chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One vesicle was identified that was approximately 3cm anterior to the location of the vaccine inoculation. This was a suspected inadvertent inoculation. No eye lesions or severe/excessive pain associated with lesion.
PATIENT HAD A SYNCOPAL EPISODE 2-3 MINUTES AFTER RECEVING HER GARDASIL AND FLU SHOTS.  SHE WAS ON HER WAY TO THE LOBBY TO WAIT FOR 20 MINUTES BUT FELL TO THE FLOOR BEFORE SHE COULD LEAVE THE ROOM.  SHE HIT HER HEAD, RIGHT HIP, AND RIGHT KNEE.  SHE WAS EVALUATED BY THE MD ON CALL.
Patient received TD injection on 10/16/07 and developed cellulitis, redness and induration at injection site.  Patient was treated with BACTRIM for 10 days.  Patient recovered.
Initial report was received from health care professional on 19 Oct 2010: This patient with medical history of hypertension was vaccinated with RABIPUR (batch number unknown) 2 ml, intramuscular, in upper arm deltoid in Aug 2010 (date unspecified). The patient experienced demyelinating disease recently and hospitalized in Aug 2010. The patient had paralysis. The disease reason was unknown, the treating physician considered paralysis as suspected to be related with vaccines. Follow up information received from center of disease control on 24 Dec 2010: The patient was bitten on right heel by a dog on 08 Jul 2010 and presented with bleeding from the wound (grade 3 exposure). The patient was vaccinated with one injection of RABIPUR (batch number 1775) on 08 Jul 2010 after informed consent. The patient did not agree to get vaccinated with immunoglobulin. The patient also received next four doses of RABIPUR with last dose on 05 Aug 2010. The patient complained of fatigue during the period of complete vaccination schedule but no other uncomfortable symptoms were reported. Rabies antibody was found to be positive when tested by CDC in the mid of Aug 2010. The patient felt sudden dizziness and presented with vague articulation and right upper limb weakness on 20 Aug 2010. The patient was admitted in hospital on 21 Aug 2010 for cerebral infarction. The patient went to another hospital to identify the cause of disease on 13 Sep 2010 and 22 Oct 2010. Cerebrospinal fluid oligoclonal bands (CSF-OB) were found to be positive on 16 Sep 2010 and 26 Oct 2010 while fungal culture of CSF was negative. MRI done on 05 Nov 2010 revealed multiple bilateral sub cortical abnormal signals. Based on MRI results, acute disseminated encephalomyelitis (ADEM) with demyelinating activity was considered with great possibility. After hospitalization, the patient was treated with symptomatic treatment, such as neurotrophic, hormones, etc. The patient was discharged on 18 Nov 2010 with diagnosis of acute disseminated encephalomyelitis. The patient's status at the time of discharge was reported as mild dizziness, clear consciousness, decreased memory and computing ability, fall orientation, mild left gaze palsy for both eyes (the level of tremor in both eyes), normal limb muscle strength and muscle tone. Sometime the patient was still unconsciousness and had incontinence. The patient was walking with other's help at the time of reporting.
COVID-19; COVID-19; MARKETING PROGRAM NAME NOT AVALIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4346048-00 (Agency).  A 16-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 1, single (Batch/Lot number: unknown), on 01Oct2021 as dose 2, single (Batch/Lot number: unknown) and on 20Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 16 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen at unk (citrate free) and second regimen (ongoing) at unk (citrate free), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant) with onset Apr2022, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possibility Causality for Pfizer BioNTech COVID-19 Vaccine (Tozinameran) The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possible   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Breakthrough COVID-19 case despite vaccination in Jan 2021. Current symptoms began July 6,2021. Exposure to unvaccinated individuals over the July 4 weekend. Symptoms are mild consisting of cough, sinus congestion, sore throat. No fevers, shortness of breath, diarrhea. SARS-CoV-2 nasopharyngeal PCR test positive on 7/7.
