chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee received vaccine in left arm. Employee instructed to sit in break room for 15 min following the vaccine. Employee reported to the nurse, myself, that she had tingling in her right arm and under her left eye.
Flu vaccine AFLURIA lot # 12449211A given 10/29/15. Employee stated on 2/9/16 that she has had pain from upper arm to fingers starting 3 days after shot. No fever, swelling or redness reported. Seen by occupational health - physician treating for work related repetitive motion.
Itching, warm sensations, swelling greater than 3" in diameter at injection site, developing over 6 hours, starting about 20 hours after administration
a pediatric female patient received an expired dose of Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-month-old female patient who received HBV (Engerix B) (batch number 5327R, expiry date 15th March 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th March 2021, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 16th March 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired Engerix B, which led to expired vaccine used. The reporter consented to follow up.  Follow up received from an other health professional on 31st March 2021: Patient suffered no ill effects after received a one day expired vaccine.
Pt went to reach glass of water, experienced pain in shoulder that radiated to elbow.  Could not get glass of water, it got some what better in morning
immediatly after administration left am warm, numb in hand mild chills mild headache, increased heatrate AP110 through night lightheaded, muscle aches chest pain. next day burning sensatin left arm chllls. since Feb 24th daily headahes pulsatin. pressure left occipital and frontal, temporal region, brain fogginess, lightheaded, chills and fatique,occaional numbness, face arm and muscle weakness. month later toe crampin. continue with Ongoing daily headahes left occipital , frontal and temporal, brain fog 5 weeks in
I noticed patchy rash on back right shoulder blade on Friday October 1st in the evening. Saturday or Sunday morning, rash and bumps, tried to get in touch with weekend doctor no answer. Thought I may have shingles got in touch with a doctor on Monday, who then prescribed antiviral and gabapentin and proceeded to take it that Monday within 72 hours of noticing shingles. Took antiviral for 10 days. Still receives jolts of nerve pain wrapping around her breast and rib cage.
couldn't sleep; a lot of itching in throat and mouth; a lot of itching in throat and mouth; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number was not reported), via an unspecified route of administration, administered in Arm Left at the age of 27-year-old on 07Jul2021 16:15 as single dose for covid-19 immunization. Medical history included Biotin, Y cranberry's from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on an unknown date as single dose for covid-19 immunization. On 07Jul2021 23:45, at night after receiving the second dose of the vaccine the patient almost couldn't sleep, with a lot of itching in throat and mouth. She would like to know if that event was normal. The patient did not receive treatment for the events. The clinical outcome of events was recovering.   Information on the lot/batch number has been requested.
Dizzy upon rising, fleeting, few seconds.  Dizzy 1-2 times throughout day; daily since, today's date 11.08.2009.
This spontaneous report was received from nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 23-JUL-2014 the patient received improperly stored with M-M-R II [lot # J10993, expiry date 13-SEP-2015], exposed to 9.7 degree for 6 hours 20 minutes and also to temperature of 8.4 degree for 20 minutes subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
COLD CHILLS; FEVER; WEAK; HEADACHE; FEELING VERY TIRED; This spontaneous report received from a patient concerned a male 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 not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 18-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced cold chills, fever, weak, headache, and feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold chills, weak, headache and feeling very tired was not reported. This report was non-serious.
Pain, redness, swelling and tenderness to right deltoid area. Applied warm packs.  Took 600 mg Ibuprofen on 4/24/10 and 200 mg Ibuprofen on 4/25/10.
pt recvd vax; episode of sz-like description 1 1/2 days p/ vax; 11mar whole body shaking x 2 mins;no cyanosis;  high pitched cry; spit up; no fever;
Hard core at middle of vaccine site with red streak coming down. Told pt to check with MD on red streak. Still waiting to hear back from pt.
Out break of shingles left trunk area. Prescribed antiviral acyclovir 100m mg BID x 7 days. I have not yet completed dose.
Tested NAAT positive for COVID 8/29/21 after being fully vaccinated.
Pt has a history of A. fib and is on Coumadin, diastolic CHF and COPD, but not on supplemental oxygen. He was evaluated for weakness and dizziness for 3 to 4 days and with difficulty ambulating. He tested positive for COVID prior to admission and also has hyponatremia and acute kidney injury.
