chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered the FLUZONE 6-35 month vaccination on 10/16/17. He tolerated well and had no adverse reaction. We have had no contact with patient's family since his appointment on 10/16.
Pfizer-BioNTech COVID-19 Vaccine EUA Cold sensation in the right arm, from the shoulder to the hand.    Concern that this might be related to a blood vessel disorder with clotting problems
?Pfizer-BioNTech Covid 19 Vaccine EUA? The night of getting the first shot I barely slept because I had chills all night long & my entire body was so sore it hurt to lay in any position. In the morning, I still had extreme muscle pain all over. I was extremely light headed & dizzy, I had a throbbing headache so I  took 2 aleve pills. I was getting super nauseous and almost passed out while trying to get to my bathroom just in time to throw up only water. Just before throwing up my vision went fuzzy,  my ears were ringing, I was dripping sweat, it was getting hard to breathe, & my hands were shaking.  After taking a cold shower, laying down, & drinking some water I feel a bit better but not 100% normal.
my arm started to itch around site/Have continued itching mildly all day and mild pain; y arm started to itch around site/Have continued itching mildly all day and mild pain; Injection sight started to swell approximately 2 inches around site; Site felt warm and was moderately pink; Site felt warm and was moderately pink; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 as dose 1, single (Lot number: HG6396), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Shoulder replacement", start date: 24Aug2023 (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 01Nov2023; TYLENOL; IBUPROFEN; ELIQUIS. Vaccination history included: Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 17Nov2023 at 22:45, outcome "not recovered", described as "Injection sight started to swell approximately 2 inches around site"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 17Nov2023 at 22:45, outcome "not recovered" and all described as "Site felt warm and was moderately pink"; VACCINATION SITE PRURITUS (non-serious) with onset 17Nov2023 at 22:45, outcome "not recovered", described as "my arm started to itch around site/Have continued itching mildly all day and mild pain"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2023 at 22:45, outcome "not recovered", described as "y arm started to itch around site/Have continued itching mildly all day and mild pain". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site pain, vaccination site swelling, vaccination site warmth, vaccination site erythema. Additional information: other concomitant medication (BP meds).
Patient reported to emergency room on 4/30/21 with complaints of shortness of breath and chest tightness. Onset approx 1 week prior but symptoms worsened 2 days prior.
Intense pain in right arm, patient described it as "feeling like bursitis", decreased range of motion in right arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 12:30 as dose 4 (booster), single (Lot number: Unknown), in left arm 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: "Known allergies: opioids and opiates" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19".  On 05Aug2023 the patient came down with very similar symptoms to first Covid infection (sinus, body aches, headache, cough) and test positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2023) negative; (05Aug2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient treated with PAXLOVID from 26Jul2023 to 31Jul2023. 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.
no side effects; vaccine doses at shorter interval than recimmended; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 10-FEB-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, frequency, lot #, expiration date, route of administration and anatomical location were not reported).On 26-SEP-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 injection, lot # T020638, expiration date 26-FEB-2020, (exact dose, frequency, route of administration and anatomical location were not reported). Both doses were administered as prophylaxis. The patient received the second dose at a shorten than recommended interval. However, the patient experienced no side effects from the vaccine. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
She had a reddish purplish area on leg not acting sick otherwise. Recommended she watch it for a few days and if not better to be seen.
Patient is < 18 years of age, and therefore is not indicated for a Moderna COVID-19 vaccine per EUA.
