chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days following second dose of rabies vaccine, admitted to hospital w/ left side weakness, progressing rapidly to full paralysis and aphasia. Pts neurologic status has continued to decline. On November 16, quadrapoligic, unresponsive; intubated in Neural Intensive Care Unit.   3/15/07 Received medical records from hospital which reveal patient admitted 11/11/06-11/17/06.  Received rabies vax on 11/1 & 11/8. Stated to ID consult that she received rabies vax every 3 yrs routinely while employed at vet office. Developed bronchitis on 11/4-5 & treated w/antibiotics beginning 11/6.  Awoke w/hemiparesis (initially left then became bilateral), fever, HA, neck pain, photophobia, speech impairment, right leg tremors & N/V when sat up on 11/10.  Seen at outlying hospital, admitted, treated w/steroids & IV antibiotics, then transferred on 11/11.  Consults by neuro, neurosurg, ID, ICU & gen surg.  Admitted to neuro ICU.  Approx 4 hrs s/p admit, developed aphasia.  Condition declined over next few days & began Cheyne-Stokes respiration & was intubated.  Continued tx w/plasmapheresis, high dose steroids, dilantin, mannitol & Diamox.  Severe hypotension tx w/pressors.  Condition continued to deteriorate despite aggressive tx & pt expired on 11/17/06 s/p brain herniation.   3/15/2007 Received Autopsy Report forwarded via fax from CDC which reveals COD as ADEM s/p rabies vaccine.
GARDASIL injection given in left deltoid at 4:15 pm, client stated she was dizzy and felt hot at that time. Client lost consciousness at 4:16 pm, was assisted to lie down. Client able to answer questions at 4:20 pm, BP 72/50, pulse 72. BP 88/50 at 4:35pm.
loss of consciousness x 2; nausea; loss of appetite; This is a spontaneous report from a non-contactable consumer (patients father) regarding product Pfizer BioNTech vaccine. This report was received from a Pfizer Colleague.  A 16 years old female patient received 2nd dose of BNT162B2 (Pfizer BioNTech vaccine) at single dose for COVID-19 immunisation. Medical history and concomitant drug were not reported. Patient experienced nausea and loss of appetite. Patient only had one meal at the end of that day and continued to have loss of appetite the next day following the dose. Patient experienced loss of consciousness x 2 in the afternoon the day after the vaccine. Parents took patient to ER for evaluation. Patient was given fluids & sent home feeling better. Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042620A and 201621A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy since 31-May-1969, Allergy to antibiotic (Tetracycline) since 12-Jan-1976 and Drug allergy (Aspirin) since 14-Dec-1977.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting). At the time of the report, PAIN IN EXTREMITY (arm was hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood immunoglobulin E: increased by 25% (High) IgE level had increased by 25%. On 11-Feb-2021, Blood immunoglobulin E: gone up by 30% (High) measure for allergen gone up by 30% then previous count.         Concomitant products included unspecified medications for blood pressure, for cholesterol management and for lungs medication. It was reported that 2 months later the patient remeasured and his IgE counts had come down.  Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received, Added allergy information,patient demographic,lab data, suspect dosage information; 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. Further information has been requested
skin redness/ itching; skin redness/ itching; chronic (6 months) body rash/ itching/hives all over the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 13:15 (Lot number: FC3182) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C. Vaccination history included: Bnt162b2 (Dose 1, lot number=FA6780, administration time=11:00 AM, vaccine location=Left arm), administration date: 25Jul2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 22Sep2021, outcome "not recovered" and all described as "skin redness/ itching"; URTICARIA (non-serious) with onset 22Sep2021, outcome "not recovered", described as "chronic (6 months) body rash/ itching/hives all over the body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of erythema, pruritus, urticaria.  Additional information: The patient body after a month from the date of the 2nd dose (15Aug2021) Pfizer covid-19 vaccine and consistently re-occurring every after 24 hours (up to this date) after taking Zyrtec antihistamine medicine. Patient has no history of allergies, very healthy individual. Patient haven't seen a doctor, or receive treatment, only taking antihistamine Zyrtec. Patient experienced symptoms of Covid-19 a week before 2nd dose (15Aug2021) and did recover.  No follow-up attempts are possible. No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma linked to allergens" (unspecified if ongoing), notes: Asthma linked to allergens. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Body mass index: 29. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient took paxlovid 300 mg: 100mg dose for COVID 19 treatment from 11Dec2022 to 12Dec2022. Known allergies: No actually before taking Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt recvd 3 doses of Engerix-B & did not seroconvert; pt then seroconverted p/ receiving a booster dose;
A mother reported that her son, now5 years of age, received a series of Hib-Titer vaccines beginning on 1/26/98. On 2/17/02, at 27 months of age, he began to experience lack of speech and autistic behavior. He was seen by the physician and diagnosed with pervasive developmental disorder. The reporter indicated that the child was administered other unspecified vaccines at the same time as Hib-Titer. No further info was available at the date of this report. This event was considered medically important (OMIC).
