chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX. Concomitant products included fluoxetine, Lisinopril, metformin and simvastatin. On 17th May 2018 15:20, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. In May 2018, less than a week after receiving SHINGRIX, the patient experienced feels awful. On 17th May 2018, the patient experienced sore throat, headache, injection site pain, chills, general body pain and influenza like illness. On 17th May 2018 22:00, the patient experienced fever. On an unknown date, the outcome of the fever, sore throat, headache, injection site pain, chills, general body pain, influenza like illness and feels awful were recovered/resolved. The reporter considered the fever, headache, injection site pain, chills and general body pain to be related to SHINGRIX. It was unknown if the reporter considered the sore throat, influenza like illness and feels awful to be related to SHINGRIX. Additional details were provided as follows: By 22:00 to 22:30 hours that night, 6 hours and 40 minutes to 7 hours and 10 minutes, after vaccination, the patient experienced fever of 102.4 degree F. Less than a day after vaccination, the patient experienced body aches, injection site pain, headache, sore throat and chills and felt like he had the worst flu he had ever had. The patient had some slight pain at the injection site, but it was not that noticeable. The other symptoms were terrible. Less than a week after vaccination, the patient feels awful. The patient just felt awful for the next few days. On 21st May 2018, the patient was close to normal, so the symptoms had resolved.
11/10/11 - 11:30 AM - Vision migraine. 11/11/11 - 11:30 - Vision migraine. 11/13/11 - 2:00 AM - Vision migraine. Took PRODRIN.
This spontaneous report was received from the patient's parent via social media via a company representative, concerning a female patient of an unknown age. There were no concurrent conditions, medical history or concomitant medications reported. On unspecified dates, the patient was vaccinated with the GARDASIL series (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. It was reported that each shot in the series got worse for the patient and she was so sick. At the time of the report, it was unknown the outcome of the malaise. The causality between the adverse event and GARDASIL was unknown.; Sender's Comments:  US-009507513-1706USA000467: US-009507513-1706USA000478: US-009507513-1706USA000483:
This case was reported by a physician via other manufacturer and described the occurrence of loss of vision in a 17-year-old female patient who received MENVEO. Co-suspect products included TRUMENBA. On an unknown date, the patient received MENVEO at an unknown dose and TRUMENBA at an unknown dose. On an unknown date, less than a day after receiving MENVEO, the patient experienced loss of vision (serious criteria GSK medically significant), fever and fatigue. On an unknown date, the outcome of the loss of vision, fever and fatigue were recovering/resolving. It was unknown if the reporter considered the loss of vision, fever and fatigue to be related to MENVEO. Additional details were provided as follows: This case was reported by a Pfizer sales representative. The patient's medical history was unknown. The patient received MENVEO and TRUMENBA vaccine on the same day and the patient ended up having fever, fatigue, loss of vision, everything get black with spot. The events were improved after 24 hours. As per reporting sales representative, the doctor initiated about adverse events and medical assistant provided further information. The reporting sales representative mentioned that the physician was surprised that it happened with TRUMENBA and MENVEO together because they had given TRUMENBA separately as well, but did not see anything so they were concerned with certain things and they were wondering if it was because they have given them together. The reporting sales representative had limited information and did not have any email address of Physician. This case was not associated with product complaint and there was no medical information request.
15sep95 pt recv vax; same day pt devel hives, on 01may97 pt was admitted to hosp w/ severe asthma. pt exp respiratory compromise & was incubated & ventilated. pt was thought to have a bacterial superinfection. pt also exp pneumonia,
Started with golf ball size fluid filled ball on knee cap appearing 11/23/22 which progressed to Very large Right knee/leg bruising of unknown origin measuring 6 inches a-crossed knee area and 10 inches up/down leg/knee. No known injuring creating this event
At 12 hours post vaccine I experienced the abrupt onset of headache, fever, chills, joint pains. The joint pains were so severe that I had trouble standing and was in bed for approximately 10 hrs. Highest temp recorded 101.9 orally. 90 days later I had the abrupt onset of R cervical pain, followed by bilateral thumb and forefinger pain and numbness. At 120 days later I experienced diffuse joint pain, particularly of the hands, wrists shoulders with marked swelling of the carpal phalanges joints of both hands and profound selling of the dorsum of the R hand. Intermittent hand, finger, foot swelling continues. Whenever the joint swelling re-occurs, my blood sugar and pancreatic function also deteriorates.
