chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ABLE TO ACHIEVE OR MAINTAIN AN ERECTION (Erectile dysfunction.  Erectile dysfunction)  FEMINIZATION (Feminization, Feminisation acquired)  This spontaneous; report received from a patient via a company  representative concerned a male of unspecified age.  patient height, and medical history were not reported.  The patient received JNJ78436735 (Ad26.COV2.S) (suspension for  injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, start therapy date was not  reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant  medications were reported.  On an unspecified date in MAR-2021. the patient was unable to achieve or maintain an erection as well as  feminization (making him 5'3" and giving him small hands) .  The action with JNJ78436735 (Ad26. cov2.g) was not applicable.  The outcome of the unable to achieve or maintain an erection and feminization was not reported.  This report was serious (Other Medically Important Condition) .  Version created amend previously reported information on 11-MAR-2021- Upon review, the following information  was amended: outcome was updated from possible to not reported in narrative. Null flavor unknown selected for  batch no.
This case was reported by a other professional via call center representative and described the occurrence of injection site hematoma in a 70-year-old female patient who received FLUARIX QUADRIVALENT (batch number 74Y32, expiry date 7th June 2017). On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hematoma, injection site swelling and injection site bruising. The patient was treated with medication unknown, medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site injection site hematoma, injection site swelling were recovered/resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the injection site hematoma, injection site swelling and injection site bruising to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient developed hematoma and swelling at the injection site (unknown arm) after receiving FLUARIX QUADRIVALENT. The ice was immediately applied and 3 days later the swelling had resolved and the patient's arm was bruised. No further information was reported regarding the event.
Rotateq administered after fridge excursion; This spontaneous report was received from a registered nurse regarding an 11-week-old female patient (also reported as "4-month-old"). The patient's medical history and concurrent conditions were not reported. Her concomitant medications included haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), and diphtheria vaccine toxoid (+) hib vaccine (+) pertussis vaccine (+) polio vaccine inact (+) tetanus vaccine toxoid (DTPA IPV HIB VACCINE).   On 21-FEB-2023, the patient  was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W004502, expiration date: 09-OCT-2023, administered orally for prophylaxis (strength and dosage regimen were not provided) (Product storage error).   It was reported that vaccine fridge went out of range, nurse was unaware at time of administration. The patient and physician were informed. The patient was scheduled  for a second rotavirus vaccine, live, oral, pentavalent (ROTATEQ) but did not show for appointment. The temperature of excursion occurred as a result of a reading from a Digital Data Logger. The vaccine was not available for evaluation due to it was given and the medication error occurred in the storage in clinical practice. The operator of vaccine was an healthcare professional and was trained. On 03-MAR-2023, the vaccine was resumed.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2302USA007547:
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Patient felt light headed and fainted.  Patient was alert and aware immediately and did not sustain injury.  Ambulance was called but patient did not end up needing.
Got the shot at 3pm could not sleep until 6am, was throwing up and had a fever of 102.0, oxygen was 91. Having swollen eyes, the sweats, red eyes, headache, not being able to eat, joint pain. Full body rash, 68 hours after the shot had chest pain, ringing in ears. Couldn't get out of bed for 4 days. Goes for blood work July 12th to see what is going on cause it's been over a  month and is not back to normal yet.
Within 15 minutes of the vaccination, I felt something traveling first to my left arm where I received the vaccine, then to the chest then to my right arm then to my torso. I became extremely tired and lost a lot of strength, especially in my arms. It took significantly more energy than usual to lift up my arms. It became a little hard to breathe (I did have three masks on for precaution, so I took off one.) then I briefly felt tension/stress in my heart. These symptoms went away in less than 30 min. I had a really sore arm, which lasted me a few days afterwards. It was painful to raise that arm above the shoulder for three days or so. I was very tired for the next 2 or 3 days. Then 9 days after the injection, I woke up in middle of the night with pain in the front side of my left armpit, the part that connects to my chest. It felt swollen. It lasted 2-3 days. I saw a small red patch next to the injection site. The pain came back yesterday. Every time my left upper arm touches my torso, it hurts. In general, I am feeling fatigue and under the weather.
This case was reported by a consumer via call center representative and described the occurrence of celiac disease in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and PNEUMOCOCCAL VACCINE at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and PNEUMOCOCCAL VACCINE, the patient experienced celiac disease (serious criteria GSK medically significant), Hashimoto's thyroiditis (serious criteria GSK medically significant) and drug hypersensitivity. On an unknown date, the outcome of the celiac disease and Hashimoto's thyroiditis were not recovered/not resolved and the outcome of the drug hypersensitivity was unknown. It was unknown if the reporter considered the celiac disease, Hashimoto's thyroiditis and drug hypersensitivity to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient was planning to talk with her doctor about SHINGRIX and called GlaxoSmithKline to discuss if any ingredients of SHINGRIX would be an issue with her allergies to penicillin, sulfa, or ANCEF or if celiac disease would be a contraindication to receiving SHINGRIX. The product PI (product information) was discussed, and she was referred to her HCP (healthcare professional) to address these specific inquiries and her inquiry of whether she should receive SHINGRIX or not. Towards the end of the call the patient reported that said she had allergies, celiac disease, and Hashimoto's thyroiditis and she said that she needed to get off of the phone and just before the call ended, the patient said that said she had received flu injections for years and the pneumonia injection and never called before to inquire about their ingredients prior to having received them. The patient only provided the specific mailing address for mailing of the PI to her home which she requested. The patient did not want to receive any unsolicited calls or contacts. It was unknown when the patient was diagnosed with allergies, celiac disease, or Hashimoto's relative to her having received the vaccinations for flu and pneumonia. The manufacturer of those vaccines were unknown. No further information was available.
