chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female who on approximately 30-JAN-2009, "about two weeks ago" was vaccinated with VARIVAX (Merck) (lot number, route and site not reported).  On approximately 05-FEB-2009 "one week later" the patient developed a rash at the injection site about 4cm in size with pain in the arm.  She also developed 4 lesions on the arm and one lesion on the abdomen.  The patient sought medical attention.  The patient's outcome was unknown.  Follow up information was received.  There was another physician from a different practice involved that saw the patient with the reaction who diagnosed the chickenpox.  The patient was frustrated with the situation as she received VARIVAX (Merck) before attempting to conceive which in itself was a stressful situation.  To add to things her husband never had chickenpox and was worried about transmission.  Additional information has been requested.
Genital herpes outbreaks; Increased genital herpes outbreaks after both doses; This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of genital herpes (1st dose received on an unknown date and experienced increased genital herpes outbreaks). Concurrent medical conditions included genital herpes.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced genital herpes and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown.   It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient experienced increased genital herpes outbreaks after receiving the dose of Shingrix vaccine. The reporter did not had any other information except patient's gender. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176130:Same reporter. Pt1 - 1st dose. US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. Pt1 - 2nd dose. US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. Pt1 - 2nd dose. US-GLAXOSMITHKLINE-US2021AMR177309:Same reporter. US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. Pt1 - 2nd dose. US-GLAXOSMITHKLINE-US2021AMR176130:Same reporter. Pt1 - 1st dose.
This spontaneous report was received from a consumer regarding her 1 year old male son. His medical history and concomitant medications were unknown. His concurrent drug reactions/allergies were reported with ceftriaxone (ROCEPHIN). On an unknown date in 2014, the patient was vaccinated at the age of 1 year with VARIVAX (dose, route, lot number and expiration date unknown) to prevent chickenpox. On an unknown date in 2014, immediately after vaccination, he developed "a red welt on his leg" at the injection site where VARIVAX was administered (vaccination site urticaria). The patient did not receive treatment for the event. The patient sought medical attention (office visit) and was not hospitalized for the event. The outcome of vaccination site urticaria was reported as recovered/resolved on the same day. The consumer reported that the patient was currently 4 year old. The reporter did not have any further details to provide. Additional information is not expected.
servere headache within one hour.  Severe swelling and pain in fingers and knees that lasted 4 months after vaccination. Intermittent severe pain in lower back, between shoulder blades and in toes for 4 months following  both doses of vaccine
Patient developed excrutiating pain, edema and erythema at vaccine injection site (R) deltoid.
This spontaneous report as received from a physician refers to a multiple patients of unknown ages and genders. Pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored VAQTA Adult, Lot # M005885, expiration date 26-MAY-2017, and Pediatric/Adolescent, Lot # K026529, expiration date 02-JUN-2017 (Dose, route and anatomical location were not provided). Other suspect product involved was sterile diluent (Merck Sterile Diluent) lot # L041683 Expiration date 19-MAY-2018 and Lot # M002421 Expiration date 22-JUL-2018. Temperature: Lowest 25 Fahrenheit degrees (4 cycles) below. Time frame: 1 week. Previous: No. Digital data logger was involved. No product quality complain was involved. No other concomitant medication was reported. This is one of five reports received from the same reporter. Additional information has been requested.
Itching all over face snd parts of body, itching inside throat. Onset at about 15-20 mi items after shot and continues till Time Of reporting. Has not worsened.
