chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a non-clinical-study program Pfizer.com Contact US Clinical Research from a contactable consumer, a contactable nurse and a contactable physician. A male patient (birth weight: 7 lbs 2 ounces) of an unspecified ethnicity, received a single dose of PREVNAR 13 IM, lot H47688, expiration date 31May2015 on 02Aug2014 at 2-month-old of age, and lot H866652, expiration date 31Dec2015 on 08Oct2014 at 2-month-old, but for immunization. The patient also received PEDIARIX (Batch/Lot # 54GM4, Expiration Date 30Aug2016) intramuscular in the right thigh, HIB vaccine (HIB, Batch/Lot # U7153AA, Expiration Date 20Mar2015) intramuscular in the left thigh, ROTARTIX (Batch/Lot # A41FB429A, Expiration Date 10Sep2015) oral, all on 02Aug2014 10:39 at 2 months of age for immunization. Medical history included ongoing severe milk soy protein intolerance (MSPI) since an unspecified date. Concomitant medications included PREVACID 2.5ml BID on 03Aug2014 and ongoing for reflux. Vaccination history included Hepatitis B at birth for immunization, purchased with private funds and administered by a nurse at the private doctor's office/hospital. Serotype not provided. On an unspecified date, the patient experienced severe MSPI. The clinical outcome of MSPI was not reported. Per the reporter, the patient was doing well until after his two month shots and believes that the soy from the PREVNAR 13 played a part. The patient experienced severe fussiness on 03Aug2014 recovered on 08Aug2014 and fussiness occurred on re-administration at 4 month vaccines on 08Oct2014. The patient recovered on 09Oct2014, without requiring treatment. The event fussiness did not resulted in an emergency room or doctor visit. The reported considered there was not a reasonable possibility that the event fussiness was related to the suspect product. The patient provided information to the reporter regarding the reported adverse event with the use of the product. The reporter could confirm the occurrence of the events reported by the patient. The reporter was willing to be contacted again by Pfizer for follow-up information on the reported adverse event. Follow-up (09Sep2014): New information reported from a contactable consumer includes: suspect product data (PREVNAR 7 vaccine); lot H47688 and expiration date 31 May2015). Follow-up (21Oct2014): New information reported from a contactable nurse includes on behalf of a physician in response to HCP letter: patient age and birth weight: suspect was PREVNAR 13 (not PREVNAR 7, data provided); suspects added; events added (fussiness); concomitant medications; vaccination history; reporter informed by patient about the event; reporter confirmed the events reported by the patient; reporter confirmed further contactability. Follow-up (10Nov2014): New information obtained from a contactable physician includes: confirmation of the reported events, details of vaccines. Follow-up attempts completed. No further information expected.
Pt recv vax on 1/4/99; on 1/7/99 pt exp fever (102-103), fussy, sleeping more than usual
03/06/2023 I had mild cold symptoms, I took a home COVID-19 test and it was positive. I reached out to urgent care and was prescribed a course of PAXLOVID. On 03/18/2023 I had a rebound case of COVID-19 these symptoms were much worst than the first time that I had COVID-19. I had a fever, body aches, headache, runny nose and tooth pain this lasted for about 12 hours and tested negative on 03/22/2023.
redness (gone as of yesterday), 1 lymph node swollen at right clavicle, discomfort in right lower back;  symptoms resolved 1/14/21 as of report.
Patient reports being 6 weeks pregnant (estimated Due 12/27/21) at time of vaccination.  She has been previously been pregnant 3 times with no prior miscarriages or complications.  Patient reports finding out about miscarriage on 5/22 during office visit and completed miscarriage on 5/25.   Patient experienced mild fever and chills approximately 6 hours after vaccine which was controlled by acetaminophen and resolved by the following morning 5/4.
