chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo, dizziness, continual since 30NOV12. Symptoms called MS, demyelination syndrome, Lyme's disease and just giddiness. Unable to work balance is disrupted. Visual and hearing disturbances.
Systemic: Other- Flushing, numbness, labored breathing, slightly elevated BP, anxiety, pt had not eaten all day
lt arm cont sore, red & swollen 1APR95-4APR95; 1APR95 lt arm began itching, then on 2APR95 began getting hives behind knees all the hot spots; 4APR95 eyes, face, lips, earlobes swollen, voice hoarse, seen by MD:
Less than 24 hours after the first injection the gland in the left side of my throat was significantly swollen. This resolved at the 2 week mark. Less than 24 hours after the second injection I began to suffer migraines along with feelings of hot or cold. These symptoms are still present almost 3 weeks later.
Localized 5 x 5 cm erythematous (L) leg (MMR). Localized 3.5 x 3.5 cm erythematous rash (R) leg (Varicella).
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On 07-FEB-2019, the patient was vaccinated with VARIVAX (strength, dose, anatomical location, and route of administration were not reported) lot # N026073 with expiration date of 20-SEP-2019, indicated for prophylaxis; which was reconstituted with sterile diluent (MERCK) properly stored. Administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F°) to 14 degrees Fahrenheit (F°) (9.9 (F°)) for 5 minutes on unspecified date which was recorded with a data logger. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA003793: Original Case: 1902USA003793.
Elevated bilirubin levels and lowered AST enzymes in liver. Not able to eat because eating makes her feel sick/nauseous for weeks immediately after first dose of Pfizer vaccine.
Muscular soreness in injection site starting a couple/few hours after injection, persisting 30 hours later. Soreness is not extraordinary. It is no worse than soreness from a workout and it radiates out no greater than 2 inches from injection site. No noticeable discoloration of the skin near the injection site. No rash. Starting in the morning prior to afternoon vaccination I developed a headache. I drank caffeine and a lot of water so I presume it was not caffeine withdrawal or dehydration.  The night before I moved a large number of heavy boxes in my garage.  Pain appeared to originate in back of neck, likely muscle strain induced headache. I did not want to take advil prior to the vaccination.  After surviving the day with a headache I took two advil (normal adult dosage) around 7pm or so. Last night around 8pm - 8:30pm (approximately 5 - 5 1/2 hours after injection) I began feeling the onset of a low grade fever.  Confirmed low grade fever using digital thermometer in both ears/multiple readings.  Low temperature 99.0/high temperature 99.2. Low grade fever felt like it subsided after about an hour to hour and a half.  Did not retake temperature. Has not recurred. I AM PROVIDING THIS INFORMATION SOLELY TO PROVIDE DATA FOR THIS NEW VACCINE. ORDINARILY I WOULD NOT EXPECT TO REPORT SOMETHING LIKE THIS.
A patient came in today and reported developing Guillain-Barre Syndrome from vaccinations (FLUCELVAX QUAD and BOOSTRIX) given back on 10/9/18. The patient reports starting to have symptoms on 10/14/18 "heaviness in foot and dragging the leg" but did not know why. On 11/9/18, the numbness and heaviness in the legs continued to be bothersome. On 12/7/18, the patient reports having a hard time walking up the stairs and had to leave work early. He called off from work on 12/9/18 because of the heaviness in his legs. On 12/10/18, he was found paralyzed in his bed and 911 was called. He was taken to Medical Center and was put into the ICU until 12/15/18. From there he was moved to the neurology unit until 12/18/18 and then to Rehab Center until 12/28/18. He was discharged from the rehab center on 12/29/18. According to the caregiver, the patient was under the care of Dr. His CT and MRI scans were negative so a spinal tap was done and that is what confirmed the diagnosis of Guillain-Barre Syndrome, again according to caregiver.
Expired Dose of HEPLISAV-B Given; Initial Report Received: 09-Aug-2019  and 09-Oct-2019  A pharmacy technician reported that a 61-year-old female, received an expired dose of Heplisav-B (hepatitis B vaccine) for hepatitis B immunization.  Relevant medical history was not reported.     Concomitant medications were not reported.   On 09-Aug-2019, the patient received an expired dose of HEPLISAV-B (lot #103384, expiration date: 06-Apr-2019, NDC# not reported) in the left deltoid. The injection was administered by a Licensed Practical Nurse (LPN) at a clinic. It was reported that the patient was unaware that she was given an expired dose of medication at the time of this report. It was reported that the vaccine was found expired after patient received the vaccine.  On 31-Aug-2019, the patient received the second dose of HEPLISAV-B (lot #, expiration date, and NDC # not reported).   At the time of the report, there were no adverse events reported.   The reporter reported the event as resolved, non-serious and of mild severity.    Company comment:  The company assessed the event of expired dose of Heplisav-B given as non-serious. The event of expired dose of Heplisav-B given is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired dose of Heplisav-B given as non-serious. The event of expired dose of Heplisav-B given is unlisted per HEPLISAV-B USPI and IB.
