chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US005998 is an initial spontaneous report from the physician received on 25 Mar 2014, with a follow up received from physician on 08 Apr 2014. This report refers to a 17-year-old female patient. Past medical history was not reported. Concomitant medications were none. She had no vaccination history. She was vaccinated with MENVEO (batch number: A13059) on 24 Mar 2014. On 25 Mar 2014, she experienced headaches and nausea for a couple of days. it was reported that she did not have vomiting or diarrhea symptoms. The final outcome of the events headache and nausea was completely recovery. Seriousness and causality of the events were not reported. Follow up received from physician on 08 Apr 2014: Updated outcome of the events.
chest/throat tightness, flushing Narrative: From provider note dated 2/3/21: "she reports she recevied Pfizer COVID 19 #1 -12/18/2020- experienced reaction- had hives on face and neck, tightness of chest and throat felt closed- but "drank water and stopped" , and also "really hot feeling" she was treated with prednisone, IV and benadryl and she was advsied not to receive the second dosage-she went against recommendations and on 1/8/2021 recevied 2nd dosage of the Pfizer Covid 19 vaccine - she premedicated benadryl 50 mg- and "all i got was 5 seconds of really intense heat, chest rightness and couldn't stop salivating" she had NO intervention with the second dosage." The vaccine was administered and treatment in response to ADR were all at outside facilities and no records are available to review. Reporting is based on patient recall.
Smooth, red, swollen skin blotches under injection site.  Blotches are warm to touch and 1-2 are slightly tender to touch. Three small blotches first appeared on the evening of Saturday, March 13th. I took loratadine that evening for runny nose and other seasonal allergy symptoms. By 11:00 am on Sunday, March 14th, more blotches appeared in the same vicinity as the first three and began to ?run into? the original blotches, forming slightly larger blotches (in terms of surface area). Left arm is warm at the injection site and at the site of the blotches. No pain or discomfort. Will take liquid Benadryl this evening if blotches begin to itch or worsen in terms of size,  number, or appearance.
On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to feel a lump in my throat and developed large itchy hives all over my body. My lips began to swell up.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 17-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Client received MMRV instead of just MMR.  Client also received Varicella.  Client is older then 12 years old and client received Varicella vaccine the same day.  Dr. for Dept. of Health made aware and recommendation received to give client MMR vaccine & Varicella vaccine # 2 at his return appointment on 8/28/23.  No report of any adverse side effects from client.
Pt vaccinated with Influenza Virus developed rash over trunk started 1NOV90, itches, temp 99.4. Rx Deltasone dose pack.
trouble with my throat; Stabbing pain under my arms, under my ribs, in my pelvic area. It's like they are so quick it comes like spasm it's like a jabby pain/such a sharp pain it kind of takes your breath away; Stabbing pain under my arms, under my ribs, in my pelvic area. It's like they are so quick it comes like spasm it's like a jabby pain/such a sharp pain it kind of takes your breath away; Stabbing pain under my arms, under my ribs, in my pelvic area. It's like they are so quick it comes like spasm it's like a jabby pain/such a sharp pain it kind of takes your breath away; Stabbing pain under my arms, under my ribs, in my pelvic area. It's like they are so quick it comes like spasm it's like a jabby pain/such a sharp pain it kind of takes your breath away; This is a spontaneous report from a contactable consumer, the patient. A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration in the arm left on 20Feb2021 as dose 2, single (at the dose of 80-years-old) for covid-19 immunization. The patient had medical history and concomitant medications but she was not willing to report it. It was reported that after the second vaccine yesterday (20Feb2021), on 21Feb2021, she woke this morning at 03:30 and she had pain and it was such an unusual. The patient did not ever have anything like this, it was stabbing pain under arms, under ribs, in pelvic area. It was like they were so quick it comes like spam it was like a jabby pain and it lasted for few sends but it just rotates. The patient had sharp pain it kind of took breath away, it was kind of stabbing like it pokes you with pen or something then it goes and move around, and it was back again. The patient also had trouble with throat and they gave Benadryl, right after the shot. The outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Mild rash and pain on arm where injection administered, instruct pt to take Benadryl and Motrin.
