chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling sensation left arm, light headed, body extremely weak-could not get up, almost passed out, could barely speak, stomach nausea. EMT arrived checked blood pressure with finger (she did not tell us first result when I was extremely weak and felt like was about to pass out and had blurred vision-husband said I was barely responsive and couldn't move to get up), EMT then said would take BP again and while putting on arm cuff I vomited 2 times. After vomiting I felt immediately somewhat better, EMT took blood pressure and she said it was normal. EMT took blood sugar and she said  it was normal All less than 15 minutes after shot. We then waited at EMT direction for another 15 minutes. We left the clinic and parked just outside till 10:30. I am now feeling better, just tired.
Vaccine was administered on 7/24/23, 3 days beyond BUD (7/21/23)
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was tested positive for covid about 25 days after receiving 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient was tested positive for covid about 25 days after receiving 1st dose) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient was tested positive for covid about 25 days after receiving 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient was tested positive for covid about 25 days after receiving 1st dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   05/May/2021,the patient was tested positive for COVID. The finished quarantine period of 14 days. Concomitant medication and treatment details were not provided.
Nausea, fever of 104 degrees Fahrenheit verified through personal oral thermometer, Tinitis on Left ear with intermittent effect.
Two days after the vaccine I woke up with an extreme fullness in my left ear. I couldn't hear clearly, my ear felt like it was full of water it was so heavy, but it didn't feel like anything wet in my ear. I did have some stuffiness and a headache because of the vaccine, I thought the stuffiness may have contributed to the ear. It got uncomfortably worse and would not go away. I called the ENT and made an appointment, whenever I went to the ENT, they immediately sent me to the audiologist. I saw the audiologist, they cleared my ear out and there was not a significant buildup of wax or anything, they also ruled out that my ear drum was not ruptured or anything at that sort. I was put in an audiology booth and both my ears were tested, 20% hearing loss in my left ear and some hearing loss in my right ear.  I was advised that I needed to take a strong dose of steroids to maybe help with the hearing loss. I advised that doctor that I did not want to take the steroids because I didn't want to mess up anything with the vaccine I just received, and I did not want to mess up anything with my 2nd dose that was coming up. I had a follow up appointment follow up 1 week later while my hearing has not improved at all. I called the COVID vaccine hotline to see if the steroid would mess up the vaccine that I already had, and I was advised no that they would not taking any medication 3 days prior to the next vaccine. I called my doctor to advise that I only wanted to do 3 days of high dose steroid because I did not want to do any more of the steroid because I was due for my 2nd vaccine, and I did not want to mess up the vaccine. I went back in for a follow up appointment and my hearing in the right ear did improve some but the ear that I loss 20% in it didn't improve at all. I have sense then received my 2nd dose of the vaccine and the booster and I have not experienced any additional hearing loss. It's been one year since I've first received my vaccine and I am still dealing with hearing loss.
Pt reports experiencing dizziness before passing out at the counter. Pt had initial low blood pressure, flushed, and sweating. Pt was laid supine and came to within about15 seconds of the incident. Pt was able to respond appropriately and aware of person, place, and time. Patient was provided and ice pack, place behind the neck, and vitals were assessed.Initial blood pressure at 1135 was 81/45 1140 was 97/65 and 1143 118/80. Patient reported no additional pain but was "hot" and felt nauseous. Patient was transported to ER by EMS at 1146.
SUSPECTED COVID-19 INFECTION; VERTIGO; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer, pneumonia, tuberculosis (many years ago), and allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2020 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 71 years old. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection, and vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, and suspected covid-19 infection. This report was non-serious.
