chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. On an unknown date ranging from 15-JAN-2016 to 03-MAR-2016 (previously reported as 02-JAN-2016 to 16-MAR-2016), the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, exact dose, route of administration and anatomical location were not reported). On an unknown date, the patient received also a dose of VARIVAX (Merck) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported), VAQTA (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). Concomitant therapies included influenza virus vaccine (unspecified). On an unknown date following these administrations, the patient experienced an unspecified adverse event and was sent to an unspecified emergency department for an unspecified cause. The administered doses of GARDASIL 9 experienced a temperature excursion of 48.2 to maximum 57 degrees Fahrenheit ranging from 02-JAN-2016 to 29-JAN-2016 (total time 276 hours cumulative). No previous excursions were reported. The outcome of the adverse event was unknown. The relatedness between the event and suspect therapies was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
dose received, compromised due to improper storage; This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, (batch number 7D73A)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Linked case(s) involving the same patient:  US2022055941   Additional Information: Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient received dose of Shingrix which had been compromised due to improper storage at her local pharmacy, which led to Incorrect storage of drug. The reporter asked did GlaxoSmithKline recommend that she repeat the second dose. The reporter consented to follow-up.
After about 3 - 4 hours mother brought pt to voluntary ER. He developed generalized urticaria, he was complaining of difficulty breathing. Patient hx of allergic reaction (pluria rash) to PCN and AMOX. No above meds at the time. Rx BENADRYL, prednisone p.o. PEPCID too.
Menactra vaccination given 11-2-05 (pm). Pt got sleepy, fatigued later that night. Right arm red, hot swollen - 6" in length 5" around arm. Hard and hurts really bad.  Tx: allergy tablets, Tylenol, ice, Topical allergy creams.
Injection was received Monday afternoon. Monday evening I noticed a red patch about 1" x 2" below the injection site. Tuesday morning I woke with a splitting headache, fever and achy all over. I woke up feeling fine on Wednesday but that evening when getting ready for bed I noticed a rash on my upper chest and neck and then a larger red patch under my right ear, about 1 1/2" square. I called the pharmacist who recommended hydrocortisone cream and benadryl. I had the rash and patch for about 2 days but this morning it is almost gone
Next morning, left eye started to twitch and has not stopped since- it is now 5 days later. Also have had severe gastrointestinal issues (diarrhea) since having the shot.
chest pain that I never felt before.  felt short of breath and it lingers almost daily for short periods when I am just sitting or driving the car.  I just got the second dose and am feeling chest pain in the heart 7 hours after receiving the shot.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of PEDVAXHIB (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 07-AUG-2017, the patient was vaccinated with the expired dose of M-M-R II (for prophylaxis, lot # L027432, expiration date 22-JUL-2017), that was reconstituted with  sterile diluent. No adverse effects were reported. Additional information has been requested.
Patient became "hot" and lightheaded approximately 2 minutes after vaccine. Patient laid down with feet elevated until paramedics arrived 13 minutes later. No loss of consciousness or ability to answer questions. Paramedics monitored patient as she began to feel better. Patient left pharmacy with husband after symptoms subsided.
Information has been received from a consumer concerning her seven year old son, who was vaccinated with varicella virus vaccine live. She reported that last year (unspecified date in 2004) her son broke out with shingles in his genital area. The mother stated it was the worst thing ever. The mother reported I am angry I was forced to give my children that vaccine. She mentioned I would be very curious to see any type of study done on young vaccinated children. Additional information has been requested.
blurry vision; She feels weak; She feels tired; She has been sleeping around the clock; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She has been sleeping around the clock), VISION BLURRED (blurry vision), ASTHENIA (She feels weak) and FATIGUE (She feels tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INSOMNIA (She has been sleeping around the clock), ASTHENIA (She feels weak) and FATIGUE (She feels tired). On an unknown date, the patient experienced VISION BLURRED (blurry vision). On 21-Feb-2021, INSOMNIA (She has been sleeping around the clock), ASTHENIA (She feels weak) and FATIGUE (She feels tired) had resolved. At the time of the report, VISION BLURRED (blurry vision) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   prescribed antibiotics for 7 days.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27-04-2021: one newevent added and treatment details added.
Full dose 0.5ml was given, instead of 0.25ml to the patient. Clinic monitored patient, no adverse effects reported or observed. Patient is fit for full-duty.
