chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She coudnt get out of her bed; every joint in her body hurts; my arm blew up; rheumatoid arthritis flare; Fatigue; Pain; Redness / one inch below the demarcation point, there is a  a four inch by two and one half inch red mark; Swelling; very sick for three days; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis flare up in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hemochromatosis.   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), fatigue, pain, erythema, swelling, sickness, joint pain and pain in arm. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with prednisone. On an unknown date, the outcome of the rheumatoid arthritis flare up, fatigue, pain, erythema, swelling, joint pain, pain in arm and activities of daily living impaired were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis flare up, fatigue, pain, erythema, swelling, sickness, joint pain, pain in arm and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The patient experienced swelling, redness, pain, and fatigue that started after receiving injection. The patient stated that she became very sick for three days, her arm blew up , and one inch below the demarcation point, there was a four inch by two and one half inch red mark that was becoming larger every day. The patient couldn't get out of bed because every joint in her body hurt from a rheumatoid arthritis flare. She stated that her reaction was severe. She took Prednisone on August 29, 2020, and she felt better by August 30, 2020. She was not planning to speak with her physician regarding the reaction because they did not know anything. All information was not available.
Started to experience hives, rash, welts, itching, burning and stinging pain later while at home.
Tdap 12/09 at first a lump @ injection site - painful R arm persists full ROM but 7/10 pain before paresthesias, without s/s infection.
severe migraine; a week of 102 fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 15Sep2021 10:00 (age at the time of vaccination: 33-year-old) as dose 2, single for covid-19 immunization administered in pharmacy or drug store. Patient was not pregnant at time of vaccination. Patient's relevant medical history included thyroid issues and unexplained infertility from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient was tested for covid-19. Concomitant medications included included PROGESTERONE, OVIDREL, LETROZOLE, and LEVOTHYROXINE taken for unknown indication, start and stop date were not reported. Historical vaccine included, patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FD8448) via an unspecified route of administration, administered in arm left on 24Aug2021 16:00 (age at the time of vaccination: 33-year-old) as dose 1, single for covid-19 immunization, and experienced severe persistent migraine, that started within 6 hours of getting the shot and has persisted 24/7 and is ongoing. My head feels like it's on fire and I have bad temple and nose sinus pressure, fever 102 fever and gets worse with activity, condition worsened. The patient did not take any other vaccine in four weeks. On an unknown date in Sep2021, the patient had a severe migraine that patient continue to suffer from at this time (7-8 weeks after second shot). The pain intensity of the migraine did decrease after 3-4 weeks after shot, but had not ever gone away (patient had been in pain nonstop for over 2.5 months). On an unknown date in 2021, the Patient reported that had a week of 102 fever. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature resulted as 102 on 24Aug2021 and on unspecified date in 2021 (after each shot, I had a week of 102 fever) and COVID test Binoin (sars-cov-2 test) resulted as negative on 25Aug2021 (post vaccination nasal swab). The patient did not receive any treatment for the adverse events. Outcome of the event a week of 102 fever was recovered on an unspecified date in 2021 and outcome of the other event was not recovered.  Follow-up attempts have been completed and no further information is expected.
Information has been received concerning a female patient between 65 and 78 years old who on 10-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663888/0627Y).  Subsequently, the patient experienced a fever, severe swelling, redness and pain at the injection site after she received PNEUMOVAX 23.  The patient sought medical attention with the physician.  The patient was given unspecified oral antibiotics (manufacturers unknown).  At the time of the report, the patient recovered on an unspecified date.  All telephone attempts to obtain follow-up information have been unsuccessful.  The health care professional contacted during telephone follow-up could not supply the following information:  patient's name, or date of birth.  Follow-up information has been received from an office manager concerning a 68 year old patient who was vaccinated subcutaneously with a 0.5 mL dose of PNEUMOVAX 23.  It was reported that the patient also experienced infection at the injection site after vaccination.  This is one of several reports received from the same source.  No further information is available.
rash on the side of the neck, pt stated that she will take Benadryl but has not taken it yet
Patient presents to ED with 2-3 weeks of weakness, fatigue, anorexia. No known Covid exposures. Cough, productive at times.  CT scan shows extensive lung infiltrate consistent with COVID per note.
