chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 16SEP93 830AM & started trembling lips seemed pale, seemed listless & hards appeared bluish; instructed to take for med care now; inc fever dx febrile convuls;
After immunization on 1/10 began with itching and erythema.  Post immunization noticed erythema, warmth on 1/11.  Went to Emergency Doctor.  Diagnosed in clinic 1/12 with increased erythema and warmth left arm.
Pt recvd 3 doses of Hep B vax & 1st 2 dosses may have been Engerix-B & the 3rd dose was Engerix-B & FEB92 titer was found to be neg; pt was a non-responder, will recvd a booster;
Joint pain in arm where injection was given.  Generalized muscle aches and pains.  Generalized tremors.
swollen lymph node in the neck after 1st vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of lymphadenopathy cervical in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced lymphadenopathy cervical (Verbatim: swollen lymph node in the neck after 1st vaccine). The outcome of the lymphadenopathy cervical was resolved (duration 1 week).   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Shingrix.     It was unknown if the company considered the lymphadenopathy cervical to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2023 The medical assistant reported an adverse event that happened last year after a patient's 1st dose of Shingrix vaccine.  In 2022, the patient experienced a swollen lymph node in the neck and the swelling subsided after a week.  The patient discussed with doctor at next visit. No patient demographics were known. The exact date of vaccination was not reported, and it was unsure if patient received 2nd dose of Shingrix vaccine. Permission for Safety follow-up unknown. No additional data was available about this adverse event.
On the 10th of January 2023, my symptoms began with scratchy throat, chills, fever and muscle aches.  I was having some coughing.  I had a televist on the 11th and was prescribed Paxlovid.  On the 15th I was feeling better and tested negative on the 18th.  I tested positive again on March 23rd.  My cough got worse and had a low -grade fever.  I also have more joint pain than usual at this time.
Diffuse, pale red to pink rash. Patient also some itching and and initial feeling of warmth at the injection site. Symptoms appeared 15-18 hours after injection. Upon checking with patient days later, patient reported that all symptoms and skin reactions had disappeared within 7 days (11/24/2018).
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline. . Pt did report sore arm for 24 hrs, denied redness or swelling, Otherwise no other clinical concerns reported
hives down her shot arm and by the shot site. States she had about 10 separate hives.; She got her 2nd shot at noon and she stayed 15-20 minutes and within 30 minutes she had hives down her shot arm and by the shot site; little headache; This is a spontaneous report from a contactable consumer(patient) or other non-hcp. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EP7534; Expiration date: not provided) via an unspecified route of administration in left arm on 22Mar2021 at 11:35 (age at vaccination 56-year-old) as dose 2, single for Covid-19 immunization. The patients medical history included immunocompromised. The patients concomitant medications were none. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6198; Expiration date: unknown) via an unspecified route of administration in left arm on 01Mar2021 (age at vaccination 56-year-old) as dose 1, single for COVID-19 immunization and experienced headache. The patient stated that she has some questions on reactions. She got her 2nd shot at noon and she stayed 15-20 minutes and within 30 minutes she had hives down her shot arm and by the shot site. The patient states that she had about 10 separate hives. The patient states over the 2 hours she has been holding to speak to someone the hives are subsiding. The patient also stated if she gets more hives she was assuming it was okay to take Benadryl and was wondering what she should do if it gets worse on her body. The patient did not do anything to treat the hives. States she took Tylenol but that was for just a little headache she got after the vaccine and that was a little better. The event outcome of events was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Immediately I could feel the medicine going straight to my legs. Later that night my legs felt funny and  tingly. The next day  I had tingly feeling in my toes ( bil) , tingles to my left fingers and the my lips giving me stroke like symptoms. I went to see the Practitioner on 8/27/2021  and she says that if it continues for me to some back and she will order test. So it continued  and I went to see doctor in September who ordered a Ultra  Sound on my bilateral LE and to see a Neurologist
pt recv vax & devel encephalitis p/vax;current MD does not have pt medical records;
Fever 2-3 days after receiving vaccine Redness, swelling, extreme tenderness for 5 days after receiving shot in right deltoid
Within 24 hours, arm pain at forearm with hard swelling and pain.  Injection was in upper arm.