Decreased blood platelet counts; spiked up glucose; immobility; foot joint pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 43-years-old via an unspecified route of administration, administered in arm left on 12Apr2021 11:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included blood cholesterol increased (other medical history: High cholesterol) from an unknown date and unknown if ongoing.  The patient has no covid prior to vaccination, has not been tested post vaccination and has no known allergies. There were no concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 43-years-old on 03Mar2021 11:00 (lot number: EN6204) on the left arm for covid-19 immunisation. The patient reported soon after his vaccination, he was in acute foot joint pain on 13Apr2021 03:45. Immobilized depending on she'll chair (for further clarification). His blood report on an unspecified date showed decreased blood platelet counts and spiked up glucose and so many other bio markers. He was on steroid and painkiller to manage the pain but he was not getting relief. New pains coming up. He was loosing lots of employment and fun actionable opportunities due this pain and immobility. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient underwent lab tests and procedure which included platelets: decreased and glucose: spiked up on an unspecified date. Therapeutic measures were taken as a result of foot joint pain and immobile which included steroid, Tylenol 3000 mg, Diclofenac 150 mg.  The patient did not recover from the events.
This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL (unknown route, strength, and dose). Concomitant medications were not reported. There was no known adverse effect. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
July 4th Right shoulder feels so full, thought it was just normal but by July 5th Right upper arm and shoulder radiating up neck and down to hand. Throbbing , full, tender to touch and limited arm movement by end of day July 5. Took NSAIDS and heat and Ice and BioFreeze. Nothing helpes the buring and intense pain. Went and received a Toradol shot on July 9th from PCP. At that point recommendation from PCP ice/heat and then some cyclobenzaprine 10 mg.  Then on July 10th, large red area on Right thigh warm to touch and hard and left arm is on fire inside. can not turn neck very well. Can not rotate head because pain. Now PCP  has called in some Steroids reducing doses.   Went back again on  to PCP and drew blood and I am going for Ultra Sound of Left shoulder deltoid area.
Per patient, "severe local reaction about 2-3hours after injection. Redness, swelling to tennis ball size. Extreme tenderness. swelling subsided a little after taking 400mg motrin but remained swollen and tender for two days after".
Case number PHEH2016US023360, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 33 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. No adverse event was reported following this medication error (incorrect product storage).  The case was assessed as non-serious by the nurse.
10JUN92 pt came in for MMR stated was not pregnant & last period was 4 wks prior; returned 5AUG92 & stated was 3 1/2 months pregnant;
Lips felt tingling. And so did my hands and feet.  It started 2 minutes after shot. I was in sheer panic ran out to get air walked a little and oozed 20 to 25 minutes after.
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened) and hypersensitivity (allergies) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028A21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 1, 2021, patient experienced pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened), hypersensitivity (allergies) and rash (a huge, large, wide rash below the site of injection). At the time of the report, pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened), hypersensitivity (allergies) and rash (a huge, large, wide rash below the site of injection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications not provided. Treatment included Zyrtec and Benadryl. This case linked to MOD-2021-148597 (patient link).
pain in her arm; bit dizzy at the time of getting vaccinated; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DIZZINESS (bit dizzy at the time of getting vaccinated) and HEADACHE (pounding headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm), DIZZINESS (bit dizzy at the time of getting vaccinated) and HEADACHE (pounding headache). At the time of the report, PAIN IN EXTREMITY (pain in her arm), DIZZINESS (bit dizzy at the time of getting vaccinated) and HEADACHE (pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medication was not provided by the reporter.
18 year 9 month old patient received the 19 year and up dose of Hepatitis A vaccine rather than the Hep A pediatric dose. Pt tolerated the vaccine well and is aware of the adult versus pediatric dose.
Pfizer-BioNTech COVID19 Vaccine  Severe symptoms following day: injection site pain, fatigue, headache, whole body muscle pain, chills, nausea, malaise. 2nd and 3rd day symptoms: left underarm swollen lymph nodes, injection site pain, headache, tiredness, slight nausea, slight muscle pain.  Missed work 1 day, unable to drive 2 days.
1120PM 6FEB91 child fainted, was nauseated & chilling. Given Tylenol & taken to ER temp 101 & md felt was having an hysterical rxn to being injected.
