chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fly like symptoms; fever; body aches; chills; shaking; fatigue; joint pain; nausea; This is a spontaneous report from a contactable other-HCP (patient herself). A 39-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 18Jan2021 09:00 as 1st dose single for COVID-19 immunization. Patient was 39-years-old and was not pregnant at the time of vaccination. Patient did not receive any other vaccines in four weeks. Patient did not had COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Patient medical history included asthma, known allergies, hypothyroidism, IBS, chronic migraine. The concomitant medications included antibiotic, prednisone, levothyroxine sodium (LEVOTHYROXIN). On 18Jan2021 at 17:00, patient experienced flu-like symptoms till 19Jan2021 then ran into fever, body aches, chills, shaking. On 24Jan2021, no fever just body aches and fatigue. Patient experienced fever and joint pain in between 25Jan2021 to 27Jan2021. On 28Jan2021 experienced body aches, chills, nausea. Patient did not receive any treatment for the adverse events. The lab test and procedure included Rapid Covid (Nasal Swab) test on 25Jan2021, with test result as negative. The outcome of the events was not recovered.  Information on lot/batch number has been requested  Follow-up attempts are completed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was not recovered/not resolved. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient received SHINGRIX and Flu vaccine at a different pharmacy and sometime after receiving the SHINGRIX and Flu vaccine, the patient developed Guillain Barre Syndrome. The reporter did not have any additional details at the time of the reporting. The healthcare professional was transferred to MI Vaccines for more information.
This spontaneous report was received from a physician referring to a 4 year old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 08-APR-2016, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, 0.5 ml (dose number, anatomical location, route, lot number and expiration date were not provided) instead of a dose of (Oka/Merck) VARIVAX (dose number, anatomical location, route, lot number and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient experienced fever (pyrexia).  No product quality complaint PQC was involved. The outcome of pyrexia was unknown The reporter did not assess the relatedness between pyrexia and suspect therapy. Additional information has been requested.
Pt received flu vaccine on 10/11/12. One week after started noticing red raised dots on arms. On 10/23/12 had raised red prickly rash all over arms, groin, thighs, face, forehead with burning. Reported to occupational health & was started on MEDROL DOSE PAK.
Headache, chills. By evening I was running a 101.6 temp. I have ran this fever until 10/18/14 along with headache, neck pain, and malaise. Developed a mild congested cough. Seen physician on the 18th. Temp 101.8.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route, lot# and expiration date were not reported). On an unknown date (reported as subsequently after GARDASIL 9 administration), the patient developed depression. The outcome of the adverse event and the causality between the adverse event and GARDASIL 9 were not provided. This is one of two reports from the same source. Additional information has been requested.
Have one Rotarix vial with one lot number and a Rotarix syringe with a different lot number; Have one Rotarix vial with one lot number and a Rotarix syringe with a different lot number; This case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Rota (Rotarix lyophilized formulation) (batch number ME43A, expiry date 29th August 2021) and (batch number 77YS5, expiry date 29th April 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced circumstance or information capable of leading to medication error and inappropriate reconstitution technique. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and inappropriate reconstitution technique were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked, could they use Rotarix with two different lot numbers. The reporter stated, they had one Rotarix vial with one lot number and a Rotarix syringe with a different lot number only available which led to inappropriate reconstitution technique and would led to circumstance or information capable of leading to medication error. The reporter did not consent to followup.
Fever, chills, joint and muscle pain, headache, nausea, exhaustion,dizziness
- Left Arm soreness - Back ache and all around body aches - Headache - Fatigue - Nausea - Chest Pain
lymph nodes are swelling (colar bone area); lymph nodes are sore (colar bone area); sore in her collar bone area that brings pain; discomfort; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), LYMPHADENOPATHY (lymph nodes are swelling (colar bone area)), LYMPH NODE PAIN (lymph nodes are sore (colar bone area)), PAIN (sore in her collar bone area that brings pain) and DISCOMFORT (discomfort) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN B COMPLEX for B12, VITAMIN D [VITAMIN D NOS].    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 05-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph nodes are swelling (colar bone area)), LYMPH NODE PAIN (lymph nodes are sore (colar bone area)), PAIN (sore in her collar bone area that brings pain) and DISCOMFORT (discomfort). The patient was treated with PHENIRAMINE MALEATE (AVIL [PHENIRAMINE MALEATE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), LYMPHADENOPATHY (lymph nodes are swelling (colar bone area)), LYMPH NODE PAIN (lymph nodes are sore (colar bone area)), PAIN (sore in her collar bone area that brings pain) and DISCOMFORT (discomfort) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication Vitamin B complex , Vitamin D used for B12, bine health and skin.
