chrisvoncsefalvay/vaers-outcomes huggingface dataset:
C-Section Discharge Summary    Date of Admission: 7/6/2022 Date of Discharge: 7/9/2022   Diagnosis: 37 week; substance abuse; iugr; non-reassuring fhr;    Hospital Course   OB History Gravida Para Term Preterm AB Living 1 1 1     1 SAB IAB Ectopic Multiple Live Births          0 1      # Outcome Date GA Lbr Len/2nd Weight Sex Delivery Anes PTL Lv 1 Term           38w0d   2.665 kg (5 lb 14 oz) M CS-LTranv EPI   LIV     The patient underwent a Cesarean delivery during this hospitalization due to the above listed diagnoses.   She is now 2 days post operative.  She has not had complications since the delivery.  She has not been febrile.  She did not have a surgical sterilization at the time of her C-section.     At the time of discharge, the patient was afebrile and has been tolerating a regular diet.  She has been ambulating and voiding without difficulty.  Denies symptoms of orthostasis.    Plan   She has been given discharge instructions which include the following: No driving for 2 weeks, No straining or lifting >15-20 pounds, No sex, tampons, douche, or tub baths.  Follow up for an incision check in 2 weeks.  Call for any signs of fever, foul discharge, increased bleeding, wound redness or draining, or signs of postpartum depression.   Discharge Medications Toradol 10 mg po q 6 hr #20
pt recvd 1st dose of Hep B Recombinant in AUG92 & 2nd dose SEP92; pt dx as having adult onset diabetes;  adm to hosp for surgery to remove a gangrenous appendix; lab eval revealed hemoglobin of 10 & lymphocytosis & neutropena;
A couple days after vaccine shot, Feb. 2 redness swelling started on right hand pointer finger just below cuticle, each day I noticed another finger with redness very swollen sore  to touch.  Then noticed same on left hand finger. Went to Dr. Feb. 8. She thought an immune response, but then Dr, did a COVID-19 test on Feb. 9.  It was negative.  by Feb. 12 swelling and soreness went down some but redness is now an inch  from cuticle to joint on 6 fingers on both hands. No problems with joints and any other ill feelings.  Feb. 16  still 6 fingers with severe redness .  I guess I will go to dermotologist now before I get my second vaccine shot.
Rheumatoid arthritis flare up; Shingles; Eye infection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4245187-00 (Company).  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Route of Administration: Intramuscular), administration date: 01Aug2021, when the patient was 62-year-old, for COVID-19 immunisation. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles"; EYE INFECTION (non-serious), outcome "unknown". The action taken for adalimumab was unknown. The reporters causality for the event(s) of shingles, rheumatoid arthritis flare up and eye infection was not provided for suspect Humira.   The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "shingles" and "eye infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary series Rather than the Bivalent dose designated For Primary Series
dose given was beyond the use date (BUD) of 8July2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given was beyond the use date (BUD) of 8July2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given was beyond the use date (BUD) of 8July2021). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (dose given was beyond the use date (BUD) of 8July2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose given was beyond the use date (BUD) of 8July2021) to be not applicable.    Concomitant medications were not reported.   This case was linked to MOD21-119255, MOD21-119243 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Updated query has been received from Safety and mentioned in inarrative. On 14-Jul-2021: Follow up document received on 14-UL-2021 and contains No New Information; Sender's Comments: This report refers to a case of Expired vaccine use for mRNA-1273, lot 051C21A with no associated AEs. According to Regulatory Authority's module this is an invalid case.
Delayed skin rash at site of infection. 3-4 inch across. Tender to touch, warm. Onset began 7 days after injection, small raised bumps first day (day 8), large red oval second day (day 9, today) still growing slowly (1/2? over last 12 hours) at time of reporting. Symptoms lasting 2 days so far. Measured skin temperature, peak over 100.7 mid day on day 9 (today), under 99.4 by evening.
Pt tested positive for COVID-19 on 2/10/2021, and deceased on 2/12/2021, per caregiver at.
