chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a five-year-old female. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.
After receiving a flu shot the arm has had increasing pain at the top of the shoulder. Pain interferes with ADL and sleep. Despite treatment with 800mg TID of Ibuprofen the pain is unrelieved. ROM is decreased but there is no visible swelling or redness. Client had lab work to rule out infection.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, frequency and lot # were not reported). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports from the same reporter. Additional information has been requested.
right arm lymph nodes were swollen and sensitive; a little sluggish; soreness at the injection site; tenderness under the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 10Mar2021 11:00 (Lot number: EL9269) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "recovered" (12Mar2021), described as "soreness at the injection site"; TENDERNESS (non-serious) with onset 10Mar2021, outcome "recovered" (2021), described as "tenderness under the arm"; LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "right arm lymph nodes were swollen and sensitive"; SLUGGISHNESS (non-serious) with onset 10Mar2021, outcome "recovered" (15Mar2021), described as "a little sluggish".  Additional Information: Reporter stated that that back in early Dec2020, he believed that he had COVID virus. Reporter reported that he did not have a fever and that his core body temperature was 2 degrees lower than normal. During Dec2020, he had symptoms of headache, crazy chills and the last week and a half he had a cough. He tested negative 3 days into the symptoms in Dec2020. Reporter works for a company that has events and he might be traveling in the summer so he did not want to cause problems or catch COVID.  No follow-up attempts are possible. No further information is expected.
Patient developed hives from head to toe four hours after receiving flu vaccination. Patient did not have any change in medications at visit. Patient states eating same diet. Symptoms are present (09/07/2016, 5:30PM). Patient states taking Benedryl. Patient instructed to take Famotidine 150mg twice daily and Allegra 180mg twice daily (09/07/2016).
Booster; Longer period. Much heavier. Breakthrough bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st ), for covid-19 immunization; Bnt162b2 (Dose: 2nd), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Longer period. Much heavier. Breakthrough bleeding". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Vaccination facility type pharmacy or drug store vaccine. Administered at military facility No. Everything was provided on line. Had longer period. Much heavier. Breakthrough bleeding. Just wanted it documented as other women experienced it, but they didn't report. No treatment just had to run its cause. Did report to my OBGYN.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day sore arm; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up#01 information on 26Feb2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable male consumer via Pfizer-sponsored program and in response to consumer letter sent via follow-up letter. An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, on 15Feb2021 at 11:30 as dose 2, single for COVID-19 immunization (Age at vaccination: 86 years). The patient medical history and concomitant medications were not reported. The patient previously received historical vaccine which included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9262, Expiry date: not reported) via an unspecified route of administration, on 26Jan2021, as dose 1, single (not ongoing; at the age of 86 years old) for COVID-19 immunization. The patient took the Pfizer Covid vaccine and mentioned that he was feeling fine. He wanted to know if it was okay to take a half glass of wine, which was what he did every night, considering his vaccination. On an unspecified date in 2021, the patient experienced day sore arm. The patient also mentioned that his wife also had an injection and around 4 or 5 hours ago mentioned that her arm was starting to hurt and was feeling a bit stiff. He told her that she could take Tylenol or Advil for it. He wanted to know if what he said was correct. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
immediately after recieving her second doses of Tetramune and Orimune, this infant devel a rash all over her body and hives on her lower extremities.
Sharp pain felt during injection, which could be felt all down arm and into hand. ?Felt like they hit a nerve?
first dose / on 27Sep2018. Second dose had not been given at time of call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th September 2018).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The lot number and expiration date not available to reporter. The reporter consented to follow up.
The patient did not experience any symptoms; a four month old infant was inadvertently administered one dose of GARDASIL 9; This spontaneous report was received from a physician referring to a 4-month-old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 30-DEC-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1, (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age).  It was reported that the patient did not experience any symptoms.
Fever 101.5 Body aches and pain could not get out of bed tingling in hands tingling from knees down muscle spasms tired When the fever was breaking I would not lift myself out of bed
exhausted within 4 hours of receiving shot next day, started itching. came out of shower with rash on arms, torso and face. Called Dr.  advised to take Benedryl took benedryl 2x that day.  Next morning woke up itching again, took shower and rash had intensified on arms, legs, torso and face. Had a Prednisone dose pack in my home. called Dr. Took that for 5 days and needed Benedryl another 2 days to keep itching down.
