chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE JOINT PAIN; This spontaneous report received from a patient via another manufacturer (Pfizer) of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Cipro). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 07-APR-2020 at 12:00 PM in left arm for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 31-DEC-2021 in left arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-APR-2022, patient received Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose not reported for treatment of COVID-19. The patient discontinued Paxlovid treatment on 01-MAY-2022.  On 03-MAY-2022 at 12:00, The patient experienced severe joint pain (dose number in series 2) for 5 days.  After finishing the Paxlovid, patient felt well. 3 days later the severe joint pain returned for 4 more days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe joint pain. This report was non-serious.
a little itching (after dose 1 & 2); little sore arm (after dose 1 & 2); little tired (after dose 1 & 2); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a little itching (after dose 1 & 2)), MYALGIA (little sore arm (after dose 1 & 2)) and FATIGUE (little tired (after dose 1 & 2)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication. On 24-Apr-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 PRURITUS (a little itching (after dose 1 & 2)), MYALGIA (little sore arm (after dose 1 & 2)) and FATIGUE (little tired (after dose 1 & 2)). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. At the time of the report, PRURITUS (a little itching (after dose 1 & 2)), MYALGIA (little sore arm (after dose 1 & 2)) and FATIGUE (little tired (after dose 1 & 2)) outcome was unknown.    This case was linked to MOD-2021-402840, MOD-2021-402893 (Patient Link).
high fever; vomiting; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), and meningococcal vaccine conjugate (MENINGOCOCCAL CONJUGATE), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced high fever and vomiting on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Reported skin was burning and itching. Provided with Benedryl, Pepsid, ice packs. Fever 102. Symptoms resolved except still feeling itchy. She contacted her PCP who told her not to take second dose. Referred to allergist.
The bruise from the vaccine injection has lasted for over a week. 1 week after my vaccine, a huge red rash developed around the bruise. I did not have a rash anywhere else on my body. It was below the skin, not raised or itchy. The rash faded after 1 day but there is still an outline there.
17 cm x 17 cm red and hot area of left thigh started 08/04/2017 in the morning per patient's mom.  Patient treated with Prednisolone Syrup 15 mg/5 ml - Give 2 tsp PO with food daily for 3 days.
101.6 Degree Temperature/ Chills/ Severe Muscle Aches and Pain/ Headache/ Redness and Swelling at Site of Shot/ Tiredness.
This spontaneous report was received from a licensed practical nurse, referring to a 14 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 01-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Information has been received concerning a pt who 06/27/00 was vaccinated with one dose of varicella vaccine. On 06/29/00 the pt developed lesions. The lesions were on both arms and the left side of her neck. The pt later developed vesicles on the right thigh and chest. the pt sought unspecified medical attention and was treated with Atarax. On 07/08/00 the pt developed redness, itching and swelling of approximately 5 cm at the injection site. On 07/14/00 the pt recovered from her symptoms.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Pain, swelling, arm numbness, fever 102 Degrees F. Patient iced the arm and took OTC analgesics with minimal relief. Patient scheduled MD office visit at 9am 10/02/18. Per patient's husband, the injection may have hit tendon.
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 23-OCT-2012 17;42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
hurt little bit when they put needle in; got medicine that was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got medicine that was expired) and PAIN (hurt little bit when they put needle in) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CLONIDINE, HYDRALAZINE, MONTELUKAST, HYDROXYZINE HCL, DOCUSATE SODIUM, ACETYLSALICYLIC ACID (ASPIRIN 81) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got medicine that was expired). On an unknown date, the patient experienced PAIN (hurt little bit when they put needle in). On 11-Jan-2021, EXPIRED PRODUCT ADMINISTERED (got medicine that was expired) had resolved. At the time of the report, PAIN (hurt little bit when they put needle in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Papular acrodematitis (gianotti-Crosti synd) w/midly elevated liver/enzymes, onset 5 days following MMR immun; resolved in 2 wks;
I was fine after the first dose (12/17/20).  In this instance (the 2nd dose), I woke up in the middle of the night and thought I was paralyzed.  Arms & legs so "heavy" I couldn't move them.  I honestly can't remember if I did get out of bed, but was okay the next day...just tired.  I went for my annual physical March 25th, tested positive for antinuclear antibodies, then went to Rheumatologist in April.  Got additional bloodwork and showed positive for anti-dsDNA in May.  Went for 2nd opinion in July, both docs said to continue to monitor if any symptoms arise.
