chrisvoncsefalvay/vaers-outcomes huggingface dataset:
discoloration in my face; Looks like hives; Later day and I was restless; couldnt get comfortable; I developed a fever; Chills; Significant loss of appetite; severe night sweats; Nauseous; I felt slightly ill; I began to feel aches in my joints; sick to my stomach.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 on unknown date in Nov2020. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 23:00, Within 8 hours of the first vaccine shot, the patient began to feel aches in joints, slightly ill and sick to stomach. On 08Apr2021 later day, the patient was restless and could not get comfortable, the following evening he became quite ill, developed fever, chills, significant loss of appetite, severe night sweats and was nauseous. On 09Apr2021 on the day of reporting it appears that the patient had some discoloration in face that looks like hives. That side effects were serious enough that the patient  would not get the vaccine again. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of feeling aches in joints, sick to stomach, restless, discomfort, ill, fever, chills, loss of appetite, severe night sweats, nauseous, discoloration of face and hives that  included home self care and fever reducing medications (unspecified). The clinical outcome of the events feel aches in joints, sick to stomach, restless, discomfort, ill, fever, chills, loss of appetite, severe night sweats, nauseous, discoloration of face and hives were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Developed several allergic reactions after 30 years of no allergies, developed wheat allergies, perfuse vomiting after any consumption of red sauces or tomato.
Patient received a dose but the powder containing menA was already expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 22nd March 2022) for prophylaxis.   On 2nd June 2022, the patient received Menveo. On 2nd June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: The medical assistant reported that a patient received a dose of menveo but the powder containing menA was already expired. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of menveo but the powder containing menA was already expired which led to expired vaccine used.
Patient received a partial dose with the first injection today. The need come loose from the syringe and some of the vaccine leaked out. The patient was given a second full dose of Pfizer vaccine per the guidelines.
Sore Arm; Intramuscular formulation administered by other route; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Rubella Vaccine with an associated reaction of rubella antibody negative (had received 3 times in her past, and had negative Rubella titers after each vaccine.). Concurrent medical conditions included lipoma (on left shoulder.). Concomitant products included methotrexate and hydroxychloroquine (Plaquenil).   On 15-MAR-2023, the patient received the 2nd dose of Shingrix (intercostal, left deltoid). On 15-MAR-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Intramuscular formulation administered by other route). On an unknown date, the patient experienced pain in arm (Verbatim: Sore Arm). The outcome of the pain in arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2023 The reporter was the patient who reported that after she received her 2nd dose of Shingrix, she experienced a sore arm.  The patient also reported that the 2nd dose of Shingrix was administered about 2 inches down from a lipoma on her left shoulder (Current condition but was pre- existing the Shingrix Vaccine).  The patient also reported that she has received the Rubella Vaccine 3 times in her past, and had negative Rubella titers after each vaccine. She added that the 2nd time was 2 years after the 1st Rubella Vaccine, and the 3rd time was 4 years after the 2nd Rubella Vaccine, while she was pregnant (all pre - existing the Shingrix vaccine). The patient added that she was currently on Methotrexate and Plaquenil and asked if does that make a difference. The reporter consented to follow up. The patient was administered with Shingrix vaccine by intercostal route, which led to Intramuscular formulation administered by other route.
Myocarditis/Pericarditis.  Prior to hospitalization for Myocarditis/Pericarditis the patient had severe headache, fever/chills, temperature ranging from 100.8 to 104 degrees, right side mid back pain, brief moments of random intense pain in other parts of the body, lack of appetite and excessive fatigue.
tingling sensation along recent surgical incision and along both sides; Burning pain down left leg from knee to foot; This is a spontaneous report from non-contactable or other healthcare professional. A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration on 17Mar2021 (at the age of 49 years old) as a single dose for COVID-19 immunization. Medical history includes full knee replacement on 09Mar2021. Concomitant drugs include were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On 17Mar2021 after 15minutes waiting period of the vaccination, the patient experienced tingling sensation along recent surgical incision and along both sides, and burning pain down left leg from knee to foot. The patient did not receive treatment for the reported event. The left knee was bandaged, wrapped with ace bandage and also had compression socks on. The clinical outcome of tingling sensation and burning pain was unknown.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient's name and country added in patient tab; and Treatment Received ticked Yes.
