chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sinus headache for 3 days after first shot, sore left arm.; Sinus headache for 3 days after first shot, sore left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 14:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MOTRIN [IBUPROFEN]; ZYTREC; WELLBUTRIN. The following information was reported: SINUS HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "recovering" and all described as "Sinus headache for 3 days after first shot, sore left arm.". Therapeutic measures were not taken as a result of sinus headache, pain in extremity.  Additional Information: Lot number was unknown as it got misplaced/discarded. Patient did not receive any other vaccine in four weeks. There was no covid prior to vaccination. Patient was not covid tested post vaccination. There are no known allergies or other medical history. Patient received second dose on 15Apr2021 on the right arm. Headache was manageable Fatigued for about a day, 24 hrs after second shot. Patient had Headache, sore right arm. Three days after shot, tongue and lips burning for 24-36 hrs. Patient reported that it might be from food but unsure. It is not normal and this is why patient submitted the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is very fair skinned.  Rash at injection site.  30 mg BENADRYL PO.
received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.  It was reported that the vial did not undergo any temperature excursions.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Headache-Mild
experienced Urticaria/  patient now have welts; Rash developed; This non-serious case was reported by a physician via call center representative and described the occurrence of welts in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Additional patient notes included No difficulty breathing.   On 24-JUL-2023, the patient received Bexsero. On 24-JUL-2023, less than a day after receiving Bexsero, the patient experienced welts (Verbatim: experienced Urticaria/  patient now have welts) and rash (Verbatim: Rash developed). The patient was treated with benadryl (nos) (Benadryl) and prednisone. The outcome of the welts was not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the welts and rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the welts and rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-Jul-2023 The Doctor of Medicine reported that the patient received and experienced urticarial, O2 saturation was good, rash developed, and the patient now (at the recent time) had welts. Patient received Benadryl, oral prednisone but no difficulty breathing. The physician was in a hurry and did not provide any additional details about the adverse events. The physician agrees to follow-up for more information.
Information has been received from a pharmacist on 20-JAN-2015 referring to a 64 year old female patient. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K009770, expiration date 09-OCT-2015), 0.65 ml, subcutaneous. Concomitant therapies included LEXAPRO, XANAXA and VICODIN. On 23-OCT-2014 the patient began to experience swelling at the injection site and was assessed by an unspecified physician. The unspecified physician prescribed unspecified antibiotics to decrease swelling. On an unspecified date after starting the antibiotics, the patient began to experience nausea and right upper quadrant abdominal pain. Unspecified labs studies were completed on an unspecified date, after starting antibiotic therapy, which had shown that the patient's liver enzymes were elevated. Other unspecified diagnostic studies have been completed on unspecified dates. The outcome of the adverse events was reported as not recovered. Additional information has been requested.
Patient felt dizzy after Tdap brief syncope dropped to knees- Recovered quickly rested in room. Evaluation by MD BPV'd drank juice. Layed down. No injury.
Developed a rash with raised hives all over my body. It started on my neck/chest area and then quickly spread to my trunk area, and all down my arms and legs. Every joint in my body was sore and felt swollen and hard to move.  I did take photos if needed.
I have had both vaccines i had very harsh initial symptoms that went away after a few days however i have developed twitch in my left eye
Narrative:  HPI: Patient presented to the ED on 12/28/2021 with a chief complaint of worsening shortness of breath, fevers, fatigue, and body aches x 3 to 4 days. Of note, he was discharged from hospital on 12/20/2021 following a 6 day admission for bacterial pneumonia. On arrival to our ED, patient waws afebrile, tachycardic (HR 118), tachypneic (RR 25), and hypoxic (SpO2 85% on 3LPM via nasal cannula). Labs in ED revealed leukocytosis (WBC 21.61), hyponatremia (Na 131mmol/L), hypochloremia (Cl 91.6mmol/L), AKI (Scr 1.2mg/dL, baseline = 0.7mg/dL), elevated AST (106 IU/L), elevated CPK (3932), elevated CKMB (20.7), positive d-dimer (GREATER THAN 20), positive lactate (2.8), positive troponin (0.17), and elevated BNP (221.6). EKG was negative for acute changes. CTA chest was negative for PE but did reveal worsening RLL consolidation. Blood cultures were obtained. ABG was attempted unsuccessfully x 4. Patient was given NS x 1L, ondansetron 4mg IVP x1, ceftriaxone 1g IV x 1, acetaminophen 650mg PO x 1, albuterol/ipratropium neb x 1, and methylprednisolone 125mg IVP x 1 in the ED. He was admitted to ICU for further care. Update of Present Illness: SpO2 was stable at 4LPM on admission. Meropenem + doxycycline initiated. ID consulted. Dexamethasone initiated. Remdesivir held due to elevated AST. Patient transferred to Medical COVID Unit on 12/29/2021.
