chrisvoncsefalvay/vaers-outcomes huggingface dataset:
testing positive for SARS-CoV-2; COVID-19; This is a literature report for the following literature source(s):   A 14-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "genital ulceration" (unspecified if ongoing), notes: first having occurred several months previously following fever, headaches, and body aches.; "presented to the emergency department" (unspecified if ongoing); "severe vulvar pain" (unspecified if ongoing), notes: with 2 days; "ulceration" (unspecified if ongoing), notes: with 2 days; "fever" (unspecified if ongoing); "headaches" (unspecified if ongoing); "body aches" (unspecified if ongoing); "second episode of genital ulceration" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clobetasol for genital ulceration, reaction(s): "She had no improvement", notes: 0.05 percent ointment twice daily; Lidocaine for genital ulceration, reaction(s): "She had no improvement", notes: 2 percent gel; Acetaminophen for genital ulceration, reaction(s): "She had no improvement", notes: oral; Ibuprofen for genital ulceration, reaction(s): "She had no improvement", notes: as needed; Nortriptyline for genital ulceration, reaction(s): "She had no improvement", notes: oral; Lidocaine for genital ulceration, notes: 5 percent ointment; Prednisone for genital ulceration, notes: oral; taper (20 mg twice daily for 5 days followed by 20 mg once daily for 5 days). The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "testing positive for SARS-CoV-2"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: normal or negative; normal or negative; normal or negative.; Antinuclear antibody: normal or negative; Blood immunoglobulin G: normal or negative; Complement factor: normal or negative.; Epstein-Barr virus antibody: negative; Epstein-Barr virus test: negative, notes: performed at the time of her first episode; Faecal calprotectin: negative or normal.; Herpes simplex test: negative, notes: performed at the time of her first episode; HLA marker study: negative or normal.; Ophthalmological examination: negative or normal.; Physical examination: was notable for left labial swelling and 2 ulcerat, notes: 2 ulcerations on the inner aspects of the left and right labia near the introitus; Rheumatoid factor: normal or negative; Rheumatological examination: normal or negative; SARS-CoV-2 test: negative, notes: performed at the time of her first episode; positive, notes: 6 months later.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.,Linked Report(s) : US-PFIZER INC-202200948342 Same article/drug/patient and different event;
Information has been received from a medical assistant (C.M.A.) concerning a 73 year old female with elevated cholesterol and hypertension, and adverse drug reaction to VICODIN and cyclobenzaprine hydrochloride (MSD), who on 13-OCT-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot # 665925/0932Z, expiration date 18-JUL-2011). Concomitant therapy included influenza virus vaccine (unspecified), PREMARIN, unnamed cholesterol medication, TRIAM/HCTZ and atenolol. On 14-OCT-2010 the patient's left arm was "blown up" from the shoulder at the injection site to the wrist. the arm was hot and she had difficulty moving it. The patient was treated with ice and BENADRYL. No lab/diagnostics studies were performed. The swelling was starting to go down today on 19-OCT-2010. The patient received PNEUMOVAX 23 (lot # not reported) in December 2004 and no reaction noted. The patient sought unspecified medical attention. The patient subsequently experienced adverse drug reaction while on therapy with cyclobenzaprine hydrochloride (MSD, WAES # 1010USA02714). This is one of several reports received from the same source. The doctor was requesting a lot check since each patient received the same lot number. The doses were administered by different staff members. The doctor had four more vials of the vaccine and was concerned about using them because of the above reactions. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Received Moderna COVID vaccination 4/1/21. About 27 hours later, he felt muscle spasming across his chest. He then developed neck pain, tingling that goes into right and left arms/fingers. Was started on oral steroids by his PCP on 4/6/21. Given worsening symptoms and new development of urinary retention. Patient was admitted to Hospital 4/8-4/11. Suspected to have cervical transverse myelitis.  Re-admitted 4/12 due to worsening generalized weakness, significant numbness, gait/coordination issues, and several falls. Differential diagnosis includes guillain barre syndrome vs. transverse myelitis. No MS on brain MRI. No cord lesion. Treatment included IVIG 0.5g/kg daily x 4 days, B12, 1 mg IM daily x 3 days. bilateral neural foraminal stenosis at L5-S1.  4/7: MRI cervical spine: Small focal area of increased T2 signal within the central cervical cord at the C2 level without associated postcontrast enhancement. A demyelinating disease is leading differential consideration. 4/11: MRI brain: normal, no de-myelinating disease; MRI C-spine: severe cervical stenosis with flattening of spinal cord but no cord edema/enhancement.
