chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was given on 4/14/2021 and  pt mother contacted us on 4/15/2021 and was scheduled for a visit on 4/15/2021. Treatment was Ibuprofen 200mg 10ml by oral route in office.Symptoms were that he was limping and avoiding weight bearing on L lower extremity the day after vaccination  and struggling to walk but that morning he was also walking a lot with mom while she was running errands. Soreness at L thigh was also reported ( Quadracel was given on L thigh)  , noted to use both lower ext equally when patient was not being conscious of being evaluated. In office later that day on 4/15/2021Was able to jump off the step stool and also climb up on exam table although on exam noted to be dragging L lower ext on walking . Talked to parent over phone on 4/19/2021 and was told that symptoms completely resolved on 4/17/2021.
worsens brain injury symptoms /previous brain injury felt a worsening of their brain injury condition after receiving the vaccine.; worsens brain injury symptoms; This case was reported by a consumer via call center representative and described the occurrence of brain injury in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included brain injury (had a previous brain injury).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced brain injury (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the brain injury and condition aggravated were unknown.   It was unknown if the reporter considered the brain injury and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but it was selected as adult as per the vaccine indication. The patient who had a previous brain injury felt a worsening of their brain injury condition after receiving the vaccine. The reporter did not consent to follow up. There are no additional details for this report.
Cellulitis left arm in the location vaccines were administered. No induration or fluctuance. Erythema and warmth measuring 14 cm x 14 cm.
She presented today with weakness and said she "knows it's her sodium." She had N/V/D and abdominal pain starting 3 days ago. When I told her she had a COVID-19 infection she did not believe me. She said she has had both vaccines and a booster.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 11-JAN-2018 and 05-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively (Incorrect product storage). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Chills , body aches, fatigue, swollen lymph nodes in right axilla, throat, and under right clavicle
19 year old male who presented to Medical Center with presumed syncope leading to an MVA. He was the restrained driver of a car that was involved in a rollover. He was admitted to the trauma service, had trauma and syncope workup initiated.  Pt has had 2 prior episodes of syncope, once when seeing blood and the other after smelling a noxious odor, suspect vasovagal syncope.  Pt reports not feeling well since receiving covid vaccine on 5/4, and had vomited x 2 the morning of the accident.  Trauma evaluation revealed nasal bone fracture, remained of imaging negative.  He will follow up with the trauma facial surgeon next week
Pt recvd 2 doses of Engerix-B vax 5NOV91 & 10DEC91 following vax pt exp felt sick, throat glands were swollen, devel aphthous ulcers on tongue, lymphadenopathy, fever, sore throat; sx cont for next few months;
Booster dose of Pfizer was given too early:  1st dose 8/3/21 - 2nd dose 9/7/21 - Booster dose 11/16/21
Information has been received from a pharmacist referring to a 71 years old male patient. Information about medical history, concurrent condition and concomitant therapy was not reported. On an unspecified date in 2014, the patient received a dose of PNEUMOVAX 23 (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unspecified date in August 2018, the patient received a dose of PNEUMOVAX 23 (lot # reported as R00692, expiration date 09-SEP-2019; in right arm, strength, dose and route of administration were not reported) for prophylaxis (inappropriate schedule of vaccine administered). On unspecified date in August 2018 (reported as the next day), the patient experienced pyrexia and injection site pain in his right arm. On unknown date in 2018, the patient contacted an unspecified physician regarding pyrexia and injection site pain and the physician told the patient to "rest for a few days". The patient reported he "could not get out of bed for 3 or 4 days". Some unspecified treatment was given for the evnets. At the reporting time, the patient was recovered from the events on an unspecified date in 2018. The causality between the events and PNEUMOVAX 23 was not provided. The reporter considered the events as disability due to the patient couldn't get out of bed for 3 or 4 days.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA injection (lot # L009521, expiration date 28-APR-2017, reported as lot# M003025 with expiration date 26-MAY-2017, lot# L023936 with expiration date 15-MAY-2017, lot# L032749 with expiration date 04-NOV-2016, dose, anatomical location and route of administration were not reported). The vaccine was exposed to 4 hours and 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour and 30 minutes at 51.3 F, also 2 hours at 56.3 F on the seventh of April (year unspecified) and 1 hours at 51.6 F, also 1 hours and 30 minutes on the sixth of May (year unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & approx 1PM started screaming & did so cont until around 5PM; pt would not take bottle or pacifier; t99; MD called-to avoid pertussis in future;
PT RECEIVED #2 POST-EXPOSURE VACCINE IN OUR OFFICE ON 8/6/20- REPORTED TO US ON 8/11/20 THAT AFTER EACH VACCINE SHE HAS EXPERIENCED FEVER ON THE DAY OF, UP TO 101F- STATES SYMPTOM IS RESOLVED THE FOLLOWING DAY-
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received vaccine, sat in observation chair for about 3 min speaking on his phone, patient leans forward and passes out, falling out of the chair and hitting the floor. The patient was unconscious for about 10-15secs. Pharmacist administering vaccine, immediately went to his aid and had his sit. I was called over and offered medical care, which he declined. Patient was given water and an ice pack for the abrasions received.
