chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVER MIGRAINE; ARMS WERE HURTING SO MUCH / ARM PAIN; HEADACHES; EXHAUSTED; PAIN AT SITE OF INJECTION; LOWER BACK PAIN; TWITCHING ON LOWER RIGHT HIP OR AS IF SOMETHING WAS KICKING HER; BODY WAS IN A FIGHT MODE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 05-SEP-2021) dose was not reported, administered on 03-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced lower back pain. On SEP-2021, the patient experienced twitching on lower right hip or as if something was kicking her. On SEP-2021, the patient experienced body was in a fight mode. On SEP-2021, the patient experienced pain at site of injection. On 03-SEP-2021, the patient experienced headaches. On 03-SEP-2021, the patient experienced exhausted. On 04-SEP-2021, the patient experienced arms were hurting so much / arm pain. On 12-SEP-2021, the patient experienced sever migraine. Laboratory data included: COVID-19 virus test (not provided) Negative, and Pain scale (not provided) 8/10, and Vital signs measurement (not provided) stable. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever migraine on SEP-2021, lower back pain, arms were hurting so much / arm pain, and exhausted, and headaches on 03-SEP-2021, and the outcome of twitching on lower right hip or as if something was kicking her, pain at site of injection and body was in a fight mode was not reported. This report was non-serious. This case, from the same reporter is linked to 20210924029.
Very very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 029L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS and CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very very sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very very sore arm) outcome was unknown.            Concomitant Medications also includes Something for neck pain.
This spontaneous report as received from a physician refers to a patient of unknown age. Medical history, concurrent condition and concomitant medication not reported. On an unknown date the patient was vaccinated with VAQTA. Other suspect therapy included RECOMBIVAX. On an unknown date the patient experienced rash. The patient received both RECOMBIVAX and VAQTA on the same day, and developed a rash. The patient sought medical attention for the event. The rash was a hypersensitivity reaction. Physician declined to provide by additional details. Treatment for the event was unknown. The outcome of rash was reported as recovered/resolved. Action taken with the product was unknown. The causality of the event was not reported. No PQC was reported. Additional information has been requested.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long Covid", start date: 2020 (unspecified if ongoing), notes: Other medical history: Long Covid; "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "chronic fatigue syndrome", start date: 2020 (unspecified if ongoing), notes: Other medical history: chronic fatigue syndrome (since Covid infection 2020); "migraines" (unspecified if ongoing), notes: Other medical history: migraines; "shortness of breath" (unspecified if ongoing), notes: Other medical history: shortness of breath; "BPV" (unspecified if ongoing), notes: Other medical history: BPV; "high cholesterol" (unspecified if ongoing), notes: Other medical history: high cholesterol; "anxiety" (unspecified if ongoing), notes: Other medical history: anxiety; "depression" (unspecified if ongoing), notes: Other medical history: depression; "PTSD" (unspecified if ongoing), notes: Other medical history: PTSD. Concomitant medication(s) included: AMLODIPINE; SERTRALINE; ALPRAZOLAM; VITAMIN C [ASCORBIC ACID]; ACETAMINOPHEN; VITAMIN D3. Past drug history included: Propranolol, reaction(s): "Allergy", notes: known allergies: Propranolol; Imitrex, reaction(s): "Allergy", notes: known allergies: imitrex; Relpax, reaction(s): "Allergy", notes: known allergies: relpax; Hctz, reaction(s): "Allergy", notes: known allergies: hctz; Phenergan, reaction(s): "Allergy", notes: known allergies: phenergan; Prednisone, reaction(s): "Allergy", notes: known allergies: prednisone; Buspirone, reaction(s): "Allergy", notes: known allergies: buspirone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment yes, Reporter type patient, If vaccine received yes, Other medication in 2weeks yes, Product COVID 19 Treatment start date 04Jan2023, treatment stop date 09Jan2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300014654 Same patient, different product and event;
I found out I was pregnant the day after receiving the first dose of the COVID-19 vaccine. My last period was on December 8th and I received the vaccine on Dec 30th. I developed a fever and muscle aches after the first dose, but was managed with Tylenol.  I received the second dose on January 22nd and again developed a fever that was managed by Tylenol. I began having vaginal bleeding on 24th. I had an ultrasound revealing a heartbeat on the 25th. After continually bleeding, another ultrasound a week later on Feb. 2nd confirmed a miscarriage. I've had two healthy pregnancies prior to this one.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from other Health Professional. This case involves male patient who experienced injected limb mobility decreased and painful arm, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported). On an unknown date, the patient developed a non-serious immobility after vaccine administration (injected limb mobility decreased) and significant arm pain (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was injected limb mobility decreased and painful arm. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as Unknown for injected limb mobility decreased and painful arm. List of document held by sender: None.
