chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered reconstituted pentacel along with another non-sanofi hib vaccine to a patient concurrently with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-year-old female patient for whom reconstituted Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered along with another non-sanofi hib vaccine HIB vaccine CONJ (OMPC) [Pedvaxhib] concurrently with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Aug-2023, the patient received a dose of 0.5 ml (Frequency: twice)  dose 1 of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine of standard strength suspension for injection (lot: UJ8768A, Expiry date: 19-Mar-2024) via intramuscular route in left administration site for Immunization along with another non-sanofi hib vaccine PEDVAXHIB not produced by Sanofi Pasteur with unknown strength, batch number & expiry date to a patient concurrently with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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.
About 5 minutes after being given his shot he complained of feeling hot and mildly nauseated. He was also dizzy. He looked a little pale. He was immediately attended to by myself and an RN. A fan was directed towards him and he was given cold water and wet cloths to his face and neck. He recovered from the incident within 10 minutes, stated he felt much better, and walked out of the clinic with his mother in no distress about 10 minutes after the event occurred.
16 year old patient was administered flublok for immunization with no reported adverse event; Initial information received on 03-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2022SA457603(CLUSTER).  This case involves a 16 years old male patient who was administered influenza quadrivalent recombinant vaccine [flublok] for immunization with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2022, the patient received an unknown dose once total of suspect influenza quadrivalent recombinant vaccine (lot: QFAA2231; expiry date: 30-Jun-2023; strength: standard) via intramuscular route in the left deltoid for prophylactic vaccination.  On 26-Oct-2022, a 16 year old patient was administered flublok for immunization with no reported adverse event (product administered to patient of inappropriate age).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
Red warm region mid upper right thigh vaccine given 12/19/2011. Mother noticed red lesion right mid thigh. To ER pm 12/20/2011. JCE and hydrocortisone cream applied, amoxicillin p.o. given. To clinic 12/21/2011.
At 3am on June 26, 2008 my parents were awoken to a bat flying around their bedroom. They went to their local Emergency Room on June 27, 2008 to begin rabies prophylaxis. DAY 1: At 3pm my mother received her 5 shots (4 immunoglobins and 1 rabies vaccine). At 3:05pm she developed a continual cough which lasted for 30 minutes. At 3:10pm she began experiencing muscle shaking throughout her body, excluding her head and neck. She reports that you could not see her body shaking, but that she had the sensation. She also reports that her body was extremely cold and she could not get herself warm.  The shaking and coldness lasted for about 3 hours at which point her toes and knees were no longer having the shaking sensation but the rest of her body did. About 30 minutes after her injections, she experienced severe headaches, nausea, extreme confusion/disorientation and malaise. She continued to experience coughing intervals for about 24 hours post-injection. She reported to me that she felt like she was "going to die." DAY 2: She continued to experience headache nausea, fatigue, malaise, confusion/disorientation throughout the morning. Around 1pm she felt improved malaise, nausea, fatigue. Around 6pm the above symptoms returned and she again developed a cough and experienced the sensation of tremoring in her fingers and toes. The symptoms subsided somewhat overnight. DAY 3: At 5am she was awoken by an extreme headache and nausea. The whole day she experienced waxing and waning of headache, nausea, fatigue, malaise, confusion/disorientation symptoms. DAY 4: She experienced severe headaches followed by nausea approximately every 2 hours and the confusion/disorientation was intermitent. She called the ER and left a message for MD with his nurse, but her call was never returned. For the next 4 days, the headache, nausea, confusion/disoriention symptoms continued intermitently. She did not feel "normal" until July 5, 2008. As a side note: My father talked to the nurse and asked for the information sheet that should have come with the rabies vaccine, so he had the manufacturer information. However, the nurse reported that the pharmacy could not locate it. Thus, I cannot report that information in this form. My mother did not proceed with any additional rabies vaccines.
A consumer report has been received. The report concerns a 16 year old, Male consumer, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 05-Jan-2015. The patient experienced TESTED POSITIVE FOR FLU A which started on 11-Mar-2015. The outcome of the event of TESTED POSITIVE FOR FLU A is unknown. The report was considered to be non-serious.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-SEP-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (strength: 0.5ml, lot # L006233, expire date 03-APR-2016; dose and route unknown). This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time of the first time was 272 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the second time was 152 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 64 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the fourth time was 88 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the fifth time was 8 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information  has been requested.
