chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003965 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: USBAV22-1628) and concerns a patient of unknown demographics (tenth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Med Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963 and US-BN-2022-003964, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
My blood pressure is normally 120/70.  For the last approx 3 weeks, I've have been averaging around 150-160/ 85-95.  Tonight, my BP is 166/99.  My brother had the same kind of reaction and has previously been reported to VAERS by his doctor.  He was placed on blood pressure medication.  He was higher -- approx 200/110. My resting pulse has varied between 82-116.  Normal for me is 88.
little pimples; Red rash; his arm kind of hurts; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (little pimples), RASH ERYTHEMATOUS (Red rash) and PAIN IN EXTREMITY (his arm kind of hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 ACNE (little pimples), RASH ERYTHEMATOUS (Red rash) and PAIN IN EXTREMITY (his arm kind of hurts). At the time of the report, ACNE (little pimples), RASH ERYTHEMATOUS (Red rash) and PAIN IN EXTREMITY (his arm kind of hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Patient got Moderna Covid 19 vaccine a week ago, caller stated a few days ago he started to get type of rashes ,there are more like a little pimples but more red and they don't go away. Patient used creams and it's kind of going away but is really not doing anything. He also had arm pain sometimes.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient said she is having itching at the injection site. I advised patient to notify her Dr. right away and to go to emergency room for evaluation.
Patient stated that she was very irritable, fatigue, snappy and very emotional. Patient felt stiffness in her right arm and the right side of her face.  She noticed that her right shoe would not go on.  She thought that she was having  stroke,
Patient was given first dose Moderna vaccine series at a vaccination clinic. Gave second dose Moderna vaccine as directed and advised by Health Director.
Described large reddened area around injection site about 30 minutes after administration followed by generalized itchiness x 4 days.
Patient was the 4th person to receive today?s vaccine of Pfizer. This was his second dose. He did fine the first dose. Patient sat down in the chair and rolled sleeve up. Chose L deltoid for injection site. He was talking with a friend and writer gave injection. Placed band aid. Patient was quiet and looked like he was going to get up but fell forward out of the chair. He hit his L forehead on side of wall. Writer caught patient and sat him up on the ground. Eye?s were dilated, he was diaphoretic, zoned out and not responding initially to voice, but eyes were open. Eventually got patient up to a wheelchair and taken to office area to lay down and monitor. Father was notified and sat with us after he arrived at the school. Patient drank 1 full 120cc orange juice and approximately 6oz of water. Throughout monitoring patient gradually felt better. Pupils corrected to normal, wasn?t diaphoretic anymore, and vitals improved. He stated this has happened before with lab draws and shots, but not this severe. Writer and colleagues informed him to notify people that are going to give him shots or lab draws about his history. Also informed him to notify his teachers if he feels anything out the ordinary for the rest of the day. Make sure he hydrates. Patient then sat up and walked in the room. He stated he felt fine like before getting the shot. Patient left stable and under his own power.
I've noticed a rash this week on my left arm at the injection site. It doesn't itch and I have no other symptoms.  It did not appear until days after my 1st shot.   I'm not experiencing any discomfort, I just want to report the side effect.
This spontaneous case reported by a consumer, describes the occurrence of foot fracture (fractured his foot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 044A21A) for COVID-19 immunization. The patient's past medical history included stroke (30 years ago). Concurrent medical conditions included speech impairment (NOS). On Mar 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 5, 2021, patient had a foot fracture (fractured his foot). The patient treated with rehabilitation therapy (2 weeks) for foot fracture. At the time of the report, foot fracture (fractured his foot) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication provided.
Pounding heart, heart palpitations chest pain pain in neck muscles (like a cramp), numbness tingling  along both sides of jaw, shortness of breath.
Patient recurred FLUZONE high dose vaccine at 10:30 AM. Went for a 3 mile walk after flu shot. About 3:00 PM she started to ache all over. In early evening her husband noted she had a light seizure (has had previously) but did not lose consciousness. All symptoms resolved by 8 PM.
