chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rashes on left flank /the physician called these out as shingles; chills; shivering; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in Arm Left on 09Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks, patient didn't receive other medications within 2 weeks of vaccination. Patient didn't had covid prior to vaccination. The patient medical history and concomitant medications were not reported. Patient had no allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN60207) via unspecified route of administration on 19Mar2021 in Arm left as DOSE 1, SINGLE for covid-19 immunisation. On 09Apr2021 the patient experienced rashes on left flank /the physician called these out as shingles, chills, shivering, fever. Patient had physician office visits for the events physician recommended to wait for 72 hours before starting antivirals and anti-inflammatory medications. Therapeutic measures were taken as a result of chills, shivering, fever was 3 Advil's, every 8 hours. Patient was not tested with covid to post vaccination. The outcome of the events, herpes zoster, chills, pyrexia was recovering.  No follow-up attempts are possible; No further information is expected.
starting at about 1pm pt states that her skin has become itchy, and she is developing a rash and is sweating.    Advised her to take benadryl and to call her MD to discuss if anything else needs to occur.  Advised her that due to reaction may not be advisable to get second dose.
tired; weak/ less energy; chest pain on exertion; This is a spontaneous report from a contactable consumer. Report 2 of 2. Caller is reporting on herself and her daughter. This is the report for callers daughter. A 43-years-old female patient (reporter's daughter) received Pfizer Covid19 vaccine (Formulation: Solution for injection, Batch/Lot Number was unknown, Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration, on an unknown date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was not reported.  On an unknown date reporter stated that after getting the first dose of the vaccine Mother had continues to have less energy every day, and chest pain on exertion, her daughter has gone through the same thing. Her daughter had been to the doctor 3 or 4 times for different things. For her daughter, it happened very shortly after the first vaccine. Her daughter had to miss work since so she was tired and so weak, or take a half day. Her daughter explained it as something was just not right. They came to the conclusion that it had to be the vaccine. The out come of all events were unknown.  Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
pt recv vax 12FEB96 & 20FEB96 pt devel little pimple like bumps w/o fluid that devel into a rash the next day which was not varicella;dx as vesicular rash by a dermatologist;No further details were provided;
soreness in the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (soreness in the arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (soreness in the arm). On 22-Feb-2021, MYALGIA (soreness in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
First effects looked like psoriasis after the first dose. More skin lesions appeared and after the second dose my arms and legs were affected with various skin disorders. Dermatologist seen 3/2/21 indicated herpes and another bacteria. Was given Valacyclovir 1gm 2 x day, Cephalexin 500mg 2 x day, Prednisone packet and Mupirocin ointment. Festering lesions have continued to grow and now are painful. More lesions are appearing on extremities.
Hearing loss; Virus in ear; Arm was sore; A spontaneous report was received from a consumer, concerning a 73-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed arm sore, hearing loss and virus in my ear.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the events included losartan, fluticasone, escitalopram, esomeprazole sodium, simvastatin, cetirizine hydrochloride, alpha lipoic acid, chromium, cinnamon oil, ascorbic acid, folic acid, nicotinic acid, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, turmeric [curcuma longa rhizome], vitamin B complex, vitamin D3, levothyroxine;liothyronine, fish oil, probiotics nos, ascorbic acid, melatonin, calcium, ubidecarenone, vitamin e nos, magnesium and polycarbophil calcium.  On 29 Jan 2021, approximately 1 day prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the next day, after the first dose of vaccine, the patient woke up with arm sore which had lasted for two days. On 25 Feb 2021, the patient experienced hearing loss which was from a virus in her ear. Treatment for the events included high dose of prednisone tablets.    Action taken with mRNA-1273 in response to the events were unknown.  The event of arm sore was considered resolved on 01 Feb 2021. The outcome for the events of hearing loss and virus in my ear were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt reports having redness to both arms after vaccine with no previous history of same. Pt had never noticed any reddening to either arm. Pt also reported tiny re pinpoint dots to both arms. No signs of urticaria, no respiratory Difficulty or other associated s/s.
