chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child reported to nurse that her throat "feels like it's growing". P.C. to mom. Verbal consent obtained for BENADRYL. BENADRYL/2.5mg po x 1 dose given. No wheezing or swelling of throat present. Observed child 30 minutes. Child was laughing, pitching paper up in the air & catching same. No respiratory distress noted. All lung fields were clear. Child allowed to return to class.
Patient called pharmacy and reported dark red clumpy urine and sore shoulder near injection site. I referred him to urgent care clinic for evaluation.
Patient reports a large bruise on his rib cage and right arm which started approx. 1 week after vaccine.
Pt presented to pharmacy the next day after she got the vaccine with erythema, swelling and severe pain on the injection site. Pt was treated at the ER and was diagnosed with cellulitis. Pt was prescribed Bactrin DS/ for the injection and Vicodin for pain. In addition, pt was instructed to take the Motrin for inflammation and to apply cold compresses. The injection site felt warmth to touch.
Patient came to the pharmacy today 11/22/21. She informed pharmacist that after she was done waiting post covid & Flu immunization (on 11/13/21), on her way to her car she felt a swelling sensation in her lips which went away after 15 minutes and did not have any problems with her breathing. On 11/19/21 she developed redness on the injection site (left arm) where covid vaccine was administered. Her armpit also became swollen. She states that now she has gotten a lot better, and redness and swelling is gone for the most part. But she still feels a little bit of weakness and nerve problems in her left arm. She states that she cannot grab onto things well. Patient never made a trip to visit the doctor for this issue, but she will be seeing her provider on her upcoming appointment where she will address her concern.
Child was here with mother for immunizations.  Was to receive Hep B, however, MenB was given, tolerated well without incident.  Monitored for 15 minutes.  Discussed with mother, she verbalized understanding of incident.  Was given VIS handout.  Hep B was given as required for school.  Tolerated well without incident.
Hard red half dollar sized area where vaccine was given. Warm to the touch. Tender. Arm feels sore to move when reaching above my head to put stuff away in the kitchen and bathroom
Swollen lymph node in left arm pit close to breast.  A lot of pain even without applied pressure.
Pt developed hives, swollen lips, sneezing with 10 min of vaccine. Was give subcutaneous epinephrine and all symptoms resolved within 5 minutes. 25mg BENADRYL given orally as well.
Leg Cramps/ Numbed/ Unable to walk Headaches Antibodies blood test yielded negative/low antibodies Ultra sound results pending
Patient had a scheduled appointment with provider for school physical and immunizations.  Administered 3 vaccines (MMR, Varicella, Dtap/Polio ordered by provider.  After giving the 3 vaccines,  Patient's guardian, decided to add the pediatric covid vaccine. I let the guardian sign consent form for the patient.  Prepared  pfizer covid vaccine, unfortunately,  prepared the covid vaccine for 5-11 year old instead of the Pfizer (6mos-4yrs). After realization of administration error,  I contacted the clinics charge nurses and also notified the director of clinical services, FNP.  I also informed guardian and instructed to observe for any side effects and also informed when to seek urgent care.  I also  notified guardian when to come back to get the appropriate dose for patient. Guardian stated patient is doing well.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-NOV-2015 at time- 11:11, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose *, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature at which the product was stored were 4.3 and 2.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Around 9:00 p.m. that evening started out with small rash.  By 11/25/2014 9:00 a.m. went to pharmacy to speak to pharmacist because rash spread from injection point to armpit and down to elbow.  By then blisters appeared and rash area was hot and burning.  Hurt to have any clothing over rash area.
tested positive for mononucleosis; This spontaneous case was reported by a consumer and describes the occurrence of INFECTIOUS MONONUCLEOSIS (tested positive for mononucleosis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 since an unknown date. Concomitant products included AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN & CLAV. POTASSIUM), CETIRIZINE, FAMOTIDINE, CYCLOBENZAPRINE and PREDNISONE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTIOUS MONONUCLEOSIS (tested positive for mononucleosis). At the time of the report, INFECTIOUS MONONUCLEOSIS (tested positive for mononucleosis) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Infectious mononucleosis: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Husband received vaccination at work.  That evening he was extremely pale and tired.  The following day this continued along with significant confusion (he did not recognize the turn onto the major street to our home where we have lived for nearly 2 years, he also forgot the a  pizza was still in existence even though there is one down the street for us that we have passed many times and discussed at length in the past 2 years).  The week after his injection he would get home from work and be falling asleep in his chair by 7:30pm with no change to his sleep schedule.  He has remained pale and still struggles with exhaustion.
