chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe chills began at 2:30 am , 1/11, body aches, headache and fever of 100.7. Took ibuprofen  then two hours later took acetaminophen and 6 hours later took more ibuprofen . Fever finally was down to 98.8 by 3:00 pm on 1/12.  I did have to miss a day of work due to the fever and not feeling well on 1/12.
ANXIETY, PT FELT OVERWHELMED WITH EVERYTHING, REFUSED TRANSPORT 140/82, 80
Erythema on left thigh 3 cm x 4 cm with induration at site of IM injection, minimal tenderness, no bluish discoloration.  Cold compresses to left thigh, CBC drawn.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. Medical history and drug allergies/reactions were denied. On 25-SEP-2103, the patient was vaccinated with PENUMOVAX23, lot J007059 exp 31-JUL-2014, 0.5 ml, intramuscular in the right deltoid. Concomitant medication was denied. In September 2013, within 24 to 72 hours after administration, the patient experienced fever with redness and swelling at vaccine administration site. Treatment was recommended over the phone from provider was ice and Tylenol. No lab diagnostics were performed. The medical assistant requested a lot check. At the time of the report, the outcome of fever with redness and swelling at vaccine administration site was reported as recovered. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. Later in 2008, the patient was treated by a medical group for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Initial report was received on 22 December 2011 from a consumer who is also the patient's parent. A seven month-old male patient who had a possible ear infection at the time of vaccination had received at 2PM on 21 December 2011 a second dose intramuscular left thigh injection of FLUZONE, lot number UT4119BA and later the same date at 9:30PM, developed a fever, shaking, vomiting and decreased alertness. The parents called 911 and the patient was taken to the ER (emergency room). According to the parent, "tests done" and the patient was prescribed antibiotics and was sent home. The patient was reported to have been tugging on his ears two weeks prior to vaccination. The patient had received a flu vaccine "one month ago" and developed a fever. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of fever in an unknown number of subjects of unspecified age and gender who were vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date (s) the subject(s) received a dose of PEDIARIX (unknown details). At an unspecified time after vaccination with PEDIARIX, the subject (s) experienced fever. The nurse reported that her office had "received a lot of calls asking about fever after having the PEDIARIX vaccine." The nurse indicated that the office staff was "a little bit concerned about this." At the time of reporting the outcome of the event was unspecified. The nurse reported 2 other cases with PEDIARIX. See cases A1044386A and A1044387A for details on the other cases. Follow up was received from the nurse on 21 October 2013. The nurse reported that this case had been reported to a Regulatory authority; however, the reference number was not provided. The nurse described the occurrence of fever in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 1 October 2013 the subject received a dose of PEDIARIX (0.5ml, unknown details). Concurrent vaccination included haemophilus influenzae type b (non-gsk) ;non-GSK manufacturer;intramuscular;unknown given on 1 October 2013; pneumococcal vaccines (non-gsk) ;non-GSK manufacturer;intramuscular;unknown given on 1 October 2013; rotavirus vaccine (non-gsk) ;non-GSK manufacturer;oral given on 1 October 2013; seasonal; influenza vaccine (non-gsk) ;non-GSK manufacturer;intramuscular;unknown given on 1 October 2013. On 1 October 2013 the subject received 3rd dose of PEDIARIX (.5 ml, unknown details). On 2 October 2013, 1 day after vaccination with PEDIARIX, the subject experienced fever and irritability. The diagnosis was fever. On 5 October 2013, the events were resolved. The nurse identified the suspect product as PEDIARIX. The nurse did not consider the case of as serious.
after the 2nd shot, I felt the odd feeling behind my neck again; I was tried for the 2days after; for 2nd shot due to patient experienced breast seemed tender for a few weakened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Feb2021 (Lot number: E19269) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Location :left arm), administration date: 26Jan2021, for COVID-19 Immunisation, reaction(s): "When I got the shot, I felt something should shoot into the arm and if felt a little starting or shocking to body", "My left arm was the shot arm feeling numb in my left pinky and a little in the ring fingers plus a strange feeling (achy) in left arm/light numbness on outside of my left leg from the knee down to ankle", "feeling numb in my right pinky and a little in the ring finger plus a strange feeling (achy) in right arm soreness up the outside of my left forearm", "The pinkies feel swollen when I bend them", "Soreness at the injection site", "Back of neck at the spine began feeling odd and maybe the middle of my spine". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "after the 2nd shot, I felt the odd feeling behind my neck again"; FATIGUE (non-serious), outcome "unknown", described as "I was tried for the 2days after"; BREAST TENDERNESS (non-serious), outcome "unknown", described as "for 2nd shot due to patient experienced breast seemed tender for a few weakened".  Additional information: after the 2nd shot, I felt the odd feeling behind my neck again. I did not get numb in finger on my left leg. I was tried for the 2days after, I have felt my breast seemed tender for a few weekend. Today they do not.  No follow-up attempts are possible. No further information is expected.