Case number PHEH2014US020969 is an initial spontaneous report received from a pharmacist on 15 OCT 2014. This report refers to an adult female patient in her sixties. Her past medical history and concomitant medications were not reported. On 14 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly at a dose of 0.5 ml. On the same day, after the vaccination, she developed a headache, generalized aches, sore muscles and felt unwell like she was coming down with something. The patient had no adverse reactions the past year. The outcome of the events were not reported. The events were reported as non serious and the causality of the events was not reported.
Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from a contactable physician. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration on 20Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced near syncope, lightheaded, dizzy, vision narrow and tingling in lips on 20Dec2020 09:30 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given to the patient for the events. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Information has been received from a doctor of pharmacy concerning a 12-month-old female with a history of a liver transplant in June of 2005, who in November 2005, was vaccinated with a dose of MMR II. Concomitant vaccination included a dose of Varivax (Oka/Merck). In February 2005, the patient developed elevated liver function tests. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Notes: 2 PM email from NP supervisor. Called. Mom claimed hives all over body got better after took BENADRYL. Denied vomiting but damp, her mom mentioned that she had egg allergy when she was little same as her son too, but both of them eating egg now as overcome, so never mention nowday like her son is ok now. I urged to both of them to go ER now. Allergy reaction could be deleted, better be safety side b/c YF vaccine is egg base a 2:30.
inflamed; her arm that she received the injection in is red, inflamed, itchy, and hot; itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE WARMTH (her arm that she received the injection in is red, inflamed, itchy, and hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE WARMTH (her arm that she received the injection in is red, inflamed, itchy, and hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). On 27-Feb-2021, VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE WARMTH (her arm that she received the injection in is red, inflamed, itchy, and hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Fever, chills, extreme muscle soreness, extreme joint soreness, headache, fatigue, nausea, itching
Itching at the site of the injection, periodically, particularly at night. Skin thickened at the site of injection.
It hurts like hell and I had the shot/ suspected vaccination failure; It hurts like hell and I had the shot; hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot years ago and still got shingles. The patient stated that the shingles hurt like hell. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a pharmacy technician regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and drug reactions/allergies were unknown. On 20-MAR-2018, the patient was vaccinated with an expired but properly stored dose of ZOSTAVAX 19400 PFU (lot # N012092, 13-MAR-2018) (route and dose unknown) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects were reported.
This spontaneous report as received from a pharmacy technician refers to two patients of unknown age. On 20-JUN-2014, the patients were vaccinated with GARDASIL (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
That same day of receiving them he had a bad headache. The next day he had BAD gut aches and diarrhea that is still happening to this day. His gut aches have subsided some. (3/23/17) Still has stomach cramps and diarrhea.
Client was given 1st dose of Moderna on 3/25/21 and 2nd dose on 4/13/21 at day 19.
Hives on hands and feet and injection site lasting for 4 hours the morning after vaccination.   Headache for 4 days after requiring an NSAID to stand.
Issues with the tongue, mouth, and throat that began after her Tdap shot in September.  Notes a burning tongue, lymph node neck pain, back of tongue feeling swollen. Noted 7-10 days later, developed situation in mouth. Still had soreness in arm. He saw dentist for consult for tongue and throat pain noted to have scallops tongue and burning tongue.  Also seen by oral surgeon who prescribed a steroid mouthwash. Completed impression for bottom teeth to relieve pressure of the tongue against teeth; retainer does not cover all bottom teeth so doesn't work but tried to use..  Had blood work done.  Seen by ENT who ordered MRI which was normal. When talking, touching teeth is painful.  Feels like pressure at base of tongue.  Feeling like squeezing. Tongue seems bigger when talking. Started taking pain medication recently.  Last 2-3 days to see if reduction of pain and does help somewhat. Lost 8-10 lbs because uncomfortable to eat
REDNESS IN CIRCULAR AREA SURROUNDING INJECTION SITE. SHE STATED THAT SHE HAD A SIMILAR REACTION THE YEAR BEFORE BUT NEVER REPORTED IT. NO TREATMENT WAS ADMINISTERED.
Varicella type rash has erupted over the last 24 hours (onset 12/20/2005) about 20 lesions some weeping clear fluid. C/o rash being itchy. Plan isolation, skin care, no ASA.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Approximatley 12 hours after vaccination given patient experienced fever(102.0), body aches,and malaise.Symptoms lasted about 24 hours. No redenss or swelling at the site of injection. Mother states that patient did react with fever with some chilhood vaccinations.
