chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IRREGULAR HEARTBEAT; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sudden cardiac death (in 2011), and concurrent conditions included: tachycardia (heart issues), premature ventricular contractions (Pre-ventricular compression (PVCs)), sulpha allergy (Sulfonamide allergy), drug allergy (Steroids (unspecified)), no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient had previously received elasomeran (Moderna covid-19 vaccine) (Dose number in series 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, dose 1 administered on 27-JAN-2021 for covid-19 prophylaxis. On an unspecified date following vaccination with elasomeran (Moderna covid-19 vaccine), the patient experienced allergic reaction (Dose number in series 1). The outcome of allergic reaction was not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: Unknown) dose was not reported, 1 total, dose 2 (first booster) administered in left arm on 13-SEP-2021 for covid-19 prophylaxis which was an off label dosing frequency associated with Off label use and revaccination with different covid-19 vaccine (Dose number in series 2). The outcome of the off label dosing frequency and revaccination with different covid-19 vaccine was not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: Unknown) dose was not reported, 1 total, dose 3 (second booster) administered in left arm on 19-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second booster of covid-19 vaccine ad26.cov2.s (Dose number in series 3). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 4) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: Unknown) dose was not reported, 1 total, dose 4 (third booster) administered in left arm on 09-APR-2022 for covid-19 prophylaxis which was an off label dosing frequency (Off label use) (Dose number in series 4). Age at time of vaccination 74 years old. No concomitant medications were reported. On an unspecified date following vaccination with third booster dose of covid-19 vaccine ad26.cov2.s, the patient experienced irregular heartbeat (Dose number in series 4). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irregular heartbeat, and the outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20221225921.
Tinnitus onset a couple hours later. Still persists today. Noticible mostly at night in silence.
Findings in the great saphenous, common femoral, and proximal femoral veins suggesting nonocclusive thrombus.
Chest pain, trouble breathing, elevated heart rate, hives Transported to hospital, EKG and blood work  given methylpresnisone, oxycodone, famotidine, lorazepam, hydromorphone
This spontaneous report was received from a pharmacist regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, drug reactions/allergies, past drugs and concomitant medications were unknown. On 06-MAR-2019 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose and frequency were unknown) (lot # N019837; expiry date: 21-FEB-2019) intramuscular for prophylaxis (expired product administered). No adverse effects (no adverse event) reported. No additional information provided.
Attempted to give flu vaccine but there was resistance when inserting needle into lateral left thigh during administration. A small amount of vaccine was given but most of the dose was left in the syringe. I examined him after this, he had a 0.5cm wheal after administration, this is either from some subcutaneous vaccine vs possible local reaction. No signs of systemic reaction. Mom preferred not to give remained of vaccine today. Recommended that they apply ice at home and give motrin. She was instructed to call for worsening swelling or other symptoms.
she was in bed for about a day after each Moderna Covid-19 vaccine; sore injection site arm; felt tired after receiving each Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine). At the time of the report, ASTHENIA (she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided.  It was reported that patient drank a lot of water and that she felt better.   This case was linked to MOD-2022-482739 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow up received contains no new information
pt recvd vax; chills; 4dec t 102;5dec sharp pains lower lt abdo; deep cough & productive  cough; n;
Patient reported that the day (12/12/20) after she had flu-like symptoms with a bad headache and was in bed all day and night.  On Sunday 12/13/20, she  woke up to a raised rash all over my body.  She took Benadryl to relieve the itching but had to go to the doctors on Monday for tightness in throat but did not have difficulty breathing.  The prescriber put her on a 5 day Prednisone and continue with a 24 hr. allergy medicine and Benadryl as needed.  On Tue 12/15/20 she still had the rash.  The rash is fading but still itchy underneath her skin.