Pt presented to phcy on 11/08/18 and asked if it was normal to have bruising following SHINGRIX immunization. Pt had rec'd 1st SHINGRIX injxn on 04/30/18 without any SE's. Today pt reports bruising at injxn site following 11/05/18 immunization. Pt stated there was very little blood on her Band-Aid following shot, but her L deltoid started bruising & swelling following injxn.  Assessed arm on 11/08 and there was residual bruising (yellow and purple), some tenderness on palpation, no palpable bruise under the skin, no swelling present 11/08/18. The residual bruising was approx 3.5 inches from the acromion process & est'd to be less than 2 x 2 inches in length x width. Pt asked about additional sxs, and denied recalling any sxs other than bruising and swelling. Pt states she would not have mentioned the bruise if she had not come in for refills today & did not see her PCM for side-effects. Pt asked the following: any decreased range of motion? Pt denied. Any decreased grip strength? Pt denied any changes in arm mobility or feeling.
No symptoms; improperly stored vaccine administered; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) of lot # S009562, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019 for prophylaxis (strength, dose, route of administration and anatomical location was unknown) (product storage error). No symptoms reported (no adverse event). The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of 48 Fahrenheit (F) for a time frame of 30 minutes. There was previous temperature excursion reported as 50.4 F for 30 minutes and 47.3F for 30 minutes. Data logger was involved. No product quality complaint (PQC) was associated with this report.
after 1st shot on 4/27/21 , low grade fever 99 and aches. and lethargy which lasted 2 days. After the 2nd shot on May 18, became pretty ill with higher fever and racing heart and was unable to eat which lasted two days.   okay after that.   Today, 8/10/21, i felt a swelling on my arm where injection site was and it is painful and feels like a lump  under there.
slept 12+ hrs afternoon through noc p/vax; fever next morning 103, APAP given by mom;p/lunch temp 104, sleepy;mom contacted MD;adm to hosp MN 24JAN-28JAN; pt having inc fever & was started on ATB as reported by grandma;
Swollen tongue; Tingling tongue; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), PARAESTHESIA ORAL (Tingling tongue) and VACCINATION SITE PAIN (Pain in the arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue), PARAESTHESIA ORAL (Tingling tongue) and VACCINATION SITE PAIN (Pain in the arm). At the time of the report, SWOLLEN TONGUE (Swollen tongue), PARAESTHESIA ORAL (Tingling tongue) and VACCINATION SITE PAIN (Pain in the arm) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
On 1/25/21, 7 days after receiving first shot, developed rash at injection site.  Hot, itchy, welt like, size a little larger than an egg.  This lasted approx 3 days before slowly resolving. Treated with a hydrocortisone ointment.  Developed erythema nodosum on right calf at same time, and another on the front of left shin early February 2021.
No chief complaint on file.   Patient is a 25 y.o. female who had no chief complaint listed for this encounter.       History of Present Illness   Patient is at the Covid vaccination clinic  Received her vaccination and approx 5 min following administration notified staff that she was feeling a little lightheaded Was also c/o feeling hot at time Patient admits that she did not have breakfast this AM and has not had anything to drink Denies throat discomfort or tingling No shortness of breath or headaches Patient brought to the bay for evaluation       History Review / Additional history   Review of Systems   Patient's medications, allergies, past medical, surgical, social and family histories were reviewed and updated as appropriate.   Objective   Blood pressure 126/74, pulse 88, SpO2 98 %, not currently breastfeeding. Physical Exam HENT:     Head: Normocephalic.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal.  Musculoskeletal: Normal range of motion.  Skin:    Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.          Assessment / Plan   VSS on arrival to evaluation bay Following laying down for 10 min, drinking water, and eating a granola bar patient reports feeling much better.  Sat at the bedside for an additional 5 min with no recurrence of symptoms.  Repeat VSS Instructions given to go to the ED if worsening symptoms, lightheaded, throat swelling or shortness of breath. Encouraged to eat and drink prior to next immunization.   Per Attending APRN Electronic Signature 12/18/2020 10:10 AM
vaccine was administered to 1 patient past the 30-day refrigeration date; Product storage error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 1 patient past the 30-day refrigeration date) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 1 patient past the 30-day refrigeration date) and PRODUCT STORAGE ERROR (Product storage error). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 1 patient past the 30-day refrigeration date) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
reports dizziness on 14FEB;unable to get out of bed;has not felt well since this time & cont to exp intermittent dizziness;
An hour after my shot my arm started feeling very sore and was tender to touch or move.  At 3am the next day I woke up with terrible body chills and I was achy and my head started hurting. I felt like I was getting the flu except I didn?t have a sore throat, or swollen glands. Took my temperature at 7am and it was 101.  At 4:30 I went to Urgent Care and my temperature was at 102.  I tested negative for the flu.  A day later I am still a little achy, and my arm is still tender and swollen through the bicep.  No fever.