The best guess is contact dermatitis on the upper-back. Not as severe as shingles, but warm, stinging, and itchy red bumps. Started roughly five days following injection.
Lingering pain in (R) deltoid no physical signs but persistent tenderness & decreased range of motion (R) shoulder.
bicep tendonitis in the left arm; This case was reported by a consumer via call center representative and described the occurrence of tendonitis in a 86-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tendonitis. On an unknown date, the outcome of the tendonitis was unknown.   It was unknown if the reporter considered the tendonitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a case of bicep tendonitis in the left arm which received the vaccine. The reporter asked could there have been a slip up.
nausea, sore throat, cough, congestion, chills, fever took paxlovid for 5 days well by 7/08/22
On day 22 post vaccinia administration, she developed headache at 0400 that woke her from sleep. later that day around 1600 she developed a truncal rash that spread peripherally. rash was very pruritic and spread to palms / soles/ arms/legs. she saw ER doc (employed as an RN there) and was prescribed 20 mg of prednisone. she took benadryl 50 mg and called me on april 12 in the am..took photos and contacted Dept of Health and CDC.
This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 23-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Patient had entire thigh swell 2 days after receiving KINRIX, MMR, Varicella and FLUMIST. Patient went to Immediate Care Center and was treated for cellulitis. Within 1 day of treatment almost completely healed.
patient received undiluted peds vaccine 0.2mls, patient developed chest pain, fatigue, muscle pain, fever goes up and down, loss of appetite, no difficulty breathing, increased heart rate, leathery, solmanence , weakness in leg. father and mother took the patient to the pediatric dr, did the lab test, no result has come yet,  fever seems to be controlled by tylenol and Ibuprofen.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-MAR-2014 the patient was vaccinated with an expired VARIVAX (Merck) (dose route was not reported) (lot# reported as 0604AE exp. 23-MAR-2014) no adverse effect was reported. The patient's outcome was unknown. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, anatomical location, lot# and expiry date were not reported). On an unknown date, the patient experienced unspecified neurological symptoms. The outcome of the event and the relatedness between the event and GARDASIL 9 were not reported.      Additional information has been requested.
Local reaction at injection site, including redness, swelling, tenderness, warmness, induration. No systemic symptoms.
Caller received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs / numbness in his feet / numbness in his knees; when he pinches his skin in his left leg and some parts of his body, he doesn't feel the pinch; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0196, Expiration Date was not reported), via an unspecified route of administration on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (Lot number: EW0196) received on an unspecified date (at the age of 78-years-old) for COVID-19 immunization. Patient states that, the person at the pharmacy told him to mention that he was calling in regards to the Pfizer BioNTech COVID vaccine EUA although his card after both doses has EW0196. Patient received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs, feet, and knees. Patient states when pinching his left leg and other parts of his body he doesn't feel the pinch. Patient would like to know if this is a common side effect, if there have been any other reports of this side effect, if this side effect will go away in a couple weeks on its own without having to go get medication for it. No information in PI regarding numbness in legs, feet, and knees being reported as a side effect, when pinching the left leg and other parts of the body not feeling the pinch. Patient confirms he received the Pfizer Covid 19 Vaccine.  Additonal information is expected.
No adverse event; a patient received a dose of an expired Moderna COVID-19 monovalent vaccine from a vial that expired on 11MAR2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received a dose of an expired Moderna COVID-19 monovalent vaccine from a vial that expired on 11MAR2023) and NO ADVERSE EVENT (No adverse event) in a 22-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-May-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-May-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received a dose of an expired Moderna COVID-19 monovalent vaccine from a vial that expired on 11MAR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient received a dose of an expired Moderna COVID-19 monovalent vaccine from a vial that expired on 11MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (a patient received a dose of an expired Moderna COVID-19 monovalent vaccine from a vial that expired on 11MAR2023).    No concomitant medications was provided. No treatment medications was provided. The patient received the expired dose of the vaccine on, 2MAY2023 and had not reported any adverse reactions Vial size was Unknown Vial did not undergo any temperature excursion. Individual vial was reported in source document.