A spontaneous report received from a pharmacist concerning a 45-year-old female patient who received COVID-19 vaccine and experienced receiving COVID-19 vaccine as a second dose after a Pfizer Vaccine. The patient's medical history was not provided. Patient's concomitant was not provided.  On 16 Dec 2020, the patient received a first dose of Pfizer's COVID-19 vaccine for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient received a dose (Batch number: 026120A) intramuscularly for prophylaxis of COVID-19 infection and experienced wrong vaccine administered. No adverse events were experienced, and no treatment was reported. Action taken with 73 in response to the event was not provided. The outcome of the event, receiving a COVID-19 vaccine as a second dose after  Vaccine, was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 45-year-old female patient who received a COVID-19 vaccine as a second dose after P Vaccine, reporting Wrong product administered without any associated adverse events.
Pt received the pneumococcal vaccine in the afternoon on 11/2/05 and reports her arm was stiff and sore  that evening. Wednesday the arm was red and had heat to the touch. On Thursday the redness was spreading and her arm was swollen from the shoulder to the torso.
After the 2nd dose in  March 2021, a few months later around July 2021,  I noticed blurry vision in both eyes. I could not read or drive.  It was accompanied by headaches afterwards.  This episode lasted for 40 minutes then I was able to see and drive again.  I still had light sensitivity.  My vision did return back to normal.  I did follow up with my eye doctor (optometrist) who order an ultrasound and blood test to rule out stroke and blood work came back normal.  I also followed up with my PCP who ordered an MRI which was also normal.  I went back to the optrometrist who referred me to an opthamologist.  I also went to see an opthamologist who did an eye exam which also came back normal and ordered  2 MRIs one around the brain another MRI of the eye socket.   I am still having eye pressure pain in both eyes and headaches. Recently, I am also noticing memory loss.
Petechial/maculopapular rash.  Rash, low grade fever Treatment = observation
Sore arm, headache, loopy feeling-day 1 fatigue, lethargic,  cysts on neck -day 2 Sore by groin (did not have these prior) severe muscle spasms in legs, nightmares, bed wetting days 5-6
After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days after I had itching, prickly tingly sensations everywhere, especially arms, legs, neck, and back. These lasted for 11 days after that, finally subsided. But then I got dose 2, and had sore arm, and next day, aches in muscles, low fever, congestion but all mild. Took ibuprofen and went away after 24 hours. 5 days later, the itching, tingling started up again and was more intense and everywhere. Have had some redness, swelling, red bumps in itchy areas, they come and go. Worse when I have hot flash. Itching is keeping me awake along with anxiety and restlessness. Hope this won't last for another 10 days, very uncomfortable.
This case was reported by a sales representative via a healthcare professional and described the occurrence of shooting pains in an adult subject of unspecified gender who was vaccinated with Havrix (GlaxoSmithKline).  On or after 24 July 2007, the subject received unspecified dose of Havrix (1 ml, unknown).  Immediately after vaccination with Havrix, the subject experienced shooting pains in the arm.  At the time of reporting the outcome of the event was unspecified.  She was concerned that this event may be due to a particular lot number or due to the reformulation of the vaccine.  The reporter considered that the events were probably related to the use of Havrix.
No additional AEs were reported; 14 patients received possibly improperly stored vaccines due to lack of temperature readings.; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 07-FEB-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, dose, frequency, and route of administration were not provided); which lot # T028582 has been verified to be a valid lot number with expiration date: 04-MAR-2023, administered as prophylaxis. The administered dose of the vaccine possibly experienced a temperature excursion (product storage error) since 10-JAN-2022, due to lack of temperature readings (refrigerator and freezer temperatures were not recorded since that date). No previous temperature excursion occurred. There was no adverse event reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000544: US-009507513-2205USA000533: US-009507513-2205USA000524: US-009507513-2205USA000464: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000560:
Pt recv vax on 9/25/98; on 10/13/98 pt exp swelling /pain in right wrist w/ swelling/ numb in hand then to left wrist &knees, difficulty walking; tx=Ibuprofen
developed hives at injection site 2 minutes after injection. patient was given 12.5mg Benadryl hives and redness receeded within 20 minutes
Symptoms began 9 hours after vaccine administration. Chills, fever, sore muscles, foggy brain, stuffy nose, cough, headache, frequent urination, nausea, anorexia. Still ongoing symptoms at 26 hours.