Mild chills, Headache, Diaphoresis, Swelling/ Pain to left arm, Fatigue, Muscle Aches
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (reporting for herself) reported that a 74-year-old female patient of an unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu shot for immunization about a month ago. On an unspecified date, the patient experienced sore right arm and right shoulder. Patient reported having flu shot a month ago and do not think it to be abnormal as she did not have any problems with that. Patient also reported she was supposed to have surgery on the 31st but her doctor went on vacation and it has been rescheduled for November the 17th for the right hand as she have severe damage to it. No follow-up attempts are possible. No further information is expected. Pfizer is Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has submitted the same report to the regulatory authorities.
Hives on all parts of body on and off for three days. Treated with Diphenhydramine.
Immediately following vax, the pt experienced burning in the left arm that lasted 2-3 weeks. The pt also experienced erythema and nodule, transient flu like symptoms on day 2 and 3. The pt experienced 3 episodes lasting seconds in duration with the inability to understand speech. No LOC and was aware of surroundings.
the patient received improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) lot # S007075, expiration date: 06-SEP-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose experienced the temperature excursions of 32.5 degrees Fahrenheit (F) for 8 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred.
Passed out @ 445 on 1JUL92-ran temp 100-migraine h/a x 48 hrs;
Patient reports about 2 weeks after getting Pfizer COVID vaccine, she started experiencing severe hypoglycemia in the 60s. She was previously on Tresiba 100 units once daily and Novolog 25 units three times daily with meals. She needed to decrease her insulin doses to Tresiba 30 units once daily and Novolog 10 units three times daily with meals and her blood sugars still remained on the low end of normal. She did not have a reaction to the vaccine (i.e. loss of appetite) and no other precipitating factor that would explain such a significant reduction in insulin requirements.
Day 1 - numb after injection at site. Day 2 - sore to touch/blotchy skin rash approxmiately 2 cm around site. Day 3/4 - diarrhea, fever 99.7 degrees F, flushing. Day 5/6 - swollen hands/feet/some joints, headache.
In February 2021 after my second dose, I experienced hives which went away in a few weeks. Then following weeks later, I also started to experience gastrointestinal problems, bloating, gas, which got worse the next few weeks. I also had diarrhea and terrible stomach pain. On 05-17-21 I went to ER due to the stomach pain, and a CT scan of the pelvis was performed. The CT scan of the pelvis did not show any problem that would account for my stomach pain. I then saw a gastroenterologist the following week, where they did an endoscopy, a colonoscopy and they also took biopsies and found nothing wrong but my symptoms continued and I started losing weight rapidly. I was under 120 pounds. One month ago, they put me on Omeprazole medication and within 10 days seem to settle my stomach issues. I have to continue to take the Omeprazole medication for two more months.  I do not have any more stomach pain today. My doctor could not come up with a diagnosis in relation to my symptoms. I was ill for 5 months and it was frightening.
Nausea vomiting.  Several episodes of emesis over 30-45 minutes.  Spontaneously resolved.