Patient had a seizure on 10-14-09. Was sent to ER per 911.  11/16/09 medical records received for DOS 10/14/09. Final DX: first time seizure Vaccine in am. Generalized tonic clonic seizure in bed.  Shaking. Unresponsive. Bit tongue.  Confused and combative. Emesis. Oriented x3 on arrive at ED.  AED give. Out patient diags scheduled. D/C to home. ICD9 Codes: 780.39, V56.66
Pt awoke on 8/1/04 went into the bathroom, felt strange feeling in stomach, she yell, eyes rolled back and her body stiffened, lasted about 1 minute. She saw Dr on 11th of Aug and had a normal exam and she ordered an EEG.
COVID Pfizer BioNTech- Patient and 2 siblings at clinic with father to get COVID vaccine. All children were vaccinated with 5-11 yo dose (orange cap pfizer) The patient is not 5 yo yet, turns 5 in March. She is doing fine today and has no symptoms. She is bigger than her brother so I don't think it is going to hurt her. Her dad brought her and filled out the paperwork and did not know she was too young. PCP notified.
Did not receive second dose; She states that a few days later, she had ringing in her ears (still have it).; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (She states that a few days later, she had ringing in her ears (still have it).) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced TINNITUS (She states that a few days later, she had ringing in her ears (still have it).). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). At the time of the report, TINNITUS (She states that a few days later, she had ringing in her ears (still have it).) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-123779 (Linked Report).; Sender's Comments:  MOD21-123779:
Went to Pharmacy and got a COVID and Flu shot. The next day he had a large bruise on the arm he had the Covid shot in. The right arm had a bruise and the right side of his face swelled. The reaction made it hard for him to sleep. He takes multiple medications.
inconsolable crying > 3 hrs immed following immun; pt recovered by next AM;
She got her 2nd Moderna vaccine at about 1515, then waited in the store for at least 15 minutes before leaving.  Prior to getting her 2nd shot she expressed that she was worried about the side effects of the 2nd dose--especially the 24 hours of flu-like symptoms that are common.  At about 1608 she called the pharmacy--shortly after getting home--saying she had tingling in the lips.  I told her that could be a sign of an impending serious reaction.  She took some Benadryl and called her daughter to come over to her house.  I told her if it got any worse, or if she had difficulty breathing to call 911, or to even do that now to be extra safe.  When we closed the pharmacy at 1900, I called her back.  She said she had called and they came to check on her, take her BP, etc.  She was feeling much better as of that call.
mom reports child recv 2nd dose of vax w/in a week of the first;the only rxn noted was a sore arm (not specified which arm);mom reported exp flu like sx p/prev flu vax;prev hx of fatigue & mild chest pain;
left arm sore after first dose injection administered; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK5730; expiration date not provided), via an unspecified route of administration on 23Dec2020 09:00 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that she had first dose of Pfizer COVID-19 Vaccine on 23Dec2020; she reported left arm sore after first dose injection administered. The patient recovered completely from the event after about 4 days on 27Dec2020.
4-4.5 cm orange-peel feel lesion on the right upper arm with vague swelling and redness surrounding at time of evaluation.   Swelling , redness warmth and itchiness started the day after the injection was given.   Physician recommended  10 ml of ceterizine and topical use of 1% hydrocortisone twice daily.
Information has been received from a consumer concerning her daughter a 17 year old female who in June 2008 was vaccinated with the first dose of GARDASIL orally.  On an unspecified date, the patient was vaccinated with a second dose of GARDASIL.  Lot numbers were not available.   The  consumer reported that her daughter had strep throat twice during the time period between her first dose and second dose.  On an unspecified date, the patient experienced a severe rash all over her face and legs after receiving her second dose of GARDASIL.  The patient sought unspecified medical attention. On follow-up information, the patient's mother reported that she took unspecified steroids (manufacturer unknown) and other unspecified psoriasis medications (manufacturer unknown) but they did not help to clear up her rash.  An unspecified scrape test was performed but the results were not provided.  At the time of reporting the patient had not recovered.  Additional information is not expected.