Patient developed an erythematous vesicular rash localized to her anterior trunk, flanks, and bilateral hips 24 hours after receiving her routine vaccinations (MMRV and DTaP-IPV) at her 5 year WCC on 6/9/2023. Parent reports the rash was initially faint and became more prominent within 48 hours. Patient reports the rash is itchy. Parent treated with OTC antihistamine which he reports did offer some relief. At her OV on 6/12/2023 parent reports the rash is improving in appearance. Parent reports no associated sx including fever, URI sx, sore throat, vomiting, and diarrhea. No known sick contacts.
7-28-11 4 yr old received DTaP, IPV, MMR & Varicella. Sneezing immed after vaccines. BENADRYL 8 ml po given 1125A. RTC 1225 with rash. Swelling around eye/ears. Positive faint wheeze. BENADRYL 6 ml IM given - 1227p. 1245 decreased swelling, decreased redness. 7-29-11 called home & father states no further rash or signs of reaction.
severe vertigo/almost could not walk; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (severe vertigo/almost could not walk) in a 60-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032089) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: pfizer (Dose 1) on 18-Mar-2021, pfizer (Dose 2) on 14-Apr-2021, pfizer (Dose 3) on 04-Jan-2022, pfizer (Dose 4) on 03-Jan-2023 and Influenza vaccine on 12-Sep-2023. Past adverse reactions to the above products included No adverse event with Influenza vaccine, pfizer, pfizer, pfizer and pfizer.    On 02-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 05-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VERTIGO (severe vertigo/almost could not walk). At the time of the report, VERTIGO (severe vertigo/almost could not walk) was resolving.            No concomitant medication was reported. On 05-Nov-2023, the patient developed severe vertigo. The patient almost could not walk but could walk when holding onto a railing. The patient feels 20% better today. This was the first time the patient received a Moderna vaccine. The patient regularly drinks coffee, had a protein shake with creatine, collagen, and whey protein every day but did not have this on 3NOV2023 or 4NOV2023. The patient did have it yesterday 5NOV2023. The symptoms started almost immediately after drinking the smoothie. Normally also does cold plunges, did one 2NOV2023. The patient did not had it for a couple days then did try it again on 5NOV2023. No treatment medication was reported.
A little bit of pain in the right shoulder.; Tingling and numbness into the right shoulder neck and head; Tingling and numbness into the right shoulder neck and head; Tingling and numbness into the right shoulder neck and head; Tingling and numbness into the right shoulder neck and head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "A little bit of pain in the right shoulder."; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "Tingling and numbness into the right shoulder neck and head".  The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up. Additional Information: A contactable consumer reported similar events under the same suspect product for 3 patients that this is the one of 3 reports. first dose in Jan2021, second dose in  Feb2021 and experienced adverse events:  first dose ,  a little bit of pain in the right shoulder. 2nd shot had tingling and numbness into the right shoulder neck and head.  Her age was 70.5 years. She is concerned about the booster dose. Wants guidance about receiving it. She spoke to her doctor about it. She is concerned about getting a worse reaction.   Follow-up (26Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
heart attack; severe chest pains; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EN5318) on 08Feb2021 at 02:45 PM at single dose at right arm for Covid-19 immunization. Medical history included COVID prior vaccination. No known allergies. Concomitant medications included every day meds. It was reported that next night, on 09Feb2021 10:45 PM, patient had severe chest pains thought having heart attack went to hospital. Could not go back. The events were resulted in Emergency room/department or urgent care. Treatment was received for events and patient underwent lab tests included CT scan, blood test and etc on unspecified date with unknown results. Patient did not test COVID post vaccination. The outcome of events was recovered on unspecified date.
This case described the occurrence of arthritis in a 62 year old male pt who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other health care professional.  On unspecified dates in 1999, the pt received an unspecified number of injections of Lymerix.  Approximately 3 years post-immunization, in "late summer of 2002", the pt experienced arthritis.  The event was unresolved as of 08/07/03.  As of that date, the pt had not sought medical attention.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved. The reporter considered the vaccination failure and influenza to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient stated that he got flu vaccine 20 to 30 years ago and got the flu after getting it. The patient did not know any specifics about the product, believed it must have been a live vaccine since he got the flu. This case has been considered as suspected vaccination failure since the laboratory test confirmation and time to onset for influenza was unknown. The patient had denied permission to contact their physician.
Got positive for the Covid-19 Virus after taking the Covid-19 vaccine; Got positive for the Covid-19 Virus after taking the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program, by a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 15Jan2021 for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced got positive for the COVID-19 virus after taking the COVID-19 vaccine on 15Jan2021 with outcome of unknown . The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Jan2021.    The information on the Lot/Batch number has been requested.
all the patients who received a vaccine which was more than 30 days in the refrigerator; received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) had resolved. At the time of the report, PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) 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 medications were reported.
