chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; Initial information received on 10-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included COVID-19 vaccine.  On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly, Got mine the 26th Oct n last Covid vac been sick since then with flu.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
ARM WAS SORE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 06-MAR-2021, the patient experienced arm was sore. Laboratory data (dates unspecified) included: Pain scale 5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore. This report was non-serious.
1wk p/vax pt devel a few spots 7/2/99 then they spread covered the body day 5 raw & began to spread into each other, fever 101 & anxiety, sleeplessness;DPH;
Two days after the injection noticed rash at injection site and progressed to just above and posterior to L shoulder and extended almost to his elbow. Denies pain/itching. Went to urgent care today. Said physician told them it looks like shingles but there is no pain. Prescribed an antiviral and steroid. Waiting on prescription to be filled now. Started as a flat rash but raised now and starting to blister.  Muscle aches started yesterday, 3 days after vaccine.
pt reported chills, fever, labored breathing, palpitations, chest pressure starting 12 hrs after her dose and lasting 2 hrs. No treatment needed.
Diagnosed with Guillain Barre Syndrome 2.5 weeks after vaccination. Covid and flu vaccinations were given at the same time then 2 weeks later, severe unbearable shooting pain began in arms/neck. Then loss of balance, inability of walk occurred, plus extreme muscle weakness and nerve pain. Loss of motor skills and mobility occurred. First visit to doctor they were unable to diagnosis, visit to ER they were unable to diagnosis, then second visit to ER they diagnosed with GBS.
No adverse event; received Moderna bivalent booster instead of primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna bivalent booster instead of primary series) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-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 02-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna bivalent booster instead of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna bivalent booster instead of primary series) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna bivalent booster instead of primary series).    Concomitant medication was not provided.  Treatment information was not provided.
Myalgia  Nausea & Vomiting  Severe Headache  Malaise  Riggers
This spontaneous report as received from a medical assistant refers to a group of patients of unspecified number and demographics. On 16-FEB-2017, those patients were vaccinated with LIQUID PEDVAXHIB (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. It was reported that the vaccines were improperly stored for 30 minutes, in the temperature of 10 degrees Celsius (C). It was reported that there was no previous temperature excursion and that it was a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.; Sender's Comments:  US-009507513-1702USA011948: US-009507513-1702USA011949: S-009507513-1702USA011950:
Shaking chills, lasting 2-3 hours, onset about 10 hours after administration with associated fever Also had localized soreness at site of admin that began 4-6 hours after admin, and is still a little present 2 days post admin, but improving
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    Reporter did not allow further contact
Pt began having pain in right arm at site of MenB#1 injection 1 week after he was vaccinated, has continued for 9 days. No pain at rest. Only pain if he moves his arm.
standard pain; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number P7HK7, expiry date unknown) and (batch number 275KY, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced standard pain, redness and swelling. The permission to follow-up was denied. This was 1 of 5 cases, reported by the same reporter. The discrepancies were observed regarding batch number, two different batch number was reported as 275KY and P7HK7 into the source document and correct batch number was unclear, hence both reported batch numbers was retained.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189449:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189450:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189418:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189451:Same Reporter
Headache, Myalgia, FATIGUE FEBRILE INJECTION SITE TENDERNESS AND PAIN Narrative:
Patient went to ER because the patient could not breath. His airway was closing and having trouble breathing. Patient brought in an ER rx the next day (10/18/11).
Information has been received from a LPN concerning a 12 month old male with no allergies or medical conditions who on 10/17/03 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live (Lot # 644975/0472N). Concomitant vaccinations on the same day included a first dose in the right anterior thigh of MMRII (Lot # 645520/0296N) and a fourth dose in the left anterior thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar, Lot # 493261).  There was no illness at the time of vaccination. The reporter indicated that on 10/27/03 the pt had an office visit where it was noted that lesions erupted on 10/26/03 on the back, stomach, legs and arms. The child was afebrile and had greater than 50 lesions. It was unknown if the pt recovered. Follow up was received from the LPN which indicated that there was no further information. No additional information is expected.
