chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A week after the shot, the injection area was itching. I scratched it and the injection spot turned white. There was one small hive under the injection spot. It went away after after 10 minutes. I think my clothes irritated it? Still some slight discomfort in left arm in different areas in muscles. I did not exercise my left arm after the shot. Now when i exercise the arm the discomfort goes away. Its much better yesterday and today
sore arm; neck stiffness; neck stiffness and aches; aches/ Pain; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm, stiff neck, neck pain and pain. On an unknown date, the outcome of the pain in arm, stiff neck, neck pain and pain were unknown.   It was unknown if the reporter considered the pain in arm, stiff neck, neck pain and pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The office manager stated that her son had gotten the 2nd dose of Bexsero and experienced a sore arm, neck stiffness, and aches and pains but mentioned he did not have fever.
Sore right arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore right arm) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     Patient had no allergies. Patient had no medical history relating to mentioned adverse effect and both Acute and Chronic illnesses at the time of vaccination.  Concomitant products included ASCORBIC ACID (VIT C) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Sore right arm). At the time of the report, PAIN IN EXTREMITY (Sore right arm) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis. No treatment medications were reported.   This case was linked to MOD-2022-629048, MOD-2022-629049 (Patient Link).
Tested positive for Covid 19; A Spontaneous report was received from consumer concerning a female patient of 66 age who received Moderna COVID-19 vaccine (m-RNA-1273) and Tested positive for Covid 19.  The patient has no medical history and no relevant concomitant medications.   On 26-Jan-2021, prior to the onset of the events the patient received their first of dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.   The events positive for Covid 19 were unknown. The outcome of the events is unknown.   Action taken with mRNA-1273 in response to the events was not reported.  Based on comment, COVID-19 Causality Not applicable
Uncontrollably crying, seizure like activity, non responsive to noise or touch, no longer making eye contact or making cooing noises, loss of physical skills.
Patient called the HD to report she was having a fever, cough and congestion, patient states that the fever started 2 days before she was given the vaccine.  She states it has progressively gotten worse and this morning 10/9/2020 she stated she went to the ER, the ER preformed a chest X-ray and was COVID tested and told to quarantine until results were received.  Patient states she did not develop any new symptoms after she received the flu vaccine, but her the symptoms of cough/congestion and fever did progressively get worse.  Patient did not have any of these symptoms while in the clinic receiving the vaccine.
Little red rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Little red rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Little red rash). At the time of the report, RASH ERYTHEMATOUS (Little red rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.   Reporter did not allow further contact
Low Immunity; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS (Low Immunity) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included INFLIXIMAB (REMICADE) and MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED IMMUNE RESPONSIVENESS (Low Immunity). At the time of the report, DECREASED IMMUNE RESPONSIVENESS (Low Immunity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No Treatment Medications were provided.
Patient fainted after receiving GARDASIL vaccine came to quickly but in falling out his (R) ear. States he has fainted before w/ vaccination.
Pain, redness, swelling and hives at the site of injection (left arm). Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collar; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck, and left collarbone; Pain, redness, swelling and hives at the site of injection (left arm); Pain, redness, swelling and hives at the site of injection (left arm); Pain, redness, swelling and hives at the site of injection (left arm); heart palpitations; weakness; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EH9899) intramuscularly at the left arm on 16Dec2020 12:45 at a single dose for covid-19 immunisation. Medical history included migraine from an unknown date.  The patient's concomitant medications were not reported. On 16Dec2020 15:45, the patient experienced Pain, redness, swelling and hives at the site of injection (left arm). It was further reported that the pain spread out from the injection site to the left shoulder blade, side of arm, left ribcage, left side of neck and left collarbone. The patient also experienced weakness, dizziness and heart palpitations on 16Dec2020 15:45. The events were reported as non-serious. The patient did not receive treatment for the reported events. Outcome of events was not recovered.
15 month old female patient administered expired dose of Daptacel, no AE; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 month old female patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 23-Sep-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date: 20-Sep-2020) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
I didn't get any swelling around the injection sight, but I got swelling in the lower and mid area of my armpit. Maybe the lymph nodes are just reacting to the shot. Just wanted to report just in case it hasn't been recorded yet.
Tongue became numb; Difficulty swallowing; Chest pain; Hives; This is a spontaneous report from a contactable health care professional (patient). A 26-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 17Sep2021 at 11:30 (lot number was not reported) as dose 1, single for COVID-19 immunization.  Medical history included multiple sclerosis and allergies to almonds and apples all from unknown dates. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included dimethyl fumarate (TECFIDERA) and bupropion hydrochloride (WELLBUTRIN) both taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in four weeks. The patient previously took iodine and experienced allergies. On 17Sep2021 at 11:45 (also reported as within 30 seconds of receiving the shot), the patient's tongue became numb, had difficulty swallowing, chest pain and hives. The events resulted in a visit to the emergency room/department. The patient received steroids as treatment for the events. The outcome of the events was recovering.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Hypoaesthesia oral, Dysphagia , Chest pain, Urticaria cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Nose and eyes itching, flushed face, closing throat, respiratory distress. Epinephrine and Benadryl given, 4:00 PM. Methylprednisolone - 6 days.