Per pt states on 10/19/02 she woke up feeling ill and R arm hurting and red at injection site. Fever of 100.2 degrees either 10/19/02 or 10/20/02. Took Tylenol for fever, pt also says she too ? which did not relieved redness or swelling. Per phone report by pt. Pt states she was examined by MD 10/23/02 and was prescribed Cipro 500mg po bid x 10 days. Per call pt reports on 10/21/02 she called her PMD office and talked with his nurse. Pt says her swelling and redness of R arm had worsened and spread to axilla, within 1 inch of her elbow and to back and shoulder. Pt says she did not describe in detail to PMD nurse. Pt says she used ice pack on 10/21/02. On Wed. 10/23/02 pt reports she had not improved and she went to MD at 4pm and was diagnosed with cellulitis and was prescribed Cipro 500mg po bid x 10 days which she is taking. 10/25/02 approx 1-1:15pm pt called HD and talked to RN. Pt says swelling and discoloration of R arm is down today. Says discoloration is dark and diffuse. pt reports R upper arm (mid arm to shoulder) is sore and tender. Pt also reports tingling of her R hand. Pt advised to call PMD office and follow up with PMD regarding these symptoms. Pt voices desire to following with MD and understanding to do so. Pt advised that PHN is completing a vaccine adverse event report. 10/25/02 3:15 pm call to pt to complete question 17 and 19 on form. Pt says she did call MD office and talked with nurse. Pt says she was assured that she has not given enough time for antibiotic to work. Pt says she was advised to call office back on Monday and to go to hospital ER if needed over weekend.
Patient vaccinated x3 (Moderna): 3/18/21, 5/15/21, 12/1/21  Patient then COVID positive 2/11/22 and admitted to hospital
pt recv vax 5AUG96 & 3SEP96;3-4 hr p/dose 2 pt exp a rash on chest;reported the rxn as mild, has not seen  MD & has recv no tx;rash was only sx;described rash as welts for the initial period of time followed by fine raised rash;
Pt vaccinated with FLU developed fever 102, vomiting, sore throat, red, mattered eyes, runny nose, cough.
A mild fever; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: A mild fever) and headache (Verbatim: headache). The outcome of the fever and headache were not reported.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.     It was unknown if the company considered the fever and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR111144   Additional Information: GSK Receipt date: 14-AUG-2023 This case was reported by a consumer via interactive digital media. The patient hated the shingle shots because it was a two part series. The 1st shot was not bad, minor residue effects. A mild fever and headache. The 2nd one hit me like a bat to the head. Headache, fever, lethargic etc. But it was worth it. The patient had friends who had shingles and they hated life. For tolerance of 2nd dose refer case US2023AMR111144.; Sender's Comments:  US-GSK-US2023AMR111144:
Hives and Chest Pains about 8 hours after vaccine.  Went to ER given benadryl, corticosteroids, pepcid.  Given a prescription for 4 days of 20mg Prednisone and instructed to take OTC Pepcid if needed. Symptoms resolved after about 3 days
A non-serious report of twitching in eye has been received from a physician concerning a three-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The patient, adopted, had no medical conditions and took no concomitant medications.  The patient received FluMist on 26-Nov-2007.  The physician stated the father reported on the day the patient received FluMist, twitching of the child's eye started.  The twitching continued at the time of this report.  Additional dosing with FluMist is not applicable.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Pain, swelling at inj. site within several hours. Significant band of erythema, itching on inner aspect of bicep in affected arm. Treated conservatively with tylenol, cold compresses: benadryl if needed.
Have a bad itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Have a bad itching) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056H21B) for COVID-19 vaccination.     Concurrent medical conditions included Liver disorder (Liver ailment).    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Nov-2021, the patient experienced PRURITUS (Have a bad itching). At the time of the report, PRURITUS (Have a bad itching) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient had a bad itching and not have any rash. She did not had any reaction with first and second dose.  She had liver ailment and still contacting her doctor if she can take allergy medicines.
2 days after receiving patient was seen for vomiting. Started 24 hrs after vaccine. Today 9/29, he was seen again with swelling on (L) jaw extending under (L) ear.