Soreness on his arm; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on his arm), PYREXIA (Fever) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dyslipidemia and Heart rate abnormal.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness on his arm), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) on 05-Feb-2021 for Adverse event, at a dose of 1 dosage form. On 08-Feb-2021, VACCINATION SITE PAIN (Soreness on his arm), PYREXIA (Fever) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medicine for cholesterol and heart rate.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up report included outcome of the events
shortness of breath/ out of breath; high blood pressure; tachycardia; D-Dimer elevated at 0.68; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). An unspecified age male patient received the third dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 22Oct2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the second dose and the first dose of BNT162B2, both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. In Oct2021, the patient experienced flu like symptoms. The patient stated "Sunday, yesterday, he was feeling more like normal". On 24Oct2021, the patient experienced shortness of breath, was out of breath, and was rushed to the emergency room. At the emergency room, he was told he had high blood pressure and tachycardia and elevated D Dimer at 0.68 (Caller stated it wasn't really high, since a normal D-Dimer is 0.5.). On 24Oct2021, the people at the ER stated that it was not a pulmonary embolism. They ran tests and they were all normal. In Oct2021, the patient performed CT angiogram because they suspected a pulmonary embolism (PE),  the result was negative for PE. The doctor stated the caller did not have a PE and the doctor could not explain the caller's situation. The report was not related to a study or programme. Caller stateed he had no clotting problems or history of clotting before the vaccine. Caller states that he works as a lab assistant. The patient was wondering if this was a possible side effect. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
administered FLUZONE HD to a 44 yr old female with no adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid non-serious case via pharmacist.  This case involves a 44 years old female patient who was administered influenza quadrival A-B HIGH dose HV vaccine [fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 27-Sep-2022, the patient received suspect influenza quadrival A-B HIGH dose HV vaccine at an unknown dose (lot UT7718BA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunisation.  On 27-SEP-2022 influenza quadrival A-B HIGH dose HV vaccine was administered to a 44 year old female with no adverse event (product administered to patient of inappropriate age, latency: same day). They stated the patient had been contacted and they feel fine. They would like to know if there were any recommendations on what to do in this scenario.  Action taken: Not applicable.  Outcome: Unknown.   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 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.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 14-JAN-2015 the patient was vaccinated with a dose ROTATEQ (lot# was unspecified, 2 ml, oral) and a dose of PEDVAXHIB (lot# was unspecified, 0.5 ml, intramuscular) which both underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Rash started on 7/18/21. Seen in office on 7/19/21 and diagnosed with hand, foot, and mouth and a left ear infection.
pt recv vax; when woke up from nap & picked up, pt's eyes rolled back & began having sz which lasted over 1 hr; to hosp; IV valium given;
Sudden onset fever 103.5 seizure activity, eyes rolled back, generalized stiffness;
Follow up information received 06/23/03 from the physician provided specific dating of event, other vaccines administered that day, and event outcome (recovered).  A physician reported that a 6 month received his 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine on 05/13/2003.  He also received his 3rd doses of Infanrix (diphtheria and tetanus toxoid and acellular pertussis vaccine) vaccine, polio vaccine (poliomyelitis vaccine inactivated), and Act-Hib (haemophilus b conjugate vaccine) vaccine.  Four days post-immunization, on 05/17/03, the child developed a fever of 103.2 deg. F.  On 05/19/03, he was seen by the physician and prescribed Tylenol (acetaminophen) and Motrin (ibuprofen).  On 05/20/03, he developed a rash on the trunk of his body.  He has recovered.
Started vomiting within an hour....with no warning followed by uncontrollable diahrea over a few hours.  Contacted doc office at 4:45 PM; I was told that nurse may not call me back until next day.  Got a nurse to call back about 6 PM who thought my symptoms were 24 stomach virus or flu; no mention was made of allergic reaction to the shot....or possibly nurse wearing possible latex gloves.
No other adverse event; Improperly stored dose of VARIVAX and PROQUAD was administered to two patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 25-AUG-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # U009259 (rHA) and expiration date 19-SEP-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -13.5 degree celsius (°C) for 6 hours and 39 minutes on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported. This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2108USA008014:02000587
Immediate itching at injection site, that progressed to full body itching  through 8/25. Body aches started the next morning (8/23) and lasted until 8/25 when she went to bed. Woke up feeling better on 8/26
Patient that is under 18 years of age was given Moderna vaccine for first COVID vaccination on 10/22/21. Pt presented in clinic on 11/19/21 for 2nd dose and this is when error was discovered. Pt received one dose of Pfizer on 11/19/21
Erythema and induration 8 days after vaccine administration, suspicious for cellulitis.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 9:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 45.80    Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 09 AM, temp was 35, total doses given for the day was 42, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vial was moved to clinic. Vaccine BUD date was 19-May-2021.  Vial was stored on cooler 1, on 27-Apr-2021, Excursion duration At 8 AM: 41, 9 AM: 35, 10 AM: 36, 11 AM: 38, 12 AM: 43, 1PM : 43, 2 PM : 44, 3 PM: 43, 4 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Mild lacey rash on lower neck, chest, and upper abdomen. No other S/Sx. Positive constitution. No redness, pain, or rash around injection site or arm. Patient working in yard in high heat temperature - possible heat rash.
