chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18Jan2021 Dose 1 Lot # 026L20A Right arm,02Feb2021 Dose 2 Lot # 032L20A Right arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (18Jan2021 Dose 1 Lot # 026L20A Right arm,02Feb2021 Dose 2 Lot # 032L20A Right arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (Leukemia diagnosis goes back at least a year or two (but could not give specifics).), Hypercholesterolaemia and Blood pressure high (medicine). Concomitant products included ACALABRUTINIB (CALQUENCE) for CLL, ZINC and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (18Jan2021 Dose 1 Lot # 026L20A Right arm,02Feb2021 Dose 2 Lot # 032L20A Right arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (18Jan2021 Dose 1 Lot # 026L20A Right arm,02Feb2021 Dose 2 Lot # 032L20A Right arm) outcome was unknown.            Patient had no history of COVID. Concomitant medications included blood pressure medicine, high cholesterol medicine and Glameron. No treatment drug was reported.   This case was linked to MOD-2022-546508, MOD-2022-546680 (Patient Link).
the spot on her arm is red, hard and itchy; the spot on her arm is red, hard and itchy; the spot on her arm is red, hard and itchy; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INDURATION (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "the spot on her arm is red, hard and itchy". Additional Information: The patient just got her Pfizer shot on Wednesday and since then she had hardness like in a circle about 2 inches all around and it's red, not real red, but red enough for her. She received her first dose of the Pfizer COVID-19 vaccine on Wednesday 24Mar2021. She stated that the spot on her arm is red, hard and itchy. Her friend who is a nurse looked at the injection site and advised her that she should report this to Pfizer. The caller stated that she wanted to know if she should take the second dose due to this reaction to the first dose. She has an appointment on Tuesday with her HCP and will ask for further guidance on proceeding with the second dose and treatment for the place on her arm at the injection site if it is still bothersome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist and described the occurrence of feeling unwell in a 62-year-old male patient who received ENGERIX B adult (batch number AHBVC148AB, expiry date 6th September 2014). Co-suspect products included PNEUMOVAX VACCINE. On 27th October 2014, the patient received the 1st dose of ENGERIX B adult and PNEUMOVAX VACCINE. On 27th October 2014, an unknown time after receiving ENGERIX B adult, the patient experienced feeling unwell and expired vaccine used. On an unknown date, the outcome of the feeling unwell and expired vaccine used were unknown. It was not reported if the reporter considered the feeling unwell to be related to ENGERIX B adult.
Information has been received from a consumer concerning her 20 year old daughter with peanut allergy and other unspecified "bad allergies" and a history of Hashimoto's thyroiditis who in 2005 was vaccinated with the first dose of PNEUMOVAX 23 with no problems after vaccination. On 17-AUG-2010 at afternoon, the patient was vaccinated at left arm with the second dose of PNEUMOVAX 23 (664537/1193Y) and had an adverse event. There was no concomitant medication. On the same day evening the patient went to the local emergency room (ER) with left collarbone pain (the bottom of left collarbone), neck pain, and swollen lymph nodes. Chest X-ray performed at the ER with normal results. The patient was placed on BACTRIM and released, was not hospitalized. The patient's left arm was warm and sore. At this time of reporting, the patient's left collarbone pain (the bottom of left collarbone), neck pain and swollen lymph nodes, and left arm was sore and warm persisted. Additional information has been requested.
Information was received on 13-OCT-2016 from a pharmacist regarding a female patient. Medical history, concurrent conditions and concomitant medications were not reported. The pharmacist reported that the patient received doses of ZOSTAVAX on the following dates: 12-MAY-2015 and 11-OCT-2016. The dose of ZOSTAVAX received on 12-MAY-2015, was administered at another location, therefore the pharmacist was unable to provide the lot number and expiration date. The dose administered on 11-OCT-2016 was lot # L046899, expiration date 23-FEB-2017. No adverse experience had been reported. No additional information was provided. Additional information is not expected.