Information has been received from a registered nurse concerning a 25 year old female patient who on 29-SEP-2009 was vaccinated by the nurse with 0.1mL of MMR II (Lot #665207/0871Y (rHa)) intradermally instead of subcutaneous.  There was no concomitant medication.  The nurse stated that she thought she was administering a tuberculosis shot, but that it was a staff error only.  The patient sought unspecified medical attention.  No adverse affects reported at the time of the report.  Follow up information has been received from a registered nurse who reported that on 29-DEC-2009 (previously reported as 29-SEP-2009) the patient was vaccinated with a dose of MMR II due to a staff error and not product confusion.  The vaccine was labeled correctly with an office label.  No further information is available.
pt recvd vax & w/in 1 hr devel h/a, nausea, vomiting & dizziness which lasted for 24 hrs;
PATIENT  RETURNED TO CLINIC WITH RED,SWOLLEN, AND FIRM LEFT ARM THE SIZE OF A SMALL BASEBALL. PATIENT STATES SHE APPLIED COOL COMPRESS TO AREA THE NIGHT BEFORE BUT AREA HAS GOTTEN WORSE SINCE THEN.
The pt experienced a high fever for 3 days ranging from 103-105. The pt also experienced a poor appetite, irritability, crying, spells for 4 days. "Would turn blue especially around the mouth and extremities shock.
Information has been received from a nurse practitioner concerning a patient over 65 years old who on approximately Nov 15 2004 during the past month was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650082/0691P). During the past month, the patients arm was swollen affecting the whole arm, with warmth, tenderness and redness after the swelling was resolved. The patient also had difficulty raising the arm. It was noted that the patient was afebrile. The patient was treated with ice packs and ibuprofen, it was reported that the patient is recovering. The reporter was unsure if the patient was previously vaccinated in the past. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pt presented 11/6/03 with significant inflammation of left upper arm. Plan of Tx included Benadryl, cool compresses and Alotin. Will return 11/7/03.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Date the vial was initially stored in the refrigerator was 04Nov2021. Dates of administration of vaccine were 05Nov2021 and 12Nov2021. The vial didn't undergo any temperature excursions.
experienced dizziness; ultra high blood pressure reading for one day; headache; no appetite; flushing; weakness in legs; fatigue; malaise; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A 81-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 14:00 (at the age of 81-years-old) as Dose 2, SINGLE for COVID-19 immunization. The patient medical history had not reported. The patient had not any allergies. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient had not received any other vaccine within four weeks prior to vaccination. The patient had not received any other medication within two weeks prior vaccination. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 19:00 (at the age of 81-years-old) as Dose 1, SINGLE for COVID-19 immunization. On 21Feb2021 07:00 after the second dose of vaccination, the patient experienced dizziness, ultra-high blood pressure reading for one day, headache, no appetite, flushing, weakness in legs, fatigue and malaise. It was reported no side effects at all initially from either vaccination but after second shot on the 4th day after patient experienced dizziness, ultra-high blood pressure reading for one day, headache, no appetite, flushing but no fever, weakness in legs, fatigue, malaise...lasted 4 days and then reverted back to totally normal. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: ultra-high blood pressure reading for one day. The patient had not received any treatment for the adverse events. The outcome of events was recovered on an unspecified date.  Information about Lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Severe Headache; This is a spontaneous report from a non-contactable consumer (Patient).   A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6198), via an unspecified route of administration in Right arm on 25Feb2021 10:00 Am (43-year-old at the time of vaccination) as single dose for covid-19 immunisation. Medical history included asthma and Sulfa allergy (drug hypersensitivity). Concomitant medication(s) included escitalopram oxalate (LEXAPRO) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient did not receive any other vaccines in 4 weeks. Other medications the patient received in 2 weeks includes Lexapro, Zyrtec. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On26Feb2021, at 04:00 Am, the patient experienced severe headache on. No treatment was received for event. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient received first injection left deltoid in April; 2 weeks later swelling and pain with reduced range of motion to the left shoulder.  Received second injection right deltoid in May; 2 weeks later swelling and pain with reduced range of motion to the right shoulder and worsening persistent symptoms to left shoulder.  Symptoms are persistent.  Not related to Sickle Cell Crisis; has been seen by specialists.
