chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"COVID Arm" - Red rash, about 3-4 inches in diameter, around injection site. Itchy. Also tenderness in underarm area for the past few days
Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer. ( This VAERS writer assigned to form completion was not the administrator of this vaccine.)
pt recv vax MAY2896 & 4JUN96 pt devel a few vesicular lesions w/clear fluid;pt then devel a gen, raised, itchy rash described as red non-vesicular papules on arms & ne on forehead w/erythema & induration;pt to MD;
Patient suffered seizure activity and severe hypoglycemia x 9 hours, requiring multiple dextrose loads and dextrose by I.V.
5-13-18 - shingles Famciclovir - headache. 6-4-18 - shingles - Famciclovir - tired. 6-6-18 - gave info on shingles - chills. 6-13-18 - shingles - Famciclovir - blisters. 6-20-18 - Blisters on stomach - itchy and mild pain. 6-21-18 - under breast chicken pox? -Acyclovir. cream
No additional adverse events were reported; patients received possibly improperly stored vaccines due lack of temperature readings; This spontaneous report was received from a healthcare worker, referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 17-MAR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U010396, expiration date: 01-APR-2023, administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided).  The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown by the reporter. There was no previous temperature excursion. No additionally adverse events were reported, and no further information was provided.  This is one of several reports received from the same reporter.
By mid-afternoon on Monday 2/7, I was having muscle spasms on the right side of my head above my ear radiating down to the base of my skull. It dawned on my that it was the same side as the vaccine.   It lasted for a good 24 hours.  Ibuprofen took the edge off but it was still bad enough to keep me up at night and made me very nervous.   By Tuesday, 2/8, I could tell that it was lessening and by Tuesday afternoon, I felt much better.   I felt a few twinges yesterday, 2/9 but nothing today. 2/10.
Upper arm swelling, itchy rash on arm and both wrists Narrative:  Pt received his second COVID vaccine on 2/12/21. Next day upper arm swelled up and started getting red bumpy rash upper arm. 'Itchy like expletive'. Then started to get same rash inside of my wrists on both arms. rash covers inside of both wrists and extends about 3-4 inches proximally per pt. Was looking for relief and put Store brand hemorrhoid relief cream: (phenylephrine hcl 0.25%, pramoxine 1%, petrolatum).- last use last night. Thinks that made it worse. Yesterday the rash was bumpy and had a little clear liquid oozing as well. Better today, Feb 18. itching is also a little better today Upper arm is still little swollen and the rash is about the same but not as itchy. Immune/Allergic reaction after second shot of Moderna COVID vaccine. Symptoms improving today compared to yesterday. Recommended Cetirizine 10mg once daily for symptomatic itching relief which he will purchase at store.
appears Shingles rash; appears Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix. On 4th July 2019, 3 days after receiving Shingrix, the patient experienced shingles and rash zosteriform. On an unknown date, the outcome of the shingles and rash zosteriform were unknown.   It was unknown if the reporter considered the shingles and rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix on an unknown arm. The patient appeared as Shingles rash. The reporter wanted to know, how to proceed with the 2nd dose of the Shingrix vaccine. The reporter was unable to provide patient and vaccine details. This case has been linked with case US2019123786, reported by the same reporter.
Severe cough and clear phlegm and gagging and cough lasts for minutes and at times I feel like I will pass out from lack of oxygen. Gag spit out clear mucus not green or yellow just clear.
Redness and itching and swelling and that got worse over the course of next two days (at injection site).  Dr prescribed Bactrim - I took that - oral antibiotic - started Sunday evening (17th) and then it started getting better and it took three or four days to resolve.
