chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: Gh9694) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: Fe3592), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: Fj9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ASPIRINE; TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no known allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202467 same patient, different drug/event;
Puffy feeling in face, lips, eyes. Hives to hands, feet, neck, underarms, abdomen. Patchy, not itchy. No dyspnea. Noticed symptoms about 24 hours after vaccine given. Tried small amt Benadryl, but she is allergic to antihistamines, and it didn't help. Denies nausea/vomiting. No other symptoms. States she will contact PCP.
Right-handed patient recalls receipt of 4 injections (AVA, ViCPS, MMR, IPV) on 20 Feb 2019 in readiness clinic, as above. Two injections were given in each arm -- sites not recorded. Patient recalls vaccine administrator identifying, "this shot is anthrax" as she received 2nd injection in right arm -- and she immediately felt severe right shoulder pain. Pain and stiffness precluded being able to use right arm for several hours after injection. Sxms resolved with NSAIDs and rest over next two days. Sxms returned on 01 Mar 2019 (10 days after vaccination) when doing heavy lifting. Patient contacted DHA Immunization team and, at the time of this report (03 Mar 2019), sxms reported as not severe, but somewhat limiting for full use and comfort of arm. SIRVA was discussed and follow-up plan made with patient's primary care team.
Soreness in injection site, muscle aches, shivers, general uncomfortable impacting sleep pattern, tiredness. Taking acetaminophen and rest. Symptoms ramped up about 12-18 hours after injection. Started treatment around same time.
passed out; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administration on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller reported that someone he knew, the patient, who did not wait the recommended 15 minutes after receiving the Covid-19 vaccine. Caller reported that after leaving the vaccination facility, the patient passed out in his car and hit 2 parked cars. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Hives all over seen in ER, no SOB given Prednisone 20 mg TID, & BENADRYL 25 mg.
became very tired, coughing and leg pains, fill the need to vomit but cant
Erythema, pain: Left arm proximal humeral aspectthere is a band of erythema approximately 4 cm by 10 cm wide. No subcutaneous crepitus, fluctuance, or purulant drainage. No other abnormality. Normal ROM of left upper extremity. Benadryl for itch, Clindamycin 300 mg by mouth in ED and 300 mg every 6 hours for 7 days.
patient had a head cold since the day after his shot. The Dr. said it was allergies; patient had a head cold since the day after his shot. The Dr. said it was allergies; This is spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on left arm on 19Feb2021 at 12:00 AM (at the age of 71-year-old)  as a 2ND DOSE, SINGLE DOSE for covid-19 immunization. Patient had known allergies with quinine and other medical history included diabetes and heart. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on left arm on 29Jan2021 at 12:00 AM as a 1ST DOSE, SINGLE DOSE for covid-19 immunization. Other medications received by the patient in two weeks were 6 daily prescription medicines. Patient did not receive other vaccine in four weeks prior to the vaccination and not diagnosed with covid prior vaccination. On 20Feb2021 at 12:00 AM, patient had a head cold since the day after his shot. The Dr. said it was allergies. He took benadryl, no better then switched to Tylenol for colds. He still was not better. He was only allowed to take certain over the counter meds because of his heart. Events resulted in doctor or other health care professional office/clinic visit. Patient did not receive any treatment for allergies. Patient did not test for covid post vaccination. Outcome of both the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Immediate onset-severe pain when touched. Approximately 24 hr. post vaccine-rash over 25% of upper arm, warm to the touch, erythema.
Swelling of R lymph nodes; Swelling of R lymph nodes resulting in severe pain; This is a spontaneous report from a contactable healthcare professional. A 29-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the arm right on 13Jan2021 at 17:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, depression, patellar instability, milk soy allergy, adhesive allergy, allergy to dogs and cats, beeswax allergy. The patient previously received cefalexin(CEPHALEXIN) and cortisone injection(MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC) and birth control pill (MANUFACTURER UNKNOWN); all from unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the arm left at 16:45 (at the age of 29-years-old) on 23Dec2020 as a single dose for COVID-19 immunisation.  On 13Jan2021 at 22:15 the patient experienced swelling of R lymph nodes resulting in severe pain. 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 event swelling of R lymph nodes resulting in severe pain was recovered in 3 weeks post-vaccine on an unknown date in 2021.    No follow-up attempts are needed. No further information is expected.
Please has had temperature for 8 days. To 102.7 . Substantial confusion and weakness . Temperature has been present every day since about 15.hrs post inj. Acet/Asa used q4h.
Rash/ rash developed on her back, mostly on her left side; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number K3593, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that she received the Fluarix Quadrivalent vaccine on either 31st October 2019 or 1st November 2019 on the left arm. Within 24 hours, a rash developed on her back, mostly on her left side. The patient still had the rash. The reporter was unwilling to provide additional information.
