chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event: developed papular rash to right flank 12/24, treated with topical hydrocortisone cream, rash remained through 12/27. OTC PO benadryl taken the night of 12/26. Developed another papular rash to right neck and subclavian region  on 12/27 @0800. Papular rash to left neck smaller but also developed 12/27 @0800-0900.
This spontaneous report as received from a physician via a company representative refers to a 7-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown date, the patient was vaccinated with unspecified dose/doses of PROQUAD (dose, route of administration, lot# and expiry date not reported). On 08-JUN-2017, the patient was vaccinated with booster dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter injection (route of administration, lot#, expiry date and albumin status not reported). On 01-MAR-2019, the patient developed shingles on the left tricep. The patient saw physician on unknown date and treatment with acyclovir was started. The outcome of event was unknown. The causality assessment was not provided.
My head feels foggy more than headachy; My head feels foggy more than headachy; intermittent tiredness/fatigue; had heaviness in my legs over the weekend; Feels weird. Her head feels weird; stuffiness and maybe some sinus issues; cluster headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 11:50 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bladder infection" (unspecified if ongoing); "hand issue" (unspecified if ongoing), notes: she was having hand issues( "unrelated to the vaccine, from a previous hand issue"). The patient's concomitant medications were not reported. Past drug history included: Meloxicam, reaction(s): "Inflammation", notes: Pharmacist told her she could take some Meloxicam for inflammation prior to taking the vaccine. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "Feels weird. Her head feels weird"; HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset 2022, outcome "unknown" and all described as "My head feels foggy more than headachy"; CLUSTER HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "cluster headaches"; LIMB DISCOMFORT (non-serious) with onset 2022, outcome "recovered" (2022), described as "had heaviness in my legs over the weekend"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "intermittent tiredness/fatigue"; NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "stuffiness and maybe some sinus issues". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
thyroid eye disease; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age (Age: 68; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included thyroid problems and was autoimmune; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received her second dose of BNT162B2 on Tuesday 16Mar2021 and the patient needs to start the steroids due to she was diagnosed with thyroid eye disease on unspecified date after the first dose of BNT162B2. The patient had some thyroid problems before the BNT162B2 but was diagnosed after her first dose. The patient wanted to know when can she start taking her steroids and asked of any effects on the efficacy of the BNT162B2. The patient did not take any steroids in between doses. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Local injection site rash on right arm with mild tenderness, mild pruritus, and warmth to the touch beginning 4 days after vaccine administration.
This spontaneous report was received from a currently 64 year old male patient, reporting on himself. The patient did no have pertinent medical history. The patient's concurrent conditions included a drug reaction or allergy to amoxicillin, also reported as "immoxicilin". On 08-JAN-2016, the patient was vaccinated with ZOSTAVAX (dosage information and anatomical site of vaccination were not informed) (which had the lot # L006392, expiration date 25-MAY-2016) for prevention of shingles. There was no concomitant medication. On several unknown dates, the patient experienced "aches at the injection site". The patient contacted his physician, but did not receive treatment for the adverse event. The patient continued experiencing aches at the injection site. It was also reported that no laboratory tests were performed. There was no product quality complaint involved. At the time of reporting, the outcome of vaccination site pain was not recovered. The causality assessment between aches at the injection site and therapy with ZOSTAVAX was not provided. Additional information has been requested.
06/29/2002 8;30 Child woke up with a rash on his back, No itching or fever, Has gotten worse but has not spread beyond his back, Mom reporting has not seen referred to ER if needed, Child out of town, To call if worsens.
Itchy arm, red rash, appeared more than a week after vaccine. Very very itchy!
Similar to 1st dose (given early Jan. 2020), arm became inflamed, hot to touch, red, and slightly swollen within 3 hours even though an ice pack was applied immediately. 2 Ibuprophen taken when arm movement & touch became more painful. More ice applied evening and 2 more Ibuprophen at bedtime. Around 10:30 next morning (6/24), nose started running, slight headache, chilled, extremely tired, achy, coughing, soreness in lower arm, particularly R side, Thinking foggy. Returned to bed for 4 hours. Took temperature 2x oral = 100.4, underarm = 99.5. Phoned physician, could not reach. Called VAERS. Applied more ice and rested. 2 more Ibuprophen at bedtime. Thursday morning 6/25/20 Temp back to normal, arm still painful, head still foggy but respiratory better. Concluded that recovery was too swift to be flu; reaction (likely) to vaccine (physician when she returned my calls next day 6/25, concurred). Slight heat and swelling in the arm persisted for another day. Returned to fully functioning by 6/26/2020.