Had anaphylactic reactions about 30 years ago, Then, January 15 received first dose Pfizer and had anaphylactic reaction which resulted in going to ED. Epi administered.  was advised to take Janssen vaccine,  Began with dizzyness which continued in waves BP initially 155/84 HR 80s. Decreased to 129/76, Blood sugar 110
(L) arm swelling, pain, elevated temperature at site for greater than 2 weeks after injection.
She cannot take the vaccine herself due to an allergic reaction; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "She cannot take the vaccine herself due to an allergic reaction". Additional information: The patient wanted to know if the Pfizer COVID-19 vaccine EG.5 was available for her very disabled husband. The patient mentioned that she cannot take the vaccine herself due to an allergic reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a patient who received MENVEO (batch number M16124, expiry date unknown). On an unknown date, the patient received MENVEO .5 ml. On an unknown date, less than a week after receiving MENVEO, the patient  experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to MENVEO. Additional details were provided as follows: It was reported that, the clinic recently changed their meningococcal vaccine from MENACTRA to MENVEO. The patient received the dose 2 days earlier and had redness that was 1 and 1/2 to 2 inches. All the injection site reactions were resolved without further sequelae. The nurse raised concern that there was an increased rate of reactions when compared to what they were used to seeing when they used MENACTRA. In obtaining the lot number for the report, the nurse noted that all doses from that box have been administered. No additional reports from remainder of the doses administered from that box were noted. The case was linked to 2 other cases (US2017GSK119107 and US2017GSK119108), reported by same reporter.
Headache, neck pain, nausea, malaise and local pain and redness (left deltoid).
Patient reported feeling dizzy and lightheaded. She did not take her BP meds in the morning (likely due to lack of BP medication).
First dose: His arm was sore; First dose: He was weak; This is a spontaneous report from a Pfizer sponsored program COVAX US Support via a contactable consumer (patient, self-reported). A 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 20Apr2021, as a single dose for COVID-19 immunization. The reason for no lot number was he lost his vaccine record card. The patient taking Pfizer COVID vaccine because he could be able to go to events and participate in different things, so whenever he was around family, they were not worried and feeling unsafe. He was tired of wearing a mask. The patient's medical history and concomitant medications were not reported. The patient reported that on 20Apr2021, his arm was sore, and he felt weak, after first dose. He clarified that the first dose of the COVID vaccine actually hurt his arm more. After the first dose of the COVID vaccine, he was weak for 2 or 3 days. He did not have many side effects. He lost his vaccine record card. He and his step dad both received the COVID vaccine on the same day. He had his step dad's vaccine record card, so he was able to provide exact dates. Outcome of the events was recovered on 22Apr2021.  Information about lot/batch number has been requested.
Irregular heartbeat for 1-2 days beginning the morning after the vaccine. I also ran 15 strenuous miles that morning but I run almost every day.
within an hour headache.  For two days following the vaccine aches and pains accompanied by chills, much like a flu.  After that cleared, I noticed a pain in my upper chest on the left side.  To this day it is still tender to the touch.
Fatigue; Headache; Chills; Nausea; Low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) had not resolved.            No Concomitant medications were reported.
Sore Injection Site Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-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 VACCINATION SITE PAIN (Sore Injection Site Arm). At the time of the report, VACCINATION SITE PAIN (Sore Injection Site Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
I lost my sense of smell; sense of taste is diminished; head congestion; fever; fatigue; body aches; flu-like symptoms; headache; A spontaneous report was received from a healthcare professional (HCP) concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, head congestion/nasopharyngitis, fever, fatigue, body aches/pain, flu-like symptoms, lost sense of smell/anosmia and sense of taste diminished/ageusia.  The patient's medical history was not provided. No concomitant medications were reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the patient experienced a headache.  On 26 Dec 2020, the patient experienced head congestion, fever (number is not reported) , fatigue, body aches and flu-like symptoms.  On 30 Dec 2020, the patient experienced lost sense of smell and sense of taste diminished. The fever was 99.7 F.  Treatment of the events included Advil.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, headache, head congestion, fever, fatigue, body aches, flu-like symptoms were considered unknown.  The outcome for the events, lost sense of smell and sense of taste diminished were considered not recovered/not resolved.; Reporter'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.
