chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnozed with influenza strain A; This is a spontaneous case , initially received from other health professional (nurse) via agency (reference number: SEQ20-00663) on 18-Feb-2020, concerning a 56-year-old, female patient.  The patient's current condition included diabetes.   The patient's concomitant medications were not provided.  On 10-Oct-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, batch number: 261204, expiration date: 26-Jun-2020 and route of administration: intramuscular) as influenza prophylaxis.  On 16-Feb-2020, 4 months and 6 days after vaccination, the patient was diagnosed with influenza strain A. The patient received Tamiflu (oseltamivir phosphate) as treatment medication.  At the time of this report, the patient did not recover from the event of influenza'.  The event of influenza' was assessed as serious due to criterion of medical significance, per company.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent.   This case is linked to 2020001854 due to same reporter.  Company comment: The patient experienced influenza after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. Medical history of diabetes may have contributed to development of the event. No concomitant medications and diagnostic findings were provided.  Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced influenza after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. Medical history of diabetes may have contributed to development of the event. No concomitant medications and diagnostic findings were provided.  Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Gave MMR vaccine on 08/18/2003 on 08/19/2003 patient complained of nausea (flu-like symptoms) and redness on area where injection was given.  Patient had 2 MD's evaluate patient was told to take ibuprofen TT tabs three times per day as needed for reaction and swelling.
swollen arm; painful arm; flu-like symptoms; red arm; horrible headache; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm) and HEADACHE (horrible headache) 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.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm), HEADACHE (horrible headache) and FATIGUE (exhausted). At the time of the report, PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm), HEADACHE (horrible headache) and FATIGUE (exhausted) had resolved.        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.   No concomitant medications were reported.  It was reported that the patient took acetaminophen for the adverse events.  Upon internal review on 21-May-2021, the ague was corrected to unknown.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Event outcomes updated.
Patient received 4 doses; Patient received 4 doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2020) and Shingrix (2nd dose received on an unknown date in 2020).   In DEC-2020, the patient received the 4th dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. In DEC-2020, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient received 4 doses). On an unknown date, the patient experienced extra dose administered (Verbatim: Patient received 4 doses). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 18-MAR-2023 The reporter discovered that a patient had received 4 Shingrix between June 2020 and December 2020 at two facilities. The reporter asked was there any safety data or additional steps we should take as a pharmacy now that we have discovered this. The reporter provided all details available per web form.  No further information available at this time.    The reporter consented to follow up. The patient received 3rd and 4th dose of Shingrix, which led to extra dose administered.
received Engerix that was expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 8th November 2022) for prophylaxis.   On 15th November 2022, the patient received Engerix B. On 15th November 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: The reporter stated that the patient received Engerix B 2 days ago on 15th November 2022 and the expiration date was 8th November 2022.  The reporter declined to provide any additional information on call. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Engerix B which was already expired, which led to expired vaccine used.
Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Talked to patient over the phone. Has fully recovered.
Janssen COVID-19 Vaccine EUA  Injection @ 1130a 1hr after - diarrhea 5hrs after- Rt Arm (opposite arm of shot)  tingling  sensitive to touch 7hrs after- Skin Crawling painful to touch - low back,thighs, arms, scalp 9hrs after- Freezing and fever sweating 12hrs after- 102 fever, racing BP about 180 high for me, Wrist and Elbows Ached terribly, Lower legs - knee down felt swollen but no                               sign of swelling.  Low back Ached with Pain in Right rear side.  Felt like I needed to stretch back and legs tight/anxious.                                slight Headache 14hrs after- took 2 Tylenol PM & slept restlessly until 8:30 a (12hrs later)  8:30a - Much better with slightly achey back and forearms and occasional headache ting... not constant.   Moving slow   Had Covid Nov11 2020.  Symptoms lasted 6week, each week one symptom would go away and a new would arise- -fever 2days -intensively painful skin crawling 2days -loss of taste and smell -diarrhea (still have loose stools and occasional watery) had diarrhea morning of shot -eyes painfully itchy irritated dry - still occurs most days about 3p -extreme exhaustion in afternoon about 1-3p still
first dose administered to a 17 year old; A spontaneous report was received from a consumer's guardian concerning a 17 year old female patient who was administered a COVID vaccine at an inappropriate age. The reporter requested to enroll their 17 year old child into the pediatric clinical trial.  The reporter wants to know what to do about the second dose.      The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number :041L20A) on 12 Jan 2021 for prophylaxis of COVID-19 infection.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event administered a COVID vaccine at an inappropriate age was considered as resolved.; Reporter's Comments: This report refers to a case of 17 year old female patient  administered vaccine ( inappropriate age at vaccine administration) for mRNA-1273, lot #041L20A). There was no associated AEs with the event of inappropriate age at vaccine administration.