The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023; No adverse event; Administered expired Moderna Vaccines to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 22-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023).    No concomitant medications were provided.  Pharmacist was calling to find out about the stability of expired Moderna vaccines as it was administered to several patients after 30-day use by date.  Dose administered after 30-day use by date or after manufacturer date of expiry.  The individual vial size was 2.5 ml.   The vial was initially stored in the refrigerator on 13-Mar-2023.  The vial did not undergo any temperature excursions.  No treatment medication was provided.  This case contains information for the 11th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Follow-up received included patient age, gender, initial, date of administration added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Master case
Red skin reaction approx 4cm around injection site (L deltoid) with L axillary lymphadenopathy
Im not sure if this was vaccine related, I got my shot on the right side and I ended up with a knot on the same side. On the 16 of May I woke up with a knot on under my ear in the right side ( lower jaw). It was tender to touch and the next day it was bigger, so I went into to see my doctor.  May 17 PCP She thought it was a aggravated lymph knot prescribed an antibiotic. Sulfamethoxazole-Tmp ss400-80 14 pills for seven days. After two days the knot was bigger and still tender, and I was given a   Methylprednisolone 4mg dose pack It finally started going down on May 20th still tender but not as bad and its still visible but not as painful.
Severe headache, N/V, cough, SOB with talking, fever, fatigue, body aches and severe ear pain. Shingles lesions started appearing couple days later (shingles location included the ear with pain and down neck).
Patient had facial itching and tingling of the lips.  Did not report any shortness of breath. Patient was given oral Benadryl.
A female vet student received pre-exposure rabies series, and developed body aches and fever. She received her first dose of RabAvert vaccine on 9/24/03. Afterwa0rds she complained of body aches, headache and chills, which worsened over next 2 days. The pt then developed a fever of 103 F, and a backache and went to urgent care. She was examined and had normal CBC. No further testing was done. Her symptoms, especially fever, subsided. She was due for #2 vaccinations on 10/1/03. The pt had not been medicating until seen in the urgent care center. Since then she had been taking Tylenol or NSAIDs with relief. The physician reported that the pt had improved, and insisted on continuing with treatment. She had the second injection on 10/2/03. The pt was sent home with instructions to take Tylenol for three days and also Benadryl if necessary for the next three days.
Patient was on hospice for senile degeneration of the brain. She had been having abnormal vaginal bleeding in the months leading up to her death, and in mid July, she had increased facial drooping. The vaccine was administered on 9/16 and on 9/18 at 0540, her sister/ primary caregiver called to report that she was breathing "differently" and her "eyes were glassy". She died at 2239 on 9/18.   It is unclear if the vaccine is related to her death; however, we are reporting to VAERS per CDC guidance. She is also being reported to the Office of the Medical Examiner.
10-02-06 Pneumovax 23 vaccination sq to rt arm and Influenza vaccine IM lt arm in early am. Reported flu like symptoms and swelling and warmth to rt arm symptoms started at about 12 am.
Dose 1 given 2/10/2021 Moderna Lot # 024M20A Patient was hospitalized at Medical Center from 8/4/2022-8/6/2022 for colitis, Covid +
booster; booster; Diagnosed with COVID; Diagnosed with COVID; This is a Solicited report from a Non-interventional study report from a FACILITATED COLLECT based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4086192-00). A contactable consumer (patient) reported a 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 intramuscular on an unspecified date in 2021 (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 29Jan2021 (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 05Jan2021 (Batch/Lot number was not reported), all as single dose for covid-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported) for moderate to severe rheumatoid arthritis. Medical history included moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. On unknown dates, the patient was tested positive for COVID and experienced COVID. In 2021, the patient was diagnosed with COVID after booster shot. The patient underwent lab tests and procedures which included COVID-19 test with positive in 2021 and COVID-19 test with positive on an unknown date. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The outcome of event was recovered.     The reporter's causality for the event(s) of diagnosed with COVID after booster shot with adalimumab was a reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available in narrative the reported  event of Booster, Off label use and lack of efficacy of suspected vaccine is assessed as related.
Severe fever, chills, head ache, body aches, and cough lasing about 36 hours.  Low grade fever and cough still persisting as of today, 9 February.  Saw the NP on 5 February for both symptoms.  Breathing treatments and Azithromycin prescribed by NP.  Chest x-ray taken on 8 February showing pneumonia is clearing up.
