chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my heart rate went up/I had a very rapid heart rate of 157 and it was beating so fast; felt very shakey; felt strange/weird; heart pounded so hard; it was frightening/ very scary; going to drop to the floor; felt my whole body was weak, weird, like I was going to drop to the floor; slight nausea; slight headache; This is a spontaneous report from a contactable consumer. This Female consumer (patient) reported that:   A female patient of an unspecified age received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 25Jun2021 at 17:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient Historical vaccine included BNT162B2 for COVID-19 immunization Dose 1. The patient's concomitant medications were not reported. The patient experienced My heart rate went up/I had a very rapid heart rate of 157 and it was beating so fast, I felt like I could die thereon 2021, slight headache, slight nausea, felt very shakey, felt strange, Felt my whole body was weak, weird, like I was going to drop to the floor, Heart pounded so hard, It was frightening/ very scary, Going to drop to the floor on 2021. The patient underwent lab tests and procedures which included heart rate: 154 on Jun2021, Heart rate: 147 on Jun2021, Heart rate: 59 on Jun2021. Upon follow up received on 28Jun2021 NDC number and UPC number of Covid-19 Vaccine were unknown. Consumer was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM as per EST.  Consumer further stated, I am going to do that now. Have you, has anyone reported that to you? No but you are taking the information down from people who had a side effect so, what I am asking you when people have called you, have you heard to mention that? I guess they don't want you to. Okay I will call them; you are going to connect me or should I just redial? Yes, it's nothing, nothing happens when I pull the number and press option 3, thank you so much for your help but I will hold. The outcome for all the events was unknown  Follow-up (28Jun2021): New information received from a contactable consumer. This report Included: dosage details, events and clinical information.  Information on the lot/batch number has been requested.
tested positive for covid.  Severe sore throat, fatigue followed by 4 weeks of cough
Breakthrough case admission after 2 vaccines Moderna 9/15/21 Lot# 004f21A;  Moderna 10/11/21 Lot# 039D21A
Receiving expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 10-Nov-2021, the vial was initially stored in the refrigerator.  The vial did not undergone any temperature excursions.  The patient administered dose of vaccine after 30 day use by date or after manufacturer date of expiry.  No treatment medication was provided.   This case was linked to MOD-2021-413275, MOD-2021-411099, MOD-2021-413238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Follow up received contains no new information.
17 days later still have arm pain and feel achy and sore all over. Still feel as if I am coming down with a flu with aches in muscles all oever body
CHILLS, ACHES, HEADACHE FOR 2 FULL DAYS.  SLIGHT HEADACHE FOR 5 DAYS
COVID-19 on 2/15/2023 Positive. I spoke to a doctor out of state which was not my regular doctor. They told me I could not take Paxlovid. I was tired with a little headache with a low grade fever 99 or 100 degree for one day with a bad cough. General feeling of malaise and like bad head cold. The cough lasted about 5 to 6 days.
Patient became very confused and could not come up with words. She had big behavior changes that were inconsistent with how she normally behaves. She had a bad headache and a lot of pain at the injection site
Fever 4/15; peaked 4/16 at 104-105; 101 4/17 & 4/18. Fussy. Rash on trunk - blanched.
Severe headache that over the counter medication, like a aspirin powder did not help.  Was bedridden for the day. Vomiting and diarrhea.
shingles; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Mar2021 (Batch/Lot number was not reported) as unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed shingles on 30Apr2021 with outcome of unknown. He read on the internet that this was happening a lot. His doctor gave him prescription, Acyclovir for one week.   No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Relatively severe pain in joints (knees, ankles, shoulders) where there was none previously. Still ongoing as of today (01/07/2021). OTC anti-inflammatories taken with very little relief.