Sinuses affected; throat affected/trying to get voice back; ears affected; throat affected/trying to get voice back; severe allergy reaction like he was exposed to dust or mold; This spontaneous case was reported by a patient and describes the occurrence of SINUS DISORDER (Sinuses affected), OROPHARYNGEAL DISCOMFORT (throat affected/trying to get voice back), EAR DISORDER (ears affected), APHONIA (throat affected/trying to get voice back) and HYPERSENSITIVITY (severe allergy reaction like he was exposed to dust or mold) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Sinuses affected), OROPHARYNGEAL DISCOMFORT (throat affected/trying to get voice back), EAR DISORDER (ears affected), APHONIA (throat affected/trying to get voice back) and HYPERSENSITIVITY (severe allergy reaction like he was exposed to dust or mold). At the time of the report, SINUS DISORDER (Sinuses affected), OROPHARYNGEAL DISCOMFORT (throat affected/trying to get voice back), EAR DISORDER (ears affected) and HYPERSENSITIVITY (severe allergy reaction like he was exposed to dust or mold) outcome was unknown and APHONIA (throat affected/trying to get voice back) was resolving.            No concomitant medications were reported. The sinuses, throat and ears were affected as if it were an allergy reaction.  Patient's voice was bad for the first three days. No treatment medications were reported.
Mom states child had inconsolable crying x 5 days; Frequently awakened from naps w/crying & jumping; No fevers, inject sites were w/o redness per mom, no n/v or any other s/s of ICP;
After about a week after the shot I noticed raised, itchy, burning red patches on my right hand.  I will say that I am not sure this is related to the shot but wanted to report it as it is different from any other skin reactions I've had.  It's been three weeks now and it still itches and burns as much as it did three weeks ago.  I have tried applying Triamcinolone Acetonide .1% steroid cream which does help.  I have also tried antibiotic ointment covered by bandages overnight (no effect), Eucerin (no effect), and Aquaphor (no effect).
chills; fatigue; high fever; This is a literature report:  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (life threatening), outcome "unknown", described as "chills"; FATIGUE (life threatening), outcome "unknown", described as "fatigue"; PYREXIA (life threatening), outcome "unknown", described as "high fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events pyrexia , chills, pyrexia and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
GOT COVID; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious.
Client developed tightness & tingling in lower Right arm. Dr present and evaluated. No other symptoms present .Instructions given to follow up c Medical if s/s worsen
ON 12/24/20 AT APPROXIMATELY 10PM, DEVELOPED CHILLS, SHAKING, VOMITING LASTING 4 HOURS. ALSO HAD FEVER/BODY ACHES LASTING 24 HOURS. FELT GROGGY FOR 2 DAYS AND A SORE ARM FOR 4 DAYS.
patient did not say anything after injection or during waiting period bu called back to the pharmacy and stated when she received the injection she felt a little pinch in her lower back and as felt it every now and then ( a few times since)
This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Tested positive for COVID; Tested positive for COVID; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "booster shot"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Clinical Course: The reporter stated that, her husband had COVID, and thankfully his was a mild case of COVID which they credit to the total of 3 Pfizer Covid Vaccine doses including the booster shot that he was adminsitered prior to being diagnosed with COVID. Tested positive for COVID about 2-2.5 weeks ago, before time of this call. He has been out of isolation for about a week now. She stayed in isolation with him just to follow guidelines even though she did not have COVID.Pfizer Covid Vaccine:First dose: Date administered: A week or two after 25Feb2021 or 26Feb2021, so around Mar2021 reporter thinks.Second dose: Date administered: A week or two after 19Mar2021, so around Apr2021 reporter thinks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
about 2 hrs p/vax pt vomited became listless color very white, lips & greyish color; restless nocs until 28FEB94;
One hour post vax, pt had sudden onset of shortness of breath. Used inhaler with Primatene mist with some relief of symptoms. Pt describes chest tightness with jaw tingling and left arm/shoulder tingling that persisted Occasional episodes of fast heart rate. She was driven to an occupational health clinic by significant other but upon her arrival, she refused any evaluation or treatment. She rested at home with observation by significant other. Symptoms alternately improved and flared over next two days. All symptoms resolved at this time.
