chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had her first influenza injection December 5th. On January 7th the child was brought in for the second immunization and the mother reported that the site "got a little sore the last time." On 01/08/2002 the child was seen at the medical clinic and was admitted to the hospital with grand mal seizures and transferred to a different hospital a later that day.
Tongue had a tingling sensation; lips started to swell; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue had a tingling sensation) and LIP SWELLING (lips started to swell) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Itching. Concurrent medical conditions included Pollen allergy, Dust allergy, Mite allergy and Allergy to plants (Allergic to trees).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tongue had a tingling sensation) and LIP SWELLING (lips started to swell). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Mar-2021, PARAESTHESIA ORAL (Tongue had a tingling sensation) had resolved. At the time of the report, LIP SWELLING (lips started to swell) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood pressure measurement: unknown (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.. Patient was recommended to take second dose of vaccine by the allergist in facility with emergency room was reported.
Child started developing redness and swelling at both injection sites on 3-8-2018. Both sites are raised. Parents gave child BENADRYL on 3-8-2018. Today, the right leg, KINRIX site, measured 4.2 cm X 5.5 cm. The left leg, PROQUAD site, measures 15 cm X 8 cm. Both sites had a line drawn around. There is no drainage.
Rash, first all over my face. Comes and goes, then my neck and upper shoulders. Some now on arms and fingers
Pt reported not feeling well.  He looked pale, sweaty and appeared to be breathing normally.  He reported not having difficulty breathing but was feeling light headed and thought he may vomit.  Monitored patients blood pressure and respiratory rate--both were normal (114/76; 93bpm; 19rpm).  Called ambulance who arrived in about 7 minutes and took over his care.  He was still not feeling well and was light headed/dizzy and feeling like he could throw up.
The recipient was feeling well immediately after the vaccination,  all day on 2.8 and in the morning of 2.9.  His daughter in law text him at 0930 and he did not respond to the text (atypical) and then he missed a morning meeting.  His wife was downstairs in a meeting herself and after the meeting was over she called to him and he did not respond.  She found him with no pulse and was not breathing.  She called 911 and attempted CPR.  They did not complete an autopsy, they stated that they believe the cause of death was either an embolism, Heart attack or aneurism.   The wife stated that she does not believe the death was due to the vaccination; however, there were no tests completed to prove or disprove.
nurse gave an expired dose of menactra with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old male patient got expired dose of INGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 16-Jun-2022, the patient received 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6920AA exp date: 15-Apr-2022 (formulation, strength: unknown) via intramuscular route in the right arm for Immunization.  On 16-JUN-2022 the patient developed a non-serious event "nurse gave an expired dose of menactra with no reported adverse event" (expired product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event nurse gave an expired dose of menactra with no reported adverse event.   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 the guidelines. 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.
Palpitations like I drank too much coffee Narrative:  Monitored by monitor staff, vital signs collected. Patient able to ambulate without assistance
received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The lot was shipped 06-Dec-2021 and the new expiration date should have been 05-Jan-2022 due to the refrigeration of the vaccine.  The error was caught when a new shipment was received.  No concomitant medications were reported.  No treatment information was reported.