Hives on arms and legs nightly; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on arms and legs nightly) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced URTICARIA (Hives on arms and legs nightly). At the time of the report, URTICARIA (Hives on arms and legs nightly) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: Follow-up received on 13 Jul 2021, contains patient demographic details, patient visited doctors office for reported event.
Information has been received from a physician concerning a patient who was vaccinated po with the third dose of ROTATEQ vaccine live (human-bovine) (date unspecified). The patient subsequently, experienced prolonged diarrhea (date, duration unspecified). It was reported that the patient sought unspecified medical attention. The outcome was not reported. A product quality complaint was not involved. Additional information has been requested.
doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported
My son was given the flu shot (unknown which type, the office isn't answering). The day after receiving the shot in his thigh 3/4 of his leg developed rash like symptoms and was extremely hot to the touch. We drew a perimeter around the area and let him sleep it off. He seems to feel normal and well but the next day the area of infection slightly grew past the perimeter marked and was still hot to the touch. He still seems well but we are monitoring the area. We have him a detoxifying bath today and essential oils topically. Lots of water. We wanted to report this in case it gets worse and in case he develops a sickness as a result. Health care provider recommended cold compress and TYLENOL.
Numbness in arm, foream and fingers; Tingling  in arm, foream and fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in arm, foream and fingers) and PARAESTHESIA (Tingling  in arm, foream and fingers) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No Medical History reported).    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in arm, foream and fingers) and PARAESTHESIA (Tingling  in arm, foream and fingers). At the time of the report, HYPOAESTHESIA (Numbness in arm, foream and fingers) and PARAESTHESIA (Tingling  in arm, foream and fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Fatigue, Joint pain, headache, fever, nausea, diarrhea, lymph node swelling.
Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
shortness of breath appears; I felt burning in the heart area; I have constant pain in the chest, sometimes lower, sometimes stronger; I feel constant fatigue, tiredness; I don't have enough sleep; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EW0186, expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 02Aug2021 (age at vaccination: 42-years-old) as dose 2, single for covid-19 immunisation. The patient did not have any other medical history or known allergies. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EW0181, expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 23Jun2021 (age at vaccination: 42-years-old) as dose 1, single for covid-19 immunisation. On 02Aug2021, patient felt burning in the heart area which lasted for 2-3 weeks, after that he had constant pain in the chest, sometimes lower, sometimes stronger. After the second shot, he felt constant fatigue, tiredness as he did not have enough sleep. Often, when walking, shortness of breath appeared, and chest pain increased. Patient did not receive any treatment for the events. He did not have covid prior vaccination and not tested for covid post vaccination. Patient did not have other vaccine in four weeks and not received other medications in two weeks. The outcome of the event burning in the heart area was recovered and the other events was not recovered.   Follow-up attempts are completed. No further information is expected.
shingles; other zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 78 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 14-OCT-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: Shingles and other zoster-related conditions (ill-defined disorder). At the reporting time, the outcome of the events was unknown.  The reporter considered the events of Shingles and other zoster-related conditions (ill-defined disorder) to be related to zoster vaccine live (ZOSTAVAX).
injection site pain; Headache / severe headache; Difficulty Breathing; Pain / body aches /; could not use her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, headache, difficulty breathing, pain and injected limb mobility decreased. Shingrix was interrupted. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the headache, difficulty breathing, pain and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, difficulty breathing, pain and injected limb mobility decreased to be related to Shingrix.  Additional information were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and she developed pain, difficulty breathing, body aches throughout,a severe headache,injection site pain and injected limb mobility decreased. The reporter stated that  the headache did not resolve for more than a week, and she could not use her right arm for 3 days, with the soreness lasting more than 3 weeks,and her difficulty breathing resolved the night she received the vaccination.  The reporter informed that  her HCP advised her not to get the second dose. The reporter consented to follow up.