102.2 F temperature, chills, joint pain, severe headache,  body ache, swelling all over, increased heart rate (108 bpm), BP was good,
It was reported in a published article, title as stated above that a 15 month old patient was vaccinated with a first and second dose of PEDVAXHIB at 2 and 6 months of age.  There was no booster dose given, per CDC recommendations during a shortage.  Subsequently, the patient experienced invasive haemophilus type b (Hib) disease.  In January 2008, at 15 months of age the patient had a clinical syndrome of meningitis.  It was noted that the patient survived.  It was also noted that subsequent to Hib infection, the child was diagnosed with hypogammaglobulinemia.  The child was not enrolled in group child care.  At the time of the report, the patient's status was unknown.  Upon internal review, meningitis was considered to be an other important medical event.  No further information is available.  A copy of the published article is attached as further documentation of the patient's experience.
Began feeling tired on way home at 3 pm, rested in chair until 9 pm,  in bed was so cold and shivering even with two heavy blankets.  Headache developed, heart was pounding (97 pulse rate), headache was the worst ever. Could not sleep, then got up all night until 4 am , finally got back into bed, slept a little, then got extremely hot and sweaty.  Finally slept until 9:45 am, still have headache but not as bad.  Heart more normal, pulse 75.  My temperature stayed a little below normal, 96.6 degrees.
the patient has been diagnosed with cancer; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number, NDC number and Expiry date: unknown), via an unspecified route of administration on 01Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown) in Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date in 2021, the patient was diagnosed with cancer. Outcome of the event was unknown. Investigation Assessment: Not Provided  Information on the lot/batch number has been requested.
Patient was inadvertently given Tdap instead of Dtap. Patient did not experience and side events as a result.
Erythematous and indurated at right upper arm.  Nontender, moves arm well.  Benadryl 3/4 teaspoon every 6 hours.
I received the vaccine I don't recall anything, only today there was pain at injection site and its painful, pink and warm to touch.
Patient reported a rash on his throat that was spreading and itchy. He reported no problems with breathing. He also reported arm pain.
The patient have a severe red area in the left arm (in the inside part of the arm). The patient have the area hot and with pain. If the area don't improve, the patient in Friday October 26 tell to the pharmacist that she want to visit her primary doctor.
This spontaneous report was received from a registered nurse refers to a 62-year-old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. The patient's concomitant medication included ENBREL. On 07-APR-2018 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, units and frequency were unknown) (lot# and expiration date unknown), subcutaneous for shingles prevention at unspecified local pharmacy. On an unknown date in April 2018, the patient experienced soreness, tenderness, swelling, redness at the injection site. It was reported that on 09-APR-2018, the patient went to urgent care for an unspecified reason "not related to the vaccination" and patient was asking about the arm where she had been vaccinated as there was soreness, tenderness, swelling, redness at the injection site, "a little bigger than what might be expected". The reporter stated that the location of the injection seemed very far down the patient's arm much lower than deltoid. It was reported that no treatment was given for the events soreness, tenderness, swelling, redness at the injection site. Outcome of the events soreness, tenderness, swelling, redness at the injection site was not recovered. The casual relationship between events soreness, tenderness, swelling, redness at the injection site and ZOSTAVAX was not provided. There was no product quality complaint (PQC) reported.
