chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm soreness, no other clinical symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 09:15 (Lot number: EP6955) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021 16:00, outcome "recovering", described as "Left arm soreness, no other clinical symptoms". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Concomitant medications in two weeks included Multi-vitamin. Patient administered no other vaccine in four weeks. Patient not had covid prior to vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
The patient received Moderna Dose #1 today at our facility. Within ImmTrac, it states that patient received the Pfizer series.  Dose #1 3/1/21 and Dose #2 3/28/21. I called and spoke with patient and she states that she has not received any previous COVID vaccines although all the information was correct: name, address, DOB, and phone number. Please advise on further action and if patient should received 2nd Moderna dose. Was able to reach patient at spouse's number
Patient stated she felt fuzzy in her head, numbness running down left arm where injection was given, had a headache within about 15 min of receiving injection. Brought pt to a room. Pt declined treatment, she stated she just wanted to go home. Monitored, pt until her head felt better. Vitals normal.
Bilateral rash upper arms with pruritus on 12/ 9/11 after vaccines on 12-8-11.
Reporter documented the following occurred on 1/15/21  "Patient was accidentally given a Dtap instead of a Tdap". Additional documentation from reporter "A couple months ago or so, we did not have Tdap and then a supply came in and a  long green box  of Dtap appeared on our top shelf in the fridge, which is designated for OBGYN medication, family medicine has the rest of the shelves for their medication.  It is a different brand, I looked at the ingredients were the same , so I had thought it said Dtap was because it was a different company. I didn?t realize that one was the initial vaccine (Dtap) and the other was the booster (Tdap). Someone did recently  write on there for 6 weeks to 6 years. It was still  on our shelf in the fridge until I moved it to the bottom shelf. I did notify my fellow employees the difference in Tdap and Dtap and to double check you are always giving Tdap.  I did report this to the midwife as this was her patient.  Patient was notified. I also reported this error when I found out to my supervisor".
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 20Aug2021 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 20Mar2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "slightly elevated cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: No known allergies. Patient received Paxlovid from 18Feb2023 to 23Feb2023 for COVID-19 Anti viral treatment.
DEVELOPED FLU-LIKE SYMPTOMS, LETHARGY, COUGH, SINUSITIS .
HIVES ON LEGS AND RIGHT ARM; PRURITIS; JOINT PAIN; GENERAL MUSCLES ACHES; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 62 kilograms, and height was 166 centimeters. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, treatment medications included: paracetamol. On 02-MAY-2021, the subject experienced pruritis. On 02-MAY-2021, the subject experienced joint pain. On 02-MAY-2021, the subject experienced general muscles aches. On 02-MAY-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.4 to 37.8 C. On 03-MAY-2021, treatment medications included: camphor/diphenhydramine hydrochloride/zinc oxide. On 03-MAY-2021 13:00, the subject experienced hives on legs and right arm. Additional treatment medications (dates unspecified) included: mometasone furoate, levocetirizine dihydrochloride, and loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, general muscles aches, fatigue, and fever on 02-MAY-2021, and had not recovered from pruritis, and hives on legs and right arm. This report was non-serious.
The arm was sore after inflection for three days then two weeks after the vaccine arm is sore again.
Information has been received from a physician concerning a 4 yr old white male who on 01Mar04 was vaccinated SC with a second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot 645911/0613N). On 08Mar04 the pt experienced local inflammation at injection site. There were no diagnostic lab tests performed. Subsequently, the pt recovered. No further information is available.
Swelling of the face and rash. Treated with diphenhydramine, and a doubling of his chronic steroids (prednisone 20mg to 40mg PO daily)
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: States she has syncope following vaccines. She was advised to sit for her entire 15 minute observation period which she did. After 15 minutes, she went to the front store where I'm told she passed out twice, hitting her head at least one of those times. By the time I was alerted, she was responsive. I tried to keep her laying down, but she sat up and began vomiting. I was unable to get a BP reading before EMS arrived.
TINGLINGS ON LEGS AT ONSET. PARALYSIS ON FACE AND LEGS AND LOSS OF BALANCE NOW.
expired IPOL was accidentally given with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old male patient who was administered expired ipol was accidentally with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 27-Jul-2022, the patient received a  total dose of suspect IPV (VERO)( lot T1D482M and expiration date: 25-Jul-2022) at a dose of 0.5ml once via unknown route in the right deltoid as prophylactic vaccination.  On 27-Jul-2022 (latency: same day), the patient developed a non-serious event of expired ipol was accidentally given with no reported adverse event  (expired product administered) following the administration of IPV (VERO).  Action taken: Not applicable.  Outcome: Unknown   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.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:38 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 21.53 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021. 18 vials from this batch were sent to the clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
The following day after my second vaccination I experienced major fatigue, headaches, and pain. I also experienced pain in the shoulder same side as shot site. Friday 2/20/2021 I was not able to roll over on my side due to the pain in my shoulder. I checked my blood pressure that same morning and it was very high. I think 145/95 after taking my blood pressure medication. I wanted to confirm that the headaches I was experiencing were from the high blood pressure I had after being given the shot. Some time after I recall having some tightness in my chest afterwards.
