chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a patient's mother concerning her daughter of age 10 years. No concomitant medication or relevant medical history has been reported. The patient received Nasal FLUMIST on 22-Oct-2012 at school. On 22-Oct-2012, the patient had a peppered rash on face and in the morning 23-Oct-2012, the face was swollen and eyes were swollen. Mother has not taken daughter to doctor. She has been giving BENADRYL at home and applied a ice pack to face, which has helped. At the time of reporting, the event of face is swollen, eyes are swollen and rash on face was ongoing. The reporter considered the event of rash on face to be non serious. The company physician considered the events of face was swollen and eyes were swollen to be non serious.
administered expired vaccine with no reported adverse event; Initial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional via Media Information (under the reference 00773128).  This case involved a 59 years old female patient who had administered expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  The patient had no concomitant vaccine.  On 16-SEP-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5ml, total, lot UJ477AB and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported, "they administered expired FLUZONE QUADRIVALENT to a patient; asks if they need to revaccinate following administration of expired product".  At time of reporting, the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Tingling of lips, red spot near injection site, itching. Liquid Benadryl administered with improvement of symptoms.
Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my throat felt odd and was accompanied by a hoarse voice.  I was driving home at that point and considered turning back for medical advice (should have but did not).  Over the next few hours itching sensation on my tongue, face including eyes, head and back.  Developed just one hive on my eyebrow approx 3 hours after vaccination, and one on my thigh at least six hours after vaccination.  The symptoms were not severe but obviously I monitored them.  Now 24 hours after the vaccination and still have some itching as described above.  Throat is somewhat better.  Eyes feel odd more than itchy at this point.
Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number El266) via an unspecified route of administration in the left arm on 05Mar2021 at 09:00 (at the age of 71-year-old) at single dose for COVID-19 immunisation. Relevant medical history included atrial fibrillation, asthma, chronic obstructive pulmonary disease, high cholesterol, acid reflux disease, depression and anxiety.  Concomitant medications included clonazepam, apixaban (ELIQUIS), fluoxetine, metoprolol and simvastatin. On 07Mar2021 at 14:00, the patient experienced Afib episode, rapid heart beat, pain in jaw, diarrhea, headache, nausea and dizziness; the events Afib episode and rapid heart beat were considered serious as life-threatening. The patient received corrective treatment for the reported events, which included 2 tablets of metoprolol. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Swelling and warmth to right thigh. No fever or erythema on 4/7/01. Resolved with warm compresses. Had fever of 104F and vomiting; onset 4/8/01 X 24 hours.
Starting on the 1/08/21 experiencing vertigo when laying down or lifting my head. It began to get more frequent about 6-7 days a week. That lasted for about 6 months. I visited the doctor on 1/8. The frequency of the episodes has drastically reduced.
2 DAYS AFTER SHOT RED, RAISED, WHEAL AND FLAIR AROUND INJECTION SITE. ABOUT 4 CM.
This is a spontaneous report from a contactable consumer received via a Pfizer sales representative.  A 45-year-old male patient of an unspecified ethnicity received PREVNAR (lot number unspecified), via an unspecified route of administration on an unspecified date as single dose for immunization.  Medical history included asthma from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  On an unspecified date, patient reported that he had a pretty bad reaction after vaccination that she reported as sore arms, fever and chills. The outcome of sore arms, fever and  chills was unknown.
Patient fainted shortly after 2nd pfizer dose and was unresponsive for a period of about 10-15 minutes, 911 was called, cold compress applied to back of neck, patient laid onto ground, BP was monitoring by vaccine administering nurse and reported as 98/58 and 98/52 for the 2 readings. EMTs arrived about 15mins later, by which time patient had just become responsive and was sitting upright, EMT performed their own evaluation/assessment of patient and was cleared by them, she sat in pharmacy waiting room for additional 15 minutes prior to leaving pharmacy.
Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 27th May 2022, the patient received Havrix. On 27th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: A medical assistant reported that a patient received an expired dose of Havrix. No symptoms reported. The reporter consented to follow up via email. Additional Supportive Information: The patient received havrix which was already expired, which led to expired vaccine used.