Intussusception (6 weeks after 3rd dose of Rotavirus vaccine) requiring surgery. 02/16/07-Records reviewed for DOS 01/26-01/28/07- DC DX:Intussusception Surgical procedure:Laparotomy for manual reduction of intussusception. Unreducible intussusception status post attempted radiographic reduction.  Presented with history of vomiting hematechesia loss of appetite fever 100.4 plus. Reports currant jelly or blood stools present. Temp in ER 100.4 PE:WNL except for abdomen soft tenderness in periumbilical mild in intensity. Mass soft mobile mass approximately 5cm in diameter to right below of umbilicus, hypoactive bowel sounds. Rectal exam shows empty vault.
Lightheadiness, diziness BP 126/84. water given, pt felt better. refused  transport
per patient - about 2 hours after her injection she began to experience itching and hives and tightness in her throat.  she sought treatment at the emergency department where she states she was given Benadryl and steroids and discharged after observation.
Migraine headache for 3 to 4 days, extreme pain in my arm from my shoulder down to my fingers.  Hot intense burning pain
edema circumferential 3/4 an inch size around the injection site; tenderness on his axilla lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE OEDEMA (edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (tenderness on his axilla lymph nodes  ) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and unk) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and DIAZEPAM (VALIUM) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE OEDEMA (edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (tenderness on his axilla lymph nodes  ). On 21-Feb-2021, VACCINATION SITE OEDEMA (edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (tenderness on his axilla lymph nodes  ) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient smokes marijuana.  No  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-258030 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-significant follow up
This spontaneous report was received from a physician's assistant refers to a patient of unknown age and gender. On 12-OCT-2013, the patient was inadvertently administered with a dose of GARDASIL (lot # 1073AA), 0.5 ml, intramuscularly that had expired on 11-OCT-2013. No adverse effects reported. Additional information has been requested.
Rash along the left flank consistent with shingles outbreak starting approximately 8 hours after vaccination.
Developed redness, itching at injection site  approx. 8-10 hours after injection.  Developed large blisters and swelling  at injection site approx. 24  hours later. Bullae noted at site (3.5 cm x 2.5 cm) and induration 4.5 cm in diameter.  Denied fever, chills, shortness of breath, lip/tongue swelling or difficulty breathing.    Probably self limited local reaction.   Advised OTC Claritin or Zyrtec for itching. Advised cool compresses.  To contact clinic for any fever or worsening of symptoms.  Advised to avoid "popping" blister, apply topical Benadryl ointment and increase hydration.
I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started burning under my armpits. Then, I started having issues swallowing. I felt a general feeling of weakness all over. I went to the ER because I was scared I was having a stroke.
This spontaneous report as received from a physician refers to a now 50 year old female patient with no pertinent medical history or drug reactions/allergies. On an unknown date the patient, as a child, was vaccinated with a dose of MMR II (lot # unknown). There was no concomitant therapy. On an unknown date, about 6 months to 1 year later, the patient got measles. The patient told the physician the MMR II, she may have received as a child at that time there was "a problem with the vaccine lot and it was in the news". The patient's titer currently were as follows: mumps titer was less than 5, measles titer was over 400 and rubella was over 4.5. It was reported the patient was new to this physician's practice and the patient did not have vaccination record dates. The physician stated that his was "historical" information that patient provided that was told to the patient by the patient's mother. The physician did not have any other information. The outcome of the events were unknown. Additional information is not expected.
Redness and edema of the area and warm to touch; measuring 11 1/2cm X 6 1/2cm. Was told to use ward packs. Phone call to mom on 1/29/01; she states area looks much better.
I experienced symptoms similar to brochities with general body aches and mucus that went from yellow to green, fever up to 100.8 degrees at the highest. I had general fatigue and body aches and a fairly bad headache two or three days after commencing my sickness.
No additional AE; Caller reporting a patient received VARIVAX on 11JUL2022 that was improperly stored multiple times; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-JUL-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U002396 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and confirmed as 22-JAN-2023) (exact dose, route of administration, and anatomical location were not provided) as prophylaxis (product storage error). The temperature excursion was of 45.3 degrees Fahrenheit (F) for 20 hours and 44 minutes. The vaccine also suffered previous temperature excursions of: 72.2F for 21 hours and 14 minutes, 70F for 24 hours, and 70F for 23 hours and 59 minutes. No additional adverse events (AE) were reported.
Information has been received from a medical assistant referring to a multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On an unknown multiple dates, the patients were vaccinated with an improperly stored doses of PROQUAD, (lot # N013865, expiry date 31-OCT-2018) for prophylaxis (dose and route of administration were not reported), the vaccine was; reconstituted with properly stored sterile diluent (manufacturer unknown), (lot # and expiry date were not reported). Administered doses of vaccines experienced a temperature excursion of 6 Fahrenheit (F) to 14 F for 8 hours and 45 minutes.  Additionally, the vaccine had previous excursions, which were: 6 F to 14 F  for 1 hour and 9 minutes, and another one of 15 F to 46 F  for 24 hours and 18 minutes. It was a call because of a data logger. No adverse effects were reported.