SOB High Respiratroy Rate- 30 High Pulse- 130  Send to hospital.  via emergency services admitted due to sepsis
No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.   On unspecified date since 08-JAN-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA009326: US-009507513-2001USA006234: US-009507513-2001USA009328: US-009507513-2001USA009323: US-009507513-2001USA009327: US-009507513-2001USA009324:
I started out with a rash on my left arm. It was a pretty good size and it was hard. The rash, over the course of the next month, traveled to my arms, my legs, back and stomach. My dermatologist did a few biopsy's on my rash and he told me I have hypersensitivity dermatitis. To this day, I am still battling this. I have seen my dermatologist, Dr. a few times about it. My PCP did some blood work to make sure my levels were all still normal. I was referred to an allergist, Dr. to see if I had a PEG type allergy to the medication. In the past I had a reaction because of the PEG in Miralax. I'm still in the process of being seen by the allergist and a dermatologist. My dermatologist and allergist prescribed medication to help me. The medication may have helped a little, but I am still experiencing this rash all over.
1/2hr p/vax had local itching @ site, then 6hrs later had large local rxn along w/entire body muscle aches, SOB & could not blow out to do a peak flow; pt has severe asthma chronically; felt very ill
Patient stats,awoke at 8:00am on 5-20-08 feeling dizzy, weak, feverish, and felt like increased heart rate. By 4:30p.m. patient states is feeling better still a little dizzy and weak.
I was a child (6-7 years old) I received the Measles vaccine. A week ago, I received the first dose of Pfizer, the next day I noticed the scar from the Measles vaccine was red and slightly swollen. I thought it was an allergic reaction that would last 1 or 2 days, however yesterday July 19 my arm still red and inflamed and I perceive minimal pain.
I started with a tickle in the throat that was irritated. I had congestion, body aches, headaches, and a little bit of chills. That was how it started. It started early Sunday morning and I had stayed up really late and felt fine. Monday, I felt a little achy and had some chills during work. I came home and did a COVID-19 test and it came back positive. When I did come home, I was achy and had a headache. The headaches reminded me of when I get headaches when I?m dehydrated. It was a severe headache but after taking some Tylenol and drinking water, I haven?t had a headache in the last day or so. I had a little bit of a cough but was not producing any phlegm at the time. On Tuesday, I went to see the nurse practitioner and she did a test for strep A and, I was positive. We also did influenza A and B but I was negative. She also did a COVID-19 PCR test, and it came back Wednesday as positive. So the strep A on Tuesday, I was prescribed a z-pack and I?ve been taking that since that Tuesday. She offered me the antiviral Paxlovid or Molnupiradir, I noted that I did not want to take Paxlovid because of the possible rebound. The Molnupiradir was prescribed, and I started that on Wednesday. When she examined me, she did also notice some effusion in the middle section of both of my ears. I feel better today. Still have a light cough and producing a slightly white and yellowish tinted phlegm.
patient called the store to inform us that ever since she got the J&J vaccine on 4/6/2021 she has not gotten a period. She also states that previous to the vaccine she never had cramps when getting her period but now she is having cramps every month although she is not bleeding. She is concerned that is not healthy that she is not getting her period regularly. I told her we would report this adverse event and give her any feedback or information we find out. I advised that her that I have heard that the same issue has happened to other patients that have received the COVID vaccine (not just J&J) and to reach out to her gynecologists  to inform them as well.
This case was reported by a physician via call center representative and described the occurrence of generalized rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced full body rash following administration of SHINGRIX. The HCP terminated the call when asked for patient details. No further information was obtained. This case has been created from case US2018188530 and US2018GSK192914, reported by the same reporter.
Red welt like area to injection site with edema. Instant itching to site. Removed bandaid with improvement to itching. Kept pt 30 min to monitored. No systemic reactions. Phone pt 4/1/21 F/U
Feeling a little sore; whole body feeling sick; high fever in the night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feeling a little sore), MALAISE (whole body feeling sick) and PYREXIA (high fever in the night) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Feeling a little sore), MALAISE (whole body feeling sick) and PYREXIA (high fever in the night). At the time of the report, PAIN (Feeling a little sore) outcome was unknown and MALAISE (whole body feeling sick) and PYREXIA (high fever in the night) was resolving.            No concomitant medication was reported   No treatment medication was reported  The first day patient wasn't too bad, day 3 started to feel better   This case was linked to MOD-2021-341228 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow up received with significant information , events updated
Pt recvd 3 doses of Engerix-B & titers were reported as negative p/3 injects; plan to revaccinate;
Pt was given MENACTRA 0.5 ml @ deltoid on 5/12/09.  On 5/13/09 at approx 7pm pt & parent noted large localized reaction.  Redness & warmth 5x5 inch area L upper arm.
