chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fine red rash all over body started 5-24-10 evening. Only face itched. Oral BENADRYL and cream. Monitor.
Day of vaccination only sore arm was noticeable. Awaken with abdominal cramps the following morning around 8:30am, suspected bowel movement with no immediate result, sudden nausea and vomiting just shy of 9am, sweating, chills, and cramping, followed by diarrhea. Once vomiting and diarrhea settled about 30 minutes later, itchiness began all around my body, no visible signs of hives or bumps, but started at the scalp, and slowly started feeling upper body itching, then arm, down to the leg.  Once symptoms of vomiting subsided, took a Pepcid AC 20mg and a Claritin 10mg, water, then returned to bed shortly before 10am. Awoken every few hours from sweating or chills, but by 3pm most discomfort had subsided.
On the 24th I started developing a tickle in my throat, no other symptoms that day. The same thing on the 25th, until about 2:30 that afternoon and that's when I developed a cough. No other symptoms until later that night, I started coughing up a lot of dark colored phlegm. On the 26th, I had a sore throat and still coughing up the phlegm, I got a COVID-19 test later that morning and it was negative. By that evening still a sore throat and nonproductive cough. The 27th I went to see the doctor, I got two shots, a steroid shot and an antibiotic shot as well as some prescriptions. The doctor said I have bronchitis, there is also a virus going around at work so I believe it may have something to do with that as well.
Vaccinator did not draw up COVID vaccine into the syringe and administered a sterile, empty needle to the patient's left deltoid. Vaccinator confirmed to the patient that the patient did not receive a dose. The patient understood the situation and consented to receiving her full dose.   The patient was given a full 0.3 mL Pfizer vaccine and witnessed by 2 medical providers and a data support individual to the left deltoid by the vaccinator. Patient was observed for 15 minutes without any adverse reactions or incidents.
Fever (100.5), chills, general body aches, fatigue, sore throat, mild nausea.  Noticed when I woke up next day after injection.  Fever lasted about 24 hours.  other symptoms have continued after fever.
Approx. 5-10 minutes after vaccine administration client became lightheaded and clammy; reported feeling better within 5 minutes of lying flat; no recurrence of adverse symptoms after resting supine x 15 minutes; vital signs remained stable; left clinic feeling well with no return of complaints.
Student reported to school nurse with hives on face and above left eye.  Mother arrived at school and gave student 25mg of Benadryl.  Mother reported that symptoms were already resolving by 2:50 PM, on their way to see the MD.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 19-OCT-2013 the patient was vaccinated with M-M-R II (dosing details not reported). On 29-NOV-2013, the second dose of M-M-R II was administered 43 days after onset of first dose. The patient experienced no adverse effect. No product quality complaint involved. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated with Gardasil vaccine (dose# unknown). The next day the patient experienced fever and chills, presented to the physician's office not feeling well. Patient outcome was unknown. Additional information has been requested.
This is a report from a contactable physician reported through a Pfizer sales representative. This physician reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient got really sick and started vomiting about 3 hours after vaccination. Vomiting was better within 24 hours. Outcome of the reported events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016542398 Same reporter/product, different patient;US-PFIZER INC-2016542418 Same reporter/product, different patient.
1/12 11:00 p.m. symptoms began (chills, fever, runny nose, sore throat) - treated with Tylenol, symptoms gone by morning 1/13 headache, fatigue, muscle/body aches lasting 1 day intermittent itchiness lasting 1 week from date of vaccination - treated with Benadryl
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 031M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergies to medications), Food allergy and Allergy (Other products).   On 16-Jan-2021 at 11:42 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021 at 10:03 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there was no adverse event noted.  Concomitant medication information was not reported  Treatment information was not reported
Patient was given a dose of Moderna and the patient is only 16 years old. Per follow up patient is doing fine.
Woke up with mild joint pain in shoulders, elbows, and knees. Treated with ibuprofen.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 02Jan2022 at 14:30 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (21May2022) negative, notes: I tested negative for covid 2 days after I finished my 5 days of Paxilovid; (26May2022) positive, notes: I tested positive five days after that. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
night sweat; chills; swelling at the right arm; tenderness at the right arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling at the right arm), TENDERNESS (tenderness at the right arm), NIGHT SWEATS (night sweat) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 17-May-2021, the patient experienced PERIPHERAL SWELLING (swelling at the right arm) and TENDERNESS (tenderness at the right arm). On 18-May-2021, the patient experienced NIGHT SWEATS (night sweat) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling at the right arm), TENDERNESS (tenderness at the right arm), NIGHT SWEATS (night sweat) and CHILLS (chills) had not resolved.            no concomitant medications and treatment details reported.
Extensive induration with swelling of right thigh, resolved slowly over 3-5 days. Completely resolved on follow-up exam 04/21/2000.  Recieved authorization to release information on 09/29/2000."