Hives.  This did not happen in our office but occurred where she worked.  I believe treated with benadryl.  Did not require epipen.  Resolved with treatment and no further symptoms.
A dose of the Pfizer Bivalent 30mg/0.3ml was given to an 11 year old child on 9/24/22. Spoke with the legal guardian on 9/27/22 and the child experienced no adverse side effects from this dose.
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
About 18:00 on 1/22/01, she had 1 diaper of severe diarrhea and no more. About 7 or 8 PM, she began vomiting and vomited everything. Mom was finally able to give her a bottle about 23:59. Baby had fever and vomited again at 02:00 on 1/23/01 (temperature was 100.3F). Had Tylenol hours before she vomited and more after. Then baby went limp and turned white as a ghost. Could not wake her up. Went to ER. Stayed with way 2-3 hours. Began responding better at hospital. Color back the next day. Temperature 100.3F (A) at 10:00 and 20:30 was 100.8F. Refused to eat but did take about 8 oz fluid on 1/23/01. Had only 2 wet diapers from 05:00 to 23:00 on 1/23/01. Went to PMD on 1/24/01 with dx of tonsillitis.
I received the vaccine on 12/20/21 and on 1/1/22, developed an extremely itchy scalp and hairline. The following day (and every day since), I have experienced full body hives on my neck, ears, arms, legs, and trunk. They come and go but are consistent throughout the entire day.
I couldn't relate the two at the time thought maybe I slept on my shoulder. The pain I was experiencing was at the injection thinking it would go away. After time I went to a Orthopedic doctor was prescribed Meloxicam for one month. When the dosage was completed the pain returned I went back to the doctor. I was referred to the physical therapy. My right arm still has discomfort from the site of the injection especially when lying down at night. I'm scheduled for tomorrow to have MRI done.
Hardness of right breast; Deep-deep burning in my right breast / pain in my breast / burning pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: EH6206) at the age of 84 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2005 (unspecified if ongoing); "Cancer surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 09Mar2021 05:00, outcome "recovered" (Mar2021), described as "Deep-deep burning in my right breast / pain in my breast / burning pain"; BREAST INDURATION (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Hardness of right breast". The events "deep-deep burning in my right breast / pain in my breast / burning pain" and "hardness of right breast" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast pain.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 01May2021 as dose 2, single (Lot number: EW0167), in left arm and on 27Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "past history of breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 11Aug2023 to 16Aug2023.
Information has been received from a 68 year female patient referring to herself. The patient had high blood pressure and thyroid condition and was taking "blood pressure medication and thyroid medication" concomitantly. In 2009 (reported as " 7 years ago" at the time of this report), the patient was vaccinated with a dose of ZOSTAVAX (dose and route unspecified). On 11-JUL-2016 (reported as "two weeks ago" at the time of this report), they broke out with shingles. The patient sought an unspecified medical attention and treatment was given for the event. The outcome of the event was unknown. Additional information is not expected as we were not permitted to contact physician.
