chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches, pain, and chills that were minor but not fever. He is now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping.; it's hard to walk; muscle aches, pain, and chills that were minor but not fever. He is now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping.; muscle aches, pain, and chills that were minor but not fever. He is now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping.; muscle aches, pain, and chills that were minor but not fever. He is now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization, carbamazepine (TEGRETOL), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. Medical history included ongoing diabetes; ongoing congestive heart problems; ongoing blood pressure high; ongoing mild kidney disease; ongoing gastroparesis; peripheral neuropathy, pain. Concomitant medication included hydrocodone bitartrate, paracetamol (NORCO) for pain, insulin glargine (LANTUS) for diabetes, insulin lispro (HUMALOG) for diabetes, carvedilol (COREG) for congestive heart problem, lisinopril for high blood pressure, spironolactone for high blood pressure, furosemide for high blood pressure, insulin for diabetes. The patient received the Covid-19 vaccine on 18Dec2020. After receiving the vaccine he had muscle aches, pain, and chills on 18Dec2020 that were minor but not fever. He was now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping. The patient noticed on 20Dec2020 that his left foot it's not muscle tone it's kind of flopping there, it's hard to walk. The patient just took Tylenol and took his normal Narcan and Tylenol nothing in addition and one hot shower but it was more of nuisance. The patient stated that the main thing was that the loss of muscle tone in his left foot, that's what bothers him more than chills and everything like that because it was making difficult to walk and he want to walk around. The patient also stated that one of his health problems was peripheral neuropathy and that was what it just seem to make it why he can't feel his foot at all or he can do was move his big toe just a little bit and it was just kind of due to that. The patient just concerned whether that was supposed to go away in a couple of days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
COVID + Rapid: 3/4 and 3/10; COVID+ PCR: 3/6 (negative); Symptoms 3/4: cough, runny nose, headache and sore throat.; Source: Mother and brother who tested + on 2/26
My arm is itching all over; This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: Unknown; expiry date: unknown), via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took a shot earlier today at Pfizer BioNTech shot and now the arm was itching all over. On an unspecified date in 2021 and when got too low left (Not sure as voice was not clear hence not captured as event) on each hour. The patient reported it was not on all the arm, not gonna itching bad under skin it is an hour ago. The clinical outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Severe injection sure pain, jaw pain, hip pain, headache, palpitations, chills, nausea/vomiting, dizziness, fatigue
5 days later got sore arm and some redness around injection site (like a small rash) no itching, I put ice on it and took Aleve
I started with having a cough, feeling weak, discharging phlegm. I had started feeling better, so I did not think I needed to see a doctor. Then my symptoms came back and I felt even worse. I called to make my appointment with my PCP and was advised to take a home COVID-19 test. The test came back negative. I had a chest x-ray at the doctor's office that came back negative. I was prescribed three medications that I started taking that day. I am feeling much better now.
Itching; itchy lump all over my body my butt, my leg, my arm everywhere my neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and SWELLING (itchy lump all over my body my butt, my leg, my arm everywhere my neck) 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 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching) and SWELLING (itchy lump all over my body my butt, my leg, my arm everywhere my neck). At the time of the report, PRURITUS (Itching) and SWELLING (itchy lump all over my body my butt, my leg, my arm everywhere my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.
-Heart pounding, pins and needles in thoracic area and head -head rushing, pain and strain feeling behind left eye - pinching, squeezing sensation in veins in - heart, calves and head  - extreme fatigue, brain fog, sometimes dizziness -rashes on trunk and groin -grew skin tags from no where -heart pounds and can't sleep and then becomes faint like not there -stomach piercing feeling
This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient received the first of the two COVID-19 vaccines and had an immediate allergic reaction. The patient mentioned a recommendation of not getting a second dose of this vaccine. The patient queried about level of protection would that they'd have long-term after just receiving one dose of this vaccine. Patient asked where would they be able to obtain samples of the ingredients in the vaccine to tell what exactly they are allergic to. The patient went to the allergist. He was at a loss for where to obtain the ingredients. The outcome of event: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
Vomiting; Runny stools; Headache; Weak muscles; Nausea; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: US-ABBVIE-4140883 (Company).  A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 21May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years intramuscular for COVID-19 immunisation; risankizumab (SKYRIZI), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "not recovered"; DIARRHOEA (non-serious), outcome "not recovered", described as "Runny stools"; HEADACHE (non-serious), outcome "not recovered"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Weak muscles"; NAUSEA (non-serious), outcome "not recovered". The action taken for risankizumab was unknown. Additional information: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Causality: The reporter's and Company's opinion on causality for the events of Headache, Nausea, Runny stools, Vomiting and Weak muscles with Risankizumab Solution for Injection was Not Provided. The reporter's and Company's opinion on causality for the events of Headache, Nausea, Runny stools, Vomiting and Weak muscles with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Assessment Results: Skyrizi: Headache, Loose stools, Nausea, Weakness, Vomiting; Market Authorization Holder (MAH), Non-Health Care Professional, Global Introspection, Not Reported Pfizer/BioNTech Covid-19 vaccine: Headache, Loose stools, Nausea, Weakness, Vomiting; Market Authorization Holder (MAH), Non-Health Care Professional, Global Introspection, Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
practice had given 2 vaccines the MENACTRA and the TDAP that had been expired for 3 month/no AE; Initial information regarding an unsolicited valid non-serious case was received from the physician assistant via medical information (Reference number- 00730400) and transmitted to Sanofi on 18-Aug-2021.  This case involves two patients (of an unknown demographics) to whom practice had given 2 vaccines the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE  that had been expired for 3 months (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patients received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) that had been expired for three months (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (same day).  It was reported, "calling to report their practice had given 2 vaccines the MENACTRA and the TDAP That had been expired for 3 months. She wants to know from a healthcare standpoint should they be on the watch for anything and does the patient need to be re-vaccinated. physicians assistant states the expired MENACTRA was given to 2 patients and she doesn't know what brand of Tdap was 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 the 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.
