chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given in tricep not deltoid; This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a 31-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number 339DL, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site 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 details were reported as follows: The pharmacist reported he was administered FluLaval Tetra 2021-2022 season and it was given in his tricep area not in the deltoid, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The patient has fever after getting Shingrix approximately 14 hours ago from the reporting. The reporter was asking, was there a safe medicine he can take to bring down the fever.
This case was reported by a healthcare professional via sales representative and described the occurrence of cellulitis in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown given on 21 MAY 2009, varicella virus vaccine (non-gsk); Merck; unknown given on 21 May 2009. On 19 May 2009 the subject received 1st dose of KINRIX (.5 ml, unknown). On 21 May 2009, 2 days after vaccination with KINRIX, the subject experienced cellulitis and fever. At an unknown time after vaccination with KINRIX, the subject experienced erythema of leg and warm to touch. The subject's legs were red, warm to touch, fever and diagnosed with cellulitis. The case was assessed to be medically significant by GSK. At the time of reporting the cellulitis and fever were resolved. The redness of the legs and warm to touch outcomes were unknown. The healthcare professional considered the events were probably related to vaccination with KINRIX.
14hours after injection severe muscle cramps  22 hours after rash on chest and injection site  48 hours after rash on chest, injection site, back, itching on whole body and itchy throat
The symptoms I experienced after the vaccination was trembling pain in my legs. I also fainted and started getting clammy and began to vomit. An ambulance was phoned and I was hospitalized and under observation. As of today I am still experiencing dizziness and a sense of instability.
This spontaneous report as received from a registered nurse via company representative refers to a 6-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2017, reported as "about 2 years ago", the patient was vaccinated with a dose of M-M-R II (dose, lot #, expiration date and route of administration not reported). On an unknown date, reported as "recent", the patient presented with mumps. The outcome of mumps was unknown. The causality assessment was not provided.
One hour after I received the vaccine, I ate cookies bought in the bakery with birthday cake icing. Immediately after ingesting the cookies, I developed irritated throat, felt as if my throat was burning, developed coughing, throat felt funny. This lasted for the entire day. Throat looked inflamed for 2 days. This was after my first dose, so I am praying it was a reaction to the cookies and not the vaccine.
This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions of the patients were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored VAQTA with lot number #L013380 (expiry date: 04-NOV-2017) or lot number #K019560 (expiry date: 02-JUN-2017). Concomitant medications of the patients were unknown. No adverse event reported. The outcome of the event incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
arm began swelling; warm to the touch; redness; rash; This is a spontaneous report from a contactable nurse via Pfizer sales representative.  A 65-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included omeprazole. On an unspecified date, the patient experienced arm began swelling, warm to the touch, redness, rash. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Patient noticed a band of redness/warmth that was 2 inches below injection site - area resolved in a few days injection site had no redness/swelling or warmth.
Patient states arm got swollen, hot to touch, sore and itchy starting a few hours after administration of vaccine. Soreness seems to have gotten better. Swelling at injection site has improved but now some swelling has moved down her arm and to her hand. Patient states arm is still itchy and warm to the touch. Patient states they have not taken any medications to try to reduce swelling, pain or itching. Patient was advised to call their doctor to discuss the adverse reactions and treatment options.
breast cancer; lymph node cancer on her left breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) and LYMPHOMA (lymph node cancer on her left breast) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant) and LYMPHOMA (lymph node cancer on her left breast) (seriousness criterion medically significant). The patient was treated with Surgery (Lateral  Mastectomy) for Breast cancer and Surgery (Lateral  Mastectomy) for Lymphoma. At the time of the report, BREAST CANCER (breast cancer) and LYMPHOMA (lymph node cancer on her left breast) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. The patient got her first dose on left deltoid muscle (non dominant arm). The patient had surgery-lateral mastectomy on an unspecified date in Jun-2021. The patient mentioned that the lymph node cancer was on her left breast and that it was very minimal, small. She had cancer only in one but, she did not want to take a chance. The patient did not clarify whether she took the surgery on both breasts. She only mentioned later that her left breast was cut off.  Company Comment: This case concerns a 73-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of Breast cancer, and lymphoma. The event occurred after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. Elderly age remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-344364 (Patient Link).; Sender's Comments: This case concerns a 73-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of Breast cancer, and lymphoma. The event occurred after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. Elderly age remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
On 6/7/2022, I woke up with sore throat, headache, sneezing, and runny nose. I took Tylenol, but the headache persisted. My throat also became scratchy and sore, and I had trouble talking. On 6/8/2022, I had the same symptoms, but I thought that I was just getting a cold. Later that afternoon, I took an at-home test for COVID, and the result was negative. I was very fatigued, but I had just returned from a plane trip, and I thought that might have been the cause. On 6/9/2022 and 6/10/2022, I continued to have the same symptoms, but I also felt like I was getting laryngitis. On 6/10/2022, my headache was gone, but I still had sneezing, runny nose, coughing, and fatigue. The sore throat was getting better, but I began to feel a tightness in my upper chest. I was taking DayQuil, NyQuil, and Robitussin. The symptoms improved with the OTC medications, but they were still present. Around 4 PM that day, I took 2 at-home tests for COVID, and the result was positive both times. I went to an urgent care clinic for further confirmation, and they confirmed that I indeed had COVID. My oxygen level was fine. They gave me benzonatate tablets (200mg). They also offered me an antiviral, but they said that it probably wouldn't help, as I had had symptoms for too long, so I declined. They sent me home and advised me to take care of myself and call them if there were any changes. From 6/10/2022 until 6/18/2022, I isolated from my husband and child at home. I slept and took both OTC medications (Tylenol, DayQuil, Robitussin) and the benzonatate tablets. On 6/14/2022, I noticed I had lost my senses of taste and smell. My other symptoms gradually resolved. On 6/16/2022 and 6/17/2022, I had left inner ear pain. On 6/17/2022, I gradually began to regain my taste and smell. On 6/18/2022, I tested negative and came out of isolation. Since then, I have felt pretty much normal.
