chrisvoncsefalvay/vaers-outcomes huggingface dataset:
missed the second dose /due to covid-19 pandemic; This case was reported by a nurse via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about one year and 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination did not receive the second dose due to Covid-19 pandemic. The patient received 1st dose 1 year and 6 month prior to reporting and did not know the exact date. The HCP declined to provide any data and declined to follow up.
pt recvd vax & mom noted 10 hives on torso & neck 5 days p/vax;pt given DPH; Hives (10) noted by mom - on torso and neck 5 days after Hep B#3 injection - given BENADRYL PM. 4 days after Hep B#2 - (+) itchy rash (-) resp distress- ?allergic reaction to shellfish - Rx with AVENO baths,1 Box 2, BENADRYL PM. Urticaria, pruritus, rash, allerg react .
Tinnitus in both ears a few days after vaccine/Also what felt like an autoimmune flair; This is a spontaneous report from a contactable consumer, the patient. A 50-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 in the right arm on 31Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history included post lyme syndrome and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D) and calcium (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. On 02Apr2021, a few days after vaccination, the patient experienced tinnitus in both ears. The patient never had this before and it was persistent and also what felt like an autoimmune flair. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus in both ears was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the flu vaccine on 1/4/14 72 hours later he developed Bells Palsy.
Pt called reporting vomiting, diarrhea, and rapid heart rate. We told her it would be best to call/go to her MD. Called MD to verify condition->MD believes sx's were not due to vaccine but rather gastritis (verified at 3:25 PM). She was admitted to the hospital but doing fine now and going home (12/18) 3:30 PM. Gastritis triggered her irregular heartbeats.
This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for an 81-year-old male patient. The patient received PREVNAR 13, (Lot Number: 108483, NDC number: 00005-1971-02, Expiry Date: Sep2019), intramuscular to left arm on 17Nov2017 12:00 at 0.5mL, single for immunisation at Pharmacy/Drug Store. The patient medical history was none. Concomitant medications were not reported. The patient experienced painful, raised, swollen, red and itchy on 18Nov2017 with outcome of unknown. The events occurred at injection site. The event painful was considered as medically significant. The pharmacist advised the patient to ice and use TYLENOL for pain. The events did not require visit to emergency room nor physician office. Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect drug PREVNAR 13 cannot be excluded for the reported event.
Had 2 Gardasil vaccines, next day 3 hours headache & stomach ache.  Reported to public health.
My left shoulder hurt for 6 or more months. Pain under right scapula. Generalized muscle aches and pains. My stool turned yellow. Abdominal bloated. Left foot pain.  I was having noise in my ears but did not think it needed treatment at the time.
One of four pt's who were immun fr the same vial developed local rxn, size of a quarter or fifty cent coin; The site of inject was red, hot to touch & pt c/o tenderness;
Mom states that pt started with a rash around the injection site on 8/3/11 and has some papules on body since (maybe 10)
bump on the back of her hand; Have a bubble on the back, have a bubble, under back of my hand, just a little raised area on the back of my hand; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 70-year-old female patient (pregnant: No) received first dose of bnt162b2 (Lot number: EL1283, brand: Pfizer), via an unspecified route of administration in right arm on 19Jan2021 15:30 at single dose for covid-19 immunization. The patient had no other medical history. The patient's concomitant medications were not reported. The patient experienced bump on the back of her hand , have a bubble on the back, have a bubble, under back of her hand, just a little raised area on the back of her hand on 21Jan2021 12:15. Caller received the COVID vaccine last Tuesday and then developed a bump on the back of her hand that was not going away. A raised area on the rack of my right hand. Feels like something is in it. Not painful, just concerning. She had her vaccine last Tuesday and she had a bubble on the back, had a bubble, under back of her hand, just a little raised area on the back of her hand. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment for adverse event. The outcome of events was unknown. Facility type vaccine: Other. No other vaccine in four weeks. No other medications in two weeks.  No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies.
Brief syncopal episode. sitting in waiting room and came to Mother at check out with c/o 'I don't feel right'. She slumped in sitting position beside her Mom, not striking anything on the way down. She was diaphoretic, lips pale initially, hugging the waste can and trying to vomit but she had eaten no breakfast. She was helped to an exam room by the RN. BP 100/50 HR 97. She quickly recovered and drank some juice. After 20-30 min she was d/c ambulatory from clinic with her Mother.
This spontaneous report as received from a physician via a company representative refers to a female patient (physician's wife) "in her 40's" (currently "in her 50's"). On unknown dates, when the patient was "in her 20's", she received two doses of VARIVAX (Merck) (dose, route and lot numbers not reported), respectively. On an unknown date, when the patient was "in her 40's", she was diagnosed with shingles. The outcome of shingles was reported as recovered/resolved (date unspecified). Relatedness between shingles and VARIVAX (Merck) was not reported. Additional information has been requested.
Mild headache, mild fatigue, dry non productive cough, soreness in injection site, and 100.6 °F temperature.