Pt present to clinic on 06/12/02 with right leg swelling an d hot to touch. diagnosis: Local reaction to DTaP vs Cellulitis. Treatment: Duricef BID X 7 days
Symptoms began next morning after vaccing administered.  Patient states tongue felt dry and "hairy". She kept drinking plenty of fluids and my Friday she had to leave work because all her muscles and joints in head and neck were achy and felt like she had been "hit by a truck". she took Tylenol and Benadryl and slept all day Friday and Saturday. went to ER Sunday and was diagnosed with serum sicknes.  No rash. She also had muscle jerks and was given IV saline for hydration.  Went to PCP on Monday and was prescribed Ativan. Went to neurologist Tuesday and prescribed prednisone for 5 day taper and Benadryl for tongue symptoms.  She did not work all week and has follow-up neuro appt on Monday oct 13, 2014. Patient states she received the influenza vaccine every year since 1999.
Bedridden; This case was reported by a consumer via call center representative and described the occurrence of bedridden in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced bedridden. On an unknown date, the outcome of the bedridden was unknown.   It was unknown if the reporter considered the bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The caller reported that, her pharmacist told her that some peoples were bedridden for a couple days after having the vaccine. This case linked with US2019AMR200940 and US2019200243, reported by same reporter
Knees (R.L) pain -sore difficulty walking used a cane to walk. Saw my doctor, prescribed P.T. going to 11 sessions. Improving after 5 but will continue P. therapy.
5/9/18, fine macular rash developed bilaterally on arms bilaterally; biceps down to dorsum nd palmar surface of hands. Left occipital node enlargement since 5/2/18.
delayed cutaneous hypersensitivity  Narrative:  onset of reaction X 1 day post vaccination; duration approximately 3 weeks.
Gross hematuria for 2 days after both COVID-19 vaccines given; This is a spontaneous report from a contactable pharmacist (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 09:00 (Batch/Lot Number: PAA156051) as dose 1, single (at the age of 56-years-old) and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included vitiligo, appendectomy, gall bladder removed, broken wrist and ankle; and occasional inflammatory bowel disease (IBS): Only once a year on average. Concomitant medication included amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported. The patient previously took tramadol and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Dec2020, the patient experienced gross hematuria for 2 days after both COVID-19 vaccines given. It then stopped. The patient has never had this before. The patient was now having hematuria off and on for last 8 months. The event was still happening at the time of this report. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had lab tests (urinalysis), CT urogram and cystoscopy in 2021 with unknown results. On 23Jun2021, COVID-19 nasal swab was negative. The patient has not recovered from the event.
recent discharge from outside hospital after testing positive for COVID; EMS brought pt to ED with cardio-respiratory arrest; family states pt sat up from bed and was SOB, then collapsed; EMS started CPR, gave O2, bagged, intubated and gave medications but pt passed away in the ED
On the morning after the vaccination, I woke up, turned to my left in bed, and got dizzy.  Rolled back onto my back, let my head clear, turned to my right, and got dizzy again.  Felt nauseous, but did not vomit.  Problem was worse with eyes closed than with eyes open.  Spent most of the day  in bed.  Vertigo slightly better on day 2 after vaccination, took Dramamine after consult with doctor.  Much better on day 3.  Essentially back to normal on day 4, but do experience slight dizziness upon waking before getting out of bed.