While sleeping in the middle of the night, I was awakened at 01:00 am with symptoms of allergic reaction - I had mild nausea; intense itching in my palms and in my buttocks and swelling in my lips and numbness (severe swelling of lips - almost couldn't close my mouth) an numbness in my lips and face. Giant hives: buttocks, armpits. The symptoms persisted severely for about 6 hours and then gradually got better over the next 6 hours. I took 2 Benadryl almost immediately and two more at 03:30 am and two more around 6 am. That helped to finally get the symptoms under control. My last meal had been around 07:30 that evening - many hours since eating.  The symptoms persisted another 6-8 beyond those initial 6 hours. It was another 6-8 beyond those initial 6 for my face to be back to normal. My lips were swollen as big as my thumbs. I did not have any breathing difficulty.  Just that one time occurrence of this.  I saw the doctor a couple days later. I have an appt with an allergist coming up on the 15th of October.  I have a booster shot scheduled on the 18th of this month. Had a flu shot in August 3, 2021 - NOTE - Pharmacy -  Locatoin
still felt rather weak; body ache; felt malaise throughout the day that lasted until night time; headache; fatigue; drowsiness; This is a spontaneous report from a contactable nurse reporting for herself.  A 31-year-old male patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) intramuscular in left arm on 22Dec2020 16:15 at single dose for COVID-19 immunization.  Medical history was none. Concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. The patient reported that after the vaccine was administered at 4:15 pm on 22Dec2020, she experienced headache and fatigue about 4 hours after. She also experienced drowsiness and had to sleep 2 hours earlier than usual. The following day 23Dec2020, she experienced more fatigue, body ache and felt malaise throughout the day that lasted until night time. on 24Dec2020, the body aches went away but still felt rather weak and got tired easily 25Dec2020 she felt almost back to her normal sel. No treatment was received. The outcome of all the events was reported as recovered on 25Dec2020.   No follow-up attempts are possible. No further information is expected.
Reports starting night of vaccine: nausea/vomiting, fatigue, myalgias, mild headache, shaking in fingers.
Return COVID symptoms 96 hours after completion of Paxlovid treatment in Oct2023; Return COVID symptoms 96 hours after completion of Paxlovid treatment in Oct2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Mar2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "atrial tachycardia" (unspecified if ongoing); "afib" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2019, stop date: 21Oct2023; METOPROLOL, start date: Aug2017; VITAMIN D3. Vaccination history included: Covid-19 vaccine (Dose 4), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Oct2023 at 13:00, outcome "recovering" and all described as "Return COVID symptoms 96 hours after completion of Paxlovid treatment in Oct2023". Therapeutic measures were not taken as a result of drug ineffective, covid-19. 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.
red, blanching, intensely pruritic rash on trunk and sacrum relieved by hydrocortisone cream
Incorrect dose. Moderna booster dose administered: 0.5 milliliters. Booster dose should have been 0.25 milliliters.
Post vax, the patient developed upper arm swelling, erythema above the elbow, chills, sweats, deep muscle ache, and itching. No fever was noted but the patient feels feverish and flushed.
scratchy and sore throat; scratchy and sore throat; her ribs are sore; her muscles are aching (muscle near the injection site).; chills; her head feels like she is in the clouds; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202) via an unspecified route of administration on 26Feb2021 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. Medical history included allergic to whole strawberries. No concomitant medications were reported. Patient got the first dose of the Pfizer BioNTech COVID-19 vaccine today (26Feb2021) and she developed adverse events. Her adverse events are scratchy and sore throat, and she feels like she has the flu, her ribs are sore, her muscles are aching (muscle near the injection site), her head feels like she was in the clouds and also chills, she began feeling all of this about 45 minutes after the shot. She wanted to know if it was a typical reaction with the Pfizer COVID-19 vaccine. Patient also stated instead of the standard 15 minutes they had her wait 30 minutes. She didn't feel sick or anything at all, her throat didn't start bothering her. She was telling her daughter about how she got the vaccine and everything was flawless, she had no aches and pains then she had to tell her she was going to have to go because her throat, she thought she was talking too much she told her daughter maybe her throat was dry. She told her daughter she was going to have to stop talking and it has gone since then. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Anaphylactic shock; Swelling of throat; hives all over back and arms; swelling of wrists; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 27Mar2021 10:15 (Batch/Lot Number: GR8732) as SINGLE DOSE for COVID-19 immunization at the workplace clinic.  Medical history included asthma allergies.  Concomitant medications were not reported.  On 27Mar2021 13:00, the patient experienced anaphylactic shock with swelling of throat, hives all over back and arms and swelling of wrists. The patient had no COVID-19 prior to vaccination and not tested post vaccination. The patient was treated with antihistamines/steroids and recovered in 2021.
