chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heartburn; lethargic; Pain at the site of injection; Nausea; CHILLS; fever; Sore arm; warm to the touch at the site of injection; Red knot; itchiness of the lymph nodes in the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit) and DYSPEPSIA (heartburn) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit), VACCINATION SITE PAIN (Pain at the site of injection), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (fever). On 05-Mar-2021, the patient experienced DYSPEPSIA (heartburn) and LETHARGY (lethargic). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (warm to the touch at the site of injection), NODULE (Red knot), PRURITUS (itchiness of the lymph nodes in the arm pit), DYSPEPSIA (heartburn), VACCINATION SITE PAIN (Pain at the site of injection), NAUSEA (Nausea), CHILLS (CHILLS) and PYREXIA (fever) had resolved and LETHARGY (lethargic) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
NO TEMPERATURE SINCE YESTERDAY; SO UNWELL; ARM IS STILL REALLY SORE; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-JUL-2021, the patient experienced so unwell. On 31-JUL-2021, the patient experienced arm is still really sore. On 31-JUL-2021, the patient experienced nausea. On 31-JUL-2021, the patient experienced headache. On 31-JUL-2021, the patient experienced no temperature since yesterday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no temperature since yesterday on 05-AUG-2021, and had not recovered from so unwell, arm is still really sore, nausea, and headache. This report was non-serious.
A few days after injection I noticed a red, palm sized area at the site of the injection.  It was warm to the touch.  It  was itchy.  The site lasted approximately 3 days and slowly disappeared.  I do have a photograph of the area if needed.   No further symptoms.
Bullous/blistering erythematous rash covering most of the body. Mostly on the scrotal/inguinal area and looks like an induced hypersensitivity reaction.
Red facial rash, facial flushing, feeling hot, mild dizziness, ringing in both ears, left side facial and tongue numbness and tingling, left arm and hand numbness and tingling, mild to moderate head and neck ache (meloxicam only took edge off), legs tingling, left arm soreness 5 days, extremely tired, took 2 hour nap after vaccine, slept 10 hours each of two nights following vaccine, upset stomach and diarrhea and yellow stool for two days after vaccine.  Most side effects resolved by day 4 with arm pain resolving by day 6.
Redness at injection site; Chills; Headache; Decreased arm mobility / only being able to lift arm halfway; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema, chills, headache and mobility decreased. On an unknown date, the outcome of the injection site erythema, chills, headache and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, chills, headache and mobility decreased to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received the 1st dose of Shingrix and experienced redness at the injections site, chills, headache and decreased arm mobility. The patient reported that she only being able to lift arm halfway.  The patient reported that all the symptoms were ongoing. Limited information were provided and no patient demographic details provided, as caller did not want to document anything. All  the information provided was reported. The reporter did not consent to follow-up. GSK note- it was not clearly mentioned, if patient had mobility issue with injected arm only. Therefore injected limb mobility decreased is not considered as adverse event.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as DOSE 5 (BOOSTER), SINGLE (lot number: GH9694) at the age of 79 years, administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 13Apr2022 as DOSE 4 (BOOSTER), SINGLE (lot number: FJ4989), administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown), as DOSE 2, SINGLE (batch/lot number: unknown) and as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "triple bypass 3 years ago" (unspecified if ongoing). Patient had no known allergy. Concomitant medications included: ATORVASTATIN; ASPIRIN 81; LOSARTAN POTASSIUM; METOPROLOL; TAMSULOSIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Increased heart rate for 3-4 hours (120-150 bpm at baseline) Fluctuating heart rate upon getting up or moving slowly Irregular ECG at 2.5 hours after vaccination
Severe muscular soreness in upper arms  and shoulders primarily, but also in legs and hips initially. I had some arm soreness prior to the vaccine that I attributed to snow shoveling but it got severe in the days after the shot. After various tests and diagnoses I was eventually diagnosed with PMI (polymyalgia rheumatica) and have been on low dose methyl prednisone for about nine months now. Symptoms are basically gone.