Fever, severe body aches, severe headache, vomiting, vertigo and disorientation.  Unable to get out of bed to get help.
Patient developed sudden onset of right arm shaking at 6pm (19.5 hours after 2nd Pfizer vaccine). The shaking originated at the injection site in right deltoid and radiated in shooting sensation down her right arm. Her entire body was shaking. She describes feeling "like I got the shakes and I couldn't control it." Felt like she needed to urinate (uses catheter) but no urine passed. Was unable to speak. Adult daughter was present. Event lasted approximately 30 minutes before gradually stopping. Took her temperature afterward and it was 99F.  Slept very deeply that night, which is unusual for her.
Patient became excessively weak and fatigued. "Was like a rag doll" and fell. Broke 2 ribs.
On the morning of May 9th 2017 I received the GARDASIL 9 vaccine for the first time. (Just to note, I had not done anything out of the ordinary from my daily routine). Later on that evening the palms of my hands became extremely red, itchy, and painful. Also my fingers had became a little bit swollen. My hands stayed like this throughout the following day as well. So in the evening of May 10th I took an antihistamine which seemed to help my symptoms get better.
Initial report received from a health care professional on 10 Dec 2009: This patient (2 year old) was vaccinated with FLUVIRIN (batch no: 102123P1A) on 09 Dec 2009.
husband got Bell's palsy right after this new vaccine; This case was reported by a consumer via media and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got Bell's palsy right after this new Shingles vaccine. The reporter asked was this coincidence or not. The follow-up would not possible as no contact details were available.
On day 3 post vaccination, I am still experiencing significant joint pain and neck pain as well as new discovery of enlarged lymph node on clavicle region on the same side as vaccination site.
Pediatric 0.5mL dose of Hepatitis A vaccine given to an adult.
This spontaneous report was received from a Nurse, referring to an unknown number of patients of unknown age and gender. No pertinent medical histories, concurrent conditions and concomitant therapies were reported. On 04-AUG-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB. Dose, route, lot #, indication and anatomical location were not reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
4days p/vax pt devel fatigue, malaise & herpes zoster, along dermatomes:  C4/C5/C6/T1/T2; tx w/ antiviral w/ good result
Severe leg pain the evening of shot, shooting muscle pains and fever. Fever, body aches, joint paint, muscle pain, fevers (chills and sweating) and lump under skin hot, itchy and sore (size of an orange).  Fever, body aches etc continued or 3-4 days. Continued to feel ill for a week and a half. Now 4 weeks later injection site still itching with a raised spot. In addition wide spread muscle/joint pain continues.
aches; extreme fatigue; a possible fever; This is a spontaneous report from contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2(Pfizer COVID-19 Vaccine, formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. Patient historical vaccine included patient received first dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that the following day around 2 PM she began to experience aches, Extreme Fatigue, and a possible fever on unspecified date. patient stated that she left work that day and upon arriving home felt asleep in her vehicle for approximately 3 hours. She continued to experience the symptoms for several days and couldn't return to work until 18Apr2021. Patient stated that she doesn't experience any reaction her initial dose of the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
"Golf ball" sized knot @ injection site, pain in arm where administered BOOSTRIX.
This spontaneous report as received from a healthcare worker and refers to a 61 year old male patient. The patient had no know drug allergies or reactions, there was no pertinent medical history. On 25-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose was not provided) lot # L037797, expiration date December 2016, subcutaneously in left upper arm. There was no concomitant medication. On 25-FEB-2016 about 21:00, the patient began to develop pain in the palms of his hands and on the bottoms of his feet, his feet were swelled and he developed either a rash or hives on his torso, between his fingers, and in his groin area. On 02-MAR-2016, the patient was examined by the physician who noted that the patient still had some evidence of a rash between his fingers and did not have a rash on the groin area. The swab was performed with result reported as "there was nothing to swab". It was also reported that there was no lab diagnostics studies performed. The outcome of adverse events was reported as recovering. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
temp 100.5, chills, nausea, headache, body aches, fatigue, dizziness
Symptom onset of 7-23-2021 with chills, muscle aches, runny nose, sore throat, cough, wheezing, shortness of breath, chest pain, fatigue, loss of taste and smell, difficulty breathing.
pt recv vax 25FEB97 & 7MAR97 pt devel a gen rash consisting of more than 50 lesions;
Headache and nausea started at 6pm on 17th and resolved next am at 6 am. Sore arm with no swelling
This spontaneous report as received from a medical assistant via a company representative refers to a female patient in her 70's. Medical history was not provided. On an unknown date, in the past year, the patient developed postherpetic neuralgia on the back of her head. The physician assistant examined the patient and identified a few lesions on the back of her head. The patient was treated with an unspecified antiviral medication. The outcome of postherpetic neuralgia, with a few lesions on the back of the head was reported as not recovered. Additional information has been requested.