chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had dose 1 0n 01 Sep 2021 and dose 2 on 20 Sep 2021; COVID-19; COVID-19 aggravated / COVID-19 worse; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 0n 01 Sep 2021 and dose 2 on 20 Sep 2021), COVID-19 (COVID-19) and COVID-19 (COVID-19 aggravated / COVID-19 worse) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 0n 01 Sep 2021 and dose 2 on 20 Sep 2021), COVID-19 (COVID-19) and COVID-19 (COVID-19 aggravated / COVID-19 worse). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 0n 01 Sep 2021 and dose 2 on 20 Sep 2021) outcome was unknown, COVID-19 (COVID-19) was resolving and COVID-19 (COVID-19 aggravated / COVID-19 worse) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Rash appearing suddenly in large ring around injection site 14 days after injection.  Raised edges, warm to touch but not itchy. Very slightly tender.
headache; nausea; suffer with migraines; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea) and MIGRAINE (suffer with migraines) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 278A21A.) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included NARATRIPTAN HYDROCHLORIDE (NARATRIPTAN ACTAVIS) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), NAUSEA (nausea) and MIGRAINE (suffer with migraines). At the time of the report, HEADACHE (headache), NAUSEA (nausea) and MIGRAINE (suffer with migraines) outcome was unknown. Not Provided
One patient received one dose of MMRII and VARIVAX that were reconstituded with expired DILUENT; One patient received one dose of MMRII and VARIVAX that were reconstituded with expired DILUENT; No adverse effects reported; This spontaneous report was received from  an office manager, concerning to a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.  On 28-JUN-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (M-M-R II) (Lot. No. R030810 has been verified to be a valid lot number for measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live rHA, expiration date on 24-OCT-2020) and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot. No. N021582 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 28-AUG-2019, but upon internal validation establish as 09-AUG-2019) (inappropriate schedule of product administration) that were reconstituted with expired sterile diluent (Lot. No N026990 has been validated to be a valid lot number for sterile diluent, expiration date on 26-SEP-2018) (expired product administered), it was reported that all products were stored properly with no temperature excursions. No adverse effects reported, nor product quality complain involved.; Sender's Comments:  US-009507513-1907USA011428:
Mother called - c/o vomiting & increased fever since early am today (11-6-07).
Developed redness, warmth, swelling to right upper arm, low grade fever 99 degrees F. Pain to area of injection approx. 24 hours post injection. Administered on 9/10/18 by RN.
On 9/18/12 patient came into pharmacy at 7pm and received a ZOSTAVAX vaccine in the left deltoid and a flu vaccine in the right deltoid. On 9/21/12 nurse called in an antibiotic for redness at the site where ZOSTAVAX vaccine was administered.
Swelling at injection site, reddened skin, slight itchiness and heat radiating from swelling.
I had a seizure and I have never had a seizure in all my life; It was like my lungs are about to collapse and especially my left lung; Difficulty in breathing; Dizziness; Have been bothered with my hand; Have been terrible ever since I had my shot; My first symptom was like in my head, it was like sinus pressure; My first symptom was like in my head, it was like sinus pressure; This is a spontaneous report from a contactable consumer. A 65-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, had been having difficulty in breathing, dizziness, bothered with hand and have been terrible ever since had the shot, had never felt like this before. These symptoms started like about two weeks after taking the first one and first symptom was like in my head, it was like sinus pressure and everything but now, it has gone. And it just kept going on for about two weeks. Then on March the 11th, the patient went to doctor and told him about how the feeling was, and they gave a shot, a steroid shot (Unspecified Medication) as he was having difficulty breathing, like lungs are about to collapse and especially left lung and then, was okay for a day or so and two days after. The patient had a seizure and never had a seizure in all life of 65 years. The patient had to go to the hospital. The patient does not feel well. The outcome of events was unknown.  Information on the lot/batch number has been requested.
administered with the vaccine from a vial punctured for more than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Within hrs of receiving vax felt nautious, dizzy, fatigued, had headache, sore throat, dry itchy eyes, felt dehydrated.
Developed severe H.A., sore neck 8PM 10-22-10. 8 AM 10-23-10 left eye lid began twitching 10:30 AM 10-23-10 left side of face, lower lip began twitching.
This spontaneous report as received from a physician refers to an unknown number of patients of unknown age and gender. On an unknown date the patients might have been vaccinated with a dose of PNEUMOVAX23 (lot number, dose and route not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same source (related MARRS # 1310USA000403). Additional information has been requested.
Immediately after getting the shot the injection site developed a non-painful welt the size of a quarter. No redness or discomfort. Patient remained calm and mentioned she has bruises easily with injections. The welt was iced and appeared to receed upon later inspection about an hour later.
