chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He is a school employee receiving the Hepatitis B serie. Dose #1 was given on 3/26/04 then second dose was given on 4/30/04. Around 9:30 am on 4/30/04 before administering the second dose I had asked him if he had any reaction to first dose. He said he had no problems. So then the second dose was administered. Then on 5/3/04 around 9:00 am Monday morning school nurse called to visit with me about him. He was complaining of fast heart beat a day after having the injection. I advised nurse to tell him to see Primary Physician for check up. On 5/23/04 I had a follow-up visit with him. He stated having a wellness check 2 weeks and an EKG was done and showed normal. Heart palpitations was discussed at that time. Physician stated heart palpitations was related to high caffeine intake- Instructed patient that dose #3 would not be given unless I had written permission from Primary Physician pt has no histroy of heart problems or blood pressure problems. Pt also states that since changes in diet he has not had any more problems.
Pt called and reported feeling achy all over and had a fever of 102. Denied breathing problems, chest tightness, or rash. Denied pain at injection site.
Mom reported patient slept for 5 hours following the vaccine appointment and then started crying and would not stop despite comforting. Mom was concerned and brought patient into our office about 5.30pm. Upon exam patient was extremely fussy, would not stop crying and screaming. Pt did calm down after administering 3.5ml of acetaminophen.
The patient was inadvertently administered and expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 06-FEB-2020, the patient was inadvertently vaccinated with an expired dose (expired product administered) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter (ml) for prophylaxis (strength, frequency, route of administration, and anatomical location were not reported) (lot number R009163 had been verified to be a valid number; expiration date 06-JAN-2020).
cluster head aches; viscious head aches/Headaches after each dose; fatigue/ extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Stent placement. Concomitant products included LISINOPRIL, METOPROLOL and CLOPIDOGREL for an unknown indication.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired). At the time of the report, CLUSTER HEADACHE (cluster head aches), HEADACHE (viscious head aches/Headaches after each dose) and FATIGUE (fatigue/ extremely tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had reported that he can only be mobile for 5 to 6 hours at a time.  No treatment medication was reported   This case was linked to MOD-2021-316382 (Patient Link).
A few hours following vaccination, my left deltoid around the vaccine site was mildly painful. Generalized pain in the left arm became gradually more painful over the next 24 hours leading to severe pain on any movement, especially with lateral arm movements and when laying on the affected side. The severe pain ended after about 72 hours and changed to a more nerve-like sharp pain on lateral lifting and is gradually dissipating. I have noticed this pain following annual flu vaccines is increasing slightly each year.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021 at 9:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient age was reported as 70.06. No concomitant product use was reported. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vial was stored in cooler 1, on 31-Mar-2021, Excursion duration at 8 am 32, at 9 am 32, at 10 am 40, at 11 am 42, at 12 pm 43, at 1 pm 44, at 2 pm 46, at 3 pm 46 and at 4 pm 44 and 5 pm 44 taken using a Fisher brand traceable temperature monitor in F. On 31-Mar-2021, Excursion time- 9 am, temp- 32, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-MAR-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were moved to clinic. Vaccine BUD date was 29-APR-2021 for batch number 030B21A. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic. No treatment information was provided. This case was linked to MOD-2022-566976 (Patient Link).
This case was reported by a pharmacist and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX quadrivalent (unknown route and injection site). On second day after vaccination with FLUARIX quadrivalent, the subject experienced swelling and warmth and injection site. The subject also experienced 3-4 hives at the injection site. Antibiotics were prescribed. At the time of reporting the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX quadrivalent.
Case previously recorded as MA2009-3759. Initial case report received from a registered nurse on 10 NOV 2009. A 54-year-old female patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 101716P1A) i.m. in left deltoid on 26 OCT 2009. She had a complaint of progressive soreness of the upper left arm; pain progressed to neck and shoulder with weakness of arm. No numbness, no tingling of left upper extremity was observed. The patient does not have pain at site of vaccination. Follow up information received on 12 NOV 2009: No significant information received. Follow up report received on 26 Apr 2010: There was an attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost to follow up.
Pt complained of a headache after injection, she was messaging her doctor then she asked for Benadryl. I have her 5 ml Benadryl.
After administering the vaccine, pt had said she felt funny...and then she fainted for few seconds.  She was flushed and after few seconds she was conscious and said she feels fine.  911 had already been called. We had offered some water for patient and asked if she would want to continue sitting down for some time. She did agree to sit down for some time.  Paramedics had come quickly and checked the patient out.  She was asked if she would be willing to come to hospital but she declined after saying she feels fine.  The pharmacy tech and I asked her if she was indeed feeling okay and was able to drive. To that she replied she feels allright to drive.