Hospitalized 8/26/22-8/28/22 Abdominal pain, nausea, vomiting, weakness, hypoglycemic, headache, tachycardia, ETOH withdrawal, ETOH hepatitis,
About 10-15 minutes post-vaccination, she started to have itching in her mouth (her tongue, mainly). Also felt like tongue was swelling and throat was tight/swelling. Chest felt tight as well. She has asthma and said it felt like she had just breathed in the "worst allergen." She did not seek help from the EMT at the site and remained sitting in the observation area. She then developed a flat, mottled rash that started on her neck, spread to her chest and stomach. She sought help from the EMT who took her vitals (BP, HR, O2 sat), which were all normal, per the patient. She was observed closely by the EMT and medical review staff for about another 20 minutes. No treatment was given. The rash resolved on its own
This spontaneous report as received from a nurse refers to a 6 months 19 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 09-DEC-2011, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. Thi  is one of 182 reports received from the same source. Additional information has been requested.
An 84 year-old female resident at a memory care/long-term care facility had accidentally received a 3rd dose of COVID-19 vaccine (Pfizer) on 2/17/2021. Already received 2 doses of COVID-19 vaccines (Pfizer) on 1/25/2021 and 2/15/2021. Then the resident was transferred sometime between 2/15 and 2/17. These are two separate care facilities but operated under same management. A facility care coordinator stated they did not receive COVID-19 vaccination records. Therefore, the coordinator carelessly registered her to receive a 1st dose of COVID-19 vaccine (Pfizer) on 2/17/2021, when  visited the site to conduct vaccine clinic. The vaccine administration record showed that this was the resident's first time getting COVID-19 vaccine.  After pharmacy staff found out about the accidental third shot, contacted the coordinator on 2/17 afternoon and found out that the coordinator was not aware that this resident had already received the 2 doses of COVID-19 vaccines. Per the coordinator, the resident seems normal and stable.
Mom states p/1 of prev immun pt devel scaly rash on upper leg & buttocks same day not sure which 1 of visits this was; rx w/cortisone cream & took 2 mo to dissipate; This visit recvd HIB/MMR 10 days p/vax devel scaly rash & pimply red rash;
11X12CM NONTENDER, PINK, WARM, SLIGHTLY RAISED AREA ON LEFT THIGH @ SITE OF DTAP/MMR IMMUNIZATION.
Received Shingrix vaccine Nov 2018. 5 days later had signs/symptoms consistent with left T8 postherpetic neuralgia. Lasted 7-10 days and resolved. Received 2nd Shingrix vaccine on 2/28/19 and 5-6 days later had recurrence of same symptoms in same location. Never had rash. Symptoms included moderate pain, numbness in left T8 dermatome, and tingling. Symptoms have been unchanged since that time. Topical lidocaine patches help with discomfort. Pain is not debilitating and have not used oral meds.
Severe itching of the ears, head, neck, upper extremities, and abdominal pain.
Patient presented the pharmacy to report her arm is red and swollen. Upon physical inspection it was red and inflamed and patient stated hot. Possible skin infection upon examining visually.
I noticed irregular heart beats in January 2022.   Had an EKG done in Hospital March 2, 2022 and then a 24 hour monitor.  They have determined I have Atrial Premature Contraction.  I have an appointment with a cardiologist April 12, 2022 just to see what they have to say.  My doctor says it's nothing to worry about at this time.
Erythema and edema in left deltoid region. Tender to touch. Red lesion at injection site. Developed in evening after afternoon injection, did not apply ice to swelling. RTC at around 24 post injection. Had MD appt @ 1 pm today. 4/2/10 TC to pt. No answer. Work-phone-left msg.
Cough  Fatigue  Muscle or body aches  Sore throat  Diarrhea
Patient received Pfizer vaccines on 5/7/21 and 5/28/21.  On June 1, 2021, she started to notice LEFT arm weakness while texting.  She presented to the emergency room June 2 2021 with LEFT arm and leg weakness, difficulty walking, and slurred speech.  Over the next few days, sx progressed to dense hemiplegia of the LEFT arm > leg.
The nurse stated that she reconstituted the 5-11 year old Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
An NP reported that a 15 month old female received her 1st dose of Prevnar, as well as, her 4th doses of DTAP and haemophilus influenza type B vaccines and on the day of immunization, developed an injection site reaction characterized by redness and hardness. The symptoms resolved within 3 to 4 days. The reporter indicated that the immunization was administered "more lateral than vastus lateralia".