Information has been received from a 92 (units not provided) old female referring to herself. Patient's concurrent conditions included lymphoma and Congestive heart failure. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously. Concomitant therapies included LOPRESSOR, BELSEREN, LASIX and chemotherapy. On an unknown date the patient developed an itchy rash only on her torso. She stated that the rash is on the front of her torso and back (itchy rash). Patient received treatment with cortisone treatment and sought medical attention with cortisone cream. No lab diagnostic test were performed. Action taken with the suspect therapy was not reported. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to a 15 year old male patient. Concurrent or medical conditions were not reported. On 19-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular, lot # reported as L000610, expiration date 31-JAN-2017 (dose and strength were not reported) for papilloma viral infection. Secondary suspect and concomitant therapies were not reported. On 20-AUG-2015 (reported as a day later), the patient began to feel "joint pain and malaise". On the same day, the patient had various unspecified lab work (result was not reported). The outcome of joint pain and malaise were not reported. It was reported that the patient sought medical attention by a visit office. The events did not required intervention to prevent serious criteria, did not product significant disability or incapacity, did not required hospitalization and it were not life threatening for the patient. No product quality complain was reported. Additional information has bee requested.
PANIC ATTACK; NOT ABLE TO SLEEP LAST NIGHT; BURNING FACE; DRUMMING IN HER RIGHT EAR; POSSIBLY HALLUCINATING; TIREDNESS; ANXIETY WENT UP; ARM NUMBNESS; MORE FOCUSED THAN USUAL; ARM SORENESS; HOT FLASHES; ARM, HEAD, FEELING HOT; FACE TINGLING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polycystic ovarian syndrome, diabetes, attention deficit hyperactivity disorder, and anxiety.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included amitriptyline, and medroxyprogesterone acetate.  On MAR-2021, the patient had ongoing arm soreness like a knot and being more focused than usual since receiving the vaccine. On 27-MAR-2021, the patient experienced a panic/anxiety attack. It was reported that, the patient's face was burning and tingling and her anxiety went up. The patient's head and her arm also felt hot during this experience. On MAR-2021, the patient also experienced hot flashes and arm numbness. The patient jumped out of bed and went to the bathroom and felt blurry around her face. The patient saw that her face was red in the mirror, then back to normal, then red again. The patient believed that she was possibly hallucinating during this episode on the night of 27-MAR-2021. On 27-MAR-2021, the patient's left arm had felt like it did not have circulation and felt drumming in her right ear. The patient also had tiredness and was not able to sleep on the night of 27-MAR-2021 because of this experience.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness, and the outcome of anxiety went up, panic attack, possibly hallucinating, more focused than usual, tiredness, not able to sleep last night, arm, head, feeling hot, face tingling, arm numbness, drumming in her right ear, hot flashes and burning face was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210353962-Covid-19 vaccine ad26.cov2.s-HALLUCINATION. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, UNDERLYING DISEASE.
I had a severe headache, sore arm, fatigue and overall malaise for two days.
Subsequently the pt experienced swelling and redness at the site of injection down the arm and to the elbow. Additionally it was noted that 3 other pts experienced  similar reations.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. On 01-SEP-2017, the patient were vaccinated with improperly stored vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 05-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N008077, expiration date: 09-MAR-2019) for prophylaxis. This is one of several reports from the same reporter.  Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Onset was a cough and congestion on July 7th. I was irritated by the cough. My eyes were also oozing. I went to see nurse practitioner. She gave me drops for my eyes. I reached out to her again on July 12th I contacted her again because things were not clearing up as expecting. My ears were so clogged that it was impairing my hearing. My eyes are red and swollen. She thought I had symptoms of latest strain of COVID-19 but test was negative. Nurse then prescribed a prescription for my cough. Today my symptoms are reduced hearing from congestion and my eyes are red and swollen.
Following the administration of the 1st (of 3) Gardasil vaccines, patient has developed angioedema.  It is ongoing (eyes, lips, hands, feet).
Client complains of a mildly itchy macular red rash. A numbness of small red spots on her neck and torso approx. 24 hours after receiving vaccines. No other symptoms. Rash is improved at time of this report.
Patient  was administered a 2nd Shingrix vaccine at an immunization event held at church. After the event (during the billing process at the store), we noticed that his first Shingrix was billing at our store as well. It was given to him on 1/18/22, which made the interval between the 2 doses 42 days, and less than the recommended minimum interval by the CDC of 2 months.
Swelling and pain at site of injection lasting 3-4 days Fatigue on day after injection.