Patient at field trip next day became pale, had to sit down passed out for 15 seconds had had good breakfast. Was standing watching Blacksmith when got pale, syncope and passed out for 15 seconds.
It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's from below where the shot was; Going around the arm and it's kind of like a burning itch; it is annoying; little redness on my arm; allergic to the preservatives in the vaccine; Going around the arm and it's kind of like a burning itch; it is annoying; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing cholesterol. Concomitant medication included rosuvastatin taken for cholesterol, start and stop date were not reported. Historical vaccine included FLU for patient had a Flu Shot but it only got little red, little redness on my arm and first dose of BNT162B2 (Lot number: EN6200, Expiration date: Jun2021) via an unspecified route of administration on 27Jan2021 for Covid-19 immunization. Patient stated, "patient got the Pfizer second shot on Wednesday (Clarified as 17Feb2021) patient arm didn't start to bother me or it was very sore (Further clarification was unknown if consumer's arm was sore or not, hence captured as event) but then on Friday patient noticed patient was getting a reaction and it started to turn red so patient had an allergic reaction to it, except that it keeps spreading on patient arm it's from below where the shot was, it didn't hit the elbow yet but it is going around the arm and it's kind of like a burning itch it's not something terrible it's not something patient cannot deal with but patient was concerned about it and patient wondering if there is something patient can take or do because it is annoying on 19Feb2021" Patient believe because patient had a Flu Shot (Captured as provided) but it only got little red. patient think patient was allergic to the preservatives in the vaccine (COVID-19 Vaccine) because a friends of my works in a doctor's office and she was with me and she said I am probably allergic to, what you call the preservatives in the vaccine." Patient stated, "No it's been a while, it's been, you know it was just a little redness on my arm on 19Feb2021." Patient received a treatment that put some Ice on its last night and then patient took a Benadryl, you know generic Benadryl from a Walmart. The patient underwent lab tests and procedures which included Cholesterol and Urine: unknown results on an unspecified date in 2021. The outcome of the events was unknown.  Information on Batch/Lot number has been requested
Wrist stiffness, soreness, and swelling on the same extremity as I received both doses of the vaccine
Pt's Home health aide called today updating that she noticed a quarter size rash on the left side of her neck and a nickel size rash on the upper left arm where the vaccine was given. No fever, chills swelling, warmth or discharge.
(Administered outside of clinic - records from outside facility) Student presented for his booster shot.    Date and age needed to be corrected on his questionnaire.  Registration and RN did not catch that he was only 4 months (11/18/21) from getting his 2nd shot. Mistake was noted when the team returned to the clinic that afternoon.
This is in follow-up to report (s) previously submitted on 5/14/2008. Information has been received from a physician concerning a 12 year old female with concomitant medications and pertinent medical history reported as unspecified, who on approximately 02-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot:634535/0960F).  0.5 ml IM. The second dose of GARDASIL was given on 02-APR-2008 (Lot # not reported).  Following the first dose she did not get a period for 5 months (she has had her period since age 11).  She sought the medical attention of a physician and her mother refused to allow her to take a pregnancy test.  The outcome was unspecified.  No product quality complaint was involved.  Additional information has been requested. Followup information was received from the physician who reported that the patient had no mentrual cycle for 5 months from AUG-2007 until approximately JAN-2008. It was reported that she recovered in approximately JAN-2008.
Fever or Chills  Cough  Muscle or body aches  Headache  Sore throat
Patient age 9; arm is paralyzed; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer) from medical information team. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 21Nov2021 16:45 (Lot number: FZ5127) at the age of 9 years as dose 1, 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Caller was notified by a Pharmacist that the patient received the adult dose (30mcg) vaccine. Caller said that almost immediately after the vaccine on 21Nov2021, the patient complained of a sore arm, not normal but really bad that his whole arm was paralyzed. It is better than 21Nov2021, half way it hurts. Caller states that his son did not take any pain medication to relieve his symptoms. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. No family medical history relevant to AE(s). The outcome of sore arm and arm was paralyzed was not recovered.
