chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effect reported.; temperature excursion / temperature 30.4 F; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 21-SEP-2021, the patient was vaccinated with an improperly stored dose of hepatitis B vaccine (recombinant), thimerosal free (RECOMBIVAX HB) lot # T025374, expiration date 25-JAN-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 30.4 degrees Fahrenheit (F) for 76 hours 20 minutes. No previous temperature excursion nor adverse effect were reported.
After 3 vaccines given Pt c/o dizziness, fan on pt - cool cloth on forehead - B/P checked, decreased 88/46 -head of bed down - foot of bed elevated. Remained alert, oriented, c/o weak, MD notified -vital signs monitored B/P slowly rising - HR decreased 46 - Oxygen offered 0.5, sips of water offered - Pt remained less than 1 1/2 hrs monitoring vital signs. EKG done. Sinus brady/borderline per MD. Vasovagal episode - D/C home at 4:50 - B/P 107/60- HR 63 - Pt feels much better.
Information has been received from a physician and an other medical professional concerning a 13 year old female with no pertinent medical history and no known drug allergies who was vaccinated with the first 0.5ml dose of GARDASIL (Lot#660553/0070X) on 18-JUN-2009 in the right arm. Other vaccines given that day included: HAVRIX (unspecified) (GSK) (Lot#AHAYB296BA) and ADACEL (Sanofi Pasteur) (Lot#C2826AA). There were no other concomitant drugs. On 18-JUN-2009, after receiving the first dose of GARDASIL, the patient's eyes rolled back in her head and she fainted while in the office. While she was unconscious the patient experienced "seizure-like head shaking". The other medical professional said there was nothing definitive in the chart to confirm or negate a seizure, as the physician was in another room when the event occurred, chart showed "seizure-like head shaking". The patient had sought medical attention, in the office. There were no diagnostic tests performed. The patient was not sent to emergency room. There was no treatment required. The event was not disabling. At the time of report the patient's status was recovered. Upon internal review, "seizure-like head shaking" was determined to be an other medical event. Additional information has been requested.
Muscle soreness, chills, fever and red raised rash around injection site that itches and is warm to the touch
Injections were completed as of they were an EpiPen, rough, & too fast.  (patient) became lethargic and is having trouble moving his legs, left thigh is experiencing more pain than right. Usually he stands and walks after shots even though there is soreness caused my shots which I?m aware of. He cannot stand without screaming in agony and does not want to get himself up from bed. This is not normal.
Pt received Tdap vaccine as recommended in pregnancy. Pt woke the next morning with pain in arm. Pain would wake pt in during the night w/ pain at a 10/10 on pain scale. Pain radiated down into left arm. Pt tried Tylenol and heat/ice with no relief. Pt was put on 6-day course of prednisone. Pt had f/u apt and states symptoms are 70% better.
I started itching and then I broke out in a bad rash. I am still dealing with this at this time.
HEADACHE; TIRED FOR 2 DAYS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown and expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced headache, and tired for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and tired for 2 days was not reported. This report was non-serious. This case, from the same reporter is linked to 20210356458.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Rash and severe swelling of the face, Hands and throat. Given intravenous benedryl, Pepcid, Ativan,  Prednisone
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022; First dose administered on 30-MAR-2022 and second dose administered on 09-MAY-2022; administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired dose of the Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 30-MAR-2022 and second dose administered on 09-MAY-2022) in a 95-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 065K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired dose of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 30-MAR-2022 and second dose administered on 09-MAY-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired dose of the Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 30-MAR-2022 and second dose administered on 09-MAY-2022) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. On 11-Jan-2022  the vial was initially stored in the fridge. The patient had not reported any adverse reaction. The vaccine in question did not experience any temperature excursions No treatment medication information provided.
Dizzy; Vertigo; Feeling Disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), VERTIGO (Vertigo) and DISORIENTATION (Feeling Disoriented) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced DIZZINESS (Dizzy), VERTIGO (Vertigo) and DISORIENTATION (Feeling Disoriented). At the time of the report, DIZZINESS (Dizzy), VERTIGO (Vertigo) and DISORIENTATION (Feeling Disoriented) outcome was unknown.            No treatment indication was provided by the reporter.
