chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One of our technicians filled out the CDC vaccination record card and gave back to the patient.  Pharmacist checked pt's consent form. The consent form did not show any problem, but the pharmacist couldn't get a chance to see her CDC card.  One Immunization certified tech administered the second dose.  After the tech gave a shot, we found the second dose was administered only 14 days apart. The first dose was given on 5/15/21 and the second dose was given on 5/29/21. I called the patient to notify the error and gave information how to monitor the possible adverse effects. When I was speaking to the patient, patient did not show any adverse effect.
Patient came in for her first pediatric  covid vaccine which we gave to her.  Later it was discovered that an insufficient amount of diluent was added to the vial making the dose more concentrated than what was intended.  We contacted the manufacturer and reached out to the parent of this child to check on her well being and explain the incident.  Her mom said she was doing fine and had no adverse reactions from this vaccine.
Narrative: Patient received 1st dose of Pfizer COVID-19 vaccine on 2/27/21. His daughter later reported he developed a  rash on day 5 of hives on legs, back, chest, and right forearm. Patient contacted outside PCP who recommended applying diphenhydramine cream.
Patient developed severe left flank pain 5/7/2021. On his second trip to the emergency department for pain, May 8, he was diagnosed with left renal infarction.
6 days later - 101-102 degree degree fever for 3 days (1/1/2021-1/4/2021) followed by 3 days of migraine headache (1/5/2021-1/8/2021)
After receiving her vaccine, client stated she felt lightheaded and anxious.  Vital signs obtained by EMS  BP 177/106, HR 83, O2 sat 99%.  Client stated she feels better. Client discharged home.
swollen lymph nodes; lymph nodes were very inflammed; headache; flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th May 2019, several hours after receiving Shingrix, the patient experienced enlargement of lymph nodes and lymphadenitis. On 31st May 2019, the patient experienced headache and influenza-like symptoms. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved and the outcome of the lymphadenitis was unknown and the outcome of the headache and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, headache and influenza-like symptoms to be related to Shingrix. The reporter considered the lymphadenitis to be possibly related to Shingrix.  Additional details were provided as follows: This case was identified as duplicate of case US2019114238. All future correspondence would be added in case US2019114241, which stands as case of record for this patient and the case US2019114238 would be deleted. The pharmacist reported this case for his wife. The patient received Shingrix in her left arm, and a few hours later she had a mammogram.  The mammogram showed lymph node swelling in her right arm. One lymph node was still swollen a few weeks later.  The biopsy was negative for cancer, but the reporter said that, the provider had not seen this before. The patient experienced a headache and flu-like symptoms the next day after receiving Shingrix.  The patient took Aleve, and she felt better 12 to 14 hours later. The reporter consented to follow up. This case has been linked to the case US2019114246, reported by the same reporter. The reported batch number 92M53 was corrected to 92M54 as per sales data review.
Pt initially had soreness. Soreness went away. Then pt developed redness to upper arm approximately 5 inches in length on 11/4-11/6. 11/5-11/6 now warm to touch. Pt will be seeing MD on 11/07/17.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (past the 30-day refrigeration time) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Aug 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 13, 2021, patient administered expired product (past the 30-day refrigeration time). On Aug 13, 2021, administered expired product (past the 30-day refrigeration time) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. Date of refrigeration of the vial reported as Apr 13, 2021 and temperature changes reported to be 40-42 F. Sender's comments: This case of expired product administered in a patient (unknown age and gender) with no associated events. The patient administered Moderna COVID-19 vaccine (past the 30-day refrigeration time). The re-challenge not applicable. The causality for the event expired product administered will be considered not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 vaccine not affected by this report.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast). Subsequently, post vaccination, the patient was nauseous all day. The outcome of the patient was not reported. Unspecified medical attention was sought. No further information is available.
a fever of 101.4; headache; fatigue; severe body aches; chills; nausea; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old female patient received the second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration in left arm on 17Jan2021 15:00 at single dose for covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis. Concomitant medication included dexamfetamine (DEXTROAMPHETAMINE), cetirizine, and unspecified prenatal multivitam. The patient previously received the first dose of bnt162b2 (lot number: Eh9899), via an unspecified route of administration in left arm on 30Dec2020 10:00 at single dose for covid-19 immunization. Starting 12 hours after 2nd vaccination (18Jan2021 03:00) patient developed severe body aches, chills, nausea. Within 18 hours after vaccination (18Jan2021 09:00) patient had also developed a fever of 101.4, headache, and fatigue. No treatment and pregnant. The outcome of the events was Recovering.
Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site. The patient was hypertensive (175/97) with a FSBG of 152 mg/dl. EKG demonstrated NSR, rate 86bpm, no ST elevation. EMS transported the patient toEmergency Department for further evaluation. In the ED, the patient reported dizziness, lightheadedness, near-syncope, aching headache, generalized fatigue, and weakness. Physician administered 25mg PO Meclizine. Upon reevaluation, the patient reported improvement and was discharged with diagnoses of Vaccine reaction and Dizziness.