Arm was so sore/arm hurt for 5 to 6 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was so sore/arm hurt for 5 to 6 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LEVOTHYROXINE, OMEPRAZOLE and TRAMADOL for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was so sore/arm hurt for 5 to 6 days). At the time of the report, PAIN IN EXTREMITY (Arm was so sore/arm hurt for 5 to 6 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) No antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Information was not provided Patient had two blood tests.Patient said that has no antibodies   This case was linked to MOD-2021-233339 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Started to feel dizzy and lightheaded 7 minutes after receiving vaccine.  Soon began to feel numbness, tingling on tongue and around mouth.  Started to feel tingling in legs.  Moved from sitting position to laying down.  Epi-pen administered at 10:24am.  Patient responded, numbness and tingling resolved.  At 10:40am she began to complain on numbness and tingling around mouth and on tongue.  2nd Epi-pen administered at 10:41am.  Patient taken to ER with RN in escort.
patient got pneumovax and shingrix shots same date on her right arm. patient complained of redness and soreness few days after the immunization. patient advised to take tylenol and benadryl if redness doesn't go away and to see PCP if symptoms are worsen.
Bleeding at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.    Reporter did not allow further contact
4SEP97 c/o h/a shortly p/vax (at approx 11-12AM) lasted all day;rt arm from elbow to shoulder sl swollen, red, warm to touch, mod hard to touch;told not to skip regular meds;8SEP97 no h/a, swelling gone, arm soft to touch, only sl redness
Parsonage Turner Syndrome (extreme pain began April 10, 2018; diagnosed late April, 2018).
Pt had soreness in arm and possible leg pain 2 weeks after vaccination of Fluzone high dose that doctor thought could be blood clot.
ringing in ears that was minor about a half hour after receiving the shot, now the ringing is much louder, especially when waking up in the morning
Fever starting 14 days after initial Hep A injection rash began 16 days after injection. Welt with a center. Tx: Zyrtec liq. Benadryl-3 office visits required. Varicella/ Erytheme multiframe.
patient indicated on her PCQF that she had been faint or dizzy after previous vaccines, but she indicated that she just gets nervous and she was nervous about this shot, she had a negative response for allergies on PQCF.  she waited the 15 min required and left because she needed to go eat before starting her shift.  She returned after a few minutes and said the back of her throat was tingling so I administered 25 mg benadryl (oral liquid).  She waited a few minutes after that and indicated that she wanted to go to the urgent care because she just didn't feel well (nausea, hot and cold flashes). Her sister was there to transport her.  Her BP at the time of benadryl administration was 140/87 and pulse was 61.  That was 11:28 am. Urgent care did no treatment and her symptoms resolved soon after being seen.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient had no medical history or drug reactions/allergies. On 11-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, once, lot# and expire date were not reported) subcutaneously. No concomitant medication was reported. On 12-JUN-2015, the patient experienced redness at the injection site. The patient sought medical attention via seeing in the pharmacy. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. Causality was not reported. Additional information has been requested.
Urticaria - hives, itching for 48 hours, treated with Benadryl
Swelling noted on left thigh, got gradually worse and worse . Red hot tender painful seen by MD 3/9/12 and diagnosed with cellulitis.
Patient had little red bumps appear all over neck and shoulders within 24 hours of receiving vaccine. They persisted for over 3 weeks but were improving. She asked prescribed about them at check-up.
This spontaneous report as received from a pharmacist refers to "at least 4 unspecified patients" (age and gender: unknown). On an unknown date the patients were vaccinated with 0.5 ml of (Oka/Merck) VARIVAX, subcutaneously (dose, frequency, anatomical location: unknown) (lot#, exp date: unspecified) which underwent an unspecified temperature excursion. No adverse effect was reported. Additional information has been requested.
Complete Cranial Nerve 3 Palsy, left side  Symptoms: Diplopia, Ptosis
Dehydration, severe cramping, weakness, fainted. Given antibiotics and IV fluids at Urgent Care. Blood and urine were drawn, MRI done.
patient is under the FDA approval use of 16 years of age and older. Contacted CDC, Pfizer, and NDDOH. CDC stated to not give another dose until the patient turns 16 years of age.
