chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: bee venom allergy" (unspecified if ongoing), notes: Known allergies: Penicillin keflex bee venom allergy; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin keflex bee venom allergy. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2023) Positive, notes: Rebound positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 17Aug2023 to 21Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Beginning 2-4 weeks after vaccination, patient states has sharp pain that runs between the shoulder and elbow with exertion of muscle and joint.  Per consult of regional office suggested patient consult PCP.
They wouldn't allow her to get the second one; broke out in hives/Within the next two weeks, on and off, she would break out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives/Within the next two weeks, on and off, she would break out in hives) and PRODUCT ADMINISTRATION INTERRUPTED (They wouldn't allow her to get the second one) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 prophylaxis.     No relevant medical history/conditions, allergy, concomitant diseases, and risk factor.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (broke out in hives/Within the next two weeks, on and off, she would break out in hives). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (They wouldn't allow her to get the second one). At the time of the report, URTICARIA (broke out in hives/Within the next two weeks, on and off, she would break out in hives) had resolved and PRODUCT ADMINISTRATION INTERRUPTED (They wouldn't allow her to get the second one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. She had a reaction to the Moderna shot in 2021. She took the first dose on 19 Mar 2021 but broke out in hives and went to emergency room on the same day. They wouldn't allow her to get the second one. The hives went away pretty fast because they gave her Benadryl. Within the next two weeks, on and off, she would break out in hives. After the two weeks, it stopped.
it was rpt fr MD p/vax pt exp numbness down arm into fingers. 24hrs p/vax pt inject site was swollen & red approx 3-4'' wide. sx lasted 3 days.
anaphylactic shock; almost died; sever neuropathy; could not walk, or use her hands; could not walk, or use her hands; severe neurological damage; experienced PEG Allergy; felt bad; had swollen throat; swollen tongue; hands and legs tingle; trigeminal neuralgia; infection against her spine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000003467 (Novavax).  A 62-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost died"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "sever neuropathy"; GAIT INABILITY (medically significant), MUSCULOSKELETAL DISORDER (medically significant), outcome "unknown" and all described as "could not walk, or use her hands"; NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "severe neurological damage"; POLYMERS ALLERGY (non-serious), outcome "unknown", described as "experienced PEG Allergy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad"; PHARYNGEAL EDEMA (non-serious), outcome "unknown", described as "had swollen throat"; SWOLLEN TONGUE (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), outcome "unknown", described as "hands and legs tingle"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown"; INFECTION (non-serious), outcome "unknown", described as "infection against her spine". On 09Sep2022, it was reported that the patient started treatment on an unspecified date in 2020 with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for Covid-19 immunization. It was reported the patient experienced PEG allergy, anaphylactic shock, felt bad, almost died, had swollen throat, swollen tongue, bedridden, sever neuropathy, could not walk, or use her hands, severe neurological damage, hands and legs tingle, trigeminal neuralgia, and infection against her spine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Weak; Fatigue; On and off sharp spiking head pains; Arm started hurting; Extreme body aches everywhere; Fitful sleep; Immobilized; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), ASTHENIA (Weak) and MOBILITY DECREASED (Immobilized) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020. Concurrent medical conditions included Meat allergy (Allergic to Chicken), Allergy to legumes (Allergic to Beans), Depression and Arthritis. Concomitant products included MELOXICAM from 01-Apr-2005 to an unknown date for Arthritis, CALCIUM for Bone disorder, BUPROPION HYDROCHLORIDE (BUPROPION HCL ER) from 01-Mar-2000 to an unknown date for Depression, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication.   On 26-Dec-2020 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Dec-2020, the patient experienced PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), MOBILITY DECREASED (Immobilized) and ARTHRALGIA (joint pain). On 26-Dec-2020 at 8:00 PM, the patient experienced PAIN IN EXTREMITY (Arm started hurting). On 27-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weak), FATIGUE (Fatigue) and HEADACHE (On and off sharp spiking head pains). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), PAIN (Extreme body aches everywhere), POOR QUALITY SLEEP (Fitful sleep), ASTHENIA (Weak), MOBILITY DECREASED (Immobilized), ARTHRALGIA (joint pain), FATIGUE (Fatigue) and HEADACHE (On and off sharp spiking head pains) had resolved.            Patient took a hot bath which helped with pain. No other treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received on 07-APR-2021 included patient's few basic information, allergies, Second dose date, time and batch number, Concomitant medications, addition of new events experienced after first dose of vaccine and description of the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Immediately after receiving the shots he became flushed and light-headed.  States it was hard to formulate his thought into words at the time.  He layed down with feet elevated for approximately 15 minutes.  Color returned to normal and no longer c/o light-headedness when he left.  States at 1 PM the same day, he developed a headache that lasted all day.  That night he slept 18 hours and woke up with a severe headache.  Temp was 96.7.  Went to ER- CT scan and "blood work" were reported to be normal.  ER Dr told him it was probably a reaction to one of the shots- probably Typhoid injection.  Dr told him it was OK to get #2 dose of Twinrix next week.  Was given Toradol for severe headache pain.  Headache was gone the next day.
