chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm to the touch Injection Site; Severe Itching on Injection Site; Swollen Injection Site; Mild Itching on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE PRURITUS (Mild Itching on the Injection Site), VACCINATION SITE PRURITUS (Severe Itching on Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Mild Itching on the Injection Site). On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE PRURITUS (Severe Itching on Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE PRURITUS (Mild Itching on the Injection Site), VACCINATION SITE PRURITUS (Severe Itching on Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
A report from Glaxosmithkilne (20001006323-1) regarding events in Ohio. It was reported that an 18 month old male patient experienced swelling and redness at the injection site. Outcome as of 02/08/01, unresolved. From additional correspondence received on 04/15/01, it was reported that the patient recovered from this experience. It was reported that the patient also received DTaP (SKB) and hepatitis B (Merck) on 03/06/0-1."Patient seen in our office on 03/08/01 for URI, diarrhea. The injection site redness and swelling were resolving at the time. No other reports of complaints from patient or parent."
Itching and rash which worsened on Sunday. Monday seen in office and dx with shingles.
INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex.  The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 05-MAR-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649704, 20220649045, 20220649137, 20220649370, 20220649421, 20220649804, 20220650014, 20220649488, 20220649626, 20220649803, 20220649884, 20220649915, 20220650185 and 20220649417.
I am the epidemiologist reporting on behalf of 89-year-old female patient. The patient received two doses of the Pfizer vaccine on 1/20/21 and 2/10/21. The patient tested COVID + via rapid antigen test on 7/24/21 and again on 8/27/21 via both PCR and antigen test (vaccination breakthrough). The patient was reported as having died on 8/30/21. Cause of death is listed as acute hypoxic respiratory failure; COVID 19 pneumonia. Underlying health conditions are not provided in system.
COVID Breakthrough. Patient presented to the Emergency Department on 11/12/21 with complaints of 5 days of COVID symptoms. As of 11/15/21 he is still admitted and is on high flow oxygen therapy.
Information has been received from a physician concerning his 3 yr old granddaughter who was vaccinated, at 1 year of age, with a dose of varicella virus vaccine live. A few years ago in approx 2003, the pt experienced a breakthrough case of varicella with about 15 lesions but no other symptoms. No treatment was given. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # R022116, expiration date 02-FEB-2020; strength, dose, frequency and route were not reported) for prophylaxis (poor quality product administered and product storage error). Administered dose of vaccine experienced a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit (also reported 18 Fahrenheit), which lasted for a time frame of 1.5 hours. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms reported.
On 4/12/21 at about 10:50 am approximately 10 minutes after vaccination, pt allegedly slipped out of his chair in the observation area and fell to the ground.  He got back up on his own and was directed to sit back in the chair.  Pt was given apple juice to drink as he said he had not eaten that morning.  His blood pressure was measured and found to be within normal limits.  Pt was asked to stay for another 15 minutes for observation which he did.  He stated he was feeling much better at that time.   I asked him to stay a few minutes more but he elected to leave a that time.  I called the patient later on that afternoon around 3pm at which time he stated he was feeling fine and didn't require any medical treatment.
swelling at injection site; itching at injection site; redness at injection site; This case was reported by a consumer via  interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling, injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had his/her first shot on Wednesday. The patient had swelling, itching and redness at injection site.  The patient asked when should be concerned about if it was not going away.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 18-FEB-2022) dose was not reported, 1 total administered to left arm on 12-AUG-2021 for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported.  On 26-JAN-2022, the patient had a COVID-19 PCR (polymerase chain reaction) test, which resulted positive (coded as confirmed covid-19 infection and clinical vaccination failure). The Patient was given with an infusion after he tested positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000239971.; Sender's Comments: V0: 20220700574 -Covid-19 vaccine ad26.cov2.s -Confirmed Clinical Vaccination Failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related. 20220700574 -Covid-19 vaccine ad26.cov2.s -confirmed covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms for 24 hours after the second shot), MYALGIA (very achy after the second shot), FATIGUE (tired after the second shot), PYREXIA (may have had a fever after the second shot) and CHILLS (shivering a little bit after the second shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BREZTRI AEROSPHERE) for an unknown indication.    On 04-Feb-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 INFLUENZA LIKE ILLNESS (flu like symptoms for 24 hours after the second shot), MYALGIA (very achy after the second shot), FATIGUE (tired after the second shot), PYREXIA (may have had a fever after the second shot) and CHILLS (shivering a little bit after the second shot). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Fever, at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) ongoing since an unknown date for Adverse event, at a dose of 500 mg. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms for 24 hours after the second shot) had resolved and MYALGIA (very achy after the second shot), FATIGUE (tired after the second shot), PYREXIA (may have had a fever after the second shot) and CHILLS (shivering a little bit after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had his COPD under control for some time, but now if he does not use his inhaler, he cannot breath.  On unknown date, the patient had an additional test performed that included a nostril (strip test), however, the result was that he had the flu and an infection in his lungs provided.  If he did not take advil/tylenol he experience a fever.   This case was linked to MOD-2021-348854, MOD-2021-348936 (Patient Link).
