chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left armpit was swollen. She doesn't hurt, there was an area about 3 inches across that is swollen and soft.; feeling very fatigued; slightly achy all over; Left arm was slightly sore to the touch; Left arm was slightly sore to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing); "aspirin exacerbated respiratory disease" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies:aspirin"; Quinolones, reaction(s): "Known allergies : quinolones". Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunization; Bnt162b2 (dose 2, single), for Covid-19 immunization; Bnt162b2 (dose 3, single), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN OF SKIN (non-serious) all with onset 08Sep2022 at 07:00, outcome "recovered" and all described as "Left arm was slightly sore to the touch"; FATIGUE (non-serious) with onset 08Sep2022 at 07:00, outcome "recovered", described as "feeling very fatigued"; PAIN (non-serious) with onset 08Sep2022 at 07:00, outcome "recovered", described as "slightly achy all over"; LYMPHADENOPATHY (non-serious) with onset 08Sep2022 at 16:00, outcome "not recovered", described as "left armpit was swollen. She doesn't hurt, there was an area about 3 inches across that is swollen and soft.". Therapeutic measures were not taken as a result of lymphadenopathy, fatigue, pain, pain in extremity, pain of skin.  Additional Information: Patient did not received other vaccine within four weeks of COVID vaccine. Patient received other medications within two weeks. Patient has known allergies to antileukotrienes. Patient did not have COVID prior to vaccination. Patient did not tested for COVID post vaccination. Adverse event reported as, woke up feeling very fatigued and slightly achy all over. Left arm was slightly sore to the touch. Patient previously reported other symptoms she had this morning. This afternoon, she noticed that her left armpit was swollen. She doesn't hurt, there was an area about 3 inches across that is swollen and soft.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021090765 same reporter/patient/product, different dose/AE;US-PFIZER INC-2021211563 same reporter/patient/product, different dose/AE;US-PFIZER INC-202101276219 same reporter/patient/product, different dose/AE;
pt recvd vax on 17jan90;on 15feb90 recvd 2nd dose of hep B vax;at time of report, no problems noted;
got 1 dose in fall of 2019. Then COVID happened. And I never got dose #2.; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received  on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose of shingrix due to covid 19 which led to social problem. The reporter inquired could he/she still get that dose. The follow up would not possible as no contact details were available.
Initial case was received from a consumer on 08 February 2013 and involves a case misuse due to inappropriate age at vaccine administration. An 84-year-old female patient received an injection in the arm (side unspecified) of a second dose of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) on an unspecified date (exact date of injection was not given). The patient came in a week later, on an unspecified date, for a routine blood pressure check, and the nurse noticed the arm where the ADACEL was given was very swollen and red. The area around the injection site was yellowish in color. According to the reporter, the physician diagnosed cellulitis. Laboratory or diagnostic testing and treatments were not reported. The nurse stated that the patient had already received Tdap vaccine years ago (unspecified date) and was incorrectly given a second dose. The patient's outcome was not reported. Documents held by sender: None.
Janssen COVID-19 Vaccine EUA Broke out in rash/hives covering neck, torso, arms, stomach and back
tested positive with covid-19; tested positive with covid-19; This is a spontaneous report from a contactable consumer (patient).   A 29-year-old female patient received the 1sy dose of bnt162b2 (BNT162B2, Batch/lot # E23249) at single dose at left arm on 11Jan2021 for Covid-19 immunisation, as being a teacher.  Medical history was none. There were no concomitant medications.   The patient was tested positive with covid-19 on 19Jan2021. On 19Jan2021 she took a rapid test and a PCR: the rapid test came back negative the PCR test came back positive (received on 22Jan2021, as reported). The outcome of events unknown. She asked if she can still receive the second dose or  what to do if she would miss the receipt of the second dose of the COVID-19 vaccine due to isolation measure, and if she get excluded or if she need to get revaccinated?. A Product Complaint was filed.
102 degree fever, headache, congestion within 24 hours of receiving immunizations lasting 24-36 hours.
Patient ambulated independently  to observation after receiving moderna 1st dose.  Initially sat in chair for 5 min and wife alerted the nurses that her husband became unresponsive.  Nurses came to his aid and guided him to floor.  Patient not responsive, eyes closed, pale, resp nl, sternal rub done with no response.  Ammonia inhalent administered, began to slowly respond.    2:37p vitals 130/80 62; 98 % o2 sat.  Pt became alert and oriented, remained on floor with legs on chair. 2:47p BP 110/68 2:54 Pt states feeling better and was assisted to chair by nurses. While seated in chair vitals were taken 82/40-64-99% and Pt became diaphoretic, pale and stated feeling dizzy.  Assisted to cot from chair, elevated legs. 2:56 84/67-67  99%. Remained alert, diaphoretic. 2:58 Placed 911 call  3:02 100/72-67- 95% 3:03 911 on scene and report given.