Fever Sweating Pain in muscles Pain in joints  Skin feels hot and sensitive  Dry mouth Headache Extreme Fatigue  Tremors Inability to concentrate  Shortness of breath  Sore throat Impaired ability to work
Mild joint aches/stiffness prior to physical activity. No prior stiffness existed. Recurrent since 5/99. The annual follow up states occasional joint stiffness.
I began to note a raised itchy bump on my forearm, very small and blister-like on the same day as my shot about 6 hours after the shot.  It reminded me of poison ivy.  Another bump appeared near the first.  In the subsequent days, including today,  new bumps have appeared on various parts of the Left side of my body (a cluster of bumps behind my left knee.  Two bumps on the left side of my neck.  Two bumps on my left underarm.  Total of 6 bumps now on my left forearm (below inside of the elbow).  Two bumps below my jaw.
child received PENTACEL as well as ACT-HIB on the same day, with no reproted adverse event; Initial information received on 08-Dec-2021 regarding an unsolicited valid non-serious case from nurse via Agency (under reference 00890410).  This case involves a 4 months old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and HIB (PRP/T) VACCINE [ACT-HIB] on the same day (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination as concomitant vaccines.  On 08-Dec-2021, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (Oral solution, Lot: UJ425AA and expiration date: 21-May-2022) via intramuscular route in the left thigh and dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiration date: not reported) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (same day latency).  It was reported "Nurse calling to report that a 4 month old child received PENTACEL as well as ACT-HIB on the same day. Caller is asking what to do."  At time of reporting, no adverse event 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 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.  There will be no information available on the batch number for the suspect PENTACEL.
Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could only lay down..Extreme headache and huge reaction from injection site..Blood sugars would not come down..Remained stubbornly high..Sleep...Wake up..have extreme leg cramps and body aches..Made way to bathroom brvause of nausea..Nearly threw up..Ended up just lying on the floor and going to sleep again...Got up ..Went into bedroom. Sip of diet soda..Back to sleep...Finally got up at 3pm...Signs of being able to come through..Was very close to going to Urgent Care but physically would have been too challenging to go...Had food at 10pm ...Slept through 5am...Soreness in arm has become much less..Signs of survival...Seriously have second thoughts about ever having another vaccine in future unless they improve the process...
Patient Received Moderna vaccine 2/11/2021, 3/11/2021, and 4.14.2021- 3 doses instead of 2
Feeling sick; Shoulder pain; Neck pain; Hives on back and legs; Woke up in the middle of the night itching really bad; Arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on back and legs), PRURITUS (Woke up in the middle of the night itching really bad), PAIN IN EXTREMITY (Arm started hurting), NECK PAIN (Neck pain) and MALAISE (Feeling sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025H21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced URTICARIA (Hives on back and legs), PRURITUS (Woke up in the middle of the night itching really bad) and PAIN IN EXTREMITY (Arm started hurting). On 03-Mar-2021, the patient experienced NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced MALAISE (Feeling sick). On 02-Mar-2021, URTICARIA (Hives on back and legs) and PRURITUS (Woke up in the middle of the night itching really bad) had resolved. On 03-Mar-2021, NECK PAIN (Neck pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm started hurting) had resolved and MALAISE (Feeling sick) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment provided include diphenhydramine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: The patient said that she is feeling sick and was going to see the doctor. The patient stated that thedoctor is prescribing antibiotics and wants to know if she can take them.
Patient stated they were having heart palpitations, was feeling dizzy, and light headed. Patient requested an ambulance which we called and they came out to pick her up and take her to the ER.
Constant screaming...Took to ER. Has intussusception. Given morphine and flown by air to another facility. Self-corrected.
aching; pain; This is a spontaneous report from a non-contactable consumer (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 73-years-old) for Covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on unknown date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient experienced aching, and pain the previous night on 02Mar2021, and that day, she was having some sharp pains. She wanted to know if she can take some Tylenol. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Although I drank more than a liter of water before and after the injection, by late afternoon, I began to experience extreme fatigue and mild nausea along with a start of a headache. Despite the exhaustion, I was unable to sleep throughout the night and was so I exhausted I could barely be out of bed until Sunday mid-morning (more than 48 hours after receiving the injection). The headache grew severe and not relieved by regular dosing of Tylenol.  I had little appetite and did not eat much but continued to try to stay hydrated. By evening, I was vomiting and still had the extreme headache. By Sunday, I was still very tired but able to resume some activity and ate a small amount more. I also experienced pain at the injection site.
second dose administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion). On 20-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that storing vaccine experienced a temperature excursion for a duration of 1 hour and 24 minutes on 18Sep2021.