Red, swollen area/lump at site of vaccine, (L) UE, warm to touch. About 1 cm mass with exam. Pt said it had been slightly larger.
raised red rash; itchy; Vax 2 - Normal (flu-type) symptoms; sore to touch; location same arm as injection; Vax 3 - Normal (flu-type) symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Nov2021 11:45 (Lot number: FH8028) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; AMLODIPINE BESILATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8736, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 22Apr2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01Apr2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Normal (flu-type) symptoms".  The following information was reported: IMMUNISATION (non-serious) with onset 14Nov2021 11:45, outcome "unknown", described as "Vax 3 - Normal (flu-type) symptoms"; RASH ERYTHEMATOUS (non-serious) with onset 17Nov2021 16:00, outcome "not recovered", described as "raised red rash"; PRURITUS (non-serious) with onset 17Nov2021 16:00, outcome "not recovered", described as "itchy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 17Nov2021 16:00, outcome "not recovered", described as "Vax 2 - Normal (flu-type) symptoms"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 16:00, outcome "not recovered", described as "sore to touch; location same arm as injection". Therapeutic measures were not taken as a result of rash erythematous, pruritus, influenza like illness, pain in extremity.  Additional Information:  Patient covid prior vaccination was unknown. Covid tested post vaccination and known allergies was no. Device Date: 19Nov2021.  Follow-up attempts are completed. No further information is expected.
PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Numbness and tingling in Left arm 3 hours after injection.  Evaluated in ER same day,  no deficits noted. Significant improvement within 24 hours of symptom onset, complete recovery within 48 hours of symptom onset.
Red raised rash appox.  1 1/2 " X 1 1/2.  Very itchy.  Pt. observed for one hour post 25mg po Benadryl. 05/12/09 Patient reaction was to the tuberculin skin test, not the HEP B or TDAP she was given on that day. Her reaction was a localized skin reaction which included rash, swelling, and uticaria.
Pfizer BioNTech COVID-19 Vaccine EUA: Vaccine Administration Error - Pediatric Formulation Patient administered 0.2 ml pediatric vaccine, then administered 0.3 ml adult dose on 11/19/2021  Previous doses administered on 12/19/2020 and 1/6/2021
Chills; sweats; red swollen arm; red swollen arm; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 11Mar2021 at 08:30 (at the age of 66-years-old) as dose 2, single for COVID-19 immunisation at Health department in a tent by the fire department. Medical history included blood pressure high (Blood pressure high/Diagnosed a long time ago, may be 15 or 20 years ago). Concomitant medications were not reported. The family medical history relevant to AE included heart attacks, cancer, and stuff. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6202), via unspecified route of administration, administered in left arm on 18Feb2021 as dose 1, single for COVID-19 immunisation and did not have any problems, it was sore and red but not a big deal. The patient previously took flu shot (expiration date and Lot number: unknown) on an unspecified date (reported as October) and experienced arm gets red, a red dot and couldn't raise her arm. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. It was reported that the patient had her shot on Thursday, and on 12Mar2021 she had a reaction, her left arm became red arm and swelled. On an unspecified date, she also had chills and sweats on the first night. The patient was taking Benadryl, now the redness is spreading and blotchy, the redness is not going away. It was reported that a round circle began on the 12Mar2021, really big on the 13Mar2021, it looked like it spread but it was not as dark, still was fevery. The patient was expecting that her arm to be red where the injection went in, but not that its going to go clear across. The patient tried tylenol (Lot PLAO52, expiration Jun2023) but did not seem to be helping. The patient was seeing her Physician on the day of report. The patient wants to know if it is normal and what to do the patient gets a reaction from anything, she gets side effects from an aspirin. Is this a normal reaction. The patient reported that she was taking COVID-19 vaccine because everyone told her she had to and because she was old. Therapeutic measures were taken as a result of red swollen arm. The patient underwent lab tests and procedures which included blood potassium: unknown results on Mar2021. The outcome of the event red swollen arm was recovering and chills, sweats was unknown. The relatedness of drug to reaction red swollen arm was reported as related by primary source reporter with global introspection method of assessment.  No follow-up attempts are possible; no further information is expected.
Very bad headache, fever of 101, arm so painful i could not even lift it, general aches and pains all over, extreme tiredness, extreme thirst  - lasted about 36 hours and is easing up gradually.  I reacted to the second Moderna shot, but not this strongly.  This was so painful and uncomfortable that it makes me hesitant to get any more boosters if they become an annual recommendation.  Couldn't you try to regulate the dosage by weight?  The folks I know who weigh a lot more than i do did not have any reactions.  One person in particular had his antibody levels tested before getting the vaccine,  and they were very high.  He still did not have a reaction.  So, it is not that my antibodies were high!
Swelling and induration with erythemia on the upper brachin reported 3 days after vaccination. Cold compresses, APAP, antihistamines, suggested. Patient resolution attained. (injection site Rxn).