102.1 FEVER REPORTED AT 1:45AM, ACHES, CHILLS, TOOK acetaminophen AT 2:15AM WENT BACK TO SLEEP AND WOKE UP AT 6:30AM WITH FEVER REDUCED TO 99.7, WENT TO WORK AT 8:00AM TEMPERATURE BACK DOWN TO 97.4.  STILL HAD ACHES AND FELT LETHARGIC AND TIRED.  TOOK ANOTHER ACETAMINOPHEN AT 10:15AM.  CURRENTLY 10 WEEKS 4 DAYS PREGNANT DUE ON NOV. 1.
the patient received their first dose of GARDASIL 9 in OCT2019 when she was 17 but never received her second or third doses. The patient was in the pharmacy today 9SEP2022 to receive her next dose of GARDSIL 9; No additional AE details were provided; This spontaneous report was received from a pharmacist and refers to a female patient . The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in October 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (strength, lot #, and expiry date were not provided) administered intramuscularly for prophylaxis.The patient never received her second or third doses (inappropriate schedule of product administered). There were no additional adverse events details provided (no adverse event).
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022.; No adverse event; Patient administered dose after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022.) and NO ADVERSE EVENT (No adverse event) in a 10-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered dose after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered dose after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022.).    No concomitant medications were reported.  On 08-Jul-2022, the vials were initially stored in the fridge.   The health care professional (HCP) stated they administered dose of Moderna COVID-19 Vaccine after 30-day use by date.  The vial did not undergo any temperature excursions.  The HCP was not aware of any symptoms for patient after the vaccine was given.  No treatment medications were reported.
Janssen vaccine was drawn on 11/15/21 at 12:16pm and given to patient on 11/16/21 at 11:05AM.  Patient is aware and no side effects. Will follow up with patient in the next couple days.
Tennis ball bump under the arm.; Arm soreness; Feel burned at the arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Tennis ball bump under the arm.), PAIN IN EXTREMITY (Arm soreness) and SKIN BURNING SENSATION (Feel burned at the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Tennis ball bump under the arm.), PAIN IN EXTREMITY (Arm soreness) and SKIN BURNING SENSATION (Feel burned at the arm). At the time of the report, AXILLARY MASS (Tennis ball bump under the arm.), PAIN IN EXTREMITY (Arm soreness) and SKIN BURNING SENSATION (Feel burned at the arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported.  No treatment information specified.; 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. Further information has been requested
This spontaneous report was received from a nurse regarding a 14 years old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-AUG-2013, the patient was administered with a dose of GARDASIL (dosing details not reported). The patient also received a dose of GARDASIL 9 on 11-SEP-2015 and a dose of GARDASIL 9 on 10-NOV-2016. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports: 1611USA006730 (same reporter link). Additional information is not expected as there is no consent to contact the reporter.
Extreme fatigue,muscle ache, feeling chill at times, joint pain. for 2 days.
This spontaneous report as received from a medical assistant refers to a 10 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA00794148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Patient received MMRV instead of MMR at 12 month well child check in addition to the varicella vaccine. Medical staff called the mother at 1624 on April 20, 2023 to check on how the family was doing and if the patient was okay. The mother stated about a week ago, one week after vaccine administration, the child has gotten the Varicella Virus and had about 30 red bumps over her body. The mother stated she had given her a breast milk bath last night, April 19th, and noted that the red bumps over the patient's body were clearing up today, April 20th.  The mother stated she called the nurse advice line this morning and the nurse advice line at the hospital recommended coming back in to visit the doctor is the rash worsened.
Vaccine was placed in freezer on 12/6/21 and was pulled out of freezer on 1/3/22.
Suspected vaccination failure; shingles; post therapetic neurological pain.; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   The reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had shingles and later received Shingles vaccine and have now had 2 bad times with post shingles now called post therapetic neurological pain. The patient stated that no fun. google it. if you had shingles and live long enough. The patient told that this will occur. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown.
