chills) and PYREXIA (Fever of 100.1). On 02-Mar-2021, the patient experienced NASOPHARYNGITIS (Feeling like she has a cold) and SINUS CONGESTION (Sinus congestion). At the time of the report, NASOPHARYNGITIS (Feeling like she has a cold), SINUS CONGESTION (Sinus congestion), ADVERSE REACTION (standard side effects), PAIN (Achy), FATIGUE (Tired), CHILLS (Chills) and PYREXIA (Fever of 100.1) outcome was unknown.             No treatment information was provided.
prolonged menstrual period and menstrual bleeding.; her menstrual period involved bleeding a bunch of blood; severe stomach ache; she also stated that her feet are swollen and she can barely stand; she also stated that her feet are swollen and she can barely stand; heavy bleeding; This is a spontaneous report from a contactable consumer reported for herself. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that, she got her first dose of the Pfizer Covid-19 Vaccine on 05Jun2021. The next day, 06Jun2021, she started experiencing severe stomachache which lasted for a week. It comes and goes, and still experiences this from time to time. She also stated that, on unknown date in Jun2021 her feet were swollen, and she could barely stand. On unknown date in Jun2021, she had heavy bleeding. She also stated that her menstrual period started on 12Jun2021 and until today 28Jun2021, she still had her period. She also mentioned that her menstrual period involved bleeding a bunch of blood. She spoke with her doctor and was prescribed Transaxemic Acid, 650MG twice every 8 hours (Total of 1300MG/8 hours) which she continued to take to relieve heavy bleeding. She also stated that she had no prior history of heavy bleeding. Caller was concerned that she might be contraindicated in getting the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine because of her prolonged menstrual period and menstrual bleeding. The patient wanted to know if the symptoms that she was experiencing were among the commonly reported adverse events of the Pfizer BioNTech covid-19 Vaccine. The patient saw similar accounts of prolonged menstrual period and menstrual bleeding with stomachache on google and she would like this to be raised for attention. The patient still did not have her 2nd dose of the Pfizer BioNTech Covid-19 Vaccine, the patient would like to know if she could still get her 2nd dose beyond the 21st day. The event heavy bleeding was assessed as serious (medically significant). Therapeutic measures were taken as a result of the events heavy bleeding, prolonged menstrual period and menstrual bleeding and her menstrual period involved bleeding a bunch of blood. The outcome of the events, severe stomachache, prolonged menstrual period and menstrual bleeding and her menstrual period involved bleeding a bunch of blood was not resolved while the outcome of other events was unknown. No PQC involved.    Information on the lot/batch number has been requested.
A non-serious report of administered expired FLUMIST has been received from a nurse concerning a 36-month-old of unknown gender. No medical history nor concomitant medications were provided. On 26-Nov-2008, the country health department inadvertently administered expired FLUMIST to ten patients. The product was expired by one day. The patient did not experience any adverse events and will be re vaccinated in four weeks. There  was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 11/26/2008. Based on the results of the investigation, this root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 04-Apr-2009: product complaint investigation results.
The Shingrix shot was injected in to my left upper arm at 2:55 pm on Saturday, June 15, 2019.  At 9:00 pm my deltoid muscle was very sore.  At 8:00 am on Sunday, which was the next day, I had a 102 degree fever that lasted until 6:00 pm that same day.  I had no nausea.  Simply a high fever and extreme fatigue.  I stayed in bed all day and drank fluids.  The injection site was sore for 3 days.
The skin on 5 fingers (including both thumbs) turned red starting at the fingertips and spread beyond 2 knuckles. About 4 days later the skin started peeling.  Same thing happened to both big toes. 17 days later, the peeling is almost finished on my fingers. Toes are still peeling. Fingers are now very sensitive to heat.
Patient received vaccine on 10/07/19 around 09:00 am. She developed Flu like symptoms (body aches, Malaise, fatigue) around 4:30 am on 10/08/19. Today she was seen in clinic with a flat, pink/red, non-pruritic, non-painful rash on stomach, lower back, inner thighs and upper arms. She states she feels fine today but was concerned about the rash.
First two days after the vaccine extremely dry mouth. Then progressively increasing rash on right palm - Itchy and dry to the point of not able to sleep.  On some days itchy tongue too. Going to see a doctor on March 30th.
Confusion, Myalgia,  fatigue, arm soreness Narrative:  Fatigue, myalgia, sore arm, confusion; taking ibuprofen.
Deep red rash about 3cm in diameter with hardness underneath about 5-6cm  and swelling.  Also swelling in lymph under arm.  Dr. was seen who ordered a course of antibiotics and steroids after which the swelling and redness resolved.