2.5 x 3.0 in Red patch. Thigh - medial to injection site.
01Oct96 Pt recv 1 dose vax. 01Feb98 Pt devel mild case varicella w/approx 18 lesions. MD noted lesions typical vesicles.
Achy 12:30 am ( 11 hours after shot ) fever 3 am, 6 am nauseous, 7 am  nauseous and headache ,  headache all day and nauseous , 7- 1130 pm  dizzy and vertigo   Then I was better.  The next day felt general malaise and out of sorts.  No specific symptoms. 48 hours later no symptoms
Right arm pain in lymph nodes in underarm; Pain radiating from shoulder to fingers; Fingers numb; Fingers numb and tingling; Pain on right side of body below shoulder; Right arm pain increases as the day goes on and with use.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 20Mar2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer in 2012, lymphoedema in left arm and mastectomy bilateral in 2012. The patient had no known allergies to medications, food, or other products. Concomitant medications included tapentadol hydrochloride (NUCYNTA) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN602) via an unspecified route of administration in the right arm on 27Feb2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 28Mar2021 at 14:00, the patient experienced right arm pain in lymph nodes in underarm, pain radiating from shoulder to fingers, fingers numb and tingling, pain on right side of body below shoulder and right arm pain that increased as the day went on and with use. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with prednisone, advil 800 mg, every 4 hours and tylenol 1000mg in between. The clinical outcome of the events right arm pain in lymph nodes in underarm, pain radiating from shoulder to fingers, fingers numb and tingling, pain on right side of body below shoulder and right arm pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever, myalgia, vomiting, localized rash, swelling, sign of inflammation over injection site.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (side effects after second vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (side effects after second vaccine). At the time of the report, vaccination complication (side effects after second vaccine) outcome: unknown. No concomitant medications and treatment information provided.
Pt had PREVNAR 9/2016 and accidentally got PREVNAR again 9/24/2017 when she should have and wanted to get PNEUMOVAX. Haven't been able to get ahold of pt yet to see if any symptoms.
Red rash on left arm that extends 2 inches from injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash on left arm that extends 2 inches from injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Red rash on left arm that extends 2 inches from injection site). At the time of the report, VACCINATION SITE RASH (Red rash on left arm that extends 2 inches from injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Tested positive for covid after 1st dose; Very sick and thought it was a bad cold; Congested; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid after 1st dose), NASOPHARYNGITIS (Very sick and thought it was a bad cold), NASAL CONGESTION (Congested) and FATIGUE (Feeling tired) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Jan-2021.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced NASOPHARYNGITIS (Very sick and thought it was a bad cold), NASAL CONGESTION (Congested) and FATIGUE (Feeling tired). On 22-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid after 1st dose), NASOPHARYNGITIS (Very sick and thought it was a bad cold), NASAL CONGESTION (Congested) and FATIGUE (Feeling tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
induration at the injection site; left arm sore; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 21st January 2020, 1 days after receiving Shingrix, the patient experienced injection site induration, injection site pain and tiredness. On an unknown date, the outcome of the injection site induration, injection site pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site induration, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix dose on left arm and next day, developed tiredness, induration at the injection site and soreness in the left arm. The reporter gave consent for follow up.
Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Chills, muscle and joint pain, and fatigue  from 11:00am. Till 5:00pm the day following the injection
Gave a dose >12 hours post puncture/ 16 hours or longer but less than 24; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a dose >12 hours post puncture/ 16 hours or longer but less than 24) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a dose >12 hours post puncture/ 16 hours or longer but less than 24). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Gave a dose >12 hours post puncture/ 16 hours or longer but less than 24) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
1AUG93 fever,malaise, fatigue then CNS & motor problems; hospitalized by 8AUG93; sx began 3 wks following oral polio vax; dx polio virus;
Patient received expired vaccine. DH and Pfizer recommend revaccination. Patient was contacted to schedule an appointment. Patient scheduled appointment.