chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Raynaud's-like symptoms; left toes started tingling after exercise walk; right toes started tingling and little swollen when taking an exercise walk; Right hand felt cold and was discolored; Middle finger on right hand felt cold and was discolored; Right hand felt cold and was discolored; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Middle finger on right hand felt cold and was discolored), PERIPHERAL COLDNESS (Right hand felt cold and was discolored), SKIN DISCOLOURATION (Right hand felt cold and was discolored), PARAESTHESIA (right toes started tingling and little swollen when taking an exercise walk) and PARAESTHESIA (left toes started tingling after exercise walk) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included MALT lymphoma.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2010, the patient experienced SKIN DISCOLOURATION (Right hand felt cold and was discolored). On 21-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Middle finger on right hand felt cold and was discolored). On 23-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Right hand felt cold and was discolored). On 24-Jan-2021, the patient experienced PARAESTHESIA (right toes started tingling and little swollen when taking an exercise walk). On 26-Jan-2021, the patient experienced PARAESTHESIA (left toes started tingling after exercise walk). On 23-Jan-2010, SKIN DISCOLOURATION (Right hand felt cold and was discolored) had resolved. On 21-Jan-2021, PERIPHERAL COLDNESS (Middle finger on right hand felt cold and was discolored) had resolved. On 23-Jan-2021, PERIPHERAL COLDNESS (Right hand felt cold and was discolored) had resolved. On 25-Jan-2021, PARAESTHESIA (right toes started tingling and little swollen when taking an exercise walk) had resolved. On 27-Jan-2021, PARAESTHESIA (left toes started tingling after exercise walk) had resolved.        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.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.
some loose bowel movements; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Not Provided, NDC number of Pfizer COVID vaccine: Not Provided, Expiry Date of Pfizer COVID vaccine: Not Provided), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller (patient) mentioned that "she got her first dose of the covid 19 vaccine today. She says that she had some loose bowel movements on Feb2021 and she would like to know if that is normal. She asked also what would happen if someone got a vaccine that was not kept in refrigeration since she lives in a little town and she does not know if they have the conditions to keep the vaccines in the right refrigeration." Caller wanted to know how long the side effect will last. On 04Feb2021 following details were provide: Unspecified if Pfizer COVID vaccine a Pfizer product; Unspecified if Pfizer COVID vaccine manufacturer. Reason for no lot number of Pfizer COVID vaccine reported as caller unwilling to complete the report. Investigation Assessment was not provided. The patient experienced some loose bowel movements on Feb2021. The outcome was unknown.  Information on the lot/batch number has been requested.
Started urinating orange urine about 12 hrs after getting 2nd covid shot. Had fever, chills, sweats, body aches, joint pain. I was better on third day post vaccination but urine was still orange. spoke to ID Dr. He ordered labs and urine testing. Labs showed elevated kidney enzymes. I was referred to nephrologist where more tests were done and i'm awaiting results
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K005426, expiration date 15-APR-2016; lot# L023589, expiration date 26-JUN-2017; lot # L048468, expiration date 02-DEC-2017; lot # L042265, expiration date 26-OCT-2017; lot # K007784, expiration date 28-MAY-2016; dose , anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 35.1 Fahrenheit (F) for 2 hours and 48 minutes and previous temperature excursion was reported as 10.6 F for 1 hour and 45 minutes for lot # K005426 and lot # L023589/ Temperature  was 35.1 F with time frame 2  hours and 48 minutes and there was no previous temperature excursion reported for lot # L048468, lot # L042265, lot # K007784. The data logger was involved for all lot numbers. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 14 year old male patient. On 22-MAR-2013, the patient was vaccinated with a dose of 0.5 ml ZOSTAVAX, (lot number reported as H014366, expiry date 06-NOV-2013, route was not reported) in place of the second dose of VARIVAX (Merck). Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Pt recvd 2nd dose of Hep B vax & 24 hrs later on 3JUL92 exp severe, generalized itchy rash (burning & red); became itchy, warm & exp redness; also exp SOB; tx DPH & Epi; hospitalized overnight;
Really feeling sick; Chills; Nausea; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really feeling sick), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Body ache) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (Really feeling sick), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, ILLNESS (Really feeling sick), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Body ache) 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
fatigue, head congestion, burning sensationon left side of the face and body, rhinnorhea, sore throat x5 days Narrative:
About 2 hours after received vaccine, patient states she went to lift her left arm and was unable to. State has not been able to use left arm for daily activities for 2 weeks, since receiving vaccine. Denies and redness or swelling at injection site.