This spontaneous report was received from a physician concerning a patient of unknown age and gender. On 10-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000427 and 10-APR-2014 respectively), subcutaneously instead of VARIVAX (Merck). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
My symptoms are muscle soreness, knee, and joint pain and unable to bend knee forward or backward without experiencing pain.
Shot given before noon, and by 8 pm patient said her face had a bad rash that itched. She took a Benadryl and was fine in 24 hours.
Blister formation -- day one post vaccination 11/28. Presented to office 12/1 with redness / warmth. Possible localized infection at this point vs allergic response.
1-3 days of achy flu like symptoms, and fatigue. Felt better each day &  Completely subsided within 3 days.
Information has been received on 12-MAR-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 ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2016, the patient was administered the 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 ZOSTAVAX. The outcome was not provided. Additional information has been requested.
The day after I received the vaccine, I developed chills, headache, fatigue. Approx. 23 hours after vaccine administration I noticed throat swelling/difficulty swallowing. I took 50 mg of benadryl and went to a local walk in clinic. O2 sat 98%, no respiratory distress, nurse practitioner reported my throat and rest of assessment were within normal limits. Instructed to continue taking benadryl and monitor symptoms. Later that evening I developed congestion, so the morning of 12/24 I called my work's COVID hotline and they instructed me to come in to be swabbed. I received negative COVID-19 results from my works Occupational Health department on the morning of 12/25. The throat swelling/difficulty swallowing has gotten better, but still not back to baseline as of 12/28. I have a appointment with my PCP, to follow up.
Pain down arm of injection within 1 hour. Then up into shoulder and progressed into neck and down to left low back within several hours. Lasted 5 days. Also had headache.
A 27-year-old female patient had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2507AA, on 18 October 2007. It was determined that the patient was approximately two months pregnant at the time of vaccination. Last menstrual period and estimated date of delivery were not provided. Per the reporter, the patient did not experience any adverse event. Follow-up report received from a health care professional on 06 August 2008. On an unspecified date, the patient was found to have polyhydramnios. A level 2 ultrasound performed at 28 weeks gestation showed bilateral hydronephrosis in the fetus. The patient went into premature labor at 32 weeks gestation. on 17 March 2008, 35 weeks gestation, the patient went into labor. A Cesarean section was performed resulting in the live birth of a male, born with bilateral hydronephrosis. The reporter indicated that the mother's health during pregnancy had been unremarkable, except for the polyhydramnios. The reporter of this case is the same as case 2008-02516, the report for the above-mentioned baby.
Chills, body aches, fever, injection site swelling and pain, headache, fatigue
Patient injected with expired ZOSTAVAX (2014). Patient informed. Will re-vaccinate in 30 days.
aching in her joints real bad; headache; Then at 5am on the 19Oct2019 she passed out; Initial information received on 24-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case is linked to cases 2019SA297783 and 2019SA297790 (same reporter).  This case involves a 50 years old female patient who experienced aching in her joints real bad (arthralgia), then at 5am on the 19oct2019 she passed out (loss of consciousness) and headache (headache), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's family history included Type 1 diabetes mellitus (but her daughter was just diagnosed with Type 1 DM). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) was not provided.  On 18-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left arm.  On 19-Oct-2019 at 05:00, 1 day 5 hours after the vaccination the patient experienced passed out (loss of consciousness). This event was assessed as medically significant.  On an unknown date, following the vaccination the patient experienced aching in her joints real bad (arthralgia) and headache (headache). Both events was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was joint pain, passed out and headache.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case involves a 50 years old female patient who experienced joint pain, passed out and headache after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed
Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: n/a
SWOLLEN, HARD, TENDER TO TOUCH, REDNESS AND HOT TO TOUCH.   LEFT THIGH CELLULITIS.
This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247; Expiration date: unknown) intramuscular, administered in Arm Left on Jan2021 (at age of 51-years-old) as DOSE 1, SINGLE and patient had received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) intramuscular, administered in Arm Left on 09Feb2021 (at age of 51-years-old) as DOSE 2, SINGLE both for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID taken for an unspecified indication start date and stop dates were not mentioned. There was not any past drug event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Jul2021 patient experienced fatigue, headache, cough, and congestion. On 02Aug2021 the patient experienced SARS COV 2 RNA/positive (drug ineffective and COVID-19). Patient did not receive any treatment for events. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included COVID test post vaccination on 02Aug2021 (Nasal Swab) which was positive. The outcome of event SARS COV 2 RNA/positive was unknown while outcome of events fatigue, headache, cough and congestion was resolving.