Week later she tested positive for Covid virus.; Week later she tested positive for covid virus.; This is a spontaneous report from a Pfizer-sponsored program Pfizer first connect from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, on 11Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient received COVID vaccine on 11Jan2021. A week later she tested positive for COVID virus. Ended up in hospital. Wanting to know when and if she can get next dose of vaccine. The clinical outcome of the event was not reported.  Information on the lot/batch number has been requested.
PM on 11/7/08 - Site sore with small lump felt AM on 11/8/08 - 1 1/2 by 2 inch hard lump at injection site and arm sore, PM on 11/8/08 - Same size area, but arm hurt from elbow to neck with Rt shoulder sore.  11/10/08 - area smaller and arm less sore by 11/14/08 almost gone, arm achy, arm remains swollen and sore.
Information has been received from a physician concerning a 26 month old male who on 27-JUL-2010 was accidentally vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot number 665607/1332Y) instead of hepatitis A vaccine (Manufacturer unknown). No adverse effect. Follow up information has been received via telephone call from a nurse who stated that what happened was, a nurse pulled two vaccines out to be given to two different patients. She gave the wrong one to another nurse to give to the other patient. The nurse confirmed that it was not a case of product confusion but just an accident. Additional information is not expected.
Immediately following immunizations child c/o intense itching all over body.  Skin became reddened.  He was taken to MD for assessment.  Within five minutes of receiving vaccines, hives erupted all over child.  MD administered 0.3cc epinephrine R upper arm. EMS was called and child transported to ER at approx. 11:15am.
NO S/S REPORTED;  SPOKE WITH MERCK REGARDING THIS ADMINISTRATION OF PROQUAD AND REPRESENTATIVE STATED THAT VACCINE WOULD NOT NEED TO BE REPEATED AND COULD CONSIDER THE SERIES TO BE COMPLETE.
Swollen Arm - Near Injection Site; Vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of VOMITING (Vomiting) and VACCINATION SITE SWELLING (Swollen Arm - Near Injection Site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022A21A) for an unknown indication.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VOMITING (Vomiting) and VACCINATION SITE SWELLING (Swollen Arm - Near Injection Site). At the time of the report, VOMITING (Vomiting) and VACCINATION SITE SWELLING (Swollen Arm - Near Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.
redness at the injection site 4.5 to 5 inches; blotchy at the injection site; arm sort of itchy; headache; swelling at the injection site after the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site after the shot), VACCINATION SITE ERYTHEMA (redness at the injection site 4.5 to 5 inches), INJECTION SITE DISCOLOURATION (blotchy at the injection site), PRURITUS (arm sort of itchy) and HEADACHE (headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included blood pressure medicine for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site after the shot) and HEADACHE (headache). On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site 4.5 to 5 inches), INJECTION SITE DISCOLOURATION (blotchy at the injection site) and PRURITUS (arm sort of itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site after the shot), VACCINATION SITE ERYTHEMA (redness at the injection site 4.5 to 5 inches), INJECTION SITE DISCOLOURATION (blotchy at the injection site) and PRURITUS (arm sort of itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient tolerated vaccination administration well. She moved into the chair while her sister received her vaccination. I noticed patient face started to turn white and starting sweating. I went to check on patient and her head slumped down as I made it to her and she began convulsing. This episode lasted less than 15 seconds and patient setup and asked what had happen. PA was grabbed by the father while I attended to the patient. He immediately moved her to the table and elevated her feet.
This was not an emergency reaction to the vaccine but apparently something to do with the location of the shot that has caused a prolonged period of muscle pain around the site and beginnings of what my doctor called a frozen shoulder as the pain moved into my neck and down my arm. A week after the shot at our Employee Health dept., I consulted with them about the pain and they asked me to have a doctor evaluation. I saw my doctor the next day, she diagnosed it as frozen shoulder and gave me PT exercises to do. I've been doing these and the frozen shoulder symptoms are going away, although three weeks later I still have a sore arm around the shot location when I move my arm around. I've always had typical 1-2 days of soreness in the past and never any other type of problem with the flu vaccine. I'm hoping the arm pain will eventually go away. I did report my doctor's evaluation back to Employee Health and they asked me to report it here as well.
