chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a patient on 03-Nov-2017. This case involves a 66-year-old female patient, who was vaccinated with first dose of 0.5 ml of FLUZONE HIGH DOSE once (batch number, expiry date, and administration site were not reported) via intramuscular route on 25-Oct-2017. The patient's medical history included allergy to erythromycin and concomitant medications were not reported. On 25-Oct-2017, same day evening, after the vaccination, the patient developed headache, on 26-Oct-2017, next morning at 6.00 a.m., following the vaccination, the patient woke up with severe pain on the whole left side of her head and her left ear was very painful to touch. Also reported that she stayed in bed for most of the next 4 days and continued to have severe headache, temperature of 101F, and right arm was swollen and hot to touch. On an unspecified day, the patient required visit to neurologist and was scheduled for an MRI. She did not receive any other vaccines that day. Other laboratory data and corrective treatment was not reported. Outcome of all the events were resolved after 4 days except headache, which was not recovered. List of documents held by sender: none.
No aditional adverse event reported; Inbound call from pharmacist who reports expired GARDASIL 9 was administered to a patient. Product was administered today 31MAY2023 and expired 23MAY2023. Product was stored according to labeling through the date of administration.; This spontaneous report has been received form a pharmacist, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 31-MAY-2023, the patient was vaccinated with an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (lot number: U007665, which was determined to be valid as syringe, with an expiration date on 23-MAY-2023) (strength, dose, scheme, route and anatomical location of administration were not reported).  No additional adverse event was reported.
Sensitive skin, joint pain, sensitive hearing, mentally 'foggy', sweats, malaise approx. 7 days.
Diffuse c-pox lesions everywhere. Tx: Atarax 100 mg every 4-6 hours
shingles in his left eye; shingles on left side of face; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 67-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 08-JAN-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions by a licensed practical nurse (LPN) as prescribed by a healthcare provider (HCP). The patient suffered the following injuries and was diagnosed on the following dates as result of the zoster vaccine live (ZOSTAVAX) vaccine: shingles on left side of face and shingles in his left eye, which were diagnosed on 12-JAN-2018. The outcome of the events was unknown. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Ophthalmic herpes zoster was considered a medically significant event.
The morning of the 9th day post-vaccine I noticed a red rash around the injection site that was warm to the touch. Friday morning, it had faded and two smaller rash dots away from the vaccine site appeared. By Friday at 10pm the lower dot about inches from the site of the vaccine was the size of a 50-cent piece and warm to the touch, and the other spot had faded. Then Saturday morning it had increased in size and became itchy. This morning around 6:50am the size had increased to about 2.5 inches and two more rash spots approximately 1 inch across appeared toward the site of the injection. Urgent care suggested monitoring it since no other symptoms were present, as well as reporting to the site where the vaccine administered .
fall and made knee swell and ankles; knee caps out of place to strengthen/ patella dislocation; fall and made knee swell and ankles; fall and made knee swell and ankles; This is a non-interventional study report from the marketing program received from a contactable consumer (patient). This is based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4074903-00).  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiry date was not reported), via intramuscular route of administration on an unspecified date as Dose 3 (Booster), Single for COVID-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Lot number was not reported) via subcutaneous route as Dose 1 (1 in 1 once), Single, Dose 2 (1 in 1 once), Single, Dose 3 (1 in 1 once), Single from an unspecified date to an unspecified date for moderate to severe rheumatoid arthritis and psoriatic arthropathy. It was unknown date (reported as disco) if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history and concomitant medications reported. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported) via unspecified route of administration on an unspecified date as Dose 1, Single and via unspecified route of administration on an unspecified date as Dose 2, Single for COVID-19 immunization. On an unspecified date, patient experienced knee caps out of place to strengthen/ patella dislocation, slipped on ice/fall and made knee swell and ankles/ knee swelling and elbow swelling. Action taken with adalimumab (HUMIRA) was unknown. The outcome of the events was knee caps out of place to strengthen/ patella dislocation and joint swelling was not recovered, and the outcome of other events was recovered on an unknown date.  The reporter's causality for the event(s) of knee caps out of place to strengthen, slipped on ice and made knee swell and ankles and elbow swelling with adalimumab (HUMIRA) was no reasonable possibility.  The reporter's causality for the event(s) of knee caps out of place to strengthen, slipped on ice and made knee swell and ankles and elbow swelling with BNT162B2 was possible.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further inform expected.; Sender's Comments: The evens of fall, patella dislocation, knee swelling and ankle swelling are unrelated to the suspect product BNT162B2 since fall is accidental due to slipping on ice and patella dislocation, knee swelling and ankle swelling are consequential to fall.