PATIENT PRESENTED TO THE CLINIC ON 8/20/2018 C/O LEFT ARM REDNESS AND BRUISING. PATIENT STATED HAVING SOME PAIN AND FEELING WARMTH AFTER SHE GOT THE VACCINES ON 8/16/2018. TODAY 8/20/2018 SHE DENIES ANY PAIN, ITCHING, RASH, FEVER OR CHILLS. PATIENT WAS INSTRUCTED TO TAKE TYLENOL FOR PAIN AND APPLY COLD COMPRESSES.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-DEC-2017 , the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002559: US-009507513-1801USA002560: US-009507513-1801USA002561: US-009507513-1801USA002563: US-009507513-1801USA002564.
On the 10th day after the vaccine place where I got shot started itching and became red and hot
Red, slightly raised itchy area around injection site; Delayed Reaction; red area around injection site; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PRURITUS (Red, slightly raised itchy area around injection site), SKIN REACTION (Delayed Reaction) and INJECTION SITE ERYTHEMA (red area around injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (red area around injection site). On 11-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Red, slightly raised itchy area around injection site) and SKIN REACTION (Delayed Reaction). At the time of the report, INJECTION SITE PRURITUS (Red, slightly raised itchy area around injection site), SKIN REACTION (Delayed Reaction) and INJECTION SITE ERYTHEMA (red area around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
asplenic; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 69-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumovax 23, administration date: 2011, for immunisation. The following information was reported: ASPLENIA (medically significant), outcome "unknown", described as "asplenic". The patient wanted to get the Prevnar 20 and they have questions about eligibility  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently provided, the reported event ASPLENIA is considered not related to PREVENAR 13 but represents the patient's underlying medical condition.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Redness and swelling of arm with heat radiating from the site of injection, patient called doctor and  is putting ice on arm  and taking benadryl per doctor's orders.
Patient received third covid shot by accident; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received third covid shot by accident) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ALPRAZOLAM (XANAX), SIMVASTATIN and ATENOLOL for an unknown indication.   On 17-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 17-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received third covid shot by accident). On 17-May-2021, EXTRA DOSE ADMINISTERED (Patient received third covid shot by accident) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received third shot  two weeks later after the first dose by accident.  Treatment information was not provided.
Pt recvd 3 doses of Engerix-B 30OCT90, 27DEC90 29APR91 & 8SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Red raised rash from top of thighs to just under breasts all the way around my body.  Started taking Benadryl 50mg at 9:00pm  2/9/21 . Unable to take every six hours per nurse hot line instructions been doing 2x during the day. As of 3:21 pm on 2/11/21 still some raised red rash but not completely covered.
Information was received on 11-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No concomitant medications or medical history was reported. On 11-JUL-2017, while the pharmacist was administering a dose of ZOSTAVAX (lot # N013289, expires 04-JUL-2018) (dose, route and site not reported) reconstituted with sterile water diluent (lot L033143, expires 16-APR-2018), the pharmacist stated that "the tip of the plastic syringe and the needle separated while administering [the vaccine] and the ZOSTAVAX vaccine splashed into my eyes, mouth and face and I am 13 weeks pregnant" (MARRS# 1707USA004607). The pharmacist confirmed that the full dose was not administered to this patient. No adverse effect reported. No further information was provided. Additional information has been requested. This is one of two reports from the same reporter.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 10-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Dizziness, Headache, Fever, NauseaVomiting, CHILLS, DIZZINESS, INJECTION SITE PAIN Narrative:
At Wellness Event, patient did not have a card with him or have a picture of the vaccine card and he said that he wanted a pfizer booster and double and triple check with him and he said he got the pfizer vaccine. Gave the patient the pfizer booster based on eligibility and pt came back 10 minutes later saying he remembered that he got moderna and not pfizer. Apologized to the patient and told him that he got pfizer and that it should not be any problems and if he would like to let his doctor know about what happened he can. The patient was fine he was not worry.
I started having a reaction right away, but didn't think anything of it. I was itchy sporadically. I started getting really red, hot, and very itchy. I had bright red rash on my face, neck, and chest.  I immediately took a Zyrtec and called my MD. The rash and redness subsided a little after taking the Zyrtec. The itchiness was less, however, still itchy. I started to have diarrhea. On my way home, my bottom lip was swelling. I spoke with my PCP.  He told me to take 50 mg additional of Benedryl when i got home and to take Pepcid for my stomach. I was much better the next day.
Arm Soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
Narrative:  66-year-old female presented to EDfor evaluation of cough, shortness of breath, weakness, fever, chills, not feeling well. She received her COVID-19 to her knowledge. Her COVID-19 test was positive at ED. She felt markedly improved after liter of IV fluids, IV Solu-Medrol, and observation. Her oxygen saturations were in the 97% range. Pt was discharged the same day. Of note,  patient had anxiety and headache with the first dose of covid-19 vaccine, no adverse events were reported with second dose.
Began waking up and unable to get back to sleep; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) and INSOMNIA (Began waking up and unable to get back to sleep) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 09-Feb-2021, the patient experienced INSOMNIA (Began waking up and unable to get back to sleep). On 18-Jan-2021, VACCINATION SITE PAIN (Sore arm at injection site) had resolved. At the time of the report, INSOMNIA (Began waking up and unable to get back to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information provided: Reporter Address, contact(Email) updated
Dizziness after the 3 weeks after the vaccine. Chest pain, shortage of breath, palpitations started on August 13th, 2021. They are getting better, but I still have all these symptoms from time to time.