chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 101.4F; This case was reported by a nurse via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pneumonia. Previously administered products included Shingrix with an associated reaction of diarrhoea (received 1st dose on 26th October 2019, refer case US2020AMR027656).   On 9th February 2020, the patient received the 2nd dose of Shingrix. On 9th February 2020, 7 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The reporter stated that about 7 hours after receiving vaccine, the patient experienced a fever of 101.4F. The patient had another temperature elevation the next evening, then was afebrile on 11 February 2020 and had no recurrence of fever.
Gave patient the Moderna monovalent as booster before finding out the Bivalent was approved the day before.
Pt recvd Pneumococcal vax & devel a local reaction which consisted of cellulitis & swelling of the entire arm; pt recvd inject of cortisone & w/in 3 to 4 days sx subsided; No further details were provided;
my hair started falling out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANFACTURER: UNKNOWN, DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER: UNKNOWN, DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "my hair started falling out".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Mar2022): 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 completed. No further information is expected.
HPI  this is an 86-year-old female past medical history significant for CAD, hyperlipidemia, hypothyroidism who was sent by primary care physician for evaluation of hypoxia.   Admitted to CCU.
Ever since I got the vaccine shots I have been sick on and off and had horrible allergies. Before the vaccine I was rarely sick and didn't have bad allergies. There is no proof this is related to the vaccine but I just think it's strange. I have had sore throat, snotty nose, cough, sinus pressure, blisters in my mouth, headaches, I went and got a steroid shot last month and I'm finally getting some relief. I dont know that this is related but I just think it's crazy I have been sick so many times after the shot and the actual shots made me sick too.
3/23/21 ~noon - vaccine ~few hours later started having L deltoid soreness   ~2320- chills and rigors started  ~2330- Temp 98.8F but subjectively felt febrile  ~0025- T 99.9F but subjective fever  ~0027- 400mg ibuprofen ~0145- T 100.8F, chills and rigors resolved  ~0229- T 100.3 F,  felt hot  ~0630- fever resolved but had dry cough 3/29/21  06:00- subjectively felt febrile and tired, T 100.0F,  200mg ibuprofen; COVID test negative that day; dry cough persists 4/2/21- dry cough improving
-AEs: flashes of hot and cold, heartburn, SOB, GERD, chest discomfort, rash on chest, increased BMs, burning in stomach and throat, nausea, elevated blood pressure -Time course: began 35 minutes after vaccination, contacted pharmacy 1.5 hours post-symptoms, urged to go to urgent care, arrived and received medications around 5: 15 medications began working in 20 minutes. Has recovered except was fatigued yesterday.  -Treatment: Zyrtec, famotidine, Tylenol
My skin has been itchy in various places since the first dose. My stomachs (upper and lower), My chest especially in-between my boobs and under them and my chest has broken out into red bumps when I itch it. I have a sensation of lactation in my breath even though I haven't been pregnant since 2017. My breaststroke feel cystic and swollen but my period isn't due. Lots of extra sensation in my chest. I feel more irritable. The itching has been every since my first Pfizer shot. I am sweating abnormally in my chest area. Daily. Since first dose. Arm had more tenderness with the first dose than the second.
I received COVID vaccine on December 23rd and had tongue swelling one hour later. I took Tylenol and benedryl and swelling went away
shingles rash and blisters on upper left back on scapula area; shingles rash and blisters on upper left back on scapula area; shingles rash and blisters on upper left back on scapula area; This case was reported by a consumer and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included omeprazole, metformin, bupropion, gabapentin and oxycodone.   On 10th December 2022, the patient received Shingrix. On 13th December 2022, 3 days after receiving Shingrix, the patient experienced shingles, rash and blister. On an unknown date, the outcome of the shingles, rash and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Dec-2022. Reporter's Comment: On 14th October 2004, patient received Ariprozole and lioitir as concomitant for Osteoarthritis, schizophrenia bipolar type I, hypothyroidism. The reporter requested consent to follow-up.
Mother first noted redness/warmth at and below injection site 1/7/10 at 19:00;  seen in office 1/8/10 at 09:00 with 10cm x 8cm oval shaped area of mild redness and swelling recommended IBUPROFEN
swollen lymph under rt arm pit due to TD vax applied on rt arm; MD prescribed APAP 3 times a day to reduce the presumed swelling & alleviate arm discomfort caused when arm rested @ nl position or when it moved forward & backward;
PT Reported to clinic 1 April 2015 at 1520 with complaints of redness, induration, edema, and warm to touch.
Patient claims pain in her left arm following the immunization. She has limited range of motion in the left arm and is unable to lift the left arm. Patient has visited her family doctor on 10/12/18 and is currently on a muscle relaxant to treat the pain and stiffness.
Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer.  This patient  reported for 2 patients.  A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at  10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin   The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face,  my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist.  The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae.    No follow-up attempts are needed. No further information is expected.