Information has been received from a medical assistant concerning an "approximately 16 to 17 year old" female, who in August 2007, was vaccinated with "either the first or second dose of" GARDASIL. There was no concomitant medication. The patient left the office after the vaccination and passed out in the parking lot and hit her head on the asphalt. The patient's father called the office and one of the medical assistant's came down to the parking lot where the patient passed out. It was reported by the medical assistant that the patient returned to the office on an unspecified date and received "either a second or third dose" of GARDASIL. The office made the patient lie down post vaccination. Subsequently, the patient turned blue. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Moderna 2/18/21, 3/19/21. Pfizer 9/7/21. Positive on 7/22/22
Immediate Redness like swelling around injection site.  fine Rash like appearance swelling and rash went away after 15 min. No pain or itchyness, Stayed 30minutes  no further issues. not red, not warm to touch after 30 minutes.
Patient presented for second dose of Pfizer COVID vaccine. Per mom, patient had anxiety attack after first dose last approximately 45-60 minutes. Patient transferred from vaccine clinic to private room with stretcher prior to vaccine administration. Post vaccine administration, patient exhibiting typical symptoms of panic attack per mom (seizure-like activity, unable to respond to verbal stimuli, sternal rub or fingernail pressure). EMS arrived at 0925. Patient regained consciousness after EMS arrived, back to baseline at 0940. Patient and mother declined EMS transfer to ED for further evaluation. Patient and mother informed to seek medical attention immediately for any worsening/concerning symptoms. Patient discharged via wheelchair with mother.
Arm swelling and pain, left wrist to finger tingling and pain. Fever 102 starting 2100 continuing 20 hours. Taking Tylenol brings to 100. Rigor, chills, nausea, insomnia despite taking clonazepam. Significant headache. Swollen neck glands tender. Rapid heartbeat.
Pneumonia; Sick for 19 days after the Moderna shot; Flu like symptoms; She is not feeling well at all; 102 degree F fever since 19 days every day/ running fever all day; This spontaneous case was reported by a consumer concerning a 45-year-old female patient who experienced pneumonia, illness (sick for 19 days after the Moderna shot), pyrexia (102degF) fever since 19 days every day/ running fever all day),Influenza-like illness and malaise (She is not feeling well at all).   The patient's past medical history was not reported. Concomitant product use was not provided by the reporter.    On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number not reported) intramuscularly (injection site not reported) for the prophylaxis of COVID-19 infection.   On 28-Feb-2021, the patient received the second of two planned doses of mRNA-1273 (Lot number:012M20A ) intramuscularly (injection site not reported) for the prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced Pneumonia, Sick for 19 days after the Moderna shot, 102degF fever since 19 days every day/ running fever all day, flu like symptoms and not feeling well at all. Treatment for the events included antibiotics, steroids, IV fluids, levofloxacin, antibody shots, ibuprofen and was on home health.   The action taken with mRNA-1273 in response to these events was not applicable.   The outcome for the events PNEUMONIA (Pneumonia), ILLNESS (Sick for 19 days after the Moderna shot), PYREXIA (102degF fever since 19 days every day/ running fever all day), INFLUENZA LIKE ILLNESS (flu like symptoms) and MALAISE (She is not feeling well at all)  were considered not recovered/not resolved.; Reporter's Comments: Based on the information provided, a causal association between the administration of and the event of pneumonia is assessed as not related as pneumonia is of an infective etiology. However, although the other events are consistent with symptoms of pneumonia, based on temporality with product use, causal association cannot be excluded.
Chest pain 11 days post vaccination with AVA and SPV. Admitted, elevated troponin I (peaked 9.96) and EKG changes. Neg echo and MRI. DX myopericarditis  Symptoms: CHEST PAIN, UNSPECIFIED(R079), SHORTNESS OF BREATH(R0602).
