chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches; menstrual cycle has been extremely irregular; lost a lot of my hair; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 at 12:00 as dose 2, single (Lot number: 32030BD) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO. Vaccination history included: BNT162b2 (dose 1, lot number FE3590, on 22Oct2021,02:15 PM, vaccine location Right arm), administration date: 22Oct2021, when the patient was 41-year-old, for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 29Dec2021, outcome "not recovered", described as "headaches"; ALOPECIA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "lost a lot of my hair"; MENSTRUATION IRREGULAR (non-serious) with onset 29Dec2021, outcome "not recovered", described as "menstrual cycle has been extremely irregular". Therapeutic measures were not taken as a result of headache, menstruation irregular, alopecia.  Additional information: The patient had received no other vaccine in four weeks and had no known allergies. Since getting second vaccine in Nov2021 her menstrual cycle has been extremely irregular, after decades of being the same day every month. She has also lost a lot of hair and developed weekly headaches where she never had headaches before. No Covid prior vaccination and tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Patient assessed today (12/13/10) with signs/symptoms of Bells Palsy. Symptoms started on Saturday 12/11/10. Her lip goes to the side when smiles, and can't eat well because food falls out. No fever. Left eye is more tearful. Has been approximately 1 month from the vaccine, but no other changes have been seen.
This case was reported by a pharmacist via other manufacturer and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patients experienced fever and malaise. On an unknown date, the outcome of the fever and malaise were unknown. It was unknown if the reporter considered the fever and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that many patients experienced fever and malaise after receiving SHINGRIX.
Patient said he started to feel tingles around his face within the first 24 hours. Then had a "shingles breakout" on face and head within 48-72 hours after injection. Patient said he had a skull crushing headache 24/7 for about 5 days, and has a stiff neck. He went to see his physician and was prescribed Valtrex.
Child received vaccinations at 9:45 a.m. Mom called clinic at 1:00 p.m. and said that the child had hives on his legs and trunk and was getting them in his mouth.  She had already given him Benadryl at 11:30 a.m. and it hadn't helped.  She had a doctor's appt. scheduled for 1:30.  Instructed her to see her doctor for that appt. I tried to call the client's mom later and didn't get an answer.  I called Mom the next morning and she told me that the P.A. she saw at the doctor's office thought that the child had Hand, Foot, and Mouth Disease and that it was unrelated to the immunizations.  That night at home the child started getting what the mom described as hives again in his mouth and his lips were turning blue.  She took him to the E.R. in another town.  She said they gave him a shot of steroids and observed him over- night.  She said he is home and doing fine now, but the E.R. doctor thought it was an allergic reaction.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Severe
10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
ABOUT 15 MINUTES POST VACCINATION, PATIENT FAINTED IN THE WAITING AREA OF THE PHARMACY. HER BLOOD SUGAR AND BLOOD PRESSURE WERE CHECKED AND WERE NORMAL.  SHE HAS A PHOBIA OF NEEDLES AND IT MAKES HER DIZZY AND LIGHTHEADED.
A nurse reported the occurrence of rash in a ten year old female who received hep A vaccine inactivated. There were no concomitant medical conditions, concurrent conditions, or concomitant medications reported. On 8/2/02, the subject received the first injection of hep A vaccine. On 8/3/02, the subject experienced a rash on her back, chest, and buttocks without fever or itching. The subject was treated with Benadryl. The outcome of the event was unknown. The reporter considered the event to be possibly related to Havrix. However, upon follow-up info received on 9/17/02, the reporter indicated during  on office visit on 9/6/02, the father reported he felt the event was due to an allergic reaction to a strawberry pop.
I did not get my period at the end of April and then not again at the end of May (after second shot). It resumed at the end of June. Significant concern over how the vaccine impacts puberty, especially if consideration about my 11 - year daughter to get the vaccine pre-puberty.