Patient received second dose of the COVID19 Pfizer vaccine. During the 15 minute observation period, patient reported feeling dizziness and chest tightness/pain. She felt shortness of breath. EMR was called and patient was transported to the hospital. (All within 10 minutes after vaccination)
3 to 4 weeks post vaccine, (I don't know if it was caused by the vaccine), I started having BP issues. I had never had BP issues prior to the vaccine, 90/60 was my normal BP. The doctors would always ask me if there was something wrong with my BP because it was so low, but my Dad always had low BP also. The BP issues started getting worse. It was the fatigue that started off, it was total fatigue. I had no energy to get out of bed. It was keeping me from doing my daily activities that I normally do. I would walk 80 miles a week prior to the vaccine.  A couple of months later, it started getting worse, and I went to see my internist and he started ordering test and in turn of my test he referred me to a cardiologist. I had never seen a cardiologist. The cardiologist found an occlusion of my left axillary artery. I had surgery on my left rotary cuff years prior and that is a result of it. It has nothing to do with this. My BP fluctuated from 190/95 - 140/90 during the times the doctor had me checking my BP. They prescribed me on Maxzide triamterene HCTZ 37.5/25 mg. About 6 to 7 weeks ago, I started feeling better. My BP is 137/80. It took almost a year before I felt better.
Patient confirms she was fine prior to the injection. Injection done in the left arm but having pain in the right-side, which prevents her from lifting her right arm properly.
No Adverse event patient was administered the Monovalent Pfizer vaccine and should have received the Bivalent.
Patient describes pain in left arm with numbness and tingling.  States the shot was very painful when she received it, and has progressively gotten more uncomfortable.  Patient has been seen twice more since original vaccination date with same complaint.  She received a 5 day course of Prednisone 10mg with some relief, but symptoms returned once she quit taking the steroid.  Currently trying Voltaren 1% gel to affected area.
Red, swollen ring around injection site for 4+ days. Knot underneath skin for 4+ days. Know/swelling is hot to touch for 4+ days.
Initial report received from a healthcare professional on 01 November 2012. A 34-year-old female patient received IMOVAX rabies vaccine (lot number, route and site of vaccination was not reported) and also received RIG manufacturer unknown (lot number, route and site of vaccination was not reported) on 05 September 2012. The patient's illness at the time of vaccination includes bat bite. The patient had Food allergies and was allergic to Flu vaccine, FLONASE, DEMEROL, Codeine and CIPRO; and had medical history of Fibromyalgia, Blindness, GERD, Cataracts, "orthostatis", Pituitary Adenoma, Ehlers-Danlos Syndrome Type III. The patient also had received an intramuscular dose of IMOVAX rabies vaccine (lot number H1180-1) in right deltoid on 08 September 2012 and on 12 September 2012; and received an intramuscular dose of IMOVAX rabies (Lot number: H1091-1) on the left deltoid on 19 September 2012 and 03 October 2012. After completion of a post exposure series for Bat bite, on an unknown date the rabies IgG serum titer was checked and was found to be low "0.4 international unit/ml". Laboratory investigations and corrective treatments were not reported. The patient's outcome was reported as recovered. Documents held by sender: none. Follow-up information received from healthcare professional on 23 January 2013. The reporter's facility administered last four doses of the vaccine. According to the reporter, the patient was very anxious and did not feel that she was treated well at the initial facility. The patient also may have had an allergic reaction to the RIG because she had no issues after each of the four vaccines administered at the reporter's facility. The initial titer was drawn two weeks after the last IMOVAX dose and has since been drawn again and the patient ended up achieving a good titer (exact level was not reported). No treatments were provided.
This spontaneous report as received from a other health professional refers to an unspecified amount of patients of unknown age and gender. It was reported that an unspecified number of VAQTA vaccines were administered to unspecified patients on unspecified dates. VAQTA was involved in an unsupported temperature excursion in August 2013 (reported on 26-FEB-2013). No further information was available. The case is linked to 1303USA007279, 1303USA007275 and 1303USA007276 which respectively describe unsupported temperature excursion of GARDASIL, ROTATEQ, Oral and RECOMBIVAX HB. Additional information has been requested.
Fever of 102.5, joint pain headache and insomnia starting at 9pm almost 12 hours after shot Then high blood pressure for the 6 days so far  Average blood pressure 170/105
This spontaneous report as received from a nurse refers to a 5-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 23-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
One of his friends had same side effects and all over his arms and legs.; This is a spontaneous report from a contactable consumer (patients friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER0161, Expiry date: unknown), dose number unknown via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. Medical history and concomitant medications were not reported. Caller stated that, one of his friends had same side effects and rash all over his arms and legs, all over his body for the last three months and nothing is curing it and it started off on their (friends) legs as well. Reporter stated that, he will tell him about reporting, but that is up to him. Reporter declined to complete report on behalf of his friend. No further details provided. The outcome of the event of rash was not recovered at the time of this report.