Nurse:  the resident received her vaccine at 09:25 am and immediately began to feel cold. This nurse was notified at 0945 at which time the resident complained of nausea and dizziness. The resident was also emotional, confused and experiencing high blood pressure (170/78) .
See attached documents. Onset: 6 Day(s) ago. Severity level is severe (10). It occurs constantly. Location: upper arm. The pain radiates to the fingers. The pain is aching and sharp. The pain is aggravated by lifting. Associated symptoms include decreased mobility, night-time awakening, numbness in lower arm, tenderness and weakness. Additional information: Had a PNEUMOVAX  last Thursday and painful ever since.
3-11-21 5:25PM FEELS 'LIGHTHEADED'.  A/O, PINK, W/D, RESP REG WITH EASE.  5:35PM 'FEELS A LITTLE BETTER'.  'FEELS BETTER'.  A/O, PINK, W/D, RESP REG WITH EASE AMBULATORY TO EXIT - GAIT BRISK AND STEADY. NO SOB, NO PAIN. 3-12-21 2PM TC:  STATES 'NO LIGHTHEADEDNESS, DOES HAVE A HEADACHE'.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 53F (11.6 Celsius) for 53 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
PATIENT WAS GIVEN PARTIAL DOSE OF MODERNA; STAFF HAVE BEEN RETRAINED ON PROPER ADMINISTRATION OF VACCINE; ATTEMPTING TO SCHEDULE PATIENT FOR RE-VACCINATION
Vaccine had expired last week. Despite checking the lot number and expiration date did not realize it was expired until entering Lot number and expiration date in EMR. Notified Supervisor, and parent using a translator. Parent verbalized understanding and will bring patient in next month to repeat Hep A vaccine,
Unilateral facial edema/puffiness, fatigue, tenderness at the injection site
Fever 101-103 associated with headache & body aches.  Intense muscle aches lower extrem > upper extrem to the point of difficulty walking, getting out of chair, etc.  Duration 5-6d.  Rx ibuprofen 600mg q 6 hr.
got Covid; got Covid; This is a spontaneous report from a non-contactable consumer (patient, self-reported) received from a Pfizer-sponsored program. A male consumer of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 31Mar2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got his 1st dose on 31Mar2021 and he was supposed to go on wednesday at noon but he got COVID and he wanted to know whom to talk to reschedule. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had the shot years ago, have shingles now/ Suspected vaccination failure; Have shingles now; These are so painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the shot years ago but had shingles now. The reporter advised to get the shot as these shingles were so painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Received vaccines along with twin sister and spiked a fever of 103 degrees (rectal) within 8 hours after administration.  She wasn't having the vomitting and diarrhea that her sister was experiencing but she was also seen by physician at urgent care.  Attending physician told parents that it was from the flu vaccine. Continued with what mother describes as low grade fever for approximately three days.
Received 2nd shot of Pfizer-BioNTech COVID-19 vax on 04/14 @ Church (vax card not on hand). 04/15 - felt fine, able to mow lawn + ride her Harley. 04/16 - started to have some localized pain on R arm at vax site - tolerable. 04/17 PM - started to have worsenign pain, swelling in R arm at vax site, radiating down. 04/18 - presented to hospital for evaluation, R arm swelling, warmth, redness noted, most prominent in upper arm surrounding deltoid. On DVT US - found to have partially occlusive thrombus in subclavian, axillary, and basillc veins. Plt = 201K, within baseline of 170s-210 within the past 10 years.
headache, mild hypertension, flushing of face.  Started 8 hours after receiving shot, patient reported to ED. No treatment administered.
Loud ringing in both ears; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 31Mar2021 at 10:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to 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 31Mar2021 at 10:15, after second dose of vaccination, the patient experienced loud ringing in both ears which was ongoing. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event loud ringing in both ears was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.