I do not know if vertigo has anything to do with this vaccine and don't blame a vaccine for it.  I'm only doing this report because I got a follow-up call from vaccine study. I have vertigo. It started  approx 1/15/23. I went to the doctor on 2/1/23 and was given Fluticasone Propionate nose spray and Meclizine. I got better for a couple weeks and then it came back. I have it right now and will have to go back to the doctor.
Large, local reaction with redness, induration & warmth the PM after shot was administered. Didn't see this pt. back (mom is a PA for internist) but she described it to me. (R) thigh was only one involved.
FATIGUE, MALAISE, ARTHRALGIA, FEVER, HEADACHE, CHILLS.  SYMPTOMS OCCURRED FOR AT LEAST 2 DAYS
TOOK ONLY ONE DOSE OF VIVOTIF IN APRIL; This spontaneous case report (PVX2019-1720) was received from a consumer on 01-Jul-2019. It describes a female consumer who "took only one dose of Vivotif in April", while being on Vivotif for an unknown indication.  Case report: The consumer took only one dose of Vivotif in April. Then, she went out of town. Thus, did not take another dose.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took only one dose of Vivotif in April" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose of Vivotif in April" was considered as not applicable.
Vaccinated with expired dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with expired dose of Moderna COVID-19 Vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with expired dose of Moderna COVID-19 Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated with expired dose of Moderna COVID-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.     Patient was administered with 0.25 ml of vaccine on 03-May-2022 (Expiry: 29-Apr-2022). It was unknown if the patient experienced any symptoms. The vial didn't undergo any temperature excursions. Date the vial was initially stored in the refrigerator was unknown.  No treatment information was reported.
My daughter received the flu vaccine at school which was a medication error because we did not sign the vaccine form, The school apologized because they admitted that she received the vaccine in error. 2 days later my daughter began to experience a little left knee pain without injury. On 11/3/21 Her Left knee pain was severe and the joint was swollen and warm. She also began to complain of pain in the left ankle as well. She was seen by her doctor  who ordered xrays and lab work. Treatment with ibuprofen every 8 hrs provided some relief but pain persists with pain in left ankle worsening.
Three days after the vaccine I started to get a feeling of pressure on my chest. I woke up during the night because it was hard to breath. I had leg  pain in both my sides.  The leg pain lasted three days. I took it easy for the next two days. I called the doctor and she advised me to go to the ER. I was given an EKG and Chest X-Ray and blood work. I still have the feeling of pressure on your chest after two and a half weeks. It is a similar feeling to when I had the Covid-19 in October of 2020. It is not any better or worse than when it started.
Patient stated she felt tingling at site of injection, difficulty hearing, cold arm, sweaty under arm along side of body, face was pale. She requested and drank orange juice. RPh offered Benadryl and a wheelchair and medical assistance of urgent care if needed. The primary care provider was paged and stated the patient did not need diphenhydramine. It was more like a near syncope event (vasovagal reaction). If she does not feel better after ten more minutes, then seek ER followup, otherwise she is authorized to go home.
Ear ringing; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6202) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 58-years-old) as a dose 2, single for COVID-19 immunisation. Medical history included breast cancer. It was reported that the patient was a Breast cancer survivor. The patient previously had Cephalosporin on unknown date for unknown indication and experienced allergy to antibiotic. Concomitant medications taken within two weeks of vaccination included rosuvastatin calcium (CRESTOR) and thyroid (MANUFACTURER UNKNOWN); both from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9265) via an unspecified route of administration in the left arm on 04Feb2021 at 08:00 (at the age of 58-years-old) as a dose 1, single for COVID-19 immunisation. 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. On 13Apr2021 at 17:00, the patient experienced ear ringing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of ear ringing and included sinus treatment, ear testing. Since the vaccination, the patient had been tested for COVID-19. On 16Apr2021, the patient underwent COVID- 19 test and the result was negative. The clinical outcome of the event ear ringing was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Type, Name, City, State and Country added. Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Type, Name, City, State and Country added.
