chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M036056 and lot # M036057, for prophylaxis. Sender's Comments: US-009507513-1708USA012994: US-009507513-1708USA012863.
This spontaneous report as received from a medical assistant refers to a 5 months old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
After vaccination pt. experienced high fever 102.5 and (L) upper arm was hot/swollen/red. Mom took to ER 10/19/13 dx - cellulitis meds - KEFLEX given. Pt. came to our office today for ER follow up 10/21/13 pt. to continue KEFLEX.
Immediate runny nose and terrible headache.  After about 8 minutes, lip feeling weird.  After 25 minutes of receiving shot, numb chest, neck, lower fac3 - and swelling of throat and lower face. The numbness and swelling lasted for approximately 3 hours.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates in October 2016 (reported as "at the beginning of October 2016"), the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # M011665 with expiration date 17-MAY-2017, lot # M020902 with expiration date 18-JUL-2017; dose and route were unknown). The vaccines were exposed under temperature of 14 degrees Fahrenheit for a short amount. The previous temperature excursions started at the beginning of October 2016. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Immediately after receiving the vaccine, I had stinging pain spreading like a wasp sting (to which I am allergic) traveling down my left arm. Within a half hour, sharp muscle cramps took place simultaneously on top of the "wave" of sting like pain. These waves of cramping pain changed in location, but were strongest in my arms and legs. Between these waves, sharp pinching nerve pain happens in specific spots which could be anywhere including scalp and between toes. I had one good day with little pain. Other days are not so bad if I keep ibuprofen consistently in my system. It has been 12 days, and these pains have lessened but not stopped.  The remaining pains are more of the sharp isolated nerve pains.  I have not had any flu like symptoms, and I've had very little pain at the injection site.  I have not been able to work much of the 12 days since the shot. I worry that the nerve pain may not go away.
Pt's mom reports today that child is dizzy and has redness about size of a "fifty cent piece" some swelling and warmth in area where TDAP was given.
Hepatitis B surface antigen positive.   This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The subject's medical history included hemodialysis. On an unspecified date the subject received unspecified dose of Engerix-B.  On an unspecified date between 01 October 2006 and 16 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antigen test was positive.  The outcome of the event was not reported.
an expired dose is given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose is given) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired dose is given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired dose is given) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 16MAY2022. The vial did not undergo any temperature excursions. No treatment information was reported.
Swelling of throat making breathing difficult. Two doses of Benadryl with no effect. Administration of EpiPen.
pt recv vax 13SEP95 & on 16OCT97 pt devel chickenpox that consisted of mult vesicles on face, chest, back & groin;w/in 2wk of onset pt recovered;
Narrative:  49 yo male with PMH Afib, b/l wrist pain and tobacco dependence reported that he vomited 4x the evening that he received the first covid (Moderna) vaccine on 2/8/2021. Per records, patient did not seek medical care. Pt received his second dose on 3/1/2021, which was the day he reported this ADR. Both vaccines were administered without complications and patient did not have side effects during the observation period.
Had vaccines on 7/14/08.  At 1015 7/15/08 pt developed fever 101.7 (rectal) and rash across chest + L arm, L thigh + R calf.  HR of 180 and was tachypnic.  Seen in ER and given TYLENOL.  Followed up 7/16/08 at pediatrics for monitoring.
Sore arm; This is a spontaneous report from a contactable consumer, (patient).   A 34-year-old female patient (non-pregnant) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN9581, Expiration date: Unknown), via an unspecified route of administration in the left arm on 29Jan2021 at 18:45 as 1st dose, single dose for COVID-19 immunization. Medical history included Hashimotos Disease known allergies Shellfish, bees. Concomitant medications included levothyroxine sodium [SYNTHROID], multivitamin. 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 an unknown date, patient experienced sore arm. The patient did not receive any treatment for reported event. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected
A stroke occurred approximately 3 hrs after receiving vaccine.  He was flown by helicopter to Medical Center.  He had dysphasia which did resolve by the time he was admitted into the ER.  He has since had CHF and Afib and is now on anticoagulation and diuretics.  He continues to have problems with CHF, SOB, weakness and is undergoing treatment as outpatient.  He is now followed by Cardiology, Neurology.