Case number PHEH2014US015548 is an initial spontaneous report received from a pharmacist on 02 Aug 2014. This report refers to a 19 years old male patient. Past medical history and concomitant medications was not reported. He was vaccinated with MENVEO (batch number M13047), subcutaneously instead of intramuscularly on 30 Jul 2014. No adverse reaction reported following this administration error.
This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (dose and route not reported) from lot # M016193 and expiry date 24-APR-2018 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014706: US-009507513-1610USA014705:
Shot given 4/29/16. On 5/16/16 back for numbness in hands and feet. 5/22 in emergency could not walk or use hands. Pain was unbearable. Admitted treatment started.
Chills, fever, whole body ache and extremely tired.  It lasted 15 hours .
(L) Side pain - from neck to foot. Describes as an ache. x1wk. Exam several point tenderness to trapezius muscle & Sl joint. Do not believe vaccination related but pt was concerned about. Report filed at her request.
I had my shot which I felt through my neck first of all I was super sore the day of and after but very sleepy the following day.  On Tuesday, April 20, 2021 I had itchiness where the shot was administered.  I woke up next day with a little red bumps which I thought it was from itchy the night before.  Until on Thursday, April 22, 2021 when I woke up I notice a big red round spot only circling around the area where the shot was inserted and where the needle went in.  Then Tuesday, April 27, 2021 I had red bumps all over my back in between my should blades.  Everything is still noticeable!
11/4/07 - fever of 102. 11/5/07 - woke up with itching rash on back, vesicular, persisten with a few ulcerations on entire body - as described by Dr.. Prescribed Voltrex. Siblings are going to be given Varivax booster.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown date these patients were vaccinated with M-M-R II (dose, route and lot# were not reported). On unknown dates these patients experienced injection site pain after receiving M-M-R II. The reporter stated that the injection site pain the unspecified patients experienced with M-M-R II was more painful compared to the injection site pain the other unspecified patients experienced with VARIVAX (Merck). the reporter also reported that all these unspecified patients cried after receiving M-M-R II because the injections were so "uncomfortable." No treatment was given for these adverse events. No lab diagnostics studies were performed. The outcome of these events was reported as recovered/resolved. The relationship between discomfort and M-M-R II was related, the relationship between other events and M-M-R II was not reported. This is one of several cases reported by the same reporter. Additional information has been requested.
Case number PHEH2014US012570 is an initial spontaneous report from the nurse received on 19 Jun 2014 with a follow up information received from a nurse on 19 Jun 2014. This case was initially reported as a multiple patient case (2 patients), but upon follow up, the patients became identifiable. This report refers to an 11-years-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. This patient was vaccinated with an intramuscular dose of MENVEO (batch number: M13030, expiry date: Sep 2014) on an unknown date in Jun 2014. The nurse reported that the patient experienced a fainting episode, described as an in and out feeling after receiving MENVEO and had to lie down for 15 minutes before being able to leave the facility. Patient completely recovered after episode. The seriousness and causality of the events were not reported. Follow up information received from a nurse on 19 Jun 2014: Updated report type, patient demographics (age), suspect vaccine expiry date and date of administration and event onset date.
Local reaction-raised, redness, and warm-to-touch around site of injection. Patient advised cold compress and BENADRYL by pharmacist and physician. Reaction cleared in approximately 5 days per patient.
I have had a rash come up; it's come up like a hive; it itches real badly; This is a spontaneous report from a contactable consumer or other non hcp. A 84-years-old female patient received first dose of bnt162b2 (BNT162B2,Solution for injection, Lot number: unknown, Expiration date: unknown) on muscle of my right arm via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included estradiol taken for an unspecified indication, start and stop date were not reported. The patient had first Covid-19 vaccination and she supposed to have my second one on 29th of this month but she had a small reaction, so she was little concerned. She had a rash come up, it happened about the day after that she got her first shot. It was come up, like a hive and then it had, it itches her real badly and it spread from the right side of my face, down it to her neck, behind my ear and down her throat. She was little concerned about that second shot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mom reports swelling and pain at the injection site. Also a low grade fever. Symptoms lasted one day per mom, and swelling is now going down.
Despite being on birth control for the purpose of controlling her periods and hormones, my daughter started her period very prematurely and it has not stopped for over a month. She's had heavy menstruation, cramping and extremely emotional. Additionally she has developed severe pain in her right thigh upon standing after rest. Upon having her evaluated at the emergency room, X-ray and ultrasound found nothing. Leg pain comes and goes everyday for no reason.