pt c/o throat sore, breathing diff x 1min-head pain & tooth pain on rt side inj on lt deltoid;pt was observed during entire time pt refused to stay for longer than 5mins observation
PATIENTSTATES EVER SINCE HE RECEIVED THE VACCINE IN THE LEFT DELTOID THAT HE HAS FELT LIKE SOMEONE "FROGGED" HIS ARM AND IT IS SORE. THE MORE HE USES THE ARM THE BETTER IT FEELS. NO REDNESS AT PREVIOUS INJECTION SITE AND HE IS HESITATNT TO TAKE A BOOSTER BECAUSE OF CONTINUED PROBLEM. FIRST INJECTION IN RIGHT DELTOID CASUSED NO ISSUES.
Diaphoretic - blurred vision - pale - did not become syncopal happened within one minute of vaccine administration.
The entire upper left arm swelled up for several days and hurt a great deal.  The swelling has since subsided, but I am unable to completely lift my arm above my head without some pain.
Headache, dizziness and shortness of breath following vaccine, then left sided numbness to ear, face, hand and arm x 1 week. 1/5/2010 ED records for 9/8/2009, patient with c/o's left facial and arm numbness, neuro exam wnl 1/5/2010 ED records for 9/9/2009, patient with c/o's lightheadedness, nausea, dull chest pain, felt flushed and faint, Impression Near syncope
Pt recvd vax & devel cellulitis on arm & chest on the same side as the inject site; pt was hospitalized & tx w/unspecified ATB; addtl details are being requested;
INADVERTENT ADMINISTRATION TO CHILD UNDER AGE 18 OF MODERNA VACCINE, NO KNOWN ADVERSE EFFECTS
This spontaneous report as received from a Licensed Practical Nurse refers to a physician who is a male patient of unknown age. On 16-APR-2014 (reported as "today" at the time of report) the patient administered both VARIVAX (Merck) and M-M-R II (lot#, dose, frequency for both vaccines were not reported) to the patient. On 16-APR-2014 the physician experienced burning to his left eye when a small amount of vaccine squirted from the syringe while the needle was "retracting" after the injection was completed. The physician was not sure if the vaccine in question was VARIVAX (Merck) and M-M-R II. The physician flushed out his eye with water for an unspecified time. The outcome of the events was unknown. Additional information has been requested.
Pt received incorrect dose of Covid Vaccine. Pt received for age group 6- 11 years instead of the 6 months to 5 years dose.  Provider notified and felt medically that pt is stable and explained situation to father at the time of differnace and signs and symptoms to be aware of.   Mother contacted 1/25 to check on pt and stated he was doing well and denied any adverse reactions.
lungs were still hurting; not feeling well; pneumonia/pneumonia from COVID; COVID Positive; This is a spontaneous report received from Medical Information Team and from a Pfizer-sponsored program  from a contactable consumer (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient received her 1st dose of the Pfizer COVID Vaccine on 06Apr2021 but came back COVID Positive on 09Apr2021. She mentioned that she was diagnosed with pneumonia on 19Apr2021 in the hospital and was sent home with antibiotics. She mentioned that she was a healthy person, but her lungs were still hurting and she was still not feeling well. She is due for her 2nd dose tomorrow (27Apr2021) and was asking if she should proceed with it as she had pneumonia from COVID. Outcome of the events was unknown.  Information for lot number has been requested.
WORRIED; CHILLS; HEADACHES; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included colon cancer, and concurrent conditions included codeine allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headaches. On 13-APR-2021, the subject experienced worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headaches on 14-MAR-2021, and the outcome of worried was not reported. This report was non-serious.
Within 48 hours of the vaccines being administered the pt complained of extreme itchiness, insomnia and coughing. Recommended she try hydrocortisone cream and ZYRTEC x 5 days.
Arm was sore, hurt; Felt kind of yucky; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm and malaise. On an unknown date, the outcome of the pain in arm and malaise were recovered/resolved.   It was unknown if the reporter considered the pain in arm and malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had first shot about two and half weeks prior to the reporting.  The patient arm was sore for a couple of days, it actually hurt.  The patient felt kind of yucky for a day nothing you could really pinpoint but the patient's 38 year old daughter just had shingles and the pain she was in scared the heck out of. Additional supportive information: The follow-up would not possible as no contact details were available.
Edema noted to bilateral hands 12 hours after injection. Resident states they became red, began to itch, then they were swollen. He also states he felt a tingling sensation to bilateral hands.
Patient fainted a few mins after the shot was given. It took over 20mins for him to be able to walk with assistance after eating a candy bar and drinking orange juice. He was still light-headed, nauseous and pale a few hours after the shot. However, he woke up the next morning feeling well enough to go to school.
