chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She complained of feeling dizzy and nauseated approximately 10 mins after receiving the Moderna COVID vaccine #1 at 11:30am. She was placed on VS monitor, BP 144/78, Hr 78, O2sat 99%. 11:55am She stated she was feeling better and she just may have been nervous. She remained alert and oriented x3. BP 129/69, HR 76, O2sat 98%. She left the vaccine clinic with steady gait.
Systemic: see below-Medium, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Additional Details: prior to vax, voiced anxiety re: coming outside house for vax (reports not having left home since 3/2020).  Reported h/o severe cardiac palpitations & possible swelling w/lidocaine, so instructed to wait 30 min obs post-vax (vs standard 15 min). Recieved vax w/o issue. Around 20 min into obs time, reported heart racing, anxiety w/ shakiness in arms. Eval'd by in-store NP; paramedics contacted. Fully cleared; normal BP, HR 100, clear lungs. Pt declined transport to hosp & left w/daughter
Mom reported:  Difficulty going to sleep last night-restless for 2 hours from the time mother started putting patient to bed Patient woke this morning extremely lethargic, unable to stay awake.  Patient seemed to be breathing rapidly Patient vomited 3 times yesterday
A 36 year old FEMALE who received Covid 19 vaccine today at 1009, started c/o  mild lightheaded and "tingling throat" at 1026 am, nurse notified this provider. NOTE: This is a late entry due to documented reaction was on paper and not  available for documentation at the time of adverse reaction complaint. Oral hydration, patient stable, symptoms subsided at 1037. Employee discharged to  work station.
Mom didn't notice any reaction first day as pt was wearing a long sleeve and went to bed because she wasn't feeling well due to food she ate before appt. Next morning around 9 AM mom went to shower pt and she noticed 9 cm x 4 cm red, raised, warm welt on Rt arm. By night time welt was 12 x 4 cm per mom that was the worst it got, then the redness. Area was warm to the touch. Area of reaction diminished until leaving a 5 cm x 4 cm bruise on right arm.
Developed normally up to age one. Received MMR shot and over the next two weeks he stopped saying words, became withdrawn, started to bang his head.
Received Pfizer vaccines on 12/21/20 and 1/13/21 Tested positive for COVID by PCR on 3/5/21 Onset of symptoms 3/2/21; unknown symptoms
Supposed to have meningococcal B vaccine administered/ Menveo was administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30th June 2023) for prophylaxis.   Previously administered products included Menactra (received on 17th September 2021).   On 12th August 2022, the patient received Menveo. On 12th August 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.       Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comments: The medical assistant reported patient came in to clinic on the day of the reporting and was supposed to had meningococcal B vaccine administered, however she inadvertently administered Menveo.  The vaccine administration facility was the same as primary reporter. The consent to follow up was granted.  Additional Supportive Information: As patient received Menveo vaccine instead of meningococcal B vaccine, which led to Wrong vaccine administered.
This spontaneous report was received from a nurse via company representative refers to multiple unspecified patients of unknown age. The patients' pertinent medical history, Drug Reactions/Allergies and concomitant medications were unknown. On an unknown date between 01-JUL-2016 and 05-AUG-2016, unspecified number of patients were vaccinated with GARDASIL 9. The nurse had several patients' who fainted after vaccination. Each person only fainted once. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with GARDASIL 9. Additional information has been requested.
Back started itching then front stomach area and spreed to both side and neck. then hives started appearing. followed by Jagged spots with white ares and jagged round ring. Welt on rump x. chills, on and off. followed buy hot spot ankle side of shins and side of thighs. Went to ER  IV Benadryl Took blood sample. Did CBC & Differential. Comprehensive Metabolic Panel. After a few hours the Red color in my forearm started to disappearing. Gave me a prescription for Benadryl and Famotidine 20mg ,Prednisone 50mg. Returned to ER next day as swelling started back up. IV Benadryl sent me home. No improvement. Dr  changed to Hydroxyzine 25mg. home no improvement and Most of my body was covered. I had hot spot   Hot spots feet, shins, thigh, fore arms. Put wet towels on hot spots to stop pain and itching. change ever 30 minutes no sleep for days Finally got in to DR  he increased the famotidine to 40mg. Around 3am I finally slept, When I woke My lip was swollen and my throat was tight had a lump in it. drank water and ate a cookie. would not clear gaged down the Medication some dissolved before I could get them down. Drove to the hospital. They gave me injection in my thigh and IV Benadryl. Added Loratadine and had me get a Epinephrine Pen. Dr  increased the medication. Very slowly the welt, and hives started changing to red rash, hot spots and itching continued. only got short sleep during the day and night at times exhausted. coughed several times for minute non stop. Slight fever followed by chills and some shaking. Very nervous at times. As thing started getting better I took some pictures. Could not believe what my body was going threw. March 18 finaly starting to go away getting better skin wise but still cold and hot. Mouth all this time would go from no taste to bad taste. Throw up feeling at times had to fight it off. March 16,17, after I would fall asleep I had very bad pounding headache took Aspirin and Tylenol. after three hours put a wet towel on my forehead. finally let up and was able to sleep a little. the second night same thing except after I went to sleep the towel dropped my core temperature could not get warm took temp 94.4. Turned heat back up to 78 degrees Wrapped upper body as had to keep lower legs in open air with wet towels on hot spots. Stopped taking my Blood Pressure and switch to from Hydroxyzine to (Banophen Diphenhydramin ) The spots are finally getting smaller. Feet are still swollen and are hard to walk on, still have to go everywhere in open slippers and pant legs rolled up. blisters broke on ankle finally getting better. March 20 left foot still swollen and stiff, right foot swelling going down a little. I could not handle filling this out until now. My memory and even my eye site was affected. I had to write it down in case some one asked me. When they asked me I couldnt remember everything. has to look and my notes to remember. Finally got a referral to infectious disease and a allergist.
