chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache has been going on for 25 days and hasn't stopped; "my ears are killing me. The pressure behind my ears are killing me."; "my ears are killing me. The pressure behind my ears are killing me."; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me."), EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") and HEADACHE (Headache has been going on for 25 days and hasn't stopped) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 immunization.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LEVOTHYROXINE SODIUM (SYNTHROID), HYDROXYCHLOROQUINE, MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) and METOPROLOL SUCCINATE (TOPROL) for an unknown indication.   On 06-Apr-2021 at 8:00 PM, 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) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me.") (seriousness criteria hospitalization and disability) and EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") (seriousness criteria hospitalization and disability). On 07-Apr-2021 at 2:00 PM, the patient experienced HEADACHE (Headache has been going on for 25 days and hasn't stopped) (seriousness criteria hospitalization and disability). At the time of the report, EAR DISCOMFORT ("my ears are killing me. The pressure behind my ears are killing me.") and EAR PAIN ("my ears are killing me. The pressure behind my ears are killing me.") outcome was unknown and HEADACHE (Headache has been going on for 25 days and hasn't stopped) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Lumbar puncture: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.         Patient was admitted to the hospital. Patient also visited a walk-in clinic.Reported Treatment that patient received including Naproxen, Prednisone, Fioricet, Toradol.  Action taken with mRNA-1273 in response to the events was not Applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Small round disc where I got the, at the injection site, kind of itching and kind of red and itching and in a big round circle; Runny nose; Small round disc where I got the, at the injection site, kind of itching and kind of red and itching and in a big round circle; slightly tender to the touch; Small round disc where I got the, at the injection site, kind of itching and kind of red and itching and in a big round circle; slightly tender to the touch; Slightly tender to the touch; This is a spontaneous report from a contactable Nurse (patient). A 78-years-old female patient received second dose BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL9267), via an unspecified route of administration on unspecified date (Age at the time of vaccination was 78 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included diabetes, hypertension and haemoglobin low. Concomitant medications included Aspirin. The patient previously took first dose of vaccine BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL3249), via an unspecified route of administration on 16Jan2021 (Age at the time of vaccination was 78 years) as DOSE 1, SINGLE for COVID-19 immunisation. Patient experienced runny nose, small round disc where she got the, at the injection site, kind of itching and kind of red and itching and in a big round circle, slightly tender to the touch in 2021. Patient had not received treatment for events. The outcome of events was unknown.  Follow-up attempts were completed. No further information was expected.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 65-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The patient was 65 years old at the time of reporting. The age at vaccination was not reported, however, it could be 64 or 65 years old. The patient experienced extreme arm pain that lasted for greater than 3 weeks. The reporter did not agreed to be contacted for follow up.
painful, swollen lymph node in neck the very next day. Is still swollen 3 weeks later.
pt recv vax 10APR96 & on 17MAR97 pt devel chickenpox;It was also reported that a sibling recv varicella vax on 10APR96 & another sibling (WAES 97031344) devel chickenpox post vax;
no adverse event; Expired vaccine used; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 24-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) (lot # S015428, expiration date 20-MAY-2021) for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No further information provided. No additional adverse events reported. No product quality complaints.
The patient received a second booster of Janssen COVID19 vaccine which is currently not authorized.  The patient previously received a primary dose of Janssen and a booster of Janssen previously.
vaccinated pt with flu shot.  upon withdrawal of syringe, vaccine squirted out of pt's arm
Raised area after administration, 3" diameter; Red area 3 inches diameter; Tender area 3 inches diameter; Hot area 3 inches diameter; This case was reported by a nurse via other manufacturer and described the occurrence of swelling in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced swelling, erythema, tenderness and feeling hot. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the swelling, erythema, tenderness and feeling hot were recovered/resolved.   It was unknown if the reporter considered the swelling, erythema, tenderness and feeling hot to be related to Kinrix and Kinrix Pre-Filled Syringe Device. 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: 14-APR-2022 Reporter's comment: The patient was administered Kinrix in the left upper anterior lateral thigh and experienced a raised, red, tender, and hot area after the administration of Kinrix that was 3 inches in diameter.  The physician recommended treatment with a warm compress.  The nurse reported that the patient was fine and no further recommendations from the physician was provided. No further details provided.
