chrisvoncsefalvay/vaers-outcomes huggingface dataset:
thinks someone in house, someone listening to her conversation, someone bugged the car; Cannot report to work; rearrange things, keep talking about puzzle pieces, putting them together again, does not make sense in different situations and scenarios; Drastic neurological changes; Extreme paranoid; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (Drastic neurological changes), PARANOIA (Extreme paranoid), SUSPICIOUSNESS (thinks someone in house, someone listening to her conversation, someone bugged the car), ABNORMAL BEHAVIOUR (rearrange things, keep talking about puzzle pieces, putting them together again, does not make sense in different situations and scenarios) and ILLNESS (Cannot report to work) 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 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced NEUROLOGICAL SYMPTOM (Drastic neurological changes), PARANOIA (Extreme paranoid) and ABNORMAL BEHAVIOUR (rearrange things, keep talking about puzzle pieces, putting them together again, does not make sense in different situations and scenarios). On 10-Mar-2021, the patient experienced SUSPICIOUSNESS (thinks someone in house, someone listening to her conversation, someone bugged the car) and ILLNESS (Cannot report to work). At the time of the report, NEUROLOGICAL SYMPTOM (Drastic neurological changes), PARANOIA (Extreme paranoid), SUSPICIOUSNESS (thinks someone in house, someone listening to her conversation, someone bugged the car), ABNORMAL BEHAVIOUR (rearrange things, keep talking about puzzle pieces, putting them together again, does not make sense in different situations and scenarios) and ILLNESS (Cannot report to work) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.
Fever (101), headache, lethargic, slept pretty much all day & night, no appetite.
Wheezing - shortness of breath- Reported he felt his throat was thickening. Reported local reaction in past about 7 years ago. Epinephrine IM5cc SQ BENADRYL 50 mg P.O. Symptoms subsided after 15 min post epinephrine.
Nausea, Vomiting, Diarrhea   Vomiting - 3/10  Diarrhea - 3/10 - 3/12 Nausea -3/10 - 3/12
The unknown vaccine was an inactivated or recombinant Influenza vaccine, but I don't know which one.  By 4 pm I was having pain in my arm and could feel swelling starting.  By 5pm the swelling was about the size of an egg.  By 7pm the swelling was the size of a mini football, I had redness surrounding a white area, it was hot, hard and very painful.  I took 2 ibuprofen and an over the counter allergy pill.  The next day the swelling was still present, but about half the size, and the pain was less. Now, almost a week later, I can tell there's still some fluid present in my armpit, but I'm mostly back to normal.
Child received COVID vaccine in Health department clinic on 07/25/22. Phone all from mom on 07/27/22 to report seizure on 07/26/22 at 7:00 am.  Child transport to Hospital by ambulance. Temp was 100 upon arrival.  Child spent the night at the hospital for "monitoring" per mom.   Per mom DX with "complex febrile seizure".  Mom called to report to health department .
16-year-old patient was given Moderna vaccine .25ml. Mother was called and alerted by the pharmacist who administered the vaccine. There was no adverse reaction according to parent of the child. Medication incident report was created.
pain in arm; Injection site nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patients received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm and injection site nerve damage. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site nerve damage was unknown.   It was unknown if the reporter considered the pain in arm and injection site nerve damage to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, she knew few people had the same problem and would never get that shot again. The patient got Flu vaccine in October and reported that the arm still hurts. The patient reported that they told her that they hit a nerve. This case has been linked to US2019AMR073097, reported by the same reporter.
Information has been received from a nurse concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. The reporter stated that a patient was vaccinated with expired RECOMBIVAX HB (dose and frequency unknown) (lot# K018796, expired date 24-OCT-2016) on either 29-OCT-2016 or 30-OCT-2016. The reporter was not sure which date the patient was vaccinated, and the RECOMBIVAX HB did not have any previous temperature excursions. Additional information is not expected because the reporter does not want to be contacted further.
13OCT95 pt returned for PPD check & was having no problems;18OCT95 woke up vomiting, had elevated temp & weakness;In full arrest on arrival @ ER;deceased;blood culture & preliminary autopsyconfirm meningococcal meningitis
Soreness (left arm); Slight headache; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to soy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included loratadine (MANUFACTURER UNKNOWN), metronidazole (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE) and unspecified vitamins; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 19:00, the patient experienced soreness (left arm), slight headache and lethargy. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness (left arm), slight headache and lethargy were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
BODY ACHES; SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and sore arm. This report was non-serious.
This spontaneous report was received from an office manager and medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 13-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent (manufacturer unknown), lot number reported as M033585, expiration date: 21-APR-2019 was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered dose of VARIVAX was stored at temperature between 15 Fahrenheit degrees to 46 Fahrenheit degrees (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015679: US-009507513-1705USA015681: US-009507513-1705USA015682: US-009507513-1705USA015683.