Systemic: Headache-Medium, Additional Details: Patient reported still having a headache 6 days after recieving the Shingrix vaccine
Rash/ bumps near injection site. Rash across chest and back and middle of right thigh. Reported on 1/29/10 (vaccine given on 1/28/10 at 4:35pm) patient report onset at 8pm.
pt recv vax 18JUN96 & 19JUN96 pt devel swelling & hardness @ inj site & a hematoma @ inj site which was about the size of a 50 cent piece;
Local reaction with swelling, erythema, over 24-36 hours after injection; left anterior thigh. OTC Benadryl only.
Patient called on 8.30.21 complaining of swollen, sore glands under the armpit of her vaccinated (right) arm.  She stated that it appeared on Friday, and got worse over Saturday and Sunday.  She felt that it was slowly getting better as of Monday.  Patient states she was taking ibuprofen to help with the pain and swelling.
patient under 50 years old received the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 47-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (had herpes zoster last year).   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided are as follows: The age at vaccination was not reported but patient was under 50 years old. The patient received 1st dose of Shingrix 3months ago of the reporting date, which led to inappropriate age at vaccination. The pharmacist mentioned that the patient had herpes zoster last year which was the reason that the doctor gave him the shot, which led to off label use. The reporter did not have available patient demographics neither lot number and expiration date.  The reporter consented to follow up.
The patient called on 10/25 and said that he got redness around the injection site for a few days but his redness got better as following up with him on 10/26.
Fever to 103, subjectively swollen lips, coughing and wheezing resolving without treatment, myalgias, malaise.
Redness, swollen at site of shot (7 days); tightness of chest (1 hour); swelling at shot site (3 days); muscle pain all over like flu (10 hours); shivering (one evening); fever with sweats (evening plus over one night); headache (one night); nausea (one day); upset stomach; abdomen pain (2 hours); weakness (8 hours).
Had experienced intermittent tinitus (ringing) in left ear (less than 1x/week) when laying down; starting after Covid infection in March 2020 - had never had previously.  2 days after second shot, woke to have persistent ringing in both ears; has not subsided.
Swelling in my lips; Swelling in my throat; Sore throat; fever; eniter upper body rash; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling in my lips), PHARYNGEAL SWELLING (Swelling in my throat), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (fever) and RASH (eniter upper body rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swelling in my lips), PHARYNGEAL SWELLING (Swelling in my throat), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (fever) and RASH (eniter upper body rash). At the time of the report, LIP SWELLING (Swelling in my lips), PHARYNGEAL SWELLING (Swelling in my throat) and RASH (eniter upper body rash) had resolved and OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided Treatment included Steroids
Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.) 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 EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided by the reporter.
This was the start of 6 weeks of lethargy, excessive fatigue, random vomiting episodes (at least once a week) and loss of appetite leading to weight loss.
Skin rash, rash, urticaria, pruritus and swelling. Ibuprofen 800 mg prn, tramadol 50 mg qid, cephalexin 250 mg tid.
On July 2022, I really had a stomach pain, burn and nausea. I went to the doctor, and he said I had gastritis and I had endoscopy. With that the result was that I had gastritis and GERD. He gave me medications for that.
LIGHTHEADED, DIZZINESS, ANXIETY, FOGGY SIGHT. EVALUATED BY EMS-CLEARED
Left arm developed a rash, itching.  Size was about the size of a pancake.  Appeared about 9pm Saturday, April 17, 2021.  Got bigger and redder on April 18 and April 19, 2021.  As of today, April 20, 2021 rash is still present, red, swollen and itchy.
mom called 20JUL94 stated pt had adult TD 18JUL94, woke up this AM 20JUL94 c/o chest pain (heaviness), trouble breathing sore lt arm; pt taken to ER;
This spontaneous report as received from a pharmacist via field representative refers to a 66 year old female patient. On 03-OCT-2013, the patient was vaccinated with a dose of influenza virus vaccine (manufacturer unknown) (lot #, expiration date, dose, frequency and route not reported) and a dose of PNEUMOVAX23 (lot #, expiration date, dose, frequency and route not reported) in a local physicians office and a dose of ZOSTAVAX, lot # J005720, expiration date 13-AUG-2014 (dose, frequency and route not reported) in their pharmacy on the same day. The patient had a history of an unspecified heart condition and she was prone to PVCs (premature ventricular contractions). No allergies were reported. On 03-OCT-2013, the same day she received the vaccines, she was admitted to an unknown hospital for premature ventricular contractions or atrial fibrillation. The patient recovered at an unknown date and was discharged from the hospital. Additional information has been requested.
Generalized red rash noted 3APR91 @ 5PM no fever, irritability/crying for short period improved p/bath; mom states used over the counter lotion on pt which improved condition;
Flu like symptoms started within 24 hours, temp 100.1 degrees, myalgias, painful to breathe, slight cough.