Patient was given adult dose of Hep A instead of child dose, Patient was 3 years old
emergency appendectomy; This is a spontaneous report from a contactable consumer or other non hcp.  A 17-years-old male patient received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Reporter stated that his son, withheld is a 17-year-old athlete that competes in High school track & Field and Cross-Country Running. He had his 1st Pfizer Vaccine on 29Mar2021 (Vaccine Proof enclosed). Immediately after this Pfizer Vaccine his son had an Emergency Appendectomy. From the input of physicians and other medical experts, it has been studied and verified that the Pfizer Covid-19 Vaccine may have played a significant role in this Acute Appendectomy from the side effect profile listed for the Pfizer Vaccine. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
By Friday night my left arm was swollen from shoulder to elbow.  There was also immense heat radiating from the swollen area and itchiness as well.  This was not just a local site reaction, nor was it a bleed.  I did infuse with Novoeight Friday night just in case but it didn't help.    On Saturday the swelling got worse and started to drain into my forearm as well.  I took a dye-free Benadryl Saturday afternoon and it seemed to stop the progression of the swelling.  I took a second dye-free benadryl Saturday evening and by the time I woke up Sunday the swelling was improving.    There was no pain in the arm, just heat, itching and tightness.  As of noon Monday, the swelling had dramatically improved but there was still noticeable swelling in the bicep and deltoid.  The glands do not seem to have swollen at all.  On Monday I reported the event to health staff.  As of 5pm Tuesday the swelling in the bicep and forearm is completely gone, along with the heat and itching.  The deltoid remains slightly inflamed but almost back to normal.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant therapies was reported. On 06-APR-2017, the patient was inadvertently vaccinated with a dose of expired M-M-R II injection, lot # L009213 with expiry date on 17-MAR-2017 (dose and route of administration were not reported) for prophylaxis. The M-M-R II was given with sterile diluent (manufacturer unknown) (reported as "diluent MRK injection"; dose, lot # and expiry date were not reported). Product quality complaint (PQC) was not involved. Additional information is not expected, as there was no consent for further contact.
Fever over 104 degrees for two consecutive days, migraines, nausea, pain in leg joints, constant chills.
Patient rec'd vaccine on 1-25-2021. Patient woke up on 1-26-2021 feeling so bad with joint stiffness and trouble breathing, he called 911. He was taken to Hospital where he was admitted. He says by 1-27-2021 he was feeling much better with each passing hour. He was discharged on 1-27-2021. Then on 1-28-2021 he noticed a red and very itching rash at the injection site and all across his back.
Muscle weakness; Hives; muscle pain; Fatigue; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 18:30 (Lot number: FF2587) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Auto immune disease" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose Lot number: FC3181, Prev dose Administration time: 18:30, Prev dose Dose number: 1, Prev dose Vaccine location: Left arm), administration date: 18Aug2021, when the patient was 53 years old, for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 29Sep2021 23:00, outcome "not recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 29Sep2021 23:00, outcome "not recovered", described as "Fatigue"; PAIN (non-serious) with onset 29Sep2021 23:00, outcome "not recovered", described as "pain"; URTICARIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Hives"; MUSCULAR WEAKNESS (non-serious) with onset 30Oct2021, outcome "unknown", described as "Muscle weakness". The events "muscle pain", "fatigue", "pain", "hives" and "muscle weakness" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, fatigue, pain, muscular weakness. Therapeutic measures were taken as a result of urticaria.  Additional Information: Patient had COVID prior vaccination. Patient was tested for COVID post vaccination. Covid test post vaccination: covid test type post vaccination-Nasal Swab, covid test name post vaccination-SARS Coronavirus 2-PRL, covid test date- 14Oct2021, Covid test result - Negative. The patient did not take any other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2013US007526, is an initial spontaneous report received from a nurse on 01 Apr 2013 and a follow up report from the nurse received on 23 Apr 2013: This case refers to a 29-year-old male patient. His medical history and concomitant medication were not reported. He was inadvertently vaccinated with expired MENVEO (batch number: A10053 and expiry date: not reported) intramuscularly at the left deltoid at a dose of 0.5 ml on 01 Apr 2013. It was reported that the vaccine was 2 months outdated but was properly stored and temperature was monitored. No adverse reaction was reported following the administration error. No other information was available. Follow up report from the nurse received on 23 Apr 2013: The information related to the storage, batch number and route of administration of MENVEO vaccine were updated.