chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from  18Aug2023 to 23Aug2023. 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 called call center c/o temp of 99F, chills, bloody nose and swelling lymph nodes. Pt denied acute distress at time of call. Pt received moderna vaccine on Friday 4/23/21 at facility.  Pt informed to go to Medical facility due to swelling.
Apx. 7-10 minutes after getting the shot, i became dizzy, i started shaking, and having a difficult time breathing. The nurse came over and check my arm and stated that the injection area from red and swollen, She also checked my chest and neck that was also red. They then took me to the ER and I was given steroids, and antihistamine. After hours I then was released and went home. I have followed up with my primary care and was on oral steroids and an inhaler. My lymph nodes were swollen under my armpit and breast a few days after. I am not experiencing anxiety and panic attacks and seek help for this.
Information has been received from a nurse concerning a female patient who was vaccinated with a first dose of Gardasil (lot# not reported). Subsequently, the patient experienced pain while receiving the injection. The nurse indicated that it seemed as if the needle was "too big for girls with small arms and it almost feels as if the needle is hitting the bone in the child  patients". The nurse said that they have to switch to a 5/8 inch needle when administering the vaccine to patients. Unspecified medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested.
5 minutes after vaccination with Dtap/Varivax developed redness swelling and hives on R upper arm where had received Dtap. Bp0102/68 given epinephrine 1:1000 0.15 ml SQ and Benadryl 18.75 mg PO. Observed x 1 hr, hives redness resolved. BP nl HR 100 playing in waiting room. Sent home on steroids x 48 hrs, Benadryl x 24 Hrs. Disc signs of allergic rx.
About 5 minutes after the injection, patient had dizziness, cold sweats, drowsiness.  She was recommended to lie down.  A minute or two after that she suffered a very short (about 5-10 second) loss of consciousness.  She did not fall.  She returned to consciousness shortly after and shortly after that stated the dizziness/sweats had subsided.  She was monitored for an additional 20 minutes but had no other adverse effects.
I had a fever and intense headache for approximately 12hr beginning about 6hrs after the vaccination injection. After the fever broke I'm just feeling a bit weak.
Culture-confirmed meningococcal infection (serogroup Y), bacteremia and meningitis with probable myocarditis. (Note: Patient received meningococcal conjugate vaccine Menactra 3/28/2007. Patient was diagnosed with complement [C3] deficiency after developing meningococcal disease.)
No other AE; The customer said an expired dose was administered to a patient.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 01-APR-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 1 dose expiration date 20-MAR-2022 (Expired product administered) (route of administration and lot number and expiration date were not provided) administered as prophylaxis.  No other adverse event was reported.
Experiencing sore throat, ear ache, jaw bone pain. Been on two different antibiotics which have not cured the issues.
after few hours my left arm is heavy and experience a covid related symptom like muscle aches, chills, headache, burning sensation on my eyes
This spontaneous report was received from a nurse refers to an approximately 9 year old male patient. The patient's medical history included acne, sinusitis, and pharyngitis. No Drug reactions or allergies were reported. On 29-SEP-2008, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (Manufacturer unknown) (lot#, expiry not reported). On an unknown date, the patient experienced Gianotti-Crosti which lasted for several weeks, following the administration of a hepatitis A vaccine (Manufacturer unknown). No other adverse effects were reported. It was unspecified if the patient had sought medical attention or treatment. On an unknown date the patient recovered from Gianotti-Crosti rash. Additional information has been requested.
After PT got her 1st dose of the Covid-19 Vaccine, on the 7th March 2021 she complaint of severe migraine headache and chills. On 19th March 2021, she consulted, medication given ketorolac (TORADOL) given 10:49 AM for acute nonintractable headache, unspecified headache type. Later that evening at 9:00 pm she was incoherent and complaint of more severe chills and headaches. She was transported to the hospital for care and stayed hospitalizes for 15 days from March 19 to April 3, 2021. Diagnosis: New onset seizure Encephalopathy, Lumbar puncture, Encephalitis, Viral encephalitis, acute kidney failure. Loss of memory, illucinations, easily erratated.
One day following vaccines, pt had 2 welts on (L) leg (site of PENTACEL & MMR) & later had generalized hives with swollen hands, feet, & periorbital edema. No resp distress. (+) pruritis. 1st visit to MD was 9 dys after sympt started. Pt still has generalized hives, mild swelling of hds, feet & face. Tx: BENADRYL/ATARAX PRN.