No adverse event; Vaccine was administered post expiration date 13-JUL-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Patient did not describe any medical history or conditions. It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022).    No concomitant medication was reported.  The expiration date was reported as 13-JUL-2022. Caller wanted to know what the stability of the vaccine after 13-Jun-2022. No treatment information was reported.  This case contains information for patient 1 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-737011, US-MODERNATX, INC.-MOD-2023-737012, US-MODERNATX, INC.-MOD-2023-737013 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737011:Patient 2 US-MODERNATX, INC.-MOD-2023-737012:Patient 3 US-MODERNATX, INC.-MOD-2023-737013:Patient 4
PSORIASIS ISSUES ON BOTTOM OF BOTH FEET AND ITCHING ON HANDS/BURNING AT THE BOTTOM OF FEET; TENDONITIS IN EAR; RINGING IN EAR; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis issues on bottom of both feet and itching on hands/burning at the bottom of feet, tendonitis in ear, and ringing in ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient had not recovered from psoriasis issues on bottom of both feet and itching on hands/burning at the bottom of feet, and tendonitis in ear, and the outcome of ringing in ear was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Patient one minute after giving vaccine to RD fainted x3 seconds fell to floor at 8:20 AM. BP 103/61 Doctor present x 10 min. BP 106/69, continued to monitor patient, asked mom and patient to stay in clinic x 30 min. to continue monitoring mom left 5 minutes later, telephone call from mom saying son having problem, advised to go directly to ER. Mom agrees Doctor notified okay with plan.
DVT in her right leg; DVT; multiple pulmonary embolisms; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), via an unspecified route on 06Feb2021 ((age at time of vaccination 78 years) as dose 2, single for COVID-19 immunization. The patient medical history included she had a blood clot DVT in 1950 during her first pregnancy. The concomitant medications were not reported. The historical vaccine included bnt162b2 dose 1, single via an unspecified route on 16Jan2021 for COVID-19 immunization. On 18Feb2021, she was hospitalized with multiple pulmonary embolisms in both lungs and DVT in her right leg. She was in the hospital for 2 days and discharged her on Eliquis that she is still taking. It had been a long time. She still have blood clot in her right leg. She was saw a hematologist and has seen multiple doctors. Hematologist says, she could not take the booster shot. Non-occlusive thrombus within distal right main pulmonary artery as well as occlusive and nonocclusive pulmonary emboli within the right upper middle and lower lobar segmental and sub segmental branches. Occlusive and nonocclusive pulmonary emboli within the lobar segmental and sub segmental branches of left lower lobe pulmonary artery. Occlusive and non-occlusive pulmonary emboli within the segmental and sub segmental branches of left upper lobe of pulmonary artery. The patient had x ray test on an unknown date in 2021 and result was unknown. The outcome of the events was unknown.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
sore arm; bad headache; felt that bad; This is a spontaneous report from a contactable nurse, other hcp. (Patient mother). A 28-year-06-months old male patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number and Expiration date was unknown), via unspecified route on an unspecified date (this past Saturday in Apr 2021) for COVID-19 immunisation. The patient previously received first dose of BNT162b2 vaccine on an unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced a sore arm. Reporter then stated that her son was now complaining of a bad headache and would like to know if it was unusual to experience this side effect 4 days after the vaccine dose. The patient took 2 extra strength Tylenol on morning that did not help, and reporter stated that her son had to ask his professor for an extension on his homework because he felt that bad. Reporter stated that the patient normally do not have headaches but did for a while a couple of months ago, but he cut back on his caffeine consumption which helped. She stated that she has heard on TV and from friends and relatives that this was a common side effect with the vaccine. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
severe diarrhea (ongoing); Non severe rashes on face and arms and chest that resolved in a day; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 31-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 03Mar2021 18:00, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. No other vaccine in four weeks. No Covid prior vaccination. On 05Mar2021 04:45 PM, patient experienced Non severe rashes on face and arms and chest that resolved in a day and on 06Mar2021 patient experienced severe diarrhea (ongoing). No treatment received as a result of adverse event. No Covid tested post vaccination. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Pt reported feeling like her heart was racing and dizziness. No c/o shortness of breath, or chest pain. VS BP 100/75 HR 78. Pt was brought to ED for further eval & documentation. (Per pt normal BP is 80s/50s).