12 hours after vaccination pt woke up with excruciating pain at injection site (L deltiod), fever, and malaise. 3 days following vaccination erythema and induration developed at injection site. At time of evaluation labs show increase in WBC, left shift, and ultrasound negative for abscess. Diagnosis: cellulitis. No response after 3 doses of PO Bactrim Rx. Admitted to Inpatient Care 6/23/13 for pain management and IV clindamycin Rx.
1.5 hrs of extreme irritability following DTP vax; blotchiness but no urticaria occurred near inject site & on face;
I developed a case of herpes zoster on my left flank area; This is a spontaneous report from a contactable physician. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 20Dec2020 01:15 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, coronary artery disease, asthma, hypertension, and gastrooesophageal reflux disease (GERD). Concomitant medications included irbesartan, sulfasalazine, and hydroxychloroquine. The patient previously took lansoprazole (PREVACID) and experienced drug allergies. On 28Dec2020, the patient developed a case of herpes zoster on his left flank area. Therapeutic measure was taken as a result of herpes zoster that included valaciclovir (Valtrex). Clinical outcome of event was recovering.  Information on lot/Batch Number has been requested.
1ST DOSE ADMINISTERED TO PT PAST 6HOUR TIMEFRAME FROM VIAL PUNCTURE. ATTEMPTED TO CONTACT PT VIA PHONE AND LEFT VOICEMAIL. AFTER FOLLOWING CDC GUIDANCE TO ATTEMPT MANUFACTURER AND NO INFORMATION. WILL TRY TO GET PT IN ASAP TO RECEIVE DOSE AGAIN TO COUNT AS FIRST DOSE.
Patient Mother called said her son leg was swollen he presented to clinic with some swelling on his right leg bandage was tight tried to remove bandage patient did not handle the removing of bandage well. Upon removal of bandage noted reddened area at bandage site, Injection site was noted to be swollen with no redness and it was cool to touch patient's mother was instructed by License Nurse to give ibuprofen and apply warm compresses to leg pt was also schedule a appointment to see Dr. in clinic on Monday June 25. Patient mother given instructions to watch increase swelling and redness to injection site and to present to ER if needed.
2/26 97.5 deg C. A few spots behind ears. A few rashes on stomach Doc Dx-ed reactions she is fine. Temp 102 deg F. No appetite.
Tachycardia and Typical atrial flutter observed intermittently from Sept 27 thru Oct 13 , Ablation performed,  Oct 14, 2022.
Given flu shot 9/21/10 (treated for sinusitis 9/16/10 but afebrile of 9/21/10). Returned 9/27/10 c/o pain on (R) side but under arm (not at flu shot site) that he said started day after flu shot & so thought soreness was due to it. Had herpes zoster on (R) back & under (R) arm 9/27/10.
3 inch red, swollen, hot area on left upper thigh, no discomfort and gait problems
Took vaccine on 1/21/21. Symptoms on 1/23/21 included widespread rash, lips swelling, hives, dizziness, trouble breathing. Received epinephrine, steroids, benadryl.  Diagnosed with acute anaphylaxis due to possible allergy to Polyethylene Glycol
Severe headache approx 4 hours after the shot. Advil relieved the headache. Some hives on the chest right below the neck. Dizziness and lightheadedness approx 8 hours after the shot. Went away by the next morning.
Started with rash on left hand, then on left forearm developed a spotted pin prick red rash. About 5 minutes later, my throat started to swell up. I took liquid children's Benadryl which helped the rash go away and the throat swelling to go down. About an hour total trying to figure out what to do.
A few minutes after receiving the vaccine pt became lightheaded and pale, did not lose consciousness, and condition resolved after a snack and fluids, since this time has remained dizzy and weak, heart beating irregular and rapid, leg spasms, weight loss.
SkinRash, Rash, Awoke with flat, red rash to abdomen and back Narrative:  Other Relevant History:
Felt bad but went to work; Panic feeling; Extreme nausea; Anxiety; Facial swelling; Warm tingling at the injection site; Left arm swelling; Hot all over the body; Pulse was up; Blood pressure up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Facial swelling) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fever. Concurrent medical conditions included Asthma and Pollen allergy.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SWELLING FACE (Facial swelling) (seriousness criterion medically significant), PARAESTHESIA (Warm tingling at the injection site), PERIPHERAL SWELLING (Left arm swelling), FEELING HOT (Hot all over the body), HEART RATE INCREASED (Pulse was up), BLOOD PRESSURE INCREASED (Blood pressure up), ANXIETY (Anxiety) and NAUSEA (Extreme nausea). On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt bad but went to work) and PANIC REACTION (Panic feeling). At the time of the report, SWELLING FACE (Facial swelling), PARAESTHESIA (Warm tingling at the injection site), PERIPHERAL SWELLING (Left arm swelling), FEELING HOT (Hot all over the body), HEART RATE INCREASED (Pulse was up), VACCINATION COMPLICATION (Felt bad but went to work), ANXIETY (Anxiety), PANIC REACTION (Panic feeling) and NAUSEA (Extreme nausea) outcome was unknown and BLOOD PRESSURE INCREASED (Blood pressure up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 140/98 (Inconclusive) 140/98 mmHg and 182/108 (Inconclusive) 182/108 mmHg. On 08-Jan-2021, Heart rate: 118 (Inconclusive) 118 beats per minute and 132 (Inconclusive) 132 beats per minute. On 08-Jan-2021, Respiratory rate: 24 (Inconclusive) 24 breaths per minute.     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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-005905 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: follow up received on 14-Apr-2021 included historical condition (asthma and fever), Allergically condition pollen allergy, lab data (blood pressure, heart rate and respiratory rate), concomitant medications (Symbicort Inhaler), treatment medication (Benadryl and Xanax), event (Panic Feeling).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-005905:
Arm become very sore and hot from site of injection into left side of breast and left side of shoulder. Also slight fever. Next day muscles throughout body were very achy.
