chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness; Swelling; Swollenness like a lump in the area, it was itchy, very itchy and I have a lump like where the injection site is; Swollenness like a lump in the area, it was itchy, very itchy and I have a lump like where the injection site is; It is like it is a nut right in the injection site; This is a spontaneous report from a contactable consumer (patient). A 45-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included none. Concomitant medication included multivitamin (Vitamins Nos) for unspecified indication, start and stop dates were not reported. Investigation assessment and prior vaccinations (within 4 weeks) included none. The patient had the Pfizer vaccine on Monday (unspecified date) in right arm and experienced some soreness and some swelling, but at the time of this report patient was experiencing swollenness like a lump in the area, it was itchy, very itchy and had a lump like where the injection site was. So, was real concerned about that, after reading the material that was given to patient about the vaccine, didn't know if should be really concerned because it was like it is a nut right in the injection site. Didn't know if patient should put like a lump compress on it. Consumer was informed about Pfizer Medical Information department and provided with the number. Patient received no treatment for the events. Clinical outcome of events was unknown.  Information on lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Immediate pain upon withdrawal of needle (given high on arm) then sore for a couple of hours with increasing pain noted and limited ROM/mobility. Have had pain for 6+ months now. Have seen MD, PT, X-rays, MRI. Doing PT @ home presently. Never had pain in arm until after vaccine.
Soon after 1st Hep B vaccine started getting sick with sinus (we thought) then facial swelling after 3rd vaccine swelling got worse then found out I developed systemic erythematosus lupus, hypertension, kidney problems (proteinuria & blood in urine). Tinnitus, rashes with blisters, rashes on face. Now I am on several medications to try and keep it under control.
Approximately 5-6 minutes after receiving vaccine, my left arm that was injected started to tingle and then suddenly I felt like I couldn?t breathe and had shortness of breath. The staff called a non-patient medical response and  administered 0.3mg Epi. I was transported to the ER and received oxygen via nasal cannula, labs drawn, chest x-ray, soft tissue neck x-ray, IV Benadryl and Pepcid.
Generalized discomfort, weakness, sore throat, headache, chills, runny nose- started on 12/4/22
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer-BioNTech on 3/12/21 and 4/09/21. Tested + for Covid 19 Friday, RX'd Azithromycin, prednisone 10 mg and cough medicine by PCP. Presented to ER w/fever, chills, fatigue, nonproductive cough started Tuesday prior. Admitted for acute hypoxic respiratory failure and severe sepsis given 100% 60 L hi-flow O2, initial BP was 74/53. CXR w/patchy bil interstitial and alveolar opacities, suspect multifocal PNA, poss. pulmonary edema. Labs BUN 60, Cr 1.50, Na 146, Co2 20, BNP 285, WBC 12.3, HGB 9.7. Cont'd to worsen, transitioned to comfort care. Exp. 09/07/22. TX'd w/rocephin, remdesivir, doxycycline, Ancef, azithromycin and decadron.
This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced uncontrollable nervous system, and can't quit shaky. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the uncontrollable nervous system and can't quit shaky was not reported. This report was non-serious.
Client received third dose of HPV vaccine.  Her brother received vaccines after she did.  About ten minutes passed between the time she got her shot and the family was leaving the clinic.  While walking down the hall to exit, patient fell forward and collapsed on her face.  Bleeding from mouth, scraped chin.  Unable to determine source of bleeding because child could not open her mouth more than 1/2 inch.  After juice and cold compresses were used, parents left to take her to emergency room.  Used wheelchair to go to car.  3/25/08 Reviewed hospital medical records of 2/18-2/20/2008. FINAL DX: Multiple mandible fractures, surgically reduced. Records reveal patient experienced syncope s/p vaccination.  Seen at outlying ER & transferred to higher level of care.  In recuperative stage. Jaw was broken, surgically repaired. Last contract with client was 3/11/08. Mouth was rubber-banded together - still healing.
an unspecified patient received the complete 3 dose treatment for GARDASIL 9 on unspecified dates when "the patient was a teenager". A HPV test was ordered and the result came back positive for HPV type 16.; This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, and drug reactions or allergies were unknown by the reporter.  On unknown dates, also reported as when "the patient was a teenager", she received the complete 3 dose treatment of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular injection (dose, frequency, lot number, and expiration date unknown by the reporter) with an indication reported as vaccination (prophylaxis).  On 05-MAR-2020, the patient sought medical attention and she was seen by the physician; a human papilloma virus (HPV) test was ordered and the result came back positive for HPV type 16. It was unknown by the reporter if treatment was given for the event and if additional laboratory diagnostics or studies were performed. The outcome of human papilloma virus test positive was reported as not resolved. No product quality complaint was reported. No further details were provided.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Breast nipple is a different color; This is a spontaneous report from a non-contactable female consumer (patient).  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced different colour in her breast nipple. She came back and was so surprised and shocked. She got the Pfizer vaccine and her breast nipples each have a different colour. It is something she has never experienced. Caller is wondering if it is okay for her to get the second Pfizer Covid-19 vaccine if she had a side effect to the first one. she is concerned it will be heavy and worse than the first. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
29yom with no significant medical history was diagnosed by CT with acute pulmonary embolism involving the branch vessel in the right lower lobe 14 days after receiving Johnson & Johnson vaccine.  Symptoms of right pleuritic pain began 4 days prior to the diagnosis.  Initiated therapy on oral anticoagulants.