COMPLAINTS OF PRURITIS AROUND SHOULDERS AND CHEST. NO SIGN OF RASH OR HIVES.
On Wednesday night I started seeing flashes on the right side of my right eye.  When I turn my head to see to my right side is when this happens.
Pt inadvertently given MMR 3 instead of Varivax 2, no physical signs symptoms.
This initial spontaneous case, was received from other health professional on 13-Oct-2017, concerns a patient of unspecified gender and age. On an unspecified date, the patient was administered with AFLURIA (dose: 2 ml, route of administration, anatomical location, batch no: 15149221A and expiry date: 30-Jun-2018) (explicitly coded as overdose). It was reported that, no events were noted after the overdose of the vaccine (reported as none at all). The reporter assessed the events as non-serious. Follow-up received on 03-Nov-2017: The product details were updated (batch number: 15149221A and expiry date: 30-Jun-2018). It was reported that, no events were noted after the overdose of the vaccine (reported as none at all). Narrative amended accordingly.
Patient came into the practice today for a routine follow up visit. Dr. was under the impression it was to her digression to administer the Booster Pfizer\BioNTech. Pt was administered the  COVID 19 Pfizer\BioNTech as directed by the clinician. No physical adverse reaction to the patient from the vaccine, Vaccine booster time line changed and not followed.
This spontaneous case reported by a consumer, describes the occurrence of adverse reaction (side effect) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 22, 2021, patient experienced adverse reaction (side effect). At the time of the report, adverse reaction (side effect) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant and treatment medication provided.
Patient received his first dose against the Covid virus on 04/14/2021. It wasn't until after the administration of his second dose, when I wanted to do the documentation on his vaccination card, that I noticed that. We gave him the other company. We kept him in our office longer than usual to make certain that he wouldn't have any adverse reactions to the interchanged vaccine. Patient left the clinic feeling well. I also followed up with the patient via phone today, May 11, 2021 at 10:16 am, I was able to speak to the patient directly, and he reassured me that he is well. I still reminded him to contact us if anything changes, and go the the nearest emergency room if anything severe arises.
I was infected with the COVID-19 virus in mid-July 2020, symptoms experience included loss of oratory function, severe body aches, headache, and severe fatigue and lasted between 3 and 14 days. In December 2020 COVID-19 test results showed zero anti-bodies  My Covid-19 vaccination was administered on 4/25/21 and 5/25/21. On 5/24/21 my antigen levels were reported at >20. I was tested for dates for my two Moderna shots are listed above.   Since the second of two shots I have simply not felt right. Cannot place my finger on it, but, my body doesn't feel familiar.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; CHILLS; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced suspected immunological vaccine failure. On 2021, the subject experienced chills. On 2021, the subject experienced severe headaches. On APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) positive for antibodies. On 29-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) negative for antibodies. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The outcome of the severe headaches, chills and suspected immunological vaccine failure was not reported. This report was non-serious.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional information received were as follows: Around the end of May 2019, the patient received Shingrix on left deltoid. The patient experienced headache for 2 days and then it completely resolved. The reporter consented to follow up. For tolerance to 2nd dose, refer linked case US2019178962.
Time when reaction appeared after injection: 24 hours: body and joint aches, 36 hours: sore injection site, rash across front and back trunk and on arm below injection site, hot swollen arm where rash appeared, 48 hours: rash has lessened but still on trunk, left arm and underarm is swollen and tender to touch, arm rash is still prominent. Took extra strength Tylenol for aches and pain for first 2 days.
Red raised streak around injection area on R arm - pneu shot. Got larger as day went on - like hives - 3 days later started to itch. Size larger than a golf ball. Day #4 - went away. Local reaction only.
Hep B vaccine given accidently TDAP vaccine needed to be given Per mom patient is having no side effects to injection site where Hep B was given.
Sever Headache, Nausea, Vomiting  Felt like a black out hangover lasting until 10/17/2020 at which time there is still some mild nausea and headache.  I didn't not have this reaction in 2010 and with this type of reaction I am very unlikely to ever recieve/accept/consent to another vaccine.