This case was reported by a consumer via call center representative and described the occurrence of drug allergy in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included BENADRYL for an unknown indication, ZYRTEC for an unknown indication, ALEVE for an unknown indication, ambiguous medication, CLARITIN for an unknown indication and EXCEDRIN MIGRAINE unknown for migraine. Previously experienced adverse reactions included back pain and multiple allergies. Concurrent medical conditions included migraine. Concomitant products included SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient started BENADRYL at an unknown dose and frequency, ZYRTEC at an unknown dose and frequency, ALEVE at an unknown dose and frequency, CLARITIN at an unknown dose and frequency and EXCEDRIN MIGRAINE at an unknown dose and frequency. In August 2018, less than a year after receiving SHINGRIX, EXCEDRIN MIGRAINE, the patient experienced drug allergy, allergy aggravated, burning sensation, vesicular rash, skin swelling and itchy skin. The patient was treated with Prednisone Cream. On an unknown date, the outcome of the drug allergy, allergy aggravated, burning sensation, vesicular rash, skin swelling and itchy skin were recovering/resolving. The reporter considered the drug allergy and allergy aggravated to be related to SHINGRIX. It was unknown if the reporter considered the burning sensation, vesicular rash, skin swelling and itchy skin to be related to SHINGRIX and EXCEDRIN MIGRAINE. It was unknown if the reporter considered the drug allergy and allergy aggravated to be related to EXCEDRIN MIGRAINE. Additional details were provided as follows: The age at vaccination was not reported. In August the patient started noticing that she was getting worse and having a bad reaction anytime that she took some over the counter medication. The patient had visited various physicians, dermatologists, allergists and all her symptoms have gotten worse when they have recommended taking one of the medications that she mentioned as being allergic to. The patient did not take anything orally. The patient clarified that the only event that was new after having SHINGRIX vaccines was that she was allergic to medications she had not been allergic to before.
Heavy fatigue with intermittent mild chest pain and intermittent mild headache continues since receiving vaccine
Thursday the 9th I had a slight headache which was abnormal for me. I had drank a lot of green tea and then took some ALEVE and it went away. I didn't think anything of it so I woke up Friday morning and had a really runny nose. I went through a box of tissue and thought it was due to my grandson that I had the weekend before. I was then at work and was using a lot of KLEENEX. On my drive home that day I was thinking I needed to test. I did test and I was positive for COVID-19. I reached out to my doctor that prescribed PAXLOVID and within 24 hours I was able to breath so much better. By yesterday I took another test and the result were very faint. I tested again today for COVID-19 and the results were negative.
Swelling right deltoid. 4cmx4cm. Area warm to touch. ROM of right arm intact. Right radial pulse 2+. Fingers warm and pink cap refill<2sec swelling occurred within 24 hours inst warm compress with Tylenol.
Received Moderna vaccines on 2/2/21, 3/2/21 tested positive for COVID by PCR on 3/17/22 Hospitalized on 3/17/22 d/t myalgias, dizziness, elevated glucose and lactate. No respiratory symptoms and CXR did not show pneumonia. Underlying DM2 w/ medication non-compliance, HTN, ETOH, polysubstance abuse,  homelessness
Nausea, vomiting, dizziness, not able to sleep, loss of appetite, weakness, abdominal pain.
After the vaccination, the patient developed nausea, vomiting, and diarrhea with myalgias. Then she felt better then restarted even worse. Had poor appetite then felt weak for another week. She ate poorly and was back to normal about 20 days after the vaccination.
Patient returned with itching skin, burning eyes and "scratchy" throat. She said she was allergic to Benadryl so I gave her a 10mg dose of loratadine and monitored her for an additional 20min.
a little bit of nausea; diarrhea; dry cough; fatigue; dizzy headache; This is a spontaneous report from a Pfizer sponsored program via Regulatory Authority support. A 49-year-old female patient received bnt162b2 (PFIZER-COVID-19 VACCINE, formulation: Solution for injection, Lot number EK5730), via an unspecified route of administration, administered in arm left on 29Dec2020 09:00 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ethinylestradiol, norethisterone (ORTHO 777) taken for contraception from Aug1989 and ongoing. On an unspecified date, the patient experienced a little bit of nausea, diarrhea and dry cough. On 29Dec2020 09:30, the patient experienced fatigue and dizzy headache. No treatment received for dizzy headache. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included magnesium: low magnesium, potassium: low potassium, chest x-ray: abnormal lung, CT scan: heat enlargement and electrocardiogram: abnormal. On an unspecified date in Apr2021, magnesium: low magnesium, potassium: low potassium and electrocardiogram: abnormal. The outcome of the events a little bit of nausea, diarrhea and dry cough was not recovered. On 29Dec2020, the patient recovered from fatigue and dizzy headache.   No follow-up attempts are needed. No further information is expected.