Information has been received from a pharmacist on 10-FEB-2015, referring to a patient of unknown age. No concurrent or historical conditions were reported. On that day the patient was inadvertently administered a dose of 0.5 ml PNEUMOVAX23 (lot # J013344, expiration date 22-JAN-2015), intramuscular (expired vaccine used). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
patient developed a rash about 9-10 days after initial vaccination around the area of the injection site . she stated this went away in a couple of days
Left thigh at injection site is reddened in an area 3 inch x 1 3/4 inch, slight warm and induration. No other symptoms. No treatment needed, but can use ice to area and BENADRYL if wants to. T - 97.6 temporal.
The pt experienced itchiness at the back of neck, and upper chest, approximately 1 hour post vax. No rash was noted.
patient arm was sore and then got red- went to his primary provider and was diagnosed with cellulitis and given antibiotics- pt is doing fine now per patient on 10/24/2020
Hive-like rash and itch initially on both sides of torso below armpits that gradually spread to larger area or torso, arms and upper back despite 7-day course of oral steroid  and topical soap (both prescribed and commenced on 12/18/2021).
Fever 99 - 100 had chills no sore on hand notice on 7/15/10.
Pt recvd a series of 3 Engerix-B on 1DEC89, 2JAN90, & 19JUN90 subsequently tested for Hep B Antibodies & found not to have converted;
lt deltoid area hard indurated area, erythematosis w/petechial hemmorhages; pain radiated into lt shoulder & neck;
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and Lab data information was provided. No Treatment medication information was provided   Reporter did not allow further contact
got the moderna vaccine back in March. (One shot)  Never went back and got the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the moderna vaccine back in March. (One shot)  Never went back and got the second shot) in a patient of an unknown age and gender 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 PRODUCT DOSE OMISSION ISSUE (got the moderna vaccine back in March. (One shot)  Never went back and got the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the moderna vaccine back in March. (One shot)  Never went back and got the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 28-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Onset of primary immune deficiency requiring monthly IVs of Igg at 34 cc of gammagard in hospital. Repeated tests at 4 weeks after IVs show little improvement of Igg levels from the onset in July, 2021.
no additional adverse effect reported; MMR II and Sterile Diluent was given to a patient that was expired; This spontaneous report has been received from a medical assistance, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 31-JUL-2020, the patient was vaccinated  an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) 0.5 milliliter, lot # R019979 with expiration date 11-JUL-2020 which was diluted with an expired sterile diluent, 0.5 milliliter, lot number reported as N03021 with expiration date 20-JUL-2020 (frequency, route and anatomical location were not provided for any suspect therapy) and were administered for prophylaxis. The reporter stated that the vials were throw in the biohazard box. No additional adverse effect reported.
Hand was "puffy"/ Swollen hand; Redness; Rash going up the arm / like a heat rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand was "puffy"/ Swollen hand), ERYTHEMA (Redness) and RASH (Rash going up the arm / like a heat rash) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Malignant neoplasm of prostate (Patient is taking 3 medications.) since 11-Feb-2021. Concomitant products included RELUGOLIX from 11-Feb-2021 to an unknown date for Prostate cancer.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (Hand was "puffy"/ Swollen hand), ERYTHEMA (Redness) and RASH (Rash going up the arm / like a heat rash). On 05-Mar-2021, PERIPHERAL SWELLING (Hand was "puffy"/ Swollen hand) and RASH (Rash going up the arm / like a heat rash) had resolved and ERYTHEMA (Redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.
Developed hives three days after the vaccine. "Not very swollen or inflamed-over whole body". Not itchy. A little less red now but still present. Also had an itchy throat recently. Lymphoma now out of remission (had stem cell transplant).  Had been in remission the last 7 years. Nothing going on at the time of the shot. Changed laundry detergent etc. after developiing the rash.  Had a hostory of a rash with initial mantel cell lymphoma. Going to start Car T transplant in a week. Oncology team reccomended the booster dose and is aware of the rash. Has taken pictures. Has not notified primary MD. Encouraged to notify and discuss if another dose is eligible to consider close observation for anaphlaxis Cont. or not receving the same type of COVID vaccine. States "I don't think I will be getting another one". Wanted to report the rash in case others need to know that it could be a side effect.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). An 82-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0151), at the age of 82, on Apr 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6207), on Mar 20, 2021, for COVID-19 immunization. The patient experienced rhinorrhea (runny nose), fatigue (felt tired) and pain (body aches), with outcome of  unknown. No follow-up attempts possible. No further information expected.