Expired vaccine dose administered to 1 patient/ 1 moderna dose was administered to 1 patient passed the 30 days shelf life.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/ 1 moderna dose was administered to 1 patient passed the 30 days shelf life.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/ 1 moderna dose was administered to 1 patient passed the 30 days shelf life.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/ 1 moderna dose was administered to 1 patient passed the 30 days shelf life.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  Date the vial was initially stored in the refrigerator was 29-Dec-2021. Vial did not go under any temperature excursions.
Pressure behind right ear radiating alongside of right neck area, pressure of right ear, facial mask of right side.
patient received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278136, 2019SA278137, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On 27-Oct-2019, the patient received a dose from a multi-dose vial of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) expiry date: 30-Jun-2020, (no dosing details were reported).  It was of actual medication error case due to product storage error.  It was reported that patient received a Flu shot from an extended shipment of Fluzone Quadrivalent.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
24 hours post-vaccination patient became extremely exhausted and had a fever of 100 degrees F that lasted on week. Since her vaccination she has had 3 more episodes of these same symptoms that last 24-48 hours. At the time she has no other symptoms at this time and has taken covid tests each time that have all shown negative results. She also complains of tendonitis in her left elbow but unsure if this is related to the vaccines but wanted to report since both vaccines were received in the left arm.
Left lateral thigh with fluid/firmness and 2 1/2 x 2 1/2 cm pink gflat irritation (-) warm to touch, non-tender
Patient is complaining of a quarter sized lump at the injection site. The area is currently warm and painful to the touch. The patient complained of a fever on 9/20 which has since subsided.
shingirx vacccine 4/9/19 at 8 am was feeling fine before that  first day R arm mildly sore  nexy day r arm really hurting red and swollen day after vaccine -rash R side of face under eye/over cheekbone saw pt on 4/11 ( 2 days after vaccine) had erythematous rash with swelling over R maxilla.  no vesicles or pustules  rash on face and swelling / redness on arm resolved on own over about 4-5 days
After waiting our required 20 minutes after vaccine 5:05 pm we left. Upon arriving home she complained of her tummy hurting and didn't eat dinner at 5:30 pm. Laid on bed holding tummy. She felt warm but not hot. At approx 6:30-6:45 pm she vomited and had diarrhea not making it to bathroom, everything. Vomiting continued every 1/2 hour to 45 min. until midnight then again at 2 am on 10-15-08. She couldn't drink water. Dry heaves again at 3 am. She was able to sleep off and on until 6:30 am on 10-15-08. She missed school that day. (10-15-08).
Mother states that patient was in her USOH up until two days PTA when she developed mild cough and rhinorrhea. 1 day PTA patient developed fever to 103, treated with anti-pyretics. On the day of admission patients was slightly low energy and with slightly decreased appetite but was overall playful with normal mental status and adequate PO/UOP. While in her dad's arms at a cousin's birthday party this evening patient suddenly began to stare slightly upward, looking past her dad, and her body became stiff. Father laid her on the ground and she bagan to have a generalized tonic clonic seizure with symmetric involvement and progression. Parents report a subtle blue appearance to patient at that time and concerns for whether or not she was breathing- GM gave a few rescue breaths with unclear effect. EMS arrived within 5 minutes and initially felt patient's respirations were sufficient, however they report apnea en route and subsequently intubated her with a 3.0 ETT. Patient continued seizing en route and was given ativan x1 with no apparent effect. In the ED patient received an addtional dose of Ativan. She had a CSR which showed ETT at the thoraci inlet and was subsequently reintubated with a 4.5 ETT. Sedation maintained with propofol drip. Blood culture, CBC, BMP were obtained and was WNL. PICU transport team was called but was out on transport; patient was transferred to pediatric ICU via lifestar.
Information has been received from a licensed practical nurse concerning a 19 weeks and 2 days old female patient with no pertinent medical history and no known allergies who on 29-SEP-2010 was vaccinated orally with the first dose of ROTATEQ (lot # not reported). There was no concomitant medication. No adverse experience was reported. There were no laboratory diagnostics studies performed. The patient's outcome was unknown. Additional information has been requested.
