chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm turned red; Arm hurting; Tightness in the neck; Developed rash in her arm; Fever with temperature of 101; Chills; Headache; Tightness in her throat; Tightness in her chest; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), ERYTHEMA (Arm turned red) and MUSCLE TIGHTNESS (Tightness in the neck) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), PYREXIA (Fever with temperature of 101), CHILLS (Chills) and HEADACHE (Headache). On 12-May-2021, the patient experienced RASH (Developed rash in her arm). On 13-May-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in the neck). On 14-May-2021, the patient experienced ERYTHEMA (Arm turned red) and MYALGIA (Arm hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-May-2021, MUSCLE TIGHTNESS (Tightness in the neck) had resolved. At the time of the report, THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), ERYTHEMA (Arm turned red), RASH (Developed rash in her arm), PYREXIA (Fever with temperature of 101), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Arm hurting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-132312 (Patient Link).
looks like there is blood under the skin in the arm where patient received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMATOMA (looks like there is blood under the skin in the arm where patient received the injection) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMATOMA (looks like there is blood under the skin in the arm where patient received the injection). At the time of the report, VACCINATION SITE HAEMATOMA (looks like there is blood under the skin in the arm where patient received the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
This spontaneous report was received from a female of unknown age regarding herself. The patient had history of allergy to penicillin, allergy to sulfa and high blood pressure. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose and route of administration was not provided). Concomitant therapies included LIPITOR and CENTRUM, unspecified medications for high blood pressure and Allopurinol (also reported as Alpurinol) to prevent kidney stones. On an unknown date in February 2012, the patient developed shingles on her neck and then on her scalp and they burned but did not itch. The patient received pills as treatment Valacyclovir and she recently finished. The patient stated that her mother has shingles and she did not want to get them, as they were awful. The patient also stated that she was completely over it now and there was just a little red scar on her neck. No laboratory diagnostic tests were performed. The outcome of the events were reported as resolving. The patient sought medical attention. Additional information has been requested.
Mother noticed that patient was very sleepy for 24 hours after vaccine administration, as she was after her 2 month immunizations. After that, parents and daycare worker noticed a significant decrease in patient's spontaneous verbalizations, which had been fairly good. This lasted about one month. Patient now 7 months and verbalizing spontaneously again.
Breakthrough case admission after 3 vaccines Moderna 4/15/21 Lot# 044B21A; Moderna 6/16/21 Lot# 033B21A;  Moderna 12/26/21 Lot# 041J21A
Rash, redness at injection site. Hives, redness, non- itchy on chest and face. BENADRYL 25mg 1-2 caps every 4-6 hours plus ZYRTEC 10mg 1 tablet each day.
This spontaneous report was received from a other health professional refers to a 8 year old female patient. On 06-AUG-2009, the patient was vaccinated with dose 1 of GARDASIL (lot#, expiry not reported) and second dose on 06-OCT-2009. No adverse effect reported. Additional information has been requested.
Headache, Myalgia, FATIGUE, INJECTION SITE PAIN Narrative:  Other Relevant History:
missed the second dose; hysterectomy; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HYSTERECTOMY (hysterectomy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included OMEPRAZOLE and VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HYSTERECTOMY (hysterectomy). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HYSTERECTOMY (hysterectomy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the second dose of the Moderna COVID-19 Vaccine on it's intramuscular on May 5th, 2021.batch no 013A21A (013AZIA).      No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Live Follow-up information received on 16-JUL-2021 contains non-significant information.
Chills, feverish, body aches, sore injection site- started night of the injection; lasted the whole next day ( I had to stay home from work)
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
5/12/21 felt sudden pain, burning sensation to Left side of left breast, swelling sensation of L breast, left under arm, below left collar bone area. Used icepacks, motrin, extra-strength tylenol for 4 days.  Pain reduced slightly, but for 2 more weeks felt off & on left arm pit,  and left arm swelling, sensation of fluid under skin near left chest, left upper back, left upper side. Minor relief by keeping left arm elevated, wearing a compression sleeve, wearing a sports bra all day and at night. Swelling is not going away. It increases and decreases but never feels normal. Its now 4 weeks. Inaddition to the above I had the expected side effects: bodyaches, left arm injection pain, tired, low grade temp, headache, foggy head for 10 days.