Patient came in for Moderna Booster after having J&J in the spring.  Called about an hour after vaccination complaining of tingling on the right side of his face and said it felt like his eyelid was drooping although he could not see anything drooping on his face.  I advised him to go to urgent care to have them check it out and rule out anything serious.  I told him I found an article that said they might prescribe oral steroids or the may not so it is best to get the professional opinion of a physician to be safe.
a patient was administered a 1 ml dose of IPOL vaccine/ No AE; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from another health care professional via physician via consumer via phone via Medical Information number: 00775110.    This case is linked to cases 2021SA311330, 2021SA312326, 2021SA314197 and 2021SA312255 (same reporter)  This case involved 5-year-old male patient was administered a 1 ml dose of IPV (VERO) [IPOL] vaccine (overdose)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received 1ml total dose of suspect IPV (VERO) (lot: U1A452M and expiry date: 20-Feb-2023) frequency: once, strength: standard via unknown route in unknown administration site for prophylactic vaccination (overdose).  It was a case of overdose (latency: same day).   It was reported " Caller/ Medical Assistant reports that IPOL was administered to 5 patients, caller states that she does not know if patients received a 1 mL dose or a 0.5 mL dose, caller requests information on possible adverse effects from a 1 mL dose of IPOL. Caller states she does not have time to look through all patient charts for adverse event information, she will call back at a less busy time."  At time of reporting, no adverse event was reported.
When the nurse went to give the vaccine, some of the vaccine leaked out of the syringe where the needle and syringe screw together.
Day One: chills, headache, site arm pain; Day Two: chills, aches, site arm pain, fatigue; Day Three: chills, aches, site arm pain, fatigue; Day Four: arm pain, redness at injection site, slight swelling at injection site.
This spontaneous report was received from an office manager on behalf of a physician, and refers to a 38 year old female patient. The patient had no concomitant medications, concurrent conditions, drug reactions, allergies or historical conditions. On 18-JAN-2019, the patient was vaccinated with M-M-R II lot # R000551, expiration date 08-JAN-2020, subcutaneously as prevention of measles, mumps and rubella, which was diluted with MERCK STERILE DILUENT. On 29-JAN-2019, the patient developed a generalized rash all over her face and body. She sought medical attention by calling the physician, however, she did not receive any treatment for the event. No laboratory tests were carried out. By the time of this report, the patient had not recovered from the event. Causality assessment was not reported.
I woke up at around 7 am feeling like I had an upset stomach. I went to the restroom and afterward i started to feel very dizzy as if I was having a vasovagal attack. I kept walking towards the bedroom and got dizzier and started shaking and shivering uncontrollably for about 1 minute. I also broke out in a sweat and squatted down to the ground to avoid falling. I felt like I was about to pass out. I sat on the floor hanging my head over my legs and my husband got an icepak for my neck. I sat there until the dizziness and shaking subsided. The whole event lasted about 8-10 minutes. I took a BENADRYL and 600mg of ibuprofen and went back to bed for 3 hrs.
Initial unsolicited report received from a consumer on 23 August 2016. This case involves a 67-year-old female patient who was vaccinated with dose of FLUZONE HD (batch number: UI620AB, expiry date: 14-MAR-2017), intramuscularly in the left deltoid on 21 August 2016 in the am (morning). The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as nkda (no known drug allergy), HTN (hypertension). Illness at time of vaccination was reported as no. Concomitant medications were not reported. Any other vaccinations within 4 weeks of vaccinations was not reported. On 21 August 2016, few hours following the vaccination in the evening, the patient had blurred vision, who was seen by an eye doctor and diagnosed bleeding behind the retina. Relevant diagnostic tests/laboratory data was not provided. The patient's corrective treatment was not reported. The patient had not recovered from the event. Upon medical review, the case was considered as serious due to important medical event: bleeding behind the retina. The patient required ER/doctor visit. List of documents held by sender: none. Sender's Comments: Bleeding behind the retina is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
migraine daily; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 15:00 as dose 2, single (Lot number: F48027) at the age of 40 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Drug Allergy". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 301458A, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 30Sep2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 10Dec2021 at 15:00, outcome "not recovered", described as "migraine daily". The event "migraine daily" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: Patient presents with migraine daily since 10Dec2021. Has seen multiple physicians and specialists for follow up and no relief.