Pt fainted. Staff alerted by customers that someone was laying in floor. We immediately ran out.  Pt was laying face door on floor. Pt was tapped, and verbally asked if he could hear us. Initially there was no response. Checked for breathing, then begin checking for pulse, but he came to. He started speaking with us, saying he was feeling light headed, and got up to notify us, but then he couldn't remember the rest. Asked if he had a history of seizures or diabetes and he said no to either. At some point he went out again, briefly. Meanwhile, the tech called 911. He came to again, begin talking with us. At some point he requested water, which we got. After seeping, he wanted to sit up. We asked him to place his back against the wall, if he wanted to. He did so, and after a few seconds said he wanted to lay down again. EMS came. They asked if he wanted to go to the ER which he consented to. They rolled him out on a stretcher.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced red blotches. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain and red blotches were recovered/resolved. It was unknown if the reporter considered the injection site pain and red blotches to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on left arm. The patient felt pain immediately upon receiving the injection which lasted for few days. The patient reported that, that pain was the most painful shot she ever received. Four days after vaccination with SHINGRIX, the patient had red blotches on her left arm between her shoulder and elbow. The blotches was treated with BENADRYL and the blotches were gone away the next day. This case has been linked with the case US2018182772, reported by the same reporter.
At 7PM 8/15/2013 parents noted rapid breathing and rash and went to hospital. Evaluated as viral axanthum, given Tylenol and sent home. Albuterol x1 at home. Seen again at pediatricians around Noon 8/16/2013 for rash on cheeks, arms, and legs. No further fever or breathing diff. Clingy not playful. Generalized morbiliform rash on trunk, extremities. Cheeks flushed.
+1 day: Swelling at injection site. +2 days: Itching at injection site. +3 days: Large reddened patch of skin surrounding injection site; mild itching; mild swelling in ankles.
States she started having whelps approx. 1 to 1 1/2 hours after rec. the vaccine. 10/19/2009 records from ED visit 9/24/2009 and records from Inpatient admit 9/27-9/29/2009.  DC Dx: Allergic reaction to flu vaccine.   Patient initial sx of rash, itching and facial swelling post vaccine tx'd at ER with IV Solumedrol, Benadryl, and Pepcid. Patient returned to ED 3 days later with c/o's difficulty swallowing, feeling like throat closing and difficulty breathing. Admit to Telemetry, tx'd with IV steroids, benadryl, pepcid and racemic epinephrine neb tx's.10/20/2009 received ICD-9 codes: 693.0, 401.9, E949.6, 250
Felt warm; Tender; Red Blotches from site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site). At the time of the report, VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Rash began one day after injection and consisted of painful itchy large red bumps in 2 clusters (abdomen and hip). Bumps are still there 6 days later (today). Patient called physician and was told to keep an eye on rash and report any further problems. She is keeping the area clean and dry and applying triple antibiotic.
At 1630 child fever of 103. Recieved Tylenol and temp went down to 101.6. At 2245 T 105, child with difficulty standing and shakey. Mother gave Ibuprophen and tylenol also spoke with on call nurse practioner at pediatric office. Used cool cloths to reduce temp. No redness or swelling at injection site. on 5-22-07 morning child is playing and temp is normal.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 52-year-old female subject who was vaccinated ENGERIX B (GlaxoSmithKline). On 31 March 2009, the subject received 1st dose of ENGERIX B (1 ml, unknown, right deltoid). On 7 May 2009, the subject received 2nd dose of ENGERIX B (1 ml, unknown, left deltoid). On 27 August 2009 the subject received 3rd dose of ENGERIX B (1 ml, unknown, right deltoid), (drug dose administration interval too short). On an unspecified date, the subject's titer was less than 0.1 with a decreased therapeutic response. The nurse reported that the first and second dose were from the same lot number. The third dose was from another lot number. Vaccines were given in the deltoid rotating from right with the first vaccine, left with second vaccine, and right with third vaccine. The nurse reported that the titers were showing that the series of ENGERIX-B that she provided to the workers at her assisted living facility did not work. Specifically the report stated that the subject was not immune and needed to restart series. The subject's titer was less than 0.1. It was determined that the third dose in the series was administered five months from the first vaccine instead of the recommended six months. This is one of nine cases reported by the nurse; see cases A0832030A, A0832034A, and A0832035A for female subjects who experienced decreased therapeutic response and drug dose interval too short; and see cases A0832032A, A0832102A, A0832103A, and A0832104A for female subjects who experienced drug dose interval too short.