It was reported that a male pt received a Rabies Imovax ID and TD-TD ADS Adult vaccination on 8/10/1999. Reportedly several days after the injection the pt developed a blister like rash on arm, face and back. The pt reportedly was not seen by a health care provider. From correspondence received on 10/3/2000 it was reported that the pt did not receive TD Adult vaccine as previously reported. From correspondence received  on 10/4/1999,it was reported that the pt recovered from this experience.
contracted COVID; has not received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID) and PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported. .  Concomitant products included CITALOPRAM and LEVOTHYROXINE for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID) and PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose). At the time of the report, COVID-19 (contracted COVID) and PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Case number PHEH2011US04306 is an initial incomplete spontaneous report received from a nurse on 13 Sep 2011: This report refers to multiple patients of unknown age group and gender. An unknown number of patients were vaccinated with less than 0.5 ml dose of MENVEO (batch number: A10062) intramuscularly on unknown dates. No other adverse event was reported.
Red rash. Started small and has grown in size. Warm to the touch. Itchy.  The whole red rash feels hard.
ear infection from the flu which she got 3days ago; ear infection from the flu which she got 3days ago; ears started having a sound like crickets; chills; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ears started having a sound like crickets), INFLUENZA (ear infection from the flu which she got 3days ago), EAR INFECTION (ear infection from the flu which she got 3days ago), CHILLS (chills) and MYALGIA (body aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 10a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stevens-Johnson syndrome. Concomitant products included OLMESARTAN, ZINC, PROBIOTICS NOS, MELATONIN, GABAPENTIN, SERTRALINE and CENTRUM SILVER +50 for an unknown indication.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 10-Mar-2021, the patient experienced TINNITUS (ears started having a sound like crickets), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever). On 23-Apr-2021, the patient experienced INFLUENZA (ear infection from the flu which she got 3days ago). On an unknown date, the patient experienced EAR INFECTION (ear infection from the flu which she got 3days ago). At the time of the report, TINNITUS (ears started having a sound like crickets), INFLUENZA (ear infection from the flu which she got 3days ago), EAR INFECTION (ear infection from the flu which she got 3days ago), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.            Treatment was unknown.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-090546 (Patient Link).   Reporter did not allow further contact
Pt states he felt fine, worked rest of day, loaded truck of hay after work & unloaded hay in barn before evening. Next day, arm had lump "size of softball", c/o pain. Called PHP & was told by nurse to take Benadryl. 1/24/00, arm ok, no pain
Day after vaccine, I developed a vesicular rash on my right forearm and upper arm. Went to my doctor and was diagnosed with shingles. Other side effects were minor such as body aches and headaches, which only lasted one day.
This spontaneous report as received from a medical assistant via a company representative refers to 4 patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with PNEUMOVAX23 via intramuscular route (dose, lot number and expiration date were not reported). On an unknown date, the patients returned to the office complaining of severe pain and swelling at the injection site. There was no product quality complaint involved in this case. The outcome of the events and the relatedness between the events and the vaccine were not reported. Additional information has been requested.
Received 2 doses pneumococcal vax within 8mo 2/5/10 & 10/13/10. CDC was notified.
Temperature of 100.6 and a 1 minute generalized tonic/clonic seizure 24 hours after vaccine.
sudden hearing loss in his left ear. He went totally deaf and was diagnosed with bilateral sensorineural deafness; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 21-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (the dosage regimen information was not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden hearing loss in his left ear, then, he went totally deaf and was diagnosed with bilateral sensorineural deafness. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using this vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. The patient sustained severe and permanent personal injuries, serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of vaccination, the patient had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic losses.
I tested positive for COVID-19 on 10/16/2022. I had chills, severe headache, fatigue, a little stuffy nose, and cough. I had just got back from out of town and so I thought it was jet lag at first. I went to the doctor and as prescribed Paxlovid and finished taking it on 10/21/22. After finishing the medication, I had a severe headache for 3 days. I took Motrin and Tylenol to help the headaches. I am feeling better today.
Low grade fever; headache; arm soreness; Dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Dec2021 14:00 (Lot number: FF8839) at the age of 46 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Prev dose Lot number: EN6023,, dose number: 2, Prev dose vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (Prev dose Lot number:EL3247, Prev dose dose number: 1, Prev dose vaccine location: Left arm), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 14:00, outcome "unknown", described as "Dose 3"; PYREXIA (non-serious) with onset 02Dec2021 21:00, outcome "recovered" (Dec2021), described as "Low grade fever"; HEADACHE (non-serious) with onset 02Dec2021 21:00, outcome "recovered" (Dec2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 02Dec2021 21:00, outcome "recovered" (Dec2021), described as "arm soreness". Therapeutic measures were taken as a result of pyrexia, headache, pain in extremity.  Additional information: Patient had no receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Ibuprofen treatment for the adverse event. Patient had no diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Awareness Date was 02Dec2021.  No follow-up attempts are possible. No further information is expected.