12 days after shot slight bump and itch at vaccination site, that progressed down arm over 24-36 hours to an area about 6 in. long and 3 inches wide. Area is slightly raised, hardened, hot to touch, and itchy. At the time it began itching and for next 36-48+ hours I was very tired, chilly and had very slight sore throat that I wrote off as allergy related.  My Dr. said I should fill this out and check back with her if it doesn't improve.
Around 13.5 hours after receiving the 2nd vaccine, I started shaking and chilling.  My temp very quickly went up to 103 and stayed close to that for the next 30 hours or so.  It went as high as 103.7 for a while and hardly went below 102.  The fever I treated with extra-strength acetaminophen.  Additionally, I was extremely weak, slept most of the day, was nauseous, and had little appetite.  The fever broke in the early morning of Wednesday, 4/21; however, I again had a low-grade fever that evening.  Around 9:00pm on 4/21, I discovered a bright red rash on my upper chest, shoulders, armpits, upper abdomen, and my back (shoulders to hips).  The rash was flat and not well-defined.  By morning, the rash was no longer so pronounced, but it had spread to most of my body.  It does not itch or irritate me in any way.  I have taken Benadryl a couple of nights for it.  On Sat., 4/24, it is still barely visible.
She can't walk anymore.; The initial case was missing the following minimum criteria: ICH-unspecified AE. Upon receipt of follow-up information on [02Jul2021], this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) reported for herself via telephonic activity. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0180)dose 2, via an unspecified route of administration on 09Jun2021 (at 53 years of age) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0168) on 19May2021 (at 53 years of age) via an unspecified route of administration as single dose for Covid-19 Immunization. The patient stated first dose Pfizer Vaccine was received 21 days before the second dose Pfizer Vaccine. She received the second dose Pfizer Vaccine and had a reaction and is in the hospital. She states she and the doctor are trying to reach out to Pfizer to see if Pfizer can give some type of recommendation on what Pfizer does if someone has a reaction to the Pfizer Vaccine. She states she is laying there and cant do anything and can not walk or do anything. She cannot walk anymore. She is still in the hospital. The outcome of event was not recovered.  Follow up needed, further information has been requested.  Follow-Up 14Jul2021: Follow-up attempts are completed. No further information is expected.
My son awoke with a severe headache. As the day progressed, he had body aches and chills.
Patient came in 10/05/22 for a COVID booster and flu vaccine with spouse. Shots were not separated and patient received 2 doses of flu shot. Patient was informed of receiving two dosing of flu and advised on waiting to receive COVID booster shot. Patient did not report any side effects at time of shot and as of 6:48pm on 10/05/22, reported one arm was sore with no other reported side effects. No interventions or treatments have been completed.  Patient's Dr was contacted and Dr did not feel patient would be affected.
Dizziness, very pale, weak, cold sweat.  Started about 1-2 minutes after injection at 12:30pm.  Lasted 2-3 minutes.  Rest of day still had upset stomach, severe headache.
01/06/22: CHILLS, COUGH, FEVER, MUSCLE PAIN
On 3/30 PM, I experienced very severe nerve pain in lower extremities and muscle weakness that last over 48 hours.  I was initially very unstable walking for first 24 hours.  Symptoms were very similar to severe reaction in 2018 with yellow fever vaccine (Sanofi) but not as severe.  Home treatment with Aleve 200 MG every 3 hours.  Recovery on 4/4
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 13-NOV-2015 the patient was vaccinated with ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Within an hour half of my body went numb My tongue went numb and I was in the emergency room unable to speak with what appeared to be the worst hemiplegic migraine in my life.  The feeling has not returned in my left hand side of my body or my tongue.  I am told the second vaccine injection will be worse.  Then I was misdiagnosed with muscular sclerosis after an MRI was done and damage was found to my brain.  I could not be more angry
Initial information received on 15 October 2007 from a health care professional. A 55-year-old male patient, with no illness at the time of vaccination, had received a left arm, intramuscular injection of Adacel, lot number C2769AA, on 06 August 2007. Three weeks post-vaccination, the patient experienced general malaise, coughing, night sweats, and wheezing. He was examined by his personal physician twice and referred to a pulmonary specialist. Per the reporter, the patient had possible whooping cough per the pulmonary consult. Relevant diagnostic testing was reported as "none done." At the time of this report, the patient had not recovered.