Indication as Reported by the Primary Source: COVID-19; Indication as Reported by the Primary Source: COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201), on 04Mar2021 as dose 2, single (Lot number: EN6198) and on 11Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Mar2022 as dose 2 (booster), single (Lot number: 0466214) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Indication as Reported by the Primary Source: COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.
Vestibular neuritis; Ataxia; This case was reported by a physician via sales rep and described the occurrence of vestibular neuronitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced vestibular neuronitis and ataxia. On an unknown date, the outcome of the vestibular neuronitis and ataxia were unknown.   It was unknown if the reporter considered the vestibular neuronitis and ataxia to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Lot number, expiration or vaccination date was unknown at the time of reporting. The patient experienced vestibular neuritis and it got worse with time until the patient experienced ataxia. The reporter consented to follow up.
allergic reaction; full-body hives; facial swelling; dizziness; fast heart rate; high temperature(103.3); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2023, outcome "unknown", described as "allergic reaction"; DIZZINESS (non-serious) with onset Sep2023, outcome "unknown"; SWELLING FACE (non-serious) with onset Sep2023, outcome "unknown", described as "facial swelling"; HEART RATE INCREASED (non-serious) with onset Sep2023, outcome "unknown", described as "fast heart rate"; URTICARIA (non-serious) with onset Sep2023, outcome "unknown", described as "full-body hives"; PYREXIA (non-serious) with onset Sep2023, outcome "unknown", described as "high temperature(103.3)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had reaction had an allergic including: full-body hives, facial swelling, dizziness, fast heart rate. He also had a high temperature (103.3). Former participant was not enrolled in any Pfizer study at time of reaction. Vaccine was received in the community.  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.
This initial case was received from a consumer on 16 January 2014. Two cases of unidentified patients, who each experienced pertussis following administration of ADACEL, were reported by the same reporter. The other report is captured in case number 2014SA007170. An 11 year old female patient was vaccinated with "ADACEL" lot # U4418AA (lot number corresponding to MENACTRA in SP) in April of 2013, date not specified. The route, site of administration and dose were not reported. On an unreported date the patient experience coughing lasting for past 4 weeks. Blood work for each patient was positive for pertussis on an unreported date. The reporter stated that they do not have any cultures. The patient's medical history and concomitant medications were not reported. The patient outcome was reported as not recovered. No further details were available at the time of this report. Documents held by sender: None.
A non-serious report case was received from a nurse concerning a 18-month-old and a vaccine administration error. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No relevant medical or drug history information was reported. The infant was given FluMist on 29-Oct-2007. The reporting site administrated FluMist to the 18-month-old in error as the vaccine is indicated in patients 2 years to 49 years of age. No adverse events were reported from this medication error. No additional information is available. Rechallenge and causality is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/2008.  Patient date of birth is 01/11/06 and lot number of vaccine is not provided, 03/07/08. 13-NOV-2007 follow up information obtained and incorporated in above narrative: No adverse events after receiving vaccine.
Increased BP and heart rate way above the my normal.  No treatment and waiting outcome at this point.  The same is true for my puffy eyes that are almost shut like I am squinting.
Patient came to pharmacy on 09-21-20. she complaiend that her left arm has been itching with trobing pain and felt warm to touch. left are was shown hives. she said today a little better. but still bothering her. I recommended to consult with her doctor.
Rash on right arm swollen and hard the size of a half baseball high fever in arm itching rash on face very painful to the touch
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapy included sterile diluent. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency were unknown) (Lot# N021317 and expiration date 07-AUG-2019) at a temperature excursion from 14"C to -10"C (-13.5"C) for 1 hour 5 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. No further details were provided.
devel severe abd cramps, nausea, vomiting about 90min p/vax;tx w/Iv hydration, antiemetics & antispasmodic meds w/improvement;
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna/dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 14:00 as dose 5 (booster), single (Lot number: Czm970z) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9267), in left arm and on 06Mar2021 as dose 2, single (Lot number: EN6200), in right arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 28May2022 as dose 3 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild emphysema" (unspecified if ongoing), notes: Mild emphysema; "Graves disease" (unspecified if ongoing); "Subarachnoid haemorrhage (SAH)" (unspecified if ongoing); "Transient ischemic attack (TIA)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28May2022, outcome "unknown", described as "vaccine brand other: Moderna/dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; Paxlovid 20 was taken from 05Oct2022 till 10Oct2022. Details were as follows: event was noted as COVID rebound, runny nose, and a positive test on 14Oct2022 at 08:00 am.
Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All over body aches worse than flu, fatigue.
Fever - 103 degrees. Shaking episode, (not seizure) lips turned pale.
no adverse event; expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    No Concomitant medication was provided by reporter. No Treatment medication was provided by reporter.  Completion date was reported as 28-Apr-2022.
The pt experienced a 13 x 9 cm indurated erythemic patch surrounding injection site, right thigh anterior.
- Severe pain, swelling & redness at the injection site (RA) - Chills, headaches, dizziness, tiredness, hunger.
10:20 A Shot given. 1 P Itchy eyes, headache onsets. 5 P Shaking. 7 P Low grade fever > 100 degrees. 11 P Unquenchable thirst, splitting headache, insomnia.
pt recv vax; 15 hrs later, exp recurrence of grand mal sz & was hosp 27feb85;MD's stated that sz activity was unrelated to vax;
Chills (8pm date of vaccine), treated by water, rest. painful lymph nodes in left armpit (8pm day after vaccine). treating with tylenol/advil, hot compresses.
COVID arm - rash, redness, painful to touch, itchy, firmness, warmth, oval shape about 2-3 inches in length (at injection site); occurred exactly one week after receiving first dose of Moderna COVID vaccine.
Pain in left arm and into axilla, with raised red confluent rash over upper arm starting 24 hours following injection.
Patient inadivertently admnistered Vaxelis and Engerix; This non-serious spontaneous safety report with the following reference numbers #02078030 and #02078019 was received by a partner on 20-DEC-2021 and forwarded to Agency on 21-DEC-2021 from a health care professional.  The causal relationship between Vaxelis and the reported event "Patient inadvertently administered Vaxelis and Engerix" was assessed as not applicable due to the nature of the event.  Further information is expected.
pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain at the injection site after 1st dose of Shingrix The reporter did not consent to follow up.
right hand was immobile and can not write; rheumatoid arthritis flare ups; pain in right hand; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4344885-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (medically significant), outcome "unknown", described as "right hand was immobile and can not write"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "rheumatoid arthritis flare ups"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in right hand". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "right hand was immobile and can not write", "rheumatoid arthritis flare ups" and "pain in right hand" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Joint range of motion decreased was Not reported. The reporter's causality for the event(s) of rheumatoid arthritis flare ups and pain in right hand with Humira (Adalimumab) was no reasonable possibility.   Clinical course: Solicited report by a consumer of an adult female with an event of non-serious right hand was immobile and cannot write, rheumatoid arthritis flare ups and pain in right hand with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced right hand was immobile and cannot write, rheumatoid arthritis flare ups and pain in right hand. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  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 RAs, Ethics Committees, and Investigators, as appropriate.
The booster dose was given in May; The booster dose was given in May; This is a spontaneous report from a contactable nurse. This nurse reported for an unknown (patient).    A 83-year-old female patient received fourth dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: 30145BA, expiry date: Nov2021), via unknown route of administration in Deltoid Left on 07Oct2021 (at the age of 83 years old) as DOSE 4, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported.  Historical vaccines included first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via unknown route of administration on unknown date as dose 1, single, second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via unknown route of administration on unknown date as dose 2, single and dose 3 of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via unknown route of administration on unknown date in May2021 as dose 3 (booster), single for COVID-19 immunization. It was reported that the patient received four doses of Pfizer COVID-19 vaccine instead of three. the patient experienced The booster dose was given in May2021. It was also reported that patient received her first two Pfizer from reporter and she came to get her booster and gave it and she had already received a third Pfizer vaccine back in May at a different 'range' the patient said wasn't aware she got seriously the flu shot they have done it already in her arm, she call them did they she gave receive a Covid shot instead so she receive 4 dosage of the Pfizer instead of three and she wasn't sure if there was anything need to do or the report there she should not do anything. The outcome of the events was unknown.  Follow-up (21Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.