This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced serious and permanent neurological injuries which was attributed to toxic mercury exposure. The following information was received via medical records: The subject was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine on 1/28/88. The subject was also vaccinated with live attenuated oral poliomyelitis vaccine, MMR (strain not specified) and Haemophilus influenza type B vaccine for prophylaxis. The subject began to babble at 10 to 11 months of age, but at 2 years old was no longer saying distinct words and indicated needs by crying or pulling caregiver's hand. Motor milestones were normal, with delays in language and social development. He exhibited poor eye contact and preferred solitary play. Between 5/10/92 and 5/14/92, the subject was admitted to the hospital and underwent a comprehensive medical evaluation. He was diagnosed with pervasive developmental disorder and probable moderate to severe mental retardation. Speech/language evaluation suggested severe speech and language delays. The subject was described as hyperactive and difficult to manage. His receptive communication skills were in the nine month old age range. Between May 1992 and July 1992, he was medically evacuated from overseas due to concerns including severe asthma and developmental delays. He was subsequently diagnosed with autism. The subject received concurrent therapy with prednisone and theophylline for asthma. On 3/19/01, the subject was diagnosed with a seizure disorder. In July 2001, diagnoses included a psychomotor retardation and attention deficit hyperactivity disorder. On 7/26/01, the subject underwent a neurodevelopmental evaluation for concerns including autism and significant neurobehavioral disturbances. At the time of examination, behavioral problems included violent behavior, aggression, hitting, destructiveness, and unpredictability. He continued to converse in single words with verbal reasoning described as rudimentary at best. Past medications included Ritalin, Risperdal, Adderall, Prozac, Mellaril, Zyprexa, and Trileptal; however it was noted that he experienced seizures on the major tranquilizers which were discontinued. At the time of examination, medications included Ativan, Depakote, and Clonidine. On 9/25/01, the subject's problem list included 1) severe pervasive development disorder (autistic) since age of 2 years old and getting worse, 2) severe mental retardation and attention deficit hyperactivity disorder, 3) reactive airway disease, 4) seizures. Medications at that time included Risperdal and Depakote. On that date the subject received his initial vaccination with hepatitis B vaccine, and received his second Engerix B vaccination on 11/21/01.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
weak; painfully sore; very lumpy; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had internal shingles and it was so bad and painful) and covid-19. Previously administered products included Shingles vaccine (1st dose received when hit 51 years). Concurrent medical conditions included nerve damage (it was a year and ten months in and it was getting better).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced weakness, pain localized and mass. On an unknown date, the outcome of the weakness, pain localized and mass were recovered/resolved.   It was unknown if the reporter considered the weakness, pain localized and mass to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient waited 6 months after 1st dose and then received 2nd dose of Shingles vaccine and felt weak and painfully sore that was very lumpy. It went away in seven days. The patient waited another month and received the pneumonia vaccine, waited another month and received the flu vax too. The patient had all three vaccines with covid. He/she rather had 300 percent than Covid vaccine at 47 percent. The follow-up would not possible as no contact details were available.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 28-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Rash and fever onset 1/17/2015 AM - Seen by PMD that AM and sent to the ER for evaluation.  Ended up being admitted to the pediatric ICU with Toxic epidermal Necrosis resulting in 5-1-% skin loss.  Required intensive wound and eye care management.
Shortness of breath; A spontaneous report was received from a consumer concerning for herself, a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath/dyspnoea.  The patient's medical history included Covid-19 in an unknown date in Dec 2020 and current condition includes lung disease since birth, belly pain, arm and shoulder pain. Concomitant medications includes levothyroxine and vitamins.  On 11 Mar 2021, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (Batch number: 010A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced shortness of breath for which patient was admitted to hospital and was given oxygen. The patient stated that symptoms resolved.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome for the event, shortness of breath was resolved on an unknown date at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of shortness of breath, a causal relationship cannot be excluded. Patient's underlying lung disease may have been contributory.
looks like she has the mumps; whole right side of her neck under her jaw and ear were swollen; This spontaneous case was reported by a consumer and describes the occurrence of MUMPS (looks like she has the mumps) and EAR SWELLING (whole right side of her neck under her jaw and ear were swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mumps in 1900.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MUMPS (looks like she has the mumps) and EAR SWELLING (whole right side of her neck under her jaw and ear were swollen). The patient was treated with IBUPROFEN for Mumps, at a dose of 1 dosage form. At the time of the report, MUMPS (looks like she has the mumps) and EAR SWELLING (whole right side of her neck under her jaw and ear were swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Had burning when first administered for about 5 minutes.  Then 1/23/13 have one spot where shot was administered that looks like a chicken pox or shingle, soreness and a little swelling.
swollen arm, redness, warmth, low grade fever. treatment -ice to effected are, ibuprofen, started 24 hours after vaccine.