Started with SOB hard time breathing a lot of pressure called her primary PCP and he stated this is a rare but side effect to the influenza vaccine this year. He suggested to take TYLENOL or Ibuprofen or ALEVE to help with the side effects. It should last for a few days. If gets worse or doesn't get better to go to ER or PCP.
Evening of vaccines fever 101, vomiting, bulging fontanelle -> Pseudotumor cerebri ->begun on Diamox, Zantac for GI upset. Continues to require these7/18/08 records received for DOS 1/31/08-Presented to ED with C/O bulging fontanelle. Multiple ED visits and hospitalization for pseudotumor cerebri. 7/18/08 records received for DOS 1/31/08-Presented to ED with C/O bulging fontanelle. 7/28/08-records received for DOS 1/8-1/12/08-DC DX:Fever, vomiting, dehydration, bulging fontanelle, possible pseudotumor cerebri. Presented with fever of 101, vomiting and bulging fontanelle. Lumbar puncture normal, opening pressure not obtained.  Developed diarrhea while in patient. Ophthalmology consult no papilledema.
mild, moderate to intense burning sensation/strong burning/ burning sensation thorough out her whole body/; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (mild, moderate to intense burning sensation/strong burning/ burning sensation thorough out her whole body/) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced BURNING SENSATION (mild, moderate to intense burning sensation/strong burning/ burning sensation thorough out her whole body/). The patient was treated with IBUPROFEN in August 2021 for Burning sensation, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (mild, moderate to intense burning sensation/strong burning/ burning sensation thorough out her whole body/) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient informed that in the evening after the vaccination of her first dose, she experienced burning sensation thorough out her whole body which lasted a little bit. Next morning, it returned in her entire body including legs, face, arms and it was very intense which went on for the whole day. Patient went to a clinic and they told her to take Ibuprofen which helped her and the burning subsided.  On the following Monday, the burning sensation was present but was not that intense. During the following week, she kept experiencing mild to intense burning sensation which lasted sometimes 1 hour or so. Caller took Ibuprofen and the burning subsided. Last week, the caller started experiencing mild, moderate to intense burning sensation again in her whole body and she still experiencing the same as of today.  The strong burning sensation kept coming back.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot number not provided). On an unknown date the patient experienced received an expired ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
After 10 pm that night 5/20/2021 I was very sleepy and later that night I had chills and fever. On 5/21/2021 the fever, chills, brain fog, body weakness, lethargy, sleeping all day, chest pain, neck pain, and migraine level headache continued into 5/22/2021 in the morning. I took an extra-strength Tylenol at 10 am and 5 pm on 5/22/2021 to help break the fever. I continued to feel weak, headache, and mild brain fog on 5/22/2021.
pt recv vax & exp severe swelling & soreness of the lt arm p/inj & poss cellulitis;some patients may have recv a prev inj in less than 1yr;
Patient started having back pain.  Ended up having a T8 plasmacytoma requiring back surgery; pain was worse,  lytic lesion to left femur required IM nailing surgery; dx in June with multiple myeloma req chemo and radiation
This spontaneous report as received from a pharmacist refer to a 65 year old male patient with a history of tetracycline use and allergy (unspecified). In November 2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) for vaccination. There were non concomitant medications. In November 2013 after receiving ZOSTAVAX the patient has developed muscle pain. The muscle pain comes and goes, and the pain goes away when he takes over-the-counter TYLENOL. The outcome of muscle pain, comes and goes is unknown. No lab diagnostics were performed. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
Swelling; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was not recovered/not resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the husband who reported for her wife. The age at the vaccination was not reported. The patient received Shingrix and had swelling. The reporter asked how long the swelling last did.