Swelling at injection site. Injection site not the deltoid muscle.  Injection site looks like on top of shoulder; injection site small round swollen area surrounded by red swollen tissue around the injection site lump; pain on scale of 0-10 "8-9".  Took 3 OTC ibuprofen (200mg each) and ice on the left arm.  Left arm stiff and unable to move the left arm.  No pain relief with vicodin.  Called local ER and advised by them to call PCP.  PCP said take two Benadryl, 2 pain pills and ice the area.  Symptoms did improve by morning on Sept 11th.  Pain now a 5-6 on scale of 0-10 and able to move the arm but limited in rom and function.  Took another toradol and went to work.  Still sore in evening of Sept 11th but better than yesterday per member.
Patient was given pediatric Hep A vaccine and it should of been Adult Hep A vaccine. Patient will need to return to office to receive Adult Hep A vaccine.
Developed pruritic red rash (not urticarial) that was symmetric on thighs and trunk.
This spontaneous report was received from a pharmacist refers to a 75 years old female patient with none drug allergies and reactions. The patient's medical history included "thyroid and blood pressure". The patient was vaccinated intramuscularly in right arm with a 0.5 ml dose of PNEUMOVAX23 (lot# reported as H010515 exp. 13-FEB-2014) on 26-SEP-2012 (it was reported that the patient did not receive the vaccine after age 65 years). Concomitant medications included: FLUVIRIN given in left arm. On 26-SEP-2012 the patient's right arm swelled that evening and traveled down the arm. The swelling was from the injection site down to the inner elbow and was warm to the touch. The patient would be following up with the physician (at the time of the report the patient had her husband visit pharmacist). No treatment was given for adverse events. The outcome of adverse events was not recovered. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. Since 01-FEB-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot# L029631 with expiration date 14-AUG-2017, lot# L027733 with expiration date 13-SEP-2017 and lot# L023387 with expiration date 22-JUN-2017 (dose and route of administration were not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
On 10/19/19, approximately 7 hours after receiving an annual flu shot, my son had a fever of 103.0. He was given 400mg of ibuprofen at 7pm. Two hours later his temperature was 103.8, at which time he took another 200mg of ibuprofen. He did not have an appetite and slept through the night. At 7am the next morning (10/20/19) his temperature was 102.4. He was exhausted and did not feel well all day. At 9pm his temperature was 100.8. He did not have any other symptoms prior to the fever or after. He missed school one day of school on 10/21/19, but returned the following day.
extreme headache and dizziness about 4 hours after the shot at around 4:00 PM. migraine continued to get worse and i was seeing spots, vertigo  and loosing balance and that lasted until 7 pm on 3/13
patient complained of severe left arm pain the evening of the vaccine administration date.  The next day, which is today, she has pain in her left arm, total body pain which she describes as "bone" pain, nausea and vomiting with inability to keep any fluids down.  It is a hot day today and there is concern for dehydration.
ER visit for fever, chills, myalgias, loss of taste, oral blisters, nausea, headache,  3/10/2022.  Seen at ER.  Sxs onset within 1 hour of vaccine.
T103 the same day as DTP given w/sz & subsequent ER visit w/Phenobarbital given & a spinal tap;
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Lot number: 030L20A), in right arm, on 13Feb2021 as dose 2, single (Lot number: 016M20A), in right arm, on 04Nov2021 as dose 3 (booster), single (Lot number: 034D21A), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: 015321A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Interchange of vaccine products "; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of  COVID-19; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment).
Numbness on the left upper extremities/face reported about 1.5 hours after vaccine administration
Approx 10 mins after receiving vaccination, the patients significant other reported that the patient was not feeling well. Pharmacist checked on the patient who reported loss of vision and a feeling of dizziness. Pharmacist contacted 911 and EMS came in to evaluate patient. Patient refused transport to the Emergency Department, reported feeling better after EMS evaluation, and left store under own power.
Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date 30th November 2023) for prophylaxis.   On 2nd December 2022, the patient received Menveo. On 2nd December 2022, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.       Additional Information: GSK receipt date: 02-DEC-2022 Reporter's comment: The reporter stated that patient received diluent of a dose of Menveo vaccine by the patient. Additional supportive information: As patient only received only the diluent part of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Swelling on the right side of my neck; Headache; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medication were not reported. 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. The patient had no known allergies to medications, food or other products. On 15Apr2021 at 12:00, the patient experienced swelling on the right side of neck, headache and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling on the right side of neck, headache and dizziness was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Pt went to hospital with abdominal distention and vomiting. Was dx with intussusception. Was taken to operating room on 8/31/2010 and they preformed a resection of the terminal ileum and right hemicolectomy for non reducible intussusception. Pt had two doses of rotavirus. One was Rotateq on 6/10/2010 the other dose on 8/10/2010.
Patient was injected with an expired vial that had passed the 12 hour mark. No side effects reported as of today.
Patient fully vaccinated with 2 dose series of Pfizer vaccine (2/5/21 and 2/26/21).  The patient was diagnosed with COVID-19 pneumonia and had a positive COVID-19 test on 9/1/21.  The patient was admitted to hospital for treatment on 9/1/21 and again on 9/14/21.
I started off with a sore throat that turned into what was like a bad cold. I was blowing my nose a lot and had a fever with fatigue. It lasted about a week. I was given Paxlovid.
Improper storage of product in use; No additional adverse event; This spontaneous case report has been received from an office manager, referring to a two child patients. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were provided.  On an unknown date the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB)  which was exposed to a cold chain breach, (strength, vaccination scheme, route and anatomical location of administration were not reported; lot # T042014 has been verified as valid lot number and expiration date established as 23-JUL-2023)  for prophylaxis.     Also pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, vaccination scheme, route and anatomical location of administration were not reported; lot # T009743 has been verified as valid lot number and expiration date reported as 13-MAR-2021, but established as 27-JAN-2022)  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, vaccination scheme, route and anatomical location of administration were not reported; lot # 1821247 has been verified as valid lot number and expiration date established as 23-JUL-2022)  for prophylaxis; were also exposed to a cold chain breach   The vaccines were exposed for 3 hours and 15 minutes and the reported maximum temperature excursion reached was 49.7 degrees Fahrenheit (ºF).  information about if a temperature excursion was called with a data logger nor previous temperature excursion was reported. No adverse event was reported.
Right eye twitches often now since the vaccine.  No eye twitches ever before this second shot.  Not sure if the muscle under the eye or above the eye is causing it, but it twitches for roughly 25% of the total day, intermittently and is very annoying and concerning.
Hives/ Migrating rash.  starting on or about 11/22/21. Itchy and red patches come and go.  Treatment has been Zyrtec and Cortizone cream as directed from virtuwell consultation on 11/29/21.
pt recvd vax 16OCT95 & w/in 48hrs p/vax exp excessive high pitched non-stop crying for 4 1/2hrs;excessive drooling,projectile clear vomit,clammy skin but no fever;reported could not find anything wrong & determined that pt scratched eye
Swelling of knuckles; Code Knuckles Pain/ Hip is hurting; Jaw hurt / Felt like she had a toothache; Fingers and knuckles became inflamed; Fingers and knuckles became swollen; Pain; Neck became sore; Knuckles again became red; This case was reported by a consumer via call center representative and described the occurrence of inflammation localized in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included unilateral renal agenesis, celiac disease and hypothyroidism.   On 28th August 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 9 days after receiving Shingrix, the patient experienced inflammation localized and swelling of fingers. On 14th September 2019, the patient experienced toothache. In September 2019, the patient experienced pain, neck pain and red hands. On 17th September 2019, the patient experienced pain in hip. On an unknown date, the patient experienced swollen joints. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the inflammation localized, toothache, pain in hip and swollen joints were unknown and the outcome of the swelling of fingers, pain, neck pain and red hands were not recovered/not resolved.   It was unknown if the reporter considered the inflammation localized, swelling of fingers, pain, neck pain, red hands, toothache, pain in hip and swollen joints to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her fingers and knuckles became inflamed and swollen.  She took Alleve for 4 days and the pain got a little better but then then her neck became sore and her knuckles again became swollen, red, and painful. she said it almost felt like she had a toothache and her hip was hurting. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. Unable to obtain additional details the reporter was difficult to follow she reported adverse events seen with her husband.   This case linked with US2019170058, reported by same reporter.