persistent headaches for more than 2 weeks; muscle weakness; easy tiredness; ligament and body aches; After the second dose of vaccine patient felt like as she ingested a barrel of soy, she had all the symptoms of her sensitivities; This is a spontaneous report from a contactable female consumer (Patient) reported for herself. A 53-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/Lot number: EW 0170), via an unspecified route of administration on 09May2021 (age at vaccination: 53-year-old), as a single dose for COVID-19 immunization. Medical history included pretty bad food sensitivities for dairy and soy which make her body hurt as if she had a bad arthritis. The patient previously took penicilina [benzylpenicillin]. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient not been tested for COVID-19. On 09May2021 at 17:00pm, the patient experienced persistent headaches for more than 2 weeks, her muscles become weak, and she was not able to function, muscle weakness, easy tiredness, ligament and body aches, she has a pretty bad food sensitivities for dairy and soy which make her body hurt as if she had had a bad arthritis. She completely avoids these foods and without them she did not have any symptoms of pain, nor did she have arthritis. After the second dose of vaccine patient felt like as she ingested a barrel of soy, she had all the symptoms of her sensitivities. The pain and aches went away in about 1/12 weeks, but muscle weakness persists. Since the second dose of vaccine, she was having headache every day. The clinical outcome of pain and aches went away in about 1/12 weeks, patient seldom have any headaches at all/not recovered, muscle weakness persists, easy tiredness and after the second dose of vaccine, she had all the symptoms of her sensitivities was not recovered.  No follow-up attempts are needed. No further information is expected.
Expired vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported.  HCP reported Moderna Covid-19 vaccine vial which was expired on 01-Apr-2022 was administered to four patients on 05-Apr-2022 as a booster. HCP said there was no side effects had been reported.  No treatment medications details were reported.
patient pulled away during vaccine immunization and did not receive a full dose.  Pfizer representative said they do not have specific guidance on these situations and to follow off label guidance which is if patient receive a lower than authorized dose of the correct vaccine, repeat the dose immediately.  The guidance was discussed with the patient's parents and they were comfortable with him receiving the dose again, which was then administered to the patient.
Fever, rash, unsteady with his gait, shaky, crying instead of communicating with almost words. Crying constantly unless held. Just off.
3/27/21 - ER   zpak & steroids   Hives, pressure on skin 3/28/21 ER steroids w/ taper 3/30/21 Office Visit with pcp - famotidine 40mg QHS prednisone 20mg taper
Dizziness due to syncopal episode. Patient with previous reaction to "painful procedures." Last being her ears getting pierced. Spoke with mom who is a physician and states this happens to her frequently with procedures that can result in pain. VSS. Pt hydrated with PO fluids. Tolerated well, no nausea/vomiting. Observed for 25 minutes after event. Got up, ambulated steadily without discomfort/dizziness. VSS. Patient left clinic in stable condition, no acute distress. Left clinic ambulatory with dad.
Fussiness & screaming after immunizations on 9/18/12 muscle felt knotted/hard, TYLENOL & warm bath did not help. Fell asleep 4:54 pm.
8 days after receiving Moderna vaccine, the area on my arm where the shot was administered became itchy and red (warm).
Patient  fainted after receiving first Covid vaccine. Patient admitted to a history of fainting after vaccines. Patient given water and rested. Vitals signs were stable X3. He was able to stand with no issues and walked out of clinic after recovering.
It was reported that a 26 year old female received Imovax vaccine on 7/7/99. The pt developed headaches following the injections. This reaction progressively got worse.