He received his vaccine, had a sore arm and that evening around 7 hours later it was as if a switch flipped he was not able to breath, and his wife noticed on his body she could see all his veins like a track on his trunk and everywhere.  He could not talk.   He said that he was burning up, was hot and clammy.  He got in the shower to cool himself down, and was told that the oxygen was not getting to where it was supposed to go.  His wife called 9-1-1 and the EMT's said that his oxygen had dropped down into the 60's. He went to the hospital and they said he had pulmonary edema that filled his lungs that quickly.  He was not intubated, and is on a BiPAP.  He was given Lasix, steroids, antibiotics trying to pull the fluid off of his lungs.  He has had so many different scenarios from people at the hospital right now and at one time one of his nurses said that his blood work showed a possible blood clot.  They looked at his lungs and they said that they did not see it in his lungs.  Then they said that he had a heart attack and that he needed a valve replacement.  Today, 3/25/21 they told him that he did not have a heart attack, did not need a valve replacement.  Last night they said that his BP was dangerously high and today, his BP is fine.  He also had an adverse reaction to the steroids and had a ROID rage from that as well giving the nurses and his wife a hard time, hanging up the phone on her, and said that he was leaving the hospital.   He was fine prior to the vaccine, and does not have any other issues for him to have this reaction.  He is in ICU and they keep saying that they are going to put him in a cardiac care unit.  He has a lot of IV lines and his 2nd COVID test came back negative.   He feels like they are just running test to get money out of him.  They said that he may be able to go home tomorrow.
Vaccine administration error: Covid booster (3rd dose) was administered 1/2022 but was not recorded on our immunization records.  At today's visit, I advised a covid booster on the belief that patient had had only 2 doses of her covid vaccine.  After administration of her covid vaccine today, family produced covid vaccination card showing 3 previous doses of covid vaccine.  Patient received an unintentional 4th dose of covid vaccine today.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient received 2 doses of GARDASIL intramuscularly (dose and lot # not reported) on unspecified dates in 2012 (reported as unspecified dates 2 years ago) and then, on 20-AUG-2014 received the 3rd dose of GARDASIL intramuscular (dose and lot # not reported). There were no known adverse effects. Additional information has been requested.
experiencing pain when she takes a deep breath that extends to her right shoulder blade after receiving the first dose of the Pfizer COVID vaccine.; experiencing pain when she takes a deep breath that extends to her right shoulder blade after receiving the first dose of the Pfizer COVID vaccine.; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- unknown), intramuscular in arm right on 23Jul2021 (age at vaccination 51 years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. On 24Jul2021 patient experienced pain when she takes a deep breath that extends to her right shoulder blade after receiving the first dose of the Pfizer COVID vaccine. Therapeutic measures were taken as a result of the adverse events which included Aleve. The outcome of events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Headache, Myalgia, Fever, NauseaVomiting, SWELLING AND CHILLS Narrative:
Mom reports subjective fever, decreased oral feeding and then shaking and seizure like episodes for "a few days".  Patient admitted to the hospital 11/25/09 and found to have elevated aldolase and CK.
ANAPHYLACTIC SHOCK; This spontaneous report received from a company representative concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic reaction with unknown cause. The patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were Unknown) dose was not reported, 1 total, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 11-MAY-2021, the patient experienced anaphylactic shock, and was hospitalized and given high dose of steroids to manage adverse reaction. Patient was discharged on the same day (11-MAY-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylactic shock. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523394-COVID-19 VACCINE AD26.COV2.S-Anaphylactic shock. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recv vax & 12hr later pt face got flushed, red & itchy;pt recovered 19OCT95;
This spontaneous report has been received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included Diluent Mrk Inj used to reconstitute the PROQUAD was properly stored. On 31-MAY-2018 (also reported as 25-MAY-2018), the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (degrees F) to 14 degrees F (also reported as "9F") for a time frame of 10 minutes; and of 15 degrees F to 46 degrees F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
4 nodules to the injection areas; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): GL-111621-26885 (RA).  A 66-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Feb2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation; hyaluronic acid, lidocaine hydrochloride (RESTYLANE DEFYNE), since 23Sep2021 (Batch/Lot number: unknown) at 1 mL. Relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: Med history of osteoporosis. Concomitant medication(s) included: FOSAMAX taken for bone disorder. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown.), administration date: Jan2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: INJECTION SITE NODULE (non-serious) with onset 15Oct2021, outcome "unknown", described as "4 nodules to the injection areas". The action taken for hyaluronic acid, lidocaine hydrochloride was unknown. Therapeutic measures were not taken as a result of injection site nodule.  Additional information: Patient was injected with Defyne to both marionette lines. About a month ago on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WEAKNESS/NO ENERGY; BACK PAIN; ARM PAIN AT INJECTION SITE; WEIRD FEELING LIKE AGONY; FEELING LIKE FAINTING; TACHYCARDIA; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None as per patient. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced tachycardia, weird feeling like agony, and feeling like fainting. On 03-DEC-2021, the patient experienced arm pain at injection site. On 04-DEC-2021, the patient experienced back pain. On 28-DEC-2021, the patient experienced weakness/no energy. Treatment medications (dates unspecified) included: meloxicam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on 07-DEC-2021, had not recovered from tachycardia, weakness/no energy, and weird feeling like agony, and the outcome of arm pain at injection site and feeling like fainting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Irritability post vac. A physician reports post vaccine pt became fussy. The infant recovered after 24 to 30 hours.