Approximately 20 minutes after receiving vaccines, pt developed few red macular blotches on forehead and cheeks. No other symptoms noted.  Pt rxd Benadryl to take every 6 hr if rash present. Rxd Tylenol every 4 hr for pain/fever if occurs. Advised mother to RTC if symptoms worsen. ER precautions provided.
After approximately 5 days of receiving the second Moderna shot, my mom noticed a slight rash and red spot. The spot is better but the rash is now all over her body.
TT given 8:05am L deltoid, 8:15am pt's vision went black and she fell to floor. Pt was unresponsive approximately 5 sec. Pt came to and vomited x 1 clear liquid. Skin cold, clammy, pallor. BP 110/58 and 110/62 (sitting and lying down). Denies HA, dizziness, or stomach ache c/o feeling "shaky." Pt back to baseline by 8:30am.
Information has been received from a physician concerning an unknown number of patients who were vaccinated with GARDASIL and complained of pain and burning when the vaccine is being injected.  Additional information has been requested.
Shoulder swelled and became sore. Eventually whole body became sore, weak, hot and sleepy. Developed fever/chills 99.5. Headache all day. Cough for about two hours. Symptoms faded overnight. No treatment.
Patient immunization record was transcribed, and second dose of MENACTRA was indicated as overdue in SHOTS. This writer was not aware that Agency guidelines state that MENACTRA is for patients over the age of eleven years and administered the second dose after reading the manufacturer administration is "For 9 months through 55 years of age".
pt's mom - (contact information is for mom as patient is a minor) reported urticaria reaction diffusely that began on post-vaccine day #4.  No dyspnea, mucosal-/angioedema, fever, or other systemic sx.  Pt is not an established patient of mine; have just seen for COVID care (testing, vaccines).  Recommended pt be seen for eval & tx (likely symptomatic care) and watchful waiting.  Warning signs discussed.
The morning after the  booster shot, my mother experienced confusion, disorientation, and memory loss. This was in addition to the more "normal" side effects of fatigue, muscle aches, and low grade fever. From about 12 to 36 hours after the booster shot, my mother couldn't tell me the day, the date, or who the president was. She did know my name, and after some consideration, our pets' names, but couldn't name her siblings.  She had trouble completing everyday tasks like taking her pills and had low situational awareness. She was very vague in her verbal responses to me, and I could tell she did not have full comprehension of what I was saying or asking.
ON July 21 had shot.  On July 26 passed out 4 times at the fair.  August 3 blacked out but she said didn't pass out all the way.  Aug 10 not feeling well feels tired and stomach hurts when standing.  Aug 11 took to doctor.  Aug 12 passed out at the mall.  Always very tired.  Doesn't like to eat makes her sick.  Was fine before this.  9/15/09 Received vaccine & PCP medical records. Records revealed patient experienced general good health on day of HPV #1.
syncopal episode after second injection. 1st injection was HPV right delt. 2nd injection was menactra left delt. Pt began leaning to the right. Medical provider caught patient and lowered to supine position on exam table. Syncopal episode approx. 5sec. Pt then confused for 10 sec. Then alert and oriented x 3. Drank a bottle of water and felt normal. Obseved pt for 15 min after episode. Pt able to ambulate without difficulty at discharge. Pt has had syncopal episode in the past while aunt was trying to put in pt's earing
Mom called the nurse line on 10/23/19.  Said that her son received a flu vaccine the day prior and now the arm felt warm to touch, was swollen w/a hard lump.  Nurse informed mom that the reaction can be normal.  Discussed  how long it could last, use of warm and cool compresses, messaging the area, and use of Tylenol.  Told to call back if concerned, or any new symptoms occur.    The next day 10/24/19 grandmother brought pt to office.  Rash described as red with bumps and swelling. and child had started Benadryl the evening prior. He had already had 3 doses.  Dr diagnosed pt w/Left Arm Swelling, due to reaction to flu vaccine.  Arm erythema, due to flu vaccine. Use Benadryl q 6-8 hours and observe closely.  Follow up in 24 hrs.  Pt was brought into the office on 10/25/19, by his father.  Dr charted that arm was much improved.  Follow up if any change or symptoms worsen.
came down with Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (came down with Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2022, the patient experienced COVID-19 (came down with Covid). At the time of the report, COVID-19 (came down with Covid) outcome was unknown.            Concomitant medications were not reported. Caller was scheduled to get the new booster on Thursday. No treatment information was provided by the reporter.   Reporter did not allow further contact