TDAP and hepatitis A vaccines were given on right arm and then HPV (GARDASIL) was given on left arm. Patient began looking pale and almost fell off exam table. Patient fainted and was laid down. Patient recovered and went home.
I was pulling weeds and notices that I was feeling a little funny but finished what I was doing. When I stood up to pick up the bag I staggered and dropped it. When I looked up everything looked strange, kind of like it was all messed up and didn't fit together right, maybe a little out of focus. My husband stepped out on the deck right then and I motioned for him to come down and when I started to walk toward him I could only stagger to the right. He caught me as I was falling. He got me in the house and I was very thirsty so drank some water and then felt very nauseous. The right side of my face, right arm and right leg was feeling We waited about 15 min for it to clear up and it didn't so we went to the ER.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F".; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F".) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F".). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F".) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been.It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 16-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator.The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit.  The vaccine was returned to the freezer or refrigerator or ultra cold freezer, or maintained at room temperature.The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Administered Pfizer vaccine, about 7 minutes post vaccination, patient presented with feeling faint and clammy; approximately 2 minutes later patient began wheezing and feeling short of breath. RXT called 911, I administered 1 Epipen in right thigh (through patient's clothing). She began feeling as though she needed to use the restroom and/or vomit (she didn't vomit, but I accompanied her to the bathroom).  Wheezing resolved after a few minutes, patient left with EMS via ambulance to be checked out at hospital.  She was awake and alert and was able to answer all questions EMS asked her
allergic; Covered in hives; Swelling in my face; This case was reported by a consumer via interactive digital media and described the occurrence of drug allergy in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included cold and influenza. Previously administered products included Proair.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced drug allergy, hives and facial swelling. On an unknown date, the outcome of the drug allergy, hives and facial swelling were unknown.   It was unknown if the reporter considered the drug allergy, hives and facial swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, had only pro air and nebulizer to fall back on and tried to avoid cold and flu. The patient reported that, after vaccination had very allegic to flu shot and covered in hives, and swelling on face past 2 times. This case has been linked with case US2019AMR167075, reported by the same reporter.
2 month old infant received 2 month immunizations on 12/02/2003.  Mother reports fever the evening of shots and 1 day later a rash on left and right thighs were shots were given.  No edema or redness reported.
Positive rapid test, 7 days after negative rapid test.; Positive rapid test, 7 days after negative rapid test.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Past drug history included: Dicloxicillin, reaction(s): "Known allergies: Dicloxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive rapid test, 7 days after negative rapid test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive rapid test, 7 days after negative rapid test; Negative, notes: Positive rapid test, 7 days after negative rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient hadnt ate much (oatmeal) and stated he was nervous about getting the shot in general. We offered him some candy after the shot but he declined. Within 10 minutes he rose his hand...and then passed out.  he was warm, and we offered him water, he decided to eat his treat. and then we used cold washcloth and ice pack to keep him cool. elevated legs and he recovered completely.
pt c/o h/a (severe); pt was taken to ER spoke w/MD; MD dx strep throat, WBC 8000, Bands 11, PCN was prescribed for pt & APAP was administered;
After my first dose of the Moderna  vaccine on 2/16/2021 I started to experience weekly diarrhea problems. About 2-3 times a week. For about a month. I did report this to my oncologist. I have had previous problems with diarrhea from my Keytruda alone without any vaccinations. Then I received my 2nd Moderna vaccination on 3/17/2021. I also received a Keytruda infusion on 3/18/2021. On 3/210/2021 I have had pretty severe diarrhea everyday. At least 3-4 times a day.  I went to my nurse practitioner and to the emergency room as directed by my oncologist. There was nothing found in my stool sample to be parasitic or to that nature. So it was caused either by my Keytruda or the vaccine. Or perhaps a combination of both.                              I?m just writing to make you aware to be cautious of other cancer patients. So they might be cautious of this type of vaccine   Please feel free to call or message me with any questions
No Adverse Event; The patient's first dose of Moderna was on 20Dec2020 and second dose (Lot#039K20A) on 28Jan2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose of Moderna was on 20Dec2020 and second dose (Lot#039K20A) on 28Jan2021) and NO ADVERSE EVENT (No Adverse Event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose of Moderna was on 20Dec2020 and second dose (Lot#039K20A) on 28Jan2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose of Moderna was on 20Dec2020 and second dose (Lot#039K20A) on 28Jan2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant medication information was provided.  No treatment medication was provided.   This case was linked to MOD-2022-658643 (Patient Link).
