chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after the shot, the vaccine site was swollen, hot and very painful. My husband and I both experienced swore upper bodies to our necks. I never had a fever. A few days after I started to notice sharp stabbing pains up the right side of my back. The pain kept me up all night. It was like someone stabbed me in the back periodically. I woke up the next morning and contacted my doctor. By the time I got to her office the pain had stopped. She did not believe the back pain was from the shot. She thought I had kidney stones and set me up with an CT Scan. While I was waiting for the scan, the pain started again. From the scan, they found I had no kidney stones, but I do have pulmonary nodules. My doctor's office told me they would test me again in 6 months. I had a CT Scan about 4 years ago and nothing was found. The pain stopped later that evening. My arm is still red but it is not swollen or painful. I think I have developed a sensitivity to the vaccine and I will not be getting another booster.
Patient 12 month old was given Varivax and Proquad instead of MMR only. So, the patient received 2 doses of varicella vaccine. Patient parent reports no adverse reaction noted.
pt was vax in oct95 & in feb99 pt devel less than 50 skin lesions located all over body.
On 09/30/17, mom called MD pt started with fever and rash, red pinpoint rash on face and trunk. No distress. Not itchy.
Today, I gave flu shot FLUVIRIN 2010-2011, NDC 66521-113-10, lot#111785P1, exp 03-31-2011 (it was opened-been used). Patient 53 yoa, she has flu shot every year. On the consent and release-injectable vaccinations, question#1: 8 years for tetanus shot, question #2: NA and question #3: NA; question#4-#9: No. I gave flu shot at 1:35PM on left arm, IM; she had reaction: fainting, extreme paleness, swelling of the throat, wheezing, short of breath, difficult breathing. Pharmacist asked her husband to call 9-11 at first but pharmacist came back to pharmacy to call 9-11 and paged manager store to come for help. Manager talked to 9-11 agent. Pharmacist and husband let the patient lay down on the floor; check ABC's- patient was breathing. She had pulse-ok'd--No CPR. Injected epinephrine 1 dose 0.3 mg only, on left thigh, NDC 49502-0500-02 lot#0GM199, exp 09-2011. Wait for paramedics arrive.
When the patient awoke on 10/18/2001 she had a small raised rash on her forehead. The rash progressed to her cheeks and neck throughout the day. The Dr diagnosed the patient with a reaction to the Hepatitis B vaccine. The patient was treated with Claritin for 12 days and topical Benadryl with relief of the rash. The patient was advised to use no new creams, cleansers or makeup on her face.
Patient began with fever and rash 11/19/04. Then began dizziness and falling down on 11/21/04.
Arm was still painful at injection site 2 weeks after vaccine given. Pharmacist recommended OTC ibuprofen.
Pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joints) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in joints). At the time of the report, ARTHRALGIA (Pain in joints) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  It was reported that patient thought it could be occurred due to work out.   This case was linked to MOD-2021-337202 (Patient Link).
10MAR97 recv vax several hr later mom brought baby back to clinic-crying, loudly, inconsolable;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Additional Details: After vaccine administration at approximately 09:10a, per mother stood up from vaccine area to walk to post-vaccination area with complaints of feeling light headed. Pharmacist notified & went to help pt in the post vaccination area. Pt was diaphoretic, pale, and appeared as though she was going to faint. Pts mother, pharmacist, and bystander assisted patient to the ground with legs bent, water, crackers, and ice pack provided. Patient was starting to become more responsive. Paramedics called.
Warm to touch beneath injection site; Itchy beneath injection site; There was initial red mark was beneath injection site; Patient had a little red spot on left arm after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch beneath injection site), VACCINATION SITE PRURITUS (Itchy beneath injection site), VACCINATION SITE ERYTHEMA (There was initial red mark was beneath injection site) and VACCINATION SITE ERYTHEMA (Patient had a little red spot on left arm after receiving 1st dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included HYDROCORTISONE and DESMOPRESSIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Patient had a little red spot on left arm after receiving 1st dose). On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch beneath injection site), VACCINATION SITE PRURITUS (Itchy beneath injection site) and VACCINATION SITE ERYTHEMA (There was initial red mark was beneath injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. On 09-Mar-2021, VACCINATION SITE ERYTHEMA (Patient had a little red spot on left arm after receiving 1st dose) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch beneath injection site), VACCINATION SITE PRURITUS (Itchy beneath injection site) and VACCINATION SITE ERYTHEMA (There was initial red mark was beneath injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Thyroid Medication. Treatment include ice pack and alcohol.