Symptom onset was 08-23-2021. Symptoms included cough, shortness of breath, sore throat, vomiting, headache, fatigue and myalgia. The case tested positive on 08/24/2021 at Medical Center. He was hospitalized from 08/24/2021 through 08/28/2021.
Developed urticaria over axilla and around eyes; watery eyes; sore throat; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 9 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2022 17:30 (Lot number: FL00007) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (1st dose, Batch/Lot No: FL00007, route of administration: intramuscular), administration date: 16Dec2021, when the patient was 9 years old, for COVID-19 immunization. The following information was reported: URTICARIA with onset 13Jan2022 22:30, outcome "unknown", described as "Developed urticaria over axilla and around eyes"; LACRIMATION INCREASED with onset 13Jan2022 22:30, outcome "unknown", described as "watery eyes"; OROPHARYNGEAL PAIN with onset 13Jan2022 22:30, outcome "unknown", described as "sore throat". The events "developed urticaria over axilla and around eyes", "watery eyes" and "sore throat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of urticaria, lacrimation increased, oropharyngeal pain (BENADRYL). Additional information: no known allergies.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Urticaria, Lacrimation increased and Oropharyngeal pain due to temporal relationship.   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.
pt recv vax & exp area of hyperpigmentation @ the inj site;each area was approx 2.5cm;pt did not return to the office;no further details available;
Itchy face, eyes, hoarseness, face swelling, stomach upset, ? fever.
Patient received Pfizer COVID-19 vaccine which was beyond the manufacturer recommended use time of 31 days at the refrigerated temperature. Organization has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures.  The vaccine given was within this range which is supported by the above data. No known adverse outcomes.
Information has been received from a Registered Nurse reporting that a physician from another practice called her office and reported that one of the physician's patients on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). The patient developed a rash at the injection site about two weeks after receiving ZOSTAVAX (Merck). At the time of reporting, the outcome of the event was not reported. The patient sought medical attention via contacting office. The nurse did not speak to the physician and did not have any other information about the patient, rash or physician. VZV packed was not faxed to the office. No further information is available.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 86-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and shoulder pain. On 4th September 2018, the patient experienced injection site lump. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved and the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the injection site pain, shoulder pain and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that he experienced extreme pain in the site for 3 days after the injection. The pain had decreased but not resolved. He noted the pain was a 4 to 5 during the day but a 8 to 9 at night, often awakening him from sleep. The pain was noted at the injection site and in the shoulder area also. He noted he also felt a lump in his muscle like it was swollen. The size noted was 1 and a inches by 4 to 5 inches, and that he did not notice until the day of reporting. He stated he had notified his physician, who instructed him to not get the 2nd dose of SHINGRIX.
Area is red, swollen (5 x 4 area), tender, & warm to touch. Pt told to take BENADRYL, ibuprofen, & ice affected area.
Urticaria. Isolated, no systemic sx such as SOB, abd pain, N/V, etc
Pain at injection site (Right) arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site (Right) arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 024A20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Liver transplant.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site (Right) arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 20-Jan-2021, VACCINATION SITE PAIN (Pain at injection site (Right) arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine has been reported by reporter.
Sore arm at injection about 10 hours after shot.  About 14 hours later developed joint/muscle pain, fatigue, headache, chills and fever of 100.2. It lasted about 43 hours.
Patient was given an undiluted Pfizer COVID vaccine, orange cape, 5-11. He was also given a higher dosage (0.3mg) than he should have received.
Initial unsolicited report received from a physician (patient's mother) on 15 June 2016. This case involves a 05-year-old female patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (manufacturer, batch number: unknown, dose in series, route of administration and expiry date: not reported) in thigh on an unspecified date in 1996. The patient's illness at time of vaccination was reported as none and reporter refused to provide pre-existing physician diagnosed allergies, birth defects, medical conditions. Other vaccinations within 4 weeks of vaccination was reported as unknown and other concomitant medications were not reported. On an unspecified date in 1996, after vaccination, patient's thigh swelled up to 2 times the normal size. It was reported that patient had taken TD since then without incident. The patient required ER/doctor visit. The patient's laboratory data was reported as unknown. Patient's corrective treatment was not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
pt. stated that she starts to experience swelling of feet ,knee, arms and fingers. by Friday she could not bend her knees. she experienced a little rash on and off in fingers and chest areas. she stated joints and ankles hurts. but no swelling at injection site or areas around it. patient came in to report on 10-21-2019 . At this time, her fingers has decreased in swelling.