Patient presented to pharmacy with sore arm. It had been sore for 2 weeks. Seems to be getting worse. Patient will be visiting PCP on Friday. May have been injected too high.
Dtap given in Right thigh on 5-23-07. Area became red 24 hours later and became enlarged today at redness 10cmx10cm.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: 30-OCT-2021) dose was not reported, dose number in series was 1, 1 total, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient had covid after receiving the JnJ/Janssen Covid 19 vaccine. On 13-JAN-2022 (a day before this report), the patient was sent home from work after testing positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The type of test used is unknown (dose number in series was 1).  Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000211931.; Sender's Comments: V0: 20220126351-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
delayed site reaction. On post-vaccination day 9, the vaccination site became red, warm, edematous, and painful.
I almost surely had RSV, contracted from my grandson during the first week of November, when my grandson was RSV test positive.  When my moderate respiratory infection lingered into mid-November, I went to urgent care on 16 November.  I was negative for influenza and negative for Covid-19.  It must have been an RSV infection.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. On 18th October 2018, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The pharmacist was the patient. The patient received SHINGRIX on left deltoid. The pharmacist reported that his injection site reactions went from his deltoid down towards his elbow. The reporter consented to follow up.
I had gone on a vacation and came home and started having a sore throat and thought I may have a mild flu as time went on. I had some congestion and achiness. I did go see my health provider and I was positive for COVID-19. They gave me Paxlovid to help. I did recover but then it came back and I was still positive. I was having watery eyes, a sore throat, I was tired, coughing, very fatigued and just had about three days that were pretty bad. Currently I wake up in the mornings with mild symptoms and then they get better throughout the day.
had both shots and have it now / suspected Vaccination failure; Have it now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient both the Shingles shots and had shingles now. The patient believed it easier because of shot though. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Client called clinic after receiving a Flu shot and Pneumonia vaccine - reports received shots here 11:20 AM - clinic - home 45 mins later shaky; itchy; felt like throat closing up - panicked - 1 full dose EPIPEN and 2 BENADRYL oral with recovery/resolution.
Facial rash, torso blotchy approx. 10 min. No difficulty breathing. No acute distress.
None Vaccine expiration date was 10-27-21 The vaccine was given 10-29-21  due to an oversight.
10/21/2004. TD shot administered. 10/25/04 phone call from mom. Arm red, hot,hard and achy. Mom states has not gotten worse since yesterday. Denied fever. Inc ice. 10/26/04: resolving. 10/27: mom states much better.
SEVERE ONSET OF PSORIASIS LASTING UNTIL CURRENT DATE AND BEYOND. HAD HISTORY OF PSORIASIS, BUT ONLY A COUPLE 'BUMPS' ONCE IN A WHILE.  THIS ONSET TOOK OVER ENTIRE LEFT ARM AND SPREAD TO RIGHT ARM.
The patient received her vaccine at 0855.  She was monitored for 15 minutes for any allergic reactions. The patient left the facility after being monitored. She was no exhibiting any reactions.  She returned to her home and began experiencing, itchiness around the eyes, ears, nose and mouth along with tightness in her throat and chest.  The patients husband brought her back to the vaccination clinic. She was monitored by the EMS staff. PH nurse at site administered Benadryl 25mg P0 @ 10:20.  The patient was monitored for 20 minutes.  Symptoms resolved. The patient was offered transportation to the ER by EMS.  The patient refused transport and signed refusal document per EMS.  The patient was advised to visit her doctors office before going home. The patient refused to go to her doctors office for follow-up today.  She and her husband decided to go home and monitor symptoms and stated that they would notify their healthcare provider and follow up if necessary.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9894) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "adhd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Developed a cellulitis in left upper arm one week following the injection. Treated with oral Keflex QID X 7 days. Cellulitis resolved with some ongoing skin discoloration noted still at this time.