chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Scalp psoriasis flare-up; Psoriasis flare-up; Throat tightness; Numbness of lower extremities; Bone pain; Paraesthesia lower limb/tingling on legs and feet; Joint pain; Increased skin sensitivity; Muscle pain; Psoriatic arthritis aggravated/psoriatic arthritis flare up; This is a solicited report based on information received by Pfizer from AbbVie (Mfr. Control No.: 21K-163-4096772-00). A contactable 36-year-old female consumer reported that:  Solicited report from the USA by a consumer of a 36 year old female with events of non-serious throat tightness, skin sensitivity, numbness on legs and feet, psoriatic arthritis flare up, muscle pains, bone and joint pain if bumps into. Things which was different from psoriatic arthritis pain, tingling on legs and feet and scalp psoriasis flare up with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced throat tightness, numbness on legs and feet, bone and joint pain if bumps into things which was different from psoriatic arthritis pain, tingling on legs and feet and scalp psoriasis flare up. In 2021, the patient experienced psoriatic arthritis flare up and muscle pains. In Jun2021, the patient experienced skin sensitivity. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 19Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer Biontech. On 09Apr2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer Biontech. Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of throat tightness, skin sensitivity, numbness on legs and feet, psoriatic arthritis flare up, muscle pains, bone and joint pain if bumps into things which was different from psoriatic arthritis pain unknown onset, tingling on legs and feet, scalp psoriasis flare up and bone and joint pain if bumps into things which was different from psoriatic arthritis pain unknown onset with Humira (Adalimumab) was a reasonable possibility. Causality as per reporter for the events with bnt162b2 was probable.  The lot number for the vaccine bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events Psoriatic arthropathy, Psoriasis, Throat tightness, Hyperaesthesia, Hypo aesthesia, Myalgia, Bone pain, Paraesthesia, Athralgia. 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.
Fever, fatigue, body aches, chills, headache, swollen lymph nodes - 12 days out, still experiencing symptoms
arm pain; feeling a little more tired than normal; This is a spontaneous report from a non-contactable consumer (patient).  A 4-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced arm pain and feeling a little more tired than normal on an unspecified date with outcome of not resolved at time reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 15-minutes of vaccination, the patient reported that their tongue felt like it was swelling and tingling. EMS evaluated the patient on-site. The patient was hypertensive (184/117). EKG demonstrated NSR, rate 71 bpm, no ST elevation. EMS administered 50mg IM Benadryl. EMS transported the patient. In the ED, the patient was hypertensive (156/90) and reported chest tightness, tongue swelling/numbness, and their heart racing. Patient has had a similar reaction to other allergens in the past. Upon examination, the patient was in no acute respiratory distress and there were no signs of angioedema. The physician administered Solu-Medrol IV, Benadryl IV, and Pepcid IV in the ED. Patient was discharged with a diagnosis of Acute Allergic Reaction s/p COVID-19 vaccine. Physician prescribed 3-day course of Pepcid 20mg PO BID and Prednisone 50mg PO QD, while also taking OTC Benadryl PO 25mg QID.
severe allergic reactions; Skin is starting to blister, like a poison ivy breakout, where the rash is located.; Elevated heart beat, feels flushed; Elevated heart beat, feels flushed; Itching; Broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in left arm on 20Apr2021 10:00 (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included ongoing diabetic reported as 10 years ago. No other products. No investigation assessment. No prior vaccinations within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 20Apr2021 after 10 am, patient experienced broke out in a rash, it improved when he took his medication, that he was given in the hospital, but then the rash came back as the medications wears off. About a half hour after the vaccine on 20Apr2021 10:30, patient had itching, when he took the medicine it helped the itching, but as the medicine wears off, the itching came back, with a vengeance. He went to the emergency room, yesterday for treatment. He was released and made contact with his family physician. He was taking Famotidine 20 mg by mouth once a day, and Benadryl every 25 mg, 2 pills, by mouth every 4 hours. He had some relief with these medications, but then started to feel the events as he got closer to taking his next dose. An hour or so after the initial shot on 20Apr2021 11:00 and then at the hospital, patient had elevated heartbeat, felt flushed. He seemed ok, but he wasn't sure, what his heart rate was, as he felt flushed once in a while. This morning on 21Apr2021, skin was starting to blister, like a poison ivy breakout, where the rash was located, it was about the same as when he took the medicine it helped, but as the medicine wears off, it came back. He had severe allergic reactions. Events required a visit to emergency room and physician office. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
RespDepression, CoughWheeze, TIGHTENING OF THROAT Narrative: Seen by NP on duty. Epi pen given at 12:50. Sent home.
Fever, vomiting, upset stomachs, nausea, headache, chills, body aches, fatigue, loss of appetite.  Pt give Motrin, water and juice. Home care my parent.
colds; This is a spontaneous report from a contactable healthcare professional via a Pfizer sponsored program Pfizer First Connect and Medical information team. An adult female (reported as in her late 30s) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, it was reported that the patient has colds but tested negative for COVID and was asking if she can get the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This case was reported by a consumer and described the occurrence of excessive menstrual bleeding in a 13-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent medical conditions included asthma and Augmentin allergy.  Concurrent medications included Zoloft.  On 23 August 2007 in the morning and 18 October 2007 the subject received 1st dose and 2nd dose of Havrix (unknown).  At an unspecified time after vaccination with Havrix, the subject experienced excessive menstrual bleeding, headache, tiredness, sore throat, stomach pain and inappropriate schedule of vaccine administered.  Medical attention was required in the emergency room and the subject consulted a healthcare professional.  The headache, tiredness, sore throat and stomach pain were unresolved.  The outcome of the excessive menstrual bleeding was unspecified.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: tender and warm to touch at injections site
Nausea, body aches, fever all started 24 hours after vaccine. Slept 12 hours. Ok next morning.
ON 11/6 HEART BEGANTO SKIPS BEATS--CONTINUED 1-3 TIMES A DAY, EACH EPISODE LASTING 5-10 SECONDS FROM 11/6/07 TO 11/14/07 --INSTRUCTED TO CALL PCP.
N17.9 - AKI (acute kidney injury) R19.5 - Occult blood positive stool E87.6 - Hypokalemia R55 - Syncope
soreness; cold; fever; armpits swollen up like a softball; sore throat; This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (soreness), NASOPHARYNGITIS (cold), PYREXIA (fever), PERIPHERAL SWELLING (armpits swollen up like a softball) and OROPHARYNGEAL PAIN (sore throat) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced MYALGIA (soreness), NASOPHARYNGITIS (cold), PYREXIA (fever), PERIPHERAL SWELLING (armpits swollen up like a softball) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, MYALGIA (soreness), NASOPHARYNGITIS (cold), PYREXIA (fever), PERIPHERAL SWELLING (armpits swollen up like a softball) and OROPHARYNGEAL PAIN (sore throat) 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.
This initial spontaneous case, received from pharmacist on 19-Oct-2017, concerns a 28-year-old adult female patient. The patient had no relevant medical history. The patient's concomitant medication included unspecified birth control medication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195126, expiry date: Apr-2018 and anatomical location: not reported). After the administration of the vaccine, the patient's period was late by 14 days. It was reported that, the patient underwent a pregnancy test which was negative. No treatment was taken for the event. The reporter assessed the event as non-serious and assessed the causality of the event as related to the vaccine. Follow-up report received on 27-Oct-2017: The patient's period was late by 14 days. It was reported that, the patient underwent a pregnancy test which was negative. Amended narrative accordingly.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 14:00 (Lot number: FC3182) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, injection in left arm, Lot Number: EW0176), administration date: 02Aug2021, when the patient was 57 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 24Aug2021, outcome "not recovered", described as "Headache".  Additional information:The caller is reporting on her husband. They had the second dose of the Pfizer covid shot yesterday. She is asking what can be taken for a headache and fever. Clarifies her husband is experiencing a headache that started this morning. There are no relevant test.Prior Vaccinations (within 4 weeks) was none.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098022 same reporter/product/event, different patient
This did not result in an adverse event but in a medication/administration error. Patient was a 4 month old that received Kinrix instead of Infanrix. Patient was monitored for 30 minutes after administration of vaccine with no adverse changes to health. Was sent home stable.
Elevated blood pressure reading consistently higher than previous  Headaches  Bells Palsy Left side of face
Patient received 2nd COVID vaccine, instructed to wait 15 minutes before leaving. She began to feel hot after approximately 10 minutes, came to the nurses station, reports her legs  And arms began to spasm. Was assisted to an exam room by MA's. FNP at bedside. Severe muscle cramping to extremities and jaw. No shortness of breath or difficulty breathing, no altered sensation in her throat. IM injection of epinephrine was given to the left thigh at 1532. Began to feel better after epi injection, muscles started to relax. 22G IV placed to the right wrist, 2nd attempt by RN, 1L NS hung. Given 125 mg solumedral at 1535. AMR/PWFD arrived at 1540 and transported to the ED for further evaluation for allergic reaction.
Towards the end of August, on my right upper thigh, there was  like a constant pain. The pain is still going on today, it's not unbearable but it still hurts. I don't know what caused the pain. In September, I went to see the doctor, I went for a yearly check up. He did lab work, like a yearly check up. I was diagnosed as borderline diabetic. I was put on Metformin. My entire life my blood sugars run about 70. I have gained 20 lbs since then, so I don't know if that has something to do with being diagnosed as borderline diabetic, and I have retired since then. I am not as active as I was.
March/97 & May97 pt recv 1 & 2nd doses of vax. 11Mar98 reporter noted pt exp fever & devel mild,varicella-like rash.
This spontaneous report as received from a Doctor of pharmacy refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX23 (lot# not reported) that were stored in a refrigerator that was below the recommended storage temperature for the "past month" July 2014. At the time of the report, firma data were not available to provide a definite stability assessment, but informed that the vaccine was most likely not supported. There were any adverse experiences. Additional information has been requested.
patient received  1.0 ml  of Fluzone Quadrivalent, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 50 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, 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 holders 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.
I was the patient. I went to another doctors office the following day urgent care had a latent adverse reaction. Fever/lump/swelling- hot to the touch.
given vaccines on 5/10/04, on 5/11/04 developed area of redness and induration in right upper thigh, approx 5-6 cm, went to the ER and was given antibiotics,Keflex. Meds were started and pt followed up in the office on 5/12/04. Redness is better, less indurated but still present.
Immediate tachycardia,  tingling in throat and mouth, hypertension. Treatment in ER.  Anaphylaxis protocol.     Days later nausea w dizziness.  By day 6 sudden onset of vertigo, diagnosed as vestibular neuritis. PT, supportive meds, continued dizziness.
She has been out of work sporadically; Jaw infection requiring root canal; extreme pain in tooth; jaw pain; Temporomandibular joint syndrome; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (jaw pain), TEMPOROMANDIBULAR JOINT SYNDROME (Temporomandibular joint syndrome), TOOTHACHE (extreme pain in tooth), TOOTH INFECTION (Jaw infection requiring root canal) and IMPAIRED WORK ABILITY (She has been out of work sporadically) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN JAW (jaw pain) and TEMPOROMANDIBULAR JOINT SYNDROME (Temporomandibular joint syndrome). On 04-Apr-2021, the patient experienced TOOTHACHE (extreme pain in tooth). On 05-Apr-2021, the patient experienced TOOTH INFECTION (Jaw infection requiring root canal). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (She has been out of work sporadically). The patient was treated with AMOXICILLIN at a dose of 500 mg every six hours and Surgery (Diagnosed with a major jaw infection requiring a root canal.) for Tooth infection. At the time of the report, PAIN IN JAW (jaw pain), TEMPOROMANDIBULAR JOINT SYNDROME (Temporomandibular joint syndrome), TOOTHACHE (extreme pain in tooth), TOOTH INFECTION (Jaw infection requiring root canal) and IMPAIRED WORK ABILITY (She has been out of work sporadically) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a nurse practitioner and the mother of a 13 month old female patient with no pertinent medical history and no drug reaction or allergies who on 23-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided). There was no concomitant medication. On 04-NOV-2010, the child broke out with a rash around her neck and the rash had spread all over her body. Nurse practitioner stated it was chickenpox. She was treating the child with CALAMINE lotion. No lab diagnostics studies were performed. At the time of the report the patient had not recovered. Additional information has been requested.
Injection site urticaria; Injection site erythema; Injection site swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an attorney (subsequently medically confirmed) and describes the occurrence of INJECTION SITE URTICARIA (Injection site urticaria), INJECTION SITE ERYTHEMA (Injection site erythema) and INJECTION SITE SWELLING (Injection site swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (Injection site urticaria), INJECTION SITE ERYTHEMA (Injection site erythema) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE URTICARIA (Injection site urticaria), INJECTION SITE ERYTHEMA (Injection site erythema) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-005587 (Patient Link).
I first had diarrhea that lasted 3 days. Then I went into a psoriatic arthritis flair. Pain, inflammation and fatigue. It still is a problem. I had to restart a biologic.
Pt. not seen -> states: fever 102 degrees and chills, arm red and swollen - started day after injection - all sx. gone in 2 days.
right hip was really sore; it's painful to walk; This a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, on an unspecified route of administration as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unknown date, 2 days after receiving the bnt162b2 vaccine, she said that her "right hip was really sore, it's painful to walk". She added that she was never had hip problems before. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
chills- had on shirt and two sweatshirts and 3 blankets, low-grade fever, headache, pain everywhere, achy, very tired, short of breath - much like I felt when I had Covid the month of January.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patient of unknown age. The nurse reported that the patients might have received PROQUAD (Merck) (lot#H015787, exp 24-FEB-2014) that was exposed to 45F for 3 weeks (504 hours). The temperature excursion had been determined to be unsupported by in-house stability data. There were no adverse symptoms reported. Follow up information received which reported that lot number H015787 was verified as valid lot number for PROQUAD (Merck). Follow-up has been received from a healthcare worker, who reported that, on 20-MAY-2013, a patient was administered a dose of PROQUAD (Merck) that had been exposed to 45 F for 3 weeks (504 hours). No adverse symptoms were reported. This is one of three reports from the same source. The other linked reports are: MARRS# 1305USA016986 and MARRS# 1306USA001037. Additional information is not expected.
Approximately 10-15min following vaccination, pt endorsed feeling dizziness, facial numbness and tingling (without weakness or pruritis), generalized tingling/"bug-crawling" sensation. This resolved within 5 minutes. Approx 30 minutes after vaccination, patient then endorsed dizziness, nausea, stomach cramping, became clammy/cool and was trembling, anxious-appearing then intermittently sleepy, with agitated/labored breathing. Pt was transferred to the ED by EMS. ED impression per ED report was vaccine reaction, anxiety reaction. Lower suspicion for anaphylaxis by initial clinic and ED evaluations.