Had nerve pain in arm and swelling from the evening of the shot but Tuesday May 3rd I woke up with sciatica down my left leg.  Thursday shooting nerve pain in lower arms and wrists AND the left leg.  On Tuesday May 10th My neck and shoulder hurt REALLY bad like a inflamed pinched nerve.  By 5 pm I realized I had swelling on the  left side like the mumps and it was difficult to open my mouth.   Couldn't sleep it hurt so bad and very  difficult to swallow. Continued to worse, where Wednesday May 30th I had times  my breathing whistled and swelling had spread down both shoulders and neck.  I could only open my mouth slightly - enough to get a pinky finger in with some effort.    Used heating pads, sat in a recliner and  Had nerve pain in arm and swelling from the evening of the shot but Tuesday May 3rd I woke up with sciatica down my left leg.  Thursday shooting nerve pain in lower arms and wrists AND the left leg.  On Tuesday May 10th My neck and shoulder hurt REALLY bad like a inflamed pinched nerve.  By 5 pm I realized I had swelling on the  left side like the mumps and it was difficult to open my mouth.   Couldn't sleep it hurt so bad and very  difficult to swallow. Continued to worse, where Wednesday May 30th I had times  my breathing whistled and swelling had spread down both shoulders and neck.  I could only open my mouth slightly - enough to get a pinky finger in with some effort.    Used heating pads, sat in a recliner and took 800mg Ibuprofen every 6 hours.  Negative Covid Home tests on Tuesday May 10th and Thursday May 11th.  Took because on May 6 our daughter came to visit and commented her throat was "dry from allergies" no other symptoms but on Sunday she tested positive for Covid with a home test and a PCR.  I reported this so my doctor had to see me via video.  Had a telehealth visit with my doctor, on Thursday morning.
6 days after injection, developed an itchy raised red bump on the injection site about the size of 3 quarters
He is not hungry; just feeling unwell; Dizziness; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6202) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "Chills"; DECREASED APPETITE (non-serious) with onset 04Mar2021, outcome "unknown", described as "He is not hungry"; MALAISE (non-serious) with onset 04Mar2021, outcome "unknown", described as "just feeling unwell"; DIZZINESS (non-serious) with onset 04Mar2021, outcome "unknown", described as "Dizziness". Therapeutic measures were taken as a result of chills.  Additional information: The patient's wife was calling about her husband who took the Pfizer vaccine (Covid vaccine) on Monday (01Mar2021) and yesterday (03Mar2021) he had chills and he went to bed, all day. She gave him Tylenol, and well today (04Mar2021) he was still in bed but he does not have the chills, but he was not hungry, just feeling unwell and he has like dizziness today (04Mar2021), so she wanted to know is this normal or what she need to do.  No follow-up attempts are possible. No further information is expected.
I tested positive for COVID-19 01/06/2023. My symptoms were hoarseness, lightheadedness, weakness and feeling very fatigued. I never had a fever. I didn't have much appetite and drinking a lot of fluids. I rested, and I had a bad dry cough which I still have and some hoarseness and raspiness in my throat. When I got up and walked around I was short of breath. I didn't move around much for 3 days. I had a stuffy nose. I also had body aches. My doctor offered for PAXLOVID but I opted not to. I took TYLENOL and CLARITIN D and MUCINEX for the cough and congestion. Yesterday, I was given a MEDROL dose pack because everything was congested. Everything was basically over the counter for treatment. I'm finally starting to feel a little better today. Fatigue and lightheadedness were some of the worst parts. Still in the process of recovering.
Joint pain and swelling. Severe dizziness. Trouble breathing. Tightness in chest. Mental confusion.
