chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information; adult patient received ENGERIX-B 12OCT2021 and did not receive second dose of RECOMBIVAX HB until today 11APR2022; This spontaneous report was received from a nurse and refers to an adult female patient. On 12-OCT-2021, the patient received HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B). The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  The patient did not receive second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1ml/once, reported lot # T0035865 was evaluated and changed to the valid Lot # T035865, expiration date: 28-APR-2023 (strength and route of administration were not provided) until 11-APR-2022 for prophylaxis (Inappropriate schedule of vaccine administered). The patient's titers were good and she was fine. The patient doesn't need any further doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB). No adverse event occurred.
unable to lift arm; severe joint pain right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (unable to lift arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062620A) for an unknown indication.     The patient's past medical history included Capsulitis and Surgery (capsulitis).   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. 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 INJECTED LIMB MOBILITY DECREASED (unable to lift arm). At the time of the report, INJECTED LIMB MOBILITY DECREASED (unable to lift arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Information has been received from a licensed practical nurse concerning a 26 month old male patient who on 7/17/03 was vaccinated wtih a dose of varicella virus vaccine live. On 6/24/04, the patient presented with 15 to 20 vesicular lesions that were widely disseminated. No other symptoms were reported. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Pt recvd vax & exp sore arm, neck pain, SOB, tight throat & voice change which lasted for 3-4 hrs; 530PM pt became lethargic, disoriented & devel abdo cramp;  19APR93 neck is stiff & sinus h/a has devel;
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-JUN-2012, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a physician's office. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
1JAN90 started itching urticaria over trunk- denies SOB, respiration regular, non labored, c/o pain in joints.
This spontaneous report was received from a registered nurse via a company representative and refers to a 12 year old female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in 2014, at the age of 12 years old, the patient was vaccinated with GARDASIL (dose, route of administration, lot # and expiry date were not reported). On 01-MAR-2018, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, route of administration, lot # and expiry date were not reported). No adverse effects were reported.
Pt went to her car and did not wait for 15 minutes after receiving the vaccine in the designated area.  She called the Clinic located in our same facility reporting she was about to pass out.  The nurse checked her blood pressure which was low and gave her water.  After about 10 minutes the patient returned to her normal state.  The patient ended up just having a panic attack.
Swollen upper left thigh. Rx for KEFLEX 250 mg/5mL 1 tsp p.o. tid for 7 days.
had the same reaction from the second shot/Blood pressure just goes through the roof, up over 200; received dose 3 (booster); received dose 3 (booster); This is a spontaneous report from a contactable consumer (patient's spouse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in 2021 (lot number and expiry date: unknown) as dose 3 (booster), single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date, and second dose on unspecified date in 2021 (8 months ago), for Covid-19 immunisation. The reporter stated that the patient had a terrible reaction to the Pfizer booster. She had the same reaction from the second shot, eight months ago (not clarified further). On unspecified date in 2021, patient's blood pressure just goes through the roof, up over 200 so, they were wondering how to neutralize it. Patient experienced 'crisis' at the time of the report and reporter stated that she might be taken back to the emergency. Outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow-up.
Patient was nervous about the vaccine at the time of the injection. Parent had to hold the child in his lap to complete the vaccination. After the vaccine, the parents and the (patient) were told to wait in the observation area for 15 minutes. 10-15 minutes passed, the dad said the pt was having a reaction. When I went over there, the dad had the oxygen tank out that he brought with him and started to give the pt oxygen. The pt did not seem to have any anaphylactic reactions at the time, he was breathing and moving around, so no Epi-pen was utilized. My technician at the same time called EMS. After a minute or so, the dad stopped the oxygen treatment and the pt was walking and moving around with no issues. After the paramedics come, they monitored the pt's vitals and no abnormality was found. The paramedics left after a few minutes. I informed that parent to follow up with the neurologist before getting the second dose vaccine and to monitor the pt closely for the next few days.
Unexpected therapeutic benefit; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit) and VACCINATION SITE PAIN (Vaccination site pain) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic benefit) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
All the severe complications such as Fever, shortness of breath, headache, body ache, chest pains, heart palpitations.
