chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 10-SEP-2014, the patient was vaccinated with a dose of improperly stored PROQUAD injection (lot# K007798, expiration date 29-NOV-2015 (strength, dose and route not reported). No adverse effects reported for the patient. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (at an age of 30 years). On 17th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, 8 days after receiving SHINGRIX, the patient experienced shingles and blister. On 17th August 2018, the patient experienced pain in arm. On 18th August 2018, the patient experienced loss of consciousness (serious criteria GSK medically significant) and sleep excessive. On 19th August 2018, the outcome of the sleep excessive was recovered/resolved. On an unknown date, the outcome of the loss of consciousness and pain in arm were recovered/resolved and the outcome of the shingles and blister were unknown. It was unknown if the reporter considered the loss of consciousness, shingles, blister, pain in arm and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness in her arm and the next day she was knocked out. She slept for about 25 hours. She had shingles appeared, it began with 3 at her belly button and they have almost resolved completely. Then she had 1 in the middle of her back toward the right side and that was subsiding. At the time of reporting, she had 3 coming up on her left side further down her back. She was encouraged to consult her physician, as she had not notified them. The patient reported having 3 shingles blisters on her stomach 8 to 9 days after vaccination with an additional 3 blisters appearing on her back 12 days after vaccination.
Aggressiveness; soreness; Headache; fatigue; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9263) via intramuscular route of the administration in Arm Left on 17Feb2021 11:30 (age at vaccination: 74-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't receive other medications within 2 weeks to post vaccination. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 9231) via unspecified route of administration on 27Jan2021 11:30 in left shoulder as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced soreness on 28Jan2021, headache on 28Jan2021, fatigue on 28Jan2021, chills on 28Jan2021, aggressiveness on 17Feb2021. No Therapeutic measures were taken for the events. The outcome of the event aggression was recovered on Feb2021, the outcome of the event arthralgia, headache, fatigue, chills was recovered on 30Jan2021.  No follow-up attempts are needed. No further information is expected.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 26-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II (strength was unknown) (lot# M034856 and expiration date 27-JUL-2018) subcutaneously for prophylaxis. The MERCK STERILE DILUENT was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017; 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 07-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Chills Fever 104 Loss of upper body strength and inability to stand (legs buckled)
This spontaneous report as received from a physician via a company representative refers to a 4 year old female patient. Patient with unspecified immunodeficiency disorder. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The physician reported that the patient initially had positive antibody titers after administration of PNEUMOVAX23. The antibody titers were rechecked on an unspecified date and the titers were negative. The patient sought for medical attention and visit office. The outcome of the event was unknown. Additional information has been requested.
3:00 or 4:00pm 3/22/12 temp 100.8. TYLENOL 0.8mL given every 4-6 hours. At 9:00-10:00pm patient had episode of body & extremities stretching out & body & extremities jerking (once). Mother woke her up. She then vomited once. Mother cleaned her up & took her to ER (10:00-10:20). Pt given PEDIALYTE & TYLENOL dose greater than (.8).
Pain in knees began in 1995 with a steady increase in pain and swelling, intermittently, primarily climbing stairs. Unresponsive to NSAIDS and steroids. Became disabled 2/27/01. Left knee replaced on 7/10/01.
This spontaneous report as received from a other refers to a patient of unknown age. On 26-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # N016185 for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On 26-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. {Additional information has been requested. Additional information is not expected.}
This spontaneous report was received from a 65 year old female patient referring to herself. The patient reported that she had gotten prior case of shingles 3 to 5 years ago. The patient's concurrent conditions and concomitant mediations were not reported. On an unknown day, reported as "six months after her first case of shingles", the patient was vaccinated with ZOSTAVAX, (dose, lot# and route of administration not reported, in the right arm). On 10-APR-2015 (also reported as this past Friday), the patient experienced "small pox" on both arms and sought medical attention. The physician who attended her, advised that she was having another case of shingles. The outcome of the adverse event was not reported. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
pain in arm of the injection; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (pain in arm of the injection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm of the injection). At the time of the report, PAIN IN EXTREMITY (pain in arm of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
covid  test  result=Positive; covid  test  result=Positive; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 16:00 (Lot number: EW0196) at the age of 38 years as dose 2, single and administered in arm left, administration date 22Jun2021 10:00 (Lot number: EW0181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromicen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Aug2021, outcome "recovered" (24Aug2021) and all described as "covid  test  result=Positive". The event "covid  test  result=positive" and "covid  test  result=positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Aug2021) positive, notes: Nasal swab; (24Aug2021) negative, notes: Nasal swab; (26Aug2021) negative, notes: Nasal swab; (07Sep2021) negative, notes: Nasal swab. Clinical course: No other vaccine in four weeks. The patient had not covid prior to vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101466860 same patient, different dose, different events
Faster heart rate 70's and 80's. High Blood pressure rose, irregular heartbeat still persistent till this day fatigue. Nervousness. Blood pressure dropped 3days later and went up again after 2days. Heart rhythm changed.