Hives within 15 minutes after onset of vaccine. Given benadryl and full resolution
Information has been received from a physician concerning a 4 year old male with no past medical history or allergies who on 08/15/2001 was vaccinated with a first dose of varicella IM in the upper thigh. There was no illness at the time of vaccination. On 10/02/2001, the pt developed chicken pox. For 3 days the pt had an itchy rash with a red base and central vesicles. No further info is available.
Pt experienced a pre-syncopal event approximately 15-20 minutes following vaccine administration. Pt reported her vision went black and she could not see, she felt hot and light headed. Pt was assisted to the ground and quickly assessed by medical staff from in-house Urgent Care. Symptoms quickly resolved, no further complications. Pt reports she did not eat or drink anything prior to appointment.
Information has been received from a nurse and a physician for the pregnancy registry for GARDASIL concerning a 15 year old female student with no pertinent medical history and no allergies who on 31-AUG-2007 was vaccinated with the first dose of GARDASIL IM 0.5 ml in the deltoid. On 03-JUN-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5 ml in the deltoid (lot # 660391/0063X). Concomitant therapy included prenatal vitamins. The patient was 23 weeks gestation. The patient's last menstrual period was 09-APR-2008. The estimated due date is 14-JAN-2009. No adverse symptoms. The patient sought medical attention in the office visit. The urine pregnancy test was performed. Follow-up information has been received from the physician from questionnaire. On 02-OCT-2008 ultrasound was performed for routine with normal results at 19 weeks 6 days. On 25-NOV-2008 serum alpha-fetoprotein test was performed with fetal demise at 24.3 weeks. It was reported that the patient was 24.3 weeks by ultrasound date but was 28 plus weeks by first ultrasound date. On 27-NOV-2008 the patient with 0 previous pregnancy underwent induction for fetal demise at 24.3 weeks. The fetus was normal with no autopsy done. There was no complication during pregnancy. Upon internal review, fetal death was determined to be an other important medical event. Additional information is not expected.
Patient Went to her room with her nurse and after 15 or 20 minutes she was unresponsive. The nurse took her blood pressure and pulse and there was not any response. Patient is on hospice. The nurses ran and got me. Since she was not responding we administered one dose of epinephrine in her thigh. She started opening her eyes after this. She also had a pulse and we were able to take her blood pressure. The nurse wanted to give her 2 tablets of 25mg of Benadryl. She crushed them for the patient and put under the tongue. Patient was seen by her hospice nurse, and her family was made aware of incident.
Ive had 5 pfiser vaccines/booster for covid19.  The first 4 I had some achy arm, a slight headache and felt tired for about 2 days. My last booster on 1/2/22 has given me really bad reactions.  (I'm thinking allergic reaction). The left arm hurt a lot.  I had a red thick circular area at the injection site which was quite itchy, starting on 10/2 through 10/4.  Today the arm is achy and the redness has spread and become light pink. I took pics. I've had difficulty breathing with pain in the middle of my chest.  I used (albuterol inhaler) which helped a lot yesterday.  I used it again this morning but it didn't help as much.  I have taken 1 Benadryl tablet last night and 1 this morning.  I have also taken 5mg of prednisone.  Im still itchy all over, but I don't have a rash.  I still have a lot of pressure in my chest. ( I  don't have a cold or other respiratory problems).  This reaction is so much more severe than the other vaccine reactions I've had, I thought you should know.
Vaccine given on 6/19/23. Patient started running 100.2F temp on 6/20. Abebrile for two days. On 6/23/23 patient ran a 100.4F fever and had bloody stools. Bloody stools continued until 6/25/23. Patient had ER visit where a stool panel was run and came back positive for rotavirus.
Four inches long by three inches wide swelling of injection site - 24-48 hours from injection.  Red & hot to the touch. Tylenol for discomfort.
Rash on left arm on bicep. From top of arm down per patient half way to elbow. She said she noticed yesterday morning after a shower, she had a headache, fatigue, fever and painful rash. She took some ibuprofen and slept. She says that symptoms have improved today but rash is still present though not as painful as yesterday.