30min after the shot. Cold, Pain everywhere,  swelling at injection site, cold sensitivity,  headache, achey everywhere.
Diarrhea, foul odor, fatigue, not sleeping well, runny nose, congestion, decreased appetite, abdominal pain. Positive for Rotavirus after full series of vaccine.
When I started my menstrual cycle after the Modena booster (please note Dose 1 and Dose 2 were Pfizer) I had extremely heavy menstrual flow with some large clots that continued for several days. I didn't contact the hospital and or my healthcare provider because I saw where this can happen. It is now better as I'm further along in my cycle.
This spontaneous report as received from a 45 years old female patient with no pertinent medical history or drug reaction and allergies refers to herself. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot number not reported) in December 2011. Other suspect therapies included ZOSTAVAX (lot number not reported) vaccinated simultaneously. Concomitant medications included: lovastatin (manufacturer unknown). In December 2011, immediately after vaccination, the patient experienced flu-like symptoms. The patient was given TYLENOL for treatment. No lab diagnostics studies performed. On therapy of TYLENOL, the patient's flu-like symptoms recovered approximately 1 week later. The patient did not sought medical attention. Additional information has been requested.
Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment drugs were provided.
Didn't get 2nd dose due to pandemic; This non-serious case was reported by a physician via call center representative and described the occurrence of social problem in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in March 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Didn't get 2nd dose due to pandemic). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 16-MAR-2023 The reporter consented to follow up via email.
On day of vaccination: unable to lift arm 2 hours after shot persisted for 24 hours. Past 2 weeks constant ache.
dizziness; Initial information was received on 23-Dec-2020 regarding an unsolicited valid non-serious case from the patient.  This case involves an 87 year old female patient who experienced dizziness, while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient had not received other vaccine concomitantly.  On an unknown date of August-2020, the patient received unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, lot unknown and expiration date unknown) via an unknown route for prophylactic vaccination.  On 23-Dec-2020, the patient developed non-serious dizziness, immediately following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.
Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 MALAISE (Felt sick). At the time of the report, MALAISE (Felt sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a Medical assistant regarding unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA (digital logger) (lot # M011116, expiry: 17-JUN-2017; lot# L015460, expiry: 20-JUL-2017). The vaccines were exposed on 10-AUG-2016 at 28.9F for 3.8 hours, on 11-AUG-2016 at 31.8F for 1.7 hours and on 26-AUG-2016 at 31.1F for 3.75 hours. There was no previous temperature excursion. No adverse effects were reported. This is 1 of 3 reports from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 02-MAR-2016 the patient was administered an expired dose of M-M-R II (lot # K002527, expiration date 18-FEB-2016) (dosage, strength and route unknown). There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
Warm  sensation at the injection site; Injection site itchiness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm  sensation at the injection site), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm  sensation at the injection site), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE WARMTH (Warm  sensation at the injection site), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment was received.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Shortly after receiving the influenza vaccine, patient returned to the clinic and reported shooting pain in left arm from injection site down. No systemic symptoms. Injection site 2 finger breadths below the acromion. Instructed patient to take advil/tylenol. ice and notify PCP if not better or if symptoms persist.
This case was reported by a physician and described the occurrence of Bell's Palsy in a subject of unspecified age and gender who was vaccinated with Flu vaccine (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of Flu vaccine. At an unspecified time after vaccination with Flu vaccine, the subject experienced Bell's Palsy. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bell's Palsy was unspecified. The physician considered the event was not related to vaccination with Flu vaccine. The physician reported that a patient received a GSK flu vaccine and soon after was diagnosed with Bell's Palsy. The physician reported that he did not think there was any relationship with the flu vaccine and this diagnosis. The physician was anonymous. The subject denied permission to contact their physician.
Patient given pediatric (5-11 year old) formulation of Pfizer COVID 19 vaccine as a booster instead of the age-appropriate  adult formulation.
