chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 73 year old white female with hyperlipidemia, seizure disorder, rhinitis, and osteoporosis who on 03-OCT-2006 at 11:00 AM was vaccinated SC (also reported as IM) in the deltoid with a 0.5 mL dose of Varivax (lot # 651049/0328R). Concomitant therapy included aspirin, alendronate sodium, DILANTIN, CLARITIN-D, calcium (unspecified), ATIVAN, NASONEX, and "Niacspan." The reporter noted that the patient was actually suppose to have received Zostavax. She ordered Zostavax from a wholesaler but Varivax was delivered and stored in the freezer. The office staff was not familiar with Zostavax and gave Varivax. Unspecified medical attention was sought. No adverse reaction was noted. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been received from the reporter who indicated that there were no adverse effects reported by the patient. No further information is expected.
RECEIVED A VACCINE THAT WAS LEFT OUT AT ROOM TEMPERATURE FOR UP TO 4 HOURS; This spontaneous report received from a pharmacist concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced received a vaccine that was left out at room temperature for up to 4 hours. The action taken with covid-19 vaccine  was not applicable. The outcome of received a vaccine that was left out at room temperature for up to 4 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521658.
Pain in arm at injection site.; Nightmares; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient 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 18Mar2021 (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 since the vaccination. On 19Mar2021, the patient experienced pain in arm at injection site and nightmares. The patient did not receive any treatment for the reported events. The clinical outcomes of the events vaccination site pain and nightmares were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient stated that 1 week later, she had a red itchy rash about 3x4" diameter around injection site.
Patient immediately became unresponsive after administering HPV vaccine. Leaned forward into his mother when I brought his head up eye were fixed w/ pupils dilated. Laid back on to exam table. Went to get PAC. Patient began having a convulsion. When PAC and I returned to exam room patient was alert and oriented. Mom stated he blinked his eyes and then he was fine. Entire syncope episode lasted less than a minute. Mom reported that patient gets nervous about vaccines and hadn't had breakfast yet. No medical or family history of seizures. Patient did become diaphoretic. Had him lay down for a few minutes, was given water to drink. Slowly had him sit up and then stand to obtain orthostatic blood pressures. Patient remained in office for at least 15 minutes to be observed, before being released. P - 54 B/P 100/62; P - 62 B/P 104/70; P - 65 B/P 98/70
pt recv vax 13JUN96 & 17DEC97 pt presented w/varicella that consisted of 70 fluid filled blister like vesicles predominantly located on trunk & back;
Information has been received from   a nurse referring to two unspecified patients. On 188-AUG-2015 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L001335, expiration date 13-JUL-2017) (dose and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left arm pain with paresthesias  Bruising starting 24 hours later on inner biceps area.
Patient complained of her uvula feeling elongated.  Said she felt like something was stuck in her throat.  I advised her to take 2 Benadryl and then go to ER if no improvement.
Initial report received from a non-healthcare professional on 13 OCTOBER 2014. Case is linked to 2014SA129883. A female patient (age not reported), whose concomitant medication were not reported, had received a dose INFLUENZA (batch number, cycle in series, route and site of vaccination not reported) on an unspecified date. On an unspecified date, patient experienced cold like symptoms (felt sick). Corrective treatment and laboratory investigations were not reported. Patient previous medication was reported as BETASERON (2009-2009), AVONEX (2009-2009), COPAXONE (2011-2011) and AVONEX (2011-2014). At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder injury (In march 2021 had surgery to remove it.) from January 2021 to March 2021. Concurrent medical conditions included Asthma. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, PANTOPRAZOLE for Acid reflux (esophageal), APIXABAN (ELIQUIS) for Anticoagulant therapy, BUSPIRONE for Anxiety, LEVOTHYROXINE, ESTRADIOL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ALBUTEROL [SALBUTAMOL] and BUDESONIDE (BUDESONIDE ALMUS) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had diagnosed with a heart condition except for a murmur as a child that was never an issue for them as adults.   This case was linked to MOD-2021-390775, MOD-2021-390776, MOD-2021-390776, MOD-2021-390775 (Patient Link).