Case number PHEH2014US014959 is an initial spontaneous report from the medical assistant received on 24 Jul 2014. This report refers to a 19 year old male patient. On 21 Jul 2014, he was inadvertently vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: X14040) without being reconstituted with Men A lyophilized component. No adverse event reported following this medication error (inappropriate preparation of medication).
Felt itchiness and tingling in throat. BP 103/68 (pulse 60), O2 sat 100%. Given Benadryl 50 mg PO.
started getting hives; vomiting; nausea; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm right on 20Apr2021 at 09:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included shrimp/shellfish allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Apr2021 at 10:00, 10 minutes after the wait time for the vaccine, patient started getting hives (not critical enough to warrant a hospital as had worse allergic reactions) and from 22:00 patient was vomiting due to the nausea that had been increasing throughout the day from the vaccine. The hives and vomiting lasted until 02:00 the next day. The clinical outcome of the event hives and vomiting were recovered on 21Apr2021 at 02:00. The clinical outcome of the event nausea was recovered on an unknown date Apr2021.  No follow-up attempts are needed. No further information is expected.
After injection a single drop of blood dripped from injection site. After approximately 15 minutes swelling began and progressed to about 2 inches in diameter and was raised about 1/2 and inch. The swelling was very lightly purple in color. Pt reported some tingling in hand.   Patient stated after vaccination when swelling started that she remembered she should not have had an injection in that arm - due to recent hx of breast cancer removal surgery.    I recommended patient be seen in ER or I could call physician immediately. Pt opted to call "navigator" - a nurse assigned to assist her post surgical care.  Pt called back after speaking to nurse later upon our request. She was recommended to ice and observe over several days. Over those few hours she reported the swelling had gone down by 4.  Followup 2 days later the patient had pain in the arm next day (often common with that vaccine). Otherwise she was feeling much improved. She mentioned her nurse said that may consider a compression sleeve if pain or swelling persists.
The first two shots gave me gastrointestinal issues for about 4 days afterwards.  I contacted the dr.  the first time because it was unusual.  The third shot gave me flu like symptoms for 2 days.
This spontaneous report as received from a registered nurse refers to a 6-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Initial report received from a Registered Nurse in the USA on 23//May/2006. A 42 year old female patient became diaphoretic and had chills immediately after receiving the subcutaneous injection of YF-VAX, lot number UE814AA (expiration date 06/Feb/2007) in the right arm, the intramuscular injection of TYPHIM VI, lot number Y0794-2 (expiration date 24/Aug/2007) in the right arm, the subcutaneous injection of Menomune A/C/Y/W-135, lot number UE518AA (Expiration date 23/Jan/2008) in the left arm, the intramuscular injection of HAVRIX, (manufacturer Glaxo Smith Kline) lot number AHAVB106AA in the left arm and the subcutaneous injection of Measles, Mumps, Rubella Vaccine, lot number 0615P (manufacturer Merck) in the left arm. It was reported that all vaccines were received on 23/May/2006. Per reporter, the patient had no illness at the time of vaccination. The patient was diaphoretic and had chills for 20 minutes then fully recovered. No further information is expected. Per reporter, the patient had no pre-existing medical conditions or allergies.
Slight Swelling of the throat was report at the time of vaccination. After phone conversation about 8 hours later, pt also complained about slight swelling of lips and tongue.