Menveo reconstituted with saline; Administered just the lyophilized portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo reconstituted with saline) and inappropriate dose of vaccine administered (Verbatim: Administered just the lyophilized portion). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Mar-2023 The nurse Practitioner reported that the patient received the lyophilized portion of Menveo and it was reconstituted with saline.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The healthcare professional could not pull up details during call; follow up ok via email in healthcare professional detail. The patient received the lyophilized portion of Menveo and it was reconstituted with saline, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Body aches/whole body was aching; Blood pressure high/Blood pressure was 174/104 and it stayed high like that all day; felt like I have flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A female (Patient Age: 68 (units not mentioned)) patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: LEL3248 (that was all it said on the card she had, she assumed this was the Lot number) and expiry: not reported), via an unspecified route of administration on 26Jan2021 as single dose for covid-19 immunisation. Medical history included Covid-19 around November (unknown if ongoing). The patient's concomitant medications were not reported. On 26Jan2021 (late Tuesday) towards evening, the patient's body started to get the body aches, chills, her blood pressure went up really high and it was like that all through the night and continued running high like that (had the Pfizer COVID-19 vaccine first dose on Tuesday). On 26Jan2021, she felt like she had flu and whole body was aching. On 27Jan2021 (Wednesday) she was in bed with all the same symptoms of felt like had flu because of the body ache and the chills and the high blood pressure. She kept taking Tylenol as therapeutic measure and her blood pressure was 174/104 and it stayed high like that all day on Wednesday. On 26Jan2021 (Thursday morning) everything was gone, her blood pressure was back to normal, body ache and chills were all gone. Now, what she wanted to know was, should she be getting the second vaccine because of all the side effects that she had with the first one and she was wondering of should she get the 2nd vaccine again as she was very concerned her blood pressure was 174/104.  She also had covid around November and wanted to know if she was supposed to wait 90 days before getting the vaccine and was that normal for it to affect her blood pressure. The outcome of felt like I have flu was unknown and it was recovered for rest all the events on 28JAN2021. Follow-up attempts are completed. No further information is expected.
Symptom of sore throat began the evening of vaccination on 05/13/15 then by mid-day 05/14/15 employee developed symptoms of low grade fever, malaise, muscle aches, and fatigue.
Patient was administered vaccine. Shortly afterwards tested positive for covid.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a patient that the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. The past medical history and concomitant medication was not reported. The reporter stated that shortly after vaccination, the patient tested positive for COVID. Patient was transferred to hospital where they were told to wait 90 days before receiving the second dose.   The clinical outcome for the event was unknown. It was unknown if the reporter is a Health Care Professional. The reporters contact information was available to you or a sub-contracted party.   It was unknown if the reporter was the prescribing HCP. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Numbness; Tingling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling). At the time of the report, HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) outcome was unknown.            Concomitant medication were not reported  Treatment medication information were not reported  Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The reporting medical assistant informed that on 30-MAY-2018, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 Injection, lot # M018810, expiration date 28-MAY-2018 (strength, dose number, dose and route not reported). No adverse effects were reported.
Information has been received from a certificated medical assistant concerning a 15 year old female patient with no drug reactions or allergies reported and no pertinent medical history, who on 13-SEP-2010 (also reported as 18-SEP-2010) was vaccinated IM with the first dose of GARDASIL (Lot # 0765Z). Concomitant therapy included vaccination with a dose of FLUZONE. On an unspecified date, the patient reported shaking in her leg and knee edema after receiving her first vaccination with GARDASIL. It was unknown whether it was her right or left leg. On an unspecified date at the medical center the patient had a knee x-ray which was negative for fracture. The patient's mother was convinced that the events were because of GARDASIL. At the time of the report the patient had not recovered. Additional information is not expected.
developed a rash on the back of her left hand and backway on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed a rash on the back of her left hand and backway on the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 029K20A) for COVID-19 vaccination.     Previously administered products included for Vaccination: flu vaccine and flu vaccine. Past adverse reactions to the above products included Hives with flu vaccine; and Itching with flu vaccine. Concurrent medical conditions included Drug allergy (many allergies to around 40-50 medications, Benadryl).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced RASH (developed a rash on the back of her left hand and backway on the left arm). At the time of the report, RASH (developed a rash on the back of her left hand and backway on the left arm) outcome was unknown.            NO Concomitant medication was reported NO treatment Drug was reported Over the years when patient got the flu shot, patient would break into hives and bad itching. To avoid this, patient was advised to take Prednisone before getting the flu shot which helped.
1 week after GARDASIL, patient woke from a sound sleep w/ severe shooting pains in shoulder and upper arm muscles -> continues w/ certain movements and positions.
Received 3 shots - flu and DTAP and ZOSTAVAX. Red rash at site at inj SQ of ZOSTAVAX on left arm. Onset within 1 hr, fever next day. ER said cellulitis. KEFLEX, primary MD changed to BACTRIM DS.