Information has been received from a physician referring to an unknown number of unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 30-JUN-2016, the patient were vaccinated with improperly stored dosed of VAQTA (lot # L015460 with expiration date 20-JUL-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 34.4 Fahrenheit (F) for 18 minutes and 51.5 F for 2 hours 50 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
24JUN96 @ 250PM: last noc, pt ran t101 & now today pt has splotches on back, chest, & face, not itching the spots
After 1st COVID (02/27/21) MVX (Manuf); Lot#; Exp Date: MOD; 012A21A; 08/17/2021  patient had splitting of skin at nail bed on hands After 2nd (03/27/21)  Patient woke in middle of night  was dizzy flee and hit his head LOC for 10 minutes per wife .  He was rushed to hospital by ambulance.  He awoke the next morning (03/28/21) with generalized red scaly very itchy body rash.  Spread to back, Buttock, trunk, ? arm and not spreading to legs.  Hospital physician unsure of cause  ? alopurinol  so dosage was cut in half while hospitalized.  Patient was still an inpatient on 4/5/21
Patient was given Adult dose of Hepatitis A, instead of the Pediatric dose that was ordered. The patient did not have any symptoms or signs. Mom was made aware of the mistake on 10/26/17 after going to the Health Department for some other immunizations that the patient needed.
Tongue swollen. Did not block airway but scary. Took two doses of Benadryl spaced out and resolved
Pain, / in the arm (site of injection); Swollen / in the arm (site of injection); Redness in the arm (site of injection); General discomfort; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 12 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160: US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210166: US-GLAXOSMITHKLINE-US2020208660:same reporter
Presented for for s/s COVID x 1 week. Admit for COVID PNA. Hx of Afib, CA, CVA, HTN. Tx w/ abx, steroid, zinc, Toci, Remdesivir, supplemental O2. Weaned dow to 11L NC will go to LTAC for continued weaning.
Case number PHEH2015US018515 is an initial spontaneous report received from a health care professional on 17 SEP 2015. This case refers to a 62 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 SEP 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72  hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). The reporter declined further follow up contact. Follow up information received from the health care professional on 27 OCT 2015: Clinical notes updated.
Tongue felt a little bit thicker; Numbness and tingling in my arm and hand and leg; Tingling; Throat and tongue started swelling; Tongue swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness and tingling in my arm and hand and leg), PARAESTHESIA (Tingling), PHARYNGEAL SWELLING (Throat and tongue started swelling), SWOLLEN TONGUE (Tongue swelling) and TONGUE DISORDER (Tongue felt a little bit thicker) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history was not reported .     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness and tingling in my arm and hand and leg), PARAESTHESIA (Tingling), PHARYNGEAL SWELLING (Throat and tongue started swelling) and SWOLLEN TONGUE (Tongue swelling). On an unknown date, the patient experienced TONGUE DISORDER (Tongue felt a little bit thicker). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness and tingling in my arm and hand and leg), PARAESTHESIA (Tingling), PHARYNGEAL SWELLING (Throat and tongue started swelling), SWOLLEN TONGUE (Tongue swelling) and TONGUE DISORDER (Tongue felt a little bit thicker) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache and chills was not reported. This report was non-serious.
Severe tinnitus in right ear; Paresthesias in upper limbs for 2-3 days; intense vertigo; vomiting; cold sweats; tremors; intestinal colic; Similar symptoms to severe vasovagal response; Weakness in legs when walking; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 13:00 (Lot number: EN6204) at the age of 48 years as single dose for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Colon irritable" (unspecified if ongoing), notes: Other medical history: Colon irritable; "adverse reaction to opiates" (unspecified if ongoing), notes: Known allergies:  adverse reaction to opiates. Concomitant medication(s) included: CANDESARTAN; ONDANSETRON. The following information was reported: PARAESTHESIA (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Paresthesias in upper limbs for 2-3 days"; VERTIGO (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "intense vertigo"; VOMITING (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "vomiting"; COLD SWEAT (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "cold sweats"; TREMOR (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "tremors"; ABDOMINAL PAIN (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "intestinal colic"; PRESYNCOPE (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Similar symptoms to severe vasovagal response"; MUSCULAR WEAKNESS (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Weakness in legs when walking"; TINNITUS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Severe tinnitus in right ear". The events "paresthesias in upper limbs for 2-3 days", "intense vertigo", "vomiting", "tremors", "intestinal colic", "similar symptoms to severe vasovagal response", "weakness in legs when walking" and "severe tinnitus in right ear" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of paraesthesia, vertigo, vomiting, cold sweat, tremor, abdominal pain, presyncope, muscular weakness, tinnitus. No follow-up attempts are possible. No further information is expected.
Patient began feeling nauseous and lightheaded 5-10 mins post-vaccination and alerted pharmacy staff. Patient vomited shortly after. Pharmacist checked blood pressure which was very low at 60/45. RPh rechecked every 5 minutes getting readings of 67/48, 80/57, 108/82. EMS was called and by arrival BP had returned to normal. Likely due to vagal response, reaction to painful stimuli.
Very heavy period with large clots of blood and cycle began 2 weeks earlier than expected. Became extremely fatigued bleeding so heavily 5 days in a row.