On 3/11, he woke up with a blotchy, itchy red rash.  He was evaluated on 3/11 in a local walk in clinic for swelling of hands and feet and worsening rash.  Rash was consistent with erythema multiforme. No fevers or other new symptoms.   Parents have been giving him antihistamines which seems to help with itchiness.   I was in contact with pt.'s parents on 3/12 who reported continued swelling of hands and feet but continued ability to ambulate (best when given a dose of ibuprofen).  No other new symptoms.  No fevers.   On 3/13, Pt. woke up with swelling of face/eyelids and continued swelling of hands and feet. His facial swelling has improved throughout the morning.  Pt. is still uncomfortable from swelling in hands and feet. His rash is fading and he is having dusky discoloration of skin where lesions have resolved.   No fevers at all- parents have been closely monitoring him for fevers. No eye redness No other joint swelling or pain. No signs of pain with swallowing or oral mucosal changes (eating and drinking well). No signs of abd pain, vomiting or diarrhea.    Over the phone, we discussed how the most likely cause of pt.'s symptoms is Serum Sickness Like Syndrome.  With pt.'s history of covid infection in the beginning of January, MIS-C is a possibility, but because pt. has not had any fevers, I think MIS-C is less likely.
She is suffering says, about to die. She is having terrible migraine everyday. She cant get out of bed.; A reaction to the vaccine that seems, neurological and possibly, they kind of like, seems sort of a inflammatory, dizziness.; She is very nauseous.; A reaction to the vaccine that seems, neurological and possibly, they kind of like, seems sort of a inflammatory, dizziness.; She is suffering says, about to die. She is having terrible migraine everyday. She cant get out of bed.; This is a spontaneous report from a contactable consumer (husband). A 27-years-old female patient received bnt162b2 (Pfizer product), via an unspecified route of administration on 11Jun2021 (Batch/Lot Number: ER8736) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Events were reported as: A reaction to the vaccine that seems, neurological and possibly, they kind of like, seems sort of a inflammatory, dizziness; she was very nauseous; She was suffering says, about to die. She is having terrible migraine every day. She can't get out of bed; it's terrible what happening in Jun2021. They had been seeing the physician and trying to help her. The event outcome was unknown.
Patient developed petechiae to bilateral lower extremities two weeks after first dose of Moderna Covid-19 vaccine
Administered Novartis H1N1 (4 yrs and older) vaccine 0.25 mL IM Right deltoid. Should have given Sanofi Pasteur H1N1 (6 months and older) 0.25 mL IM. No signs or symptoms distress noted.
given a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 reporter stated that, the patient had been given already expired dose of Kinrix, which led to expired vaccine used. The reporter consented to follow up via email.
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate.
Felt swelling in throat on L side in gland and below gland about 5 minutes after vaccine.  Refused epi-pen, refused need to be treated in ED.  Took po benadryl and remained in observation for an additional 30 minutes.
Patient with sudden onset sever upper abdominal pain.  CT was done that demonstrated free air.  Repeat CT with oral contrast did not show extravasation of contrast outside the lumen of the bowel.  It was felt that he had a perforated viscus, likely a perforated ulcer given his NSAID use history.  He was admitted to the hospital for conservative management with bowel rest, IV hydration, IV antibiotics for perforation as well as IV Protonix gtt.  Follow up abdominal xray the following day was negative for free air.  H pylori was negative via stool check.  His pain improved and he was started on a diet. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Itching, rash and swelling at the site on right arm - 2 inches by 5 inches in size. The above reaction resolved on Sunday, Jan 10 at 11:00am.  ENLARGED LYMPH NODE on the right side of my neck which protrudes enough to see without having to palpate.
Pt experienced hair loss, joint pains, cramps in muscles on head, sharp pains daily (recurring) in both arms around area of injection.
VARIVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant referring to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 20-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T035400 with an expiration date on 16-OCT-2022) after undergoing a temperature excursión of +0.4°C Celsius degrees for 13 hours and 10 minutes recorded by a data logger. The suspect vaccine was indicated for prophylaxis (product storage error).       No previous temperature excursions were reported.
At 1005 went to the ER with heart palpitations, felt lightheaded like she was going to faint, foggy head/mind, sweaty palms, body felt hot all over  - ears were  real red. Body felt real heavy and slow to walk - like she was drunk. In the ER she was treated for an adverse allergic rxn to vaccine and was given IV steroids and antihistamine by mouth; EKG was done, B/P was 180/68 and pulse was 130. She was told to follow up with doctor.
This case was reported by a physician and described the occurrence of rotator cuff tear in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of musculoskeletal pain (1st dose received in May 2018, refer case US2018195870). In November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rotator cuff tear, flu symptoms and shoulder pain. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the rotator cuff tear was unknown and the outcome of the flu symptoms and shoulder pain were recovered/resolved. It was unknown if the reporter considered the rotator cuff tear, flu symptoms and shoulder pain to be related to SHINGRIX. Additional information received as follows: This case was reported by the patient's husband. The batch number was not known. The patient experienced flu symptoms and pain in shoulder for 1 to 2 days. It was much less to correlate rotator cuff symptoms with 2nd dose of SHINGRIX than 1st dose of SHINGRIX. Lab Comments: In 2018, the patient underwent lab test Nuclear magnetic resonance imaging.