My first two shots were through Moderna. I had a mild/moderate reaction, (previously reported), so under the care of my PA, I switched to Pfizer for the booster and pretreated with 50mg of benadryl. Within an hour, I began to feel a slight itching  under my skin all  over, but mostly in the arms and torso. My throat also felt 'fuzzy', like when a body part is waking up after fally asleep. No airway obstruction.  As I neared the four hour mark when I could take benadryl again, the symptoms intensified. This cycle continued for the first two days. I continued to take 50mg of benadryl  every four hours for the first 48 hours, and then decreased to 25 mg. By day two, I  developed a rash on my chest and torso. Days three and four, I  felt dizzy, light headed, and developed a severe migraine. On day five, my eyes swelled to the point they could not be opened. I went to urgent care and was given a steroid injection, which decreased the swelling. I am continuing to treat with prednisone and benadryl  for the next few days.
After the vaccine my father had a short memory loss at 2:00 am. He didn?t remember anything for about 3 hours.
Shot in left bicep, but two days later, bad pain in right wrist/forearm.  No injury.  No overuse.   Pain going on 12 plus hours
Within 2 minutes of giving DTaP the area became red/inflamed about 4cmx6cm with hives in area of induration.
fatigue/ Tiredness; Headache; Shivering; Fever; Arm pain; This case was reported by a consumer and described the occurrence of tiredness in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2021, 1 days after receiving Shingrix, the patient experienced tiredness, headache, shivering, fever and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the tiredness, headache, shivering, fever and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, headache, shivering, fever and pain in arm to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The patient received dose of Shingrix on left deltoid at a clinic and on 27th July 2021, around mid-day she started experiencing side effects which are fever, shivering, headache, fatigue, tiredness, and arm pain.   The patient was currently taking Tylenol to treat the symptoms. From the time the symptoms started, they are getting worst, and therefore she took Tylenol. The patient mentioned that she had  colonoscopy and endoscopy procedure earlier and perhaps the tiredness and fatigue could be due to the procedure, but the patient was unsure.   The reporter did not asked further questions about the procedures(colonoscopy and endoscopy). The reporter did not had a lot number/expiration date and dose of Shingrix. The reporter gave a consent to follow up with HCP. However, the reporter did not had phone/ fax number and an email address to HCP. The reporter provided her email address.
COVID 19 Treatment; COVID 19 Treatment; Vaccine dose number=1, Vaccine lot number=GJ5342 / Bivalent Lot administered as Dose 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 13:00 as dose 1, single (Lot number: GJ5342) at the age of 67 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites. The patient's concomitant medications were not reported. Past drug history included: Atovaquone-proguanil hcl for Known allergies: Atovaquone-Proguanil Hcl, notes: Known allergies: Atovaquone-Proguanil Hcl.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Sep2022 at 13:00, outcome "unknown", described as "Vaccine dose number=1, Vaccine lot number=GJ5342 / Bivalent Lot administered as Dose 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid given as treatment of covid-19 from 18Mar2023 to 22Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Became lightheaded , sweating, faint, about 10 min after shot. EMS called
Patient received the vaccine on Friday afternoon 4/16, on Saturday, she noticed redness and inflammation on her face of the right side.
Patient experienced lip swelling post vaccine #1, which resolved with 50 mg oral Benadryl administered by EMS standing by. No transportation to hospital needed. Today at vaccine #2 she experienced a cough, and was assessed by EMS. Per EMS no adventitious breath sounds noted, no wheezing and no concern with PS02 sats. 50 mg Benadryl administered today. and she reported relief felt. Patient stated that she was in contact with her oncologist who "wasn't crazy about me getting the shot," but "he said it was up to me." No transportation needed.
Pt recv vax on 10/7/98; on 10/15/98 pt exp Rt arm numbness & weakness; dx=Parsonage Turner syndrome, mild arthritis/tendonitis
Allergic reaction, respiratory type; sore throat, earache, chest congestion, cough, sinus pressure, difficulty concentrating/thinking, dizziness, fatigue.
Information has been received from a registered nurse referring to a patient of unkonwn age and gender. Information about medical history and concurrent condition was not reported. On 23-DEC-2014 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006262 with expiration date of 17-DEC-2015; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.