chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA  Swelling/hardness, hot to the touch, red spot. Growing over more than 24 hours after administering
08may90 pt vax heptaB. follwing morn pt ex. chest soreness, shortness of breath, cough, rhinitis, muscle aches, pain on inspiration and a large amt of breakthrough vaginal bleeding. pt cont to ex shortness of breath th/out day. see worm..
Chest pain which led to being taken by ambulance to the Emergency Room where she died of a heart attack.
Patient reports arm and shoulder soreness that has worsened since time of immunization and now reports difficulty moving shoulder
Immuniz. given at 2:33 PM 3/6/13. Pt felt faint on her way out of the office but did not appear to lose consciousness - fell to floor. No injury. Was asked to wait 15 min after admin but Mom had declined due to other commitments.
Tickle in throat; Sensation of tightening in throat; Increased mucous production; body-wide intense itchiness; Paraesthesia; Hives began third day in flushes over arms, trunk, face, upper legs; Dry itchy eyes; Dry itchy eyes; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Tickle in throat), THROAT TIGHTNESS (Sensation of tightening in throat), INCREASED BRONCHIAL SECRETION (Increased mucous production), PRURITUS (body-wide intense itchiness) and PARAESTHESIA (Paraesthesia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Paraesthesia (Paresthesia of entire right side of body and left hand forearm/ left foot/ left ear since 2010 w/o known cause which flares during some viral infections or intense heat/UV exposure.) since 2010. Concomitant products included CETIRIZINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Tickle in throat), THROAT TIGHTNESS (Sensation of tightening in throat), INCREASED BRONCHIAL SECRETION (Increased mucous production), PRURITUS (body-wide intense itchiness), PARAESTHESIA (Paraesthesia), URTICARIA (Hives began third day in flushes over arms, trunk, face, upper legs), DRY EYE (Dry itchy eyes) and EYE PRURITUS (Dry itchy eyes). At the time of the report, THROAT IRRITATION (Tickle in throat), THROAT TIGHTNESS (Sensation of tightening in throat), INCREASED BRONCHIAL SECRETION (Increased mucous production), PRURITUS (body-wide intense itchiness), PARAESTHESIA (Paraesthesia) and URTICARIA (Hives began third day in flushes over arms, trunk, face, upper legs) outcome was unknown and DRY EYE (Dry itchy eyes) and EYE PRURITUS (Dry itchy eyes) had resolved.            The patient reported that since reaction was managed w/o epinephrine after first dose, it was decided to try second dose (several weeks late) with standby epinephrine and antihistamines (cetirizine) taken prior to vaccination. The reaction began approximately 20 min with tickle in throat, some sensation of tightening and increased mucous production, followed by body wide intense itchiness and paresthesia at approximately 35-40 minutes post vaccination. A second dose of cetirizine was taken at onset. Reportedly, scratchy throat/back mouth did not occur nor did tingling of lips or tongue.  The hives began third day in flushes over arms, trunk, face, upper legs. Dry itchy eyes lasted appx 4 days. As per the patient overall second dose reaction was less severe albeit that it was received quite late.   This case was linked to MOD-2021-004774 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received included no new information.
fever; The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine; The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GJ3275) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single), for COVID-19 immunization; Covid-19 vaccine (Dose 3, single), for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional Information: The reporter was under the impression her daughters, 9-year-old and 8-year-old daughters received covid 19 gray cap, monovalent instead of the omicron booster vaccine. She called the pharmacy, and the pharmacy was adamant that her daughters received the correct vaccine and asked what vaccine was this, based on Lot number recorded. Reporter stated that reporter's daughter received the monovalent Covid-19 vaccine as their booster dose. Patient was supposed to have been receiving the Bivalent booster dose (lot number: GJ3275). Reporter didn't think it was the new Omicron booster that her daughters received and didn't know if it was the pediatric dose or what. Her daughters were having side effects, but they had side effects with the other vaccines as well, so she's not really worried about that. But, when she found out they didn't get the right booster dose, it made her concerned. Pharmacy insisted that her daughters received the bivalent booster vaccine yesterday (18Oct2022). Reporter asked if someone can look up the lot number and tell her which vaccine that LOT was for. She trusted Pfizer over the pharmacy, so she wants to check the lot number first.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201243364 same reporter/ drug/ event for different patients;
Patient complained about difficulty swallowing, and tongue swelling about 12 minutes after receiving vaccine.  50mg Benadryl given and  EMS called. Patient transferred to Hospital.
