chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, hot to touch, golf ball size area on left thigh. Instructed to give BENADRYL and cold compress. Phone call to the office.
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 17-AUG-2011, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-SEP-2014, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient had been prescribed acyclovir (manufacturer unknown), hydromorphone (manufacturer unknown) and ondansetron (manufacturer unknown) for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
COAGULOPATHY, UNSPECIFIED TYPE HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA  1/21/2023 --  RECURRENCE OF SAME SYMPTOMS
Pt also received Fluzone Flu vaccine to RA UJ687AA 10 mins post vaccination (10:05) pt reported sweating, lightheadedness, dizziness.   Vitals: @ 10:15 BP 74/44, HR 49, RR 18 -- > @10:20 124/80, 70, 16. An HCP called at 10:26 Pt assessed by MD.  Likely vasovagal episode.  No LOC during event. Pt given water, crackers.  Pt mentating okay. Pt resting in Clinic gurney, and verbalizing, joking with Staff.  RN assisted ambulating pt, on Unit Floor. Pt ambulatory w/ stable vitals.  Pt stable and released from the vaccination site @10:50.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 12:00 (Lot number: ER8729) at the age of 26 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 27Mar2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: AMNESIA (non-serious) with onset 17Aug2021 12:00, outcome "unknown", described as "memory loss"; MENSTRUATION DELAYED (non-serious) with onset 17Aug2021 12:00, outcome "unknown", described as "Delayed period"; MENSTRUATION IRREGULAR (non-serious) with onset Oct2021, outcome "unknown", described as "Missed my period". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amnesia, menstruation delayed, menstruation irregular. Additional Information: The patient did not have other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. I have been experiencing memory loss at times where I forget what I was talking about and what I needed to go get. One big thing that I noticed is that I have had a very delayed period and a few months ago and this month in October I missed my period as well and negative pregnancy test. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
24 hours after vaccination patient developed HA, weakness, body aches which lasted 1-2 days.  Developed redness, swelling, warmth and pain at injection site which is still present on 08/31/2009.  Antibiotic therapy started today.
6 x 8cm area of induration & erythema surrounding injection site on lt deltoid;
I had my vaccination on 07/26/2022. On 01/11/2023 I had a cough, runny nose, wheezing, fever of 100 for 24 hours. This biggest symptom was the wheezing. I was followed up with Pediatric office who prescribed albuterol and oral steroid. I am feeling much better.
C/o greater than usual pain immediately after shot. Later that night c/o severe pain at injection site (L) deltoid & limited motion for 2 days. Pain continues now, 2 weeks after injection & is increasing & moving into neck for last 1 week. C/o continuous arm pain with sharp pain on certain movements & raising her arm is painful. Has self treated with ice/heat alternating and ES TYLENOL.
HALF DOLLAR SIZE LOCAL RAISED RED AREA WITH BUMPS, DID NOT BLISTER NO FEVER NOTICED, VERY ACHEY JOINTS COULD NOT MOVE OR FUNCTION FOR 2 & 1/2 DAYS WAS IN BED MOST OF THE TIME, NO CHILLS OR NASEA OR VOMITING JUST SEVERE JOINT PAIN. PAIN AND LOCAL REACTION GONE WITH-IN 96 HOURS OF FIRST OCCURING. TOOK TYLENOL FOR PAIN.
Pediatric dose given for Hep A and Hep B, rather then adult dose. Patient notified, no adverse reactions noted. She will return to clinic for revaccination
Rash developed on left side of body covering neck and torso; fever around 102 for 3 days and fits of vomiting. I probably should have gone to the doctor but I suffered through it with fluids and ibuprofen.
A report was received from a health care professional on 22OCT2003, concerning a 23 year old male vaccinee who experienced hives on his abdomen, thighs and arms and a red, swollen and hot injection site two days after receiving the Fluvirin vaccine on 20OCT2003. On 22OCT2003, the vaccinee woke up with hives on his abdomen, thighs and arms. His Fluvirin injection site was red, swollen and hot to touch. Following administration of Diphenhydramine the hives improved slightly. Update 1, 16FEB2004. A follow up report was received from a health care professional indicating that the 24 year old vaccinee's hives have now resolved. The vaccinee is allergic to sulphonamindes drugs and had mixed Amoxicillin Suspension the night prior to the development of the hives. The hives were persistent and re-flared for one week. The vaccinee was treated with prednisone and cetirizine hydrochloride. The reporter has assessed the relationship of Fluvirin to the event as probable. No follow up pending, all information received.
Fast heart beat (120 beats/minute) that started at about 8:00 pm on the day of the vaccine and lasted about 7 hours.  My normal resting heart rate is about 62 beats per minute. Other mild side effects were some muscle aches and feeling very tired.