Narrative:  73 year old male with a past medical history of nonischemic HFrEF, Hx of atrial fibrillation on apixaban, HLD, HTN, GERD, Hiatal Hernia, Type II Diabetes, and Pernicious anemia presented to the ED with three days of lightheadedness, weakness, and cough. Patient received both doses of Pfizer vaccine. Patient tested positive for COVID and was admitted for COVID Pneumonia. Chest X ray showed no infiltrate with lungs mildly hypoinflated. Patient did not require any supplimental oxygen. He was given PRN albuterol, loratidine, and prn guifenesin. This morning, patient denied any weakness or lightheadedness and states his cough has improved. Patient is stable and ready for discharge. Patient was told to isolate for 7-14 days and to return to the ED if he experiences increasing shortness of breath, worsening cough, weakness or lightheadedness.
This is a spontaneous report from a contactable pharmacist. A 74-year-old male patient started to receive PREVNAR 13, via an unspecified route of administration at single dose on 18Apr2016. Medical history included diabetes, hypertension, atrial fibrillation, hyperthyroidism (AFib), hypercholesterolaemia, coronary artery bypass graft, anticonvulsant drug level (DPH), heart failure. Concomitant medications were not reported. Around 21Apr2016 or 22Apr2016, the patient experienced cutaneous vasculitis with renal involvement with outcome of unknown. The patient was hospitalized for the events from 31May2016 to 05Jun2016. The patient underwent lab tests and procedures which included Skin biopsy; SPEP; Thyroglobulin; Thyrofibrogen; UPEP; ANCA; ANA; C3 and C4; CH 50; Double stranded DNA; Rheumatoid factor (RF); Blood cultures; CRP; Sjogren antibody; Hepatitis antibody; Anti glomerular basement antibody; Basic Metabolic Panel; P-ANCA. Pharmacist mentioned that the dates of all the tests were within admission dates from 31May2016 to 05Jun2016 and all the results were negative. Reporter confirmed that a patient got hospitalized and discharged with a diagnosis of cutaneous vasculitis with renal involvement. Pharmacist mentioned that the treatment taken was steroid which was Prednisone and this was before going to the hospital. Pharmacist believes that patient experienced cutaneous vasculitis because of PREVNAR 13.
Experiencing really weird side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing really weird side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experiencing really weird side effects). At the time of the report, VACCINATION COMPLICATION (Experiencing really weird side effects) had not resolved.            No concomitant medications were provided by the reporter.  It was reported they did not really have much of a reaction to any of the others, may be patient did not felt it on the first day, but it was very different and it was the same thing for both husband and wife.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-535478 (Patient Link).
Developed numbness in arms/hands that spread within minutes to both legs. High fever, high heartrate and low oxygen levels, Couldn't talk normally (stuttering) confusion at about 10 am. Was driving at the time for work and pulled into a customers  yard and collapsed. They called 911 and I was transported to Hospital. They tested for stroke since that's what the symptoms pointed to. Performed Cat Scan, X-rays, and multiple blood and urine tests. They could find nothing that would have caused it. They concluded it was an adverse reaction to the Moderna Vaccine I received the day before. I was released and then was walking out of hospital my DR. stopped me and readmitted me because he
Hives near injection site and under arm. Advised to call PCP and to take Benadryl.
102+ fever, chills, spasms, headache, moderate malaise, lasting approximately 24 hours   Acetaminophen for discomfort and fever reduction
Pt reports to clinic after noting two satellite blister-like lesions about 1cm left of inoculation site.  Two additional red raised lesions are noted abt 2-3 inches away from inoculation site.  IHD, PCM, Derm, SMO, Imms provider were all notified.  Satellite lesions will be treated like inoculation site.  Daily monitoring at clinic to ensure lesions do not spread.