Once the patient was vaccinated in his left arm, I was speaking to the patient in the health room for an additional 3 minutes. I was explaining to him what V-safe is, and suddenly he stated he felt dizzy and hot. He removed his mask and repeated again that he's dizzy. I stayed with him and about 20 seconds later he said he was going to faint. I noticed his eyes roll back into his head and he had very heavy, labored breath sounds. I called out for the other pharmacist for an epipen and for a team member to call 911. Approximately 15 seconds later, the patient was alert, and said he was fine, he was only a bit dizzy. Within 1 minute, the patient vomited. We kept him in the patient health room and he stayed alert until paramedics came by. He went on a stretcher, where they checked his blood pressure, heart rate and mental alertness. He walked back to the pharmacy within 10 minutes to let us know he was doing okay. He no longer felt dizzy. His wife drove him home and was instructed to take him to urgent care or ER if he shows any signs of anaphylaxis. We also advised the patient to keep Benadryl near by.
Patient did not know she was pregnant when she received her second MMR. She miscarried at 7.5 weeks.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hepatitis A vaccine (batch number 3397T) for prophylaxis.   On 27-FEB-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Got my booster shot like I did the other 2 times and everything seemed fine. I had minor chills and some body aches, but nothing too terrible. Fast forward 2 to 3 weeks later and my whole body started to itch. I could not get comfortable, so I took Benadryl not knowing what was going on and hoping it would just pass. after about a week of this itching rash I decided to make a doctors appointment where my dermatologist diagnosed me with dermatographia. I was so confused on how a 40 year old man would develop this condition out of nowhere, so I decided to google it. It seems that there are a ton of others like me who have developed this Dermatographia after their COVID vaccine. This is absolutely miserable to live with. I am on Zyrtec twice a day right now and I do not want to have to take this the rest of my life. I still have random breakouts like last night at the movie theatre the back of my head began to itch and before you know it I had a terrible welted rash all over the back of my head. When it itches it is just unbearable. The slightest bump, rub or scratch leaves behind bright red welts.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4294724-00 (RA). A 73 year-old female patient received BNT162B2, intramuscular, administration date 26Jan2022 (Batch/Lot number: unknown, Expiry date: Unknown) at the age of 73 years as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown, Expiry date: Unknown) at CF for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single, Route of Administration: Intra-muscular, Therapy Dates/Duration: 29Jun2021-29Jun2021), administration date: 29Jun2021, when the patient was 73 years old, for Covid-19 immunization; BNT162B2 (Dose 1, Single, Route of Administration: Intra-muscular, Therapy Dates/Duration: 08Jun2021 08Jun2021), administration date: 08Jun2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 04Feb2022, outcome "unknown", described as "Rheumatoid arthritis flare up"; VERTIGO (non-serious) with onset 2022, outcome "not recovered", described as "Vertigo"; CHILLS (non-serious) with onset 2022, outcome "recovered" (2022), described as "Chills"; VOMITING (non-serious) with onset Feb2022, outcome "recovering", described as "Vomiting"; DIZZINESS (non-serious) with onset Feb2022, outcome "recovering", described as "Dizziness"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2022, outcome "not recovered", described as "Pain legs". The action taken for adalimumab was unknown. The reporter considered "rheumatoid arthritis flare up", "vertigo", "chills", "vomiting" and "dizziness" related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the current available information, a possible contributory role of the suspect product bnt162b2 to the development of reported events rheumatoid arthritis, vertigo, chills, vomiting, dizziness and pain in extremity cannot be excluded. 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.
very  sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (very  sick) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very  sick). At the time of the report, ILLNESS (very  sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. Treatment to the events not reported.
Pain in the arm and redness. Patient complains, she can barely move her arm. Recommended TYLENOL and compresses. I will call patient in day or two to check on her. Looked like normal reaction on the shot.
little red circle in left arm; itchy circle in left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (little red circle in left arm) and PRURITUS (itchy circle in left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No allergies to medications, food and other products. No history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, DULOXETINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ERYTHEMA (little red circle in left arm) and PRURITUS (itchy circle in left arm). On 11-Feb-2021, ERYTHEMA (little red circle in left arm) and PRURITUS (itchy circle in left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not seek to medical care. The patient did not experience a similar event in the past. Patient do not have any allergies.Patient had no acute illness at the time of vaccination. No treatment information was provided by the reporter.   This case was linked to MOD-2022-559308 (Patient Link).
Extremely dry mouth, tongue swelled up. Close to anaphylactic stage.  Started about 15min after vaccine administered. Continued for 1 hour. Took Anti Histamine . Persisted for 1 hr plus