chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt started having burning, tingling, pain and numbness in his right arm about a week and a half after he received these vaccines in the same arm. He said at first he didn't think about the shots because his wife didn't have any adverse effects and she had gotten the same ones on the same day and in the same arm. However nothing has shown up on x-ray. His Dr couldn't see that anything was physically wrong. When he asked his Dr about the possibility of it being the vaccines they told him it was not at all likely. He has tried several OTC pain meds: Ibuprofen, APAP, and naproxen. He has tried topical pain relievers as well and nothing has really helped at all. He is planning to go back to the Dr next week with some additional information I gave him regarding another case I have seen with similar effects. That patient finally went to a neurologist and they determined it was from the vaccine being given too high in the arm and damaging a nerve.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with ROTATEQ (lot# not reported). Subsequently the patient experienced with a mild to moderate case of rotavirus. It was unknown how many doses of ROTATEQ and when did the patient vaccinated. The patient sought medical attention via office. At the time of the report, the patient status was unknown. Additional information has been requested.
Chills, muscle aches, dizziness. Symptoms caused me to go to bed early that evening. I had some difficulty sleeping. Starting about 12 hours after the onset of symptoms, the symptoms slowly started to improve, and were essentially gone about 24 hours after onset.
Here for fasting labs as f/u from recent physical. He also is here for left arm swelling. 4/13/16 received Tdap vaccine in left. arm. 2 days later got a pain in left axilla/lateral chest wall, had some swelling in same area. Area has remained about the same. No erythema, no warmth. No arm swelling, no numbness, tingling or pain otherwise. No recent injury, trauma, no fever, no NVD. No other aggravating or relieving factors. No other complaint.
Itchy rash on arms and legs w/in 24 hours. Subsiding w/in 24 hrs.
A registered nurse reports that while another RN was preparing Oncotice, she was squirted on her hand by some of the medication.  She immediately washed her hands with soap and water, then with bleach.  One day later she developed some blisters and sores on her finger around her ring.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a female patient of an unknown demographics who experienced feel itchy and broke out in hives, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history includes vaccination with FLUZONE. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1801, expiry date: 29-May-2019 in the left deltoid. On an unknown date, the patient developed a non-serious feel itchy (pruritus) and broke out in hives (urticaria), three hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that the hives were mostly on her face, with a few scattered over her body. There was no local reaction at the site (left deltoid), She did not receive any other vaccines at the same time. Relevant tests were not reported. Final diagnosis was broke out in hives and feel itchy. The patient was treated with BENADRYL 25 mg. The patient was recovered from the event of hives and outcome of the feel itchy was not reported. Documents held by sender: none.
developed sx and tested positive for covid 1/12/2022 on Abbott ID now molecular test has had 2 doses of Janssen covid vax- 2nd dose listed above (booster dose)
expired dose administered; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Reporter stated that between 06 January 2022 and 11 January 2022, there were a total of 69 administered doses of Lot 012H21B. On 06 December 2021, reporter placed Lot 012H21B vials in their refrigerator.
2 wks prior to flu HD & pneumo, patient was stung multiple times on (L) upper arm by a yellow jacket wasp. After immunization the areas around the stings became very inflamed.
Admitted 4/13/21at 39 weeks for planned primary low transverse Cesarean Section due to velamentous cord insertion. CS was uncomplicated. APGAARs 8 and 9, weight 6lbs, 10oz. On 4/14/21 patient got up to take a shower. After her shower she felt like her left leg felt ?tight? and was more red in appearance. She denied pain. She reports that leg got more swollen at one point in pregnancy as well. OBMD in to assess patient. Vascular US ordered and revealed extensive DVT from calf to groin on the left. Patient received her 2nd dose of Moderna 4/6/21.
Employee complained of a "very mild headache," that she attributed to being a little dehydrated. Water given to employee. Symptoms resolved with no other issues.
After my 2nd shot Im having burning eyes.; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (After my 2nd shot Im having burning eyes.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced EYE IRRITATION (After my 2nd shot Im having burning eyes.). At the time of the report, EYE IRRITATION (After my 2nd shot Im having burning eyes.) outcome was unknown.            No concomitant medication listed.  No treatment information reported.
Left arm had swelling, redness and very sore (much worse than first shot!) starting that evening.  I had a restless night due to just not feeling well.  I got up at 6:30 am Saturday, Jan. 16, with a horrific headache and just not feeling right.  Had to fly on a plane for a meeting at 10 am.  While in the airport I felt very nauseous and although wanted to take ibuprofen for headache and sore muscle feeling, I couldn't.  I put the vomit bag in my hand during the flight just in case.  I never threw up but felt terrible.  Upon arriving to the hotel, I checked in, chanced taking ibuprofen due to such a bad headache and went to bed for 1 1/2 hrs as I had no energy.  When I woke up I went to my meeting and began to experience itching on my chest and stomach.  About 4:30 my headache lessened and I could focus on the meeting better.  That night I noticed a few red bumps and continued itching.  By the next morning I had red scabby bumps on my chest and stomach.  No headache.  But tingling on the left side of my neck and jaw.
The patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00453109) and transmitted to Sanofi on 29-Jan-2021.  This case involves a 63 years old male patient who received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot C5578AA, expiry date: 28-Jan-2021, injection) via intramuscular route in the left deltoid for prophylactic vaccination on 29-Jan-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  The reporter stated that he gave an injection of an expired Tenivac vaccine and wanted to know what to do now. The health care professional asked for appropriate follow-up after expired vaccine was given  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Developed 2cm localized erythema surrounding MMR and VZV vaccine inj. sites with urticarial wheel.  No difficulty breathing or other reaction.  No treatment.  Called family 23 hours later - "bumps" decreasing in size - baby doing well.
Erythema, irribility, swelling, pain noted on right thigh on the evening of 02/26/2002. No fever. Seen in clinic the next day, still mildly erythematous in 8.5x7.5 but fading.
Felt pressure in his head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 14:30 (Lot number: EP7534) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: high blood pressure; "High cholesterol" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID; HYDROCHLOROTHIAZIDE; LEVOCETIRIZINE; FENOFIBRATE; VITAMIN D3; VITAMIN-C; ZINC; ASPIRIN. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer,, lot number= ENG198,, lot unknown= False,, administration date= 28Feb2021,, administration time= 02:00 pm,, vaccine location= Left arm,, dose number=1), administration date: 28Feb2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: HEAD DISCOMFORT (non-serious) with onset 21Mar2021 15:30, outcome "recovered", described as "Felt pressure in his head". Therapeutic measures were taken as a result of head discomfort.  Additional Information: Facility type vaccine: School or Student Health Clinic. If other vaccine in four weeks: No. Patient recovered: Recovered. If treatment ae: Yes. Treatment ae: took advil. Covid prior vaccination: No. Covid tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.
The following day, post vax, pt had soreness in the area of injection. For the next 3 days, I felt the same soreness. I was also unable to move my arm. There was a big red spot about 4" where I received the shot. Pain was so sharp I could not sleep.
stiff arm immediate.  whole shoulder upper arm to mid forearm for about 30 hours.  Stiff knee joints.  unusual tibula pain, deep in bone. nearly caused falls, but only for a few hours.  all symptoms gone in 30 hours.  no other symtoms, mild fatigue.   generally less reaction than 2nd vaccine.
This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a adult female patient who received SHINGRIX for prophylaxis. On 13th January 2019, the patient received the 1st dose of SHINGRIX. On 14th January 2019, 1 days after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), stomach pain, chills and diarrhea. On an unknown date, the outcome of the blood in stool, stomach pain, chills and diarrhea were unknown. It was unknown if the reporter considered the blood in stool, stomach pain, chills and diarrhea to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's daughter. The age at vaccination was not reported. The patient received 1st dose on the left deltoid. After vaccination, the patient experienced a terrible stomach pain at last night. The patient also experienced chills or shivering, but no fever. The patient had appointment with her physician. The reporter consented to follow up. In the source document the patient's date of birth and onset date of bloody stool was reported as future date, so we are processed this case as per narrative.
"blistery hives" treated with prednisone. Hive resolved within 3 days.
Patient approached the pharmacy counter approximately 20 minutes after vaccine was administered (~11:30 AM) and stated that her throat felt tight and swollen since just a few seconds after vaccine was administered (this was not reported to the pharmacist at the time of administration) and that it still was feeling that way, not getting any better but not getting any worse.  She stated she had no difficulty breathing but some trouble swallowing, and was feeling, "a little dizzy."  Pharmacy personnel had her sit down in front of the pharmacy counter, took her blood pressure and pulse (BP 128/72, pulse 72), store personnel called for EMS backup assistance, and pharmacist contacted MD that issued the prescription order to administer the vaccine, to advise her of the situation.  Dr. felt that the patient was having a possible allergic reaction to the vaccine and that she should be assessed in the emergency room or by the EMS.  The EMS arrived at 11:50AM, further assessed patient (R = 18, sat = 92%), and advised that she should be transported to the ER for observation/further assessment in case the reaction worsened.  Patient refused transport to the ER at 11:50AM, stating that her symptoms were not getting any worse at that time.  The EMTs facilitated the patient speaking with Dr. ER, who also suggested that she be transported and evaluated at the ER.  She refused transport again at 12:02 PM. Pharmacy Manager, called Dr. back at 12:09 PM to advise her of the patient's decision to refuse treatment.  Also called the patient at home at 5:07 PM to ask how the patient was feeling, and her husband reported that she, "still feels swollen," but was out running errands at that time.