Expired dose given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 26th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st December 2022, unknown after receiving Infanrix and Infanrix 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 Information: GSK Receipt Date: 05-DEC-2022 Reporter's Comment: The reporter was a clinic manager. The reporter reported that on 01st December 2022  the patient received Infanrix vaccine which was already expired on 26th November 2022. The reporter did consent to follow up via email. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
That night after dinner, thumping started in chest, felt like she was having a heart attack. Advised to call Cardiologist, called Cardiologist and was told to rest and to see how she would feel the next morning. When she woke up the next morning and the pain was gone.
Size = 30 cm x 50 cm redness. Redness noted Sunday morning no c/o itching, swelling, redness, reding since then. No fever. No complaints except mild pain.
MODERNA COVID-19 VACCINE EUA  day of- extreme fatigue. neck muscle pain next day- nausea, body ache/ muscle ache, dizziness, headache, extreme fatigue, injection site tenderness, pain in neck muscle, pain in front shin muscle, cramps, sore throat / sore sinuses  2 days after- weakness, headache, skin rash on face,  rash on neck, sore sinuses/ sore throat,foggy cognitive acuity  3 days after- sporadic headache, pain neck muscle, injection site tenderness , cramps, foggy cognitive acuity , rash on face, rash on leg 4 days after- rash on face, rash on neck , rash on leg
Fever, body aches, rash. All symptoms resolved within 24 hours of when symptoms began.
pt seen 3APR95 w/c/o pink eye & limping-pt intermittantly limps, holds lt leg, then sits for max 3 mins; rest of time okay; exam of extremities nl; only prob conjunctivitis ongoing @ this time;
Pt recvd 1st dose of Engerix-B & 2nd 2 doses in deltoid; 14APR92 was determined to have a borderline (titer) result
Case number PHEH2014US024339, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with follow-up from a nurse received on 21 Jan 2015. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into right deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. No adverse event reported following this medication error (incorrect storage of drug). Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Intense foggy brain, inability to think and process cognitively, trouble breathing, tightness of throat, very low blood pressure (80s/50s to 90s/60s)
Got the shot and still got the shingles/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and still got the shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-Mar-2023 This case was reported by a patient via interactive digital media. The reporter's friend got the shot and she still got the shingles, so the reporter wished all good luck. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available.
Itching at site and then all over, wheezing, chest tightness, itching eyes
Approx 5 to 10 mins after immunization infant developed erythematous urticarial rash over both lower extremities and back as well as abdomen. Extremely sore soles of feet.
Initial unsolicited report received from other non healthcare professional via other company (Pfizer) on 16 November 2016. (Manufacturer report number: 2015409683) This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (dose, batch number, expiration date site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had hypothermia, swelling and allergy to vaccine. Lab data and corrective treatment were not reported. Outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event: hypothermia. List of documents held by sender: none. Sender's Comments: Hypothermia and swelling reported post TETANUS TOXOID. Patient had allergy to multi drugs and had history of multiple disease. Patient was on Breast Cancer Therapy. More details regarding allergic test to identify the culprit antigen and patient's history of reactions after previous vaccinations and TETANUS TOXOID vaccine manufacturer is needed to completely assess the case. Based on the information available, a role of the vaccine cannot be assessed.
Red rash in my arm; Itchy; Persistent arm soreness; Pink spot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash in my arm), PRURITUS (Itchy), PAIN IN EXTREMITY (Persistent arm soreness) and VACCINATION SITE ERYTHEMA (Pink spot at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Dyslipidemia.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Persistent arm soreness) and VACCINATION SITE ERYTHEMA (Pink spot at injection site). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash in my arm) and PRURITUS (Itchy). At the time of the report, RASH ERYTHEMATOUS (Red rash in my arm), PRURITUS (Itchy), PAIN IN EXTREMITY (Persistent arm soreness) and VACCINATION SITE ERYTHEMA (Pink spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were, blood pressure medication and cholesterol medication. No treatment medication information was reported.   This case was linked to MOD-2021-097630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Updated events of 1st dose (vaccination site erythema, pain in extremity).
Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN6201) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; CALCIUM; BIOTIN; VITAMIN D3; LUTEIN. The following information was reported: VERTIGO (non-serious) with onset 19Feb2021, outcome "not recovered", described as "Vertigo". The event "vertigo" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo.  Additional information: Facility where the most recent COVID-19 vaccine was administered:Pharmacy or Drug Store. Patient other vaccine  4weeks details: [other vaccine 4weeks product=Pfizer-Bio, other vaccine 4weeks vaccine date=10Mar2021, other vaccine 4weeks lot number=EN6202, other vaccine 4weeks dose number=2, other vaccine 4weeks vaccine location=left arm.AE treatment:: Medicine (Meclizine) and physical therapy. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination the patient was not tested for Covid-19.Patient had no allergies.   No follow-up attempts are possible. No further information is expected.