Pt resides in SNF; admitted to hospice services for lung and kidney CA; DNR/hospice; pt had a positive COVID test 8/1/22; congested, weak; given Lasix; on O2 supplementation with O2 saturations in 70s; pt found deceased in the SNF
limbs are swelling; suffering since she got the booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (limbs are swelling) and IMMUNISATION REACTION (suffering since she got the booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 PERIPHERAL SWELLING (limbs are swelling) and IMMUNISATION REACTION (suffering since she got the booster). At the time of the report, PERIPHERAL SWELLING (limbs are swelling) and IMMUNISATION REACTION (suffering since she got the booster) had not resolved.            No concomitant medications were reported. Patient had been suffering since she got the booster. It's been over a year. Her limbs were swelling. No treatment medications were reported.  The patient wants to see the toxicity data on the vaccine. The patient wants to know the inactive ingredients and the pharmacology.   This case was linked to MOD-2021-029577, MOD-2021-029584 (Patient Link).
After administration of vaccine, the vaccinating pharmacist noticed that they was an air bubble in the syringe and it is possible that patient received 1/2 of the dose. Possibly 0.25 MLS instead of 0.5 MLS.
After receiving DTaP in left leg: following day experienced warmth and redness. 48 hours later became very swollen, red and warm, painful. Mother using Tylenol. Afebrile. Physicians office treated with Keflex due to reaction versus cellulitis.
Herpes zoster diagnosis in two-dose varicella vaccine recipient at ED around 9/23/14. Painful rash on right side of face and eyelid. Treated with acyclovir x 7 days.
Patient's mother reported acute onset of urticarial wheals on legs, thighs and trunk approximately 30 hrs after vaccine admin. No known exposure to other food new to him. Responded to single dose of BENADRYL.
Patient got a rash on his forehead and cheek 2 days after receiving his second covid vaccine. States that it "feels a little tight."
Pt. had first vaccine at 14:55.  Pt. walked to observation one where she fainted upon arrival.  Pt. was CAOx3 after she was laid down.  Pt. was transferred to the back via wheelchair where she was observed for 15 minutes without any further complications.  After 15 minutes patient walked out without any obvious difficulties.
Immediately follow administration of 2nd vaccine (Hep A) child slumped forward with jerking motions of upper and lower extremeties for 3-5 seconds. Child then lifted head up with PHN asking child name and place. Child answered appropriately. She was pale, c/o being hot and feeling nauseated. PHN lay child on bed, applied cool cloth and fanned. Called Dr's office and child carried to MD for evaluation. Child and child's mother returned to Clinic approximately 30 to 45 minutes later stating that Dr. evaluated and determined that this occurred due to child was very nervous and apprehensive before injections. No other problems occurred and child went to school the following day, 10/29/2009. PHN called to check on child again on 10/30/2009 with mother stating child having no further problems after leaving clinic the day vaccines given, 10/28/09.
PATIENT FELT DIZZY, WE ELEVATED FEET FOR 5 MIN. PATIENT CONTINUED TO HYDRATE.  PATIENT STAYED FOR AN ADDITIONAL 10-15 MIN.   FELT COMPLETELY BACK TO NORMAL AND WENT HOME.
Information has been received from a RN concerning a 24 month old female who on 16Aug2002 was vaccinated SC in the right thigh with a dose of varicella virus vaccine live. Concomitant therapy on 16Aug2002 included a third dose in the left thigh of poliovirus vaccine (IPOL). There was no illness at the time of vaccination. ON 22Au03, (previously reported as this year in 2003) the child developed a rash in her genital area which the physician diagnosed as chickenpox. It was noted the child also "spiked a 103 degree fever for one day on 25Aug03. It was noted that there were no relevant laboratory diagnostic studies performed however, laboratory data performed on 16Aug2002 was a mantoux test. It was also noted that the doctor "treated the rash symptomatically" but the child was "not prescribed anything for the rash". "At this time" 27Aug2003, the rash stopped progressing but did not fully disappear. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available.  Follow up information indicated that the pt had recovered. No further information is expected.
Double brain bleed which resulted in a massive stroke. No signs before the stroke. She just dropped to the floor and wasn?t able to move or speak.
Localized swelling within minutes of vaccine.  Ice pack applied. Upper arm swollen and sore for 24 hours.  Itchy rash began to appear on left forearm within 24 hours and has persisted for 7 days with slow resolution.