Nausea; Vomiting; Fever; headache; Pain in right shoulder and elbow; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 6200) via an unspecified route of administration, administered in right arm on 19Feb2021 at 13:15 (at the age of 75-year-old) as single for COVID-19 immunization and was administered at School or Student Health Clinic. Medical history included dialysis, sleep apnea and had known allergies. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for an unspecified indication from 29Jan2021 to 29Jan2021, metoprolol, heparin, cetirizine hydrochloride (CETRIZINE), calcium citrate (CITRACAL [CALCIUM CITRATE]) and aloe vera, glycyrrhiza spp. root, linum usitatissimum, ulmus spp. (OMEGA FIBRE); all taken for an unspecified indication, start and stop date were not reported. On 19Feb2021, nausea and vomiting, fever and headache (slight headache continued). The patient had pain in right shoulder and elbow which started a few days after and continued for about two weeks. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received chiropractic treatment for shoulder and elbow pain. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST.  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.  The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
patient reported full body aches and headache with a lot of pressure behind eyes beginning night after vaccination and continuing at least 3 days after at which time the events were reported. Urged patient to contact pcp for possible treatment.
She received the vaccine at an off site employee health mobile clinic. She developed a delayed cutaneous hypersensitivity reaction and presented to the occ health clinic the next day where I saw her.
Per patient: Developed rash; throat/tongue felt swollen. Patient said it took couple of hours for the reactions to calm down. Patient did not seek any medical treatment because the reactions went away.
feel like on a block of ice; couldn't get warm; achy; shaking; muscle aches; chills; muscle sore; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm) and PAIN (achy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MC0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, LISINOPRIL, TAMSULOSIN, CYCLOBENZAPRINE, PRAVASTATIN, ISOSORBIDE MONONITRATE, DILTIAZEM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm), PAIN (achy), TREMOR (shaking) and MYALGIA (muscle sore). At the time of the report, CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm), PAIN (achy), TREMOR (shaking) and MYALGIA (muscle sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078324 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078324:Crossed linked (First dose)
Headache, chills, body ache  occur intermittently approximately 2-3 times a week, lasting 4-8 hours, since March 9, 2021.
Headache, Myalgia, Arthralgia, Fever, Fatigue, chills, nausea. Narrative:
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, route unknown) (lot # H020255, expiry date: 08-NOV-2014), which was improperly stored vaccine. The outcome of the event was unknown. Additional information is not expected.
Patient was scheduled for the 2nd dose of the Moderna covid19 vaccine. However, the nurse administering the vaccine grabbed a Pfizer syringe instead. Patient inadvertently received the wrong vaccine for the second dose. Patient has not reported any additional symptoms.
pain on left side of face; prickling sensation in nerves tingling and throbbing in upper and lower rear gums at the base of the teeth jaws aching and stiff at sides where they met left sinus cavity irritated sensitivity and soreness intermittent , lasted six weeks
I experienced a sore and swollen arm that immediately traveled to my neck and head. It only took a matter of an hour to feel the joint and pain intense discomfort after the injection. I had a headache for more than 12 hours through the night, with insomnia, tachycardia, and anxiety. Systemic pain and discomfort of my joints and muscles with a headache have remained 48 hours after vaccination.
myocarditis; 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), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown".  Clinical course: After the booster shot, patient got a reaction from the booster (myocarditis) , and ended up in (hospital name withheld) Patient do not have health insurance, so now the hospital is trying to charge 31k for 24hrs in the hospital. Patient wondered if you know anyway and can handle this situation, or help because 31k patient do not have.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12/24/2020 @ 0600:  The site of the injection (right deltoid) was incredibly red, swollen, and extremely painful; the site was noticeably elevated from the base of skin.  Never did I develop a temperature. This continued until 12/26/2020 when the symptoms dissipated. 1/5/2021 @ 0600: I woke up to my right arm feeling sore and area where I had received the vaccine was warm and a thin red circular outline could be seen. Also note that a few months ago I had injections in my legs due to vein insufficiency. Interestingly enough, during the same time frames, when my arm would become red and painful, so would my right knee.
Mom said baby got shots in the morning. Went home and was fussy. Then turned pale and was clammy. Became unresponsive. mom thought she was dead. Aroused herself spontaneously within a few minutes. Had normal repeat exam in our clinic.
Redness &swellinf Left Deltoid with slight increase in skintemp.  Slight pain on palpation. Will continue obsewrvation. RX: Ibuprofen & Moist Heat