Adverse symptoms began next day on 1/23/21 at 5pm: Rash on her back and flanks and a headache. 1/24/21: Rash improved but headache persisted. 1/25/21: Blister on fingers and left side of stomach
Immediately after getting the shot in my left arm, it felt like something shot up my neck and down my arm. And the site was sore. Driving home about 25 ish after My chest felt tight and my entire left side was sore The bottom of my left foot felt like it was on fire By the time I was home, my entire body is sore With in an hour, every fibromyalgia trigger point lit up like a Christmas tree. And headache (not migraine)  My left arm feels like it weighs 40lbs (I?m 107lbs)  The benedryl has worn off and my arm keeps feeling like it?s burning  My calves are beyond killing me and random parts of my left side of my body feel like they are burning and the right side is starting as I?m typing this  This doesn?t feel like my typical day of fun with my usual daily symptoms   I have had allergic reactions to everything  I highly suspect I have a very high sensitivity to endocrine disrupters  Don?t know if this is how my body is responding to the vaccines with all my autoimmune issues that have not officially been diagnosed /just suspected  Or if it?s an allergic reaction   In October of  2020  I had an interlaminar epidural steroid injection, immediately after I couldn?t move and my chest also tightened up. The injection site hurt to the touch for a week and got a nasty rash around it  I took adderall, Allegra, benedryl allergy+ congestion and vitamin d prior to vax After about an 1.5 hours after the vax  methocarbamol, Percocet and vitamin b12 and had a liquid iv beverage
Within 24 hrs. I began to experience pain in my left shoulder. Over the next 3 days the pain began in my right shoulder, then in both hip joints. Over the next 3 weeks the pain increased in severity. Mobility became more and more difficult. Getting in a vehicle, into bed, sitting, standing, and bending over increased in difficulty and pain level. As of this date, my freedom of movement is about half of what it was prior to the shot. ADVIL, ALEVE, BC-POWDERS give temporary relief from the pain but continued use of these products is not in my best interest.
That night I had chills and bar ache but recovered.  On April 14th I developed a red rash on my arm where I received the shot.
Patient reports shoulder/arm injury related to vaccine administration. She reports not being able to lift her arm more than 6-8 inches from body. She has pain from her shoulder down to her elbow. Patient was given the vaccine around 9:45am, and pain started around noon.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a first dose of VARIVAX (Merck) (lot number, injection site and route not reported). Subsequently the patient developed a very mild case of chickenpox, very few lesions. On an unspecified date, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot number, injection site and route not reported). Subsequently the patient developed a break through case of chickenpox. The patient went to the physician's office. Subsequently, the patient recovered from chickenpox. Additional information has been requested.
Information has been received from a physician concerning a nurse's daughter who was vaccinated with GARDASIL a year ago. Coincidentally, the patient started losing her hair about the same time. The patient has subsequently been diagnosed with alopecia areata. This is one of several reports from the same source. Additional information has been requested.
pain left arm; Pain in shoulder; pain when moving arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, shoulder pain and pain upon movement. On an unknown date, the outcome of the pain in arm, shoulder pain and pain upon movement were recovering/resolving.   The reporter considered the pain in arm, shoulder pain and pain upon movement to be related to Shingrix.  Additional information received were as follows: The caller was a patient. The patient received 1st dose of Shingrix on left deltoid. The caller stated that within 24 hours after receiving Shingrix, he experienced pain in the left arm that ascended into his left shoulder.  The patient stated that when he moved the left arm, it was painful.  The patient believed that the pain was related to the vaccine.  The patient stated that it was starting to improve some, but not completely resolved.  The patient was not planning to get the 2nd dose of Shingrix. The reporter consented to follow up. The caller did not provide any additional information.
This study case was received from the investigator in a trial on 06 June 2011. A 27 year-old male subject with no significant medical history was found to have a non-specific myocarditis 14 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 18 January 2011. Relevant laboratory data was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Caller stated that headaches occurred at 12 in the afternoon and  fatigue set in through out the day. Caller took Tylenol and Advil with no relief. Caller stated 12/17/20 headache and fatigue went away.
Itchiness was happening arm, leg, face, all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness was happening arm, leg, face, all over) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PRURITUS (Itchiness was happening arm, leg, face, all over). At the time of the report, PRURITUS (Itchiness was happening arm, leg, face, all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included diphenhydramine.
Pt. states arm is "frozen" and in "incredible amount of pain", "unable to use arm and having varying amounts of pain from manageable to intolerable", ":disrupted every aspect of my life from being able to dress myself to my job responsibilities."
Information has been received from an RN concerning a 48 year old white female RN who in approx. 1994-1995 was vaccinated with Hep-B vaccine recombinant (yeast) series. Subsequently, upon titer on 11/28/00, the pt did not show seroconversion and elected to repeat the series. On 1/9/01, she received Hep-B (lot 637850/1577K) and MMR vaccine (lot 635921/1181K). On 2/20/01, the pt received her 2nd Hep-B vaccine (lot 637847/1654K). On 4/24/01, the pt contacted the nurse to report that after the 2 vaccinations on 1/9/01, she had a fever and flu-like symptoms in the afternoon of 1/9/01, her left arm was sore and she had a lump in her arm that resolved in a few days. After the second dose of Hep-B, she experienced symptoms of a sore joint, at the deltoid muscle, with limited range of motion, difficulty raising her arm to brush her hair and pain that radiated down her elbow into her wrist. The pt was concerned that it was "permanent damage". The nurse reported that the pt was able to work and as of 5/11/01, was currently working. On 5/24/01, the nurse reported that the symptoms of the left shoulder pain and wrist pain and limited range of motion were slightly resolving. No further details were provided.