chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bones were aching,especially at my joints; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones were aching,especially at my joints) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2021.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced BONE PAIN (Bones were aching,especially at my joints). At the time of the report, BONE PAIN (Bones were aching,especially at my joints) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: positive (Positive) had COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
1145: Patient developed a few hives on his face and one on his back 15 minutes after administration of the following vaccines: PCV 13, Hep A, MMR, Varicella. No wheezing or difficulty breathing. Dr. notified and assessed patient; patient observed for another 15 minutes. 1210: Hives resolved. No further signs of allergic reaction noted. Dr. assessed patient and discussed signs and symptoms of an allergic reaction and when to call clinic or bring patient to ER with mother. Patient discharged home with mother. 4/30/2013: RN called parents to follow up today. No answer. Left message requesting call back.
verbatim: "On Friday, October 13, 2023, at 11 AM I received my covid booster shot. I received spikevax by moderna and that was shot #5 for me over the years and I never had any reaction in the past and the rest of Friday was fine up until around 9 PM. I started to get cold feet and hands and the chills, I could also feel my heart racing. I went to get the thermometer and placed it near my chair and took my BP 168/69 and a HR 98. For me these numbers are exceptionally high so I proceeded to take a 5 mg amlodipine. At this point I had a hard time walking to the medicine cabinet, having to hold onto chairs and tablets to be able to stand. As I got back to my chair I needed my wife to put the thermometer in my mouth as my hands were shaking beyond my control and I had a temperature of 101. Staying relaxed in my chair my BP and HR started to decrease within a half hour and the shaking subsided. I had a fairly decent night but on I Saturday I felt weak and listless all day but my BP and HR and temperature were OK. On Sunday I feld about 70% better."
After my first dose Pfizer vaccine, I felt light headed and developed slight pain to the left side of my neck. I had slight headaches and felt fatigued. For several days I had headaches and the left side of my neck was sore and I felt very fatigued. I also had an episode of shortness of breath with dizziness. I went to play top golf with my kids and after playing I felt very fatigued, tired and this went on for about one week. I missed three days of work. I also then developed a migraine headaches to the point that i vomited profusely. I took headache medication which temporarily relieved my pain. I also started to have blurry vision, vertigo and I spent two days in bed. I had no fever. Of and on, I keep getting SOB upon light exertion. On the past Wednesday and Thursday I experienced dizziness and I had to stay in bed because I felt sick to my stomach and I continue with the pain to the my left side of my neck.  I still have not gotten my second dose Pfizer vaccine.
In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
No additional adverse event (AE); A pharmacist reported that an improperly stored dose of PROQUAD pursuant to a temperature excursion was administered to a patient.; This spontaneous report was received from a pharmacist and refers to a patient of age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 22-SEP-2022, the patient was vaccinated with a improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W023865, expiration date: 29-OCT-2023 who had been verified upon internal validation to be a valid number, administered as directed to prevent measles, mumps, rubella and varicella infection (strength, dose, frequency, and anatomical site of injection were not provided). No additional adverse event was provided.
Pt erroneously received  Pfizer dose on 12/1/21 where  vaccine lot was expired. Staff contacted Pfizer to inquire if this batch of Pfizer Adult purple top vaccines were still viable at the time of vaccination provided that the vaccines were thawed on 11/23/21 at 1:43pm .  Determine pt did not need to be revaccinated as Pfizer Mfr had stability data to support this excursion for 1 day post expiry from manufacturing data.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored ROTATEQ (which had a lot number of L038536 and an expiration date of 19-AUG-2017; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 degrees C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Excessive swelling around entire circumference of upper leg, extending down 1/2 of leg, very hot to touch, inflamed and hard. Baby very uncomfortable, no fever, swelling x 10 days, redness x 3 weeks. Treatment soaking and ibuprofen.  Follow up 11/01/2000: "Do not have, unable to provide."
disseminated BCG disease; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above, and refers to a 5-year-old male patient. His patients were consanguineous. He was hospitalized on several occasions for HSV infections by the age of 3 year. He sufferd from fungal infections, including mild oral candidiasis. The patient had R864C/R864C mutations.  On an unknown date, the patient was vaccinated with bcg live (BCG LIVE) (strength, dose, lot #, expiration date and route of administration were not provided) for tuberculosis bladder.  On an unknown date, the patient experienced  disseminated BCG disease (BCG-osis). On an unknown date, the levels od serum Ig, lymphocytes and nitroblue tetrazolium were normal. The outcome of the events was unknown.   The reporter considered disseminated BCG disease to be related to bcg live (BCG LIVE). Upon internal review, the event of disseminated BCG disease was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article. ; Sender's Comments:  US-009507513-2212USA006304:
On 08/17/2000 the patient developed a fever of greater than 101F and was very achy. The following day the patient felt very fatigued throughout the weekend. Additional information has been requested.
Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: 409017123), via an unspecified route of administration on 08Jan2021 09:30 at SINGLE DOSE (first dose, upper arm right) for COVID-19 immunization. Medical history reported as none. The patient did not have prior vaccinations within 4 weeks. No family medical history and no relevant tests. There were no concomitant medications. On 08Jan2021, the patient experienced diarrhea first at 11:00, an hour and a half after vaccination. Nausea and vomiting began an hour after diarrhea started at 12:00. Adverse events did not require visit to physician. The patient was advised by the physician office to self-treat with sips of water and bland food. Outcome of the events was unknown.
Covid Bivalent vaccine was given to patient after notification was sent that FDA is no longer authorizing the use of bivalent changing to monovalent.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 45-year-old female patient who received BOOSTRIX (batch number 9N74F, expiry date 19th August 2017). On 25th September 2015, the patient received BOOSTRIX .5 ml. On 26th October 2015, 31 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be almost certainly related to BOOSTRIX. Additional details provided were as follows: This case was not previously reported to anyone. The patient experienced soreness at the injection site one month after receiving a dose of BOOSTRIX vaccine.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a 10 decades old patient of an unspecified sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (Unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 10 decade old. No concomitant medications were reported.  On FEB-2022, the patient experienced suspected covid-19 infection which was like having a stuffy cold and patient was suggested to take a booster dose by doctor (Dose number in series 1). Reporter stated that, "I had the shots. I didn't think I needed them and didn't know what the airlines required. In Feb this year I had covid. It was like having a stuffy cold. Then my Dr wanted me to have the booster because it helps get over any side effects. I did and here I am. 92 years old and feeling strong" The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 01 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s, but the patient felt strong after booster dose (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious. This report was associated with product quality complaint:
100.4 temp, chills, very fatigued, weak, lost balance, loss of appetite, HA, and body aches.
1/11/22 to ED with generalized weakness, fatigue, abdominal pain x 3 days; AKI; UTI; started on ABX; CT showed lung bases with pneumonia; found to be positive for COVID; hypotensive; O2 supplementation; dexamethasone; worsening condition; ICU; required intubation; went into shock and required renal replacement therapy; condition continued to worsen; family decided to withdraw care and concentrate on comfort measures; palliatively extubated and pt passed away in the hospital
Muscle cramping 2/2 rhabdomyolysis from COVID-19 infection requiring hospitalization
1st dose vaccine received on Saturday, w/in 15-20mins of receiving the injection while leaving office an aura w migraine began. Multiple auras & addtl pain came on over the next 24 hrs, migraine pain continued thru Monday evening with the migraine pressure continuing thru Friday. As expected swollen glands, Fibro flared more, dry mouth and feverish sun-thurs. HOWEVER Tues evening while sitting had frightening episodes of eye balls involuntarily moving around in separate directions-couldnt focus or make it stop, each episode ended with vision going totally black.Each episode was abt 30secs. Contacted Neurologist.  I am hypersensitive to things and absolutely am not able to do the 2nd one.
Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was liver cancer. It is unknown if an autopsy was performed.            No concomitant medications was reported.  No treatment medications was provided.  03-Mar-2021: Husband was diagnosed with liver cancer. It was in his ducts and everything. He had cancer at the time we took both vaccines. He died 10 weeks after being diagnosed with liver cancer. Caller felt the vaccine escalated the process.  Company comment: Very limited information regarding the event has been provided at this time.  Further information has been requested.   This case was linked to MODERNATX, INC.-MOD-2021-019697 (E2B Linked Report).; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested. MODERNATX, INC.-MOD-2021-019697:Wife's case; Reported Cause(s) of Death: Liver cancer
35x60 mm inflammation of right deltoid. Pt's mother stated she had called EMT's on 02/15/2012 breathing was checked and no transport was made.  Area was circled with marker to monitor any progression. Pt was prescribed prednisLONE 5mg/5ml.
pt recvd vax & 3 hrs later weak, myalgia, t102.8, severe lt temporal h/a & chills;
Child was given 0.5cc of flu vaccine instead of 0.25cc vaccine.  Vaccine is for 3yrs & up.      No adverse reactions known.
BAD HEADACHE; BLURRY VISION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included asthma, antiphospholipid syndrome, and allergy, and other pre-existing medical conditions included family history of stroke and heart attack. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced bad headache, and blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad headache and blurry vision was not reported. This report was non-serious.
Five year old pt for immunizations. Pt received DTaP, IPV, and MMR.  Site of DTaP formed a large welt (approximately 3.5 inch diameter). On the following day the welt was red, raised, and itchy (29 SEP 2005) left thigh. Pt seen by pediatrician, given Benadryl on 29 SEP 2005.