At bath time, I took off bandaide, noticed approximately 2 inches circle of raised area, warm to touch. Area is dry.
Pt recvd 3 doses of Engerix-B 27FEB91, 5APR91, & 26SEP91 & 30OCT91 Antibodies were checked & pt had a borderline titer;
Headache, Fever, CoughWheeze, Diarrhea, NauseaVomiting & Palpitations Narrative:
No adverse event noted.  Patient too young to receive Janssen and RN administered in error.
After I got the shot, about four days after, I had a fever. I then started having trouble controlling my asthma. MY oxygen levels were dropping very low and I was having difficulty breathing. I felt like I had the flu, combined with a burning in my lungs. I went to the ER.  The x-ray showed that I had minor pulmonary vascular congestion.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 07-NOV-2012 13:51, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
2.5 cms x 2 cms oval cellulitis @ Dtap site. 1 cm x 1 cm round cellulitis @ IPU site. Placed on warm compress & antibiotic AUGMENTIN.
40% percent hearing loss in left ear only coupled with constant ringing.  There were no prior issues and the Ear, Nose and Throat Doctor claims to be having several people come in that had no previous hearing issues now exhibiting the same symptoms.
Redness at injection site; Swelling at injection site; Chills; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and FATIGUE (Fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On an unknown date, the patient experienced FATIGUE (Fatigue). On 05-Apr-2021, PYREXIA (Fever) had resolved. On 06-Apr-2021, VACCINATION SITE SWELLING (Swelling at injection site) had resolved. At the time of the report, CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and FATIGUE (Fatigue) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Outcome of events and new event Fatigue were added.
Information regarding FluMist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding her 9-year-old male child who received a dose on November 26, 2003. Medical History: Relevant medical history was not provided. Product Details: Indication for FluMist (2003-2004 Formula) was immunization. Product was administered on November 26, 2003. Dose regimen was 0.5 mL 1 time per day (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: The consumer reported that her son received a dose of FluMist on November 26, 2003 and developed "the flu" on November 30, 2003. Symptoms included: cough, fever over 100 degrees F., and body aches. He was treated with ibuprofen. Symptoms persisted on the day the report was received. No additional information was available at the time of this report.
Body ache, chills, throat feels like closing up headache, back pains to legs and shoulders feels sluggish. (Partner sick with flu)
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. An 8-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown manufacturer), for Covid-19 immunization. Patient experienced chest pain and fainting the day after her Second dose of Covid vaccine. She hit her head. She was taken by ambulance to the ER (Emergency room). Dr. at ER believes the vaccine caused drop in blood pressure due to immune response. Patient was released from the ER as she was stable and her EKG was normal. Her pediatrician will see her for a follow up in two days. Event took place after use of product. The event "hit her head" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: drop; Electrocardiogram: Normal. The outcome of all the events was Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received Td at 7 years old and Tdap at 9 years; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported.  It was of actual medication error due to Inappropriate age at vaccine administration..  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 and Module VI of the 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.
This spontaneous report has been received from a licensed practical nurse concerning to a 66 years old male patient with rash and shingles. Patient's medical history was not reported. The reported stated that the patient told the physician that he might have already had shingles at the time of vaccination but he did not seek medical treatment at that time. The reporter also stated that, the patient had a rash which developed "a few days" prior to receiving ZOSTAVAX (unspecified onset date of the rash) and the rash was still present when he was vaccinated. The patient thought the rash might possibly have been the early stages of shingles. On 22-DEC-2015 reported as 8 days before 29-DEC-2015, the patient was vaccinated with unknown dose of ZOSTAVAX (lot number and expiration date were not provided). On unknown date in December 2015 the patient's rash developed into blisters on his body (unspecified part of his body). So on 29-DEC-2015, the patient went to the physician once where he was diagnosed with shingles and treated with acyclovir (manufacturer unknown). At the time of the report, the patient was recovering of the herpes zoster. The causality between the herpes zoster and the vaccination with ZOSTAVAX was unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sore throat, fever, muscle aches, and headache progressing throughout the day. Around noon, swelling, severe pain and redness appeared around the injection site.
Approx 8-9pm: mild fever 99degrees F, severe chills, aches throughout whole body, dull persistent headache, severe left arm pain at injection site (unable to move arm above should height without pain and assist).  Treatment: tylenol 1000mg approx 1pm and again 9pm.