4-5 macular papular lesions, peripheral to inj site, & several macular papular lesions on the body, appearing 14 days p/vax;
My husband had the Pfizer BioNTech vaccine and he tested positive for covid today; My husband had the Pfizer BioNTech vaccine and he tested positive for covid today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6207), in arm, on 05Apr2021 as dose 2, single (Lot number: ER8734), in arm and on 09Oct2021 as dose 3 (booster), single (Lot number: 301308H) at the age of 44 years, in arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "unknown" and all described as "My husband had the Pfizer BioNTech vaccine and he tested positive for covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Follow-up attempts are completed. No further information is expected.
Aching joints; Fever (103.5); This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot/batch number: EL3249) via unspecified route of administration on left arm on 16Mar2021 at 14:45 as a single dose for COVID-19 immunisation. Patients past medical history included Angina.  Patient past drug history include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot/batch number: EL3248) via unspecified route of administration on left arm on 23Feb2021 at 14:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Patient took unknown medications within two weeks of vaccination an has no known allergies. The patient experienced aching joints and fever at a temperature of 103.5 (units unspecified) on 17Mar2021 at 01:00 am. The patient did not receive any treatment for the reported events. The clinical outcome of joint pain and fever were resolving.   No follow-up attempts are possible. No further information is expected.
Patient came down with Shingles 1 week after 2nd dose of vaccine..  There have been 2 patients that this happened to
2:30 PM - slight nausea, hot feeling, low grade fever 10:30 PM - severe muscle / joint aching, fever, diarrhea  Continuing and unresolved.
On or around June 15, an inflamed itchy red rash on both upper arms. It spread to my lower back and hip. And I also noticed a swollen lymph node under my right arm. Also, sensitive cuticles on my fingers. Sensitive gums.  And swollen face. It feels like there has been some kind of allergic reaction to something. Treatment has been Pepcid - 20 mg twice a day and Zyrtec - one at night. I did go to doctor and they tested for Lupus and it was negative. They tested for Mono and it was negative. They prescribed Prednisone but I only took a couple; it made me feel weird so I stopped. I went to a dermatologist - they have prescribed a topical steroid cream to help with the itching. They had said they want to do more testing to see if there are any auto-immune situation going on. I don't have any known allergies and this has just broken out and my body is inflamed. I have never had a history of allergies. I'm still having all the symptoms
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JAN-2016, the patient was vaccinated with an improperly stored ROTATEQ lot # L027719, 28-APR-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Bamlanivimab infusion 2/19/21 to avoid hospitalization. Symptoms started 2/16/21 and tested COVID 19 positive while  becoming significantly symptomatic 2/18/21 at Health Care Center.
Information has been received from a physician via a field representative referring to a female patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose, frequency, lot# and expiration date were not reported). Concomitant drug was not reported. On an unknown date after the vaccination, the patient broke out in a case of ophthalmic zoster and had to be treated by an ophthalmologist. The patient recovered on an unknown date. The causality was not reported. Upon internal review, the event of ophthalmic zoster was considered to be medically significant. Additional information has been requested.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of GARDASIL. On 2-MAR-2009 the patient developed a reaction similar to hives. The patient was fine within 24 hours. It is unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Monday night on 8/29 I had uncontrolled bleeding, similar to a period but worst. Years earlier I had a blood clot so the doctor was conscious about giving me strong medicine, after 48 hours I went to ER and my hemoglobin was 8.5 and within 36 hours dropped to 5.2. They gave me transfusion and medicine, and little by little I get back to normal.