Patient was vaccinated at our hospital clinic, and went into the waiting room area for the 15 minute observation. After about 10 minutes she laid on the floor and said she was dizzy and her heart was racing. She never left consciousness. Observers went over to her and took her pulse and B/P. She stood up and get into a wheelchair and they took her to ED.  Once in the ED the symptoms were resolved according the physician record. Today, January 13th, she is back at the ED with complaints of arm soreness and heart racing. She is currently in the ED and her disposition is unknown at this time.
Hi  I got my second Covid shot on Saturday July 10. Shot was in the left arm.  Severe headache within five minutes like last time. Felt like a migraine. After an hour the worse pain was in my left breast & armpit.  My left armpit was swollen significantly & my breast felt like I was punched  or stabbed.  I couldn?t lift my left arm. I applied heat & ice alternately & took Tylenol. Then whole body ached like the flu. No worries there, it?s the swollen left armpit & pain in breast that is bad.  Yesterday it got worse.  I continued with heat, ice & Tylenol. I took today off because the pain is severe & I can only lift my arm half way up. The severe pain feels like how you feel after a surgery when pain meds start to  wear off.  Do you know how long this will last?? Thanks & have a great day.
Facial swelling; swelling in sinus area; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6198), via an unspecified route of administration in arm left on 18Feb2021 at 09:00 (at the age of 68-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included hypertension, lumpectomy in right breast and breathing difficulty. The patient had allergies. The concomitant medications of the patient included fluticasone propionate (FLONASE) taken for hypersensitivity, dyspnoea 2 sprays each nostril daily, from Apr2019 and ongoing, furosemide (FUROSEMIDE) 40mg daily taken for an unspecified indication from 2010 and ongoing, letrozole (LETROZOLE) 2.5 mg daily taken for breast conserving surgery from Jul2019 and ongoing, losartan potassium (LOSARTAN POTASSIUM) 50mg daily taken for hypertension from Oct2020 and ongoing and metoprolol (METOPROLOL) 100mg daily taken for hypertension from 2010 and ongoing. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9262), via an unspecified route of administration in arm left on 28Jan2021 (at the age of 68-years-old) as single dose for COVID-19 immunisation. The prior vaccinations and relevant tests were reported as none. On 18Feb2021, the patient experienced facial swelling and swelling in sinus area. The patient reported she received the vaccine around 9:00am that morning. She came home around 1:30-2:00pm. She felt like her face was reacting like it was swelling. She typically uses Flonase daily. She called the doctor to ask if it is ok for her to take it. She is unsure if she should use the spray. She asked can she take Benadryl or Flonase to get relief in that area. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Monday , March 8 I had itching at injection site but no rash. Tuesday , March 9 before bed I began to have vaginal itching that might have been a yeast infection. ( I haven?t had one fir 20+ years). Thereafter in the middle of the night I awoke to itching on the palms of my hands. When I woke up on Wednesday, March 10 I had a puffy lip on the left side of my mouth and swelling inside of mouth.  Through out the rest of the  day I got more and more tiny bumps on my legs, feet, arms and torso. I took Claritin (the only thing in the house)  before 9 am and the swelling disappeared from my mouth but  the lip was still a bit puffy.  I contacted my doctors office and a nurse recommended Benadryl and set me up with a virtual Dr appointment for 3/11 am. I was cautioned to go to the ET if swelling came back inside mouth. At 6pm I took Benadryl and will continue through the night. I purchased Monistat3 to use in case the yeast infection  was a separate issue. Will continue to take Benedryl through the night as needed.
Patient was healthy for her age when vaccine was administered on 10/06/04.  On 10/11/04, patient was admitted to Hospital for respiratory distress.  Later diagnosis was pneumonia of an unknown itology.  Her main symptoms were a deep cough, extreme respiratory congestion, chills, high fever, etc.  Radiology confirmed presence of fluid on lungs.  Patient was given intraveneous antibiotics as well as Lasix to try and improve her condition. She did not respond to antibiotics and expired on 10/15/04.  No further information was given on Death Certificate or dischage summary, both rec'd on 03/02/2005.