Received 2nd dose of Lymerix 9/15/2000. That evening developed severe headache,stiff neck, febrile seizures, photophobia, extreme weakness, fever 105, fatigue.Seen in ER OF READING hOSPITAL.dIAGNOSED WITH encephalitis. Since that time had progressive fatigue, muscle aches, joint pain,severe depression,memory loss, mental confusion,anxiety, 55 lbs. weight loss, insomnia,constipation,bed wetting, magnified hearing loss, loss of muscle strength. Diagnosed with Fibromyalgia & CFS. Unable to perform normal activities of daily living or continue to work.This all continues to present.
Patient received the shot on Sun 11/7/10 at 12:33pm. She said her left shoulder swelled to twice the size of her shoulder very warm/hot to the touch and also gets little red bumps near the site, no fever.
SOB - 3-4 hr after, sore arm, little achy, increase in BP, 6 hr after administration, went to ER because of SOB.
pt-I received the Zostavax vaccine on Friday 4-25-08 in my left arm & I had no immediate reaction until Monday, 4-28-08 when I awoke with pain in my left axilla and a half dollar sized red wheal @ the injection site. Today the red wheal is fading but I have swelling of the glands under my arm & it is still tender to the touch-no other reactions. Thank you. 4/30/08 Pt afebrile temp 97 Right. The injection site warm to touch, pinkish, 5/8" x 1/2"-soft area, minimal swelling-R axillary node compare to left and equal in sieze, R remains tender to touch.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Additional Details: Patient stated that his blood pressure does goes low frequently. We provided him with water. We checked his blood pressure 5min after receiving injection and it was 68/40mmHg (HR 47). His blood pressure 15min after receiving the vaccination was 107/65mmHg (HR 48). Patient was feeling much better 30min after receiving vaccination.
diminished alertness/clouded headedness; mental acuity reduced; reduced attention to details; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diminished alertness/clouded headedness, mental acuity reduced, and reduced attention to details on an unspecified date. The clinical outcome of the events was recovered on an unspecified date.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
redness and swelling at injection site; Low grade fever; redness and swelling at injection site; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A 65-year-old female patient (not pregnant) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 20Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in arm. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 20Oct2023, outcome "recovered" (Oct2023), described as "Low grade fever"; INJECTION SITE SWELLING (non-serious), INJECTION SITE ERYTHEMA (non-serious) all with onset 20Oct2023, outcome "recovered" (Oct2023) and all described as "redness and swelling at injection site". Therapeutic measures were not taken as a result of injection site swelling, pyrexia, injection site erythema.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, sweats, temperature of 100, and headache about 10 hours after receiving flu vaccine didn't feel well for a day afterward.
Redness, itching, heat at right deltoid (injection site) 45 minutes after administration. Had erythema with no swelling, no hives on 10/22/13.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 00:15 as dose 1, single (Lot number: EM9810), in right arm, on 27Feb2021 at 01:00 as dose 2, single (Lot number: EN6205), in right arm and on 29Sep2021 at 13:00 as dose 3 (booster), single (Lot number: EW0179) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE; CARVEDILOL; ASPIRIN [ACETYLSALICYLIC ACID]; DUTASTERIDE; ATORVASTATIN; VYVANSE. Past drug history included: Spironolactone, reaction(s): "Allergy:Spironolactone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive, notes: 23Jun: Initial POS test and commence Paxlovid; (30Jun2022) Negative, notes: 30Jun: Symptoms minimal & NEG test; (02Jul2022) Positive, notes: 02Jul: Symptoms returned; (03Jul2022) Positive, notes: 03Jul: Strong POS test; (05Jul2022) Positive, notes: 03Jul: Symptoms remain & strong POS test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 Treatment was received. Treatment start date 23Jun2022 & treatment stop date 27Jun2022.lot number=Paxlovid. Patient received other medication in 2weeks Losartan 50mg, Amlodipine 2.5mg, Carvedilol 12mg. Aspirin 81mg, Dutasteride 0.5mg, Atorvastatin 20mg and Vyvanse 50mg. Known allergies: Spironolactone. Other medical history: High blood pressure. Relapse after Paxlovid treatment. 23Jun: Initial POS test and commence Paxlovid. 30Jun: Symptoms minimal & NEG test. 02Jul: Symptoms returned. 03Jul: Strong POS test. 05Jul: Symptoms remain & strong POS test.
Bursa inflammation reported, told patient to ice, treat with otc nsaid, and light exercise  to joint.