chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 11 year old patient (gender not provided) who on 26-DEC-2017, was vaccinated with improperly stored dose of GARDASIL 9 lot number: N021475 and expiration date: 31-JAN-2020, (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported.; Sender's Comments: US-009507513-1801USA008060:
Pt received Flu vaccine and pneumovax in right arm.  Not sure which site was which vaccine.  The lower injection site has a reddened slightly raised, hot area 3" in diameter. Below it, in the inner elbow area is an area of red, hot raised, tender tissue about 4" in diameter.  Pt c/o fever and chills 9/10 pm and was seen in ER by Dr. who called it a cellulitis-like reaction.  Pt is taking Benadryl, tylenol and using ice to the area.  The right arm has decreased mobility due to this.  Temperature last night in ER was 99.3F and this a.m. was 99.5F. At time of vaccination, pt stated she had not had pneumonia vaccine previously.  She stated today that after her vaccination she went home to find her shot record and found that she HAD had a pneumonia shot 7/20/04.  She has celiac sprue disease and stated she wanted to be sure that her immune system was protected since she had this diagnosis.
Had two doses of Shingrix, got shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala) unknown for asthma.   Concurrent medical conditions included bronchiectasis and asthma.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 11th November 2022, the patient started Nucala at an unknown dose and frequency. On 12th November 2022, unknown after receiving Shingrix and Shingrix and not applicable after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). The action taken with Nucala was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Nucala.     Additional Information: GSK receipt date: 07-DEC-2022 Reporter's comment: The patient reported that she had the Shingrix vaccine soon after it came on the market.  She had the two complete dose series of Shingrix.  She started Nucala about a year ago in 2021.  On 11th November 2022 she had the Nucala dose at the physician's office. She came down with shingles on 12th November 2022.  She visited her physician, who prescribed valacyclovir and she took it for 7 days.  She was completely recovered from shingles.  The reporter was consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
2 days p/vax c/o aching in the neck area; 15SEP92 devel rash & then shingles;
Child developed fever on 7/12/2003 and broke out into a rash all over her body on 7/14/2003.  To be seen by E.R. doctor on 7/15/2003.  Rash persists.
This case was reported by a nurse to a sales representative and described the occurrence of heart failure in a 31 year old male pt who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix). On 09/27/04 the pt received a dose of Twinrix (dose # not specified, Lot # HAB306B6).  Concurrently, the pt received an unspecified antibiotic (indication not reported). Approximately one day after the administration of Twinrix, on 09/28/04, the pt experienced heart failure. The pt "was seen in the ER."  The immunization series with Twinrix was discontinued. The outcome of the event is unknown. Comment: Heart failure was assessed as medically serious by manufacturer (OMIC). Follow up report received 03/21/2005:  Death 1-2 weeks post event.  Diagnosis possibly seizures.
New onset of seizures within 24 hours of vaccine administration. Child has never had seizures prior to this.
Narrative:  COVID infection following COVID vaccine series 01/13, Pfizer, dose #1 02/03, Pfizer, dose #2, Pfizer, dose #3 pt cc: exposure: unknown 01/03 pt admit to ED cc: COUGH/CONGESTION/DECREASED/DECREASED APPETITE, CHILS AND MILD HEADACHE dx: COVID-19 INFECTION, ATYPICAL PNEUMONIA LOS: 1 day 01/03 CXR impression: Bibasilar brochovascular crowding and atelectasis with no discrete focal airspace consolidation.
I tested positive for COVID-19. I have a cough and sore throat. The doctor prescribe Paxlovid.
Short of breath treated in ER swollen tongue 5 days of steroids antihistimines
Menstrual spotting following the first shot of the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 19Apr2021 at 09:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 19Apr2021, the patient experienced menstrual spotting following the first shot of the vaccine. The events 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 menstrual spotting following the first shot of the vaccine was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24 hours after 3rd  injection, had a fever, sweating and body aches that lasted a day.  A week later I had a mild crohn's and arthritis flare up with extreme fatigue and ovarian pains that lasted all week. Just felt unwell overall.
Rash arms and legs, feels hot, feels weird. Benadryl 25mg PO given. Rash persisted - sent to private physician.