1 of 6 pts exp inject site react, erythema, tenderness & itching w/in 24 hrs following vax; maximum size of react-approx 7 CM long;
1st 24 hours: Sleeplessness, headache, all body aches 24 hours: Left side of torso - skin was sensitive 24-48 hours: initial blister rash appears on torso, skin continues to be sensitive and painful on the left side 48- hours: Diagnosed with shingles/herpes zoster, put on Acyclovir, rash spreading on left side back and front;  is itchy, painful and blistering
1st dose on 1/13/22 and the 2nd dose on 2/15/22; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 15th February 2022, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's comment: Registered nurse reported that they inadvertently administered Havrix first dose on 13th January 2022 and the second dose on 15th February 2022 to a patient. The reporter asked how to proceed. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose of Havrix adult earlier than the recommended interval, which led to shortening of vaccination schedule.
I awoke @ 7:45 AM with an extremely painful, stiff, sore left arm. Bicep ached near vaccination entry point. Bicep, elbow, forearm and hand were stiff and painful. Left hand was numb and slightly discolored.  Soreness in left armpit and neck as well. Called and described symptoms. Advised to g immediately to ER. I did. Doctor saw me. Did ultrasound of left upper body from neck down to shoulder, bicep, forearm and hand. Chest xray. Blood work. Diagnosis: blood clot. Waited for complete blood work results; not available until Wednesday 7/28.  On 7/23 PM fever, chills and body aches throughout. Increased fatigue. Slept  11 hours on 7/23. Bed rest on 7/24. Lower back pain and pain in left arm remained. Slept 10 hours. Diagnosis: antiphosphal lipid syndrome. No personal history of blood clots or family history of such. I was prescribed Xarelto, 15 mg. X twice a day.  Also taking Tylenol 3 times a day as safe. Left arm pain has lessened. Still slight. Also pain in low back (kidneys?) eye sockets and temples.
I must have blacked out for a second; Woke up cold the following morning; I then felt light headed. I couldn't hold my head up; I couldn't hold my head up; feeling weak; I hit my head when I fell.; arm was sore where I got the shot.; This is a spontaneous report from a contactable consumer (reported himself). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0183), via an unspecified route of administration, administered in arm right on 06Aug2021 17:30 (age at vaccination 15-year-old) as dose 1, single for COVID-19 immunisation and school or student health clinic. The patient medical history was not reported. The patient concomitant medication was vitamin C (unspecified) received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated that on 07Aug2021 09:00, he woke up cold the following morning. Patient sat down to eat breakfast at the kitchen table. Patient stated that "I then felt lightheaded. I couldn't hold my head up". Patient stated that his body just went limp. Patient was feeling weak, then patient went sideways. Patient stated that "I must have blacked out for a second" because the next thing patient know, her mother was picking me up from the floor. Patient stated that "I hit my head when I fell". The rest of the day patient felt weak, his head hurt, and patient stated that "arm was sore where I got the shot". The patient received acetaminophen as the treatment for the events. The patient was not hospitalization. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.
pulsating ear pain/hurt; This case was reported by a consumer via call center representative and described the occurrence of ear pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 2nd dose of Shingrix. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced ear pain. On an unknown date, the outcome of the ear pain was not recovered/not resolved.   It was unknown if the reporter considered the ear pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and in the evenining the patient got a pulsating pain in the right ear that continued to hurt. The patient asked was this normal.
Information has been received from a 21 year old female with no pertinent medical history or drug allergy who on 20-NOV-2008 was vaccinated with a first dose of GARDASIL.  On 15-JAN-2008 was vaccinated with a second dose of GARDASIL.  Concomitant therapy included vitamins (unspecified) and birth control pills.  On 15-JAN-2009 the patient was performed a papanicolaou (PAP) smear which came back positive.  At the time of reporting, the patient's PAP smear positive persisted.  Additional information has been requested.
Patient describes painful swelling from arm (where injection given) to elbow. When asked if it was infected, it was not determined to be by patient.
Pt states they have pain at injection site when they lift their arm.  No swelling, or other symptoms.  Pain is the same, and hasn't increased since shot was given,  no fever, no pain unless arm is lifted.  Pt advised to take an OTC pain killer but states they would prefer not to.
Patient received the shot and as he was walking out towards the door to leave he fell over near the exit where a worker was able to catch him. we followed patient to their car and he started passing out again but never fell completely, stayed with patient to ensure his safety.
covid test result Positive; covid test result Positive; This is a spontaneous report from a contactable consumer from product quality group. The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single, as dose 2, single, as dose 3 (booster), single and as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "arthritis". Concomitant medication included: CYCLOBENZAPRINE. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant) all with onset 18Oct2021, outcome "unknown" and all described as "covid test result positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2021) Positive, Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, hypersensitivity of skin (aching to touch), nausea (mild, intermittent)