Worsening asthma, I used to only need my inhaler once every so often, I now need it at least once a day if not twice Extreme fatigue, foggy headiness, increased vertigo type symptoms, irregular menstrual cycle
Information has been received from a physician concerning a 12 month old female with no past medical history who on 05/23/2001 was vaccinated on the right with a first dose of MMR II (lot 633822/1168K). Concomitant vaccinations on 05/23/01 included a third dose on the left of Haemophilus B conjugate vaccine (lot 474701). There were no illnesses at the time of vaccination. On 05/26/2001 the pt experienced a rash and fever lasting 10 days. The pt was seen by a physician who felt the fever and rash were consistent with a measles-like reaction. The pt is recovered. No further info is available.
I was given 1ml,Correct Dose is 0.5ml.Headache, Tiredness, cough and slight nasal Discharge. Symptoms lasted 24 hours.
I broke out in hives, my whole back had broke out and it turned really red and it has been around my back; I can feel it tingling around my neck, like I want to scratch it again; I started itching real bad; Last night it flared back up again; I broke out in hives, my whole back had broke out and it turned really red and it has been around my back; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8727 and expiry date was not reported), via an unspecified route of administration, on 30Mar2021 (age at vaccination: 60 years), as dose 1, single dose for COVID-19 immunization. The patient's medical history included blood pressure high (hypertension, high blood pressure. I take medication), herniated disc on back, and chronic obstructive pulmonary disease (COPD, I'm on oxygen). Concomitant medications included amlodipine besilate (5 mg) for blood pressure high, losartan potassium (100 mg) for Blood pressure high, iron, and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient stated that she had the Pfizer shot and yesterday on 08Apr2021, she broke out in hives. She woke up yesterday, yesterday morning with a hive, she started itching real bad and her whole back had broke out and it turned really red and it has been around her back. So, she had her niece rub some A and D ointment in order to cool it down. Then last night it flared back up again. So she was on oxygen. she took a Benadryl. She could feel it tingling around her neck, like she wanted to scratch it again. Due date of 2nd shot of COVID-19 Vaccine, patient stated, it was supposed to be on Wednesday, but she was not sure if she was getting it. On 21April2021 was the next shot. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Soreness of upper left arm, chills, upset stomach, feeling hot all over but no fever, headache, muscle aches, malaise.
I had fever (99.8) during the night along with chills.  I felt like I could get warm. My joints and body ached and I had relentless diarrhea.  I also felt like touch of nausea.  Actually, I said to my husband that this felt as bad as COVID (which I contracted in late October).  I took tylenol  every 5 hours and drank lots of liquids.   I am beginning to feel better (about 27 hours after vaccination).
vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   NO INVALID PATIENT IDENTIFIER   Reporter did not allow further contact
Chest pain, rapid heart beat were treated at urgent care. The diagnosis was costochondritis or inflammation of the rib cage.
Pt recvd vax 4AUG92 & 26AUG92 lab eval revealed SGPT 93, SGOT 56, cholesterol of 300 & triglyerides of 800; pt otherwise healthy;
PC from patients mom c/o severe swelling left leg from hip to knee.  Hot to touch and rash
Death:   5/3/2021 Causes of death listed on death certificate: -1) Acute hypoxic respiratory failure  2) Acute on chronic diastolic heart failure  3) Atrial fibrillation  4) Covid 19 pneumonia  Other: Hypertension. Acute toxic encephalopathy. Type 2 diabetes. Esophageal dysphagia. Debility. Depression. Moderate malnutrition.
School nurse stated pt came to office complaining of feeling hot and nauseated, had rash on chest.  Complained of mouth feeling numb and trouble breathing.  Lasted about 30 minutes, sat in nurses office only.  School nurse viewed this episode as an attempt to leave school!!
Severe body and head aches.; Severe body and head aches; Chills; Nausea; Diarrhea; Intense face pain in sinus zone and red splotches in these areas.; Intense face pain in sinus zone and red splotches in these areas.; Hives in armpit, under breasts, down sides, and in groin area; Fever of 102.5; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female consumer reported for herself that she received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number 30155BA) via an unspecified route of administration in left arm on 08Oct2021 at 09:00AM (at the age of 68-year-old) at single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 16Jan2021 at 09:30AM and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 06Feb2021 at 01:00PM, both for COVID-19 immunisation. Age at first and second vaccination was 67-year-old. Other relevant medical history was none. The patient did not receive any other vaccines withing 4 weeks prior to the COVID vaccine. The patient had allergy to Levaquin, Macrobid and Morphine. Concomitant medications included colesevelam, cetirizine hydrochloride (ZYRTEC), multivitamin and multimineral. On 08Oct2021 at 06:30PM the patient experienced fever of 102.5, severe body and head aches, chills, nausea, diarrhea, intense face pain in sinus zone and red splotches in these areas, hives in armpit, under breasts, down sides, and in groin area. The patient was told to go to ER if it got worse, but she did not go. The events required physician office visit and were treated with Benadryl, Tylenol and Ibuprofen. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. Nasal swab was negative on 11Mar2021, 27Jun2021 and 18Aug2021. The events were resolving at the time of report.