Patient received immunization at about 14:40 and at 15:80 came back to the clinic with cough, runny nose and right periorbital edema. He did not have wheezing on exam. He was given Benadryl 1.5 tsp PO for 1 dose and watched. At 15:20 he was feeling better; no cough. Still had periorbital edema and wheezing; no edema at injection site. At 16:00, much better; active CTA. No cough; slight periorbital edema.
joints in arms, legs, back still ache; shortness of breath; tired later in day- somewhat exhausted; seem to be more forgetful of stuff including names; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Got my old people flu shot approximately 3-4 weeks ago.), administration date: 2022, for Immunisation; Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER),  SINGLE, Lot number: unknown), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 29Oct2022, outcome "not recovered", described as "joints in arms, legs, back still ache"; MEMORY IMPAIRMENT (non-serious) with onset 29Oct2022, outcome "unknown", described as "seem to be more forgetful of stuff including names"; DYSPNOEA (non-serious) with onset 29Oct2022, outcome "recovered" (2022), described as "shortness of breath"; FATIGUE (non-serious) with onset 29Oct2022, outcome "unknown", described as "tired later in day- somewhat exhausted". Therapeutic measures were taken as a result of arthralgia, dyspnoea.  Additional information: Shortness of breath had lessened, but stairs still affect patient the most. For the last two weeks patient had been using a backpack leaf blower for eight days for a minimum three hours at a time with seemingly no shortness of breath but really tired later in a day somewhat exhausted.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
1st dose on Nov/2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that patient had not had the second dose of Shingrix vaccine almost 1 year post 1st dose of Shingrix vaccine. The reporter was unable to provide any additional details regarding adverse event. Healthcare professional given permission for safety team to follow up. Adverse event contained all reported information. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Hypotonic, glassy eyed, lifeless, slept 7 hrs, some responsiveness as reported by mother. Lasted 2-3 days
Fever, aches, chills, headache, and asthma/hard time breathing from morning of 6-17-21 until the morning of 6-19-21.  She was in the yellow zone of her asthma action plan for about 48 hours.
This 20-year-old female subject was enrolled in a blinded study (580299 099) for the prophylaxis of cervical intraepithelial neoplasia (CINII) associated with human papillomavirus (HPV); 16 and/or HPV-18 in health young females. The subject received intramuscular investigational product single dose on 09/21/2005, 11/01/2005 and 03/01/2006 after negative urine pregnancy test. Site of injection was the left deltoid. On 09/21/2005, 11/01/2005 and 03/01/2006, the subject received the first, second and third intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug AL (OH) 3. Lot number was not provided.  On 05/22/2006, 82 days after the third dose of Blinded vaccine, this 20-year-old subject developed abundant vaginal bleeding with clots associated with pelvic pain. (last menstrual period: 03/15/2006, the subject was exposed to the vaccine before conception). On 05/28/2006, the vaginal bleeding stopped. On 05/09/2006, the subject performed a blood pregnancy test which was positive. the microbiologist indicated that the result was only slightly positive and recommended her to visit a doctor because it could be a miscarriage. The subject didn't consult a doctor because the vaginal bleeding stopped on 05/28/2006 and she felt well. On 06/05/2006, she was evaluated by the study doctor. He documented a closed, formed cervix, without vaginal bleeding, an uterus with normal height and doubtful urine pregnancy test (non serous adverse event). On 06/09/2006, when she was 12+1 weeks pregnant according to the date of last menstrual period, a quantified HCG test was performed. On 06/20/2006, the result of this test was received: 96 UI/L (normal values after 3-4 weeks pregnancy: 15-150 UI/L). The subject was finally diagnosed as having had a complete spontaneous miscarriage since she presented with vaginal bleeding and a positive blood pregnancy test with decreased HCG. The event resolved on 05/28/2006. The subject will continue in the study. The investigator reported the complete spontaneous abortion as possibly related to investigational product due to the temporal association between the last vaccine dose administration and the date of the last menstrual period. This event has been considered to be medically important. (OMIC)
Itchy, erythematous rash. Did not go to ER or get treatment immediately but then saw allergy, received allergy testing and later received 2nd dose.
slight headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "slight headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, GlaxoSmithKline. In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756531A, A0756533A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received stated AFLUA3508A. With a possibility of coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B.The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
PATIENT IS 16 BUT WERE GIVEN MODERNA INSTEAD OF PFIZER FOR FIRST DOSE, DEPT OF HEALTH RECOMMENDED GIVING MODERNA FOR SECOND DOSE ALSO TO COMPLETE SERIES. PATIENT HAD NO REACTION AFTER 15 MINUTES. NO ADVERSE EVENT NOTED.
Information has been received from a physician concerning an 18 year old female patient who was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# not reported) "about a year and a half ago". The patient developed a rash and hives after receiving her first dose of GARDASIL. The physician found out about this adverse experience when the patient came back to the office for her second dose of GARDASIL. The second dose of GARDASIL was not given. No diagnostics study was performed. The patient recovered on an unspecified date. Additional information has been requested.