A non-serious report of vaccine administration error was received from a pharmacist concerning a child of an unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No relevant medical or drug history information was reported.  The child was given FluMist on an unknown date.  The child had received FluMist and some of the second nostril dose was sprayed into one of the child's eyes.  No adverse events were reported from this error.  Rechallenge is not applicable.  Causality assessment is not applicable.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  04-Dec-2007: No additional information will be available since the contact information of the reporter no longer valid.
Swelling to right arm extending into fingers and into right lateral breast. Tenderness at site with splotchy skin.
Patient began to feel dizziness shortly after receiving her first vaccine dose. Patient has a history of anxiety and stated she was feeling anxious before arrival to receive vaccine.Patient stated she did not take her meds for anxiety today. Patient also stated she had nothing to eat today. She was brought in for observation, to lay down. After assessment and vitals checks patient was deemed okay to head home. Patient was advised to contact primary doctor , if any other adverse effects occur.
Cardiologist at the Clinic shot given at pharmacy.  Dizziness, light headedness, sweating,  racing heart rate. EMS responded, EMS techs ordered transport to Hospital, was in V-Tach. Shocked at hospital, transferred to another hospital, stayed 3 days, several test done, determined heart muscle damaged, had low Ejection Fraction of 20-25%, recommended implanting defibrillator. Returned to get second opinion and care nearer home. Had heart life vest in November, implant surgery done Dec. 9, 2021. Experience low blood pressure, some dizziness,  easily winded, still employed on sick leave, no income since March 2022.
On 10/6/07 had 3 short episodes of jerking of upper limbs, may be lower too with child turning pale, neck tiled to one side, child not responding to parents followed by short drowsiness but quick recover
29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my lips. i informed nurse and she began taking blood pressure and oxygen levels while asking if i was breathing ok.  i said yes. i then felt the right side of my lips go numb.  i felt a faint tightness in my throat but after about two minutes it felt like my right side of the lips started to feel normal and my throat.  then all at once i felt the blood rush from my body and tingling all over. i told the nurse i didnt feel good. she layed me down on the floor and put my feet up. she asked what i was feeling and i said i felt like i was going to faint.  i was aware that my tongue felt heavy and i wasn't talking clear. another nurse got the allergist or doctor on standby and she asked me what i was feeling. i just rubbed my throat and my cheeks and lips and felt numbness and my throat tight and my tongue very thick. she asked if i was having a hard time swallowing. i nodded so she said they were going to sit me up because they needed to give me an Epipen. i nodded, tgey brought a wheekchair for me and as they helped me stand because i had no strength, a nurse stabbed me with the Epipen then they took me to the emergency room and observed me until 2:30pmish to make sure i didnt have another episode. then i wss discharged and was told to follow up with my primary care doctor within 3 days. An  allergist will also see me to do a skin test.
Right deltoid area red, warm and painful to touch. Mother gave Tylenol, applied cool compresses. Area of redness measured 5 x 9 cm wide. Parent was to schedule follow up appointment if condition not improving. Pt doing well 5/21/03; no redness, soreness of arm.
4 days after 1st dose: flare up of anterior uvyitis (had gone almost 1.5 years without flare up), extreme pain in eye, could have been vaccine but unsure, given pregnazone eye drops.   After 2nd dose:  had covid
Patient noticed vaccine burned at time of administration but no other immediate symptoms. Later that day started getting very achy all over and arm started hurting. By evening could not lift arm. Then pain extended to hand accompanied with tingling. Ended up in ER. Improving not all the way better.