ZOSTAVAX administered 7/7/09. Pt called on 7/9/09 reporting redness, swelling, itching at injection site. Described site as oblong red red spot -silver dollar size. Patient iced area and took BENADRYL at night - cannot take BENADRYL during day due to work. Pt also presented to pharmacy 7/10/09- above symptoms and warm to touch and "poking pains". Patient went to prescribing physician to evaluate. Dr. wrote for Doxycycline and presumed infection at injection site. Called patient next day to check on status. Improvement stated. Called patient again on 7/13/09. Spot is improving - no longer itches or pains. Spot is getting smaller.
This spontaneous report was received from a physician via a company representative, and refers to a patient (Encounter key# 357974) of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 18-JUN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "HPV 10x1 sdv", lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported. No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 72 hours, where the lowest recorded temperature was 32 F (0 Celsius degrees). There was also another excursion on an unknown date which lasted 16 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
having swelling under armpit near the breast area; her arm pit like swollen like a lump; This is a spontaneous report from a contactable consumer or other non-health professional (patient). This 35-year-old female patient received bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0158) via an unspecified route of administration, in Left arm on Wednesday 12May2021, as DOSE 1, single for COVID-19 immunisation (age at vaccination:35-years-old). The patient medical history and concomitant medication was not reported. Patient informed that the scheduled date of second shot of COVID Vaccine was 04Jun2021.Patient reported that on the site on Wednesday where she got the shot under her arm and her arm pit was swollen like a lump. She added the swelling under armpit near the breast area. The patient wanted to know if this was normal and when it will go away, or when she should go to hospital. The patient treatment medication include Tylenol and it makes it feel better. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I was fine until almost twelve hours after my shot. Then I woke up sweating with a fever and chills to the point I was shaking uncontrollably.  I was so dizzy I couldn?t open my eyes. I vomited four times.  This episode lasted approximately three hours.  I took some ibuprofen for my fever.   I had a sore arm for about seven days after. Since the vaccine I have experienced constant tenderness on lymph nodes in my underarms.  Every three weeks or so I get dizzy spells that last for a few hours.  I have had consistent pain in my right ear and neck tenderness since the second dose. Nothing seems to help any of these symptoms.
patient got lower back and tailbone pain.  It was significant enough that it affected her being able to walk and move comfortably.  Patient went to ED and got muscle relaxes and NSAIDS.
suspected vaccination failure; developed TD / shakes; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), tardive dyskinesia (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the tardive dyskinesia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the tardive dyskinesia to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's neighbor. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. At the time of reporting, along with everything else, the patient had developed tardive dyskinesia, which was directly related to the shot.  The patient experienced a lifetime of the shakes versus a couple of weeks of discomfort. Oatmeal bath worked just fine for the patient and comparison to a lifetime of the shakes and the risk of getting the shingles was still going to be there. The reporter stated that, many people had gotten this shot and still got the shingles.  The reporter also stated that, getting the shot was not worth. Also, the government was lying to us.  They always had, and they always would.  We had been around long enough to know that. This case had been linked with case US2021AMR175884, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175884:same reporter
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: EW0183), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: 07Sep2016; LEVOTHYROXINE, start date: 05Mar2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received oral antiviral drug paxlovid from 09Jul2022 to 14Jul2022 for the treatment of COVID-19. No known allergies.  Follow-up attempts are completed. No further information is expected.
This healthy 2-year-old female received pneumococcal conjugate vaccine, 13-valent (Prevnar-13) IM in her left anterior thigh. The next morning, she woke up with mild erythema over her left thigh. The erythema spread and worsened and, the next day, she presented to the ED. The physical examination showed erythema and swelling of her entire left thigh with some ecchymosis on her posterior thigh. There was mild tenderness to palpation, but no fluctuance. She was diagnosed with cellulitis, given clindamycin IV, and discharged on hydroxyzine and clindamycin PO x6 days. Summary: Erythema and swelling of entire left thigh with some ecchymosis on the posterior thigh, the site of Prevnar-13 IM injection. Symptoms started the morning after the injection and worsened over the next day; resulted in an ED visit and treatment with an antibiotic.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications were reported.  Patient got the flu shot with no reaction. The flu Vax and Covid vac were not made using the same technique. Patient also received all the Covid boosters. Had Pfizer last time and no reaction like with Moderna fatigue.  No treatment medications were reported.
