chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 04 March 2013. A female patient (age was not reported), had received an intradermal dose of FLUZONE ID vaccine (Lot number: UT4478AA, expiry date: 04/23/2013, number in series: unknown, site of administration was not reported) on 03 March 2013. The patient was pregnant. The patient's last menstrual period date and estimated date of delivery were not reported. The patient's health during pregnancy and risk factors was unknown. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced adverse event (no further details were reported). Corrective treatment and laboratory details were not reported. Documents held by sender: none. Follow up information received from a healthcare professional on 16 May 2013. The patient had no illness at the time of vaccination. No other information was reported. Follow up information received from a healthcare professional on 21 June 2013: The patient's pregnancy details were unknown.
This spontaneous report as received from a consumer refers to himself/herself. On 06-JUN-2017 shortly after 12:00 PM, the patient was vaccinated with ZOSTAVAX in the left arm for prophylaxis. On 08-JUN-2017 at 13:00, the patient experienced injection site pruritus, nausea, dizziness and injection site erythema. The outcome of dizziness, nausea, injection site erythema and injection site pruritus was reported as recovered/resolved following a 2 hour nap. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse an refers to 6 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # reported as M034187, expiration date: 17-MAY-2019 (exact dose and route of administration were not reported). There was no adverse effect reported. The administered doses experienced the temperature excursion between 46 degrees Fahrenheit (F) and 77 F for 6 hours. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009338: US-009507513-1701USA009339: US-009507513-1701USA007030.
While I was in the army station overseas. We had to have the anthrax immunization lot # FAV020 subcutaneous injection on the following dates #1 on 16 April 1998, #2 on 30 April 1998 and #3 on 14 May 1998. The shot gave me a burning pain in both arms and headache then it went away. After a few years I was discharged from the military, gave me an exam and gave me 40% disability. 10% for lower back pain, 10% for right ankle problems, 10% gastroesophageal reflux disease with hiatal hernia, 10% PTSD, Bursitis right shoulder, cystic acne, hemorrhoids and both knees ptellofemoral. My LIPID TRIG is very high and had a colonoscopy done on june 2001 and had polyps removed no-cancer. I'm taking 100 MG of zolof for PTSD. Its hard to say if any of my problems I have was caused by the anthrax shots. But I do know my health has not been the same and not getting better since the immunizations.
Around 3pm yesterday, 12/4/12, she started experiencing body aches, fatigue, loss of appetite, and nausea when trying to eat.  She took Tylenol and ibuprofen last night but continues to feel the same today.  She took Tylenol again today but it has not helped with the body aches.  She states she will go to the doctor if she doesn't feel better by tomorrow 12/6/12.
01/11/22 presents to ED for "covid symptoms including cough, myalgias, chills, and dyspnea x1 week". PMHx of "left kidney transplant in 2020, IgA nephropathy, and HTN"
Made her to got to sleep/Have the best sleep she have ever got in 2 years; chills right after the shot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Made her to got to sleep/Have the best sleep she have ever got in 2 years) and CHILLS (chills right after the shot) in a 71-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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Made her to got to sleep/Have the best sleep she have ever got in 2 years) and CHILLS (chills right after the shot). At the time of the report, SOMNOLENCE (Made her to got to sleep/Have the best sleep she have ever got in 2 years) and CHILLS (chills right after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided   This case was linked to MOD-2021-071496 (E2B Linked Report).; Sender's Comments:  MOD-2021-071496:
Felt whole body numbness.  Sensation discrimination to sharp/dull is diminished in a stocking/glove distribution. Reflexes are normal including downward Babinsky, but when she is seated with her leg extended and me holding her ankle in order to perform the Babinski, her foot had a wobbly/serpiginous movement or lack of coordination that was involuntary and definitely not intentional.
Pt had attended an outdoor wedding over the weekend where everyone was unmasked.  He now had shortness of breath, cough, and diarrhea.  He was found to be COVID positive.  Pt had acute hypoxic respiratory failure secondary to COVID-19 pneumonia.
I received my vaccine this morning and I had no problems until I was getting ready for bed and I noticed the bandaid was very high on my arm. As a certified medical assistant I know that vaccines must be given in the muscle of the deltoid; however my injection of the Covid vaccine was administered roughly 0.25-0.5in below my acromion process on my L arm; therefore not in the muscle of the deltoid.
