chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of consciousness; Could not think straight; Difficulty walking; Having difficulty speaking; Fast heart beat; Dizziness; Gums began tingling; Gums itching; A spontaneous report was received from a consumer concerning a 70-year-old, female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced events Loss of consciousness, difficulty in walking (difficulty walking), Mental Impairment(couldn't think straight), Dysarthria(difficulty speaking), Tachycardia(fast heart beat), Dizziness, Paraesthesia oral (gum  tingling) and Gingival pruritic(gum itching).  The patient's medical history was reported as seizure disorder, diabetic, and allergies. Concomitant medications known to have been used by the patient, within two weeks prior to the event included amlodipine, Aspirin, Benadryl, azosemide, fara sulfate, levothyroxine, losartan, magnesium oxide, metformin, meloxicam, Minoxidil, montelukast , omeprazole, potassium chloride er, primidone, propranolol, rosuvastatin, stool softener, Tylenol extra strength, vitamin D3, voltaren topical gel and tramadol  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the difficulty walking, couldn't think straight, difficulty speaking, fast heartbeat, dizziness, loss of consciousness, gum tingling and gum itching. Laboratory details were not provided. Treatment details was given as Tylenol and Ativan.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event Loss of consciousness was reported as resolved. The outcome of the event, Gait inability, Mental Impairment, Dysarthria, Tachycardia, Dizziness, Paraesthesia and Gingival pruritis were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
soreness; achiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness) and PAIN (achiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness) and PAIN (achiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness) and PAIN (achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
On 07/59/01 pt called our office and stated varicella vaccination site was red, warm, painful, itchy, raised approximately 2 inches by 3 inches and looked like an allergic reaction. Pt seen by MD on //site was red, mildly tender and raised aprroximately 7 X 8 cm. Motrin and ice was recommended.
Red splotch on arm about 2 in in diameter at injection site. Warm to touch and firm.
The Covid-19  Pfizer vaccine (Grey Cap) for ages 12  years and above was administered instead of the recommended Covid-19 Pfizer vaccine (Orange Cap)  recommended for ages 5 to <12 years.
contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is a spontaneous report from a contactable nurse. This nurse reported same events for six patients. This is the second of six reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 22Dec2020 at a single dose in the nursing home for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted covid after receiving the 1st vaccine dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/drug/event, different patient
After child received second IM injection she fell forward from the chair bench to the carpeted floor. No resp. difficulties noted, family at child?s side, child unresponsive few seconds, I got my director to come and assist, child rolled from face down to back. Cool cloth applied to forehead, child noted with 3cm x 0.2cm red area noted to right forehead with no raised area noted and 0.2cm circular red area noted to upper bridge of nose.  Legs elevated.  3:00pm B/P 90/40 in laying position with feet elevated and responding to verbal stimuli and alert denying pain or discomforts at this time. At 3:15 child assisted to sitting position child C/O feeling nausea child assisted back down to floor and feet elevated with cool cloth applied to forehead and ice pack placed on back of neck. B/P 60/40. Child continues to respond verbally denying N/V or headache and dizziness at this time. 3:20 B/P 64/40 continue to lay with feet elevated with cool cloth and ice pack. 3:25 B/P 90/50 child assisted to sitting position without any c/o of N/V/HA or dizziness noted. 3:30 B/P 92/52. Child assisted to standing position slowly with no dizziness noted. Child walked out to family car with no difficulties continue to deny pain or discomfort .Father faced time with child during episode father was obviously upset and kept asking the director why she was not sitting at time after vaccine, which child was sitting and fell forward from chair bench.  Family member at child side entire time. Medical Director called and updated regarding child.  Childs primary physician notified of the incident which was written on our forms.  That doctor denied ever seeing this child as a patient.
Initially after Gardasil 9 patient became nauseated headache and vomited within next 24 hours patient had 7 separate episodes of dizziness, became light headed and nauseated no further emesis.  After 24 hours patient with no symptoms.