This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 17-MAY-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot# N035173, expiration date 09-JUN-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of PROQUAD was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1805USA010447: US-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001200: US-009507513-1807USA001201.
Besides the pain are soreness at the injection area I suffered from severe headache, extreme tiredness and weakness for three days after first injection and for two days after second injection. Muscle ache in the upper abdominal area, both biceps and thighs on third day after second injection which only last 24 hours. I took Ibuprofen for the pain relief.
pt recvd vax approx 3 mins later mom asked a question & showed site arm where size of dime @ inject site w/red arm 1/2 dollar size around it called MD;
Tetanus shot received after a cut foot on October 5th 2008. No pain other than slight irritation at the injection site. Only local pain until October 15th 2008 when injection site became itchy and was scratched. The evening of October 15th, pain (8/10) began to radiate from the shoulder to the fingertips and maintained pain level overnight. Called advice nurse to report as an adverse reaction, but it was not noted.
Patient came in to get the booster. At the time, the pharmacy was very busy and failed to verify immunization record. Pharmacy prepared the dose for Nurse, and she administered the dose to the patient. Patient received booster two weeks after the second dose.
Pruritus; Rash; Pyrexia; Revaccination with different COVID-19 vaccine; This case was received via regulatory authority (Reference number: FI-FIMEA-20215765) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021.    This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Pruritus), RASH (Rash), PYREXIA (Pyrexia) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002338) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included ARIPIPRAZOLE for Anxiety, MONTELUKAST and SALBUTAMOL SULFATE (BUVENTOL) for Asthma, THEOPHYLLINE (RETAFYLLIN) for COPD, BUPROPION HYDROCHLORIDE (VOXRA) for Depression, METFORMIN for Diabetes, ENALAPRIL MALEATE (LINATILSAN) for Hypertension, MELATONIN and TEMAZEPAM (TENOX [TEMAZEPAM]) for Insomnia, VERAPAMIL HYDROCHLORIDE (VERPAMIL) for Tachycardia, LORAZEPAM (TEMESTA [LORAZEPAM]) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced PRURITUS (Pruritus) (seriousness criterion disability), RASH (Rash) (seriousness criterion disability), PYREXIA (Pyrexia) (seriousness criterion disability) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) (seriousness criterion disability). At the time of the report, PRURITUS (Pruritus), RASH (Rash), PYREXIA (Pyrexia) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment information was provided.  Company comment: This is a regulatory authority case concerning a 52-year-old female patient with concomitant medication BUPROPION HYDROCHLORIDE, who experienced serious, unexpected events of Pruritus, Rash, Pyrexia and COVID-19 immunisation. The events occurred 8 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. Concomitant medication BUPROPION HYDROCHLORIDE remains a confounder for the events Pruritus and Rash .The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning a 52-year-old female patient with concomitant medication BUPROPION HYDROCHLORIDE, who experienced serious, unexpected events of Pruritus, Rash, Pyrexia and COVID-19 immunisation. The events occurred 8 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. Concomitant medication BUPROPION HYDROCHLORIDE remains a confounder for the events Pruritus and Rash .The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from health professional.  This case involves unknown gender (over 65 years) elderly patient who was given expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA392579, 2022SA400367, 2022SA400987, 2022SA400369, 2022SA400371, 2022SA401056, 2022SA400981 , 2022SA400131 and 2022SA401104.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, expiry date date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses with no reported adverse event" (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The patient fainted approximately 1-2 mins after administration of the vaccine, fell out of the chair he was sitting in and hit his head on the floor causing a laceration that needed medical attention.
After I got into my car in the parking lot, my arm started to feel numb. As I was driving home, the numbness spread to my neck and face. After 15 minutes the left side of my face was very numb, like when a person gets a shot at a dentist to numb the area before drilling. The numbness continued to spread to the rest of my face that evening. I also had side effects that were like I has the flu for three days, body aches, fever, chills, etc. The numbness has gone away in my arm and the right side of my face, but the left side of my face still feels numb many months later.
Order was written for IPV and HPV was given.  Md aware and patient is aware.
Information has been received from a physician concerning a female whose daughter was vaccinated po with all three doses of ROTATEQ. On 02-Jun-2008 the patient's daughter experienced gastroenteritis rotavirus. On 04-JUN-2008 and on 05-JUN-2008 the patient complained of diarrhea and on 13-JUN-2008 there were no complaints. Subsequently, the patient recovered from diarrhea. This is one of several reports from the same source. Additional information has been requested.
15 min post-vaccination, pt c/o intense pruritis to bottoms of feet. B/p-132/80, p-60, R-14. Itching spread to whole body. No resp distress. 50 mg BENADRYL adm P.O. Itching resolved et pt allowed to leave facility 1 hr 10 min following vaccination. Saw pt 12/24. States very mild pruritis continued the rest of the day (12/23). Now resolved.
Redness, swollen area hot, treatment start Keflex and ibuprofen.