Extreme weakness in left leg to the point that she could not stand or transfer between chairs or wheelchair. Lasted about 5 hours. This occured about 24 hours after the injection.  Same event occured after the second onjection on Feb 16. 24 hours later she had weakness in the left leg that lasted about 4 hours. She is bach to pre vaccine mobility.
Narrative:  Admitted to Medical Center on 4/24/21 with R leg DVT. Received Pfizer shot on 2/24/21
shoulder pain; stiff neck; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received the 2nd dose of Shingrix. On 1st August 2020, 1 days after receiving Shingrix, the patient experienced shoulder pain and stiff neck. On an unknown date, the outcome of the shoulder pain and stiff neck were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. It was reported the patient experienced achy right shoulder and stiff neck, after the patient received second part of shingles vaccine In left arm late yesterday.
Headache after administration of Flu Mist (nasal flu vaccine)- occurred immediately after vaccination. Tylenol given. Resolved within 24 hours.
Initial unsolicited report received from a consumer via other company (Pfizer, Manufacturer report number: 2015386497) on 17-JAN-2017. This case involves a 70-years-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, dose, dose in series, expiry date, route and site of administration were not reported) on an unspecified date in 2014. The patient's medical history was not reported. Concomitant medications included AFINITOR 5 mg once a day. On an unspecified date in 2014, following the vaccination, the patient experienced caught flu and dry cough. On 03-NOV-2015 computed tomography (CAT) scan revels that her tumor was shrinking from 3.7 to 3.5 and blood work was normal. The patient's corrective treatment was not reported. The events outcome was not reported. List of documents held by sender: none.
p/recv vax 1hr later pt exp hot flushing, sweating, dry mouth, dizziness, shortness of breath; continued to the next day when pt saw MD, however the severity had decreased
PPV shot given at top of  left shoulder causing electric shock type jolt down left arm while needle was being forced in by nurse. Symptoms progressed from soreness to paralyzing pain to nausea. Dizziness, uncontrollable shaking, fever, chills, immobility. Unable to leave bed from 8:30pm. until 11:00 am. The following morning when I could get out of bed to call for help. A friend had to drive me to doctor. I had severe headache continued dizziness and instability. Dr diagnosed hematoma from vaccine entering blood stream to quickly. Doctor's RX was 600 mg 4 x day IBUPROFEN for 30 days.  8/17/09 PCP medical records received DOS 10/24/07 to 10/30/07. Assessment: Pneumovax vaccine reaction. Patient presents with tingling in arm and nausea. At time of injection felt pain across left upper deltoid down into arm. Followed by chills, nausea, pain. Could not move arm. Very sore and tender. Pain with movement of shoulder. Feels something is cracking or snapping when she rotates shoulder.
2 small wheals at the site of injection; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number C7EX2, expiry date 26th January 2022) for prophylaxis.   On 26th August 2020, the patient received the 1st dose of Shingrix. On 27th August 2020, 1 days after receiving Shingrix, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was recovered/resolved.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine in her left arm and the next day experienced around 2 small wheals at the site of injection which resolved in a few days.  The reporter consented to follow up.