Flu like symptoms, body ache, fever, lethargy, fatigue, drozyness, lack of energy
Face Flushing. About 2 hours later face became red but no other symptoms and patient was counseled to go to ER if any other symptoms develop.
a second Moderna Bivalent booster was given; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (a second Moderna Bivalent booster was given) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (a second Moderna Bivalent booster was given) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (a second Moderna Bivalent booster was given) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (a second Moderna Bivalent booster was given).    No concomitant medications was provided. Patient received all previous doses of Moderna. No treatment medications was provided.   Reporter did not allow further contact
FLUZONE Peds administered to patient when she was 5 mo 7 days of age in error. No adverse reactions. (Administration error report only).
About an hour after the vaccine, my lower right lip went numb instantly for under 1 minute. It felt like going to the dentist and getting a numbing shot. I got my 3rd dose on 09/28/2021, lot number EW0182. I went to my doctor on 2/5/2022 and almost had a fall, then went to the ER and had an x-ray and blood work. I had chest pain and they said to follow up with my doctor. I went to a cardiologist. While at the cardiologist, I had a slow heartrate and my blood pressure was up. I have never had a problem with my blood pressure or told my heartrate was slow. I had a stress test on 3/10/2022, which indicated abnormal and was a block in the lower left portion of my heart and possibly the reason why my heartrate was slow. I am scheduled on 4/5/2022 to have a cardiac catheterization and my cardiologist did say if the blockage is 70% or more then they will put a stent in.
This spontaneous report was received from a medical assistant referring to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, 0.5 ml (batch #M020101, expiry date 07-MAR-2019) (dose and route not reported). The vaccine was exposed to temperature of 61 Fahrenheit for 3 hours. No previous temperature excursion was reported. No adverse effects and no product quality complaints (PQC) were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-DEC-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U015679, expiration date 18-MAY-2023 (anatomical location and route of administration were not reported) for prophylaxis (product storage error). No additional adverse events were reported (no adverse event).
Fevers, prolonged for weeks no known cause. Anorexia. Chronic cough.
No additional AE; Nurse called and reported that a dose of VARIVAX was administered to a patient after a temperature excursion. Caller stated the dose was administered on 10/26/2023 and the product had 3 temperature excursion prior being administered. Caller stated pa; This spontaneous report was received from a nurse and refers to a patient of unknown ae and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W031810, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before admission to a patient in 6 Farenheit for 35 minutes (Product storage error). Previous excursion also occured in 14 degree Farenheit for 1 hour 29 minutes and in 6 degree Farenheit to 14 degree Farenheit fo 1 hours 15 minutes. No additional adverse events were reported.
large swelling/induration, redness, warmth 6inchs in diameter Headache, neckache, fatigue, arm/hand tremors on affected arm
This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 18-JUL-2014, the patient was vaccinated with the first dose of an improperly stored GARDASIL (Lot No. J010668 Expiration date: 29-APR-2016) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. Thi sis one of several reports received from the same reporter. Additional information has been requested.
Patient states her arm is red at a different location than where bandaid is applied.  She was concerned injection might not have been given IM.  Spoke to drug information at GSK and they stated injection site redness very common, especially for second dose.  Drug information also said they have studies of SQ injection instead with similar efficacy.  Patient is ok knowing that it would be effective either way.
pt said her arm was getting redder, more swollen and warm, she had not taken anything for the arm or contacted anyone regarding symptoms.  she came to the pharmacy 24 hours latter, I gave her Benadryl and sent her to her pcp, no difficulty  breathing reported.
Narrative:  Patient passed away due to COVID-19. He had received an initial series of the Moderna COVID-19 vaccine.
Rash located on trunk and bilateral armpits onto chest, between and below breasts onto upper abdominal wall. No fevers/chills. Not itchy or painful.