Vaccines given at 9:00am and mother returned to office at 9:10 am stating patient had a rash on his face. Patient was seen by Dr. Flex and Benadryl was given. Patient also had rash to site where vaccines given.
Myalgia, extremely sore arm, now a raised lump at the injection site, significant fatigue Narrative: extremely sore arm, now a raised lump at the injection site, significant fatigue
Directly following vaccine, while driving home, I got really dizzy and had trouble focusing. I pulled the car over and called a friend and could barely follow our conversation. When I got home, I slurred my speech and my hands and legs went tingly and numb. My face grew numb too. I had an episode a week later where I couldn't move. Since then I grew faint and have had difficulty breathing, swallowing, and concentrating. Doctors cannot find anything wrong. Went to the ER that night and another ER visit a month later.
On 8/19/2019 patient reported 2 seizure events occurring since Shingrix vaccination. To note, patient also received Boostrix the day prior to Shingrix vaccine.
developed appendicitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: EW0161) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZIPRASIDONE; HYDROXYZINE; TRAZODONE; ALBUTEROL HFA. Vaccination history included: Bnt162b2 (Dose 1, Single, Date: 26Mar2021 , Batch/Lot No: ER8732), administration date: 26Mar2021, for COVID-19 immunization. The following information was reported: APPENDICITIS (medically significant) with onset 19Apr2021, outcome "unknown", described as "developed appendicitis". Therapeutic measures were taken as a result of appendicitis and included treatment with appendectomy. Clinical course: The patient received the Pfizer, COVID Vaccine back in April and after his second dose had a serious adverse reaction. He actually had appendicitis. He had to have an appendectomy. So, the patient wanted to report this as a side effect and see if it was possibly related. It happened about two days after his second shot. Anatomical site of administration: Reporter stated that he believed it was his left arm  but he was not quite sure but he thought it was his left arm. Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Currently available information is insufficient to determine a causal relationship with the vaccine.  No follow-up attempts are possible. No further information is expected.
no AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), dose: 0.5 milliliter, lot# S030211, expiry date: 25-MAR-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
This spontaneous report as received from a nurse practitioner refers to 18 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 28-JAN-2015, the patient was vaccinated with the dose of PEDVAHXIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports form the same reporter. Additional information has been requested.
Patient seen in the office this morning by M.D. Pain and swelling of right arm, starting 10 days after injection of right arm.
Infrequent (4-5x per week) 'heavy' heart beat. Lasts 15-30 seconds. Creates a sense of anxiety/panic. Uncorrelated with actual emotions/anxiety level, environmental conditions, diet, or exercise.
Rash, pink papular 2-4 mm over face then spreading down trunk and limbs. No URI symptoms, No fever. Otherwise well.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the digital data loggers and freezers expired before they were re-calibrated. The reporter was aware in some of the freezers there was a temperature excursion that the data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures.  The reporter wanted to know whether need to take any action since the vaccines stored in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021. No treatment medications were reported.
Headache; Fatigue; Aching joints and bones; Aching joints and bones; Body temperature fluctuations; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 12:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at 14:00, the patient experienced headache, fatigue, aching joints and bones and body temperature fluctuations. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fatigue, aching joints and bones and body temperature fluctuations was recovered on an unknown date in Apr2021.No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient called 11/10/08 to report bilateral axillary rash which developed within hours after receipt of Hep B (dose #3) and Typhoid Typhim Vi.  Associated bilateral ear redness and itching.  Sxs resolved by evening; no treatment.  No subsequent complaints or sequelae.
Pt with LMP 5/22/21 received first dose Pfizer COVID vaccine on 5/14/21 and second dose 6/4/21. On 7/6/21 she presented with vaginal bleeding at 6 weeks 4 days (EDC 2/26/22). Pt had a subchorioinic hemorrhage but has continued to carry the pregnancy, most recently seen 8/19/21 at 12 weeks 5 days with (+)FHT.
The patient received the HPV vaccine and felt light-headed and faint. She was given Gatorade and laid down for about twenty minutes until vials were back to baseline. BP 90/50 at time of episode. 100/80 post rest.