Started to notice small bumps on different parts of my body. At first thought they might be bug bites, then later maybe some kind of poison ivy, and then it started to get worse and worse, especially at night. Now, I erupt in full blown hives on different parts of my body (it feels like it is traveling through my blood) so it will pop on up various parts before disappearing and emerging on another. I have been taking antihistamines (allergy medicine). Benadryl lasts for about 4-6 hours when I am at my worst. Allegra as helped, and other allergy meds that last about 24 hours help the most. It has been a few months now and I still erupt in very bad hives if I do not take allergy medication. Before this, I have never had hives like this before. I have searched online and I realized I was not alone with these symptoms.
Pt recvd DTP/OPV 23JAN92 in afternoon & had self limited generalized seizure; recovered w/o sequelae;
Severe chest pain in left side; Heartburn; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Severe chest pain in left side) and DYSPEPSIA (Heartburn) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHEST PAIN (Severe chest pain in left side) and DYSPEPSIA (Heartburn). On 02-Apr-2021 at 2:00 AM, CHEST PAIN (Severe chest pain in left side) and DYSPEPSIA (Heartburn) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Moderna COVID-19 Vaccine EUA; Within minutes of receiving vaccine left side of face/lips/tongue began to tingle....then 2 episodes of rapid heart rate....tingling built in intensity over the next few minutes....no breathing issues...rapid heart rate stopped and after 15 minutes the tingling of face/lips/tongue began to decrease.  Waited for total of 30 min onsite; symptoms of tingling down by 80% when I left the site; had moderate headache for rest of the day; same day as vaccine, within 2 hours all tingling subsided.  Next day, tingling episode began again....called local urgent care center for telehealth call back from MD.  MD called and recommended I immediately take 25mg of benedryl every 6 hrs and 40 mg pepcid
14OCT96 pt adm to ICU w/ 10% dehydration w/u revealed herniated brain & poss asphyxiation;pt on ventilator & outcome looks poor;
very ill for ~1 week. Fatigue and headache. Similar to when I contract COVID Fall 2020.  Have had continued shortness of breath since.
technician was administering pfizer covid shot and as she was injecting the imz, the syringe disengaged from the needle and as a result pt got lower dose than recommended (unknown exactly how much dose got into patient.) i apologized to patient. per cdc recommendation, I repeated the dose with a full amount (done in her other arm.)
Break through positive Covid on 05/10/22. Heavy congestion and severe fatigue. Symptoms are still ongoing. Communicated with doctor via email.
Developed slight fever p/DTP vax; 5 1/2 wks later went into a 75min sz (Grand Mal) was 5 1/2 months then now 19 months is still having uncontrolled sz almost daily.
pt recv vax 18JUN96 & during the evening post vax 18JUN96 pt exp fever, itching, redness, & swelling @ the inj site;sx resolved;next morning 19JUN96 pt exp a swollen, itching, & red eye;sx were treated w/over the counter allergy eye drops;
Swelling around left ear noticed next morning. Bulging/swelling pushed ear out and ear size appeared doubled when compared to other ear. Ear stuck out noticeably. Swelling extended down below ear to neck area. Very troubling.
THE PATIENT RECEIVED THEIR 2ND DOSE AND WAS OBSERVED FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. IT WASN'T UNTIL THE PATIENT WAS HOME, ABOUT 11 HOURS POST VACCINATION, THAT THEY REPORTED SWELLING & ITCHINESS AT THE INJECTION SITE, SWOLLEN, TINGLY LIPS AND SWELLING UNDER THE EYES. THE PATIENT REPORTED TAKING BENADRYL, WHICH EFFECTIVELY RESOLVED THE REPORTED SIGNS & SYMPTOMS.
Temp spikes to 103.5 for 24 hours. Sweats, myalgias and malaise.
Information has been received from a medical assistant referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 06-MAR-2019, the patient received an improperly stored dose of VARIVAX with lot number N023961 and expiration date on 01-SEP-2019, (strength, dose, dose number, anatomical injection site and route of administration were not reported) for prophylaxis. The sterile diluent used for reconstitution of the vaccine was properly stored. It was reported that on an unknown date, the vaccines were exposed to a temperature excursion on 15 F (Fahrenheit) degrees to 46 F degrees (21 F degrees) for 2 hours and 15 minutes. There was a previous temperature excursion reported of 15 F degrees to 46 F degrees for a time frame of 3 hours and 30 minutes. The call was placed because of a Digital Data logger report. No adverse effects were reported.
unusual involuntary movement x 2 in the afternoon during bath temp had been 101 in afternoon, @ home; 2 mins generalized sz in evening; t101.1R in Er shortly p/sz;
1st shot given 3/22/2018. Developed stomach and gas problems within 3 weeks. Went to hospital for multiple visits incuding Er. Developed acid reflux symptoms and Ulcer. Also noted Mesenteric Lymphadenitis. Most disturbing was weight loss of 25 pounds. Plan taking FMLA . .
