chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(RN assessment of client and speaking with the parent) Client had booster administered on 8-16-21, mom came in with child stating child's left leg has been hurting her and she has been experiencing some chest tightness since receiving the Tdap vaccine on 08/16/21. Mother never mentioned taking child to f/u with healthcare provider for concerns/issues. Mother denied child having any other issues today. Child limped in room but did not appear to be in any distress. Any side effects of swelling, severe pain at the site, bleeding, troubling breathing, headaches, vomiting, diarrhea, or hives were not expressed as an issue during the conversation. I encouraged mom to f/u with child's pediatrician but she said it would take too long to get an appt. Discussed taking the child to an urgent care but mom stated urgent care facilities have long waits and are nasty. Explained to mom we do not have doctors here and she would need to take her daughter to f/u with a MD.    I (RN) f/u with a phone call to the clients mother to find out which leg and when did the symptoms start. Mom stated via phone call that her daughter c/o of her chest tightening Tuesday 8-17-21 and mom stated "I just chalked it up to be her asthma." I asked her which leg it was her daughter is limping on and she said "It's her left leg and she told me that she could not bend it backwards", I told her that she may want to follow up with her pediatrician and she said "it takes too long to get in with them for an emergency". Mom said she did take her daughter to an urgent care center near the Health Department  but they did not find anything. I said ok.
Marked hyperemia & tenderness to lt upper arm & elbow; no fluctuation noted; joint appears less mobile then rt; pt non-toxic;
Pt came in - she had a reaction on arm (red and itchy). She was dizzy, lightheaded, had diarrhea and tingling. Pt went to MD office and MD prescribed antibiotics and a cream.
2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhea and vomiting; 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhea and vomiting; 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhea and vomiting; 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhea and vomiting; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for herself that. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, on 26Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 2 days after that or 2-3 days after that she experienced low grade fever, body ache diarrhoea and vomiting on Apr2021. She wanted to report that and she would like to know as well that would be normal for her to experience was it normal these kind of adverse events after 2-3 days of getting the first dose of the vaccine. Patient stated, I just want someone to simply tell me that was it normal to have side effect 2 days after the vaccine and diarrhoea was one of them. That's all I need to know. The outcome of the events was reported as unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Weakness and numbness in extremities at first. Then complete paralization of body limbs and organs. She was put on life support.
Fatigue; Headache; Joint pain; Knees inflamed and very red and hot to the touch; Both knees swollen; This is a spontaneous report from a contactable consumer, the patient. A 70 years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in the arm left on 12Mar2021at 10:45 (at the age of 70-years-old) as a single dose for COVID-19 Immunisation. Medical history was reported as high blood pressure, high cholesterol and hypothyroidism. Concomitant medications were reported as Fosamax (MANUFACTURER UNKNOWN), Norvasc (MANUFACTURER UNKNOWN), Trazodone (MANUFACTURER UNKNOWN), Efferox (MANUFACTURER UNKNOWN) and Synthroid (MANUFACTURER UNKNOWN) for an unknown indication from unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via an unspecified route of administration in the arm left on 19Feb2021 at 09:45 (at the age of 70-years-old) as a single dose for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19. The patient had allergies of penicillin and flu vaccine. On 12Mar2021 at 16:00, the patient experienced fatigue, headache, joint pain, both knees inflamed (joint inflammation) which was very red and hot to the touch with swollen (knee swelling). The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, headache, joint pain, joint inflammation and knee swelling were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
all of his lymph nodes were swollen under his arm and in his neck; joints were swollen; Huge bump on his arm at the injection site; his fingers are swollen; fever of 101; General feeling of unwell and malaise; This is a spontaneous report from a contactable healthcare professional (patient's wife). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 03Mar2021 at about 15:00 (lot number: EN6201 and expiration date: 30Jun2021) at a single dose, received at the hospital for COVID-19 vaccination. Medical history included chronic inflammatory demyelinating polyradiculoneuropathy and patient was immunocompromised. The patient's concomitant medications included immunoglobulin human normal (IMMUNOGLOBULIN [IMMUNOGLOBULIN HUMAN NORMAL]) from 02Mar2021 to 02Mar2021 for chronic inflammatory demyelinating polyradiculoneuropathy. The patient previously received flu vaccine on 15Oct2020. The patient's wife called to report on the side effects that the patient was experiencing after he received the Covid-19 Vaccine. The patient had a fever of 101 started at about 23:00 on 03Mar2021 (his regular base temp is about 97). At midnight of 04Mar2021, all of his lymph nodes were swollen under his arm and in his neck; even in his fingers were swollen. Also noticed that his joints were swollen and had a huge bump on his arm at the injection site on 04Mar2021 after midnight last night. The reported added that patient also had a general feeling of unwell and malaise on 03Mar2021. The patient received treatment for the events. Outcome of the events was not recovered. The events were reported as serious (other medically important condition) and considered related to COVID-19 vaccine (source of assessment was primary source reporter and method of assessment was global introspection).; Sender's Comments: Based on available information, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded due to temporal relationship and current known drug safety profile.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The first night, around 06:00-07:00 pm, I had pretty intense muscle pain/myalgia. Joint pain; 101 degrees, chills and headache - these lessened but still continued into unspecified day- Fatigue and Muscle pain lasted the whole 12 days.   (. Unspecified date in the night into the next day - I had stomach pain ,nausea, diarrhea, dizziness and I decided to go to unspecified hospital - symptoms were getting worse. They gave me an IV treatment.  They provided my the IV because I was dehydrated and then told me to wait it out.