I received the 2nd dose of Pfizer vaccine on 2/10/21, approx 11:50 am.  I went home and in the early afternoon decided to take a nap in recliner.  When I work up <2 hr later, my left hand was completely blue (like veins in my hand but all over).  Thinking that was really weird, a began to shake my hand.  It went back to normal skin color relatively quickly.  No other side effects from vaccine that day.  On 3/10/22 I saw my ob/gyn for annual check.  She said I had swollen lymph nodes under my left arm (injection arm) and they were finding that to be a side effect of Pfizer vaccine.  She noted that on mammogram orders.  I had no other side effects. NOTE:   Vaccine record card for 1st vaccine on 1/18/21 says my patient number
PAINFUL NECK; SORE FROM HEAD TO TOE; BURNING DURING INJECTION; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced burning during injection. On 09-APR-2021, the subject experienced sore from head to toe. On 24-APR-2021, the subject experienced painful neck. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore from head to toe on 10-APR-2021, and burning during injection on 08-APR-2021, and had not recovered from painful neck. This report was non-serious.
first dose vaccine given at a blitz immunization event  pt complained of non-specific tingling sensation mid face after receiving pfizer covid vaccine denied lip/tongue swelling, rash/urticaria, wheezing, sob, cp, cough observed for total of 30 minutes no abnormal clinical findings present pt received 12.5mg po benadryl discharged from blitz event with instructions to seek medical attention if sx's worsen or persist - pt was not sent to the ER
Lethargic, hot and cold chills, body aches, temperature 102+, vomited, weak., extreme headache that lasted for 3 days.  Stayed in bed for almost 2 days, drank liquids and took Tylenol.
He did not get the 2nd dose; His doctor's said he was allergic to the shot; bled profusely through the donor site; broke out in hives from head to feethives lasted 6 weeks; This spontaneous case was reported by a consumer and describes the occurrence of POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Burn (Spent 3 weeks at a burn center for burns to both hands & his donor site was on his leg.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) (seriousness criterion medically significant), URTICARIA (broke out in hives from head to feethives lasted 6 weeks), ALLERGY TO VACCINE (His doctor's said he was allergic to the shot) and PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose). At the time of the report, POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) and ALLERGY TO VACCINE (His doctor's said he was allergic to the shot) outcome was unknown and URTICARIA (broke out in hives from head to feethives lasted 6 weeks) and PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided. Prior to getting the dose patient spent 3 weeks at a burn center for burns to both hands & his donor site was on his leg. About 10 days later patient received his 1st dose & broke out in hives from head to feet & bled profusely through the donor site.  Company Comment: This case concerns a 76-year-old, male patient with relevant medical history included burns to both hands,  who experienced, serious unlisted event of post procedural haemorrhage, among other non-serious events. The event occurred after an unspecified duration from 1st dose of Moderna COVID-19 Vaccine.  The rechallenge was unknown as the date just for first dose was provided. However, it is reported that subject never received 2nd dose of vaccine. The medical history of burns to both hands remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 76-year-old, male patient with relevant medical history included burns to both hands,  who experienced, serious unlisted event of post procedural haemorrhage, among other non-serious events. The event occurred after an unspecified duration from 1st dose of Moderna COVID-19 Vaccine.  The rechallenge was unknown as the date just for first dose was provided. However, it is reported that subject never received 2nd dose of vaccine. The medical history of burns to both hands remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Intense positional vertigo; Fatigue; Mild vertigo, overnight intense h/a, intense vertigo; Overnight intense headache/headache; This is a spontaneous report from a contactable physician, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 13Apr2021 at 12:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to seaweed and cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 23Mar2021 at 12:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient previously took tramadol (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 21:30, evening day 3, the patient experienced mild vertigo, overnight intense headache and intense vertigo Saturday (17Apr2021)- intense positional vertigo with h/a and fatigue lasted 36hours. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event vertigo, intense positional vertigo with headache and fatigue were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient reported itching of scalp and ears that still occurs about every 3 days. She also had pimple-like spots on her midriff and back of the neck, which lasted about 1 week. Patient does not currently have a PCP to follow up with due to insurance.