The night after getting the vax my left foot started tingling and spasming. The tingling and spasming has progressed upward all the way to my back. Currently I can not walk for very long, only about 200 ft.
I had a sore arm for about three days. On 08/03/2022, I began having soreness in my left calf. I thought I had strained it at work and really didn't think about it. I was advised to get it checked out. I went to the emergency room, and I was given a shot of blood thinner as a precaution. The next day, I had an ultrasound and that was when they saw the blood clot. I was given a prescription to treat the blood clot. As of today, I continue to take the medication and I have a follow up appointment to do blood work.
Looks like infection [like shingles] (injection site); Where injection site was administered - arm is swollen; Where injection site was administered - arm is red; Where injection site was administered - arm is sore, hurts; [Looks like infection like] shingles; Information has been downloaded from Agency (US-BEH-2014047322).  This spontaneous report was received from a pharmacist and two consumers, concerning a 79-year-old male patient. The patient's His relevant medical history included weight loss and testosterone low as current conditions. The patient's concomitant medications included fluoxetine, fentanyl, zolpidem, methimazole and metoprolol (XL).   On 14-OCT-2014, the patient was vaccinated with influenza virus split virion 3v vaccine inactivated (AFLURIA) (formulation, vaccination scheme, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported).  On 11-NOV-2014, the patient was vaccinated with varicella virus vaccine (manufacturer unknown), 0.65 milliliter (ml), administered subcutaneously as prophylaxis (formulation, anatomical location of vaccination, lot number and expiration date were not reported).  On 04-DEC-2014, the patient's arm was swollen, red and sore at the injection site (injection site swelling, injection site erythema and injection site pain). According to the pharmacist, it looked like a shingles infection (injection site infection and herpes zoster).  The outcome of injection site infection, herpes zoster, injection site pain, injection site erythema and injection site swelling was reported as not resolved.  The causal relationship between all the aforementioned events and both suspect therapies was not provided.  The events were determined to be medically significant.
Headache, Myalgia, chills, fatigue, injection site reaction, lymphadenopathy L axilla Narrative:
Pt states that she experienced low back pain and extreme fatigue after imz but resolved in 24 hours. On Sunday,  (4/11/21) which is roughly 3 weeks later pt noticed pain in lower right leg (calf) which was warm and tender to touch. Pt went to urgent care and was immediately sent to ER. Diagnosis was DVT in right lower leg . Pt was administered 2 shots of heparin injection in abdomen and discharged on Eliquis. Pt followed up with PCP on today 4/14/21  and was told to continue Eliquis and to follow up in 1 week for another ultrasound to ensure medication is working.
The day after dose 3 my arm really hurt, and I began to have a bad migraine. My arm was swollen, and it was hot. I had a slight fever and was lethargic. Those symptoms lasted about 7-10 days. As of today, my arm no longer hurts. When I breathe in my chest hurts.
Wife called 6/27/03 reporting approx 2-3 hrs after vaccine given pt started having speech and difficulty stuttering. Next day difficulty with speech and completing thought process. Seen by Dr. Given Zoloft 50mg 1 HS. Speech has improved today.
death was unconvincingly blamed on Gardasil; This spontaneous report was received from a physician via social media and refers to a 19 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, dose number, route, vaccination site, lot# and expiration date were not reported), for prophylaxis.   On an unknown date, the patient died (death). The cause of death was not reported and it was unknown if an autopsy was performed.  The reporter considered the patient's death to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) as he stated that the patient's death was unconvincingly blamed on  the vaccine.
This spontaneous report was received from an approximately 64 year old female patient regarding herself. Current condition of the patient included high blood pressure and allergic to aspirin. On 12-OCT-2012, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number, and expiry date unspecified), subcutaneously. Concomitant therapies included losartan potassium (100 milligrams), venlafaxine hydrochloride (extended release, 150 milligrams), atorvastatin (40 milligrams) and nortriptyline hydrochloride (20 milligrams). On 03-NOV-2012, the patient suffered from pain, redness and stiffness in the right arm at the injection site. The pain eventually became intolerable. On an unknown date, she was hospitalized after receiving ZOSTAVAX and she was diagnosed with bursitis of the arm (duration of hospitalization was unspecified). The patient lost all her mobility of the right arm, could not work and lost her job (disability). The patient sought medical attention (saw the doctor). An unspecified treatment was given. No laboratory diagnostic tests were performed for the events. The patient was recovering from the event. The relatedness for the event was unknown for ZOSTAVAX. This adverse event was sent to legal department. Additional information has been requested.