Symptoms for approximately 12 hours: headache, chills, body aches and extremely tired feeling. At the end of 12 hours the symptoms were gone.
Severe Headache began on Sunday 1/17/2021, then Monday 1/18/2021 I developed Left axillary lymph node edema and left groin swollen lymph node.
Hospitalized with a GI bleed due to ongoing diarrhea associated with COVID 19 diagnosis.
Patient reported extensive history of anaphylaxis to multiple foods. She brought her own Epi Pen to vaccine room. Pt was sitting in obersvation area for approx 25 minutes when her skin started to itch. She self-triaged to ED r/t her medical history. Pt was transported to ED by vaccine RN
pt recv vax;seen in er w/ high fever,morbilliform rash&koplick spots 1 wk p/ MMR;
Fluzone was injected, and pt returned in a couple minutes complaining of lightheadedness. He put his head down and fainted. He regained consciousness, and kept his head down for a few more minutes. he was sweating profusely, pale, and his pulse was very weak and rapid. Epinephrine was injected, and his symptoms resolved rapidly. He was transported to the hospital and observed for the possible need of a second epinephrine injection. No further injection was given and the patient was released
Initial unsolicited report received from a HCP via other company (Pfizer) (Manufacturer Report Number: 2016009819) on 06-Jul-2016. This case involves a 53-year-old male patient who was vaccinated with a dose of TDAP VACCINE (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) (batch number, expiration date route and site of administration and dose were not reported) on 07-Nov-2011. The patient's medical history included Allergies to AUGMENTIN, PHENERGAN, VIOXX noted on 03-Nov-2011. It was reported that the patient was a smoker since 42 years and consequently was suffering from emphysma further expressing his desire to quit smoking nicotine spray 10mg from 05-Oct-2015 nasally 1-5 times per hour for 8 weeks and Nicotrol 10 mg inhaler 6-16 cartridges per day for up to 3 months, end date 06-Jan-2016. Concomitant medications included XANAX 1 mg tablet orally 3 times a day for anxiety, aspirin 81 mg EC tablet orally daily, CYMBALTA 60 mg capsule orally twice daily, NORCO 10-325 mg tablet orally for pain every six hours, LAMICTAL 200 mg oral tablet twice daily, PRILOSEC capsule 40 mg orally, MIRAPEX 0.25 mg Tablet orally from 19-May-2015 in night as needed, route: none and Zocor 20 mg tablet orally in night from 19-May-2015 to 18-May-2016. On an unspecified date, following the vaccination, the patient experienced redness, swelling and allergy to Tdap vaccine. Laboratory investigations was reported none. Corrective treatment was not reported. The outcome for all the events was reported as unknown. List of documents held by sender: none.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received the first dose of PREVNAR 13, intramuscular on an unknown date in 2014 at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date in 2014, after receiving the vaccine, the patient experienced an episode of high blood pressure. It was unknown if the patient had a history of fluctuations in blood pressure. Therapeutic measures taken, if any, were unknown. The clinical outcome of the event, an episode of high blood pressure, was unknown. No follow-up attempts possible. No further information expected.
fever of 100, chills, neck pain, headache, brain fog, fatigue, overall aches
immed p/vax pt could not move fingers but had moderate pain down arm;ice helped;p/1st day thru present;cont to have weakness in lt hand/wrist;
Patient admitted to hospital  on 02/11/2022 for acute encephalopathy, productive cough, dyspnea requiring use of his home oxygen tank, wheezing, subjective fevers, and was found at the time to be covid positive.  Patient was not a candidate for Remdesivir d/t renal dysfunction.  CXR showing cardiomegaly status post remote transcatheter aortic valve replacement with interval development of a large dependent left pleural effusion and hazy interstitial opacities present within the mid and lower lungs bilaterally.  Patient was weaned from oxygen and mental status improved back to baseline.  Patient was discharged home for quarantine x 10 days and dexamethasone x 10 days.  Patient expired on 02/17/2022.