Symptoms: 1. Rash, 2. Urticaria Pruritus. Treatment Drug Used: 1. Methylprednisolone - Dose: 40 - Units: MG - Freq: Once - Route: IM.
cough; minor sore throat; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on 01Feb2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient is due to get his 2nd dose tomorrow, but he's currently experiencing cough and a minor sore throat and wants to know if he can get his 2nd dose or not. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sore throat, hoarse voice, strange overall feeling by evening half of arm, armpit, and underchest was swollen, sore and uncomfortable; next day arm from elbow to shoulder swollen, arm pit swollen on same arm, hot to touch, red rash & large red patches hot to touch, low grade fever 99.6, pain from elbow to shoulder, pain in armpit & overall body fatigue.
Case number PHEH2014US021396 is an initial spontaneous report received from a health care professional on 22 OCT 2014. This report refers to a 12 months old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 22 OCT 2014. No adverse events reported after the maladministration (inappropriate age at vaccine administration).
Pt was admitted for generalized weakness, cough, shortness of breath, confusion for 3 days.  He was found COVID-19 positive..  Chest x-ray unremarkable.  Initially, he was hypoxic per record and he was started on oxygen.  He started on steroid and remdesivir. He was eventually stable enough to be discharged.
On September 1, 2020, I had a seizure that lasted about 20 minutes. Following the seizure, I had a temp of 95.8 and chills. I was not aware of falling, but when I woke up, I was on the floor, and it took some time before I could get up. I had hit my back on the corner of the wall, and had to wrap my ribs with elastic bandages while it got better.  I had what was probably Covid-19 in April, 2020. I have never had this type of reaction to a flu shot before, only some slight pain where the shot was injected.   When I had this "different flu" in April, I had hollowness around my eyes, severe headaches, chills, diarrhea, and some vomiting. I felt like I had to gasp for air, but I could breathe well enough to stay home. I had no elevation in my temperature. I haven't had a problem with temperature since I started taking my chemo therapy medication. I later decided I must have had Covid-19, and my immune system must have changed from the covid-19.
Information has been received from a physician concerning a female patient who is also the receptionist in the office and on 20-MAR-2009 was vaccinated with GARDASIL (lot # was not available). Subsequently, the patient developed a red, swollen and itchy injection site. The physician added that the patient's arm became bigger and it continued to swell and now her arm hurts and the symptoms had been very persistent and progressing. The physician didn't specify if the patient received the first, second or third of GARDASIL. Physician added that the patient was given BENADRYL but the symptoms hadn't resolved yet. Additional information has been requested.
My arm was red, swollen and sore for a day or two after vaccine, then subsided. 10 days later it came back and my arm became swollen, hot and sore again, but now I had developed a rash that was about 2" in diameter on my arm. I saw my doctor and was told to take Benadryl. It cleared up about 3-4 days later.
5 minutes post vaccine, started feeling warm burning sensation all over, stayed on site for 60 minutes. Was briefly shaky and weak, recovered enough to drive home after waiting. Nausea started later that evening and has been on and off since date of the vaccine. Patient describes warm burning sensation from waist up nightly since vaccine, also has hot/cold flashes followed by fatigue next day. Reports headache for several days following vaccine. Patient reports similar burning sensation has happened with other medications in the past including the 2019-2020 flu shot and antibiotics (unsure what types).  Patient reports that the flu shot reaction was possibly a neomycin hypersensitivity, did not know specific type of flu shot.
Small rash that started on hands in late august. Rash was tiny at first and not painful but kept popping up through out the months after shot. Originally thought it was heat rash or anxiety so I went to the doctor to find out what was causing it. They weren?t sure but I finally was diagnosed with erythema multiforme. I then got a respitory infection in October and the rash exploded on my hands and feet(very painful). Through out the next 3 months I had recurring patches on my hands and feet but nothing as painful or major as the break out in October. In January I noticed a flare up on my arms that then turned into an all over body rash (looks like hives) that?s very painful, itchy, and red. First time it has spread to fill body.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Spinal stenosis of lumbar region with neurogenic claudication.