Patient reported to me on 1/14/22, that on 12/21/21, only 90 minutes after having received her pfizer covid-19 vaccination (dose 1), she began experiencing side effects, including a full body prickly sensation, which developed later (not sure of timing) into a rash, with hives and itching, in multiple body locations.  Her lymph nodes swelled, she experienced normal side effects such as arm pain, but ended up with a red ring around her arm (she says she has complete documentation and even took pictures).  She also experienced shooting pains that extended up into the back of her head.  As she no longer has a PCP, she contacted her OB/GYN office, explained the situation to them; they recommended she not get her second dose presently and make an appt with an allergist/immunologist to further test for exact allergy.  Patient is having  trouble finding an appt with such a specialist.  It is 3 weeks past her vaccine date and she still reports not feeling back to her normal self.
Face red; Little tingly in  face; Sun burn; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), via an unspecified route of administration in left arm on 17Mar2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not tested for COVID-19. The patient medical history included allergy to dye used for CAT scans. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included TheraCal D 200 supplement for an unknown indication from an unspecified date and unknown if ongoing. On 17Mar2021, after about 15 minutes of vaccination, the patient face became red and felt a little tingly and a little like a sun burn. No itchiness or hives developed anywhere on her body. After about 45 minutes she decided to take one dose of Benadryl. The clinical outcomes of face red, tingly and sunburn was recovered/ resolved.   No follow-up attempts are needed. No further information is expected.
Low grade fever (100.6); Chills; Aches; Stomach discomfort; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 16:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), clopidogrel bisulfate (PLAVIX), colecalciferol (VITAMIN D3), multivitamin (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 12:00, the patient experienced low grade fever (100.6), chills, aches, stomach discomfort and diarrhea. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 10Apr2021, the patient underwent body temperature test and the result was 100.6 (unspecified units). The clinical outcome of the events low grade fever (100.6), chills, aches, stomach discomfort and diarrhea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from an 89 year old female consumer refers to herself. The patient had acid reflux and papaya allergy (caused stomach ache). On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant therapies included PRILOSEC. It was reported that in March 2013, the patient developed a rash around her waist and tenderness on her waist after receiving ZOSTAVAX. The patient did not seek medical attention. Her doctor prescribed an anti viral medication (medication name and dosage unspecified) but the patient stated that the anti-viral was hard on her stomach. Lab diagnostics studies performed were reported as none. The patient continued to have this rash. The outcome was reported as not recovered. Additional information has been requested.
Axillary lymphadenopathy, myagias, malaise. Symptoms lasted 7 days.
Bruising, redness, feverish, left deltoid muscle tenderness on palpation, left AC joint tenderness on palpation, pain with left shoulder abduction (extremely limited range of motion).
Guardian described child having large welts with accompanying redness on legs and face with none on torso or arms. Child ran 102.9 degree fever and was taken to local ER.
Starting at 330pm day of vaccine I developed a low grade  temp of 99.6  8pm Back pain with continued temp 99.8  845pm Cold chills, body aches and temp 100.2  9/21/21  4am Body aches and temp of 100.6  8am Body aches, weakness, temp 99.5 1pm- weakness ,body aches  and fatigue  4pm- weakness
This spontaneous report as received from a pharmacist refers to a 68 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. On 28-OCT-2015 the patient was vaccinated with PNEUMOVAX 23 (strength, dose frequency were not reported) lot # K016294, with an expiry date of 28-APR-2016 intramuscularly. The reporter stated that patient received PREVNAR on 04-SEP-2015 and the patient inadvertently received dose of PNEUMOVAX 23 on 28-OCT-2015 which was too close in interval between recommended doses. The patient also received FLUZONE HD (manufacturer unspecified) in the opposite arm concomitantly with PNEUMOVAX 23. Patient did not seek any medical attention. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Brain fog; sharp muscle pain; paresthesia in arm and leg; random inflammation of joints; dermatographia. Exacerbation of past inflammatory symptoms; sharp muscle pain; paresthesia in arm and leg;; random inflammation of joints; dermatographia.; Exacerbation of pastinflammatory symptoms; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30(at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic urticaria and allergy to kidney shaped beans, latex. Concomitant medications included oral contraceptive pills (MANUFACTURER UNKNOWN), metformin hydrochloride (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN); all for unspecified indication and unknown start date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 30Mar2021, the patient experienced brain fog, sharp muscle pain, paresthesia in arm and leg, random inflammation of joints, dermatographia, exacerbation of past inflammatory symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. On 03Apr2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the event brain fog, sharp muscle pain, paresthesia in arm and leg, random inflammation of joints, dermatographia and exacerbation of past inflammatory symptoms was not recovered, at the time of this report.  No follow-up attempts are needed. No further information is expected.