Moderate to severe pain in upper arm, moderate pain in neck and back. Unable to lift arm without pain. Unable to use left arm for even the lightest of tasks -- going to bathroom, holding a glass, picking up anything. Unable to do normal activities. Pain interrupting sleep.Pain is constant, does not abate. Had to take afternoon off from work. I've been moaning in pain (I have low pain threshold). Have taken 4 extra strength Tylenol in 8 hrs. Nausea. Took Tums. Will need to cancel planned activities next 2 days. Feverish feeling. General muscle/joint pain (as if I have the flu). This was my second Shingrix vaccine. The first time I had moderate arm pain for 2 days and felt like I had the flu (hit by a mack truck) for 3-4 days. This time, arm pain more severe and debilitating.
Dizzy, stomach cramping, Rt arm pain down from deltoid to elbow. Immediate warmth around injection site. Temp 99.2, BP 90/60
I was experiencing vomiting, dry heaving, couldn't keep any solid or liquids down. This lasted for about two in a half weeks.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient 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 11-Jan-2023, 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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 18th of 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
Patient received his booster shot too early on 11/24/21.  I administered in error a  booster dose of Moderna (0.25ml)  82 days after his 2nd Moderna vaccination. Pt's first dose of Moderna 0.5ml  was 8/3/21 lot 939902, second dose of Moderna 0.5ml was 9/3/21 lot 048f21a. There are no signs or symptoms or adverse events at this time as reported by patient.
1st dose on 2019, never received 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 29th April 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The pharmacy student reporting about a patient from this pharmacy students.  The patient never received a second Shingrix dose. The reporter was  unable to provide any more information about the patient to the agent. Unknown if the reporter granted consent, this was not asked.   Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Exactly 2 weeks from the date of the vaccine my Husband was diagnosed with a bad case of shingles. He has never had them before, since the vaccine he had swollen lymph nodes in the neck, under the chin, and head. His skin has felt itchy and burns a times. Three days ago his skin hurt to touch and last night on April 25 he started getting a rash under his arm. This morning it had spread across his back and chest. We went to the Doctor and he was diagnosed with shingles.
macular erythematous, blanching, non coalescent rash mostly impacting the upper body, extremities, thighs and genital area.  States it started right after receing the immunization 9/1/22.  Had the initial dose on 8/5/22 as a subcutaneous injection
Patient received both Shingrix (muscle of left arm) and Prevnar 20 (muscle of right arm) immunizations on 7/10/23. On 7/24/23, the patient's daughter called to inform us that he was fine for about 1.5 days (~36 hours) after the immunization without any symptoms. She mentioned that he started to develop fever, nausea, vomiting, and body aches on 7/11/23. He is still experiencing fever to this day and his fever would not break. She mentions that he has been to 4 different hospitals and they could not definitively determine what could be wrong. She stated that the first 3 hospitals did not have any answers and thought the fever would eventually pass, however it still has not. She states that the current hospital that patient is at is the only one who is doing extensive blood work and they are determining if it's sepsis.
I received the vaccine at 11:15 am and felt fine all day, began coming down with chills, fever, body aches and headache and slightly stuffy nose about 9-10 pm that night. It is still lasting throughout today, the next day and I called off of work. Currently have a fever of 99.6, highest fever was 100.6. F.
child received one dose of Infanrix when they should have received Boostrix; This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 provided as follows: The patient should have received Boostrix but received Infanrix at 11 years of age, which led to inappropriate age at vaccine administration. The patient did not experienced any adverse reaction to the Infanrix.
Had two days with a sore arm after the injection, then recovered. Then had swelling, soreness, and rash 8 days from the injection.
Initial unsolicited report received from a nurse on 10 March 2016. This case involves a 23-year-old male patient who was vaccinated with a intramuscular dose of Adacel (batch number L-U5298, expiration date, dose was not reported) in left deltoid and first intramuscular dose of Menactra (batch number U0216AA, expiration date, dose was not reported) in left deltoid, both on 9 March 2016 at 5 P.M. Illness at time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions was denied. Concomitant medications were denied. On 09 March 2016, at 6 P.M, one hour following the vaccination, the patient developed whole body burning sensation, body then goes cold, HA, nausea, skin sensitive. Patient had experienced fever +24 degree Celsius at age of 13. Lab data was reported none. The patient received corrective treatment with Tylenol. The patient was not recovered from events. List of documents held by sender: none.
The arm was sore for three days and then it resolved after three days. Swollen, red, itchy, hot to touch in the arm that I received the vaccine. I tested positive for Covid-19 after worsening symptoms four days after vaccination. I tested positive five days after vaccination. Seven days after vaccination the arm soreness symptoms returned. It was a little bigger area than the first time. It was red and hot to touch but no swelling this time. I still received the second dose on 02/12/2021 I had lingering fatigue from Covid-19. My arm became inflamed again but only lasted a couple of days.