Information has been received from a registered nurse concerning a 37 month old female with no known drug allergies and no pertinent medical history who on 27-FEB-2004 was vaccinated SQ with 0.5 mL dose of Varivax (Oka/Merck) (lot# 647093/0886N). There was no concomitant medication. On 30-MAR-2006 the patient developed herpes zoster lesions on the back of the right thigh. No diagnostic/laboratory tests performed. Unspecified medical attention was sought. The patient was treated with acyclovir therapy. As of 06-Apr-2006, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
died; Dermatosis; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (died) (seriousness criteria death and medically significant) and DERMATOSIS (Dermatosis). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DERMATOSIS (Dermatosis) outcome was unknown.      Concomitant medication and treatment drug were not reported.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Get full with little food; Feels like a zombie; Not well; Cannot work; Pain in the arms; Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired; Pain in the arms; Face is hot and getting hard; Muscles are tense, like balls in her thighs and arms; Chest feels like paralyzed; Lost of apetite/no hungry; Cramps in the muscles of the pelvic area; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), MUSCLE SPASMS (Cramps in the muscles of the pelvic area), CHEST DISCOMFORT (Chest feels like paralyzed) and DECREASED APPETITE (Lost of apetite/no hungry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced MUSCLE SPASMS (Cramps in the muscles of the pelvic area), DECREASED APPETITE (Lost of apetite/no hungry) and NAUSEA (Nausea). On an unknown date, the patient experienced HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), CHEST DISCOMFORT (Chest feels like paralyzed), EATING DISORDER (Get full with little food), FEELING ABNORMAL (Feels like a zombie), MALAISE (Not well), IMPAIRED WORK ABILITY (Cannot work), PAIN IN EXTREMITY (Pain in the arms), FATIGUE (Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired) and MYALGIA (Pain in the arms). At the time of the report, HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), MUSCLE SPASMS (Cramps in the muscles of the pelvic area), CHEST DISCOMFORT (Chest feels like paralyzed), DECREASED APPETITE (Lost of apetite/no hungry), EATING DISORDER (Get full with little food), FEELING ABNORMAL (Feels like a zombie), MALAISE (Not well), IMPAIRED WORK ABILITY (Cannot work), PAIN IN EXTREMITY (Pain in the arms), FATIGUE (Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired), MYALGIA (Pain in the arms) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Additional information received on 06-Jun- 2021 contains significant information added new events and updated reporter information.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UI999AA and expiry date: 06-Apr-2019) via intramuscular route in the right deltoid on 28-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. The patient did not receive any other vaccine. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown if any adverse event occurred or not following the administration of vaccination. 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.  Documents held by sender: none.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to two female patients vaccinated with improperly stored ROTATEQ (oral; lot # N005078 with expiration date 22-NOV-2018) on 22-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Patient received the COVID19 vaccine at 12:00 PM.  She waited her requisite 15 observation window, at which point she reported that she was feeling well.  At 1:00 PM, patient returned to the pharmacy to speak with the pharmacy staff.  She stated that she was driving home with her daughter in the car, talking to her daughter, and that's when her daughter noticed that the patient's tongue appeared green.  We asked the patient to show us her tongue, and the flat surface of her tongue had a bright green color to it.  She stated that she had not eaten or drunk anything since her vaccine nor did she take any other medications since the vaccine.  She did not report any issues with breathing, swelling, or other signs and symptoms of an allergic reaction.  Patient was advised to monitor herself and given the option to stay at the pharmacy for us to observe.  She chose to go home, at which point we recommended she have Benadryl on hand just in case she does develop an allergic reaction.
Slight dizziness, blurry vision: immediate - 2 days after 1st vaccination Slight fatigue - 2 days - 5 days after 1st vaccination Sore,  swollen arm - 6 -10 days after 1st vaccination Increase in environmental allergic reactions (itchy eyes, runny nose) - 5 days after 1st vaccination until current Increase in food sensitivities (eczema, dry and cracked lips) - 5 days after 1st vaccination until current Sore, swollen arm - immediate - 2 days after 2nd vaccination Low-grade fever and intense fatigue - 1 day after 2nd vaccination Slight fatigue - 2-4 days after 2nd vaccination
Pt recvd vax 28MAY92 & became irritable, had no appetite & devel a fever that persisted for 3 to 4 days; 18AUG92 MD reported that pt had recovered; No further details were provided;
Within minutes had warm flushing sensation start in back of neck and head and then go through body. Felt nauseous. High pulse. Lasted 5 minutes. Returned about 5 more times lasting a few minutes over course of next 3 hrs. Had Pfizer vaccine 4/4/21 and had same reaction but worse with severe lightheadness and chills lasting from 3 minutes after vaccine to 5 hrs afterwards. Did not get 2nd Pfizer. Told Janssen would be a good choice. Took a Benadryl tablet 1/2 hour before Johnson and Janssen vaccine.