She got her vaccine, no problems.  on Easter  Sunday at 7:30 Am she vomited and noticed her legs tightening, and then took Tylenol and ben gay.  She then continued with the legs being very very tight and painful, lower body points really hurt.  She would get the restless leg syndrome at night when her legs would just kick.  She just continued with the Ben-Gay and the Tylenol.   She saw her doctor in June and told her at great lengths what happened to her.  She also mentioned that she had been bitten by ticks in June and was tested and was told that her symptoms were related to her vaccine.  She now has orthotics in her shoes as she is flat footed, and her bones felt like they were cold all the time.  She is a walker, and she had no pep to it, and this lasted until July.  Her hip would also pop as well.   In July the symptoms finally improved.    She had the booster at the end of October Moderna, and she had no reactions to that, 11/29/21.  She had a fever of 99.2 for 6 hours but otherwise it was fine and it passed.  With the first vaccine the 2nd and 3rd days she was tired but then was OK.  She also had the soreness in her arm.
pt. reported on 5/21 (shot given 5/16) a raised splotchy red area at injections site.  5-6 inches across, hot to touch, itchy, painful (5 out of 10).  suspected by me to be cellulitis from pt. description, but I am not a diagnostic provider
pain in left side; bump in left arm; lump on neck; pain radiating on the left side up her neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left side), PERIPHERAL SWELLING (bump in left arm), SWELLING (lump on neck) and PAIN (pain radiating on the left side up her neck) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left side), PERIPHERAL SWELLING (bump in left arm), SWELLING (lump on neck) and PAIN (pain radiating on the left side up her neck). At the time of the report, PAIN IN EXTREMITY (pain in left side), PERIPHERAL SWELLING (bump in left arm), SWELLING (lump on neck) and PAIN (pain radiating on the left side up her neck) had not resolved.            Patient used ibuprofen for treatment. No concomitant medication was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Soreness at the injection site; Mild itchy tingling type sensation and a mild pins and needles sensation all over her body; Mild itchy tingling type sensation and a mild pins and needles sensation all over her body; This is a spontaneous report from a contactable other hcp. (patient).  A 47-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Right on 15Mar2021 15:58 (at the age of 47-years-old) (Batch/Lot Number: EN6206) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included ear disorder from 03Feb2021 to an unknown date. Caller stated this is all COVID issue post COVID.  Caller stated this ended within the last maybe week or so. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient previously took a medication which was a steroid called Methylprednisolone for her ear problems that she ended up discontinuing because she had an adverse effect to the medication, so she discontinued it on 15Feb2021. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations details was reported as none. Caller stated she received the vaccine on Monday 15Mar2021 at 15:58 HR and three hours later noticed a pen and needle itchy sensation all over the body and it is mild not severe. Caller stated it was noticeable of course more like annoyance right now. Caller stated the other symptom was soreness at the injection site (on 15Mar2021 20:00). For pen and needle itchy sensation all over the body the as time went on and the following day it was a moderate type soreness then started declining so it is improving. Caller stated she was still feeling a little soreness, but it was improving. Called stated she was not certain of the seriousness criteria of the pen and needle itchy sensation all over the body. Caller stated she knew it was not feeling tingly and the pen needle feelings she did not feel before but now she was felling that sensation and she was not sure if it was connected. AE(s) did not require a visit to emergency room or physician office. Caller stated she tried antihistamine Benadryl (25mg) lot numbers: 1761324, expiration Mar2022, did not really, maybe a minor difference, but sensation is still there so not resolving. The outcome of the events mild itchy tingling type sensation and a mild pins and needles sensation all over her body was not recovered and outcome for soreness at the injection site was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Patient noticed tenderness at injection site since 8/18/2015. Patient noted itching and arm more achy on 8/23/205. Patient noted a "quarter" size swollen area at site of injection this morning 8/24/2015. Denies fever.
Pt had extreme muscle weakness that required the use of a walker to walk. This lasted about 24hrs then resolved.