16 year old male was administered moderna vaccine on the left arm; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male was administered moderna vaccine on the left arm) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male was administered moderna vaccine on the left arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old male was administered moderna vaccine on the left arm) outcome was unknown. Not Provided   Treatment medication was not provided. Action taken with mRNA-1273 in response to the events was not applicable    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
A little sick in the night; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (A little sick in the night) in a 74-year-old female patient 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 ILLNESS (A little sick in the night). At the time of the report, ILLNESS (A little sick in the night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
This spontaneous report as received from a nurse refers to a 2 month old patient of an unknown gender. On 12-SEP-2014, the 2 month old patient was mistakenly administered a dose of VAQTA (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
10/23/11 Dry skin on palm of hands/peeling. Treated with Cetaphil lotion.  10-24-11 7:00 AM Right eye extremely red accompanied with dull pain, and watery (none stop tears) for two hours. Rinse eye with water and lubricating eye drops. By 1:00 PM eye improved, not as red and painful.  4:00 PM Extreme itching on hands and moved up to the forearms with a rash; treated with lanacane lotion and it relieved itching for 2 1/2 hrs. 6:00 PM Itching returned to hands and forearms; treated with 2 over the counter Benadryl pills.
Developed Itching 20  minutes post-vaccination. Administered 50mg PO Diphenhydramine Capsule. Observed for additional 30 minutes. Symptoms improved.
This spontaneous report as received on 18-APR-2017 from a physician refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-APR-2017, the patient was vaccinated with PNEUMOVAX23 lot # L035686 expiration 15-FEB-2017. The physician reported that the patient was inadvertently administered an expired dose of PNEUMOVAX23 and no adverse event reported. No additional information was provided. Additional information has been requested.
Information has been received from a physician's assistant concerning a 37 year old female healthcare worker with G6PD immunodeficiency and a meperidine hydrochloride (DEMEROL) allergy, who on 15-OCT-2005 was exposed to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 6495130935F).  There was no concomitant medication.  It was noted that the healthcare worker was reconstituting the vaccine and was splashed by the vaccine on the left forearm and now has a rash on the left forearm.  It was also noted that there was a " pimple looking papule on her neck".  The rash was tender to the touch with no itching.  She washed her her arm later in the day where the vaccine sprayed her arm.  On 16-OCT-2005 she was diagnosed with contact dermatitis.  Unspecified medical attention was sought.  There were no diagnostic laboratory studies.  She was treated with hydrocortisone cream which has not helped.  At the time of this report, she had not recovered.  No product quality complaint was involved.  No additional information is expected.
Breastfeeding; Dizziness and lightheaded; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Dizziness and lightheaded) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (Dizziness and lightheaded). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding). At the time of the report, DIZZINESS (Dizziness and lightheaded) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) had not 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.
This case was reported by a other health professional via call center representative and described the occurrence of genital herpes in a 63-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date February 2019) for prophylaxis. The patient's past medical history included genital herpes (since 1980). On 25th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 1 day after receiving SHINGRIX, the patient experienced muscle soreness. On 28th August 2018, the patient experienced genital herpes, vaginal itching and lymphadenopathy inguinal. On an unknown date, the outcome of the genital herpes and lymphadenopathy inguinal were not recovered/not resolved and the outcome of the muscle soreness was recovered/resolved and the outcome of the vaginal itching was recovering/resolving.  It was unknown if the reporter considered the genital herpes, muscle soreness, vaginal itching and lymphadenopathy inguinal to be related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to the physician. The patient received SHINGRIX vaccine in left deltoid. On 28th August 2018 or 29th August 2018, the patient started to experienced really bad genital herpes outbreak. The patient had not an outbreak this bad in years. The patient stated that she had itching on her right labia and swollen glands in her groin area. The patient starting to have the symptoms in her left labia as well at the reporting time. The patient stated that she also experienced muscle soreness in her left arm one day after receiving the SHINGRIX injection. The physician's details were by the reporter. This case was link to case US2018GSK167364, reported by the same reporter for the same patient.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
Patient reported increased muscle aches from what patient normally experiences.  The 2nd dose of shingrix was administered on 02/16/20.  First dose was administered 01/20/20.  This was less than 2 month minimum between 1st and 2nd dose.
Pt felt like her throat felt like closing, denis shortness of breath. pt was able to cimmunicate and was smilingand i nformed person at the rapid response leader she can ambulate to ER, Pt was escorted by para medics to ER on wheel chair
Roughly 10 hours after injection: fever, chills, dizziness, freezing and on fire at the same time. Fully clothed in bed with hands too icy to touch together to get warm, very thirsty, but too cold and fatigued to get up. Body aches, joint aches, muscle aches, and SPLITTING HEADACHE. Symptoms slightly better at 4 a.m. , enough to get cup of water but only a couple sips would go down. Could not sit up to drink and it spilled all over sheets. No sleep yet at this point. Did not want to take any medication on an empty stomach and already slight nauseous at the thought of food. The only saving grace was not throwing up so far. By morning the chills had subsided but the fever of about 99 (my usual is 97 ish) stayed with me all the following day. Body aches, splitting head and neck aches, and slight fever stayed with me. Finally able to get a little food in and some electrolytes about 4pm next day and took some ibuprofen. Finally pain started to lift. Took 3 more ibuprofen before bedmate melatonin, and a Xanax and fell asleep. Today all is better except slight dizziness and a little fatigue. Possible dehydration effects. It was 24 hours of misery in slow motion!
no mensural cycle for 4 months. Estradiol levels normal and not in menopause; This is a spontaneous report from a non-contactable consumer (the patient). A 51-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, on an unspecified date in May2021 (at the age of 51-year-old), as single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unknown date in May2021, the patient has no mensural cycle for 4 months. Estradiol levels normal and not in menopause. The patient underwent tab tests and procedure which included the Estradiol was normal on an unknown date in 2021 and COVID-19/Nasal swab test and result was negative on an unknown date in Jun2021. Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received for event. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received the PNEUMOVAX 23 23/0.5 inj Marc vaccine on 1/14/15. Had the following side effects: fever, chills, rash, muscle aches, fatigue, tenderness, headache, joint pain, and warmth, redness, swelling at injection site for four days. Unable to lift arm (injection site) above head for 24 hours after injection.