Fever of 102.5, severe aches throughout muscles and joints, exhaustion, nausea, headache. All that lasted for about 24 hours, fever broke on Friday. Aches persisted for another 24 hours. On Saturday I noticed my lymph nodes on my left side had swollen significantly. Specifically the ones in my armpit looked like a ping pong ball, and there was also swelling on my back and left shoulder blade. Fatigue and general soreness continued through Tuesday the following week. The lymph nodes stayed swollen for about 2 weeks.
Patient started with sore arm the day of the vaccination, Monday, December 28, 2020, which radiated into  neck that night. Next day patient noticed swollen lymph node to left axillary, fever and chills, full body aches with more in knees bilaterally, and diarrhea.  Patient feels better this morning, December 30, 2020.
Had an allergy; Is hurting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Had an allergy) and PAIN (Is hurting) in an 87-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Had an allergy) and PAIN (Is hurting). At the time of the report, HYPERSENSITIVITY (Had an allergy) and PAIN (Is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information was provided.
Woke in the middle of the night to nausea and a low grade fever with chills. Took ibuprofen, fever broke around two hours later.
I had swelling in my lymph nodes under my armpits it was tender & swollen.
42 hrs p/vax were given pt awoke w/high fever & had rash on face, arms, trunk; 12MAR92 11AM; t100 ax had papular rash on face, trunk, arms, legs, thighs; throat red, lt ear red;
Moderna booster given on 4/19/2022-- Patient states that the injection went too deep and caused pulsing pain during the shot. The patient states that after a couple of days the patient was experiencing pain that had her pain level  at an 8 on the pain scale for 1 week. Patient states that she has taking a steroid dose pack and is still in pain. Patient states that she has went to her massage therapist and chiropractor. Patient stated that the physician had told that the injection had nicked a nerve and possibly hit the bone.
The patient became HPV positive; This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. Information about patient's pertinent concurrent conditions, medical history, concomitant therapies previous drug reactions and allergies were unknown by the reporter.  In 2009 (reported as approximately 10 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, intramuscularly as a human papilloma virus (HPV) protection (strength, dose, vaccination scheme frequency, lot number and expiration date were not reported).  On an unspecified date, the patient became HPV positive (papilloma viral infection) ,a papanicolaou test (PAP SMEAR) was performed, however  the result was not reported. No treatment was given to the patient, and it was unknown by the reporter if the patient sought medical attention.   At time of this report, the outcome of papilloma viral infection was reported as not recovered.  The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the aforementioned event was not reported.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-JAN-2022, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
Redness on the right side where DTaP and Polio was given. Pt left Band-Aid and put ice pack directly on the skin for so long.
Pale, clammy, loss of consciousness, unresponsive, BP low, good blood sugar levels, pupils dilated. Had to call 911.
TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case (PVX2019-1252) was received from a caregiver on 20-May-2019. It describes a 17-year-old female consumer who "took an unrefrigerated dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer did not refrigerate Vivotif doses for several weeks and then she took the first dose on 19-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.
Caller states after her and her dad received the vaccine they could no longer speak in a high tone.; This is a spontaneous report from a contactable consumer or other non hcp. An 83-years-old male patient received bnt162b2 dose 1 via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient reported that after she and her dad received the vaccine they could no longer speak in a high tone (dysphonia). The outcome of event unknown.    Follow-up (22Jun2021): This is a follow-up spontaneous report from a contactable consumer. The consumer reported for a 83-year-old male patient that.   Additional note:  The report is cross referenced to report ID: We all got it in January and February and then she got to march and we couldnt hit high notes. Her dad is the same way.    Follow-up attempts are completed. Information regarding the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758858 same reporter/drug/AE, different patient.