LARGE WATERY LUMP UNDERNEATH ARMPIT; PAIN DURING VACCINE ADMINISTRATION (FELT A LOT OF PAIN WHEN PUTTING NEEDLE INSIDE ARM); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 30-OCT-2021, the patient experienced pain during vaccine administration (felt a lot of pain when putting needle inside arm). On 31-OCT-2021, the patient experienced large watery lump underneath armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain during vaccine administration (felt a lot of pain when putting needle inside arm) on 04-NOV-2021, and was recovering from large watery lump underneath armpit. This report was non-serious.
3:00 pm the day of vaccine it started: headache, achy, exhaustion, light headed(medicine head feeling) 6:00pm same day started- nauseous, chills,  sensitivity to light and screens, headache, worse exhaustion, loss of appetite , motion sick feeling It is now Sunday morning and the light headed feeling continues, loss of appetite still here, nausea from smells still here, headache still here, chills are gone, exhaustion still here,  sensitivity to screens still here, motion sickness is a subsiding
After receiving the second dose of Pfizer I started having brain fog, fatigue, chills and the next day I had all over body, joint, and muscle pain.  I tried over the counter pain medication, and it diminished but I missed some days of work because of the pain. I still was having rib cage, shoulder and back pain. I followed up with my doctor and she said I had Costochondritis, and I was given methocarbamol. The pain medication did help, and I used it after the other dosages as well. I was told that it wasn't normal or common but its possible for someone with my medical profile to have this happened. This event lasted for 3 days.
? Guillain-Barre Syndrome (admitting diagnosis) - Bilateral facial weakness (shortly after receiving flu vaccine) which progressed to numbness/weakness in extremities - received plasmaphoresis - discharged to rehab. 4/21/08-records received for DOS 11/14-11/23/07-DC DX: Hypothyroidism. Cervical disc degeneration/displacement. Bell's palsy. Hypertension. Leukocytosis. Admitted with generalized weakness with numbness and tingling and neurologic dysfunction. Chief complaint of facial weakness, dysphagia and odynophagia.
approx 5" redness surrounded site from day of inj;chills started today for last 3hr;noted red fine rash on chest today;like when had strep infect in the past;lt arm swollen from site site to elbow all the way  to outer side;warm to touch
4 X 5 cm indurated erythematous swelling at site of injection on the left thigh.
Started with sore throat for a few days that has resolved. Cough then started on Monday and was harsh but now has improved. Feeling run down and fatigued. Notes body aches and fevers since Sunday. Feeling chilled off and on. Notes having pain in her skin for two nights but that resolved. Also notes wheezing while breathing two nights ago but that has not persisted. starting 10/24/21
second vaccine I had that too and had a similar reaction but I had an additional situation with anxiety and depression; put me in the bed for about 2 weeks with just symptomatic stuff; no energy; couldn''t get it together; I am depressed; Fatigue; second vaccine I had that too and had a similar reaction but I had an additional situation with anxiety and depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot No: EL3247), administration date: 21Jan2021, for COVID-19 Immunization, reaction(s): "tired". The following information was reported: DEPRESSION (non-serious), ANXIETY (non-serious) all with onset 2021, outcome "unknown" and all described as "second vaccine I had that too and had a similar reaction but I had an additional situation with anxiety and depression"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "put me in the bed for about 2 weeks with just symptomatic stuff; no energy; couldn''t get it together; I am depressed"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of depression, asthenia, fatigue, anxiety.  Additional information: The second vaccine I had that too and had a similar reaction but I had an additional situation with anxiety and depression something, I yes, I had anxiety. We all know, we all got that right now but I don't usually have depression and that put me in the bed for about 2 weeks with just symptomatic stuff like that no energy, fatigue and couldn't quite get it together. The patient had always have low blood pressure whole life. Just after the vaccine the patient went to see with doctor to get the regular check up, the patient was given very low dose of blood pressure medication for the first time in my life. So, you know this is not going to work for me.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101721333 similar report from same reporter