Severe chills, muscle aches, headache, nausea,  -missed 2 days of work
Adverse event: Loss of balance including numbness in feet and legs that traveled upward toward the waist. BPH symptoms with lower sensory weakness and numbness.   Treatment includes: 300 mg Gabapentin X 4 times a day / Meloxicam 15 mg 1 X per day ; reflexology and acupuncture  Outcome: Ongoing no relief
This spontaneous report as received from a Licensed Practical Nurse refers to 2 unspecified patients of unknown age and gender. Concomitant medication and current conditions were not reported. On 02-DEC-2014, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported). Concomitant medications were not provided. No adverse effects reported for any patient. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a female who was vaccinated with a first dose of GARDASIL.  Subsequently the patient experienced arm pain during her first injection.  The patient present status was unknown at the report time.  A call received from the nurse mentioned that she did not remember which patient experienced pain following GARDASIL vaccination as this incident occurred several months ago.  She would try to go back through patient records and identify the patient.  If she can find the patient, she will call back with specific details including patient name, date of birth, vaccination dates/lot numbers, AE onset date, patient outcome and / or status, etc.  This is one of several reports from the same source.  Additional information has been requested.
The pt experienced high pitched crying for 5 hours and was inconsolable. No fever was present. The following day, he was irritable and hoarse. An exam revealed no other source.
During a review it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Under armpit there is a swollen area; Swelling and tender in the left arm; Swelling and tender in the left arm; Difficulty in swallowing; Under arm was sore, Tender to touch; Little aching; Fatigue; Headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), MYALGIA (Little aching) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .  Concomitant products included LOSARTAN, VITAMIN D3, CITALOPRAM, ROSUVASTATIN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FAMOTIDINE (PEPCID AC), ZOLPIDEM, CLONAZEPAM (KLONOPIN), OMEPRAZOLE and LEVOTHYROXINE.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), MYALGIA (Little aching), FATIGUE (Fatigue) and HEADACHE (Headache). On 14-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), VACCINATION SITE SWELLING (Swelling and tender in the left arm) and VACCINATION SITE PAIN (Swelling and tender in the left arm). At the time of the report, DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), MYALGIA (Little aching), FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling and tender in the left arm) and VACCINATION SITE PAIN (Swelling and tender in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; generalized chills; head felt heavy; had a temperature of 101 degrees Fahrenheit; left underarm glands were tender and swollen; left arm was sore; felt like she had a bad flu reaction; felt dizzy walking; couldn't sit up; This is a spontaneous report from a contactable consumer, the patient. A 75-years-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 74-years-old) for covid-19 immunisation. The patient medical history included allergy to Naproxyn (Naproxen)-reactions included mouth and lips swell and feeling hot. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that patient received the second and third dose of the Pfizer Covid-19 vaccines. She received the 3rd dose on 02Sep2021 and started having complaints of swelling inside her mouth, lips, fingertips, and toes with generalized chills, her head felt heavy, had a temperature of 101 degrees Fahrenheit, left underarm glands were tender and swollen, left arm was sore, felt like she had a bad flu reaction, felt dizzy walking, and felt like she couldn't sit up.   Caller stated that she had a similar reaction but milder with the second dose of the Pfizer Covid-19 vaccine.  Caller is asking if the 4th dose of the Pfizer Covid-19 vaccine going to be worse.  Caller is asking if other people have experienced what she has experienced. The patient stated that she had a similar reaction but milder with the second dose of the Pfizer Covid-19 vaccine.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Patient received VZV vaccine on 3/27/13. Approximately 1 week later she developed diffuse pruritic rash. She was seen at walk in clinic last week and diagnosed with eczema. At visit with PCP on 4/29/13 d/t presentation and onset, diagnosis was likely d/t side effects of varicella vaccine. Prescribed BENADRYL.
Found in home by friend who said patient was unable to get off the couch. Test positive for COVID on admission. Treatment includes admission with isolation, assessment and lovenox.
Onset of itching 24 hours after varicella immunization, redness, inflammation, swelling at injection site next day. Patient provided with antibiotics.
pt recvd vax & devel swelling about 2 days p/vax; pt appears to have an abscess on lt arm @ inject site; lt arm is red, hard about 1in in diameter;
pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe/lower lumbar pain; dull headaches; Some night sweats; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265) on left arm intramuscularly from 28Jan2021 15:00 (03:00 PM) at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), allergies to trees, pollen, grasses and latex. Concomitant medication included omeprazole (PRILOSEC), sucralfate (CARAFATE), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , minerals nos/ vitamins nos (OPTISOURCE CHEWABLE VITAMIN & MINERAL SUPPLEMENT). There was no other vaccine in four weeks. The patient historical vaccine included bnt162b2 (lot number: EL1284) for first dose on 04Jan2021, 03:00 PM, Intramuscularly, left arm, for covid-19 immunisation. The patient previously took metoclopramide (REGLAN), pethidine hydrochloride (DEMEROL) and hydrochlorothiazide (HCTZ) and all had allergies. On 29Jan2021, 02:00 AM, 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe it caused me to pass out. In Jan 2021, 20 hours to 48 hours post injection continued to have dull headaches and lower lumbar pain achy at this point. Some night sweats. The vaccination facility type is hospital. There was no covid prior vaccination and covid tested post vaccination. There was no treatment for the events. The events were not result in emergency room visit or physician office visit. The outcome the events recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the event back pain and loss of consciousness are possibly related to suspect vaccine BNT162B2 administration.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.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. During 2016, the patient was treated at the Health Center for a burning vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Almost 12 hours post-injection, I experienced a rapid onset fever, soreness, muscle aches, dizziness, high blood pressure, headache. Upon awakening the following day (today, 20 hours post injection) severe allergies around eyes.  24 hours post injection, all day today, fatigue, severe dizziness, soreness, headache, high blood pressure, loss of appetite, and labored breathing.
FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021 after primary shot, the patient experienced fatigue (dose number in series 1).  On 15-DEC-2021, the patient received booster dose. No adverse events were reported (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.