CANNOT LIFT ARM, IN PAIN, MUSCLE SPASMS, HURT WHEN GAVE SHOT.
This spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient may have received an improperly stored dose of PROQUAD per subcutaneous route (dose and frequency were not provided) lot # R001540 expiration date on 15-JUL-2019 for prophylaxis. No adverse effects were provided. This was the first temperature excursion. The Data Logger registered an excursion between 15 Fahrenheit degrees and 46 Fahrenheit degrees along 384 hours.
limp, fussy, pale, crying, swollen thigh where DTP inject given today; tx ice compresses locally; APAP, nurse frequently;
It was noted at the time of the vaccination there were no illnesses. On approximately 03/07/2000 the patient sought unspecified medical attention and was found to not have any detectable IpG antibodies to rubella. Additional information has been requested.
A report was received from a health care professional on 25 November 2003 concerning a 69 year old male vaccinee who experienced Guillain-Barre Syndrome, requiring hospitalization an unspecified length of time after receiving Fluvirin on an unspecified date. On unspecified date the vaccinee experienced GBS. The vaccinee was hospitalized on an unspecified date. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
pt recv vax 16AUG95 & 27MAY97 pt exp more than 30 lesions;it was till more attenuated;no fever was noted;several child in the class pt is pt of broke out as well;
This spontaneous report as received from a registered nurse refers to a 18 year old male patient with no medical history, drug reactions or allergies. The reporter is the mother of the patient. On 18-FEB-2014 the patient was vaccinated intramuscularly with the first dose of GARDASIL (dose, lot number and expiration date not reported). No concomitant medications were reported. On 20-FEB-2014 the reporter stated that her son's axillary lymph node became extremely swollen and measured 3 inches long and 2 and 3/4 inches wide. There was no lab diagnostic studies performed. There was no treatment given for the event. The patient sought medical attention by the office visit. The outcome of the event was reported as recovering. The relatedness between the event and suspect product was not reported. Additional information is not expected.
pt recvd vax 18FEB94; devel flu-like sx over the next 2-3 days (fever, joint pain, fatigue) by day & devel a rash (fine macropapular) to the face; systemic sx;
swollen throat; Difficulty breathing; Dizzy; scratching  from head to toe; swollen face; heart rate was faster than normal; more palpitations than normal; light head headache; Shivering; thought she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 28Mar2021 at 11:00 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen throat, difficulty breathing, dizzy, scratching  from head to toe, swollen face, heart rate was faster than normal, more palpitations than normal, light head headache, shivering and she thought she was getting the flu on an unknown date, reported as a late reaction after the vaccine (received the vaccine a week ago). The clinical outcome of the events swollen throat, difficulty breathing, dizzy, scratching  from head to toe, swollen face, heart rate was faster, more palpitations, headache, shivering and flu was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe arm pain on the day after vaccine. Unable to move arm due to pain and cramping on the left shoulder.  Nausea and headache in the afternoon, and ended the following day. Able to move arm after 2 days.
This spontaneous report as received from a 60 year old female registered nurse with hypertension and hypothyroidism refers to herself. The patient did not have drug reactions/allergies. The patient's medical history included slight low Ig A and Ig G levels. On 06-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided) 0.65 ml, subcutaneous in the left arm. On 07-FEB-2013 the patient developed a blister on the end of her nose the day after she received ZOSTAVAX. She stated that she also developed a blister on the bridge of her nose and a small red area on her right cheek. She was experiencing warmth and redness on her left arm at the injection site. Acyclovir three times a day-started on 08-FEB-2013, ALLEGRA once a day was given as treatment for adverse event. No lab diagnostic studies were performed. The outcome of adverse event was not recovered. The patient had sought medical attention via office visit. Additional information is not expected.
Fever - 100.5 to 100.6. Nausea. Body aches, chills.
Pt. states that he started getting a rash on his forearms about 4 hours after immunizations. Rash is itchy, red. Later spread to his abdomin. Came to school nurse office on 10/10/08 rash continues to spread. Advised referral to Dr. to identify rash and possible cause.
