chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and lymph node swelling in armpit and upper arm on injection side; Pain and lymph node swelling in armpit and upper arm on injection side; Pain and lymph node swelling in armpit and upper arm on injection side; dose_number=3; dose_number=3; This is a spontaneous report from a  contactable other HCP. This 61-year-old female other HCP reported for herself that: A 61-years-old female (non-pregnant) patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FF2589), dose 3 via an unspecified route of administration, administered in Arm Left on 02Oct2021 13:45 (61-year-old at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included connective tissue disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported;  TURMERIC taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2, (BNT162B2, solution for injection, Batch/Lot Number: EL0142), dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 03:00 PM (61-year-old at the time of vaccination) as DOSE 1 for covid-19 immunisation and bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9265), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 01:00 PM (61-year-old at the time of vaccination) as DOSE 2 for covid-19 immunisation, tetanus antitoxin and experienced hypersensitivity. The historical vaccine included Flulaval quad (Lot Number: NDC-19515-0818-52) via an unspecified route of administration, administered in Arm Right on 25Sep2021.The patient experienced pain and lymph node swelling in armpit and upper arm on injection side on 03Oct2021 07:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Sep2021 Nasal Swab. The outcome of all event was not recovered.  Follow-up (15Oct2021): Follow-up attempts are completed. No further information is expected.
Patient reports waking up around 5AM feeling very warm, and reports malaise, reports temperature the day after 101.3F, fever resolved later that day. Reports she slept the entire day. Patient also complains of soreness at injection site after administration. Symptoms resolved without medication.
Had Varivax immunization 3/15/04 mom saw single pustle behind right ear on 3/26/04 by the time he entered the office there were pustles on right knee. Left arm where Varivax given was red and swollen.
This spontaneous report as received from a pharmacist refers to a female patient of about 64 years of age. Concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced aplastic anaemia (medically significant). The patient sought medical attention from physician (unspecified). The outcome of aplastic anaemia was reported as not recovered. Causality assessment was not reported. No further information was reported. Upon internal review the event aplastic anaemia was considered as medically significant. Additional information has been requested.
Developed itching on arms, legs, chest, about 30 minutes after vaccine. Pt developed intermittent chest tightness around 1 1/2 hours after vaccine. Treated with Benadryl. After discharge from clinic on 8/23/01, he presented to ER later that evening for continuation of symptoms. Treated  with Vistaril and Famotidine for 3 days. Re-evaluation in clinic on 8/27/01, still with itching and intermittent chest tightness, complaining of muscle spasms and feeling jittery. Vistaril dc and started on Benadryl, Famotidine continued. Re-evaluation on 8//28/01 improved.
Began to feel very cold on Friday 3/3/22, 12 hrs after vaccine booster.  Friday evening I went to bed and woke up shivering and teeth chattering.  My husband covered me with 4 blankets and I continued to shiver and teeth chattering for another 30 minutes. The next morning I  was achy all over and spent the day in bed.   The next day (Sunday)  I felt better, just very sore from shivering.
Patient went to the ER 2 months after vaccine was administered.  Presented with 1 month of increasing pain in her left shoulder. She had an XR of left shoulder and no acute bony abnormality. US impression no significant effusion. Patient had MRI and no acute findings to directly explain the patients symptoms. She had an appointment with PCP 1/19/23 and prednisone injections were offered. She then followed up for injection on 2/1/23 and kenalog injection was administered.
Patient seen on 21 March 2008 for laceration to finger.  Tdap was ordered by provider and administered on same day as visit.  Was placed on Keflex for laceration.  Patient discovered area at injection site red and swollen on 23 March 2008.  Today 27 March 2008, patient presented to clinic with large erythematous area measuring approximately 20 cm in diameter.  Was warm to touch and patient states very itchy.  Sent patient up to Occupational Health Clinic to be seen by provider for reaction.
5/22/21 day of shot customer reports she came home and took nap after got home from shot appointment woke up around 8:00pm with headache.   Took BC pill to relieve headache.  Headache resolved 24 hours later.  5/24/21 developed lightheadness and dizziness along with right side arm tingling all way down entire into hand.  Right side of arm  is tingling and continues today 5/26/2021 day of report.  Lightheadness and dizziness went away 5/25/21 sometime, tingling with "cannot lay down on my right side of body" reported .  Also same day  5/26/2021 customer reports under armpit above right breast a dull throbbing pain "feels like a boil inside under my arm "
Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other HCP (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant. Patient received the first dose on 17Dec2020 05:45 PM also at right arm for covid-19 immunization. Lot number was also EJ1685. The facility type vaccine was hospital. Medical history included Celiac. Concomitant medication included pregabalin (LYRICA), celecoxib (CELEBREX), escitalopram oxalate (LEXAPRO), spironolactone. Known allergies: Penicillin, morphine, lactated ringers. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient experienced Sore arm, headaches at 05Jan2021 06:00 PM with outcome of recovered in Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.  No follow up attempts are possible. No further information is expected.