Facial flushing, redness and warmth developed 10 mins after injection. Administered Benadryl 50mg. PO. Symptoms improved within 20 minutes after Benadryl administration.
severe fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Lot number and batch number not provided.), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number and batch number not provided.), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "severe fatigue".  Additional information: Caller reported that she just got her booster of the Biontech Pfizer Covid 19 Vaccine and was actually in one of the Pfizer trials on 2020. She was just wondering if she had come up with any other tips for major side effects. In the trial, it only came after the second shot. With the booster, it had come each time. She had severe fatigue the next day after the shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316840 Same patient, different dose/event;
From 4/24-30/12, had change in personality. Nothing life threatening usually - vigorous, talkative, excited, energetic child. During the affected period, he was quiet, not sociable, loss of energy, diminished appetite. Suddenly back to normal on 4/30 and still as usual as of 5/4/12.
pt carried into office unresponsive & hypotonic;it took several min to elicit a response (eye opening) w/sternal rib;pt was diaphoretic prior to arrival @ office;once aroused it was diff to keep pt alert-blow by )2 was provided until
SEVERE MUSCLE ACHES AND PAINS NEAR INJECTION SITE. UNABLE TO MOVE ARM UP. LIMITED RANGE OF MOTION. PT SEEN BY ER AND RECIEVED TYLENOL #3 TO HELP WITH PAIN.
Patient reports soreness in arm, limited range of motion in shoulder when lifting arm, soreness in arm when sleeping at night x 1 week without improvement. Instructed pt to follow up with PCP for symptom treatment if it is very bothersome, continue to monitor and report if no improvement.
joint pain/back pain;achiness;fever x 3 days;vomiting 1wk later;fatigue & insomnia;
Vomiting, Fever greater than 101, joint and muscle pain, unable to walk down stairs,
pt recv vax 22SEP98 & 28SEP98 pt noted joint pains (digits & wrists & feet);next day noted sore throat, fatigue;
Swollen tonsils; Swollen armpits and groin; Feeling puffiness, without anaphylaxis; Swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (Swollen tonsils), SWELLING (Swollen armpits and groin), SKIN SWELLING (Feeling puffiness, without anaphylaxis) and LYMPHADENOPATHY (Swollen lymph node) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM for Anxiety, TESTOSTERONE for Hormone therapy, MECLIZINE HCL for Vertigo, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced TONSILLAR HYPERTROPHY (Swollen tonsils), SWELLING (Swollen armpits and groin), SKIN SWELLING (Feeling puffiness, without anaphylaxis) and LYMPHADENOPATHY (Swollen lymph node). At the time of the report, TONSILLAR HYPERTROPHY (Swollen tonsils), SWELLING (Swollen armpits and groin), SKIN SWELLING (Feeling puffiness, without anaphylaxis) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.   This case was linked to MOD21-066409 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received: No significant information was received.; Sender's Comments:  MOD21-066409:
Fever 103 degrees, rash on trunk and face- lasted at least 4 days. Treated with acetaminophen and ibuprofen.
I woke up this morning with a low grade fever 99.3 and I have been just not quite feeling as well as I had then; I woke up this morning with a low grade fever 99.3 and I have been just not quite feeling as well as I had then; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 2, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1, Single for Covid-19 immunization. On an unspecified date the patient woke up this morning with a low-grade fever 99.3 and had been just not quite feeling as well as the patient had then. The patient underwent lab tests and procedures which included body temperature: 99.3 (units unspecified) on an unknown date. The outcome of event was unknown.
Irritation in my throat, getting hard to swollen, muscles in my throat felt tight. Which lead me to visit the doctor. Diagnosed with inflammation in the throat. Prescribed over the counter medication.
Fainting about 2-3 minutes after shot was administered.  Could have been anxiety.  He has never fainted from just a shot but has when he has had blood drawn.
anaphylaxis, shortness of breath, stridor given benadryl, duoneb by ems ed visit pending completion of treatment
Hospitalization for left brain mass (incidental COVID) on dates 4/10/2023- 4/19/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Started getting dry mouth/sore throat  later that eve.(6:00 pm) took lozenge, later that eve had runny nose and cough. I broke out basically with a cold and has lasted up to this date (May 1,2021) . It is, however, going away
My first Phizer In my left arm lot FA7484 3 days after I was at my desk and got dizzy like i stepped off a carnival ride, a couple different times for about 40 seconds each time,  the lymph gland in my right side neck swelled big and soft between my collar bone and neck, and I got a fingertip size rash on my right shoulder, that Is over three weeks trying to heal it to go away. , this second dose Lot FC3184  Left arm,  so far I was at my desk today 3rd day since the vaccine, and got a worse dizzy feeling like I stepped off a carnival ride for about a minute, i thought i was going to pass out or faint.