Infant cried & could not be consoled for 5 hrs; Infants was seen by MD;
chest pains; This is a spontaneous report from a contactable (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to taking the second dose of the Pfizer-BioNTech COVID-19 Vaccine, patient was having some chest pains and took Aspirin 30 minutes before the vaccine. Patient reported only to have a had a sore arm and felt a little unwell. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
09/07/22 presents to ED for "dehydration, abnormal labs". PMHx of "PKU, developmental delay secondary to multiple strokes due to pneumococcal meningitis in infancy and seizure disorder"
most of the dose was lost through the end of the plunger with no AE; dose dribbled down the patient's arm with no AE; something with the needle or barrel was wrong, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA312488.  This case involves 79 year old female patient for whom most of the dose was lost through the end of the plunger [Underdose] and dose dribbled down the arm [Exposure via skin contact], while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Patients Medical history, concomitant medication were not reported.   On 18-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot UJ285AB, exp date: 02Jun2020] via intramuscular route in right arm for prophylactic vaccination.  It was reported that pharmacist went to administer a Fluzone High Dose shot on Friday and something with the needle or barrel was wrong so a good portion of the dose sprayed back at me and dribbled down the patient's arm. The patient is fine, but most of the dose was lost through the end of the plunger. The Pharmacist reported that a consumer did not receive their full dose of Fluzone High-Dose due to the vaccine sprayed from the end of the plunger; that she does not know if the needle was screwed on correctly; that the needle went on as normal; that she has disposed of the syringe and needle; that she has used the same needles; that there were no other issue with other doses from the same LOT; and that per store policy patient identifiers are not available.  It was a case of Exposure via skin contact and vaccine underdose. It was also a case of Syringe issue.   At the time of this report, 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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
Pt recvd vax on 19NOV92 & devel flu sx on 24NOV92; No further details were provided;
MMR 11/05/08. Developed severe bruising. 11/29/2008, platelet = 4000, admitted to hospital X 3 days. Got IVIG + prednisone with good response. Platelet count normal 12/5/08. Exam normal exept for fading bruises. 1/29/09-records received -11/29/08-presented to ED with C/O hematoma and small broken blood vessesl scattered on body and limbs. 2 days prior fell and hit head had swelling on forehead with PE:hematoma and ecchymosis adn scattered pinpoint petechiae. Treated with Solu Cortef and WinRho and IVIG.  DX: ITP.
Refrigerator temperature logs were not recorded; No adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT MONITORING ERROR (Refrigerator temperature logs were not recorded) and NO ADVERSE EVENT (No adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT MONITORING ERROR (Refrigerator temperature logs were not recorded). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, PRODUCT MONITORING ERROR (Refrigerator temperature logs were not recorded) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for PRODUCT MONITORING ERROR (Refrigerator temperature logs were not recorded).    No concomitant medications were reported.   It was reported that the patient was given a Moderna vaccine as first-time vaccination two weeks prior to this report. Also, the refrigerator temperature logs were not recorded and the COVID vaccinators had advised to throw all the vaccine.  The reporter had reported that the refrigerator was working and was never down.  No treatment details was reported.
Felt nauseous and out of breathe right away. Fainted and hit head on pavement within 15 minutes of shot. Admitted into ER with concussion and found bleeding in brain within 3 hours of shot.
At approximately 7:30 pm (almost 9 hours after receiving the second Moderna vaccine), I began to have chills and a low grade fever of 100.4. My neck also became extremely stiff. The chills continued to persist and each hour my temperature increased. At 10:00pm my fever was 103 in the ear and I took 1000mg Acetaminophen. The fever went down to 101 overnight and eventually the chills subsided. The morning after the vaccine at 6:20am, I went to take a shower and nearly passed out in the shower - experiencing tunnel vision, ringing in ears, and extreme nausea. The rest of the day, I continued to have a low grade fever between 100.0-100.4, muscle and joint pain, bad neck stiffness, headache, occasional eye pressure, intermittent nausea, and fatigue. The symptoms improved by 8:00 pm (about 33 hours after the vaccine).
she recieved shot without reaction. she stood up and moved over the waiting area to sit for 15 mintues. after 3 to 4 minutes of talking with her mother (mom left to go get water from front of store). she said out loud "I think I'm going to faint."  I rushe out of the pharmacy to help. Her eyes rolled back and she fainted, the she convulsed for 5 top 10 seconds. she woke up 30 seconds later (mom returned by this time). 9-1-1 was called and ambulance came to check vitals and she left on her own accord.
Administered expired vaccine to the patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient after the manufacture date of expiration) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow up received-updated reporter address.