Headache severe fatigue, sore arm Narrative:  on 1/6/21 and 1/7/21 sever sore arm it woke me up at night. also experienced headache
Caregiver reported three dots on patient?s back and what looked like three claw marks where injection site had been
patient came in today stating that his right arm still hurts significantly from the shot he received on 4-05-2019. said that the muscles in his arm will tighten up and then relax after an hour or two repeatedly throughout the day. externally, his arm has no signs of redness, swelling or infection. advised pt to see a doctor if symptoms continue
Breakthrough case admission after three vaccines  Moderna 3/11/21 Lot# 040A21A;  4/8/21 Moderna Lot# 028A21A;  Moderna 7/20/22 Lot# 006M21A
Hurt to lift her arm; Swelling at the top of her left arm; Headache; Fever; This case was reported by a consumer and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain in arm, headache, fever and swelling arm. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, headache and fever were recovered/resolved and the outcome of the swelling arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm, headache, fever and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by consumer's spouse. The patient had the 2nd dose of Shingrix in December, 2020.  Either that night or the next night, the patient experienced a higher Fever of 101.5 degree Fahrenheit for four to eight hours, a severe Headache for six to twelve hours, the patient continues to had Swelling at the top of her left arm.  The patient had a swollen band around the top of her arm which make it hurt to lift her arm. The patient started prednisone last night and was feeling better today on the day of reporting. The reporter consented to follow up. The case had been linked with US2021AMR008109 1st dose of the patient reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008140:Husband's 2nd dose US-GLAXOSMITHKLINE-US2021007475:Husband's 1st dose US-GLAXOSMITHKLINE-US2021AMR008109:same patient, 2nd dose
Fever on and off, site of injection red and tender - swollen to the size of a tennis ball and warm to touch. Sore throat, fatigue, rhinitis. Swelling almost resolved by 4/17/14.
After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme soreness in my arm -The lymph nodes under my arm pit was swollen and tender -I broke out in hives on my hands and face -I had a rash on my tongue -A knot on the bottom of my right foot [in the area of the arch] -The skin on both of my hands have been  peeling extremely bad
At 1243 pm within 20 minutes of getting the vaccine the pt had trouble seeing and hearing for few minutes which resolved with no problems. She went to internal MD and became light headed and lost her balance & fell down. 12:39 90/60 R-18 HR 92, 12:43 110/80, HR 95, R 20, 96.7, 1:00 99/67, HR 92, Res 20. Feeling much better no longer dizzy.
This report describes the occurrence of joint pain. This pt received 2 injections of lyme vax. Pt experienced fatigue, joint pain, knee pain, weakness, fever, and chills post second vax. Pt reported missed 8 days of work and was referred to an infectious disease specialist. All symptoms are resolved except the fatigue. Please note that these events of joint and knee pain do not meet ICM serious criteria, but are being submitted expeditiously for informational purposes. FU information states the pt is a landscaper with frequent exposure to ticks.
LOW GRADE TEMP OF 100 DEVELOPED 3 DAYS AFTER VACCINE. COUGH DEVELOPED AFTER THAT.
Within 15 minutes my vision began to blur, I became shaky and disoriented. My heart rate increased and it felt as though my blood pressure decreased rapidly. After 30 minutes my symptoms had worsened and I was so disoriented I was not able to seek medical attention while being observed. I exited the building and once I got into my car my face (specifically under my eyes and on my cheeks) began swelling and a red burning rash appeared. By the time I got home (10 more minutes) I needed Benadryl immediately, I was not able to complete my sentences and all other symptoms had become more intense. I continued to take Benadryl every 4 hours for the next few days due to the symptoms consistently rebounding. I had one episode of throat tightness but it passed without use of my epipen. I checked my pulse and blood pressure frequently with the lowest reading being 93/60. Lethargy, shakiness, confusion, high heart rate all are still present after 5 days. The rash went away after 48 hours.
Patient received the vaccines on 9/16/2019 at.  on 9/17/2019 patient started  having fevers, chills, myalgia and vocal cord paralysis. After the second shingrix vaccine  was given on 2/20/2020 patient had no issues.
Developed right sided facial numbness; numbness of right side of anterior tongue; numbness progressed to some facial pain as well; This is a spontaneous report from a contactable Other Health Professional (patient).  A 47-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the right arm, first dose given on 23Dec2020 12:30 at a single dose for COVID vaccination. Medical history included asthma, seasonal allergic rhinitis and Bell's Palsy affecting that side of the face. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. He was not diagnosed with COVID-19 prior to and post vaccination. The patient previously took and had allergies to Keflex, Vicodin and Motrin. It was reported that the patient developed right-sided facial numbness and numbness of right side of anterior tongue. These occurred within 10- 15 minutes of vaccine administration on 23Dec2020 at 12:45 PM. It was mentioned that the patient has history of Bell's Palsy that was affecting that side of the face. The patient had numbness progressed to some facial pain as well. Symptoms lasted for 6 days and slowly abated with prednisone treatment which was given at 20 mg BID (twice a day) x 5 days. The events were reported as non-serious. The outcome of the events patient developed right-sided facial numbness and numbness of right side of anterior tongue and numbness progressed to some facial pain as well was recovering.