Got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 14-MAY-2023, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-JUL-2023 The case was received from the patient interactive digital media. The patient had a reaction to the first vaccine, and could not take part two. The patient got shingles on Mother's Day and stated that it was worst thing ever and he/she was still suffering. The follow-up could not be possible as no contact details were available.
Throat tightness; BP 159/84 / BP 162/102; Lightheadedness; Generalized chills / mild rigors; Warmth to body; Palpitations; Pulse 107-121; This is a spontaneous report received from a contactable pharmacist. A 33-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19266), via an unspecified route of administration in left arm on 20Feb2021 at 15:30 (age at the time of vaccination was 33-year-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines with 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. The patient's concomitant medication included Motrin 600 mg prior to arrival for headache, start and stop date were not reported. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination or test for COVID-19 post vaccination.Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9261), via an unspecified route of administration in left arm on 03Feb2021 (age at the time of vaccination was 33-year-old) as a single dose for COVID-19 immunization. On 22Feb2021 immediately after receiving vaccination, the patient complained of complained of light-headedness, generalized chills, warmth to body, and palpitations at 10:04. The patient did not eat breakfast. The patient had similar reaction after receiving the first dose, which self-resolved after a minute.  At 10:05, BP was at 159/84 and pulse 88 (unspecified units); the patient was given water. At 10:25, the patient had verbalized feeling better and was able to ambulate without dizziness. At 10:33, the patient developed chills, mild rigors, and throat tightness. The patient's blood sugar was at 85, pulse was at 107 to 121, and BP was at 162/102, so patient was given an oatmeal bar and transferred to ED (emergency department). The patient did not receive any treatment medication for the event. Upon evaluation in ED at 10:49, the patient stated symptoms had resolved. The patient was discharged at 12:22.
Red left arm; Swelling left arm; Hard left arm; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA, PERIPHERAL SWELLING, LIMB DISCOMFORT, and MYALGIA in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ERYTHEMA, PERIPHERAL SWELLING, LIMB DISCOMFORT, and MYALGIA. At the time of the report, ERYTHEMA, PERIPHERAL SWELLING, LIMB DISCOMFORT and MYALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Patient came for adult Pfizer booster.  Had 3 children with him who needed the pediatric Pfizer vaccine.  I administered one 0.2ML pediatric dose to Pt.  I noticed the error immediately and offered him a full dose by giving him and additional 0.4ML of the pediatric product.
1. Mild lightheadedness that lasted about an hour.  2. Periodic very mild headache through the time of this report. Neither of the above have impacted my activities.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-SEP-2016, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 16-FEB-2017. The outcome of the shingles outbreak is unknown. As a direct result of the ZOSTAVAX, the patient suffered mental and emotional distress due to the resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of her use of ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
9:35 patient came to health department with mom. She did consent to shots. Shots were given at then it was noted that injections were given on 5/1/14 at dr office. Their office put them in the computer at 10:35 after we gave our immunizations. No adverse signs/or symptoms noted.
01/11/2013 10:22 AM Pt received MMRV in the left leg on 01/09/13. Mother called reporting patient's left leg, around the area where the shot was given, is red, warm, and area is a little raised. Pt stated that it is "itchy". Mother instructed to place a cool wet wash cloth on the area, she can give some ibuprofen to help with the swelling, and to keep soft pants on to keep the area covered to prevent patient from scratching. Mother agreed to call if it does get better or if it worsens.
About 6hrs after administration, a flat red splotchy rash that resembled a mottling pattern appeared on both arms from shoulder to elbow, I had moderate pain in all joints of both legs, and severe fatigue came on suddenly. I had to go to bed. The next morning, I had a headache, all joints felt mildly aches, moderate fatigue, and the splotchy rash remained on both arms still from shoulder to elbow. I took ibuprofen and rested in bed most of the day.
No adverse effect reported; however, gave a duplicate dose of vaccination, patient previously received in 2015.
Nausea and complaints of stomach aching. Complaints of "bad smell". After about an hour following onset of stomach ache and smells, heavy projectile vomiting.