Moderna COVID-19 Vaccine EUA About 18 hours after vaccine, started feeling chills and tireness. Continued through the day, getting worse as the day went on. Skin was crawling, felt weak and unable to do anything. Feeling better today, 2/21/21, but still a little nauseous and not quite myself.
Upper respiratory infection requiring medical intervention with supportive care and azithromycin for persistent cough. Cough resolved after 3 weeks. In general after most of the COVID vaccinations I have also had immediate transient tongue numbness and tingling that self resolved in less than one hour without any respiratory symptoms
Anaphylaxis within 20 minutes after vaccines given - facial swelling, rhinorrhea, wheezing, urticaria.
Swelling/redness mimicking cellulitis. Patient came to hospital but was discharged the same day
Hurt like a bitch  and my body ached; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a 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 general body pain.On an unknown date, the outcome of the general body pain was recovered/resolved.  It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient reported that the shots hurt like a bitch, and his/her body ached for days.
A healthcare professional reported that a 49 year old male received an injection of Flu Shield '00-'01 on 11/27/00 and subsequently experienced tingling in his legs and nausea. This is 1 of 2 pts from this facility who experienced this event, post vax, lot #4008185.
Dizziness, Headache & Myalgia Narrative:  Slight dizziness, slight headache, sore arm
She got her vaccine, and felt a strange metallic taste in her mouth, and her roof of her mouth and the nose feels numb.  She did inform one of the techs of that and he told her that it was common, and said it was like when you get contrast dye which is what she is allergic to and concerned about it.  The inside of her mouth is numb as well.   She also has a heaviness in her forehead.
Rash developed around injection site around 7 days after the injection.  The affected area was red, very warm to the touch, and itchy. The symptoms have lessened  over the course of the last couple of days. The redness has diminished, but the itchiness remains.
"some of my friends had the same experience after their vaccine having severe diarrhea and nausea; experience hives on my back, on right shoulder; "some of my friends had the same experience after their vaccine having severe diarrhea and nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea), URTICARIA (experience hives on my back, on right shoulder) and NAUSEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea) in a patient of an unknown age and gender 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 DIARRHOEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea), URTICARIA (experience hives on my back, on right shoulder) and NAUSEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea). At the time of the report, DIARRHOEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea), URTICARIA (experience hives on my back, on right shoulder) and NAUSEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case is a cluster case.
This spontaneous report as received from a medical assistant refers to a 20 years old female patient. On 28-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot# J015378, expiry date: 09-APR-2016, dose, dose number, route of administration were not reported) that was improperly stored on 08-AUG-2014. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
w/in 24 to 48hr pt devel an inj site rxn characterized by swelling, redness & warmth @ both inj sites; rxn @ HIB TITER site was more pronounced;child was seen by MD tx symptomatically & recovered;
Intense and severe menstrual bleeding, cramping, a profound amount of bleed through throughout night and during day
In May 2023 I went to bed and woke up in the middle of the night and woke up with a terrible headache.  The next day it happened again.  I took ibuprofen to help.  The following night, it happened a third time.  That afternoon I went to the emergency department because I still had a headache.  My blood pressure was elevated.  I had a CT and an MRI.  I had an elevated troponin number.  Because of that I was admitted to the hospital.  My headache got worse.  I asked for ibuprofen, and they would not give it to me.  They gave me ice packs to help.  The cardiologist visited.  A hospitalist visited and thought it was a migraine caused by hypertension.  The cardiologist said my heart was fine.  I had another headache on June 14th and the ibuprofen helped this time.
Premature baby in 24 hrs prior to immunizations had 6 low heart rates. In 34 hr period following immunizations had 34 low heart rates, eleven of which required moderate stimulation to recover call associated with apnea. Low heart rate <80. In subsequent 24 hr period only 2 low heart rate.
Patient received a Pfizer bivalent booster on 9/15/22, then mistakenly also received a Moderna bivalent booster on 10/18/22.
Site: Pain at Injection Site-Mild, Systemic: Bell's Palsy-Mild, Systemic: Headache-Mild, Additional Details: Patient noticed the numbing on her left side of the face the next morning after her vaccination. Her face was numb to touch, had moderate to severe pain on her jaw and face only on the left side. Patient took tylenol to help with the pain and it helped a little bit but the symptom lasted for two days. Patient is fully recovered now and is worried about whether she should get the second dose.
Muscle spasms and twitching in arm.  "Bee sting" like rxn from intradermal injection.
During a review of the  Department of Healths internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Breakthrough case admission after 2 vaccines Moderna 1/4/21 lot# 025J20A;  Moderna 2/1/21 lot# 011L20A
Fever (100.7°) Chills Headache Joint Ache Light-headed  I was instructed to report any side effects to this address.  That's why I'm reporting these symptoms, which I know are expected side effects of the vaccine.