Cramps on left leg between Soleus and Tendons; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0161) via an unspecified route of administration on left arm 20Apr2021 at 08:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported by the patient. The patient had no known allergies. Concomitant medications included norethisterone (DEBLITANE) and amlodipine (MANUFACTURER UNKNOWN) since an unknown date for an unknown indication. 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. The patient had not been tested for COVID-19 since the vaccination. On 22Apr2021 at 10:30, the patient experienced cramps on left leg between soleus and tendons. The cramps started 2 days after the vaccination and remained for 3 days. It was still present and was not getting worse or better and normal muscle pain should have gone away. Therapeutic measures included acupuncture for the reported event cramps leg. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Day after immunization given, school called mom and pt had a hive looking rash from head to toe. No respiratory distress noted, pt given BENADRYL and rash subsided. Previous flu shots did not give these results.
The patient did not report any pre-existing conditions at the time of the vaccination, on 09/16/16 at 9:15 AM. She called on 09/16/16 at 1:14 PM, stating that she was 4-5 weeks expecting and was wondering if the Varicella vaccination we had administered would impact her pregnancy.
2 days of intense migraines, several areas on left arm with redness, pain and swelling that seems to be spreading
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a adult female patient who received FLULAVAL Quadrivalent (batch number H33J2, expiry date May 2016(. On 7th October 2015, the patient received the 1st dose of FLULAVAL Quadrivalent .5 ml. On 8th October 2015, 1 days after receiving FLULAVAL Quadrivalent, the patient experienced injection site redness, rash and injection site swelling. On 12th October 2015, the outcome of the injection site redness, rash and injection site swelling were recovered/resolved. The reporter considered the injection site redness, rash and injection site swelling to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The reported injection site was left deltoid. The nurse reported that next day after receiving FLULAVAL QIV, the patient experienced a severe injection site reaction with increased swelling in the entire deltoid. The deltoid was red (injection site redness), swollen (injection site swelling and a rash on the left arm. On Monday, 12th October 2015, the patient was checked and there was still a small red area around the injection site that was firm under the skin. The side effects lasted three days until they resolved.
I had mild pain and tenderness at the vaccination injection site immediately after vaccination. The pain never went away and got progressively worse over 1 month, eventually becoming severe without any other known left injury shoulder injury. I took naproxen for a week without improvement. I waited to see if it would get better on its own but after several months of no improvement, I sought medical care. I was diagnosed with adhesive capsulitis of the left shoulder. I underwent 4 hydraulic distension procedures, the first 2 included platelet lysate therapy and the second 2 procedures included dexamethasone. It was only after treatment with dexamethasone that my pain improved significantly. At the time of this report I am still having mild pain and mild restricted range of motion.
no other AE reported; patient who received Prevnar 13 on 15-OCT-2018 was scheduled to receive Pneumovax 23 on 21-JUN-2021, but was inadvertently administered another injection of Prevnar 13; This spontaneous report was received from a pharmacist and refers to a 81-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 15-OCT-2018, patient received a dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (lot #, expiration date, exact dose, dose #, route and anatomical locatio were not reported). The patient was scheduled to receive pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on 21-JUN-2021, but was inadvertently administered another injection of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) 1 injection, lot # DX8302, expiration date 28-FEB-2021, at that time. No other adverse events reported.
Swelling of arm from shoulder to elbow followed by fever and headache the next day and for the following 5 days. Redness and pain subsided after 5 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: en9581), on 26Feb2021 as dose 2, single (Lot number: en6205) and on 25Oct2021 as dose 3 (booster), single (Lot number: fc3184) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROPANOLOL [PROPRANOLOL], start date: 01May2021; TADALAFIL, start date: 01Mar2021; ZINC, start date: 03Jan2022; OMEPRAZOLE, start date: 01Jul2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment for covid-19 with Paxlovid from 20Jul2022 to 24Jul2022. The patient had no known allergies.