Dose #4, reports cephalogam, chills, increased temperature 101 PM.  Nausea after injection.  Problem resolved within 24 hours.
weak, sweaty; weak,sweaty; weak,fatigue,thirsty; left shoulder is weak; weak,fatigue,thirsty; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak, sweaty), HYPERHIDROSIS (weak,sweaty), THIRST (weak,fatigue,thirsty), MUSCULAR WEAKNESS (left shoulder is weak) and FATIGUE (weak,fatigue,thirsty) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (weak, sweaty), HYPERHIDROSIS (weak,sweaty), THIRST (weak,fatigue,thirsty), MUSCULAR WEAKNESS (left shoulder is weak) and FATIGUE (weak,fatigue,thirsty). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weak, sweaty), HYPERHIDROSIS (weak,sweaty), THIRST (weak,fatigue,thirsty), MUSCULAR WEAKNESS (left shoulder is weak) and FATIGUE (weak,fatigue,thirsty) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Day after Rdap paralysis of (L) 3-5 digits (within 24 hrs post vaccine). 2 day after complete (L) arm paralysis which is still present.
Patient had second Moderna vaccine on 3/8/21 around 5 PM. She stated 11:00 she has the chills. This morning at 7:30 AM had temp of 100.6, and now 101 after Tylenol an hour before. She stated she as sore arm, headache and is tired. Denies any SOB or chest pian, or any other symptoms. RN reviewed hydration, cool compress, Tylenol as directed. RN reviewed calling provider today if temperature is still elevated.
Could not eat all next day - slept around the clock.; 27 hours later nausea; headache; muscle ache; temperature of 99.5; discolored (orange) urine.; 1st day - sore arm only.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 32 48), via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 17:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. No known allergies were reported. Concomitant medications included atorvastatin calcium 40 mg, Metoprolol succinate 25 mg, Colecalciferol (D3) 25. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 30Jan2021, first day after vaccination, the patient had sore arm only. On 31Jan2021 at 10:00 pm, 27 hours later of vaccination, patient experienced nausea, headache, muscle ache, temperature of 99.5 and discoloured (orange) urine. The events were considered nonserious. Patient could not eat all next day and slept around the clock, drank a little bit of bubbly water. After 48 he later patient began to feel a little better and ate some grapes. The patient had not yet recovered from the events.
This spontaneous report as received from a physician refers to a 21 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in February 2017 (reported as a year ago') the patient was vaccinated with GARDASIL (dose, frequency, lot # and expiry date were not reported) via intramuscular route for human papilloma virus (HPV) vaccination. On an unknown date the patient developed HPV after receiving GARDASIL. The patient received an unspecified treatment for HPV by an unspecified physician. No product quality complaint was involved. The outcome of papilloma viral infection and drug ineffective was reported as recovered. The relationship between events and GARDASIL was not provided.
Medical Assistant was ordered to adminstered Pfizer Bio N Tech COVID-19 Vaccine to patient. MA took vial out of refrigerator and placed it in designated area to reach room temperature. When MA came back to medication room, she withdrew medication from vial without medication being diluted., she then proceeded to administer medication to patient. When MA realized her error, she notified ordering provider and clinic manager immediatly. Patient was monitored for 30 minutes in which vitals had been stable. Provider discussed error with patient and provided discharge instructions. Patient verbalized undertsanding and had no concerns.  Patient is currerntly 18 weeks pregant, EDD 05/09/2022
An expired dose was unintentionally given to the pt. This event was discovered at around 5:30pm when staff was salvaging vaccines as part of store-closing tasks, a few hours after the pt received 1st dose. Pt showed no adverse effects/symptoms during the 15+ min interval after vaccine administration, before leaving pharmacy for home. Unknown if something happened afterwards to pt. Pt will be notified of situation once upper management finalizes reviewing clinical Pfizer Covid vaccine data stability; revaccination is a possibility. Pharmacy workflow changes were immediately made to decrease the risk of expired-dose administration reoccurrences such as ordering template expiration labels and incorporating the date of vaccine reconstitution as part of the label. Staff were all made aware of incident.
Tenivac was not shaken before administration; that she is concerned she did not get the full dose; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a female patient of unknown age who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that Tenivac was not shaken before administration and that she is concerned she did not get the full dose.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to wrong technique in product usage process and vaccine underdose.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
After the shot a few hours later I started feeling sick, later I developed aches and pain in my body, flu like symptoms, burns on my skin all over my body and head aches. Feeling weak.