Day 9 - itchy spot on injection site Day 10 - large area on arm red and hot to touch, no pain, took Benadryl Day 11 - red spot getting larger and darker, no pain, took Benadryl Day 12 - red spot redder than previously with raised edges, hot to touch, took Benadryl  Day 13 - adding slightly Day 14 - faded overnight
No other AE reported; received a third dose of PROQUAD; This spontaneous report has been received from nurse concerning  a 6 years-old male patient. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.      On 02-NOV-2020, the patient was vaccinated with the third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  formulation not reported but defaulted to subcutaneous injection,  Lot # T013541, expiration date 17-OCT-2020,  for prophylaxis (patient route of administration was not reported).        No other adverse event (AE) was reported.
Case number PHEH2014US025038, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 41-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 26 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2015 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Information has been received from a nurse concerning a 12 year old female who in July 2008, was vaccinated with the third dose of GARDASIL. In July 2008, the patient passed out 1-5 minutes after her 3rd dose. Subsequently, the patient recovered immediately after gaining consciousness. The patient sought medical attention and saw nurse. No further information is available.
They give expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They give expired vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They give expired vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (They give expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator on 11-Nov-2021.   Date(s) and time(S) vial was first punctured: 10 AM on 18-Nov-2021.   Date(s) of administration of vaccine on 19-Nov-2021.   The vial was stored in fridge post puncture. the vial was not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 2-3 hours  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reproted that doses of VARIVAX (Merck) (Lot # not provided) which were exposed to unknown temperature conditions, had been administered to unspecified patients on unspecified dates since November 2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Started having a weird feeling in her left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Lot number: EN6208) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Had Covid right before having the first dose of the vaccine" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose, NDC/Expiry Date: Unknown; Lot Number: EN6203; Vaccine given in the left arm), administration date: 27Feb2021, when the patient was 43-year-old, for COVID-19 immunization, reaction(s): "felt extremely sick", "Had Covid right before having the first dose of the vaccine". The following information was reported: LIMB DISCOMFORT (non-serious) with onset Sep2021, outcome "unknown", described as "Started having a weird feeling in her left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that she had her first dose of the vaccine 27Feb of last year. States that she had Covid right before she got that vaccine. States she understands that now they tell you to wait 90 days after Covid to get the vaccine, but at that time, they were just telling you to get the vaccine. Caller states that she felt extremely sick after that first vaccine, by the time she started to feel better; it was time for her second vaccine. Caller states that in Sep she started having a weird feeling in her left arm. She received her booster dose of the vaccine on 22Oct2021. Caller states that a week after that, from her wrist up to her forearm on her left arm, looked like an elephant leg. Over 10 days later it was still inflamed, she went to the doctor and they sent her to orthopedics. Orthopedics did x-rays and said it was inflamed. Caller states that she hadn't gotten hurt. Orthopedics didn't know what it was so they sent her for an ultrasound to check for blood clots; there was no blood clots. They said she had calcification in her left arm. They started her on pain management. Caller states that her thumb, small finger, and fingertips on her left hand are all completely numb. The area from her wrist to her elbow is still inflamed. She takes unspecified pain medications. Caller states she cannot just keep going with this, she owns a preschool. Caller says that the CT Scan that was done by neurology showed the calcification. Caller states that she has heard some other people have this reaction in their arms and legs; She doesn't know if it is swollen up against a nerve and that's why she has the numbness in her fingers, or what.  Follow-up attempts are completed. No further information is expected.
Client and foster father returned to office approximately a half hour after immunization administration reporting that the client was scratching her chest. CLient's upper chest appeared red from scratches and witnessed client trying to scratch her chest. Immunization sites examined with RN and skin around injection sites where varicella and MMR were given appear bright red. Client appeared to be in no acute distress, no crying noted, and no dyspnea noted. Instructed client's foster father to have child examined by a healthcare provider as soon as possible. Client's foster father verbalized understanding and took client to nearby urgent care where she received treatment.