Right eye swollen underneath then on 28Jan2021 both eyes were affected; This spontaneous case was reported by a nurse and describes the occurrence of EYE SWELLING (Right eye swollen underneath then on 28Jan2021 both eyes were affected) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced EYE SWELLING (Right eye swollen underneath then on 28Jan2021 both eyes were affected). At the time of the report, EYE SWELLING (Right eye swollen underneath then on 28Jan2021 both eyes were affected) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was also taking antidepressants. The patient wanted to specify that she has dermatological fillers.
HBV given at 10am at school. Pt arrived home at 4:30pm complained of back itching. Mom took pt to MD. Pt had urticaria on trunk and extremities. Gave IM steroid and PO Bendaryl. Pt sent home. Mom states itching resumed today at school. Resolved with bendaryl. Arrived home with face flushed this pm and possible high temp. To flu with MD.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm, via an unspecified route of administration on 29Dec2020 15:45 at single dose (lot number: FH9899), then received the second dose on the left arm, via an unspecified route of administration on 19Jan2021 15:45 at single dose (lot number: EL3302) for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. There were no other vaccines in 4 weeks and no other medications in two weeks. The patient started having flu like symptoms on 07Feb2021. She went to the clinic. She tested positive for Covid on rapid test. They took 2nd swab and sent to lab. It's positive too. She had temp 99 even after Tylenol. Headache, chills, running nose, sneezing, and body aches. She just thought you all should know. She doesn't know if the lab tested for other strains. The adverse event started on 07Feb2021 07:00. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The patient had no Covid prior to vaccination and was Covid tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.
Had an issue after receiving the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an issue after receiving the Moderna vaccine) 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 VACCINATION COMPLICATION (Had an issue after receiving the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Had an issue after receiving the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported
Pt recvd 2nd dose Hep B vax NOV91 & 24 hrs later devel vomiting, diarrhea, myalgia, diaphoresis, weakness, & dyspnea; sx progressed to the point that pt presented to ER; tx 02 & IV fluids; MD felt that the pt was hyperventilating & dx flu;
faint; feeling weak; feverish; nauseous; cough; sore throat; I took my temperature I was alarmed that it was 94 degrees (very low); diagnosed with an unknown virus; diarrhea; sneezing; runny nose; horrible body aches.; This is a spontaneous report from a contactable Healthcare Professional (patient). A non-pregnant 45-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm on 03Apr2021 14:00, at the age of 45 years, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included thalassaemia sickle cell from an unknown date, Gitelman's syndrome from an unknown date, sarcoidosis from an unknown date and allergy to hydromorphone hydrochloride (DILAUDID) and ketorolac tromethamine (TORADOL). The patient didn't receive any other vaccine in the previous 4 weeks. She was not diagnosed with COVID-19 prior vaccination and was not tested positive for COVID post vaccination. The patient reported that after she received the first shot, on 05Apr2021 at 08:00 PM, she had a severe reaction. It started with feeling weak and feeling feverish, nauseous and faint. She also had a cough and sore throat. When she took her temperature she was alarmed that it was 94 degrees (very low). She waited 30 minutes but the symptoms intensified. When she took her temperature again it was 95 degrees and she felt like she was going to lose consciousness. She immediately called # and an ambulance came and paramedics assessed her. She was taken to the ER and she was diagnosed with an unknown virus. It was reported that she was treated with unspecified IV drips. When she was released and returned home new symptoms started. On an unknown date she had severe nausea, diarrhea, extreme sneezing, runny nose, fever and horrible body aches. This all lasted for over a week. It was an incredibly difficult time for her and she felt compelled to share her experience in hopes of informing others who have the same bizarre series of symptoms. All the reported events resolved on an unknown date.  The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: A contributory role of BNT162B2 to events eeling weak and feeling feverish, nauseous and faint, a cough and sore throat, temperature she was alarmed that it was 94 degrees (very low), diagnosed with an unknown virus cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Red induration at site, 6-8 cm, chills, body aches, fever of 101.6. Similar reaction after first injection 5/4/18.