8/20/10 - Raised red rash under arms to waist bilaterally for past 2 days. Area not itching, only irritating.
can barely move arm; feels really lethargic; she could taste the vaccine in her mouth within a minute; weak with chills.; very achy; felt a bit weird; weak; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a bit weird), ASTHENIA (weak), INSOMNIA (could not sleep), MOBILITY DECREASED (can barely move arm) and LETHARGY (feels really lethargic) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (sulfa drugs) and Drug allergy (codeine).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (felt a bit weird), ASTHENIA (weak), INSOMNIA (could not sleep), TASTE DISORDER (she could taste the vaccine in her mouth within a minute), CHILLS (weak with chills.) and MYALGIA (very achy). On 11-Feb-2021, the patient experienced MOBILITY DECREASED (can barely move arm) and LETHARGY (feels really lethargic). At the time of the report, FEELING ABNORMAL (felt a bit weird), ASTHENIA (weak), INSOMNIA (could not sleep), MOBILITY DECREASED (can barely move arm), LETHARGY (feels really lethargic), TASTE DISORDER (she could taste the vaccine in her mouth within a minute), CHILLS (weak with chills.) and MYALGIA (very achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt developed red rash on face (both cheeks) and legs. Injection area swelled to size of "goose egg" with rash surrounding. MD administered KENALOG injection and diphenhydramine.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # K015462, expiration date 10-JUL-2017) (dosage, strength and route of administration not reported). There was no concomitant medication reported. At the time of this report, no adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Reaction at the injection site  Big, red lump or mark; Reaction at the injection site  Big, red lump or mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Reaction at the injection site  Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site  Big, red lump or mark) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Reaction at the injection site  Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site  Big, red lump or mark). At the time of the report, VACCINATION SITE MASS (Reaction at the injection site  Big, red lump or mark) and VACCINATION SITE ERYTHEMA (Reaction at the injection site  Big, red lump or mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.  The patient had big red lump measuring 5 inches vertically 3 or 4 inches horizontally at the injection site after one week of COVID-19 vaccination.
arm was real red; Arm was swollen and huge; Condition aggravated; she was dizzy; it was terrible; doesn't sleep; Arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was real red), PERIPHERAL SWELLING (Arm was swollen and huge), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (she was dizzy) and FEELING ABNORMAL (it was terrible) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm was real red), PERIPHERAL SWELLING (Arm was swollen and huge), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (she was dizzy), FEELING ABNORMAL (it was terrible), INSOMNIA (doesn't sleep) and VACCINATION SITE PAIN (Arm was painful). At the time of the report, ERYTHEMA (arm was real red), PERIPHERAL SWELLING (Arm was swollen and huge), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (she was dizzy), FEELING ABNORMAL (it was terrible), INSOMNIA (doesn't sleep) and VACCINATION SITE PAIN (Arm was painful) outcome was unknown.            No concomitants were reported. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
neurological effects, like a muted GBS without paralysis; Body Tremors, both legs and upper torso; This non-serious case was reported by a other health professional via call center representative and described the occurrence of neurological symptom in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced neurological symptom (Verbatim: neurological effects, like a muted GBS without paralysis) and tremor (Verbatim: Body Tremors, both legs and upper torso). The outcome of the neurological symptom was not reported and the outcome of the tremor was unknown.   It was unknown if the reporter considered the neurological symptom and tremor to be related to Shingrix.     It was unknown if the company considered the neurological symptom and tremor to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2023 The healthcare professional inquired if there was any post marketing reported reactions to the Shingrix vaccine where the patient experienced body tremors.  The tremors would include both legs and upper torso almost like a muted Guillain-Barre syndrome which was without paralysis but similar evolution with neurological effects.
Blotchy, red area to lower abdomen and right thigh, pruritic at times Recommended an antihistamine cream or pill, if symptoms worsen suggested for her to see primary provider Symptoms are subsiding. Recommended to see provider if symptoms worsen.
Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Received the Moderna Covid 19 vaccine after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 083J21A) for COVID-19 vaccination.     Patient had No known drug allergies. Patient was not tested Positive for COVID-19.  Previously administered products included for Drug use for unknown indication: J & J (Patient received 1st dose of JNJ and Lot number is 1805031) on 09-Mar-2021. Past adverse reactions to the above products included No adverse event with J & J.   On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. Number of doses/vials were 26 doses.  The reporter reported that, found out that the vaccine had been expired for 2 weeks and the expiration date was not written on the vial and did not noticed it had already expired. The vaccine stored in fridge on 17-May-2022. The vials did not undergo any temperature excursion.  No treatment medications was provided by the reporter.