Information has been received from a RN concerning a 43 year old Hispanic female with cough, who on 3/31/99 was vaccinated with MMR. On 4/12/99, the pt experienced a headache and rash described as "small red bumps" over her face, arms and chest. It was noted that the pt woke up with a cough on the morning of episode. That same day, the pt was presented to a physician with the symptoms. It was reported that the pt took Tylenol for treatment of the headache. The reporter indicated that there was no association between the pt's symptoms and the vaccine. On 4/16/99, the pt recovered. No further information is available.
pt recvd vax;mom reports baby was fussy,almost abrupt onset of d;no fever;following day pt seemed fine;
PT DESCIBES OPPOSITE ARM PAIN AND NUMBNESS AFTER FIRST VACCINE.  CONTINUES TO HAVE SCAPULAR PAIN WHICH LIMITS ROM AND HAD A LARGE "KNOT" UNDER LEFT GLUTE MUSCLE AND ROM LIMITING PAIN "LIKE SCIATICA" PT STATED.  PT CONTINUES TO HAVE EXTREME FATIGUE AND SCAPULAR/ARM PAIN.  NO LYMPHADENOPATHY.  WAS SEEN IN CLINIC AND ER FOR PAIN.
papulo vesicular rash around LT & lt shoulder in different stages total 15-20 lesions;
Initial misuse report received from a healthcare professional on 27 November 2013. The case was received on 21 March 2014 at GPV. A 9-months-old patient received 0.5 ml dose of instead of 0.25 ml FLUZONE. No adverse event was reported.
The Moderna Bivalent 6M <6Y Bivalent 6m-5y Dark Pink Cap, 20 doses/2-dose vial was ordered in order to administer primary series doses to patients.  I believed I read that the labels were not correct and could be used for the primary series.  When the patient received the first dose of the vaccine our EMR and  did not flag any error.  I administered a 2nd dose yesterday on 6/21/23 as well and when I was reconciling vaccines it did not appear that the vaccine was deducted from inventory due to the "lot not being found.  I manually deleted the vaccine that was uploaded and re-entered the vaccine so the inventory would update.  At that time the dose was coming up as not valid (it was valid when it was uploaded but not manually entered).  I then looked further into it and realized the vaccine was a smaller a dose and should have been used for a booster.  There were no other known adverse effects.  I am currently researching to see what needs to be done but it appears the patient should be re- vaccinated.
Patient stated that injection site sore and swollen beginning 2 days after administration and lasting for a week, used heat. Was out of town. Developed itching at the site, then had one small "blister".  On 8/1 itching very severe with more blisters and during the night scratched the site. Cleaned site with alcohol and put on a Band-aid. On 8/2 came to Employee Health, injection site had 15x15mm circle with vesicles at edges. Seen in Emergency Dept. treated with hydrocortisone cream 1%, Zyrtec 10mg daily X 3wk, Keflex 750 mg daily X 10 days.
No fever, redness, swelling.Moves legs with difficulty, fussy, irritated, crying, given tylenol. Advised mom to contact MD.  Called back on 3/2/99 - Parent states that on 2/23/99 pt was ok with no fussing or irritability.  Pt is doing fine.
Erythema Multiforme and swelling. Clindamycin 450 mg QID.
Patient is complaining of a raised, half dollar sized, red, pruritic injection site. Referred pt to primary care physician for further assessment.
Pt recv vax on 1/13/98; on 1/15/98 pt exp itchy/red rash over body x 2 weeks; tx=Benadryl w/ no relief, Hydroxyzline w/ no relief
From initial information received on 19/Mar/2004 from a registered nurse regarding an adverse event occurring in the U.S.A., it was reported that a 63-year-old female patient received a dose of TD ADS ADULT, lot number U1022AA, administered in the left deltoid on 17/Mar/2004 (route of administration was not provided). That same day, the patient felt feverish with chills and sweats. The following day, she developed swelling, redness and decrease range of motion (location unspecified). The patient's recovery status was not reported. It is unknown when did the patient receive her last Td booster. From additional information received on 12/Aug/2004 from a health care professional, it was reported that the patient completely recovered from these events. No other new medical information was provided. The reporter of this case is the same reporter of case 20040154.
Chills, headache, pain in arm, underarm and in right breast couldn't move  my  right arm. Had to leave work early that Thursday didn't return until Monday. Didn't go to the doctor or hospital.