chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in the arm of the injection that lasted for a couple of days; some swelling at the injection site for the first couple of days; it has a low grade pain every once in a while.; The arm is uncomfortable , but still can use it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it has a low grade pain every once in a while.), LIMB DISCOMFORT (The arm is uncomfortable , but still can use it), VACCINATION SITE PAIN (pain in the arm of the injection that lasted for a couple of days) and VACCINATION SITE SWELLING (some swelling at the injection site for the first couple of days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic castor oil/creams) and Allergy (Allergic to PEG40). Concomitant products included OMEPRAZOLE, ROPINIROLE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (it has a low grade pain every once in a while.) and LIMB DISCOMFORT (The arm is uncomfortable , but still can use it). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection that lasted for a couple of days) and VACCINATION SITE SWELLING (some swelling at the injection site for the first couple of days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (it has a low grade pain every once in a while.), LIMB DISCOMFORT (The arm is uncomfortable , but still can use it), VACCINATION SITE PAIN (pain in the arm of the injection that lasted for a couple of days) and VACCINATION SITE SWELLING (some swelling at the injection site for the first couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Monovalent vaccine administered for a booster on 9-2-22. Bivalent booster authorized by FDA on 8-31-22. Patient contacted, will return for bivalent booster in 2 months.
rash, fever, muscle aches. headache, vomiting, could not eat, dehydrated, could  not walk very well, in bed for 6 days went into afib attack, trouble breathing, have oxygen at home
Vomit, diarrhea, dry heaving outcome, was given anti-vomit pill did not go back to school till Tues the following week.
neurological problems; abdominal pain; This case was reported by a nurse and described the occurrence of neurological disorder nos in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received Shingrix. In December 2020, 1 month after receiving Shingrix, the patient experienced neurological disorder nos and abdominal pain. On an unknown date, the outcome of the neurological disorder nos and abdominal pain were unknown.   It was unknown if the reporter considered the neurological disorder nos and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her early 50's age. The patient received Shingrix shot (unknown if dose 1 or 2) in early to mid November 2020 and about 1 month after the injection, neurological problems and severe abdominal pain were experienced. It was unknown if these events have resolved and vaccines lot number was unknown.  The patient indicated knowing of another individual (gender unspecified) that had the same issue. No additional details were known to the reporter. The reporter was open to receiving correspondence from safety department.
Information has been received from a licensed practical nurse concerning a 24 year old female assistant with thyroid disorder who on 18-MAR-2010 while she was administering a dose of MMR II (lot#665095/0839Y) to a patient, the needle for some reason came apart from the syringe and some of the MMR virus squirted out of the needle in to her eye (which eye unspecified). Concomitant therapy included AVELOX and thyroid medication. It was reported that the medical assistant experienced burning of the eye. The medical assistant flushed the eye out. The medical assistant sought medical attention in the office. At the time of the report, the medical assistant was recovering. Additional information has been requested.
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included post infectious irritable bowel syndrome (Pi ibs). The patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 20:00, the patient experienced diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event diarrhea was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a male child who was vaccinated with a dose of MMR. Subsequently, the patient experienced an unknown reaction described as possibly a rash. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
This spontaneous report was received from a female nurse via Pfizer regarding herself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient received PNEUMOVAX 23 for prophylaxis (dosing schedule was not reported). On an unknown date, the patient had allergic reaction to PNEUMOVAX 23 (allergy to vaccine). Outcome of the event was not reported. Causality was assessed to be related to PNEUMOVAX 23.
No adverse events occured, patient asked for Prevnar 13, Fluzone HD was given instead.  Patient came to pharmacy on 8/14/20 to find out which pneumonia shot she was given at that time it was discovered that RPH gave a dose of Fluzone HD instead.  No adverse events were noted by patient to the dose of Flu shot.  It was recommended to get the Prevnar 13 shot to patient on 8/14/20, patient declined immunization.