11 wk old pt exp stridor, especially inspiratory w/fever & sl cough following vax;
Received vaccine (L) deltoid. (L) arm swollen the next day - presumed local reaction. Day 2, a (L) axillary deep vein thrombosis was identified on ultrasound. Started on LOVENOX & COUMADIN in the ER.
Covid confirmed on Oct 20 with home test.  Congestion impacted hearing severely and tympanic membrane was retracted severely
Pt recvd DTP/HBCV 16JUL @ 10AM; given APAP @ home @ 1130AM approx 2 hrs later pt awoke w/crying, wheezing, coughing, & swollen eyes; no fever; On exam in ER, had diffuse wheezing & upper lid edema; Pt given 6.25mg of DPH po;
patient got in line to discuss booster with the provider and was signed off for a Moderna booster when he was age to receive the pfizer booster. Follow up with family 4 days after the vaccine and no ill effects or reaction to the vaccine.
Patient called day after reporting around 12pm she has over a 104 degree temperature and experiencing flu-like symptoms: fever, body chills, achiness and a feeling of being unwell. I asked her to contact her prescriber and to visit urgent care due to her temperature being elevated at 104. Followed up with patient around 4pm and fever went down to 99. She contacted prescriber who recommended monitoring and take OTC pain meds.
Chest tightness that started about 10 days after first dose. Lasted 4 days.  Same symptoms started two days after the second dose.  I have no cardiac history. Husband ( healthy marathon runner) also experienced chest tightness after the first dose but not his second dose. My father, who is 80 is also experiencing chest tightness after his first dose. He is scheduled for a stress test because he does have a cardiac history. I am a physician.
Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles many years ago. The patient also got the shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. No further information would be available.
30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022; No adverse event; Received Expired Monovalent booster after 30-day Use By Date; Received Monovalent booster from a Pediatric Vial (6Y-11Y) instead of Bivalent Booster by mistake; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent booster from a Pediatric Vial (6Y-11Y) instead of Bivalent Booster by mistake), PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date) and WRONG PRODUCT ADMINISTERED (Received Monovalent booster from a Pediatric Vial (6Y-11Y) instead of Bivalent Booster by mistake). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent booster from a Pediatric Vial (6Y-11Y) instead of Bivalent Booster by mistake), PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent booster from a Pediatric Vial (6Y-11Y) instead of Bivalent Booster by mistake) and PRODUCT STORAGE ERROR (30 day beyond use date of vial was 30-SEP-2022 and was administered on 13-Oct-2022).    Concomitant drugs were not reported.  It was reported that  the monovalent 6 years to 11 years individual vial of size 2.5 mL was unknown when initially stored in refrigerator but 30 day beyond use date was 30-Sep-2022. The patient was supposed to receive Bivalent vaccine. The vial did not undergo any temperature excursion. Treatment medications were not provided. This case considered of 2nd adult patient of the 3 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-659441, US-MODERNATX, INC.-MOD-2022-659434 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659441:Same reporter US-MODERNATX, INC.-MOD-2022-659434:Same reporter
Pfizer had shipped extremely short dated vaccine without the pharmacies knowledge. Vaccine was received 8/22/22 and initially assigned a BUD of 10/31/22. On 10/10/22 Pfizer informed pharmacy that product with a manufactured date of 10/2021 expired 9/30/22 instead of 10/31/22. Thus patient received an expired vaccine on 10/4/22. Patient had no adverse effects and we are waiting on guidance on Pfizer regarding future doses.
I had Runny nose,  itchy throat, head Ache,  Stuffy Nose, Achy Body and fatigue.
Woke up with a horrible vertigo; Woke up with a horrible headache; Slept most of the day; Had sore arm; A spontaneous report was received from a healthcare professional concerning a 66-year old, female patient who received Moderna's COVID-19 vaccine and experienced sore arm, horrible headache, horrible vertigo and slept most of the day.    The patient's medical history included Lyme disease. Concomitant medications included Carvedilol, Escitalopram and Hydrochlorothiazide.  On 31 Dec 20, Thursday, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 21, Friday, the patient experienced had a sore arm which had resolved by the time of report. On 02 Jan 21, Saturday, the patient reported woke up with a horrible headache and slept most of the day. On 03 Jan 21, she woke up with horrible vertigo.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event sore arm was considered resolved. The outcome of event vertigo was considered not resolved. The outcome of the events, headache and slept most of the day was not reported.; Reporter's Comments: This case concerns a 66-year-old female with medical history of Lyme disease who had NS unexpected events of somnolence, vertigo, pain in extremity and NS expected event of headache.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Vertigo ongoing, sore arm resolved, but other outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient has had swelling in bilateral legs since shortly after receiving the shot. Also has had numbness and tingling to bilateral arms. Today has swelling to left arm (injection arm). Pt normally has no health issues
Vertigo (Severe Dizziness & Nausea for the better part of 8 days)   started 2/06/2021 at 11:00 am
After receiving vaccine pt became dizzy, had nausea, became pale, & had tunnel vision. Pt also became diaphoretic. Vitals were checked, pt was laid down & was given juice. After 20 minutes vitals were stable, she was able to walk @ the room with no dizziness & vision had returned to normal.