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In February 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In February 2016, the patient was treated by a physician at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a 29 year old female patient who was not pregnant refers to herself. Medical history was not specified. The patient had no drug reactions or allergies. In December 2012, March 2013 and June 2013 (exact dates not specified), the patient received  doses of GARDASIL in the arm (exact route, dose and lot number were not reported). Concomitant therapies included ethinyl estradiol, norgestimate (a generic for of ORTHO TRI-CYCLEN). In February 2013, the patient's hair started falling out. The patient sought medical attention. The patient had blood work done on an unspecified date (results were not reported). Her doctors  had no biological reason why her hair was falling out. The outcome of hair started falling out was not recovered, also reported as her hair was continuing to fall out. The relatedness between hair started falling out and GARDASIL was not reported. Additional information has been requested.
Left arm grapefruit size swelling about 6 in long and 4 in wide. Swelling wraps around to underside of arm. Swelling below shoulder to just above elbow. There is a white ring around the swelling.
This case was reported by a pharmacist and described the occurrence of arm pain at injection site in a 70-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Omeprazole, Lisinopril, Alphagan and Lumgan. On 3 October 2013 at 11:42 the subject received a dose of FLUAIRX (.5 ml, unknown, left deltoid) On 3 October 2013, less than one day after vaccination with FLUARIX, the subject experienced arm pain at injection site. At the time of reporting the event was unresolved. The pharmacist reported as subject who is "still experiencing pain in the arm where he received FLUARIX vaccination." The pharmacist considered the event was possibly related to vaccination with FLUARUIX.
Went to emergency . Blood pressure was extremely high, heart rate very low, worst headache have ever had in my life. I was in the hospital for 4 days.
Patient reported to pharmacy for refills and asked about the reaction she is having on the back of her arm from a vaccine received a month ago. The area became swollen up with a knot and has a red circle around it the day after the vaccine. Patient reports that it itches and I recognized that there is a rash underneath the knot. The patient is concerned that it is still there after a month and it hurts if she touches it or bumps her arm on something. Patient reports using hydrocortisone cream to help with the itching and states that it has improved some. I could not find any guidance on how long a person can have a reaction after a live vaccine.
Approx 5 min after vac. inj started with flush and tachycardia  Initial BP 137/80 P129. Given 50 mg po Benadryl Repeat BP123/76 p91  @1135 No further sx BP 124/74 P91 DC stable
Syncopal event following vaccination including head trauma, followed by fevers, rigors, myalgias and tachycardia and dehydration requiring ER visit with administration of IV fluids
Initial report received on 05 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL on 18 January 2010, 22 March 2010, 25 May 2010, and 24 May 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 02 September 2012, approximately 15 months after the last dose. On 04 September 2012, the subject developed a cough and paroxysmal coughing without a whoop began on 06 September 2012. The subject also experienced posttussive vomiting, and sleep disturbance (onset dates not reported). No PCR laboratory testing was provided. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 08 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 19 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
My symptoms started 03/25/2023 in the evening and got worse on 03/26/2023. I had severe sore throat, headaches and cough. I did a COVID rapid test on 03/26/2023.  I also did the Ihealth COVID-19 at home test and it was barely visible covid test also on 03/26/2023. I spoke to my doctor on the phone and got a prescription for Paxlovid medication.  I am still recovering from my symptoms.  After 03/26/2023 I also developed rash, initially low- grade fever to 100 degrees then my temperature dropped to 96 then it went back to normal. Now my cough is resolving.
Post vax on approximately 12/14/2000, the patient developed chicken pox that lasted over 1 week in duration. There were over 40 "poxes" on the patient located all over her body. On 12/30/2000 the patient recovered. Unspecified medical attention was sought. The nurse also reported other patients that developed chicken pox.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# reported as L023111, expiration date 24-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.