Pt is a 75 yo M followed by medical clinic for HTN. Pt presented 08/17 for follow up and received Shingles Vaccination. About an hour after receiving the vaccine, pt returned to the clinic stating he had intense left shoulder pain, including having trouble lifting his arm above his head and having a weaker grip. Due to level of discomfort, pt was given decadron 4 mg IM x 1 dose.  Myalgia & Arthralgia DEXAMETHASONE 4 MG ONCE
I felt dizzy the second day of Moderna booster shot and fell down twice and hit my shoulder on the floor at 4 am
According to the patient, she was in observation and started to feel "funny". Her throat started to feel closed and her arms felt tingly. She was assessed by the physician observer and put on a stretcher with her legs elevated. Vitals report BP 140/80, HR 112, and 02 sat of 99%. Patient was provided with water and cool cloth for her head. At 3:50pm, HR 83, O2 sat 99% still lying on the stretcher with legs elevated. At 4pm patient was assisted to sit up, but felt dizzy and was repositioned lying down. At 4:10pm vitals BP 142/82, HR 84, patient at this time refused to go to the emergency department. At 4:20pm patient was reported to feel "a little shaky but better" and sat in an upright position drinking water and eating a snack. Patient was monitored while standing and released after an extended observation and patient reporting that she was "feeling better".
Patient received vaccines 10/21. On 10/22 developed hives on right arm. Hives spread the next day to left leg, itchy. No other symptoms. Rash resolved now.
5/5/21 at work had very bad chest pain and shortness of breathe. Went to the ER where they did a ECG. ECG came back abnormal.
Pt recv vax on 9/29/97; on 9/30/97 pt exp cold sx
Initial and follow up information has been received through the Merck Pregnancy Registry from a licensed practical nurse concerning a 15 year old female with asthma, depression, no previous pregnancy, and who is a smoker, who on 29-MAY-2007 had a negative beta-human chorionic gonadotropin test (unspecified) and then was vaccinated IM with a 0.5 ml dose of Gardasil (lot # 654535/0960F).  Concomitant therapy included albuterol inhaler, and prenatal vitamins (unspecified).  Subsequently, the patient became pregnant.  Her last menstrual period was 12-JUN-2007 and the expected delivery date was 20-MAR-2008.  Unspecified medical attention was sought.  On 13-NOV-2007 the complete blood cell count was reported as normal.  On 16-AUG-2007 an ultrasound was performed in order to obtain the estimated delivery date.  On an unspecified date the patient developed a urinary tract infection.  On 11-SEP-2007 the patient was given MACROBID 100mg, two times a day for 7 days to treat the urinary tract infection.  The patient was also treated with multiple unspecified antibiotics for the urinary tract infections. At the time of the report, the patient's outcome was unknown.  Additional information has been requested. Follow-up information indicated that on 10-MAR-2008 at 38 1/2 weeks from her last menstrual period the patient delivered a male infant. The infant weighed 7 pounds 1.1 ounces, was 15 inches long, and had an apgar score of 9/10. The infant was normal with no congenital anomalies, complications, or abnormalities. Additional information is not expected.
fatigue not resolved, muscle and joint pain severe all over body that has lessened but not resolved, intermittent nausea headache, feel feverish but no fever, weakness
Two days of soreness after the injection Red bumpy rash around the injection site. Very itchy for 3 days. A feeling of dehydration during the days of the rash, which continues Fatigue
extremely sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "extremely sick".  Additional information:HCP originally wanted to speak with # from Pfizer MI as they got disconnected. However, since #was unavailable, I offered to help her instead. This interaction was a follow up to the original INT- #. 54-year-old female nurse said she had been prediabetic for several years now. She said her numbers were at a 6 for several years. Then after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, her A1C levels became elevated. HCP wants to know if this was normal. She also mentioned that she and her daughter had the 2nd dose of the vaccine yesterday. Afterwards, her daughter became extremely sick. She, on the other hand, got sick yesterday for the 1st 24 hours. She said her sinus started acting up. She said she was very sick and stayed in bed all day. She had to take Allegra before and after taking the vaccine. However, she said her main concern was her elevated A1C levels. She said she researched Pfizer and found out that because of the symptoms of illness, it can lead to high glucose levels. According to her, it also stated there that one has to be careful with monitoring the glucose levels 48 hours after receiving the vaccine. She said it also says, "dehydrate" and that people with diabetes seem to experience these side effects with high blood sugar levels. Offered a warm transfer to DSU, but HCP said she already spoke with them. Etransmitting; Possible AE duplicate. Response: I told the HCP that upon review of the prescribing information for the Pfizer-BioNTech Covid-19 Vaccine, I found no information about having elevated A1C levels after receiving the vaccine. For that, I referred her to her own HCP for further guidance. However, HCP probed so I offered to escalate her question to secondline. She said she prefers a callback. Escalating to secondline for further research and handling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.