her wrist is swollen/just above the bone on her wrist it is swollen; it is like a burning; she has really bad arthritis like she has had a knee replacement/her arthritis is really bad/it just flared up; She had a little pain in her leg; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (Pfizer BioNTech COVID 19 vaccine, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration on 12Jan2021 09:30 at single dose in Left upper arm for covid-19 immunization. Vaccination Facility Type was at a hospital, they had a vaccine clinic set up. Vaccine Administered at Facility was No. Medical history included arthritis, she has had a knee replacement, she was allergic to anti-inflammatory medicines. Family history was none. There were no concomitant medications. No other vaccines was administered on same date of the bnt162b2. Prior Vaccinations (within 4 weeks) was None. No events occurred following prior vaccinations. Patient was calling about a question with the COVID-19 vaccine. She got it on Tuesday 12Jan2021 and she wanted to know if she could get a reaction now. Yesterday (20Jan2021) she noticed, she had really bad arthritis like she has had a knee replacement and she has it her hands and yesterday she noticed her wrist was swollen and she didn't know if it could have been where she had arthritis or could it be side effect? She just didn't know if she should call her orthopedic doctor. She said the joint at the wrist, it was like the side of her hand, it was the side where your pinky was, just above the bone on her wrist it was swollen. It was swollen normally but it usually didn't hurt like this, it was like a burning but it maybe her arthritis acting up but she did not know. She said the pain and swelling began yesterday 20Jan2021. Her wrist was swollen and it was like a burning was reported as worsened. She had a little pain in her leg the other day on 17Jan2021 but just coughed it up. It was all on the left side which was the same side she got the injection on. She didn't think anything of the leg pain and it went away. The pain in her leg has resolved completely. The only other thing was her arthritis was really bad, it just seemed that it just flared up but she was wondering if it could be a side effect. The events didn't require a visit to emergency room or physician office. The outcome of "She had a little pain in her leg" was recovered in Jan2021, while outcome of other events was unknown.
extreme lethargy on day 4; feel flu like; achey; low grade fever; overall feeling awful; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included Asthma, Meniere's Disease, Complex regional pain syndrome, POTS (Postural orthostatic tachycardia syndrome), penicillin allergy and Quinolones allergy. The patient reported that all her concomitant medications would not fit in space provided. The patient's past drug included LOVENOX and DEMEROL for unknown indications on unknown dates and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 09:00, on day 4, the patient experienced extreme lethargy, feel flu like, achey, low grade fever, major effort to get out of bed and overall feeling awful. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lethargy, flu like symptoms, ache, low grade fever and feels awful were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse via a field representative refers to a 15 year old non-pregnant female patient. There was no information about the patient's concomitant therapies provided. The patient did not have any pertinent medical history, known drug reactions or allergies. In 2009, the patient was vaccinated with a dose of GARDASIL 1 shot intramuscularly (lot # and expiration date were not reported). In 2010, the patient experienced numbness in her body, sore neck, myopathy, headaches, hip pain and limb discomfort. The patient sought medical attention and received unspecified infusions as a treatment for the adverse events. She had several unspecified neurological evaluations, but there was no result reported. The outcome of the events was reported as not recovered by the time of the report. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
About an hour after shot, heart racing, sweating, hot, heavy pressure down R arm to fingers and through chest, then just felt lousy for about 2 days.
Pt entered the clinic at approx.12:15 inquiring about the initial dose of the Pfizer per her primary care providers instruction. Pt reported a Hx of "her throat closing" s/p flu vaccination administration. No epi-pen administered at the time for that reaction. Pt was educated about the COVID-19 vaccine and received the first dose at 12:29 PM. Pt was instructed to wait in observation for 30 minutes. Shortly after COVID-19 vaccine administration pt stated that she "feels like her throat was getting scratchy", then proceeded to state "my throat is swelling"; "who even knows what is in these vaccines?". This RN did not observe any signs of angioedema upon examination. Pt was brought to ED for further evaluation per Nurse Manager. During transportation to the ED, Pt asked both RNs present "does this mean that I do not need a second dose of the vaccine? Who would authorize this?" Pt appeared stable during hand-off to ED triage RN.
Anthrax reaction day 1 after vaccination symptoms were redness, swelling, pain on site and occasional itching. This was on right arm and extended to the elbow. On day 2 symptoms were worse and swelling extended to the forearm. On Day 6, after treatment, no swelling, redness, mild itching.