Fatigue, muscle fatigue, tingling of hands and feet, headache, congestion, abdominal pain, digestive issues, like loose stool, hand tremors, nausea. I will be going to the doctor on July 15, 2021 regarding these symptoms.
2am awaken with muscle aches, fatigue, headache, chills, nausea & temp  99.2° 10am severe muscle pain, headache, nausea, back pain & temp 101.3° Highest temperature taken 103.6°  Still symptomatic with temperature not going below 99.7°
Information has been received from a healthcare worker concerning an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, "since 07-JAN-2015", the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # J000722, expired date as 17-SEP-2015; lot# reported as KJ008570, expired date as 05-FEB-2016) (therapy type, strength, dosage and route were not reported). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
6 hours post vaccine a red, raised, rash with itching started on neck and spread to chest and abdomen. Last x 10 days and resolved used Benadryl cream for itching - no doctor visit.
Client complains of swelling at injection site on left arm. Swelling is approximately size of golf ball.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 33-month-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 22-Nov-2010. On 10-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Muscle weakness, fever of 100 degrees, headache, neckache, nerve pain, dizziness.  These symptoms were worse the first four days, now they have mostly resolved but patient is left with weakness and dizziness.
Ten hours after injection, area was red ,hot & itching.These things persisted  & got worse for 14 days. The size of the red area    increased from 1 square inch on day 2 to 6 inches by 4 inches on day 16. Now it is that size but pink with a red rim. It still itches.  Treatment was Benadryl and ice.
date of 2nd vaccine was 1/12/22.  That night the patient awoke in the middle of the night crying around 2am.  Between 4-5 am patient became dizzy, belly hurt, headache.  Febrile up to 104.9.  Given Tylenol at 0545.  Unwitnessed seizure lasting 2 mins at home followed by witnessed post-ictal state.  Brough to ED.  Vomited once.  Second seizure in ED while being evaluted.  Less than one minute duration.  No abortive medications given.
On 3/8/21 65 y/o M received his first Covid-19 vaccine (Moderna) and states on 4/2/2021 he had a myocardial infarction with 2 stents placed. He discharged to home and was doing very well. Tuesday, 4/6/2021, he received the second Covid vaccine. The following morning, he had pain in his right ankle. It progressed and involved his left foot and ankle.  Over the next few days his pain progressed to involve his legs, but stopped at the knees. He had leg weakness and associated diarrhea, fever and chills. He thought his symptoms would pass and tried to wait it out over the weekend. When he awoke on Monday morning, 4/12/21, he could not move his feed. He went to the ER and was diagnosed with Guillain Barre Syndrome.. He received 5 doses of IVIG with very good response. Patient states his leg strength is improving, but is not back to baseline. His arms are unaffected by his Guillain-Barre. He is in Rehabilitation now.
Three days after vaccination, patient returned to clinic with right upper arm swollen, with slight erythema and mild tenderness. Ice to site and children's Motrin ordered.
Intermittent gasping - see attached. Was seen this morning for a well-child check which is on the well child form. Received PREVNAR, PEDIARIX, ROTATEQ, and HIB. Mother left the office at approximately at 10:00-10:15 am. Mother said that when she got home and put the baby down for a nap. Did not give the baby TYLENOL nor did she feed the baby. Mother said that there were some periods of apnea that she noticed. She described the periods anywhere from 1-3 seconds, where the baby would have these periods of apnea and then take a big gasp there. She did not report any cyanotic episodes. I asked her if there were any prolonged periods of apnea, and she replied as a mother she'd felt called to pick up the baby instead of watching the baby for the apnea spells. She does have other children and they have not reacted to any vaccines. She has not vomited and has had good wet diapers. Mother has tried to feed the baby and it has not fed well. She comes into the office and she is crying which started approximately 20 minutes prior to the exam. Rather fussy baby. HR 186 on pulse ox of 98, by my count it was 130. AFOS. Both TM's clear. Mouth, moist. Neck, supple, FROM. HR regular w/o murmur. Lungs clear. Abdomen soft. After a full body search there was no rash. She did move all her extremities. I put them through the FROM. Baby did suck on her pacifier. There were some periods of calm but there were more periods of fussiness. Did discuss the situation with Dr., and it was decided to send the baby by ambulance to hospital. Report was made. Called EMS. The baby was put on a monitor. Sat was 98 at discharge. In the room I did note there were some periods, that the baby would, when crying, have a period of 1-2 seconds and then take a big breath, but this is when she was crying. I did not see any periods where she was quiet. There were no actual prolonged periods of apnea that I witnessed.
This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history was not reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL lot # K011325, expiration date: 08-APR-2017 (doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.