Inconsolable screaming/crying, began approximately 3 hours after receiving vaccines, gave TYLENOL 80 mg after 30 minutes of screaming, child calmed within another 30 minutes and fell asleep - OK when awoke later.
Client reported swelling and stinging to left deltoid.   10:40  Pulse 68   Resp 16   Ice applied.  Lungs clear   no stridor 10:50   BP 106/76   Benadryl 25 mg  PO administered 11:00   Pulse 68   Resp 16   Left deltoid swelling is decreasing.   Lungs clear, no resp distress, no N/T 11:10   Patient left on own accord.   Signs and symptoms of systemic reaction to left deltoid swelling was decreasing.  No headache, dizziness, SOB.   Accompanied by husband.  On 3/26 call placed/voice mail left to follow up.  No return call received.
Tachycardia (heart rate 90s-110s), adrenaline rush in chest, tingly in chest and neck.. No treatment. Called employee covid HUB and they sent me to get covid swabbed today (12/28/20) . Called NP and she did not want to see me until covid swab back, symptoms worsen or she told me to go to ED.
A dose of MENACTRA was ordered for a patient by the clinician, but the nurse took the incorrect vaccine from the refrigerator (GARDASIL-9) and administered a dose of that vaccine instead. The nurse acknowledged that she did not double check to make sure that she had the correct vaccine. The patient was notified by the clinician that he received the incorrect vaccine and returned that same afternoon to receive the MENACTRA without incident.
the antibody test results were negative; This case was reported by a physician via sales rep and described the occurrence of therapy non-responder in a 68-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   Concurrent medical conditions included covid-19 pneumonia.   On 15th October 2018, the patient received the 1st dose of Engerix B adult. On 15th November 2018, the patient received the 2nd dose of Engerix B adult. On 9th April 2019, the patient received the 3rd dose of Engerix B adult. On 1st May 2019, 198 days after receiving Engerix B adult, 167 days after receiving Engerix B adult and 22 days after receiving Engerix B adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The patient received the Engerix-B vaccine beginning in 2018 and after each of his three doses, he ran antibody tests.   Each time the antibody test results were negative. The reporter did not had a valid lot number but would call back with that information.   The reporter consented to follow up.  This case has been linked to US2020109778, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020109778:Same reporter
a lot of joint pain; joints are just "killing her"; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (a lot of joint pain; joints are just "killing her") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), INDAPAMIDE, ATORVASTATIN, EZETIMIBE, ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (a lot of joint pain; joints are just "killing her"). The patient was treated with MELOXICAM ongoing since an unknown date for Physical therapy, at a dose of 7.5 mg once a day and Physical therapy for Arthralgia. At the time of the report, ARTHRALGIA (a lot of joint pain; joints are just "killing her") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got the blood work done and went to the chiropractor. Patient reported  that the doctor took out Atorvastatin and put the patient on rosuvastatin 5 mg twice a week.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up received :- Updated patient demographic detail and concomitant medication is added.
Patient was walking out of clinic and felt dizzy, saw blackness, brief loss of consciousness for less then one minute. Parents witnessed.  fell to ground.  Hit head.  Eyes rolled back, upper arms jerked and drooling.  loss of urine.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-APR-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA injection (strength, dose and frequency were not reported) (lot # N012324, expiration date: 05-APR-2018) for prophylaxis (expired product administered). No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010813:
diarrhea; very tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE PAIN (sore arm) and FATIGUE (very tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and FATIGUE (very tired). On 27-Feb-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, DIARRHOEA (diarrhea) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Fever, vomiting, throat irritation, full body hives lasting 48 hours so far, body aches. Soreness,  burning, and irritation at injection site.
Patient reported rash and itching about 2 hour after vaccination. She took Diphenhydramine 50mg to help with the allergy.  Rash started with both arms and eventually spread throughout body. 08/19/2021 from  2:00pm to 4:30pm, shot give at approximate 2:15pm. Patient last called around 4:30 pm to ask about reporting and commented that mouth and tongue felt swollen. Pharmacist referred patient hospital or urgent care if symptoms worsened.
Redness, swelling, and pain around vaccination site, which began 6/9/03. Red streak extending from vaccination site, approximately 2 1/2" toward armpit. C/o pain in armpit area but no palpable lymph nodes. Headache, dizziness since 6/5 with limited relief from OTC medication.