I felt slight dizziness immediately after injection/dizziness increased; feel my heart beating quickly; achiness in my joints; soreness at the injection site; feeling strange; remain uncomfortable; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EH9899), via an unspecified route of administration in the left arm on 21Dec2020 14:45 at single dose, for immunisation. Medical history included rheumatoid arthritis, osteoarthritis, anaemia, bipolar disorder II, hypertension, and GERD. She had no Covid/ Covid test prior to vaccination. She had other medications in two weeks. The patient previously took hydrocodone and experienced drug allergy. The patient felt slight dizziness immediately after injection. When she walked to the 15 min. waiting area, the dizziness increased and she began to feel her heart beating quickly. She drank 8 oz. of water and told the attendant she was feeling strange. She took a pulse and oximetry reading - 110 and 95%. A nurse came over to check on her. The patient wanted to sit where the patient was for a few minutes longer. After about 20 mins. the dizziness immediately subsided and patient felt her pulse decreased. She got her things and left. After a few minutes, the patient began to feel achiness in her joints and felt soreness at the injection site. She had taken two Acetaminophen and remain uncomfortable. She planned to go home and rest. The events were reported as non-serious. No treatment was reported for dizziness and increased heart rate. The outcome of events Dizziness, Heart rate increased was recovered on 21Dec2020; for other events was unknown.
Patient fainted, for 1 to 2 minutes.   Patient was stable and able to walk home under the care of their mother. Was advised to follow up with pcp.
Couldn't Rotate Neck Left to Right; Chest/Armpit Pains (Only on the Left); Mildly Swollen Pits (Only on the Left); Fever: Lots of sweating when woken up.
18DEC92 AM t102R later t102.6R, limp, lethargy;
Information has been received from a physician concerning a 14 year old female who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (lot no. 659180/1758U) 0.5 ml, IM. On 29-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (lot no. 660387/1967U) 0.5 ml, IM and on 24-NOV-2008 with the third dose of GARDASIL vaccine (lot no. 655604/0052X) 0.5 ml, IM. The physician reported that the patient developed Zoster 7 to 10 days after administration of her first and second dose of GARDASIL vaccine. The physician reported that the first outbreak of Zoster was below her breast bone at the end of her sternum. It was 3 inches wide. The patient had severe pain and some itchiness. The physician did not know the location of her second outbreak because the physician did not examine the patient but rather treated her over the phone. The patient was treated with VALTREX and ADVIL both times. The second outbreak required to be treated with a second course of VALTREX. Cultured cessions from the first outbreak confirmed Varicella Zoster virus. Additional information has been requested.  Follow up information has been received from the physician concerning the female patient with no illness at the timf of vaccination and with no previous medical history and allergies reported. who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL and concomitantly at the same time with the first dose of MENACTRA (Lot number U2331AA) IM into the right deltoid and with the first dose of  ADACEL (Lot number C2889AA) IM into the left deltoid. One week after the vaccination, the patient developed a rash. On 04-JUN-2008, a VZV AG, DFA was performed, the specimen source was a vesicular lesion abdomen, it was detected varicella zoster virus and the patient's diagnosis was shingles. On 10-JUN-2008, the patient recovered.  No further information is available.
no adverse event; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot# U015479, expiration date 13-NOV-2022, experienced the temperature excursion of (6 degrees Fahrenheit (F) to 14 F) for 1 hour 3 minutes; (14 F to 46 F) (20.8 F) for 20 hours 32 minutes. On 22-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, once (formulation, concentration, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No additional adverse event was reported (no adverse event).
sick; This is a spontaneous report from a non-contactable other HCP. The other HCP reported same event for six patients. This is the sixth of six reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on an unspecified date, then second dose on 20Jan2021, both at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced very sick after the injection in Jan2021. Outcome of the event was not recovered/not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076551 Same drug and event, different patient
The vaccine was administered five days too early. The patient received the first dose on 6/09/21. The patient was asked to wait an additional 15 minutes. The patient did not have any reactions.  The patient stated that she was fine.
p/vax pt constipation x11/2 wk; blood in stool; fussy; seen at medical center p/hr care; no treat
Patient found unresponsive at approximately 12:00 am 10/11.  EMS called and patient was pronounced dead at scene.
ARM AROUND INJECTION SITE BECAME RED. STATES FELT SWOLLEN. REDNESS EXTENDED FROM SHOULDER TO ABOVE ELBOW. SEEN AT URGENT CARE. STATED ARM NEVER WAS PAINFUL. ARM TODAY IS NOT RED OR SWOLLEN. NEVER INTERFERED WITH MOVEMENT OF ARM. STATES HAS HAPPENED 2 OTHER TIMES SHE RECIEVED VACCINE.