The 2nd dose of Moderna was administered on 05/12/2021  at 9:40 am, patient waited for 15 minutes he was feeling well and left the pharmacy at 09:50 am. The patient-caregiver contacted us at 12pm on 05/13/2021 stating that the patient passed away today. She stated he was feeling fine yesterday and had his breathing treatment at night and in the morning he didn't wake up.
patient complaining of tingling to tongue and numbness to upper back area. He was given 2 doses of bendaryl 12. mg/5ml. patient still wasn't feeling better after the Benadryl  and was sent to the ER
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Pfizer COVID 19 Vaccine EUA  Pfizer Dose 1 2/18/21 (EN6200) Pfizer Dose 2 3/12/21 (EN6208) COVID Positive 5/13/21  5/20/21: The patient presents with fever and stats that he started couging 12 days ago. He was seen in the ER on 05/13 for fever and cough. He was was found to have covid. Blood test were unremarkable and the chest X ray was negative. He was enrolled to the Covid  out patient risk assessment. He states that he continue to have fever with eakness. He was seen 2 days ago at the clinic. He was sent home but he continue to have fevr, cough and weakness. No shortness of breath. No chest and no abdominal pain. No nausea nor vomiting..  The onset was 12  days ago.  The course/duration of symptoms is constant.  Associated symptoms: cough, decreased oral intake, denies chest pain, denies shortness of breath, denies rhinorrhea, denies sore throat, denies nausea, denies vomiting, denies abdominal pain and denies rash.  Temperature is 102  Fahrenheit.  6/2/21: Patient continues to feel well; nurse reports he is cleaning is dinner plate thoroughly; he has questions about discharge; physical therapy was unable to assess him yesterday, they will see him this morning at 9:00 a.m.; if they recommend physical therapy we will proceed in that direction; if they state that he is at his baseline and not in need of their services, we will discharge him with monitoring.  6/3/21: Discharged home.
1-16-21 @ approx 1pm 2-6-21 @ approx 1:30pm Pfizer LOT # EL8982 Pfizer LOT # EL9262 pain to arms, throbbing to injection area, pain to neck started has been for a few weeks. unknown onset
pt recv vax 30DEC96 & 31DEC96 pt devel flu sx consisting of fever of 100, chills, shaking, nausea & fatigue;sx persisted for 24hr;
This spontaneous report was received from a Nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 07-OCT-2015, the patient was vaccinated with first dose of unidentified Merck hpv vaccine (name and lot number not provided), (dosage not reported). On 30-DEC-2015, the patient was vaccinated with second dose of unidentified Merck hpv vaccine (name and lot number not provided). The patient's mother mentioned that the patient received an additional dose at an unspecified facility on an unspecified date. The Nurse reported that the patient might had received 4 doses of GARDASIL or GARDASIL 9. No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Fever, chills. Muscle aches, nightmares, headache  unable to sleep because of side effects
4-6-05 T.C. from mother.  Reports child with redness, swelling, firmness, and warmth to injection site.  Instructed to bring in for assessment today. 4-6-05 Child assessed per RN with.  Noted R upper arm/deltoid area swollen, red, warm to touch and firm.  Pt. scheduled to see today at 11:00am. -------------------- 4-6-05 @ 3:30pm T.C. to mother.  States child received P.O. Benadryl and Ibuprofen and she is applying cool compresses to R arm.  Encouraged to phone office with any changes.  States child, "not really complaining of any discomfort." 4-8-05  T.C. to mother.  States R arm "not as bad as it was 4-6-05."  States R deltoid area continues with small area of hardness at injection site, "but not swollen as bad and not feverish."  States child does not c/o discomfort unless area touched firmly.  Encouraged to continue interventions as per physician recommendation and report changes to Dr.  Mother voiced understanding.
10/16/02 mother noted approx 8 red bumps previous evening. Today some have white centers/blisters very itchy.
Patient said she developed hives and swells around the left arm and both ankles. Symptoms are better today.  Patient uses hydrocortisone 1% cream
Information has been received regarding a case in litigation concerning a female child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from October 1997 through February 1999. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Follow up info was received that included a vaccine administration record. The pt was vaccinated with hep B virus vaccine and varicella virus vaccine live. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). Additional info has been requested.
Vaccine given about 09:20, patient ambulated 30 feet without difficulty, began texting on phone and shared her right arm & finger was numb & tingling.  Patient became anxious acting, claimed "I feel dizzy & heart racing."  Patient monitored, 09:25 heart rate less than 100,  states dizziness has resolved, patients respirations even & unlabored skin pink and dry.   09:30  Patient talking  in a relaxed manner with co-workers, does continue to complain of "my fingers feel asleep".  Pt monitored for over one hour.    Patient ambulating without issues out of observation area, skin pink warm, dry, no acute distress reports numbness & tingling resolved, has full range of motion to right arm.