I was walking sideways; very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17-JUL-2023, the patient received Shingles vaccine. On 17-JUL-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: very painful). On 18-JUL-2023, the patient experienced walking difficulty (Verbatim: I was walking sideways). The outcome of the pain and walking difficulty were not reported.   It was unknown if the reporter considered the pain and walking difficulty to be related to Shingles vaccine.     It was unknown if the company considered the pain and walking difficulty to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Jul-2023 This case was reported the patient via interactive digital media The patient got vaccine on Monday, which was very painful and hurt all night and the next day the patient was walking sideways. Follow-up not possible as no contact details provided
Information has been received from a licensed visiting nurse concerning a female patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) and may possible have developed chicken pox. The patient was sent home from school, the nurse also stated that a  parent from school called the office and reported that there were five other cases of chickenpox. This is one report from several from the same source. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Adverse symptoms occurred for about 15 mins post vaccination. She did not have a syncopal episode and vitals remained stable.
Child received 1/2 dose of ROTATEQ at 5 week 3 days of age.  No treatment given.
Asthmatic bronchitis; Arm soreness; This is a spontaneous report from a contactable Consumer (Patient) via Pfizer-sponsored program.  A 74-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date were unknown,) via unspecified route of administration, on 02Feb2021 (age at vaccination 74-years-old) at single dose for COVID-19 immunization. Patient had asthma before first shot but it was unclear if she was having more trouble now. The patient concomitant medication was not reported. The patient was scheduled for the second dose on 24Feb2021. The patient went to her pulmonologist for regular scheduled appointment for asthma who prescribed her prednisone and an inhaled steroid for her asthmatic bronchitis. The patient does not want to jeopardize the effectiveness of the vaccine so she was wondering if there may be any potential interactions between the steroids and the vaccine. The patient also stated that she had arm soreness for 1.5 days after the vaccine. Patient wanted to know if there was any information regarding the vaccine for patients with osteoporosis. Patient heard that there could be more symptoms/side effects from second dose of the vaccine. No PQC was present. Patient asked if she can have Prolia shot in between the 2 doses or she needs to delay. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Itchy; Rash; swelling on injection area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (swelling on injection area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (swelling on injection area). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (swelling on injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Fever; Nauseous; Headache; This is a spontaneous report from a contactable consumer. This consumer reported for a 57-Year-old female patient (wife) that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 20Feb2021(at the age of 57 years) as dose 2, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and she was okay with the first dose. No investigation assessment was reported. Reporter's wife had her second dose on 20Feb2021, obviously of the Pfizer vaccine and she was okay with the first dose, but the second dose she had experienced like the side effects like fever and like nauseous, and also had headache. Patient woke up with events on 21Feb2021 (morning), so they won't know the outcome of events until later on that day. So, he wanted to know if there was anything he could give her to kind of lessen the side effects. Reporter stated that they could talk to her, if they need to. The patient received no treatment for the events. The outcome of all events was not recovered.  Follow-up attempts completed. No further information expected.
Red, swollen lump on left arm 48 hours after immunization. 2cmx3cm, treated with Prelone syrup and Zyrtec syrup. No further complaints.
A physician reported the occurrence of non-response in a 50 to 55 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B). Medical history, concurrent medical conditions, and concomitant medications were not known. On unspecified dates, the subject received two series of Hep B vaccine recombinant (Engerix-B) totaling 6 doses of vaccine. The subject reportedly had no response to the vaccinations. The physician considered the non-response to be probably related to vaccination with Hep B vaccine recombinant.
Last attending ? Treatment team Sepsis without acute organ dysfunction, due to unspecified organism   Principal problem Hospital Course         Patient was admitted to the hospital on 10/19 with generalized weakness, cough, chills, and persistent symptoms of UTI found to have COVID-19.  Imaging in the hospital showed no acute abnormalities of her abdomen and pelvis and she was given IV Rocephin and IV ampicillin to start.  Her outpatient Diflucan was discontinued as it was not thought to be contributing to her symptoms at the time.  Though she was vaccinated x2, she did show Covid positivity but did not require any treatment for this as she did not require any oxygen.  CTA of her chest was negative for PE.  Blood and urine cultures were negative throughout stay.  Hope was for patient to return to facility on oral antibiotics for her chronic UTI, and she was transitioned to p.o. Augmentin twice daily for 5 days.  Hope was to have her discharged on 10/21, but due to patient feeling weak and PT OT claiming that she was not yet ready to go back, she remained in the hospital for further rest and strengthening until 10/22, when patient was deemed stable for discharge back to facility with PT OT to follow there.  She and her husband were both informed that she would likely be in isolation for a few days without her normal level of nursing care, and both agreed that this was better than going to an assisted living or rehab.