At work felt spacey and light headed.  Went home and noticed red line like rash on arm.  Came down with a 101.9 degree fever later in the day, nausea, dizziness and extreme chills for 1/2 hr.   Rash on arm expanded to about 5 in line down arm and around to shoulder area.  Slight welting also occured at injection sight.  Following morning (10/28) blood pressure dropped to 60/32mmHg, went to doctors office where he was diagnosed with cellulitus and started on Keflex 500mg three times a day.
14Aug90 pt vax;  25Sep90 exp bilateral parotid swelling & soreness.  Tx w/ APAP & soft diet.
Fever 103 degrees red deltoid to ER. Admit after hypotensive episode.
Suspected vaccination failure; Shingles/ she just got it again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it few years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ she just got it again). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 06-Jul-2023 This case was reported the patient via interactive digital media. The reporter's mother in law had shingles few years ago and even with the shot the patient just got it again last week. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Information has been received from a Registered Nurse (R.N.) concerning a 15 year old female patient who on 15-FEB-2007 was vaccinated with a first dose of  Gardasil lot #655619/1427F. On 17-FEB-2007 the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches, abdominal pain and she was "flush all over". These symptoms lasted for ten days before dissipating. On 22-FEB-2007 five days after the adverse symptoms began, the patient was given cetirizine hydrochloride (ZYRTEC) and patient said she felt a little better and her headaches stopped. The nurse who provided this information works in a health department and the name of the patient's prescribing physician was not provided. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s0 previously submitted on 6/14/2007. Inital and follow up information has been received from a health care professional concerning a 15 year old female student with sulfonamide allergy who in 15-FEB-2007, at 02:30 PM was vaccinated IM in the left deltoid with a first dose of GARDASIL vaccine (yeast) Lot #659619/1427F. On 17-FEB-2007, the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches, abdominal pain and she was  "flush all over. These symptoms lasted for ten dayus before dissipating. On 22-FEB-2007 five days after the adverse symptoms began, the patient was given ZYRTEC and patient said she felt a little better and her headaches stopped. The nurse who provided this information woks in a health department and the name of the patient's prescribing physician was not provided. Subsequently, the patient recovered. In follow up it was indicated thta on 18-FREB-2007 patient had severe headache not relieved with acetaminophen or ibuprofen (previously reported that headache started on 17-FEB-2007 and stopped on 22-FEB-2007. Patient had fever 105 degrees x2 days then fever 102 degrees x3 days. It was mentioned that on 18-FEB-2007 patient  also had body aches, flushed skin, joint pain, nausea, vomiting. Symptoms lasted approximately 10 days. Lab drawn with normal complete blood cell count. It was reported that patient required x2 doctor's visit. The patient recovered. No additional information was expected.
Patient states that he noted itching on left arm "a few days" at JE vaccine administration site.  JE site was covered by a band aid, and he removed it.  Subsequently he noted "hives" developing all over the arm, which resolved spontaneously.
Pt recv vax on 10/29/98; immediately post vax pt exp vax site swelling/ tender/ warmth/ ecchymotic, clammy, no radial pulse, unresponsive, incontinent of urine, ashen color; tx=oxygen; dx=vasovagal syncope
Fever, Rash swollen eyelids. Narrative: Initial fever and malaise. Facial rash started on 1/28/21 that progressed to face, neck, forearms, eyelids, and hands over 24 hours. Sought medical attention 2/1 and prescription. On 2/9, continues to report to have painful rash & swollen eyelids since 1/28.
Patient experienced syncope and fainted after leaving the immunization area. She hit her face and was treated by paramedics and released. Followed up with her at 1:00pm and she stated she was fine although tired.
Patient had raised bump under skin immediately after receiving the vaccine. She reported it went down with ice later on and was sore.
Patient says they developed a rash on their left arm that spread.  She says the doctor believes it was a shingles rash.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Could not breathe, heart rate and blood pressure very high (Anaphylaxis). Confused and not hearing very well.
Swollen area in left upper thigh, scant papular rash on trunk and arms with red macule on left axilla x 3 - 4 days. Left thigh swollen and warm to touch. Advised to use calamine lotion prn pruritis. Seen on 1/10/14.