Information has been received from a registered nurse concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a 0.5 ml dose of (Merck) VARIVAX subcutaneously (lot # J012210, expiration date 28-SEP-2015), which was post supported excursion (incorrect product storage). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rashes on the upper abdomen. chest and wide spread at the back.; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (Rashes on the upper abdomen. chest and wide spread at the back.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Methimazole                                                    for Grave's Dse for Graves' disease, Atenolol                                                       for hypertension for Hypertension.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH (Rashes on the upper abdomen. chest and wide spread at the back.). At the time of the report, RASH (Rashes on the upper abdomen. chest and wide spread at the back.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Reporter did not allow further contact
Mom noted on 4/20/18 that injection area starting to get red and area is hardened, mom thought it was a normal reaction. Around 4/24/18, area is more red and a bump was noted and is getting more hard. Also, pt is seemingly in pain when mom is touching the area. The pt cries and doesn't want mom to touch it.
Significant (2X normal) swelling in two fingers on right hand with dark red/blue areas 1-1.5cm in diameter.
Mild Symptoms, insomnia,  dizzy, loss of focused, Severe symptoms last two days - Died on Sept 7 - 2021  - couldn't breathe.
pain in left arm pit the same side as injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), dose 1 via an unspecified route of administration in the left arm, on 02May2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient was experiencing pain in left arm pit as the same side of vaccination. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Patient began having seizures eight days after vaccination. Grand Mal seizure began at aproximately 9 PM and lasted for greater than an hour. Patient was transported by ambulance and anti-seizure medication was administered rectally. Initial diagnosis was "febrile seizure". Patient was admitted to the hospital for one night. Upon release from the hospital, patient seemed fine for 24 hours then began having focal seizures in the P.M. Patient was taken to the E.R. and no adverse conditions were noted. The following A.M.patient was found in her crib having a Grand Mal seizure. Patient was transported by parents to E.R. and was subsequently transported to hospital. Patient was admitted for seven days for testing. Per follow up report received 06/23/2005:  Patient no longer has seizures and no longer takes medication but she now has a lesion on her left temporal lobe that has resulted in her having delayed expressive communications. Information from 2 discharge summaries state nystagmus, fever, Urinary tract infection, lethergy; chewing motion, visual deviation, contraction of face. msv 1/25/2010 Speech delay, learning disability, currently being tested for autism.
head cold; laryngitis; second vaccination >42 days after the first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination >42 days after the first), NASOPHARYNGITIS (head cold) and LARYNGITIS (laryngitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021321A and 006C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination >42 days after the first). On an unknown date, the patient experienced NASOPHARYNGITIS (head cold) and LARYNGITIS (laryngitis). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination >42 days after the first) had resolved. At the time of the report, NASOPHARYNGITIS (head cold) and LARYNGITIS (laryngitis) outcome was unknown.            Patient tested negative for COVID-19. Concomitant medications also included antihypertensives .  No treatment medications were reported.
Felt hot; Chills; Nausea; Muscle pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt hot), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT (Felt hot), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Tiredness). At the time of the report, FEELING HOT (Felt hot), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079756 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079756:1 dose case.
Patient seemed to be in his usual state of health on 11/5/19.  He received a flu vaccine that afternoon.  Next morning he developed a fever to 101.2.   At approx 3 am on 11/7/19 he was febrile and developed a febrile seizure that lasted less than 1 min.  It was generalized.    EMS was activated amd was taken to the ER.  He was diagnosed with a right otitis media and simple febrile seizure.
Post injection dizziness, sweating, lightheaded, lasting 7 and 1/2 hours laid down, gave water and electrolytes.
Marked erythema and soreness at injection site. Temperature up to 102F with marked irritability X 3 days.
(Vasovagal Response) Felt tired and ?felt like fainting? immediately after shot.  Pt laid down and elevated feet.    No additional treatment needed.  (Initial BP 87/58)
26oct89 pt vax hepta B.  pt ex some joint pain and malaise, and stated that she felt generally unhealthy.  sx were treated w/ benadryl. 05dec89 pt vax 2nd hepta B.  pt ex h/a.  by mid dec pt initiated treatment w/ motrin & darvoset.see worm
wake up during noc w/heavy breating & eyes rolling back in head; seen per ER MD-no meds administered, just observed;