Friday I felt very lightheaded and sick all day; threw up when I woke up. I felt ok by 5:00PM. Saturday morning, my bottom left lip started to swell. I took Zyrtec, Benadryl and Advil and symptoms subsided after a few hours. Saturday night, my face became very hot and red at dinner. It looked like I had a sunburn. I took Benadryl and went to sleep. I woke up at 4:00AM Sunday and could feel my lower right lip and upper lip swelling and was very dizzy, ears were ringing and it was hard for me to walk. I went to the minor ER and the right side of my face and right eye began to swell along with my tongue and throat. They gave me intravenous epinephrine, steroids and antihistamine. They released me at 7:00AM. They prescribed me Prednisone and Pepcid. I have been taking this for 1 week now, and if I do not take the Prednisone, I start to get lightheaded, hot, my face gets red, I feel dizzy and my tongue swells. I take 1 Bendaryl every 4 hours.
Tinnitus, pt reported ringing in the ears after about 12 minutes post vaccination time.
Went to had vaccine administered.   Swelling in my hands 25 minutes after shot was administered.   Had already arrived home, called and was transferred to the pharmacy and spoke to pharmacist.  Pharmacist asked a series of questions, stated my reaction was not life threatening and recommended Claritin 10mg & Benadryl 50ml  and to follow up with my doctor or go to the emergency room if I can't breath.  Experienced more swelling in hand, wrists, feet, face tingling, right ear numbness, lips itching/swelling, extremely dry eyes,  red eyes, swollen veins in my right eye, blurred vision in right eye, severe headaches, pain in both forearms, sporadic chest discomfort, fatigue, brain fog.  Left a message at my doctors office stating my allergic reaction, received a call from nurse practitioner with same over the counter medicine pharmacist suggested plus Pepcid AC 20mg & warm compress.  We to see the doctor the following Saturday symptoms hadn't subsided.  All my blood work came back normal.  Doctor said he hadn't see this before not sure what to do.  Possibly steroids but felt my body would adjust.  Also went to ER, had chest X-Ray and labs.  All came back normal.  Called my allergy doctor, also said they didn't know what to do, referred me back to my primary doctor or go to the ER.   Went to the ER didn't know what to do and recommended I ask my primary doctor to send me to a cardiologist.  I still have same symptoms and same initial over the counter medications.  No course of treatment from anyone THEREFORE I told my doctor to refer me to Immunology & Allergy, Cardiologist, and Ophthalmologist.   No sense of urgency and I'm awaiting appointments over a month out.
DTAP given 1/12/10 + mother called 1/15/10 to review Sx. Pt's leg left thigh @ injection site was red approx 6 inches, resolved this 1/15/10- mild distortion at area. Reported by phone call from parent.
All my joints hurt arms weighted down and tired at 6:30 am. went back to bed awoke at 11:00am shaking and freezing cold, back to bed sleeped till 5:30 pm awoke feeling better just tired.
The pt experienced a fever, itchy watery eyes, possible URI. No vomiting, no diarrhea until after antibiotics were taken. Possible or slight pneumonia. Throat became swollen 12 hours post vax. The pt became severely dehydrated, requiring IV fluids.
p/vax pt devel temp 101-102, fussy, in ER temp 105R. started on amoxicillin for ? sinusitis. fever broke 6/3 p/48hrs on antibiotics
Bruising, swelling, redness, and itching around injection site, and arm was painful.
a 67 years old female patient received a 0.5 ml dose of an expired Adacel vaccine, no AE; Based on additional information received on 29-Dec-2019, this case becomes medically confirmed.   Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 67 years old female patient who was vaccinated with an expired dose 0.5 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U5829AB and expiry date: 24-Nov-2019) via intramuscular route in the left arm on 03-Dec-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  It was an actual medication error due to expired vaccine used.  At the time of reporting, 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 holders compliance with the requirements set out in Directive and Module VI of the 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.  Follow-up information received on 29-Dec-2019 regarding an unsolicited valid non-serious case received from a Pharmacist.  Case became medically confirmed. No new information was received.