Administered Moderna vaccine. Patient was sitting in observation and fell face forward out of the chair. Patient hit head and chipped tooth. Pt was unconsciousness for less than 10 seconds. Patients glasses cut his forehead. Called management and 911 immediately. 911 arrived and examined and patient refused to go to ER. Said he was okay to drive home. Patient did ask for me to schedule second dose in 4 weeks.
Pt received vaccine and ten minutes later began complaining of numbness to her face and heart palpitations.  At the this time she denied dyspnea, difficulty swallowing, chest pain, nausea/vomiting.  She also experienced facial flushing, nausea/vomiting, and diarrhea.  She was given 50mg of diphenhydramine intramuscularly.  She seemed to make a full recovery.
We were under the impression we were administering the Pfizer Bivalent COVID Booster but we discovered we actually administered the Pfizer Monovalent COVID Vaccine in error. Patient was made aware and given CDC guidance on how to proceed.
30 minutes post vax, the pt developed pounding headache and sweating. One hour post vax, the pt had headache only. 2 hours post vax, the pt had no symptoms.
nauseated, v x 2 evening & noc 13FEB95 v x several day, having chills x several days; feels exhausted-too tired to stay up-sleeping feels that breathing is an effort; rt arm swollen sore-beginning to clear, neck swelled x 1 day
1/15/2021 01:42 chills and oral temp of 100.4 Fahrenheit, 02:05 body aches, nausea, chills 100.4 temp, 0815 nausea, vomiting, bodyaches, headache, joint pain 100..5 temp, 650mg tylenol taken, fever was reduced, 1530  headache nausea, body ache, fatigue more mild.
Patient states that he started experiencing leg cramps approximately 2 days after receiving his flu shot. He explains that the muscles in the backs of his legs and up into his butt feel very tight. Eventually they loosen up, but it is very painful he states.
initial fatigue, then chills and sweats overnight, tender & swollen lymph nodes in right armpit and one on right side of neck that lasted several days.
herpes zoster on rt buttocks & thigh;varicella vaccine given on 3OCT95;
Information has been received from a registered nurse referring to an unspecified amount of patients of unknown age and gender. On an unknown date, an unspecified amount of dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneous, lot number unknown) that underwent a temperature excursion were administered to an unspecified amount of patients. No adverse effect reported. Additional information has been requested.
ears are on fire; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medication included diphenhydramine hydrochloride (BENADRYL, strength: 25 mg) at 75 mg for unspecified indication. It was reported that on 23Dec2020 the patient took BENADRYL 25 mg pre-vaccination and was given BENADRYL 50 mg post vaccination, the patient experienced ears are on fire on an unspecified date. The patient outcome of the event was unknown.    Information on the lot/batch number has been requested.
Flu Like Symptoms - In bed for a day and half -  Aches and Pains, Fever, headache
Left shoulder where injection was had "itching and pain".  Following day had "hardness and more swelling".
Large, red itchy rash at injection site, lasting migraine (but I am prone to those after any illness).
injection site swelling, pain, redness, warmth/hot to touch and itching beyond 48 hours post injection
Expired dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received HAV (Havrix) (batch number 63Y6M, expiry date 17-JUN-2023) for prophylaxis.   On 20-JUN-2023, the patient received the 2nd dose of Havrix. On 20-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). 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: 20-JUN-2023 The reporter reported that a patient received an expired dose of Havrix and wished to know how to proceed.  The information about the vaccine, patient and event given. medical information relayed. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient received an expired dose of Havrix, which led to expired vaccine used.
1st dose: sore arm, redness and swelling at injection site. 2nd dose: Fever for 36 hours, rose above 104 for several hours, diarrhea, sweating, pain at injection site, lighted headed, headache, difficulty breathing,
This spontaneous report was received from a healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of M-M-R II with lot # L039551 and expiration date on 07-OCT-2017 (anatomical route of vaccination was not provided) for prophylaxis. It was stated that, M-M-R II, was exposed to a temperature of > 8°C but < 25°C, for a 568 hours and 45 minutes time frame. Data logger was involved. Furthermore, M-M-R II was never exposed to previous temperature excursions and a product quality issue was not reported. No adverse effects were suffered. This is one of several reports received from the same reporter. Additional information is not expected as consent to follow up was not provided. Sender's Comments: US-009507513-1702USA006117: US-009507513-1702USA009046: US-009507513-1702USA009048.
received / Shingrix / diagnosed with shingles / 2 weeks ago/suspected vaccination failure; received / Shingrix / diagnosed with shingles / 2 weeks ago; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In March 2021, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient was diagnosed with shingles about 2 weeks before the date of reporting. The reporter was asking if the patient should expect any adverse events. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.