Information has been received from a physician, concerning an 80 year old male patient (a retired plumber), who on 18-FEB-2008 was vaccinated in the right deltoid with a dose of Zostavax (Oka/Merck) (lot # invalid).  There was no illness at the time of vaccination.  On 29-FEB-2008 the patient developed pneumonia, bilateral with hypoxemia, and varicella zoster right facial.  A chest x-ray confirmed bibasilar pneumonia, and the patient was hospitalized for 7 days (details not provided).  Subsequently, the patient recovered from the events (duration and date not specified).  The physician considered one or more of the events to be immediately life-threatening.  Additional information has been requested.
Patient stated after 30 minutes after the vaccine, she started to get hearing loss, palpitations and diarrhea for three hours. She went kayaking after waiting for 15 minutes.  Patient was able to inform us with a phone call.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ (lot# M032636, expiry date: 06-APR-2018) (route defaulted to oral) (dosing details were not reported) for prophylaxis (incorrect product storage). Information regarding prior excursions was unknown. Temperature/Time Frame as follow: 32 Fahrenheit (F) to 35 F and 47 F to 77 F for 345 hours over a 90 day period. Call was not because of data logger. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014865: US-009507513-1705USA001550: US-009507513-1705USA001551:
Face paralysis; Bell's palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant), outcome "recovered", described as "Face paralysis"; BELL'S PALSY (medically significant), outcome "recovered", described as "Bell's palsy".  Clinical course: Patient reported that I had face paralysis after my COVID vaccine. Bell's palsy. Only lasted about a week. Could that be due to Pfizer COVID vaccine?.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache; Light head; This is a spontaneous report from a contactable consumer (patient). This 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248 and expiry date was not reported) via an unspecified route of administration in arm Left on 22Jan2021 14:45 as single dose for COVID-19 immunisation. The patient's medical history included Asthma, eczema and Known allergies to Peppermint. The patient's concomitant medications included montelukast at 10 mg, loratadine at 10 mg and cyclobenzaprine. Patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks of vaccine. The patient experienced headache and her head was light on an unknown date in 2021. No treatment was given for the events. Outcome of the events was recovering.
Got severe pain in upper arm muscle, shoulder, neck, elbow, wrist, and all the way up and down within 10 minutes of vaccination. It felt like getting an IV of potassium it was so painful. After 2 days of this, pain localized to upper arm muscle, shoulder joint (front, back, and both sides), and neck. I have been taking three ibuprofen and applying heat. I have limited range of motion. Simple things, like trying to pull a sweater on, reaching for something from the cupboard, flushing the toilet or picking something up, like a remote control, hurts like crazy, as does opening doors, driving, lying flat on my back or on my right side, typing, lifting up my arm, cooking, you name it. I am right hand dominant, and I can't do much of anything at all because my arm and shoulder hurts so much, even with constant heat and ibuprofen. It is now 3 weeks since the vaccination, and it is not improving at all. My doctor told me that I should file this report because he does not know if it will go away. He said he does not know if it is an injury or an infection, or what, but he told me that it will last for at least several months, if not longer, and there is nothing to be done about it. It could be permanent, but I will have to wait and see.
Immediately, sharp shooting pain from injection site ( the back of my arm, not the middle) when all the way down my arm and was severe in my pulse side of my wrist. I reported it.  The pain resolve mostly after 30 minutes. Either  Feb. 28 or March 1 woke up with my left eye being red from broken blood vessel. March 3, slight burning with urination. 1X March 4  no burning until about 4:30 pm, and then also much blood. 15 minutes later, the same.
runny nose; cough; head ache; Fever of 101.5 degrees Farenheight; Joints in my fingers all hurt; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA, HEADACHE, COUGH, PYREXIA, and ARTHRALGIA in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RHINORRHOEA, HEADACHE, COUGH, PYREXIA, and ARTHRALGIA. At the time of the report, HEADACHE, COUGH, PYREXIA, and ARTHRALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact.