Injection given 9/18/09 3pm in L deltoid - tongue numbness @ 24 - 48 hours. Following injection L facial paralysis began 9/29 - hospitalization 9/30/0911/9/2009 ED records from 9/30/2009. Patient with c/o's lt facial numbness/tingling, tongue numbness, lt side eyelid and mouth droop. Tx: labs and dx tests norm. DCd with Valacyclovir and prednisone. F/up with PCP and a Neuro consult. DC Dx Bell's palsy.
Intermittent dizziness since 4pm on day of vaccine. Still continuing as of May 8 2pm. Difficulty concentrating and brain fog still continuing as of May 8 2pm. Shaking chills on and off through May 7 3pm. Fatigue through May 7 10pm.
Patient was given the pediatric vaccine undiluted.  Because it was undiluted it is still 30mcg in 0.3 ml
Approximately 10 minutes after patient had received her 1st COVID-19 Vaccine she states she started to see spots and was feeling weak/dizzy and she proceeded to pass out.  Family members and Pharmacist guided patient into a chair where she did not respond to verbal commands, patient was breathing normally and eyes remained open. Patient came to after approximately 10 seconds and was shaken up/scared, but overall feeling ok. Patient stayed in facility and saw provider, noted that BP was low at 88/40mmHg. Patient also had blood sugar checked which was 101 and BP was rechecked and was 90/50mmHg. Patient reported she had not ate all day and was nervous about receiving a shot. Provider determined that patient had returned to baseline and she was ok to go home.
Pain, redness, swelling and lesions at the injection site and now developed skin lesions in other areas.
Foggy mind, red circle the size of a softball with a hard lump, itchy Started noticing on Wednesday 3/34/2021, cleared Tuesday 3/30/2021
runny nose; temperature of 99.3°F; covid arm: red; 3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy; Exuberant immune response; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), PYREXIA (temperature of 99.3°F) and VACCINATION SITE ERYTHEMA (covid arm: red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Overweight, Diabetes and Iodine allergy (iodine in shellfish).    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE ERYTHEMA (covid arm: red) and VACCINATION SITE SWELLING (3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and PYREXIA (temperature of 99.3°F). At the time of the report, RHINORRHOEA (runny nose), VACCINATION COMPLICATION (Exuberant immune response), VACCINATION SITE REACTION (Covid arm), PYREXIA (temperature of 99.3°F), VACCINATION SITE ERYTHEMA (covid arm: red) and VACCINATION SITE SWELLING (3 inch bulge size in injection arm,2 inch bulge size in the arm were they had put the Moderna under skin to test allergy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (High) 99.3°F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative on Sunday.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She had 1 Moderna COVID-19 vaccine on 02Dec2021 and was due for her second one on Thursday 06Jan2022 but her husband has COVID so she is quarantined now and won't be able to get the second dose on 06Jan2022. She had anaphylaxis before to another injection so when she got the Moderna shot they watched her for over 2 hours, but she did not have reactions then. From that past anaphylaxis they had determined she had allergy to iodine in shellfish. Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-438841 (Patient Link).
BlurredVision, Myalgia, Arthralgia, decreased sense of taste; joint pain on left side; fatigue  Narrative:
rash is from her elbow down to her arm and is not itchy/skin irritation on arm of vaccination; This is a spontaneous report from a contactable consumer reporting for his wife. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 11Feb2021 (Lot Number: Unknown) via an unspecified route of administration for COVID-19 immunisation. In Mar2021, the patient experienced skin irritation on the arm that she received the vaccination, and rash is from her elbow down to her arm and is not itchy. The husband reported it has been 5 days since she had the second dose of BNT162b2 (given on 04Mar2021) and she had skin irritation on the arm that she received the vaccination. The rash is from her elbow down to her arm and is not itchy. She has applied hydrocortisone cream and it worked a little bit. The patient is not in pain, and it is not really irritating her. The outcome of the event, rash is from her elbow down to her arm and is not itchy/skin irritation on arm of vaccination was unknown.   Information on the lot/batch number is requested
redness measuring 70 x 70 cm , itchiness, hard dense area measuring 40 x 50 cm and soreness to touch that started 24 hours after vaccine given.  Afebrile.