Patient was diagnosed with Immune Thrombocytopenic Purpura on 2/21/2021. -petechial rash, bruising -Platelets 4 thousand at hospital admission -Patient is receiving prednisone and IVIG with improvements in platelet count currently
Between one and two hours after the vaccine the injection site was surrounded by a five inch circle that was swollen and red, hot to touch and tender. Within 4 hours of injection every part of the extremity (right arm) was aching and my elbow and wrist and shoulder had pain and stiffness. Over the next two weeks the pain became worse  in every muscle in my right arm And shoulder as well as ligaments and joints there. In the third week after injection the pain spread throughout my shoulder (front and back) throughout shoulder blade area.  As of today March 27, 2021?o have had periods of numbness and tingling from the tips of my fingers throughout my arm to my shoulder and upper back right shoulder area. I have also not been able to lift a gallon of milk to pour into a glass, it is like my strength is gone in my right arm. I could not turn the car steering wheel today and therefore am Afraid to drive. Also I am noticing my knee and ankle and hip have had dull aching pains today. The pain is stabbing , dull, aching and incapacitating at times. I kept thinking these are temporary and will go away, but have done the opposite and gotten worse as time progresses. Should I get the second dose?
This spontaneous report was received from a Licensed Practical Nurse and refers to a 73-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
Tetanus site: induration, color, erythema immediately surrounding injection site 5cm height by 7cm width; Pneumovax site: no reaction at injection site but pt had 2 areas of color and erythema on lower portion of arm-see diagram on back. No lymphadenopathy noted. Low grade fever 100.
Mother reports Hx. of eczema that generally is only on trunk. Mother reports 5 days after Hep A vaccine 2 dry patches adjacent to the vaccination site appeared. Subsequently the client has a 6inx4in area of eczema localized to the area around the Hep A vaccine on left thigh. Client continue to have eczema on trunk but now dealing with flare ups on the left thigh were the vaccine was given, even 4 months after the fact.
Pt developed low grade fever and swelling, golf ball size the day after her injection. Swelling was hard, red & painful x 3-4 days. Following with 25¢ size blackened area that is fading. Pt reported reaction 17 days after injection. No discomfort after 4 days.
After 6 hours having had the vaccine, "her throat felt like it was closing and was sore when she swallowed." She waited until the next day to seek medical attention due to having no money. Clients stated doctor at that time told her it was an allergic reaction, possibly from the vaccine. Was given Diprospan IM for allergy and rash.
Nose bleeds with the second shot; Tinnitus; Vertigo; light headed with both shots; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Sep2021 16:30 (Lot number: 301458A) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: HUMIRA. Past drug history included: Humira, reaction(s): "known allergies: Humira". Vaccination history included: Bnt162b2 (COVID vaccine details: , Product: COVID 19, Brand: Pfizer , Lot number: FC3184, Lot unknown: False, Administration date: 23Aug2021, Administration time: 04:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: 23Aug2021, when the patient was 53 years old, for Covid-19 immunization, reaction(s): "Tinnitus, Vertigo, light headed with both shots", "Tinnitus, Vertigo, light headed with both shots", "Tinnitus, Vertigo, light headed with both shots". The following information was reported: EPISTAXIS (non-serious) with onset Sep2021, outcome "unknown", described as "Nose bleeds with the second shot"; TINNITUS (non-serious) with onset Sep2021, outcome "unknown", described as "Tinnitus"; VERTIGO (non-serious) with onset Sep2021, outcome "unknown", described as "Vertigo"; DIZZINESS (non-serious) with onset Sep2021, outcome "unknown", described as "light headed with both shots". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No other vaccine in four weeks. Patient had COVID prior vaccination. COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Red bumpy blotch appearing nine days after vaccination at injection site.  3?x 2 1/2? approx.  Arm swelling beneath the blotch, large than blotch.  Itchy at the beginning, then just warm to the touch.  No pain.  Five days later blotch is still there, but swelling has gone away.
Approx 5 minutes after receiving Varicella and KINRIX in left arm pt developed blotchy rash to left arm. Unclear if it was itchy, patient was crying. Given BENADRYL PO with full resolution of rash.