No additional AEs were reported; Patient received improperly stored vaccine; 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 03-OCT-2022, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1879866 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 30-OCT-2023) (exact dose was not provided) administered orally as prophylaxis. The vaccine administered suffered a temperature excursion of 55.8 Farenheit (C) degrees for a time frame of 44 hours (Product storage error), and did not suffered previous temperature excursions.  No additional adverse events (AEs) were reported. No further information provided.
blood clots in abdomen the next day; This is a spontaneous report from a Pfizer sponsored Program, received from a non-contactable consumer via medical information team. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced blood clots in abdomen the next day of vaccination. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 101 with vomiting overnight, woke up with fever at 103, seizure at 0730, in office by 08:15am. Ibuprofen, observation.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II lot # J008534 for prophylaxis. Other suspect therapies included VARIVAX lot # J012211. On an unknown date, the patient experienced adverse event. The outcome of adverse event is unknown. The relatedness between the event and the vaccines was not reported.
Experienced joint stiffness 5 days post vax, developed parotitis, 10 days post vax.
TC from patient @ 11am. Started w/diarrhea after getting 1st Hep a/b combo.injection during the night(approx.12-14 hours after shot). Morning is  now vomiting, has chills, aches and feels like she has fever but has not taken it. Could be shot, however; there is a GI bug in our community.
Approx. 9/3/12 my son spiked a fever under 101*. During this time he had one LARGE episode of vomiting. On 9/4/12  he cont.d' with fever of 101* started with diarrhoea and what looked to me like diaper rash.  9/5/12 low grade fever and rash ALL over his body. This includes inside his mouth, ears, diaper area, in his hair, his eye lids. 9/6/12 I took him to the Hospital they said it was a viral rash which was also said by Dr.  By evening the rash had DOUBLED, raised, and my son was in agony!!  I took him to my husbands pediatrician. He confirmed that the rash was indeed a case of the chicken pox. He prescribed him acyclovir. I also gave him Tylenol and Benadryl per Dr. He still has SOME pimples.  They no longer bother him and are still fading.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-SEP-2014, the patient was vaccinated with a expired dose of PNEUMOVAX 23 lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular. No adverse effects reported. Additional information has been requested.
103.0 fever; Severe swelling of nodes in left armpit; severe muscle, joint, skin aches; severe muscle, joint, skin aches; severe muscle, joint, skin aches; headache; lethargy; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), intramuscularly in the right arm, on 08Jan2021 at 10:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included interstitial cystitis, anxiety, and shellfish allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included mirabegron (MYRBETRIQ), escitalopram (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN), bisoprolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), nortriptyline (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), and colecalciferol (VIT D3). Other concomitant medications included an unspecified multivitamin. The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), intramuscularly in the left arm, in Dec2020 at 13:30 (at the age of 49-years-old) for COVID-19 immunization. The patient experienced 103.0 fever, severe swelling of nodes in left armpit, severe muscle, joint, skin aches, headache, and lethargy on 08Jan2021 22:45. The events were reported as non-serious. It was reported that the severe swelling of nodes in left armpit lasted less than 3 days. The patient underwent lab tests and procedures which included body temperature: 103.0 on 08Jan2021. The patient did not receive any treatment for the events. The clinical outcome of 103.0 fever, severe swelling of nodes in left armpit, severe muscle, joint, skin aches, headache, and lethargy was recovered on an unspecified date.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
This spontaneous report as received from medical assistant in physician's office refers to a 17 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. On 20-MAY-2014 the patient was vaccinated with first dose of GARDASIL lot # J015378 expiration date 09-APR-2016. The medical assistant spoke to the patients mother for schedule second vaccination with GARDASIL. On 21-MAY-2014 (Also reported as them other mentioned to the M. A. that the next day after the 1st vaccination with GARDASIL) the patient experienced body aches and sore (vaccination) arm along with the symptoms nausea, fatigue, stomach pains initially reported. The outcome of the events reported was recovered/resolved approximately on 27-MAY-2014 (also reported as the symptoms lasted for a week and the patient recovered). This case is linked to the cases 1409USA007180, 1409USA013915 via same reporter link. Additional information has been requested.
Patient had increased soreness redness, swelling, pain on day after vaccine given limited to (L) deltoid area (LUE).
Spike Protein in the Base of my neck.  I am receiving prescription medicine to help but it is really taking a toll on my body.