I got hives shaped rash on calves and forearms; I got hives shaped rash on calves and forearms; itching; two pea-sized blisters appeared above the heel and on the shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 (Lot number: EN6204) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal (spring) hay fever" (unspecified if ongoing), notes: Other medical history: I have a history of seasonal (spring) hay fever that was cured by hypersensitization.; "Known allergies: grass pollen" (unspecified if ongoing), notes: Known allergies: grass pollen. Concomitant medication(s) included: SYNTHROID; SIMVASTATIN; FISH OIL; CALCIUM; TURMERIC [CURCUMA LONGA]. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EN6205, prev dose lot unknown: False, prev dose administration date: 28Feb2021, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "No side effects". The following information was reported: URTICARIA (non-serious), RASH (non-serious) all with onset Apr2021, outcome "recovered" (2021) and all described as "I got hives shaped rash on calves and forearms"; PRURITUS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "itching"; BLISTER (non-serious) with onset 2021, outcome "unknown", described as "two pea-sized blisters appeared above the heel and on the shoulder". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
This non-valid spontaneous report was received from a pharmacy technician and refers to an unspecified number of patients' of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Between 06-AUG-2018 and 08-AUG-2018, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # R003557, expiration date: 20-NOV-2020 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. On 06-AUG-2018, the vaccines experienced temperature excursion of - 3.4 degrees Celsius for 2 hours 42 minutes. There was no previous temperature excursion.
24 hrs later pt with 7 cm x 5.5 cm erythema on upper (L) arm with dark 4x3 cm center. Pain with touch. ml pulse, ROM, cap refill. (L) arm where received varicella shot. Had rubbed arm
Case number PHEH2013US025576 is an initial spontaneous report received from a health care professional on 09 DEC 2013. This report refers to an 11-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 07 DEC 2013. The FLUVIRIN PFS and unopened MDV's reached 10C from 05 DEC 2013 through 07 DEC 2013, reached 9.7 C on 08 DEC 2013 and reached 11.7 C on 09 DEC 2013. No adverse event was reported following this administration error.
Covid arm; Injection site itchy; Injection site is red,Redness spread out 3 inches from injection site; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red,Redness spread out 3 inches from injection site) and VACCINATION SITE SWELLING (Injection site swelling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jan-2001 to an unknown date and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) from 01-Jan-2001 to an unknown date for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red,Redness spread out 3 inches from injection site) and VACCINATION SITE SWELLING (Injection site swelling). On 18-Feb-2021, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red,Redness spread out 3 inches from injection site) and VACCINATION SITE SWELLING (Injection site swelling) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported. The patient received second dose on 03-Mar-2021, intramuscularly in right arm.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Patient demographics were added, concomitant medications were added , new events; injection site swelling and  vaccination site reaction were added,outcome of events changed from unknown to recovered, event stop date was added and second dose details were added in I narrative.
Reporter indicated that 7 patients recvd 3 doses of vax & 4 out of 7 exp hot flashes & noc sweats 3 months p/vax;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JUL-2016, the patient was vaccinated with improperly stored GARDASIL single-dose vial (SDV) (lot # L035105 expiration date 01-MAY-2017, dose and route were unspecified) for prophylaxis. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 24 hours with the highest recorded temperature of 30.8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Follow up information has been received on 06-DEC-2016. The letter requesting follow up information has been returned by the post office. Additional information is not expected because the letter requesting follow up information has been returned by the post office. Narrative has been updated. Sender's Comments: US-009507513-1608USA005743: MERCK 1610USA006510: Mfr number.
Information has been received from a physician concerning a 79 year old female with chronic lung disease, thyroid disease, and a sulfonamide allergy who in October 2002, was vaccinated with a second dose of Pneumovax 23. On 09-AUG-2007 the patient was vaccinated subcutaneously in the left upper arm with a 0.5mL third dose of Pneumovax 23 (Lot #657525/0554U). Concomitant therapy included gentamicin nebulizer, Synthroid, Evista, Protonix, Norvasc, Zocor, Mobic and aspirin. Subsequently, 24 to 48 hours post vaccination the patient developed a severe localized reaction with redness, swelling, and severe tenderness at the injection site of the left upper arm. The patient developed a 2 inch (also reported as cm) area of necrotic tissue. On 24-AUG-2007 the patient was seen in the doctor's office and was treated with Cifloxin and topical antibiotics. A complete blood cell count was performed with outcome high for white count at 13,300, 90% poly, 4 lymph, and 6 monocytes. Hematocrit was low at 33.8. At the time of the report the patient had not recovered. The reporting physician requested a lot check. The severe localized reaction with redness, swelling, severe tenderness at the injection site of the left upper arm, and the 2 inch of necrotic tissue were considered to be disabling. Additional information has been requested.