About 18 hours after vaccination, I began to feel myalgias and burning skin while in the shower; I began to feel "hot" and very fatigued. Then my temperature went up to 101.9 degrees F, taken by an electronic touchless digital thermometer. Then, the L Deltoid vaccination site began to feel very sore. As the day went on, I felt increasingly fatigued and exhausted,  and had trouble concentrating.   I felt better the 2nd day after vaccination, but felt intermittent myalgias, increasing L Deltoid soreness, and hot and chilled at the end of the day.  Today, I felt better in the morning, exceptfor persistent L deltoid soreness, and fatigue. This evening, I am feeling cold, tired, and myalgias again.
The day after receiving the vaccine, the patient woke up with discoloration, pain, and swelling on her right upper arm.  She put an ice pack on her arm because of the pain. She developed a blister on the same area of discoloration (right upper arm). The blister seemed to get worse throughout the day so she came into the pharmacy the next day to report it.
This spontaneous report as received from a physician via a company representative refers to a female patient now in her 20's. The patient's current conditions or medical history were not reported. On an unspecified date, in the last year, the patient was vaccinated as adolescent with all 3 doses of GARDASIL (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient was diagnosed with high risk HPV. The patient cleared the HPV without requiring treatment. The high risk HPV serotype was not determined. The patient went to the doctor's office for medical attention. PAP with HPV DNA testing were performed on an unspecified date, HPV serotype was not determined. This one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 15:30, 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.
This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and general body pain. SHINGRIX was discontinued. On an unknown date, the outcome of the fever and general body pain were unknown. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is a nurse practitioner reporting an adverse event on behalf of the patient. The patient experienced body aches and fever after receiving the 1st dose of SHINGRIX. The patient did not want to get the 2nd dose. The reporter had limited information regarding this event and the patient at the time of the call. This case has linked to case US2018158757, reported by the same reporter.
Every evening for a week straight intense hip pain(both). After a week I exp the pain a couple days.
1st dose on 5/5 Moderna, more than 4 hours after dose Reports dizziness, weakness and fast heart rate. Called Nurse  line 5.11.21 and reported "had headache and was tired right after vaccine, but on Sunday and Monday developed heart racing, shortness of breath, sharp/brief pains in her head, dizziness, vertigo, and vision changes. Pt. Continues to have vertigo and states "I feel like I'm in a fog." Pt. States she drove yesterday and when she got home she told her husband "I shouldn't have driven."  Reporting for continued vertigo affecting activities of daily living and patient reporting mental status changes or "feeling like she was in a fog" (not safe driving)
blisters on her mouth, nose and chin  which were white and painful; "they're so dry that they hurt; lethargic; the regular side effects; sore arm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ADVERSE REACTION (the regular side effects), BLISTER (blisters on her mouth, nose and chin  which were white and painful) and PAIN ("they're so dry that they hurt) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Insulin dependent diabetic).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ADVERSE REACTION (the regular side effects), CHILLS (chills) and PYREXIA (fever). On 04-Apr-2021, the patient experienced LETHARGY (lethargic). On 06-Apr-2021, the patient experienced BLISTER (blisters on her mouth, nose and chin  which were white and painful) and PAIN ("they're so dry that they hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 05-Apr-2021, LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ADVERSE REACTION (the regular side effects) and PAIN ("they're so dry that they hurt) outcome was unknown and BLISTER (blisters on her mouth, nose and chin  which were white and painful) had not resolved.            Other relevant treatment included Cold sore medications. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-071139 (Linked Report).; Sender's Comments:  MOD-2021-071139:First Dose
Fever and febrile seizure 9 days after MMR. Follow-up: Rash 9-10 days after MMR. Two vesicles and cerebellar ataxia 14 days after IZs.
Diagnosed with shingles on 6/04/23/Suspected Vaccination failure; Shingles; rash on on right cheek to jaw line; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26-OCT-2022, the patient received the 2nd dose of Shingrix. On 22-JUL-2022, the patient received the 1st dose of Shingrix. On 03-JUN-2023, 220 days after receiving Shingrix and 316 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Diagnosed with shingles on 6/04/23/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and exanthema facial (Verbatim: rash on on right cheek to jaw line). The outcome of the vaccination failure was unknown and the outcome of the shingles and exanthema facial were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and exanthema facial to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and exanthema facial to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 07-JUN-2023 The patient was diagnosed with shingles on 4th June 2023. The symptoms began with rash on right cheek to jaw line. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter agreed to follow up from GlaxoSmithKline.
On 03/18/2022 I received my Covid-19 vaccine. On 12/15/2022 my heart monitor showed signs of increase signs of Atrial fibrillation. I was prescribed blood thinners.
Blood pooled down complete arm that shot was given. Patient on warfarin went to MD several days later. INR test showed blood too thin. MD thought I nicked artery during injection. MD did decrease warfarin dose. This info came from daughter.