The vaccines were administered at approximately 11:00 a.m. on Thursday, July 24, 2003. Patient was given a .8 dosage of Tylenol prior to the shots. Immediately after the shots he ate and then fell asleep during a car ride. At about 3:00 p.m. I put him in his crib for a nap and noticed that he wasn't rolling (which he typically does--he's very active). He seemed frustrated and wanted to turn over to his stomach but was unable to do so. He then fell asleep. At approximately 4:30 p.m., after he woke up, I noticed that he was not moving his legs. I put him on the floor to kick and he only moved his arms. I continued to observe closely and try different positions--sitting, lying down, in an exercise saucer--and noticed that he did not move his legs or feet at all. He seemed slightly fussy and cried when I moved his legs too much. I contacted his doctor at approximately 7 p.m. When I picked his legs up, they would fall back down limp--he still did not attempt to move either his legs or his feet at all, although when I tickled his feet his toes would curl slightly. I proceeded to the emergency room, but no diagnosis was made because he did begin to move his legs at approximately 9:15 p.m. After that point, he did begin moving more--pulling up his knees, wiggling his feet and toes, and rolling over. Aside from being tired on the morning on 7/25, he has appeared to return to normal.  Please note that the doctoris submitting this form with the specific vaccination data below.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 28-year-old male patient received BNT162b2 (BNT162B2), on 26Jul2022 as dose 1, single (Batch/Lot number: unknown, Expiration Date: 31Aug2022) at the age of 28 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 26Jul2022, outcome "not recovered", described as "constant migraine on left side of head"; EYE PAIN (non-serious) with onset 26Jul2022, outcome "not recovered", described as "reoccurring pain in left eye". Therapeutic measures were taken as a result of eye pain, migraine. Additional information: Patient states that he received his first dose of the Pfizer Covid19 vaccine primary series 3 weeks ago. Caller states he is scheduled for his 2nd dose tomorrow. Caller states that since he received his first dose of the vaccine, he has had "reoccurring pain in left eye and constant migraine on left side of head." Caller is asking "are these normal side effects of the vaccine and should I still have my 2nd dose tomorrow". Calling to see if this is something that has been reported as an issue that has been happening with other people or, if it is just something else. Everything started happening after the shot. Pain in eye: Started later that same day, that he got the shot, 26Jul2022. Outcome: Stayed pretty consistent. Would have a few days with no irritation at all. Then, all of a sudden, it would come right back. Migraines a lot more: Started same day as the eye pain. Outcome: Has stayed the same and hasn't gotten any worse. Is occurring more often than before. Treatment: No, just Advil. For  Only: Vaccination Facility Type: Pharmacy/Drug Store. History of all previous immunization with the Pfizer vaccine considered as suspect was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was No. No AE(s) require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was No.  AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): No. Relevant Tests: None. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Greater than 100 degree fever every time; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Greater than 100 degree fever every time) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Greater than 100 degree fever every time). At the time of the report, PYREXIA (Greater than 100 degree fever every time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: greater than 100 degree fever every time.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742945 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742945:PFS case
Rash on the inside of mouth, near lips and on both sides of mouth.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 12:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation.  Medical history included COVID-19. Concomitant medications included  multivitamin (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE) from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 07:00, the patient experienced rash on the inside of mouth, near lips and on both sides of  mouth. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported event which included  lidocaine ointment. The clinical outcome of the events rash on the inside of mouth was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a medical assistant concerning a 25 year old female with no pertinent medical history and a penicillin allergy who on 16-OCT-2007 was vaccinated intramuscularly in the left deltoid muscle with the 1st dose of Gardasil (lot#658560/1062U).  Concomitant therapy included AMBIEN as needed.  On 20-Dec-2007, the reporter stated that the patient developed hives 2 weeks ago (exact date not reported).  For treatment the patient was taking unspecified steroid.  Lab diagnostic test (blood work) was performed, results pending.  At the time of this report, the patient was recovering.  Additional information has been requested.
No additional adverse effect reported.; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 16-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021926 and expiration date: 15-JUL-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The administered dose of the vaccine was stored with the temperature of 1.2 degree Celsius for 3 hours and 9 minutes. There was a digital data logger involved, but there was no previous temperature excursion. The vaccine was reconstituted with a properly stored sterile diluent. No additional adverse events reported.
Non ending headache since first dose. Can hardly move my right leg its very sore and stiff. Intermediate dizzyness and nausea and extremely tired.