This "vaccine" caused about 60% of my hair to fall out.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 27Aug2021 at 17:00 (Lot number: FC3182) at the age of 41 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medication included: WELLBUTRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0169, Anatomical Location: Left arm, Time of administration: 17:00), administration date: 06Aug2021, when the patient was 41 years old, for COVID-19 immunisation.  The following information was reported: ALOPECIA (non-serious) with onset 04Nov2021 at 21:00, outcome "not recovered", described as "This "vaccine" caused about 60% of my hair to fall out". Therapeutic measures were not taken as a result of alopecia.  Additional Information: It was reported that the patient never had a hair loss issue in her life before this vaccine triggered massive hair loss. The patient stated that she got both shots of "poison" in August and her hair began falling out November 4th. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit.
Vaccine administered after 12 hours. (Vial was first punctured on 1/4/22 at 8:18am. Vaccine was given at 11:59am on 1/5/22.) No adverse reaction.
patient presented to emergency department on 10/10/21 with shortness of breath patient was admitted for further management patient was found to be covid-19 positive on 9/27/21 patient was discharged to rehab facility on 10/20/21
I have fill all of that out previously. See previous entries. Developed chills the night of the shot. Found out Monday, March 1st that I had a very badly abscessed tooth . Had a root canal on 3/5/21. Had really bad headaches & fevers. 2 ER visits, CT Head, spinal tap, blood cultures w/ possible viral meningitis or Trigeminal neuralgia from either the vaccine or the root canal or just a immune response per the doctors. CT face did show infection in maillary bone. Not sure if I should get the next shot (booster). It is set for the last possible day to receive on 4/9/21. I'd like to talk to someone in regards to this because I VERY afraid of getting my second shot...
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 77 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 20-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 20-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. Flu vaccine was delivered on 20-Sep-2016 at 13:30 to 14:00 and the refrigerator was reading 10 degrees Celsius that afternoon. On 21-Sep-2016, it was 6 degrees Celsius, on the 22nd it was 10 degrees Celsius and on the 23rd (morning), it was 7 degrees Celsius. One dose was given between 21 and 22-Sep-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 (Lot # reported as K007825 and expiration date: 13-JAN-2016) (dose, route of administration and lot # were not reported). No adverse effects were reported. Additional information has been requested.
local redness after injection, pain, and swelling; local redness after injection, pain, and swelling; local redness after injection, pain, and swelling; area was hot to touch; This is a spontaneous report from a contactable nurse.  An elderly (reported as over 65-years-old) female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date as a single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date after the vaccination, the patient experienced local redness after injection, pain, and swelling, and area was hot to touch.  The clinical outcomes of local redness after injection, pain, and swelling, and area was hot to touch were unknown.    No follow-up attempts are possible; information about lot number cannot be obtained.
Patient called office on 10/31/2011 at 4:00 pm to report she was experiencing muscle aches progressing from her left shoulder, into her neck, chest and back.  She stated at that time she was beginning to experience aches also on her right side.  The following day she was seen in office. She stated she had called physician as recommended by recorder and she took ibuprofen that Dr advised.  She states she developed a fever of 104.0 the evening of 10/31/2011 and muscle aches traveled to her legs also.  She did state ibuprofen helped with her symptoms and her fever seemed to have resolved. Vitals within normal limits on 11/1/2011.
My arm I can barely move it, it's really painful; My arm I can barely move it, it's really painful; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 23Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient got the first dose on 23Jan2021 and patient arm can barely move it and just wanted to know if she can take Ibuprofen, I mean it was really painful. It was also described as "My arm I can barely move it, it's really painful". The outcome of the events was unknown.  Information on the lot/batch number has been requested.