A report has been received from a Health Professional concerning a 3 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (Intranasal), 0.2 Millilitres, Once/Single administration on 15-Mar-2016 for influenza prevention. FLUMIST EXPIRED on 07-MAR-2016 was GIVEN TO PATIENT on 15-Mar-2016. No adverse event was reported. The outcome of the event of FLUMIST EXPIRED on 07-MAR-2016 GIVEN TO PATIENT is unknown. The report was considered to be non-serious by company physician.
Patient had 2 seizures on 2/27 after getting 2nd Covid shot; This is a spontaneous report from a contactable consumer, based on information received by Pfizer RA (manufacturer control number: EC-2021-088537), for bnt162b2. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunisation; perampanel (FYCOMPA), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 mg, oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 6 mg, oral from an unspecified date (Batch/Lot number was not reported; Expiration Date: 13Sep2022) and ongoing, at 4 mg, 1x/day for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient historical Vaccine included dose 1 COVID-19 VACCINE (MANUFACTURER UNKNOWN) for Covid-19 immunization. Patient's spouse stated patient had a New Seizure (breakthrough seizure) on 10/13. Patient had 2 seizures on 2/27 after getting 2nd Covid shot. Patient's spouse also stated patient has had progressive dose changes FYCOMPA from 2mg to 4mg to 6mg. Patient gets angry and confused on the 6mg dose and also had an outburst of aggressive behavior on the 6mg dose as well. Patient's dose was currently 4mg and seems like a better dose with the patient's all-around behavior. The action taken in response to the event for perampanel was dose not changed. The outcome of the event was unknown.
Headache, fatigue, no apetite, body aches, took Tylenol and inhaler every 4 hours.
I received the Guardasil-9 vaccine via shot in my arm on the morning of 11/26/19. That night, and every night thereafter since, I have been sweating swimming pools in my sleep. I have never had a problem with sleeping or sweating in my sleep prior to this. Given that this began occurring in the late fall/winter time, it was and has been highly uncomfortable for several months now. Initially, I had to change shirts multiple times and was awaken because of being soaked and freezing multiple times during the night. I informed Dr. of this very odd and uncomfortable issue when I returned for my follow-up appointment to receive my second Guardasil-9 shot on January 2nd, 2020. Nevertheless, I was given the 2nd vaccination shot of the series of 3 that day. The sweating had dissipated a bit, but still present, and then that night it came roaring back - and hasn't left since (has gotten slightly better with time). I have no question that my sweating at night was caused by whatever shots I was given on November 26, 2019 and then again on January 2nd, 2020. The only reason why I even inquired with Dr. about the Guardasil shot was because I had read a news article which stated that the shot was now considered safe to receive for men aged up to 45. I wish so badly now that I had not then gone to Dr. and inquired about whether I should get the shot. And then I wish even more so that after I voiced my apparent reaction to the first shot of 3, that I had not been given the 2nd shot. Last night (4/28/20), like every night since 11/26/19, I sweat a ton again. Needless to say, I never scheduled my 3rd shot.  Will this ever go away??
Fever headache chills muscle aches redness on left arm and swelling took about 40 hours to get over it
7 days after injection: 1. large swollen red patch, itchy, resolved within 36 hours. 2. mild headaches, headaches continues and increased in intensity as time went on. 14 days after injection: dizzyness and mild motion sickness, headaches. mostly resolved by 3/17/21
Pt recv vax on unknown day; post vax pt exp erythematous rx of rt leg (DTaP vax)
Inflammation at the vaccination site; Local fever sensation at the vaccination site; Irritation at the vaccination site; Redness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflammation at the vaccination site), VACCINATION SITE WARMTH (Local fever sensation at the vaccination site), VACCINATION SITE IRRITATION (Irritation at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflammation at the vaccination site), VACCINATION SITE WARMTH (Local fever sensation at the vaccination site), VACCINATION SITE IRRITATION (Irritation at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site). At the time of the report, VACCINATION SITE INFLAMMATION (Inflammation at the vaccination site), VACCINATION SITE WARMTH (Local fever sensation at the vaccination site), VACCINATION SITE IRRITATION (Irritation at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-068484 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068484:husband case
This spontaneous report as received from a male pharmacist, via company representative, refers to himself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, site and route of administration not reported). On an unknown date the patient and few other unspecified patients (MARRS # 1402USA011058) experienced a welt approximately 1-2 inches in diameter around the injection site after receiving ZOSTAVAX. The outcome was reported as resolved in 2-3 days (on an unspecified date). The relatedness between ZOSTAVAX and event was not reported. This is one of two reports from the same reporter (other case MARRS # 1402USA011058). Additional information has been requested.