Narrative: COVID infection following COVID vaccine series 12/23/2020, Pfizer, dose #1 01/13/2021 Pfizer, dose #2 08/10 pt cc:No symptoms exposure: unknown 08/10 CXR impression: 1. New faint opacities are seen in both lungs may relate to early viral pneumonia. 2. Cardiomegaly. 08/15 COVID swab, result: detected
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (healthcare worker left a voicemail stating they gave an expired vaccine to a patient) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Sep 25, 2021, patient administered expired product (healthcare worker left a voicemail stating they gave an expired vaccine to a patient). At the time of the report, administered expired product (healthcare worker left a voicemail stating they gave an expired vaccine to a patient) resolved. The reporter did not provide any causality assessments. The  expiration date for the 1st dose: Sep 18, 2021. Date the vial was initially stored in the refrigerator: Friday, Sep 24, 2021. They didn't know how much time the vial was exposed to room temperature, or whether the vial had undergone any temperature excursions. No concomitant medications or treatment information reported. Most recent follow-up information incorporated: On Sep 27, 2021: Follow-up  received on Sep 27, 2021: Reporter information, vaccine start date, event date and details updated.
got the shingles about 2 years later/ Suspected vaccination failure; Shingles; Awful. Two trips to the E.R.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had the shingles shot about 3 years before the date of reporting and about 2 years later the patient experienced the shingles and was awful. The patient had two trips to the emergency room (ER). This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
Headache  and dry nasal passages 9 days after vaccination..  Muscle aches starting day 11 to current.
Patient  received her first Pfizer COVID shot and experienced symptoms of sweating, paleness due to her anxiety. The Pharmacist followed SOP and managed patient to led down. Apply cool paper towels to patient face and neck. Patient refused to call the ambulance. The Pharmacist monitor the patient for 35 minutes until she has made a full recovery.
bulging veins in wrists and hands; experiencing side effects with her veins looking like they are bulging in her legs, feet and ankles at first and they are now spreading to her hands.; Neck pain; Caller states the Vitamin E supplement that she takes can have a blood thinner property so she is not sure if that could have caused her reaction; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 (Batch/Lot Number: EW0183; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypersensitivity and arthritis. Concomitant medication(s) included D-flame, Vitamin E, daily dose. The patient she has been experiencing side effects last night with her veins looking like they are bulging in her legs, feet and ankles at first and they are now spreading to her hands on 17May2021 22:00 and this morning the veins in her wrists and hands are bulging as well on 18May2021. She takes a daily supplement something like a multivitamin and she would like to know if the ingredients in the supplement could have caused an interaction with the vaccine? She states the Vitamin E supplement that she takes can have a blood thinner property so she is not sure if that could have caused her reaction. Ingredients of the supplement include holy basil 250 mg, turmeric 100 mg, ginger 100 mg, green tea 100 mg, baikal skullcap 50 mg, bromelain extract 100 mg, resveratrol 10 mg, berberine 5 mg and boswellia 100 mg. States the dosages provided are for two capsules and she only take one so it would be half. She said she really had bad neck pain last night on 17May2021. It was severe but went away after dinner. It was last evening, and she noticed it around 10:00pm. Took Tylenol before bed. She had nuclear stress test result unknown on 05May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event for bulging veins in wrists and hands was not resolved and for rest of the events it was unknown.  Follow up needed, further information has been requested.
Nauseated, chills, sweats, vomiting,  pain,  fever, and short of breathe
Unable to walk evening of vaccine and also day after. Continual loss of fluid through my stoma.  Everytime I would try to stand I would start to black out
join pain/ Pain in knees and ankles; cramping in hands and legs; neck pain; bad headaches; chills; This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 65-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. In May 2021, 1 week after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced joint pain, cramp of limb, neck pain, headache and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the joint pain, cramp of limb, neck pain, headache and chills were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, cramp of limb, neck pain, headache and chills to be related to Boostrix and Boostrix Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Boostrix and experienced several adverse reactions included cramping on hands and legs, join pain, chills, pain in knees and ankles, bad headaches, neck pain. The reporter mentioned that the patient was not recovered yet and had been taking ibuprofen as a treatment, that seemed to be helping with the symptoms. The reporter also stated that the patient had been needing braces for her knees and ankles. The reporter consented to follow up.
This spontaneous report as received from a nurse refers to an unspecified number of patients. On an unknown dates, the patients were vaccinated with an unspecified number of doses of PROQUAD (Merck) (lot#, dose, route and site of administration were not reported) that were reconstituted with sterile diluent (manufacturer unknown). The doses were reconstituted with 0.6 ml of sterile diluent (manufacturer unknown) and were not reconstituted with the entire volume of the supplied sterile diluent (manufacturer unknown) as recommended in the prescribing information. 0.5 ml of vaccine was drawn up for administration after reconstitution. No adverse events were reported. Product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.