Might be humira not working because of the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Might be humira not working because of the vaccines) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DRUG INTERACTION (Might be humira not working because of the vaccines). At the time of the report, DRUG INTERACTION (Might be humira not working because of the vaccines) had not resolved.            No concomitant medication was reported. For patient Humira might not be working because of the vaccines and Pfizer-Biontech covid-19 vaccine injectable was not efficacious.  Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the mailbox were missed to be booked-in.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored VAQTA (lot # M011116 with expiration date: 17-JUN-2017, dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Patient began to have a headache the night the vaccine was administered.  The following day she developed Muscle Spasms, Vertigo/dizziness and her arm became swollen (large knot on her arm and described as a bee sting with a center and red raised around in a circle) and red.
pt had recent hospital admission with positive COVID test, was dc'd to home with O2 therapy; presents to ED with acute hypoxic respiratory failure secondary to COVID pneumonia; pt sedated and placed on ventilator; 100% FiO2; no improvement during hospital stay; condition worsened and pt eventually placed on comfort measures; removed ventilator and pt passed away in the hosp
Patient came in for booster vaccine of adult Pfizer due to working within a healthcare field. Nurse was given a syringe for a previous patient, who was to be vaccinated using the Pediatric Pfizer. However, the patient finished their paperwork before the pediatric patient. The nurse was then given a syringe with the adult Pfizer dose and was filling out/double checking the patient's paperwork. The nurse then used the incorrect syringe with the Pediatric Pfizer dose and administered it in the patient's right arm.
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 17-Dec-2013. It was reported that patient  was inadvertently administered an expired FLUMIST QUADRIVALENT which started on 17-Dec-2013. The outcome of the event of inadvertently administered of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
My wife is having pain in the left hand at the vaccination point. This pain is there even after 10 days.  Vaccination point is little hard / stiff as compared to other hand.  My concern is that why effect is there even after 10 days of vaccination.  Her second dose is scheduled on 18th April and we are concerned about the effect of first does.
My symptoms started in the early afternoon of April 05, 2023. My symptoms were an extreme feeling of fatigue, no energy, and slight chills. The next day, I woke up with low energy, but the chills were gone. At some point, I started coughing. I also realized I had no appetite. All forms of activity exhausted me. I tested myself for COVID-19 the afternoon of April 06, 2023. The result was positive. The next day, I called my doctor. He prescribed Paxlovid after talking about the risks. I started taking it that evening. I took it as prescribed for the five days. Over the few days, I felt terrible. I had a runny nose, low energy, loss of appetite, and a cough. The cough was very productive. I started to feel better after the first few days of taking Paxlovid. Each day was better that the last, but the cough and runny nose persisted. I still have a lingering cough. I have my appetite and full energy back.
Experciened itchiness in evening on lower left arm, woke up next morning with itchy, swelling rash from wrist to lower arm.
Dizziness about 4 to 5 days after vaccination. Dizziness upon waking and throughout the day. Got better. Received 2nd dose 4/9 and got dizziness again and getting better but taking a while to go away.
accidentally administered flu shot to one month old patient/ No AE; Based on information previously received on 16-Dec-2019, the following information (case previously considered as non-valid became valid) has been amended.  Initial information was received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case involves a one months old female patient who was accidentally administered with 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (formulation: prefilled syringe) (lot number: UT6645KA and expiry date: not reported) via unknown route in an unknown administration site for prophylactic vaccination on 11-Dec-2019 .  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Elevated Fever (102) Night of Injection Exhaustion Evening of Injection for a 36 hour period Soreness and bruising at Injection site
administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient; administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19-JUL-2023, the patient received Menveo. On 19-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient) and inappropriate dose of vaccine administered (Verbatim: administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 Nurse practitioner reported that another nurse administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Nurse was not at the facility to provide patient's identifiers and vaccine lot number or expiration date. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.
Had a sore arm; shortness of breath; projectile vomiting; woke up with uncontrollable chills; headache; fever of 101.5; feels nauseas; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm), DYSPNOEA (shortness of breath), VOMITING PROJECTILE (projectile vomiting), CHILLS (woke up with uncontrollable chills) and HEADACHE (headache) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Had a sore arm), DYSPNOEA (shortness of breath), VOMITING PROJECTILE (projectile vomiting), CHILLS (woke up with uncontrollable chills), HEADACHE (headache), PYREXIA (fever of 101.5), NAUSEA (feels nauseas) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (Had a sore arm), DYSPNOEA (shortness of breath), VOMITING PROJECTILE (projectile vomiting), CHILLS (woke up with uncontrollable chills), HEADACHE (headache), PYREXIA (fever of 101.5), NAUSEA (feels nauseas) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) High.         No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD-2021-081505 (Patient Link).