Brain clot: acute thrombosis of the Left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (reported as 19Mar2021; pending clarification). (Batch/Lot Number: EL9266) as single dose for covid-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included desogestrel, ethinylestradiol (PIMTREA) taken for an unspecified indication, start and stop date were not reported. The patient previously took diflucan and experienced allergy. The patient experienced brain clot: acute thrombosis of the left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis (hospitalization, disability, life threatening) on 10Mar2021 12:45. The patient was hospitalized for brain clot: acute thrombosis of the left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis for 6 days. The patient was treated with Heparin and Coumadin. The event resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received the second dose of bnt162b2 on an unspecified date (reported as 18Mar2021; pending clarification), lot number: EN6204, on right arm. The patient was recovering from the event. The patient was not diagnosed with COVID prior to vaccination. Patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the current available information, the events occurred prior to BNT162B2 administration (this information need be clarified). The reported events are considered as an intercurrent or underlying condition which is not related to the suspected drug at this time.  The case will be reassessed if additional information becomes available.  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.
Within an hour of the shot extreme fatigue and flu like symptoms required bed rest for 2 days before symptoms improved. Experiencing long term shortness of breath a month after the shot.  I had no such symptoms before the shot and was able to work out hard and lift weights. There is no chest congestion or cough. I have an appointment to see my primary care doctor on April 30, 2021 on this issue.
Site of shot swollen,red, itchy, sore approx 3 inches long 1 inch wide later 7 days and went away  Called Dr. Said it should last approx 1 week.  Put a hydrocortisone OTC cream to help itching
Vaccines received 3/16/09 5pm, Mother called Health Department 3/17/09 stated child broke out in hives on trunk, back, "water blisters" under eyes. She gave him BENADRYL 50mg po. Took him to ER, they gave him PREDNISONE and a MEDROL pack. No hives on 3/17/09.
Patient presents to clinic 2 days after receiving Tdap with complaints of Rt. arm pain, loss of range of motion, cellulitis in area.
Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021.  Patient began to complain about feeling tired and wanted to take a nap later in the afternoon.  Patient's husband found patient at 16:30 almost unresponsive and checked a BG reading which resulted at 25.  Husband gave patient oral forms of sugar and transported to ER where he BG slowly normalized.  Husband reports patient has been a well controlled diabetic and has never has an incident like this happen previously.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Feb-2021 at 9:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 9:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 68.83.   No concomitant medications were reported.  On 12-Feb-2021, 3 vials were moved to clinic.   The vial was initially moved to the fridge on 09-Feb-2021 and proposed beyond use date was 10-Mar-2021.   On the date of administration, at 10:00 A.M., the temperature recorded was 35 degree Fahrenheit, at 11:00 A.M, the temperature recorded was 35 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 12-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.  This case was linked to MOD-2022-566976 (Patient Link).
Pt recd 3 vaxs 5Feb90, 9Mar90, 6Aug90. Titer was neg. 4th dose given 29Jan91. Pt serconverted after 4th dose.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 6 decade old male. 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 not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Pericarditis and Myocarditis: still persistent  Muscle pains, pain in fingertips responding to touch, limited blood flow (cold limbs) , chest pains, difficulty/painful breathing, digestive system slowed/improper bowel movements, constipation
Per mom's report via telephone: left arm swollen from mid forearm to shoulder. Fever of 101 started 8/17/05 in afternoon lasting until 8/18/05. Vomiting started 8/17/05 in evening lasting until 8/18/05. 8/22/05 instructed mom to take child to doctor, she did and they told her to give Tylenol or Motrin, no RX given. Arm with some swelling but improving.