Fever; Body aches; Sore arm; Headache; Cramps; This is a spontaneous report received from a contactable consumer (Patient). A 36-year-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, body aches, sore arm, headache and cramps. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Received phone call at clinic from patient. States left arm where vaccine was given is still sore.
30NOV93 fever devel noc of inject; swelling noted on arm; edema in area 2" around inject site; warm to touch;
This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was vaccinated with VARIVAX on an unknown date 4 days prior to the patient's 1 year birthday, which is outside of the prescribing information recommendation. No adverse event reported. Additional information is not expected as the reporter did not wish to be contacted.
PATIENT PREVIOUSLY RECIEVED 1 DOSE OF PFIZER VACCINE (2/4/202-LOT EL9265)
About a week after receiving the vaccine soreness in my arm which lasted for about 3 days. About 5 days after the soreness went  away I developed a rash on my arm. My arm was hot and swollen.  I went to an urgent care the same day I noticed the rash, they put me on steroid and antibiotic Cephalexin. They also sent me to the ER for an ultrasound to make sure I didn't have a blood clot.  It is normal now. Besides the rash I felt fine otherwise.
Diagnosis is varicella on 09/06/01 10 plus lesions on trunk and arms.
This is a spontaneous report received from a contactable other HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache (outcome unknown). The batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Afternoon after shot left upper arm elbow to shoulder very sore like a bad bruise for several days, felt warm. Several weeks later started getting pains across arm at injection site and would ache up and down arm shoulder to elbow., Sometimes sharp pinpricks, tingling, wakes me up at night sometimes, other days no pain. Not relieved by massage or Tylenol or ibuprofen, annoying ache lingers for hours at a time and then will go away and return randomly.
3 hrs p/vax pt became irritable w/icy cold hands & feet & mottled skin elsewhere; returned to clinic & visited ER; recovered on own observed for 1 1/2 hrs; no temp BP WNL;
5 min after vaccine flu shot pt started to feel dizzy, profusely sweated, was offered water and accepted all left shortly thereafter
8/13/21 pt brought to ED due to low responsiveness; no distress; found to be positive for COVID; plan was to transfer her to a nursing home with a COVID unit, but unable to get her in one; pt taken home where she passed away
Chest pains severe enough to cause her to sweat profusely; Sweat profusely; This case was reported by a consumer and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received Shingrix. On 8th October 2019, less than an hour after receiving Shingrix, the patient experienced chest pain and excess sweating. On an unknown date, the outcome of the chest pain and excess sweating were unknown.   It was unknown if the reporter considered the chest pain and excess sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was curious about how to report a potential side effect experienced by his wife. The day before the reporting date, the patient received Shingrix. Within 5 minutes of getting the Shingrix shot, the patient experienced chest pains severe enough to cause her to sweat profusely.  She was taken to the emergency room where they ran tests and were unable to find a cause.
The patient did not report any additional AEs; MMR II and VARIVAX were both given IM instead of SubQ; This spontaneous report was received from a pharmacist, referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 16-DEC-2020, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strengths, vaccination schemes and anatomical sites of injection were not reported; lot numbers and expiration dates were unknown by the reporter), both therapies intramuscularly as prophylaxis (incorrect route of product administration). The patient did not report any additional adverse effects (AE).
This is a spontaneous report from a contactable physician. A currently 57-year-old patient of unspecified race/ethnicity experienced drug allergy to pneumococcal 13-val conj vac (dipht crm197 protein), codeine and nickel on an unspecified date. Relevant medical history and concomitant medications were not provided. Outcome was unknown. No follow-up attempts needed. No further information expected.
Information has been received from a registered nurse concerning a 15 year old white female student with no medical history who on the evening of 2/28/97 was vaccinated SC in the right thigh with the first dose of varicella virus vaccine live (lot # 621191/1549D). There was no concomitant therapy or illness at the time of vaccination. The RN reported that on 7/17/04, at 20:00, the patient developed chicken pox characterized by approximately 15 pox on her face and lots on her arms, legs, and trunk with a slight fever and lethargy. It was reported that the patient was exposed to chicken pox by her unimmunized cousin. Medical attention was sought. On 7/23/04, the patient was considered to be recovered as her chicken pox had scabbed. It was noted that the patient's recovery was uneventful with no lasting effects. No further information is available.
Patient reported on 10/07/2016 that she had swelling on left side of face on 10/04/2016. She was seen in ER and told that they saw no swelling and she was advised to contact facility where vaccine was given. She reported that on 10/05/2016 that she was experiencing numbness in left side of face which she called and reported to health department on 10/07/2016.