On 12/31/20, patient started to develop nausea and vomiting.  Progressed to recurrent nausea/retching/intractable hiccups on 1/1/20.  Presented for evaluation/iv rehydration on 1/3/21, 1/5/21 and 1/6/21.  Multiple vasovagally-mediated syncopal spells on 1/5/21 - 1/6/21.  Suspected to have gastroparesis on 1/8/21.  Symptoms improved with Reglan 10 mg po qid by 1/15/21.  Received dose 2 of COVID-19 vaccine on 1/18/21.  Symptoms of gastroparesis redeveloped a few hours later, symptoms improved with domperidone 10 mg po qid by 1/23/21.
Felt very tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritic knees" (unspecified if ongoing), notes: Has arthritic knees not she does not have good bones.; "Does not have good bones" (unspecified if ongoing), notes: Has arthritic knees not she does not have good bones. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Felt very tired the next day". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Felt very tired the next day".  Additional information: A caller has about the Pfizer Bivalent vaccine. She saw on the fact sheet that the Pfizer bivalent vaccine is not FDA approved. She wants to know why it was not FDA approved. She also wants to know what were the differences of the Pfizer bivalent vaccine with the first three doses of vaccines. She had not taken the bivalent vaccine and wants to know if there would be any reactions. Caller stated she has received 4 shots of COVID 19 vaccines at the moment. She referred to the Bivalent gray cap vaccine as her potential third booster. Do the Bivalent vaccine have some sort of extra adjunct material to make it stronger? or why was it called bivalent. Caller also asked if there was something different in this new vaccine compared to the first three doses that she received. Caller mentioned that she was already in her appointment to receive a dose of the new Bivalent gray cap vaccine, but when she read the vaccine was not FDA approved, and the term "bivalent", she decided not to receive the dose. Caller mentioned she was 90 years old and had arthritic knees not she did not have good bones. She asked if she could be irritated by receiving the 4th dose with the bivalent. She also mentioned that with her previous doses she felt very tired the next day, and asked, what was going on with the fatigue. She asked if she could be fatigue with the new bivalent. She mentioned that it was concerning, but that probably apart from being more tired that she has been with the previous vaccination, caller suspects she will not suffer from anything unusual, and that she will make an appointment to receive the vaccine. Caller asked about the ingredients of the Bivalent vaccine and for the function of the polyethylene glycol. Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal to 12 years- 15/15 mcg per dos. She asked if she could be irritated by receiving the 4th dose with the bivalent. Caller mentioned that with her previous doses she felt very tired the next day, and asked, what was going on with the fatigue. She asked if she could be fatigue with the new bivalent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm was sore; That night I felt an irregular heartbeat/ Pounding heartbeat; It woke me out of my sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PALPITATIONS (That night I felt an irregular heartbeat/ Pounding heartbeat) and SLEEP DISORDER (It woke me out of my sleep) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 023C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), PALPITATIONS (That night I felt an irregular heartbeat/ Pounding heartbeat) and SLEEP DISORDER (It woke me out of my sleep). On 27-Dec-2021, PALPITATIONS (That night I felt an irregular heartbeat/ Pounding heartbeat) and SLEEP DISORDER (It woke me out of my sleep) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, Heart rate: irregular heartbeat Irregular heartbeat and pounding heartbeat.         On 27 Dec 2021, night patient felt an irregular heartbeat & pounding heartbeat. It woke patient out of sleep. It lasted about 10 minutes. No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-433482, MOD-2021-432983 (Patient Link).
about 4 hrs p/vax pt started crying & vomiting; pt vomited every time attempt was made to feed formula or water until 10PM; lt leg was swollen & red; mom did not call MD;
Information has been received from a registered nurse concerning an 10 year old male who on 31-OCT-2007 was vaccinated with ZOSTAVAX.  The nurse indicated that he grabbed the wrong vial in the freezer.  The patient will be re-vaccinated in 30 days with VARIVAX.  It was further reported that ZOSTAVAX and VARIVAX are no longer stored near each other in the freezer, and the labels were made more visible to prevent any reoccurrences.  Additional information is not expected.
Moderate local reaction, warmth and swelling 3x4 inches. At site and distal to injection site.