Migraine headache, followed by N/V/D, 23 Mar was seen for 2 wk hx of: hand tremors, fluctuation in heart rate, malaise, fatigue, poor appetite, diarrhea, body aches fever, and non healing SPV site. Required hospital admission. On 5 Apr SPV site was healing, being followed by Neurology for Intractable headache. Attempted to contact pt. To date no response.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated he felt light headed.  We were able to have him lie down with feet elevated and stated that doing that made him feel much better.  Had him lie down for a total of 30 minutes after injection.  Was stable, did not want EMS called and was able to walk with him out of the store.  I also followed up with him 30 minutes later and he stated he was feeling fine and laying down at home.
This spontaneous report as received from a pharmacy technician refers to a 5 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
I broke out in a severe rash 4 weeks after vaccine #3 (Pfizer), went to ER per transplant team and was successfuly treated with 50mg of prednisone for 5 days (prior two vaccines were Moderna - both uneventful); then I tested positive for Covid19 on 1/1/22,  had a monoclonal antibodies infusion on 1/2/22 and broker out into a much worse full-body rash, was successfully treated with 50 mg prednisone for 5 days but after waiting about 2 days to get an order; and on 3.25.22 I received my 4th vaccine (Moderna) at a sponsored clinic and 24 hours later I broke out into a full body rash again, not as bad as after the infusion, contacted the team at Facility and was given a prescription for 5 days of 50 mg of prednisone - all good after 3 doses and now all 5 are done.
inadvertently administered Bexsero instead of Menactra; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a female patient who received Men B NVS (Bexsero) (batch number ABxb58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that a patient was inadvertently administered Bexsero instead of Menactra, which led to wrong vaccine administered. The reporter did not consent to follow-up.
Febrile Seizure approximately 10.5 hours after vaccination.  1/22/07 Received medical records from reporter which reveal patient seen 1/18 for flu shot & was well at that time.  Seen again on 1/19 s/p ER visit for febrile seizure.  Exam at that time found bulging red bilateral TMs.  Treated w/antibiotics. 1/26/07 Received medical records from hospital which reveal patient experienced an apneic spell with cyanosis, congestion & seizure activity at home.  On exam, right ear TM reddened. Given 1 dose of antibiotic.  No further seizure activity in ER & was d/c to f/u w/PCP next day.   FINAL DX: Febrile seizure.
Alopecia Areata, 2 spots on head; Thinning eyebrow; Was breastfeeding when I received the vaccine; Was breastfeeding when I received the vaccine; This is a spontaneous report received from a contactable consumer (patient). This consumer (patient) reported information for both mother and baby. This is the maternal case. This 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, allergies, or concomitant medications. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. On 25Apr2021 at 09:00 the patient experienced alopecia areata 2 spots on her head, and thinning eyebrow. The patient reported she was breastfeeding when she received the vaccine, then stopped breastfeeding "cold turkey" three days after receiving the vaccine. The events resulted in a physician office visit, and the patient was treated with a steroid injection. The clinical outcomes of alopecia areata 2 spots on head and thinning eyebrow were not recovered. The clinical outcomes of was breastfeeding when she received the vaccine were unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021487595 baby case
could not lift or move arm; Shoulder was hurting from the injection site; This is a spontaneous report from a contactable consumer reported for herself. A 35-year-old female patient received first dose of bnt162b2 (report as PFIZER COVID-19 VACCINE, Lot number: E11284, Vaccine location: Left arm), via an unspecified route of administration on 08Jan2021 11:30 AM  at single dose for COVID-19 immunization.  The patient did not have allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination.  The patient medical history was not reported.  Concomitant medication included methylphenidate hydrochloride (CONCERTA) from an unspecified date to an unspecified date, influenza vaccine (FLU SHOT) on 18Dec2020 for immunization. The patient reported Friday evening (08Jan2021 06:00 PM) her shoulder was hurting from the injection site. When she woke up Saturday 09Jan2021, she could not lift or move her arm. This followed into Monday. It was now 25Jan2021 and she was still not able to life her arm all the way and she still had a constant pain in her shoulder. It was unknown if patient received treatment for the events. These events did not result in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, was not congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient did not have been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Facility. The outcome of the events was not resolved.
The pt experienced a fever of 103.6 for 7 days. A seizure was experienced on the 6th day post vax. The pt was non-responsive for 5 minutes, very tired and inactive for 24 hours afterwards.
This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that, a female patient of an unspecified age received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection), Dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her 1st dose on 23Feb2021, and 2nd dose will be on 17Mar2021 that was more than the usual 21 days interval. The patient also said that her niece visited her and tested positive for COVID-19. The patient experienced caller also said that her niece visited her and tested positive for covid on an unspecified date. Outcome of the event was unknown. Information about batch/lot number has been requested.
Pain at injection site for 3 days. Swelling, pain and itchy on rear right thigh which lasted for 6 days.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 19-year-old patient who received BEXSERO. On 19th JULY 2016, the patient received BEXSERO .5ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm was  unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the swelling arm and pain in arm to be related to BEXSERO. Additional details were provided as follows: The patient experienced significant arm swelling and her arm hurt for one whole week. Vaccine expiration date and lot number was not known.