Pt reported no problems Monday. Upon awakening Tues, had spots on left (vaccinated) arm, left neck, and front of chest. Pt reports rash is painful, not itchy. Wed AM, more "spots", and much more painful. Pt reported feeling "shaky". 88 y/o female received ZOSTAVAX 3-22-10 9AM; pt awoke 3-23 10 with painful rash on left arm, neck & chest. Rash was reported to pharmacist on Wed 3-24 afternoon ---> pt. instructed to call dr. Pt saw dr. 3-24-10 in afternood - dr. confirmed pt had shingles, Pt. was prescribed VALTREX & LORTAB prescriptions for gen. VALTREX (1 gram BID x 7 days) and gen LORTAB 7.5-500 (1-2 QID prn pain) were picked up by family members 3-26-10 early afternoon. Pt's obituary was inlocal paper Tues 3-30-10 (DOD 3-28-10). Dr's office was contacted and  nurse said pt did have shingles - like rash 3-25-10. Dr-on-call was contacted by pt Sat 3-27-10.. Pt refused to go to ER, but instead went to stay at daughter's house Pt was found unresponsive ~ 2AM 3-28-10. According to nurse no evidence of stroke, but pt had subdermal hematoma - a fall at some time is expected, but unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX. Other suspect therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage and no adverse event to be not related to sterile diluent and VARIVAX. Sender's Comments: US-009507513-1709USA002438.
This spontaneous report as received from a consumer, as part of a marketing research program refers to a 49 year old male patient. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route and lot # not reported). The consumer reported that on an unknown date, 2 months after vaccination, the patient died from pneumonia so he had no faith in pneumococcal vaccine (manufacturer unknown). The relationship between the event and pneumococcal vaccine, (manufacturer unknown) was not reported. Additional information is not expected. There is no contact information.
Dizziness, brain fog, headaches, panic attacks, racing heart rate, insomnia, night sweats, facial flushing, chills, cough, chest pain.
I have received the first shot 14 month ago. Would like to get the second shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (twice). Previously administered products included Shingrix (In 2022, an unknown date, 14 months ago received first dose ) and Zostavax (Years ago received a dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I have received the first shot 14 month ago. Would like to get the second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 2-NOV-2023  The reporter received the first shot 14 month ago and wanted to get the second shot. The patient asked if he need to get the first shot again, or how he may proceed. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Chronic urticaria; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA CHRONIC (Chronic urticaria) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA CHRONIC (Chronic urticaria). At the time of the report, URTICARIA CHRONIC (Chronic urticaria) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Heart Rate Increased (Fluctuating Max 150 BPM); A spontaneous report was received from a 53-years-old female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events heart rate increased (fluctuating max 150 bpm).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event heart rate increased (fluctuating max 150 bpm) .   Treatment details included Heart Monitor for the two weeks.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, heart rate increased (fluctuating max 150 bpm) was unknown.
Nasal congestion; Soreness in left arm; Extremely tired; A spontaneous report was received from a consumer concerning a 21-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in left arm, extremely tired and nasal congestion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: unknown) in left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced the events soreness in left arm and extremely tired. On 26 Jan 2021, the patient experienced the events nasal congestion. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, soreness in left arm, extremely tired and nasal congestion was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
felt tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025P21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (felt tiredness) outcome was unknown.            Concomitant product includes unspecified Blood pressure medication.   This case was linked to MOD-2021-377971, MOD-2021-377968 (Patient Link).
Woke up feeling weak and cold not walk or balance.  Ambulance was called early that morning to take him to the hospital as he did not get better.
Her cousin who received moderna vaccine and has been facing menstrual changes; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Her cousin who received moderna vaccine and has been facing menstrual changes) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Her cousin who received moderna vaccine and has been facing menstrual changes). At the time of the report, MENSTRUAL DISORDER (Her cousin who received moderna vaccine and has been facing menstrual changes) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician concerning his son who on 02/13/1997 was vaccinated with Varicella virus vaccine live. On 03/25/2001, the pt developed chicken pox. The patient sought unspecified medical attention. The physician also provided information regarding other patients who were vaccinated with vVaricella virus vaccine live. Additional information is not expected.
Pain, swelling, redness, itching and warmth @ injection site for 4 days after injection. Tylenol for discomfort, oral Benadryl for the itching and cool compresses.  Benadryl cream to area. Had slight relief of symptoms using above. Injection site still slightly sore to touch and some itching noted on day 5.