husband reported patient was more "confused" also with "double chin now" Pt with + weight gain -- -medical history reveals Pt is waiting for kidney transplant and has other medical issues
8:05 am Diaphoretic, B/P 120/80 orthostatic _O 110/78/110/78/110/78 8 ounce juice, muffin, P58, cold compress, pulse 80 in nurses office 810 Gatorade x 2 cups SWP-student was very anxious re: inj AP 58 - 60 Mom states she plays soccer and runs pulse is normal 46 - 60.
Difficulty breathing, flushing, patient also described a sharp pain in the low back. Dosed with oral Benadryl as patient was able to still swallow, called local paramedics to assist and stayed with patient to monitor symptoms and resolution. BP elevated at 175/86 but patient started feeling better after about 35 minutes.
Approximately 10 1/2 hours after having TRUMENBA and MENVEO patient developed hives and itchiness. Mother gave her CLARITIN tab. p.o once a day x 2 days.
Pt received her Prevnar. About dinner time (6:00 PM) Pt started wheezing and felt very short of breath. Her face was flushed and she states "I didn't think I was gonnna make it". Pt reports itching but mild. Pt used her serevent and Proair inhalers and felt better without activity. This morning her symptoms have resolved. Pt denies redness, swelling or rash.
Hard knot/muscle stiffness at injection site 8 days after receiving dose. Itching and pain lasting approximately 2 days.
Patient reported injection site redness and soreness x 6 days. On 2 or 3rd day post vaccine patient states he woke up with full body flushing that improved throughout the morning and did not return. On the seventh day, soreness at injection site was gone, still red, but now a "crusty rash" around the injection site has also appeared. Also on the seventh day the patient states both legs and entire back are "itchy".
Severe allergic reaction with swollen face, hands, feet, throat, chest congestion, shortness of breath, rash, and pruritis. Cortisone shot and prednisone oral 20 mg for 10 days , zyrtec.
Pt presented on 1/4/11 with cellulitis on bilateral anterior thighs w/some drainage. Culture grew staph aureus (MSSA). She was given a course of BACTRIM & the cellulitis completely resolved. The cellulitis occurred at the the site of vaccines given on 12/20/10 at a different clinic's office.
This spontaneous report as received from a nurse via company representative refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On unknown date in 2016, the patient was vaccinated with dose of GARDASIL 9 (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. On an unknown date (six to eight weeks after receiving the final dose of the GARDASIL 9), the patient experienced joint pain in the hips and knees. The primary reporter stated that the patient grew 4 inches in the past year, 2016. The outcome of body height increased and joint pain in the hips and knees was unknown. The relatedness between the events and GARDASIL 9 was not defined by reporter.
0N 3/14 5 DAYS AFTER INJECTION I HAD A BIT OF TROUBLE BREATHING...SEEMED A BIT MIRE EACH DAY MARCH 18 MORE NOTICEABLE AND QUICY SHORT IOF BREATH.SATURDAY 20TH IN MORNING BEFORE 2.5 HOUR  FLIGHT  DIFICULTY WALKING WITHOUT STOPPING TO CATCH BREATH ....AFTR FLIGHT SAME DIFFICUTY PERHAPS A BIT MORE . ON 22ND SAW PUKMONOLOGIST ORDERED D DIMER   HIGH POSITIVE  SCAN SHOWED MULTIPLE PULMONARY EMBOLI IN EACH LUNG.WENT TO  ER, HAD INJECTIONS OF LOVENOX. ULTRASOUND FOUND  NO   EVIDENCE OF CLOTS IN LEGS.  2 NIGHT STAY AS HAD LOW POTASSIUM LEVEL. NOW TREATED ELIQUIS  ALBUTEROL AND ANORO. BREATHING BETTER BUT STILL HAVE MORE SHORTNESS OF BREATH THAN BEFOE THE MARCH ONSET.