Pt recvd 2 doses of Engerix-B & exp severe arthralgia following both injects; following 2nd inject sx described as more severe arthralgia; ER visit required; tx unk; arthralgia still resolving;
the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a 4 years old male patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 26-AUG-2020, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection recombinant Human albumin (rHA) (lot # T005406, expiration date 12-AUG-2021; strength and vaccine dosage detail were not reported) subcutaneously for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (STERILE DILUENT). The storage temperatures of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were -9 Celsius degrees to 8 Celsius degrees (-6.1 Celsius degrees) for 13 hours and -14 Celsius degrees to -10 Celsius degrees for 116 hours. There was no previous temperature excursion. Data logger was involved.
Patient given refrigerated Moderna vaccine expired beyond the date of 01/27/2022. Vial placed into fridge on 12/28/2021, but not removed in time for 'beyond use' expiry date. It was inadvertently administered. Manufacturer's expiry date is March 25, 2022. Provider informed.  Moderna affirmed 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.' No adverse effects noted.
Since 28 December he has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affects his soles, and resolve without post-inflammatory changes. He reports chest tightness (substernal) associated with late dysphagia with initial onset of symptoms but denies chest pain; he denies chest/esophageal symptoms since this initial period. His symptoms led him to present to the ER on 29 December where he received oral antihistamines and oral corticosteroid with possible transient benefit. He denies laryngeal, pulmonary, GI/GU, and neurologic symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 16 December, 12 days prior to onset of symptoms. He has used oral antihistamines with limited benefit. He denies constitutional symptoms. No prior history of adverse vaccine reaction.
Patient was given the vaccine and seemed fine. He was talking and then just fell out of the chair and fainted. He was unconscious for about 15-20 seconds and came to. He was disoriented and complained of tingling in his hands. EMT was called non-emergency since the patient had regained consciousness. He still appeared disoriented for several minutes. Patient said he hadn't eaten since breakfast. He was given crackers and water. EMT arrived and took vitals. Patient appeared fine, just a bit shaky.
Fever began at 6pm the evening of vaccination and continued until 8am the next day. Injection was on 4/3/21. On 4/8/21, she began experiencing moderate abdominal pains/cramping which are still ongoing as of 4/13/21
severe headaches; she was very angry; she was scared; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "severe headaches"; ANGER (non-serious), outcome "unknown", described as "she was very angry"; NERVOUSNESS (non-serious), outcome "unknown", described as "she was scared". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient requested information about how many people from the general population have developed severe headaches as an adverse reaction looking to get enough information to take a decision by herself about if she should get the second dose of the Pfizer's COVID-19 vaccine. She reported that she received the first dose of the Pfizer's COVID-19 vaccine and after that she developed a severe headache that lasted for 13 days and she had to go through a CT scan to complete the diagnosis of her headache. She also reported that she had ready an Epipen just in case she needed to use if after the administration of the second dose of the vaccine. She could not get an answer on how to prevent a headache as an adverse reaction. She could not get an answer about what to do with her symptoms and she stated that she was very angry. She was scared to get the second dose of the vaccine and she wanted to take an informed decision about the administration of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 45 minutes (< 1 min) generalized seizure occurring about 15 min. post vaccines (DTAP, IPV, Influenza). Known seizure disorder, stable on medications.
This spontaneous report as received from a nurse refers to a 23 year old male patient. Patient medical history included Asperger's syndrome, attention deficit disorder (ADD), depression and basal metabolic index (BMI) of 36 and other concurrent conditions were not reported. On 01-OCT-2014 the patient was vaccinated with first dose of GARDASIL (lot # J013277 and expiry date 05-AUG-2015), dose 0.5 ml via intramuscular in the left arm. On 01-OCT-2014 the patient experienced brachial plexus neuropathy, pain, tingling and left arm weakness immediately after receiving the first dose of GARDASIL. Pain, tingling and left arm weakness resolved after one week and the patient was not seen at that time. On 10-DEC-2014, patient received the second dose of GARDASIL (Lot # K003520 and expiry date 20-NOV-2016) and approximately in 2014 (reported as again) experienced brachial plexus neuropathy, pain, tingling and left arm weakness which has continued. It was reported that the patient was seen by nurse practitioner on 07-JAN-2015. Cancer and overdose was not reported. The outcome of the events was reported as recovering. Additional information has been requested.
Child had 2 previous doses of chickenpox vaccine at age 1. Administered a dose of varicella vaccine at today's visit.