Myalgia PAIN IN UE LEFT ARM Narrative:  day 1-4 body ache along with pain in the UE in which I received the vaccine. I also have severe pain when raising the same arm above the shoulder level (in which I received the vaccine). day 5: continues to have symptoms but has improved. used motrin round the clock day 1-2 three times a day day 3-4: motrin bid
Vaccine was moved to refrigerator on 23-JUN-2023 and administered on 04-AUG-2023; no adverse event; Vaccine was administered beyond 30-day use.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond 30-day use.), PRODUCT STORAGE ERROR (Vaccine was moved to refrigerator on 23-JUN-2023 and administered on 04-AUG-2023) and NO ADVERSE EVENT (no adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond 30-day use.) and NO ADVERSE EVENT (no adverse event). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was moved to refrigerator on 23-JUN-2023 and administered on 04-AUG-2023). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond 30-day use.), PRODUCT STORAGE ERROR (Vaccine was moved to refrigerator on 23-JUN-2023 and administered on 04-AUG-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond 30-day use.) and PRODUCT STORAGE ERROR (Vaccine was moved to refrigerator on 23-JUN-2023 and administered on 04-AUG-2023).    No concomitant medication was reported.  No treatment information was reported.
Rash around injection site which was noticed on day 11.  Area was red and slightly itchy for 4 days.
I noticed that I had an increase heart rate after I got the vaccine everybody really didn?t pay much attention to it I started getting October 10 tested positive for Covid 10/26.  Developed pneumonia and that?s when I noticed increased heart rate tachycardia a fib and fluid around my heart.   I noticed the tachycardia prior to getting actual Covid
Tired; This is a spontaneous report from a Pfizer sponsored program via consumer or other non-health professional (Patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tired after the first vaccine on an unspecified date. The clinical outcome of the event was unknown.   Follow-up attempts are possible. Further information is expected.
I had a really big headache. I had chills during the day and a fever during the night. I had a lot of head congestion, very fatigue and a runny nose. The next day, I started feeling queasy and threw up once. I was prescribed Paxlovid and the medicine started to help a lot. When I got done taking the RX after day 5, the fatigue returned.
HYPOXIA 11/5/2022 MOOD DISORDER, UNSPECIFIED TYPE HYPOXIA 11/5/2022 MOOD DISORDER, UNSPECIFIED TYPE
Swelling and redness on left antero lateral thigh 24 hours after immunization.
Rash; Felt bad; Fever; This is a spontaneous report received from contactable consumer.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization.The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt bad"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: Pfizer employee reported that his sister in law had adverse events after the booster; he believes it was the Pfizer covid vaccine. His sister in law said she had a rash and also felt bad. Pfizer employee thinks she had a fever but he doesn't know when she got booster, he is pretty sure it was Pfizer's covid vaccine. Pfizer employee does not know the dates of the first, second or booster dose, and does not have any Lot numbers.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Bright red, itchy, swollen from below injection site down to elbow began day after injection.
CERVARIX was givem to a male patient, while it should be given to the female patient only.
This spontaneous report as received from a physician refers to an about 4 years old male patient who on an unknown date, at one year of age in 2011 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). At 2 years of age, on an unknown date in 2012, the patient developed shingles and then a second case of shingles was experienced at 3 years of age on an unknown date in 2013 (unspecified dates, but the patient was reported to be 4 years of age). At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for shingles and VARIVAX (Merck) was unknown. Additional information is not expected.
redness / inch and a half below the injections site.; This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the dose of Shingrix and presented redness an inch and a half below the injections site and redness was presented in a 3 inches radius. Patient refused to answer any additional questions. The reporter did not consent to follow up
Pt recvd 3 doses of Engerix-B & 7OCT91 found to be a non-seroconverter;
Haven't had afib in over two years. At about 9:30pm on March 18 while watching TV I had a severe afib event that lasted over an hour. This was followed by two hours of tachycardia. I finally got it under control by administering additional metoprolol tartrate.  If this had continued I would have gone to the ER to have them cardiovert me.
11 x 8 induration of (R) deltoid. Tender to palpation elbow - shoulder. No fluctuance or streaking.