A 13 yr old male pt was hot, dizzy, nauseated and his hands and legs were stiff immediately after receiving the injection of Adacel and Tubersol on 23Nov05. Lot numbers, route and site of administration not reported. The reporter is the pt's parent. The pt had no illness at the time of vaccination. Treatment received not reported. Per the parent, the pt recovered.
Patient made an appointment for a COVID vaccine booster (she received Moderna as her primary series). Upon checking in at the pharmacy, Technician , asked the patient if she wanted the Moderna as the booster and patient confirmed. Her vaccine was processed as the Moderna booster and the nurse gave her the vaccine. Afterwards, the patient sees that we signed off on her vaccine card for the Moderna booster and claims that she was supposed to receive the Pfizer booster, as she made an appointment for the Pfizer booster (per her doctor's recommendation). We do not assume that what the patient selects online for their vaccine is what they want. We always ask at the pharmacy to make sure we give the correct  vaccine.
pt had APAP 15min a/shot;pt was called from the babysitter that pt has been crying since 11AM & temp 101.2;@ 330 pt still fussy & crying & mom called MD-who said if temp gets any higher take pt to ER;no redness on skins;pt OK by next day;
Positive neuromuscular respiratory weakness approximately 5 days after vaccination. Work up consistent with Guillian Barre.
Developed 1 inch below the injection site a baseball size lump that turned pink and brown; Developed 1 inch below the injection site a baseball size lump that turned pink and brown; Area is still brown and it's sensitive to touch and flaking, peeling; Area is still brown and it's sensitive to touch and flaking, peeling; Light sensitivity like coming out of the cave; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that shortly after receiving the first dose, she developed one inch below the injection site a baseball size lump that turned pink and brown. After 3-4 days the lump went down. The patient iced it for 20 minutes on and off, surprised to see the lump went down but the area is still brown and it's sensitive to touch and flaking, peeling. She further reported that she had a side effect of light sensitivity like coming out of the cave, that went away the next day. The patient was expecting to get her second dose on 07May2021 and enquired whether she should have it in that same right arm or what and concerning about switching arms. She was also concerned whether she will have to live with this brown spot. The outcome of events vaccination site lump and photosensitivity was recovered on an unknown date, vaccination site discoloration was not recovered, and other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Symptoms started with mild itching behind the neck at approximately 11 minutes after injection. Itching continued, worsened and moved to arms, thighs, and face. Hives start to show on her face at approximately 20 minutes after injection. Pharmacist, who injected vaccine was notified of patient status. Patient was given 50 mg of Benadryl.  Patient was taken to Medical Center - hospital by husband. At approximately 30 minutes post injection patient describes feeling like she has ?frog in her throat?. Hives continue to get worse can be visualized on patient arms. Patient seen in emergency room at Medical Center - Hospital.  After being taken into the treatment area patient was promptly seen by PA-C and RN.  Medications administered during stay included Sodium Chloride 0.9% intravenous solution 1000 mL, Methylprednisolone 125mg IV push, famotidine 20 mg IV push, and Hydroxyzine 25 mg by mouth.  After close observation for 4 hours patient was discharged from emergency room with Epi pen and prescriptions for Benadryl 25mg, Epinephrine 0.3 mg Injectable kit, Pepcid 40mg, and Prednisone 20mg.
Chills, Leg cramps, Fever 104.1, Nausea, Convulsion
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) 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.   No concomitant medications were provided.  Treatment medications were not provided.   This case was linked to MOD21-068717, MOD21-068716, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068713, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711 (Patient Link).
Parents stated that child had slight swelling at injection site L deltoid, stated child had red, itchy rash X 2 wk. on L upper arm, no fever.
I received a COVID-19 diagnosis on August 24, 2022. Symptoms included congestion, runny nose, soreness, and cough. I am also pregnant and was 10 weeks pregnant at the time of COVID-19 diagnosis.
Left upper arm over deltoid with 8cm x 7.5 cm area of erythema. Warm and tight/swollen but no lesions or blisters or pustules. No red streaks. No significant tenderness. No abx needed as of Saturday 10/20/18.