Wrong vial was grabbed out of the fridge and not properly verified. Patient was supposed to get the Pfizer dose 1 of the original series, but instead received the updated booster. No signs or symptoms prior to patient leaving the store.
started cough approx 1 day p/receiving flu vax-treated by MD w/cough medicine; worsened; adm 28OCT93 in heart failure; had 6 beat run of v-tech;
Breakthrough COVID case:  patient received J&J vaccine on 3/6/2021. experienced fever, chills, myalgias, fatigue for 12-48 hours.   Patient developed mild upper respiratory symptoms on 4/13/2021 and tested positive for COVID via PCR testing on 4/14/2021.
little cough; eyes was burning couple days, so bad she had to used solution; little fatigue; sleeping more, 14 hours; still has bit of cough, and the allergies; nose running constantly; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (nose running constantly), COUGH (little cough), EYE IRRITATION (eyes was burning couple days, so bad she had to used solution), FATIGUE (little fatigue) and HYPERSOMNIA (sleeping more, 14 hours) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RHINORRHOEA (nose running constantly). On an unknown date, the patient experienced COUGH (little cough), EYE IRRITATION (eyes was burning couple days, so bad she had to used solution), FATIGUE (little fatigue), HYPERSOMNIA (sleeping more, 14 hours) and MULTIPLE ALLERGIES (still has bit of cough, and the allergies). At the time of the report, RHINORRHOEA (nose running constantly), COUGH (little cough), EYE IRRITATION (eyes was burning couple days, so bad she had to used solution), FATIGUE (little fatigue), HYPERSOMNIA (sleeping more, 14 hours) and MULTIPLE ALLERGIES (still has bit of cough, and the allergies) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter   This case was linked to MOD-2021-080422 (Patient Link).
Slept for 30 hours out of next 48 hours post vaccine.  Hypersensitive nerves along  bilateral upper extremities and lower extremities (tingling sensation -lasted ~8hours). Feeling of pre-migraine symptoms including nausea for 3 days post vaccine.  Migraine  on 4th day post vaccine.
Patient received 2nd COVID-19 vaccine on 06/08/2021, the day after he received vaccine he experienced pain, redness, inflammation. Patient formed a lesion  about 2 inches round and induration which claims became larger over time. Patient went to clinic to get treated for lesion.
woke up with her eye a little bit swollen was reported as worsened/swelling of left eye; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 15Jul2021 at 15:03 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 17-years-old). Medical history included had tonsils out (maybe a month ago) on an unknown date outside of that no other health issues. There were no concomitant medications. It was reported that patient received a first dose of vaccine 10 days ago and on 26Jul2021 woke up with her eye a little bit swollen was reported as worsened and had swelling of left eye. The reporter further mentioned that eye was a bit swollen, it was a little more puffy since yesterday, it's worsened, but it was not like its huge. She was hesitant about taking the vaccine so she wanted to call to make sure. The reporter also stated that she did a little research and saw that there's a potential for eye swelling and she just wanted to find out if they needed to see a doctor about it, put a little ice on it and or give some Benadryl. The patient was not recovered from the event.   Information on lot/ batch number has been requested.
Severe headaches, body aches, sinus pressure, drainage from ears, fever- all still lasting a week after vaccination
Severe allergic reaction on 4/14/21 Tongue swelling, lip swelling, body aches, nose running , hives  breathing problems.  Took 2 Benadryl  and a tagament,  didn?t work went to ER got an epi and prednisone.  Did prednisone and Pepcid at home for 5 days  Took more Benadryl on 4/20/21 for tongue and lip numbness
the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; This spontaneous report was received from a registered nurse referring to a 23-year-old female patient. The patient's concurrent conditions included ulcerative colitis, she was immunocompromised and her medical history included drug reaction to SULFA (unspecified). The patient's concomitant medications included vedolizumab (ENTYVIO). This report concerns 1 patient and 1 combination product.  On 30-JUN-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe by intramuscular route of administration in an unspecified arm, lot number T007790 and expiration date 03-DEC-2021 (specific anatomical location of administration was not reported) for prophylaxis, as the patient was immunosuppressed.  On the same day, within an hour of the administration, the patient developed redness, warmth, pain, swelling and weakness in the unspecified injected arm. She sought medical attention and was prescribed an ice, acetaminophen (TYLENOL) and an unspecified antihistamine. A routine blood work was performed on the same day and the result was normal.   The nurse was concerned about using the reported lot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for other patients, as this was the second patient who developed similar symptoms a few days after the first patient. The nurse reported that there were no such experiences in the past. The nurse asked for the lot check to be done as soon as possible and she did not want to use pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) until the lot check was done.   At the reporting time, the patient was recovering from the events with the prescribed treatment.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2007USA001323: