chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MYALGIA; ARTHRALGIA; RASH ON LEGS AND ARMS; A spontaneous case report was received from another healthcare professional on 07-Jun-2019 for two consumers.  Based on the information obtained from the reporter, two individual case safety reports PVX201906-000466 (first consumer) and PVX201906-000467 (second consumer) were created and cross-linked in the database.  This case describes a female consumer (weight: 91 kg and height: 167 cm) who developed rash on arms and legs, myalgia, and arthralgia, after taking Vivotif for unknown indication.  Case report: The consumer took three doses of Vivotif on 30-May-2019, 1-Jun-2019, and 03-Jun-2019, respectively. On an unknown date, she had rash on arms and legs, myalgia, and arthralgia.   She took Benadryl (diphenhydramine) for rash on arms and legs and ibuprofen for myalgia and arthralgia.  The consumer's medical history included obesity, anxiety, and allergic rhinitis.  Concomitant medication included oral Zyrtec (cetirizine; 10 mg once in a day), Zoloft (sertraline; 100 mg once in a day), Topamax (50 mg; once in a day).  Laboratory test included complete blood count (CBC), thyroid stimulating hormone (TSH), Lyme ab test, and comprehensive metabolic panel (CMP) test. All the test was conducted on 05-Jun-2019 and the results were found to be normal. The hemoglobin was found to be 11.2 and she had anemia.  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events.  Company's Comment: In this case, it was reported that the consumer developed rash on arms and legs, myalgia, and arthralgia after taking Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, rash, myalgia, and arthralgia is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer developed rash on arms and legs, myalgia, and arthralgia after taking Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, rash, myalgia, and arthralgia is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201906-000466:
floaters the size of an eye on the injection site; throat was scratchy; soreness; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PALLOR (floaters the size of an eye on the injection site), THROAT IRRITATION (throat was scratchy), INJECTION SITE PAIN (soreness) and HEADACHE (Head ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ANTIHYPERTENSIVES for Hypertension.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PALLOR (floaters the size of an eye on the injection site), THROAT IRRITATION (throat was scratchy), INJECTION SITE PAIN (soreness) and HEADACHE (Head ache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Throat sore, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PALLOR (floaters the size of an eye on the injection site), THROAT IRRITATION (throat was scratchy), INJECTION SITE PAIN (soreness) and HEADACHE (Head ache) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Caller reported accidentally giving a child the FLUBLOCK, with no reported AE; Initial information received on 26-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 1 years old and unknown gender patient who experienced caller reported accidentally giving a child the flublock, with no reported ae while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 26-Jan-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2154 via intramuscular route in the right thigh for prophylactic vaccination.  On 26-JAN-2022 the patient developed a non-serious event "caller reported accidentally giving a child the flublock, with no reported ae" (product use issue) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Caller reported accidentally giving a child the FLUBLOCK, with no reported AE).  At time of reporting, the outcome was Unknown for the event caller reported accidentally giving a child the flublock, with no reported ae.     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 guidelines. 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.
Headache, Myalgia, Fever & NauseaVomiting Fever, body ache, chills, fatigue, headache, Nausea
The sore arm was the same as the first two; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The sore arm was the same as the first two) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.    On 27-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 PAIN IN EXTREMITY (The sore arm was the same as the first two). At the time of the report, PAIN IN EXTREMITY (The sore arm was the same as the first two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown. After taking first dose patient experienced sore arm.   This case was linked to MOD-2021-363625, MOD-2021-363646, MOD-2021-363645 (Patient Link).
Itchiness and firmness continued at the injection side. Was quite tender until Sunday, but is no longer very tender. Itchiness has increased starting yesterday and there is also a large (2-3 in oval shaped) red spot at the site. The injection site is also still warm to the touch.
Patient noted to be asleep and then began groaning and eyes were half open. He could not be aroused with stimulation. The episode lasted 45 seconds to 1 minute. Then the patient's eyes opened wide and he came around. Patient was seen by neurology.
upon awakening the morning after I received the vaccine I felt dizzy when turning over and arising from my bed. I felt light headed throughout that day and that gradually subsided over the next five days.
Tightness in throat after 30 minutes, rash across chest. No previous adverse events to vaccinations previously.
Numbness; tingling and drooping on the entire right side of my face will move.; My eyelid won't close; my mouth doesn't move and only the left side of my face will move.; my mouth doesn't move and only the left side of my face will move.; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 28-years-old male patient received 2nd dose of bnt162b2 (Pfizer biontech covid19 vaccine,Batch/Lot Number: EW0151),via an unspecified route of administration, administered in Arm Left on 15Apr2021 14:30(at the age of 28-year-old) as Dose 2,single for covid-19 immunization. Medical history was none. The patient concomitant medications were not reported. Patient previously received his 1st dose of Pfizer covid-19 vaccine in 25Mar2021 01:30 pm, Lot number: ER8730,on his left arm  On 29Apr2021 06:45 the patient experienced numbness, tingling and drooping on the entire right side of his face will move, his eyelid won't close and his mouth doesn't move and only the left side of his face will move. Therapeutic measures were taken as a result of events. The patient didn't receive any other vaccine within 4 weeks prior to covid 19 vaccination. The patient was not diagnosed with covid prior to vaccination. The patient was not tested for covid19 after vaccination. Adverse event didn't result in physician clinic and emergency room visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
body aches; horrible pounding migraine that lasted 2 days for 1st dose; 24 hours after injection I have gotten a 102F+ fever; uncontrollable body chills; This is a spontaneous report from a contactable consumer (patient).  A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: EW0168) via an unspecified route of administration on 15May2021 at 01:00 PM on left arm as dose 1, single (Age at vaccination: 35-year-old) for Covid-19 immunization. The patient did not receive any other vaccine in four weeks of Covid-19 vaccine. The patient has no known allergies. The patient was neither had Covid 19 prior vaccination nor tested post vaccination. Medical history included disability due to back injury and nerve damage in both legs. Concomitant medications included: Buprenorphine, Oxycodone, Etodolac, and Baclofen (in two weeks of Covid-19 vaccine). 24 hours after injection (on 16May2021), the patient had gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine that lasted 2 days for 1st dose. The patient did not receive any treatment for adverse events. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: EW0187) on 05Jun2021 at 01: 00 pm on right arm as dose 2, single for Covid-19 immunization. Outcome of migraine was recovered on an unspecified date in May2021, and other events were recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Severe abdominal cramps,  syncope feeling, sweating, nausea, migraine, vision impairment, loose bowel movement, chills, muscle cramps
Patient reported normal muscle pain in left arm after injection that felt like a "charlie horse". 2 days after injection (7/19/2023) muscle pain "moved to the shoulder". This is still ongoing today 9/6/2023. It is limiting patients range of motion still months later.
The first one i was itchy that night, that was it.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 16:30 (Batch/Lot Number: fa7484) as dose 1, single (age at vaccination 55-year-old) for covid-19 immunisation. Medical history included Known allergies: cefadrixal /duricef sometimes if I eat garlic and meat from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took cefadroxil and experienced drug hypersensitivity, duricef and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced the first one i was itchy that night, that was it on Aug2021. It was reported that the first one patient was itchy that night that was it. The second one a couple days later getting these little twinges of pain in the centre of my chest that come and go. The outcome for event was unknown.   Follow-up attempts are completed. No further information is expected.
Twenty minutes after the shot, I was driving home and my face got hot, red, and tingly. I drive back to the pharmacy. The pharmacist recommended Benadryl and suggested I go to an urgent care if it got worse. I took the Benadryl at 04:30PM. The sides of my throat started feeling tight as I was driving home so I went to an urgent care. Urgent care told me to go to the ER because they were closing. At the ER, I waited for about four or five hours. The ER doctor gave me a dose of steroids. By that time, my neck was blotchy. The Benadryl must have been working because my throat felt fine. The next day, I felt fine. Halfway through the day on Sunday, I started feeling a tingling on the right side of my lower lip and my tongue. My face was red as well. I went back to the ER. They gave me another oral dose of steroids and a prescription to fill. I'm still taking the steroid. Yesterday, I had a telehealth call. I told her I'm still having the tingling. She mentioned it could be from the steroid. She said to call back next week if continues. I also had neck pain, but I have a chronic neck issue.
Temp 104F, chills, body aches, fatigue, headache and dizziness
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On 19-OCT-2015, doses of VARIVAX (Merck) (lot # L023588, expiration date: 26-JUN-2017) were excursion in temperature for 69 F for 12 hours but they were not administered. On 16-NOV-2015, the doses of vaccine were excursion again in temperature of 80 F for 12 hours. On unknown dates, the patients were vaccinated with the doses of VARIVAX (Merck) (route and dose were unknown) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
After 2 hours of receiving the Vaccine I got joint pain, tiredness, and severe headache. It's been more than 24 hours and I'm still having the same symptoms.; After 2 hours of receiving the Vaccine I got joint pain, tiredness, and severe headache. It's been more than 24 hours and I'm still having the same symptoms.; After 2 hours of receiving the Vaccine I got joint pain, tiredness, and severe headache. It's been more than 24 hours and I'm still having the same symptoms.; This is a spontaneous report from a contactable consumer and contactable other-Health Care Professional (HCP).  A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Dec2020 07:45 PM (at the age of 33 years-old) as a single dose for COVID-19 vaccination. Medical history was unknown. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were no other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Dec2020 at 09:30 PM, the patient experienced joint pain, tiredness, and severe headache. The report was reported as non-serious. Treatment was not received for joint pain, tiredness, and severe headache. The clinical outcome of joint pain, tiredness, and severe headache was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received Shingrix (batch number B334Y, expiry date 17th October 2020) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain (After receiving 1st dose, see case US2018GSK106770). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever, muscle ache, headache, chills and joint pain. On an unknown date, the outcome of the fever, muscle ache, headache, chills and joint pain were recovered/resolved. The reporter considered the fever, muscle ache, headache, chills and joint pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient began to experience fever, chills, muscle ache, headache and joint pain, which resolved by the 4th day after the vaccine.  The patient did not require any intervention, hospitalization, emergency room or physician visit, and the symptoms were not considered life threatening or disabling.
immediately following administration of the MMR vax; pt devel erythematous area about 3cm diameter @ inject site;
muscle cramp; Then my eye on that side started twitching; I started feeling numb and getting tingly on my face/Then the numbness and tingling went down my arms and hands.; dizzy; getting tingly/that feeling moved down my neck, /tingling went down my arms and hands; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 24Feb2021 16:00 (at the age of 46-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included mild PVC heart condition and Known allergies: sulfa drugs. Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), cyanocobalamin (B-12), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), vitamin d, vitamin V, zinc and quercetin. The patient previously took reglan and microbid and experienced known allergies. The patients concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 24Feb2021 the patient experienced muscle cramp, then my eye on that side started twitching, i started feeling numb and getting tingly on my face/then the numbness and tingling went down my arms and hands, dizzy and getting tingly/that feeling moved down my neck, /tingling went down my arms and hands. It was reported that Apprx 40 mins after getting the vaccine she got a muscle cramp in the left side of her neck (the side she got her shot) and also in her lower abdomen both went away after about 30 mins). Then her eye on that side started twitching. She started feeling numb and getting tingly on my face (nose, cheek bone area, chin, up around her scalp never her lips) and then that feeling moved down my neck, chest and stomach and her back. Then the numbness and tingling went down her arms and hands. She headed to the ER but the feeling was gone before she got there. But then it came back in just her face. After that feeling passed she was dizzy. It lasted about an hour and half total and never came back. She took her BP and pulse after the tingling went away and both were normal. She did not seek medical attention. The patient underwent lab tests and procedures which included blood pressure measurement: normal on an unknown date, heart rate: normal on an unknown date. The outcome of the event muscle cramp was resolved on 24Feb2021, for rest of the events the outcome was resolved on 2021. Follow-up attempts are completed. No further information is expected.
Injection site was warm, red and swollen to the size of a baseball; Injection site was warm, red and swollen to the size of a baseball; Injection site was warm, red and swollen to the size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm, red and swollen to the size of a baseball), VACCINATION SITE ERYTHEMA (Injection site was warm, red and swollen to the size of a baseball) and VACCINATION SITE SWELLING (Injection site was warm, red and swollen to the size of a baseball) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm, red and swollen to the size of a baseball), VACCINATION SITE ERYTHEMA (Injection site was warm, red and swollen to the size of a baseball) and VACCINATION SITE SWELLING (Injection site was warm, red and swollen to the size of a baseball). At the time of the report, VACCINATION SITE WARMTH (Injection site was warm, red and swollen to the size of a baseball), VACCINATION SITE ERYTHEMA (Injection site was warm, red and swollen to the size of a baseball) and VACCINATION SITE SWELLING (Injection site was warm, red and swollen to the size of a baseball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment therapy was reported
Nausea, limb weakness, ringing in ears, facial numbness, chills, rapid heart beat.
I got the Moderna shots, one in each arm,  in my center deltoid muscles,   The pain from them stayed mildly after each one, but neither ever went away.  To this day, the pain has gotten to were I can only lift both of my arms up half way, like in the form of lifting and pouring a pitcher of water, and the pain in both arms today is un-bearable. I have to sleep on my back or front, cannot sleep on my sides, due to pain.    I went to an Acupuncturist, last month and his needles brought the pain down in both muscles, about 25 percent at best.  They are still painful and effecting my ability to do my job, and as of today, have cut my job back to four days a week, due to the pain.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. The nurse reported that doses of GARDASIL were stored, improperly and administered to an unspecified number of patients on unspecified dates.No adverse effects were reported. This is one report from the same source. Additional information is not expected since se cannot contact physician.
Patient tested positive for COVID after receiving vaccination. She presented to the ED and was subsequently hospitalized on 4/8/2021.