Patient resident of Home.  Patient tested positive for Covid 19 at facility on 11/25/2021.  On 11/29/2021 patient required 5lNC for oxygen support, was lethargic, with 0ML of UOP.  Patient expired on 11/29/2021.
This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly store. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS # 1401USA000269), 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13(MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patient on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13. VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 0/25/2013(MARRS# 1401USA000278). RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013(MARRS# 1401USA000277). PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013(MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
Fever (100.3), Myalgia, chills, headache, fatigue, brain fog
48 y/o female, past medical history of Diabetes, Sleep Apnea and HTN, who presents with shortness of breath and a dry throat post vaccination. Patient states that this is her second dose in the series and denies previous reaction with first dose. Patient received her second vaccination to her R arm. Patient denies throat pain, swelling, difficulty swallowing or chest pain. NP and Paramedics at patient side. Patient noted to be hypertensive (212/103) but all other vials within normal limits (100% RA, 80 HR, 12 Resp). Patient provided with a bottle of water and legs were elevated on a chair. Patients that she didn't eat prior to arrival. Glucometer not working correctly so glucose was not able to be obtained. Patient provided with a fruit bar, which she ate. Patient placed on 3L O2 via nasal cannula and vitals were continuously monitored. Patient BP decreased (although still hypertensive) to 185/90, 177/90, 171/89, 178/86, all other vitals within normal. Patient symptoms improved post O2, oral hydration and fruit bar. Prior to discharging patient home, patient with no further complaints of shortness of breath or dry throat. Patient O2 sats on RA remained 99%.
quite severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (quite severe side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (quite severe side effects). At the time of the report, VACCINATION COMPLICATION (quite severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 18-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (quite severe side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (quite severe side effects). At the time of the report, VACCINATION COMPLICATION (quite severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Patient reports pain in arm starting 15 min after she arrived home. She had pain throughout her body the night of 11-2-15 and day of 11-3-15. Patient states on 11-4-15 site is feeling better. Did not have any rash, fever, swelling or SOB.
Brain infection viral meningitis; Psychosis; Dehydration; Almost in coma; Caused his body to go haywire; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS VIRAL (Brain infection viral meningitis), PSYCHOTIC DISORDER (Psychosis), DEHYDRATION (Dehydration), COMA (Almost in coma) and FEELING ABNORMAL (Caused his body to go haywire) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Meningitis (Spinal meningitis) and Infection (Had an infection before 1st dose and took medicine.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MENINGITIS VIRAL (Brain infection viral meningitis) (seriousness criteria hospitalization and medically significant), PSYCHOTIC DISORDER (Psychosis) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), COMA (Almost in coma) (seriousness criteria hospitalization and medically significant) and FEELING ABNORMAL (Caused his body to go haywire) (seriousness criterion hospitalization). At the time of the report, MENINGITIS VIRAL (Brain infection viral meningitis), PSYCHOTIC DISORDER (Psychosis), DEHYDRATION (Dehydration), COMA (Almost in coma) and FEELING ABNORMAL (Caused his body to go haywire) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood potassium: low (Low) Decreased. In 2021, Blood sodium: low (Low) Decreased.         Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226811, MOD-2021-072608 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Diffuse rash beginning approx 7 cm below left deltoid injection site. Still present 11 days later, warm to touch, pruritic at times, increasing in area slightly.
7/4/99 at 20:30 PM, stung by 5 bees and went to hospital. I received a tetanus shot in my left arm. I still cannot raise my arm. X-rayed-nothing. Dr. at the hospital said nothing was wrong but I have a messed up arm. Still sore.
lightheadedness, nausea,  racing heart rate, fever, left arm soreness.
GARDASIL 9 alternate dosing schedule. Caller reports that adult patient (21+ years old); No addtional AD; This spontaneous report has been received from Pharmacist, regarding to an adult patient of unknown gender. The patient's pertinent medical history, current conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On an unknown date, (also reported as over 1 year ago) the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0,5 milliliter (ml), for prophylaxis (strength, routes of administration, anatomical sites of injection, lot number, and expiration date were not provided). At the time of the reporting the patient was request second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration).  No additional adverse events were reported in the patient.
Patient called approximately 2 hours after receiving vaccine and stated she had developed severe , foul-smelling diarrhea.