Site: Pain at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild, Systemic: Chills-Medium, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Other- slight pain in left thoracic area followed by chills and fluctuation in blood pressure and pulse-Medium; lasted 1 day.
Shingles; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with shingles after the administration of the first dose of the Pfizer's COVID-19 vaccine. The patient received treatment of aciclovir and his physician recommended to postpone the administration for a few days. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were unspecified. On an unknown date the patient was vaccinated with improperly stored stored ROTATEQ lot # L013203, expiration date: 28-JAN-2017 (administered orally; dose was not reported). The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000768: US-009507513-1707USA000770: US-009507513-1707USA000767: US-009507513-1707USA000769: US-009507513-US-1706USA008487.
Pt received 3rd dose Moderna and Flu Vaccine today. He waited the 15 min for observation time. Then, our vaccine RN directed pt and family to the bathroom down the hall from the vaccine clinic. Per his family member, she assisted the patient to the toilet for a bowel movement and he "slumped over and his eyes rolled back." The family yelled for help and a Rapid Response code was called overhead. The Rapid Response RN arrived and reported the patient was pulseless and unresponsive. The Rapid Response team assisted to the ground and called a Code Blue Response. The team reports conducting CPR for "8 min." Upon my arrival, the patient was laying supine on the ground, alert with a NRB o2 mask on. The patient was lifted onto a gurney and escorted to the ED with family. The family reports the patient?s memory has changed recently and has declined. He had an appointment with Urology today for reoccurring UTI?s.  Upon my return to the vaccine clinic, the LVN that administered the two vaccines reported he came from the Lab and had NPO labs drawn.
Information has been received from a physician's assistant (PA) concerning her 13 month old daughter, who, two weeks ago, on approximately 7/17/06 was vaccinated SC with a dose of varicella virus vaccine live. Concomitant therapy included hepatitis A vaccine (inactive). Eight days after, on approximately 7/25/06, the patient developed severe chicken pox. Unspecified medical attention was sought and an oral steroid was given. Subsequently, the patient recovered from severe chicken pox. Additional information has been received from the PA and medical records indicating that her 13 month old Caucasian, birth twin daughter with no pre-existing allergies, birth defects or medical conditions and family history of high cholesterol, heart disease, high blood pressure, thyroid disease, cancer and allergies, was vaccinated on 7/17/06 with the first dose of MMR (+) varicella virus vaccine live (lot # 652234/0951R). Concomitant vaccination given on the same day included a first dose of hepatitis A virus vaccine inactivated (lot # AHAVB110AA) given in the right thigh. There was no illness at the time of vaccination. On 7/24/06, the patient developed a fever ranging from 102-103.4 degrees F. On 7/27/06 at 06:00 am, the patient was fussy and an erythematous, macular-papular, vesicular, pruritic rash developed, also described as dermatitis. The rash was noted to be over the torso, neck, arms and upper legs. The patient was seen by a physician on 7/27/06, was diagnosed with chicken pox and was treated with prednisolone sodium phosphate, ibuprofen, and acetaminophen 80 mg/0.8ml PO as needed. The physician also considered the event to be an adverse effect of medication. It was reported that the patient recovered as of 8/1/06. The patient's vaccination history includes: diphtheria toxoid (+) hepatitis B virus vaccine (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid given in the right thigh on 8/30/05, 11/2/05, and 12/21/05 (lot # AC218053AA); pneumococcal 23v polysaccharide vaccine given in the left thigh on 8/30/05 (lot # A85856E), 11/2/05 (lot # B0867E) and 12/21/05 (lot # B08658G); and HIB conjugate vaccine given in the left thigh on 8/30/05 (lot # 651250/0186R), 11/2/05 (lot # 651897/0529R) and 12/21/05 (lot # 652026/0541R). The reporter considered the patient's adverse experience to be an other important medical event (OMIC). The patient's twin brother had the same symptoms, however, the lesions were more mild (WAES0608USA01217). Additional information has been requested.