Redness, swelling, and tenderness at injection site for 5 days. Headache. Fatigue for a week.
Swelling of heart and pericardium, increased heartbeat, irregular heartbeat, shortness of breath, inability to exercise or walk a short distance, chest pains, feeling like I was going to have a heart attack.
Pt in clinic for 1st COVID vaccination. Nurse reviewed screening checklist, nurse queried pt related to severe reactions to any injected medications or immunization previously. Pt denied any severe reaction history to injected medications or immunizations. Pt was administered COVID Pfizer injection approx. 0900. At approx. 0910 pt returned to nurses room reporting having stomach cramping. Pt reports attempted to use bathroom without success. Nurse notified Lead Nurse, NP. Emergency kit obtained, vital signs collected while Lead Nurse consulted Nursing Director, DNP, per consultation Lead Nurse contacted 9-1-1. Pt SpO2 stable in high 90's, pt did not present with difficulty breathing at that time, pt reported ongoing stomach pain and itching on abdomen. Pinprick petechiae observed on thoracic area, pt actively scratching. Per Lead Nurse, NP consultation with Nursing Director, DNP IM Bendaryl advised. Pt notified nurses of PMH allergy to Benadryl. Pt indicated when school-aged had anaphylactic reaction to penicillin and given IV Benadryl at that time, resulting in hives. Pt further reported allergic reaction to unknown facewash when 18 years old, when presented at MD office at that time was given IV Benadryl, subsequently sent to hospital at that time for severe reaction. Per consultation with Nursing Director epinephrine indicated. Nurse, RN administered epi-pen autoinjector 3mg at 09:22 (lot #G200810X, expiration 12/2021). Post epinephrine administration pt experienced nausea with vomiting and expressed feeling anxious. Pt affect became more somnolent with stomach upset. EMS arrived to clinic and pt consented to transport. Transfer of care to EMS approx. 09:45. RN
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 16-FEB-2018, the patient inadvertently received an expired dose of M-M-R II for prophylaxis, lot # M004305 and expiration date on 25-JAN-2018 (strength, dose number, anatomical location and route of administration were not reported), without adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA000991:
Fever to 102.4 within 24 hours of vaccination, presumed febrile seizure - 5 min episode of stiffness and unresponsive.
12/9/99, pt came home from dialysis with back discomfort and weakness.  Hands and feet cold, nauseous.  Slept 3 hrs and pt felt better, but had very little movement in legs.  Could move toes and r/foot.
3 month patient was vaccinated with Kinrix (DTaP-IPV) which is only approved for 4-6 years of age. Physician notified. No treatment was conducted, only monitoring.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 4:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 03-Nov-2021 at 4:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 03-Nov-2021, Excursion time was 10 AM, temp was 35 , total doses given for the day was 117, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021, 6 vial was moved to clinic. Vaccine BUD date was 05-Nov-2021.  Vial was stored on cooler 1 , on 03-Nov-2021, Excursion duration at 8 AM:36,  9 AM:36, 10 AM: 36, 11 AM:35, 12 AM:36, 1PM : 37, 2 PM : 36, 3 PM: 36, 4 PM: 37 and 5 PM : 42.  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vials only punctured right before administration  Treatment medications were not reported.
Information has been received from a female RN, who in approx. 1999 was vaccinated with pneumococcal vaccine 23 polyvalent in her left arm. Post vax, she immediately had left arm swelling to twice the original size. She also had left shoulder and left back swelling "all the way around her back". A staff member of the facility administered 25 mg of Benadryl IM and then she took Benadryl orally q12 hours for 24 hours. Subsequently, she fully recovered. The pt stated that she never had pain but was concerned about the swelling. Upon internal review, the pt's experience was considered an "Other Medical Event". The RN also reported the experience of another RN that was vaccinated with the same vaccine (WAES00111986). Additional information has been requested.  Follow up on 03/28/2001: "Patient date of birth, patient age at time of vaccination, adverse event onset time, Lot # for vaccine 1, vaccine administration time is not provided."