ED visit for contusion of the right knee - treated and released. Hospitalized for acute on chronic anemia, hemoglobin was down to 5.9. I advised her to go to the Emergency Room. She had to be there quite a while before a bed became available, but she was admitted to the floor. She underwent a total of 4 units over 48 hours. Hemoglobin went from 5.0 to 9.1. ED visits and hospital admission within 6 weeks of receiving the COVID-19 vaccine.
tested positive for COVID; This is a spontaneous report from a contactable consumer (patients daughter). A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EM9809, expiry date: unknown), via an unspecified route of administration on 21Feb2021 (at the age of 93-year-old) as single dose for covid-19 immunization.  Patient had no medical history. Concomitant medications included apixaban (ELIQUIS) 2.5 mg twice daily orally (she had years ago pacemaker put in doctor wanted precautionary taking for years) and metoprolol at a dose of 25 mg, twice daily orally (not blood pressure, a long time could not figure over 10 years). On 24Feb2021, patient was tested positive for COVID. The doctor sent her as soon as she tested positive for the antibody infusion. Reporter stated that the patients next dose was supposed to be 14Mar2021 but patient had the antibody infusion and the doctor said to wait 90 days, 90 days would bring her up to the 24May2021 and she has a physical before then and they will check her antibodies but she wondered if they will have to do the whole thing over since it is way past 2 weeks, if they have to start the series over or since she got the infusion if she doesn't have to. She says no one seems to know and thought if her mother had not gotten the infusion, she would have been put in the hospital. Her primary doctor told her to get it. She takes a blood thinner which they told them about that, and she waited longer after the first shot just in case. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse via a company representative refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX. Dose, route, frequency, lot number and expiration date not reported. No co-suspect and concomitant therapies were reported.  The nurse reported that unspecified number of patients experienced redness and itching after receiving ZOSTAVAX. The outcome of redness and itching after receiving ZOSTAVAX was unknown. Additional information is not expected. (Not allowed to contact physician).
Diagnosed in August of 2012 with premature ovarian failure and early menopause, recurrent miscarriages and infertility major hairloss. NO FAMILY HISTORY. 6 miscarriages between 2009-2014.
pt recv vax 3SEP96 & next day irritable & crying 5SEP96 uncontrolled crying;this cont 6SEP96 & pt seen 7SEP96 no fever PE red dull lt ear drum not severe throat nl some neck stiffness;
Pfizer-BioNTech COVID-19 Vaccine EUA Chills, joint pain, swollen lymph node, fever, muscle pain, nausea, injection site pain, tiredness, skin hypersensitive to touch and fabric and achy.  Joint pain and muscle pain started within 5 hours.  Most other symptoms came on about 20 hours post injection, around 11:30 am.  Rested, drank liquids.  Took 1 Advil at 3 pm.  By 6 pm symptoms were gone - tiredness lingered.
Terrible cramps in all the left side of her body/After go to left side of her head, to her left calf and the left foot. And continued moving from left to right; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Terrible cramps in all the left side of her body/After go to left side of her head, to her left calf and the left foot. And continued moving from left to right) and PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Mar-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Mar-2021 at 2:30 PM, the patient experienced MUSCLE SPASMS (Terrible cramps in all the left side of her body/After go to left side of her head, to her left calf and the left foot. And continued moving from left to right). At the time of the report, MUSCLE SPASMS (Terrible cramps in all the left side of her body/After go to left side of her head, to her left calf and the left foot. And continued moving from left to right) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
1995 or 1996 Pt recv 2 doses varicella. Initial antibody tests revealed positive seroconversion (date unknown). 08Dec97 & 12Dec97 lab eval failed to show detectable antibodies.
vasovagal episode lasting 5-10 seconds with patient falling to floor and hit head of floor.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 24th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given to patient. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-703461 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-703461:Master case
Rapid heartbeat, difficulty breathing, extreme chills, body shaking uncontrollably (seizure like).
Three minutes after getting her vaccination, she started developing itching and rash on her right upper arm. On eval, her lungs were clear to auscultation bilaterally.
Shingles, characterized by right-sided lesions near the eye and on forehead and underneath hair. Treated with antivirals and antibiotics, and lesions slowly remitted. Symptoms were pain and vertigo, the latter lasting about one week, and the pain persisting for about three weeks, slowly tapering.
Booster. Pfizer.   Chest pain for 1.5 hours, went up to right ear and into back. It was horrible. I could not talk.