I HAD STROKE LIKE SYMPTOMS. I WAS CONFUSED. COULDN'T COMPLETE SENTENCES OR RECALL WORDS. THE SYMPTOMS PERSIST.
Left arm was very red and swollen from the shoulder to the elbow.  The red was a cherry color.  Warm to the touch.  Client felt cold and had a slight temp.  She was very tired and sleepy.  Slept through the day and all that night.
Slight dizzyness, almost like being on a boat with the ground rocking back and forth. Very subtle.  Sometimes lightheadedness.  Started 30 hours post vaccine, symptoms were off and on for 72 hours.
1 week after the first shot was the first sign of hives. 10 days after the first shot they were happening daily. I was prescribed prednisone initially but stopped to get the second shot. After the second shot, it got so bad and I have been unable to live my normal life. It has been 3 months and so far I have had no luck with different medications to treat the chronic urticaria that has developed as a result of the vaccine. I have also developed angioedema, which has included throat swelling. I now have to carry an epipen as that could be life threatening.
Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Pt was asleep/unconcious in the chair while waiting for the 15 minute wait period.  Pt stated that she was unable to lift her arms or walk.  She stated that it was difficult to talk.  Pt stated that she was not having trouble breathing during this time.-Severe, Additional Details: Due to the patients symptoms, the pharmacy staff contacted EMS who arrived at the pharmacy to treat the patient.
Swollen face and throat. Benadryl decreased swelling in face with one day. Prednisone is currently being taken for swollen glands in throat.
Patient states, topical adverse reaction, redness, stinging on arm where medication leaked onto skin. Patient also reported itching at the wrist of left arm. No treatment was given other than wiping off the medication and cleaning the area. Patient states reaction was day of and morning next day, all symptoms have now resolved.
Pruritic rash with intermittent pustules starting 2 weeks after administration of second dose Moderna COVID19 vaccination and lasting several months.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # N014634 with expiration date 07-NOV-2018 and/or improperly stored doses of M-M-R II lot # M045394 with expiration date 14-NOV-2018, both for prophylaxis (dose and route were not reported for the suspect therapies). No adverse effects were reported. It was stated that the temperature was -14 to -10 degrees Celsius with a duration of 33 hours and 46 minutes. A previous temperature excursion was reported with a temperature of -14 to -10 degrees Celsius for 16 hours and 53 minutes. A digital data logger was involved. Follow-up information has been received from Medical Assistant on 06-JUN-2018. A call was placed to the reporter. A request was made for patient identifiers and vaccination dates for the two lots involved. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information on 08-JUN-2018, it was determined that this case is now valid because patient identifier was received. On 27-SEP-2017, the patient was vaccinated with improperly stored M-M-R II reconstituted with properly stored sterile diluent. This is one of the reports received from the same reporter.
PATIENT IS 17Y 10M TOLD MOM I ONLY HAD MODERNA, SHE UNDERSTOOD. I ADMINISTERED VACCINE AND WHEN I WAS FILLING OUT HIS CARD REALISED SHE WAS ONLY 16. I WENT OUT AND LET MOM KNOW HE WAS TOO YOUNG TO GET MODERNA. SHE NEEDED PFYZER. WOULD CALL HEALTH DEPT FOR ADVISE.  WAS TOLD TO REPORT ON VAERS AND SHE SHOULD GET MODERNA AS SECOND DOSE. NO REACTION TO COVID VACCINE ABOUT 20-30 MIN AFTER ADMINISTRATION.
In the late afternoon of April 23rd I started to experience the effects of Bell's Palsy.  Droopiness in my lip, eyelid not closing, difficulty in drinking and eating.  We went to our local minor emergency center around 4pm and confirmed it was an episode of Bell's Palsy.  The Dr prescribed Prednisone and Valtrex.  I took the first dose around 6pm. All week long I'd been experiencing a mild headache and had seen the dr the day before.  The diagnosis was muscle tension with arthritis in the neck and was assigned to physical therapy.
Information has been received regarding a case in litigation concerning a male who on 9/3/97 (lot 622794/0554E), 10/30/97 (lot 622794/0554E) and 3/31/98 (lot 625097/1313E) was vaccinated with hep B vaccine recombinant. It is alleged that as a result of the pt's exposure to thimerosal in hep b vaccine recombinant, the pt sustained neurological injuries and as a result of those injuries the pt had been diagnosed with autism spectrum disorder. Upon internal review, the pt's autism and neurological injuries were considered important medical events (OMIC). No further info is available.
Following the shot had a sore arm.  The next day I woke up feeling achy, chills just general flu-like symptoms and very tired.  No fever. A bit of diarrhea and felt nauseaus.