stenosis; arthritis; Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots; Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots; 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 female patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Lot number: EW0172) and on 11Jun2021 as dose 2, single (Lot number: EW0176) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2023, outcome "not recovered" and all described as "Clarified that shots that caller was referring to that her and husband both had were Pfizer Covid shots"; STENOSIS (non-serious), outcome "unknown"; ARTHRITIS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) They found stenosis and arthritis., notes: Had recent MRI of lower back, because of back pain. They found stenosis and arthritis; SARS-CoV-2 test: (13Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Full body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Mar2021 13:45 (Lot number: EL3247) at the age of 46 years as unknown, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 16Mar2021 16:00, outcome "recovered" (Mar2021), described as "Full body aches". Therapeutic measures were taken as a result of pain.Ae treatment with Advil.  Additional information:Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19.the patient hasn't been tested for COVID-19.No history of allergy.  No follow-up attempts are possible. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 14Jan2022 at 12:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 38 years, in left arm for covid-19 immunisation; covid-19 vaccine, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Eggs and egg-derived products allergies" (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 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
terrible headache/bad headache; body aches; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient) and another consumer (Wife). A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 at single dose for COVID-19 immunization. Patient was experiencing body aches and terrible headache after 2nd dose of vaccine. Patient wanted to know if he could use analgesics after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The patient's wife further reported that her husband had his second dose of Covax on 09Jan2021. Today (10Jan2021) he was experiencing body aches and a bad headache and wondering if he can take pain reliever. The outcome of the events was not recovered at the time of the reporting.  Information on the lot/batch number has been requested.
Patient is a 89 y.o. female patient of MD with history of atrial fibrillation, hiatal hernia, hyperlipidemia, hypothyroidism, hypertension, who presented to the emergency room with nausea, vomiting, with subsequent cough, phlegm production, found to have acute hypoxemic respiratory failure.   Acute hypoxemic respiratory failure Secondary to aspiration pneumonia and COVID infection. Improved, weaned off oxygen  COVID-19 virus infection with pneumonia Vaccinated x2. Symptoms: Shortness of breath, weakness. Continue dexamethasone Incentive spirometer Weaned off O2.   Aspiration pneumonia Dysphagia CT chest reviewed - groundglass patchy airspace disease in the lower lobes suggestive for aspiration/pneumonia Changed to oral antibiotics on discharge Evaluated by speech and status post barium swallow   Nausea vomiting?improved CT abdomen nonacute, diverticulosis Zofran as needed Status post IV fluid hydration   AKI Creatinine at the time presentation 1.68. Improved with IV fluid Continue monitor   Atrial fibrillation, continue metoprolol XL, continue Eliquis 2.5 mg twice daily   Hypothyroidism, levothyroxine
DELAYED INJECTION SITE REACTION - MINOR SWELLING AND INFLAMMATION. MINOR DISCOMFORT WHEN RAISING AFFECTED ARM. REACTION NOTICED APROXIMATELY 7 DAYS POST INJECTION.
I woke up at 4am from the chest pain. I just got my booster around 4pm yesterday.
Imediate taste of metal after injection. Within 2 hours I had numbness, burning and tingling in the left arm and left hand. Intense joint pain in left shoulder.  Almost 72 hours later and the symptoms have gone down leaving just some burning in the left hand and occasional burning sensation in the shoulder.
Information has been received from a physician concerning a male (age not reported) who on an unspecified date was vaccinated with Pneumovax 23. Concomitant suspect therapy included influenza virus vaccine (unspecified). The physician reported that the patient had received a combination of Pneumovax 23 and influenza virus vaccine (unspecified) and had been "sick for a few days" and "had a pretty good reaction" (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Site of injection became hot, red and swollen by the next day after receiving the vaccine. Tenderness went away in about 2 days, but it took about 4-5 days for the redness to go away. Patient also reported entire body aches and flu-like symptoms for about 2 days. Treated with Tylenol and rest, did not follow up with doctor since it was the weekend and the majority of the symptoms were resolved by Monday morning.
This spontaneous report as received from a other professional refers to an unknown number of patients of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) which under went temperature excursions outside recommended temperatures. No concomitant medications were reported. No adverse event was reported. No product quality issue was reported. This case is related to case numbers 1403USA009542, 1403USA009543 and 1403USA009541 via same reporter link. Additional information has been requested.