Red welts on face and body.  R eye swollen c/o throat tickle 1-2 hrs after vaccine admin.  Taken to ER.  Resolved on own.  Physician prescribed BENADRYL 3xday x5 days plus flu with PCP.
bad reactions after third dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reactions after third dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reactions after third dose). At the time of the report, VACCINATION COMPLICATION (bad reactions after third dose) outcome was unknown.            No relevant concomitant medication was reported. Treatment information were not provided.  Reporter stated that co-workers have had bad reactions after receiving Moderna's COVID-19 third dose.
Dizziness, Headache, Myalgia, Fever, Diarrhea, NauseaVomiting,  malaise, dizzy, arm red / swollen, face red / swollen (6.5 days)  Narrative: States "went to Urgent Care. Was given toradol for pain then directed to take OTC medication for symptomatic adverse effects.
Sweating; Shaking; Sensation of heat; Sleeplessness; Adverse drug reaction; Irritable; Shivering; Exhaustion; Queasy; Headache; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness) and ADVERSE DRUG REACTION (Adverse drug reaction) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriasis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness), ADVERSE DRUG REACTION (Adverse drug reaction), IRRITABILITY (Irritable), CHILLS (Shivering), FATIGUE (Exhaustion), NAUSEA (Queasy) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (Sweating), TREMOR (Shaking), FEELING HOT (Sensation of heat), INSOMNIA (Sleeplessness), ADVERSE DRUG REACTION (Adverse drug reaction), IRRITABILITY (Irritable), CHILLS (Shivering), FATIGUE (Exhaustion), NAUSEA (Queasy) and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reference number: 21K-163-3927397-00 No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Events Adverse drug reaction, Queasy, Chills, Sensation of heat, Sleeplessness, Irritable and Headache all  having outcome Not recovered/not resolved were added. Suspect drug METHOTREXATE was added.
04/02/2021 - 04/21/2021 fever (100.5-105.9), chills, fatigue, night sweats ibuprofen
eyesight got fuzzy in the distance; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (eyesight got fuzzy in the distance) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, METOPROLOL and CHLORTHALIDONE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (eyesight got fuzzy in the distance). At the time of the report, VISION BLURRED (eyesight got fuzzy in the distance) outcome was unknown. Not Provided          Patient was hormone replacement.   This case was linked to MOD-2021-081563 (Patient Link).
The pt experienced onset 2 hours post yellow fever vax. The symptoms experienced were redness, swelling. Was seen the next day. Injection site was warm and swollen. Pt complained of numbness. Sensation was in entire right arm but  had good strength.
Pfizer Was the manufacturer  24 hours after receiving the vaccine, I started having headaches followed by illness that remined me somewhat of getting the flu.  Also, very tired and lack of appetite.
This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning an 83-year-old female with penicillin and aspirin allergy who on 08-JUN-2007 was subcutaneously vaccinated into left arm with the first  dose of Zostavax (Oka/Merck) (Lot number 656395/0290U). There was no illness at the time of the vaccination. Concomitant medication included BONIVA, NEXIUM and ATIVAN. On 13-JUN-2007 the patient experienced diffuse pain and weakness throughout her body. The patient was seen by her physician. The Complete Blood Cell count (CBC), Comprehensive Metabolic Profile (CMP) and thyroid function test were performed and the results were normal. The patient felt that her body aches were much worse since the vaccination. She first thought that it was due to the therapy with BONIVA. The patient stopped the therapy with BONIVA. The pain was the same. At the time of the report, the patient's events persisted. Follow-up information was received on 13-AUG-2008 the patient was still hurting all over. She had burning pain and drawing, cramping of hand, leg and toes. The patient felt the skin blotched all over the body. She was weak and nervous too. The patient thought that the shot had messed up her immune system. No further information is available.
Vaccine had  a low temp excursion.  Declined revaccination as recommended by SP.