t99.2 R @ time of vax;mom stated pt has head cold, 20FEB97 815AM notified by mom pt hosp 105AM in ER;inc temp, bilat OM/URI temp 102.6 R;no immun contra indications
This spontaneous report was received from a physician regarding an approximately 2 years old female patient. No medical history, drug allergies or reactions were reported. In approximately November 2009 (3 years ago), the patient was vaccinated with a dose of M-M-R II (lot # and route not reported). No concomitant medications were reported. In approximately November 2009 (3 years ago), the patient developed idiopathic thrombocytopenic purpura (ITP) (medically significant). The patient's mumps titer was negative when a titer was taken last month approximately in October 2012. No treatment was given for the adverse events. The patient's present status was reported as recovered. The patient had sought medical attention (unspecified). Upon internal review the event idiopathic thrombocytopenic purpura (ITP) was considered to be medically significant. Additional information has been requested.
I developed shingles on my right upper thigh. It was a painful rash with blisters. I also had chills but no fever and fatigue. I was prescribed anti-viral medication. The rash is still present but healing.
Right sided body px from waist down; My flexability is bad; Fever; Tooth ache; Ear ache; Right sided body aches and px; Myalgia; Legs are especially painful; Achy joints from the hips down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right sided body px from waist down), PAIN IN EXTREMITY (Legs are especially painful), PAIN (Right sided body aches and px), MYALGIA (Myalgia) and TOOTHACHE (Tooth ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myocardial infarction (Chronic or longstanding health condition: MI) since 11-Jan-2013. Concomitant products included EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) from 11-Jan-2013 to an unknown date and ATORVASTATIN from 11-Jan-2013 to an unknown date for Cholesterol, ASA from 11-Jan-2013 to an unknown date, CLOPIDOGREL from 11-Jan-2013 to an unknown date and OLMESARTAN MEDOXOMIL (OLMERTAN) from 11-Jan-2013 to an unknown date for Myocardial infarction, TAMSULOSIN HCL.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Legs are especially painful), MYALGIA (Myalgia) and ARTHRALGIA (Achy joints from the hips down). On 19-Feb-2021 at 9:00 PM, the patient experienced PAIN (Right sided body aches and px), TOOTHACHE (Tooth ache), EAR PAIN (Ear ache) and PYREXIA (Fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Right sided body px from waist down) and MOBILITY DECREASED (My flexability is bad). At the time of the report, PAIN IN EXTREMITY (Right sided body px from waist down) had resolved with sequelae, PAIN IN EXTREMITY (Legs are especially painful), MOBILITY DECREASED (My flexability is bad) and ARTHRALGIA (Achy joints from the hips down) outcome was unknown and PAIN (Right sided body aches and px), MYALGIA (Myalgia), TOOTHACHE (Tooth ache), EAR PAIN (Ear ache) and PYREXIA (Fever) had not resolved.            No concomitant medications were provided No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up was received on 28-May-2021  Non significant case included no new information. On 10-Jun-2021: Follow up-2 was received on 10-Jun-2021. Patient gender, height, weight, ethinicity, race and current condition were updated. Moderna vaccine dose 1 information and concomitant medication details were provided. Details of new events were updated.
My back is worse than it used to be. My back started to feel worse after 3-4 days of receiving the first vaccine. I am continuing to take the same medicine that I was taking before receiving the vaccine, but I am still in pain. I am also experiencing headaches now.
This case was reported by a nurse and described the occurrence of an injection, site reaction in a 6 month old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On an unspecified date in July 2004, the patient received the second dose of Infanrix in the leg (lot DTPA590B9).  The day after the vaccine was received on an unspecified date in July 2004, the patient experienced an injection site reaction characterized as redness and inflammation.  The patient was seen at a physician's office.  The outcome of the events is unknown.  The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.