It was reported that a 10 year old male experienced headache and hysteria (uncontrollable crying), after each dose of Rabies Imovax IM. No specifics were provided. From additional information received by phone it was reported that the doctor believes reaction was due to premedication and not related to vaccine. Additional pt, vaccine and responsible physician information was also provided. From additional information received on 11/9/99, it was reported. "Twelve to eighteen hours, post vax, repeatedly, the boy complained of headache, globally without nausea or vomiting but with increased emotional liability. Pt demonstrated extremes of emotional response, fuss, anxiety, sadness-over mainly minor events as if the feeling was appropriate but was amplified 10,000 fold. Reasoning to calm down or over come negative emotions was largely unsuccessful. Duration of "hysteria" was 36 to 48 hours associated findings were headache, complaints that limbs felt heavy and muscles weak (without objective loss of strength), and general pallor. Anxieties have continued more or less daily. Hysteria was decreased by regular Motrin use." The pt still complains of headaches.
PATIENT DEVELOPED ZOSTER 18 HOURS AFTER THE ADMINISTRATION OF THE VACCINE. HE HAD A LOT OF PAIN AND HE IS YET SUFFERING FROM THIS CONDITION. HE VISITED THE MD TWO DAYS AFTER THE VACCINE AND WAS PRESCRIBED VALACYCLOVIR 1GM THREE TIMES A DAY. ON JUNE 14, 2018 HE VISITED A PAIN MANAGEMENT MD AND PRESCRIBED LIDOCAINE 5% PATCHES.
This case was reported by a other health professional via call center representative and described the occurrence of chills in a 34-year-old male patient who received FLUARIX quadrivalent (batch number 9Z429, expiry date 30th June 2016). Concomitant products included PROTONIX. On 5th October 2015, the patient received FLUARIX quadrivalent (intramuscular) .5 ml. On 6th October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced chills, general body pain, fever and headache. On 9th October 2015, the patient experienced vomiting, sweating, loss of energy and sore throat. On an unknown date, the outcome of the chills, general body pain, fever, headache, vomiting, sweating, loss of energy and sore throat were not recovered/not resolved. The reporter considered the chills, general body pain, fever, headache, vomiting, sweating, loss of energy and sore throat to be possibly related to FLUARIX quadrivalent. Additional details provided were as follows: This case was reported by a medical assistant. On 5th October 2015, at 10:45, the patient received a dose of FLUARIX quadrivalent vaccine. On 6th October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced chills, body aches, fever and headache. On 9th October 2015, 4 days after vaccination, the patient experienced vomiting, sweating, no energy and sore throat. The medical assistant reported that the patient planned to continue follow-up with the office on an unknown date. No further information was available.
sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Lot number: EW0161) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER: EN6207, Anatomical Location: Arm left, Route of Administration: Intramuscular), administration date: 05Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "sore arm", "Fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown".  Follow-up attempts are completed. No further information is expected.
Reaction to Moderna COVID-19 Vaccine EUA: A few days after the vaccination a large redness appeared around the injection site on the side of my right arm.   This redness covers an area of the entire width of my arm by approximately 3 inches in length.  The area is also still moderately swollen and feels warm to the touch.  The area is still sensitive to the touch.  It has now been 12 days and I am worried since there seems to be no change.
I got / series of two shots and ended up getting the internal shingles/Suspect vaccination failure; ended up getting the internal shingles; Excruciating pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (occurred in childhood).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient got the 2 shots of Shingles vaccine and ended up getting the internal shingles. The patient had excruciating pain and was told that since the patient had the chicken pox as a child that could still get it. The patient said of course someone else told the patient that after the fact. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Redness at injection site; headache; Pink rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, red rash and headache. In November 2020, the outcome of the injection site erythema and headache were recovered/resolved. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the injection site erythema, red rash and headache to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of Shingrix in right arm the patient experienced had redness at injection site which was now a light pink rash, the patient also had a headache which was gone. For the tolerability of 1st dose, refer case US2020AMR231743 reported for same patient. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR231743:1st dose
Severe swelling in arm past injection site (to shoulder). Pain in arm and rash at site. Pt has dizziness and fever. Husband claims she is not acting like herself.