fever blisters after the administration of Shingrix / developed fever blisters several days after the second dose administration; itchy but not painful; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number J75L9, expiry date 10th October 2022) for prophylaxis.   On 2nd January 2021, the patient received the 2nd dose of Shingrix. On 5th January 2021, 3 days after receiving Shingrix, the patient experienced fever blister and pruritus. On an unknown date, the outcome of the fever blister and pruritus were unknown.   It was unknown if the reporter considered the fever blister and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 64 or 65 years. The patient received 2nd dose of Shingrix, 20 days prior to date of reporting. The patient developed fever blisters, which were itchy but not painful, several days after the 2nd dose administration. According to healthcare professional the patient had no shingles. The reporter did not want to share personal information for patient. The reporter consented to follow up
pinching on the left side of my rib cage; pinching on my arm pit; tingly sensation; tip of the tongue is numb; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (pinching on the left side of my rib cage), PAIN IN EXTREMITY (pinching on my arm pit), PARAESTHESIA (tingly sensation), HYPOAESTHESIA ORAL (tip of the tongue is numb) and HEADACHE (headache) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (pinching on the left side of my rib cage), PAIN IN EXTREMITY (pinching on my arm pit), PARAESTHESIA (tingly sensation), HYPOAESTHESIA ORAL (tip of the tongue is numb) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL CHEST PAIN (pinching on the left side of my rib cage), PAIN IN EXTREMITY (pinching on my arm pit), PARAESTHESIA (tingly sensation), HYPOAESTHESIA ORAL (tip of the tongue is numb) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported.
Per Alert profile and VAR this person received 2 Moderna vaccines, first dose on 2/19/21 and second dose on 3/19/21. Per Alert profile they also received a 3rd dose on 3/26/2021.
Hives covering body within 25 hours of administration  of vaccine; extreme pruritus needing MD visit for  corticosteroid treatment. Reported 6/16/19 at 2PM
Resident was due for a 2nd dose moderna vaccine (0.5mL) but received the booster dose of (0.25mL)
7mm Raised, red, very warm to the touch, injection site that itches, increased sleepiness.
Subsequent to receiving one dose of varicella virus vaccine live, pt experienced chickenpox with approximately 15-20 lesions. Pt was afebrile. Pt was treated with Aveeno baths for itching.  Approximately one week later pt experienced ear pain and was seen by a physician.
3-19-21 felt soreness in arm / shoulder after first vaccine. Pain continued and worsened over the next two weeks but I assumed it was a side effect. By 4-8-21 the pain  was still unbearable but vaccine #2 was scheduled for the next day . ( 4-9-21). I went and asked nurse if it was still safe to have second vaccine and she said it was , vaccine done ( no side effects ) in the right arm. I made appt. with doctor as I was still in severe pain in left arm/ shoulder area, had little use and very limited mobility. Pain and soreness caused lack of sleep for two weeks. I was prescribed Prednisone and Norco. There was little improvement . Was prescribed Naproxen and had my first physical therapy appt. on Friday, 4-23-21.  Everything is out of pocket for me but I need my injury fixed.
The morning after the injection, the arm and shoulder area were very sore for 48 hours post-vaccine. The pain moved into the axilla region and persisted for another 48 hours.  There were no problems for approximately 48 hours, then the injection site became itchy and a small rash developed around the injection site.  The rash and itchiness continued for 48 hours, after which the itchiness subsided, but the rash was still visible and had doubled in size lasting for approximately 72 hours.
15 year old male patient came in for the vaccine and the age was missed at registration as this category was not eligible at the time of the first or second vaccine to receive it. Patient had no adverse reactions, this was merely a deviation related to age. Patient became eligible on 5/13/2021 when 12-15 year olds were able to get the vaccine of the same dose and brand that was initially provided.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-MAR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5 ml dose (rHA, lot # L008684, expiration date 13-MAR-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion for eight times. The total cumulative excursion time of the first time was 24 hours with the highest recorded temperature of 7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the second time was 360 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the third time was 24 hours with the highest recorded temperature of 6 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the fourth time was 24 hours with the highest recorded temperature of 8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the fifth time was 24 hours with the highest recorded temperature of 11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the sixth time was 72 hours with the highest recorded temperature of 15 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the seventh time was 248 hours with the highest recorded temperature of 9 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the eighth time was 144 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist, received via a Pfizer sales representative. A male patient in his 70s of an unspecified ethnicity received PREVNAR 13 in a Pharmacy/Drugstore, intramuscular on 11Sep2017 at 0.5 ml, single as pneumonia vaccine. The patient's medical history and concomitant medications were not reported. The patient received a shot at a Doctor's office on Monday, 11SEP2017 in the morning. The pharmacist thinks it was a flu shot. Then the doctor gave the patient a prescription for pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) the same day. The patient went into the pharmacy that afternoon on 11SEP2017 to receive the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The pharmacist administered pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). Then the patient came back to the pharmacy on Friday of unspecified date in Sep2017, and reported that on the night he received the injection, 11Sep2017, he had so much pain he could not sleep and it had progressed to numbness. It was clarified that, the pain went away and the patient was alarmed since he started having numbness in the arm (Sep2017). The pharmacist instructed the patient to apply a cold compress and consult his physician if it does not get better. The outcome of the event pain was recovered on an unspecified date. The outcome of other events was unknown.