5-15 mins after the second dose, I started to feel:  shoulder and neck pain (stiff and tight neck) followed by  right side headache that traveled in a straight line to the opposite side then  pressure towards the eyes,  Chest restriction with breathing difficulty quickly followed  The ENT on site took my blood pressure which was high (my normal blood pressure is below normal)  I was watched for an hour before i felt good enough to drive home.  The headaches continued day and night for 4 weeks after the second dose.
Patient hospitalized due to COVID-19 after being fully vaccinated. Tested positive on 5/23/2021
Diagnosis: post vaccine seizure. Patient started having seizure the night after receiving the vaccines. Fever was around 100.5 degrees (axillary). Patient was in ER that night; was fine for 2 days, the seizure activities happened again. Patient sent to ER and was admitted to the hospital on 8/6/04; was there for 4 days and the final diagnosis is post vaccine seizure.  Nurse follow up on 09/07/04 states: "complete." Information from Annual Follow-up report states had one more episode of seizure activity on April of 05. Patient still under a neurologist care.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 at 13:15 as dose 1, single (Lot number: EW0153), in left arm and on 06May2021 at 10:30 as dose 2, single (Lot number: ER8736) at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Nov2021 at 09:30 as dose 3 (booster), single (Lot number: 034F21A), in left arm and on 07Nov2022 at 12:00 as dose 4 (booster), single (Lot number: 014H22A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Nov2021 at 09:30, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: No Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300285816 same patient, different drug/event;
This report described seizure in a "child" of unspecified age and gender who received DTaP. On an unspecified date, the vaccinee received a dose of DTaP , Prevnar and IPV. Subsequently, the vaccinee experienced a seizure. As of 04/06/01, the outcome of the adverse event is unknown.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Pt said she felt like her throat was closing-Mild, Additional Details: Pt was given immediately 25mg chew benadryl with water, then Nurse took her into her room to sit down. Nurse practitioner ordered 50mg Benadryl Liq---Pt indicated she felt better after 5 minutes. Pt waited 1/2 hr - Pt was in constant contact with her sister on her way home. We called sister and she said pt felt well. Then we called patient who confirmed she was fine and was following up with MD. We instructed her to get advice from MD before getting second shot.
LOSS OF APPETITE; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced loss of appetite, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and loss of appetite was not reported. This report was non-serious.
Dizziness; BP 102/66; HR 58; RR 18; Water PO given
july 28th fever 10. urine was dark . on the 29th urine was brown .
Patient daughter called our office and reported that patient has been double vaccinated? She received her first dose of Pfizer at our vaccine clinic on 3/9 and her second dose of Pfizer at our vaccine clinic on 3/30. She went to her dialysis appointment on 3/26 and they gave her the Johnson and Johnson vaccine there. The daughter was not aware of this until she looked into Patient purse and found a vaccine card with the J & J information written on it. They have put a call into patient primary care physician but at the time of the daughter's call to our office this afternoon, they had not heard back from patient PCP.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GJ3275) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: A few antibiotics" (unspecified if ongoing), notes: Known allergies: A few antibiotics. Concomitant medication(s) included: TYLENOL, start date: Nov2022, stop date: Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with PAXLOVID.  Additional information: Anti-Viral Details: Product=COVID 19 Treatment, Brand=PAXLOVID, Treatment Start Date=01Dec2022, Treatment Stop Date=05Dec2022, Indication=Treatment Of COVID-19
Patient's daughter called and reported he was hospitalized for a heart attack and passed away on 4/5/2021.
My mother started having falls 2 months after her second dose.  She sent me 2 text messages stating that she fell.  Her last fall was the month she died.  On October 23, 2021, she called my brother to say she needed a ride to the hospital because she was having some trouble breathing.  When he got there after 18 minutes, she had already stopped breathing.  They did chest CPR for at least 45 minutes and got her heart started again.  She would never breathe on her own.  They said she seemed to have some kind of infection and at first tested positive for COVID, later saying it was a false positive when we decided to let her go.  She spent the weekend prior with my brother, she was fine, and he saw her just a couple of days before the event, said she also seemed fine.  Her health had finally been on track other than the 2 falls.  Her A1C was the best ever since her being a diabetic for about 30 years.  She was only 58 years old.
Fever-Tremors 06/20/2003.  Small bumps all over back.  Today-generalized rash on face, trunk.  Does have ear infections.
Swollen arm from shoulder to elbow, very hot, lump, black and blue. Skin peeled. Took Keflex 500mg. Lump still there and has been ordered X-ray.
Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included lisinopril.   On 6th July 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm and his arm hurt. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2019AMR188510. This case had been linked to the case US2019187018 and US2019AMR188516, reported by the same reporter.
Patient developed cellulitis in the left arm where she had received a PNEUMOVAX 23 vaccine injection, pt. was started on oral antibiotics, OMNICEF and BACTRIM DS on 6-17-15.
Blisters on the back of the right hand where fingers join the hand, later the blisters appeared on the Left hand exactly the same place as the right hand; Felt Queasy; Sore Injection Site; Scratched-off skin area on the right hand Dime Size; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Scratched-off skin area on the right hand Dime Size), BLISTER (Blisters on the back of the right hand where fingers join the hand, later the blisters appeared on the Left hand exactly the same place as the right hand), NAUSEA (Felt Queasy) and VACCINATION SITE PAIN (Sore Injection Site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced SKIN EXFOLIATION (Scratched-off skin area on the right hand Dime Size). On 22-Apr-2021, the patient experienced BLISTER (Blisters on the back of the right hand where fingers join the hand, later the blisters appeared on the Left hand exactly the same place as the right hand), NAUSEA (Felt Queasy) and VACCINATION SITE PAIN (Sore Injection Site). The patient was treated with TEA TREE OIL for Blisters, at an unspecified dose and frequency. On 25-Apr-2021, NAUSEA (Felt Queasy) and VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, SKIN EXFOLIATION (Scratched-off skin area on the right hand Dime Size) and BLISTER (Blisters on the back of the right hand where fingers join the hand, later the blisters appeared on the Left hand exactly the same place as the right hand) had resolved.            Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-252354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information was received on 08-Jul-2021: significant Follow-up- Event Outcome for Blisters on hand and fingers, sore injection site were updated.
Initial report was received from a health care professional on 22 August 2012. A 41-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, lot number C4137AA, on 09 August 2012. Forty-eight hours later on 11 August 2012, the patient developed a sore left arm then a rash on the arm and body. The patient was seen in the physician's office on 21 August 2012 and diagnosed with shingles. Treatment was unknown. The patient had no illness at the time of vaccination and an unknown past medical history. The patient's outcome was not recovered. Documents held by sender: None.
Shingles (disease); This spontaneous report has been received from a other health professional via GLAXOSMITHKLINE, referring to a female patient of unknown age. As concurrent conditions a penicillin allergy was reported. The patient's medical history included COVID-19 and hospice care.  Concomitant medications were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, lot# and expiration date were not provided) subcutaneously for prophylaxis.    On an unknown date, the patient experienced shingles (disease) (herpes zoster). At the reporting, the outcome and the causal relationship between the event herpes zoster and zoster vaccine live (ZOSTAVAX) were not provided.
1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm
After 3 days patient experienced severe pain in arm and limited mobility...mobility has been improved but still painful. Patient saw doctor on 11/13/18. X-rays were negative, doctor noted some skin irritation.
This spontaneous report as received from a nurse refers to a patients (unspecified number) of unknown age, who were vaccinated with a dose of VARIVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patients could have received doses of VARIVAX that were improperly stored. The nurse reported that her practice had "dormitory-syle" freezer and when new thermometer was placed in, temperature reading was around 10-15 F. The nurse also reported that could not tell how long VARIVAX might had been exposed to 10-15 F. No adverse effects reported. Additional information has been requested. Update (22-JAN-2013): It was reported that client may have been vaccinated with improperly stored VARIVAX exposed 23F to 28F for 34 days. VARIVAX Lot 0660AE Exp 03/28/2014. Or client may have been vaccinated with VARIVAX exposed 23F to 28F for 21 days. Lot 0082AE Exp 01/03/2014. Captured in MARRS  1301USA005126). No adverse effects reported.
This case was reported by a consumer (subject's mother) and described the occurrence of seizure in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), Influenza vaccine unspecified. A physician or other health care professional has not verified this report. Historic vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined; manufacturer unspecified; manufacturer unspecified; unknown; unknown given on an unspecified date. Concurrent medications included CHILDREN'S TYLENOL, Multivitamin + fluoride and Fiber Well chew gummy. On 6 December 2013 at 11:00 the subject received a dose of KINRIX (unknown, unknown thigh) as the 5th dose in the DTAP and 4th in the polio series and a dose of Influenza vaccine unspecified (unknown), brand name was unknown. On 6 December 2013, at the time of vaccination with KINRIX, the subject experienced vaccine administered at inappropriate site. The mother of the subject reported that KINRIX was administered in either the right or left leg. The preferred site of administration for KINRIX is the deltoid muscle of the upper arm. On 7 December 2013, 17 hours after vaccination with Influenza vaccine unspecified and KINRIX, the subject experienced sustaining seizure. The subject had previous DTAP vaccines similar to PEDIARIX; this was the first time the subject received KINRIX. The subject was given ATIVAN intravenously and sent to the pediatric ICU (intensive care unit) and admitted to the hospital. The mother was unsure if the subject will have another seizure, at the time of the report she was no longer having a seizure. On 7 December 2013, the seizure was resolved.
Pt here for 2nd dose of Pfizer vaccine. LVN to give vaccine to patient. Upon injection, needle depressed prematurely causing vaccine to leak down pt arm. Less than half of vaccine administered to pt. Per policy, second vaccine administered in other arm successfully.