Vaccine administered 12/16/14-as of today, 12/181/14, area is very tender, with large area of involvement which is red and inflamed.
03/22/2021 - 12:43PM:  A 30mcg/0.3mL dose* of COVID-19 Pfizer BionTECH vaccine was drawn up into a 1mL syringe with a 23G 1? needle and prepared for administration in the left deltoid.  This was the patient?s second dose of a 2 dose series.           [*vaccine lot EN6207] After insertion of the needle into the left deltoid, the nurse was beginning to depress the plunger into the barrel of a needle-syringe combination, (to administer a 0.3mL dose of COVID-19 Pfizer BionTECH vaccine) when the needle and hub broke from the tip of the syringe.  The needle hub effectively spooned the vaccine to splash in the reverse direction from that of the needle. The vaccine went into the nurses left eye and surrounding facial area(s).  The needle and hub remained in the patient?s arm, but it was removed immediately with no adverse effect, bleeding, or leaking of the vaccine suspension. The nurse apologized to the patient who was to receive the vaccine.  She told him that no vaccine was injected.  She said she would immediately prepare another 0.3mL dose of COVID-19 Pfizer BionTECH vaccine and **repeat the administration.    The man gave no vocal expression of refusal or display of guarding.  Following the completed IM injection of a 0.3mL dose of COVID-19 Pfizer BionTECH vaccine, the patient was reported to express his wish that she make ?a note of what happened.?  He was escorted to a post-immunization monitoring area for the recommended 15 minutes of observation.  During this time he did not report any adverse effects, or other abnormal outcomes possibly associated with the vaccine administration.
red mark like a bruise on the vaccination site; vaccination site warm to the touch; vaccination site is still red; vaccination site puffy; Body ache; chills; fever; burning; stinging; pain at vaccination site during the injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch) and VACCINATION SITE ERYTHEMA (vaccination site is still red) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE PAIN (pain at vaccination site during the injection) and PYREXIA (fever). On 23-Jun-2021, the patient experienced VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch), VACCINATION SITE ERYTHEMA (vaccination site is still red), VACCINATION SITE SWELLING (vaccination site puffy), MYALGIA (Body ache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, BURNING SENSATION (burning), PAIN (stinging), VACCINATION SITE BRUISING (red mark like a bruise on the vaccination site), VACCINATION SITE WARMTH (vaccination site warm to the touch), VACCINATION SITE ERYTHEMA (vaccination site is still red), VACCINATION SITE SWELLING (vaccination site puffy), MYALGIA (Body ache), VACCINATION SITE PAIN (pain at vaccination site during the injection), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-234551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Outcome of event updated from unknown to recovered/resolved.
pt recv vax 5FEB96 & 26SEP97 pt started devel an outbreak of chickenpox scattered over body & then devel zoster on rt side;29SEP97 pt seen by MD who stated that rash was scattered;
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot# L024993, 14-OCT-2017. No adverse effects were reported. Data logger was yes, vaccines went to 35F for 30 hours. Vaccines were back in range. This is one of the two reports received from the same reporter. Additional information has been requested.
I woke up the next morning at 6am and my entire body hurt.  The pain increased throughout the day to the point that it hurt to move.  The pains started to subside around 3pm.  When I woke up the 2nd day after the test I was back to normal.  I will point out that my sleep, eating, and meds had been off schedule as I was working nights the week before and had just gone back to days.  I went to bed at 3:30pm on 1/7/21 and slept until 6am on 1/8/21.  So those may have been contributing factors.
pt recv vax 5JUL96 & 9DEC96 pt devel 15 generalized chickenpox lesions;
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Minutes after providing the Moderna Vaccine the patient had syncope and had seizure for less than a 1 min and was resonsive after. I was there and help the patient while my team called 911. The patient had muscle spasm from seizure in his neck and back. He was pale, his BP 110/70 and pulse was 110.  His wife was there and she wanted him to go to the emergency room however the patient refused when the team arrived. they checked on him and then decided to go home.
Narrative: Pt reported continued rash 9/2/21; saw derm who stated rash likely to this job- concrete worker
Soreness and ache in upper arm muscle and joints. Pain increases when I try to move my arm up and outward. Onset was within a day or two of when I received the vaccine.
Red, blistering spots consistent with chicken pox. Email sent to her physician, nurse called stating most likely chicken pox.