Patient reported pain and tingling that started 2 days after receiving the Covid vaccine from  the feet and calves then went through the body, the symptom resolved the following day.
Mild headache; Sensation of random but frequent, almost rapid, fluctuating air pressure in left ear causing left eye to water and want to close with fluctuation, and psychologically distressing. Some intermittent ringing in left ear. Intensity decreased over the course of about two hours to the point I could go to bed and just fall to sleep, hoping it would be gone by morning, which it was. My "awake" experience lasted about 2.5 hours.
no adverse event; Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged; We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged), PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged), PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F) 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 POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F).    No concomitant medication was reported.  The vaccine was stored above 46F for a total of 57 hours (for Lot AS7642B). The maximum temperature reached was 48.092F. Lot AS7642B (Bivalent) was delivered on 04-JUN-2023 and placed in the freezer upon delivery. Lot was relocated to fridge on 17-JUN-2023 at 8:00AM and quarantined 19-JUN-2023 at 5pm. 1 open box was impacted. Moderna vaccine may have been used up until 19-JUN-2023. No treatment information was reported.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Specific product reported Yes, specific product known from information provided.     On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
Information has been received from a physician, via a company representative, concerning a female patient in her 20's, who on 30-APR-2007 was vaccinated IM in the deltoid, with a 0.5ml dose of Gardasil. On 04-MAY-2007, "four days post vaccination," the patient developed "red, itchy hives at the injection site." At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Hospital Course: 4/9 off vent 4/11 RRT for AMS, back on vent (was not hypercapnic on ABG done before being put back on vent), sepsis, ID consult 4/14 AECOPD/pulm edema, steroids and lasux started, FEES: pureed diet/thin liquids 4/17 ceftriaxone completed 4/20 LUE WBAT per ortho 4/21 TF changed to nocturnal 4/25 minced/moist diet with thin liquids 5/6 prednisone taper completed 5/8 AKI, IVF started 5/13 junctional tachycardia, sepsis, Klebsiella pneumonia and UTI 5/15 1 PRBC 5/17 1 PRBC 5/19 recurrent fever 5/24 Pseudomonas pneumonia 5/31 Merrem completed 6/6 hemoptysis, subQ heparin stopped 6/7 1 PRBC  6/11 pt expired
Was hospitalized (unsure dates on hospitalization);  has no known pre-existing conditions; symptom onset was 3/3/2021 with fever, chills, rigors, myalgia, rhinorrhea/congestion, sore throat, cough (wet productive), nausea/vomiting, headache, loss of smell and taste, and fatigue.  Was a household contact to a known COID-19 case.
After first covid  dose on  1/8/21 I had side effects : chills , fever , headache , myalgia  I was off five days from work . Then my second dose COVID on 2/5/21: I started to have Ill effects on Saturday Eve 2/6/21 fever , chills , headache , nausea / vomiting , myalgia not as bad as first dose . Symptoms of headache , chills , nausea / vomiting  and fatigue persisted . I was seen by my pcp on 2/11/21.  I was still not feeling well and felt weak and dehydrated . I had blood work and was prescribed zofran . I am filling this out today 2/12/21 ,  I still am not feeling well with headache and fatigue noted . Zofran was effective .  I was told to complete this form  by the hospital  triage nurse yesterday . Triage nurse documented my symptoms and directed by care to pcp for follow up .
Pt felt dizzy. Pt shaking and weak after 3 vaccines given. Sucker and water given. Pt examined by nurse practitioner then released.
warm; swelling; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, 1 week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the patient experienced injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patientr received dose of Shingrix in the left arm  in the beginning of December 2019. A week later the injection site area started to swell, 3 to 4 weeks ago the swelling started to progress and was now present down her arm to the crease. Less than 2 months after vaccination, the patient experienced injection site warmth. The reporter stated that, recently  has also become warm to the touch. The reporter consented to follow up.
Experienced low grade fever (100F) and chills.  Lasted for 6 hours.
The patient received the third/booster dose of BNT162b2; Left axillae lymphedema; This is a spontaneous report from a contactable physician. A 74-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included hypersensitivity lung disease (HLD), hypertension (HTN), hypothyroidism, osteopenia and penicillin (PCN) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date; both as single doses for COVID-19 immunisation. On an unknown date, the patient experienced left axillae lymphedema. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left axillae lymphedema was resolved on an unknown date.  The lot number for BNT162b2 was not provided and will be requested during follow up.