Patient (doctor) came into healthcare facility room and stated he did not have his card and still wanted his second dose. Dose was given by RN on 1/21/21 before double checking the record of when patient's first dose was. His first dose was on 1/5/21, sixteen days prior. No treatment was given. Normal side effects were described by patient after returning to work the following Monday after the vaccination.
Patient developed a fever of 102.2,petechiae on his upper quadrant and vomited the evening after he recieved the first of the hepatitis shots.He also developed influenza-like symptoms that lasted over 3 weeks. He seemed to recover for a few weeks and then the symptoms returned. patient has been unable to eat without feeling severe nausea and abdominal pain. He continues to loss weight and has been seen multiple times by his physician and a pediatric G.I. specialist.
Received the shot on 7/17. I woke up on 7/25 with a small red dot on my right arm. It was about the size of a pencil eraser. It was very sore & tender. Over the next few days, the rash grew to be about the size of my hand & was raised, red, sore & itchy. My doctor advised me to come into the office on 7/30. There I received a steroid injection & received prescriptions for Triamcinolone & Fexofenadine.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Headache-Mild
Guillain Barre. 10/25 Numbness, tingling in arms/legs - facial numbness that got worse - ER visit, Dr visit - admitted to hosp. 10/28/15 - got worse - put on vent. until 11/12/15 - then moved to rehab on 11/19/15-12/17/15 - now doing outpt rehab 3 x's week. Prior to 10/25 daughter had been complaining of numbness, tingling for weeks prior.
Had the two shot vaccine, still got shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 2-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the most recent two shot vaccine and still got shingles. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Noticed pain on left side of waist and two sites with lesions. Lesions were red , site was painful with dull ache. Went to doctor becasue I thought it was a tick bite. Shingles was diagnosed
Admitted for acute respiratory failure from covid 19 pna; tx w/remdesivir, Actemra, steroids, diuresis, and antibiotics. On 1/23 patient was transferred to ICU and placed on bipap with precedex gtt due to increase O2 demand.  1/24 patient intubated and prone therapy initiated. 1/26 continuous epoprostenol INH initiated.  1/27 ecmo referral initiated but patient was eventually denied by all facilities.  1/30 prone therapy completed.  1/31 epoprostenol and nimbex weaned off.  Despite all interventions patient continued to decline and palliative consulted. Pt subsequently expired.
3/28/2003  chest tightness, aching under left shoulder blade in back 3/29/2003  above continued 3/30/2003  above continued, cough & cold symptoms began, felt "achey, bad" 3/31/2003  missed work due to illness 4/1/2003  "cold symptoms" gone by noon, chest tigtness cont. 4/2/2003  called doctor, chest tightness cont. 4/3/2003  chest tightness with any activity, fatigue 4/4/2003  saw doctor in office, CXR, EKG done...admitted to hospital 4/6/2003  discharged to home, adverse event reported. 4/7/2003  saw doctor--cardiac evaluation 4/8/2003  angiogram done 4/15/2003  CAT scan of lung
01/24/22 presents to ED for "altered mental status". PMHx of "anxiety, depression, Sjogren's disease"
pt recv vax 20OCT96 in rt arm & c/o pain w/swelling from upper arm to fingers;pain lasted 1 1/2 days;swelling has started to subside p/2 days;
patient was admitted and managed for atypical chest pain with negative troponins, obvious diffuse ST elevations  throughout most of the leads without reciprocal changes thought to be secondary to acute pericarditis. She had just been recovering from a viral illness about a week prior to presenting. Patient also had COVID 19 shot weeks prior to incident. Initial placed on IV heparin for unstable angina concern, but discontinued.  Cardiology evaluation to start patient on 325mg of high dose aspirin 2X daily. Fentanyl discontinued and patient started on regimen of naproxen 500mg twice daily. Patient states chest pain has resolved with use of first dose naproxen.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 28-DEC-2015, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.