Received Pfizer vaccine on 3/17/21, 04/15/21, and 9/11/21. Presented to ER on 1/19/22 and found to be COVID positive. Recently hospitalized for right-sided pleural effusion, which was a malignant  effusion.  He had PleurX catheter placed.  He was picked up by EMS.   Oxygenation was apparently in the 80s.  He has not been feeling well.  He has  had body aches.  He has been diagnosed with COVID-19 despite being vaccinated  and receiving a booster.  Chest x-ray shows bilateral small pleural effusions.   Due to the acute hypoxic respiratory failure and inability of anyone to take  care of him at home, patient will be admitted to the hospital at this time.  No antibiotics during this admission. Discharged on 1/22/22.
Patient received flu vaccine, felt fine and went to check out with mother.  While waiting in checkout line she felt faint and flushed and asked to go to the bathroom.  As she was asking the mom said she started to faint and the customer behind her in line caught her body weight and sat her down.  She was conscious again instantly and sat on the floor with me for about 5 minutes until she "felt better".  I then took her blood pressure which was 116/65 and had a HR of 63.  She sat for about 5-10 more minutes; I asked the mom if she wanted me to call anyone.  She said they were fine, and they left the store.
p/vax pt exp D; hot feel; chest tightness; & sore arm; no treatment given
I have had HSV-2 genital herpes since 1975. That's thirty-five years. I finally came to a place where my episodes were about two times a year for the last three years. I'm basically in good health haven't had the flu since 1995, or a cold since 2000. I do take meds for hypertension, and calcium/vit D-3, and strontium for osteoporosis. I have had a flu shot every year. In 2009 I took a regular flu shot, but not the H1N1 vaccine. This year I decided to take the flu vaccine which includes H1N1. It took about 7 to 10 days before I started with breaking out with herpes. This is the most unusual episodes there is no let up. It has to have something to do with the flu vaccine. I researched the web, and have found several other people reporting the same thing. I know my body and this is most unusual. I believe 100% that the vaccine has caused my problem.
entire arm painful; a lot of pain at the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (entire arm painful) and VACCINATION SITE PAIN (a lot of pain at the injection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (entire arm painful) and VACCINATION SITE PAIN (a lot of pain at the injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (entire arm painful) and VACCINATION SITE PAIN (a lot of pain at the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
pain  and hot the entire back of :L arm, swelling and redness  now Only 2" w  x  4" l   two days later.  Intense stomach pain the day of the injection , lesser the second day. ( could not tolerate solid food, it made the stomach pain worse.)   muscle pain. and headache   I took  1 Aleve and when the headache continued took 1 Maxalt 10 mg - it took the edges off.  did not check for a fever.
Initial unsolicited report received from a nurse on 30-Mar-2016. This case involves a 48-year-old male patient, who was vaccinated with a dose of ADACEL (batch number: U5235AA, expiry date not reported) via intramuscular route in left arm on 11-Mar-2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other vaccinations within 4 weeks and concomitant medications were not reported. On 12-Mar-2016, next day after vaccination, the patient experienced fever, nausea, bodyaches, joint pain, headache, stiffness and fatigue. The patient also experienced swollen lymph nodes under left arm, the area from shoulder to elbow of left arm was warm to touch, red and swollen and also experienced tingling of arm. The symptoms continued or worsened over next 4 days. It was reported that patient required doctor visit on 15-Mar-2016 for treatment. The patient was also referred to allergist for evaluation for possible allergic reaction. Laboratory investigations was not reported. Patient's corrective treatment included one tablet of sulfamethoxazole trimethoprim 800/160 mg every 12 hours for 10 days. The outcome of the events was reported as unknown. Documents held by sender: none.
Information has been received from a registered nurse regarding a patient of unknown age and gender. ON 08-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
MI (HEART ATTACK); This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known pre-existing conditions and was a very healthy man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown ) dose, start therapy date were not reported, (dose number in series was 1), 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  It was reported that, on an unspecified date, the patient got the vaccine and stayed at the clinic for the required time, while walking across the parking lot he had a Myocardial infarction (MI) (heart attack), if a nurse had not been walking towards her car he would be dead. The nurse gave him Cardiopulmonary resuscitation (CPR) (dose number in was series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of MI (heart attack) was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211258726.; Sender's Comments: V0 20211259197-COVID-19 VACCINE AD26.COV2.S-MI (heart attack). This event(s) is considered unassessable. 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).
Occasionally itches; red blotch around where they gave it; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Occasionally itches) and INJECTION SITE ERYTHEMA (red blotch around where they gave it) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Occasionally itches) and INJECTION SITE ERYTHEMA (red blotch around where they gave it). At the time of the report, INJECTION SITE PRURITUS (Occasionally itches) and INJECTION SITE ERYTHEMA (red blotch around where they gave it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021 and does not contain any new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.