Woke up with extreme shoulder pain during the night that has not gone away in the days since. I have an inability to raise my arm above a certain level, and the pain is strong enough that I?m having difficulty sleeping.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a male patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: HAVRIX that was at 17 F was administered. No other information available. This case is one of the 2 cases reported by the same reporter for the same vaccine.
A report was received from a health care professional on 1/15/02 regarding a 16 month old male patient who had an off label use and subsequent overdose after receiving a Fluvirin vaccine on 12/5/01. The patient did not demonstrated any untoward effects at the time of administration and the patient's mother was instructed to monitor the infant for unusual problems/behavior or symptoms. She has not reported any to the doctor or reporter. On 12/5/01, the patient received 0.5ml (adult dose) of Fluvirin vaccine instead of 0.25ml (child's dose) this represents an off-label use as Fluvirin is indicated for use in children 4 years and older. There were no adverse events reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment.
Patient reported that he experienced myalgia, fatigue, shivering, a fever, and a headache.  This occurred twelve hours after the administration of the vaccine.  All symptoms have subsided in 12 hours since they began except for his headache which he is taking ibuprofen to relieve.
made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: made me sick). The outcome of the sickness was recovered/resolved (duration 24 hrs).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Mar-2023 The case was received from the patient via interactive digital media. The patient just got his or her shingles booster shot and it made him or her sick for 24 hours. The patient stated better than getting shingles. The follow-up could not be possible as no contact details were available.
Numbness in his arm / on and off numbness in face; Tingling in arm/ on and off tingling in face; Pain in my arms and hands; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in my arms and hands), HYPOAESTHESIA (Numbness in his arm / on and off numbness in face) and PARAESTHESIA (Tingling in arm/ on and off tingling in face) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had no allergies. The patient never had COVID positive test or diagnosis.     On 16-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced PAIN IN EXTREMITY (Pain in my arms and hands). On 20-Nov-2022, the patient experienced HYPOAESTHESIA (Numbness in his arm / on and off numbness in face) and PARAESTHESIA (Tingling in arm/ on and off tingling in face). At the time of the report, PAIN IN EXTREMITY (Pain in my arms and hands), HYPOAESTHESIA (Numbness in his arm / on and off numbness in face) and PARAESTHESIA (Tingling in arm/ on and off tingling in face) had not resolved.            No concomitant medications were provided.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient received first dose, second dose, third dose and fourth dose of Moderna but details were unknown. It was reported that after vaccination, 2 days later patient started experiencing pain in patient's arm and hands. Patient also started having numbness and tingling in patient's arm. 2 days after this, patient started getting on and off numbness and tingling in patient's face. It had been about 10-11 days and patient's symptoms have not subsided. patient was not sure if this was due to the Moderna bivalent vaccine and wants to find out what the possible side effects could be. He will be seeing patient's family physician for further evaluation regarding the symptoms. The patient does not experienced a similar event in the past.  No treatment medication was provided.   Reporter did not allow further contact
Client received her first dose of Pfizer vaccine and during the post-vaccination wait period, she complained of chest pain/tightness. She described the pain as dull. She stated that she has a history of allergy to penicillin. She also has high blood pressure, but missed a dose today. She takes medication for anxiety as well. She was immediately evaluated by EMT personnel on site, and ?911? was called. She was evaluated by the emergency personnel for 30 minutes inside the ambulance and then transferred to the hospital
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On or about 19-JAN-2016, the patient was treated by a physician for shingles, as the patient was diagnosed with shingles or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, included but not limited to : mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.
Loose stools; Vaccination site Pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stools) and VACCINATION SITE PAIN (Vaccination site Pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease since an unknown date. Concomitant products included SENNOSIDE A for Parkinson's disease.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site Pain). On 11-Feb-2021, the patient experienced DIARRHOEA (Loose stools). At the time of the report, DIARRHOEA (Loose stools) and VACCINATION SITE PAIN (Vaccination site Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Narrative: COVID infection following COVID vaccine series 01/14 vaccine dose#1 02/02 COVID vaccine dose # 2 11/05c/o Chills, headache, Loss of taste or smell. Myalgias, Rhinorrhea, test POSITIVE for COVID 11/07 Headache and SOB improving 11/08 Mild dry cough, rhinorrhea 11/10 mild cough, loss of taste and smell, improved rhinorrhea 11/11 dry cough, fatigue, SOB 11/12 dry cough, fatigue, SOB 11/13 Cough, fatigue. loss of taste or smell, Rhinorrhea,SOB: improving CLINICALLY RESOLVED
6PM day of - brief metal taste in mouth and pain in lower front teeth. Severe headache, weak, nervous feeling, sore right arm and swelling and hot skin at injection site. that night joints and body felt like a severe flu. Missed two days of work. Very bad headache for 2 days, no energy and continued joint pain. Fourth day headache eased off by half, arm swelling started going down, still warm to touch. Continued to ease off until day 7 when I went to ER with pain in left chest possibly unrelated.