chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Flu symptoms; muscle weakness that was most pronounced in his hamstrings,muscle weakness has moved through his body and into his shoulders; bed-ridden; disoriented; Initial information was received on 19-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (Patient).  This case involves a 81 years old male patient who experienced bed-ridden, disoriented, pain, muscle weakness that was most pronounced in his hamstrings, muscle weakness has moved through his body and into his shoulders and flu symptoms after being vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IBUPROFEN (IBUPROFEN); and ACETYLSALICYLIC ACID (ASA).  On 27-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, route, administration site, formulation, expiry date: Unknown) for prophylactic vaccination (Immunization).  On 27-Sep-2022 the patient developed a non-serious bed-ridden (bedridden), disoriented (disorientation),  muscle weakness that was most pronounced in his hamstrings, muscle weakness has moved through his body and into his shoulders (muscular weakness) on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 28-Sep-2022 the patient developed a non-serious pain and flu symptoms (influenza) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that "On the 2nd day after the vaccine, his symptoms improved and continued to improve on the 3rd day until he felt like he had made it through the follow up symptoms. However, about 30-35 days ago, the patient started to experience muscle weakness that was most pronounced in his hamstrings. The caller noted that he is in very good health and does triathlons. He thought that he could push through what he was experiencing. However, the muscle weakness has moved through his body and into his shoulders. Patient continued to work out, stretch and use the steam room at the gym. He has been swimming a lap or 2 since receiving the vaccine, when he normally would swim 8-10 laps per day. He takes an occasional Ibuprofen and a baby Acetylsalicylic acid every day. He uses heating pad and notes that those feel good."  Action taken: not applicable.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  Outcome: Unknown for all the events.
Information has been received from a physician concerning her 12 month old daughter who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck).  Secondary suspect therapy included MMR II (Wistar RA 27/3).  Other concomitant therapy included "flu" and DTAP.  It was reported that "within one week of receiving VARIVAX (Oka/Merck)", the patient developed a mild rash but was not fussy.  The patient sought physician's medical attention.  Subsequently, on an unspecified date, the patient recovered.  The physician's older daughter developed an adverse experience after receiving a dose of VARIVAX (Oka/Merck) (WAES 0811USA02274).  Additional information has been requested.
Chest pressure; Trouble breathing; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest pressure), DYSPNOEA (Trouble breathing) and PALPITATIONS (Palpitations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) and DYSPNOEA (Trouble breathing). In 2021, the patient experienced PALPITATIONS (Palpitations). At the time of the report, CHEST DISCOMFORT (Chest pressure) had not resolved and DYSPNOEA (Trouble breathing) and PALPITATIONS (Palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
A physician reported the occurrence of an itchy rash in a 16-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. On 07/11/2002 the pt received his 4th injection of Infanrix. On the same date he received an injection of varicella virus vaccine (Varivax, Merck). On 07/12/2002 the pt was very cranky when going to bed. On 07/13/2003 the pt awoke with a very itchy rash on his face, inner thighs and trunk. The pt was seen by the physician on 07/16/2002; the rash persisted at that time. The physician prescribed diphenhydramine hydrochloride (Benadryl). An in-depth discussion of environmental factors to cause the rash "did not reveal anything substantial". As of 07/17/2002, the events were ongoing.
When I got the injection I had pain towards my body away from the injection site. 6 days later it became itchy, red, painful rash look like hives, it took four days for that to go away. Very fatigue.
Right leg red, swollen, tender to touch.  Warm compresses for 20 minutes every 4 hours for 24 hours.  Diagnosis: Mild reaction.
April 21st -> Tdap vaccine administered, pt describes painful administration of vaccine. Pt given 400mg Ibuprofen, sore all day April 22nd -> pt returns to clinic due to pain "severe". Ice, Ibuprofen April 24th -> pt began doing warm compresses. April 26th -> pt went back to work. Pain was not as severe but present. April 27th -> severe pain returned. April 29th -> pt  returned to clinic, pt given Ibuprofen, x-ray, exam, sed rate, CBC, sling given. Referral to PT -> vaccine inj site -> no swelling, no itching, no heat, no numbness, no weakness.
Severe pain right arm, inability to move right arm.  Pt presented to the ER last night and to the clinic this am.
I have developed an allergic reaction to  a combination of lotion and sun exposure on my arms. This allergy to lotion and sun developed 2 weeks after the first dose. My arms get hives and are extrememly itchy for 3 days. Benadryl offers very little help. It is like an intense itch. My arms although they did not sunburn they feel like they are on fire. They are very hot to the touch my blood feels like its boiling. Gosh it is miserable. I have not seeked a dr because I can't afford a drs office visit. This reaction has occurred 4 times now so I will avoid using
High fever in the morning, followed with a decrease of appetite. That went on for 3 days. Then the fever went down and his appetite still was not very good. He won't take naps like usual and at night he is very restless. Tosses and turns and one night was crying unconsolable. I have also noticed that since the MMR shot his walking that he was getting so good at took a step back and he wasn't walking as well.
Headache, fever, chills, body aches,  sore glands under left arm.
I did not have an adverse reaction to the vaccine.  I was having trouble with my left ankle, and I made an appointment with my doctor. I was diagnosed with acute tendonitis in my left ankle. As of now, I have to have surgery in July.
n 10/13/2021 persons received a full dose of Moderna at pharmacy per immunization information system. Persons than came in to Public Health on 10/22/21 and filled out paperwork stating she had never received a vaccine and was administered a full dose of Janssen per her request. Once this was caught patient is notified and patient admits to above. Public health department is then notified of this and I am directed to fill out a Vaers and call persons to educate on her booster if she will wish to do so and to call if she has any symptoms she becomes concerned of. Patient states the reason she did this was to be able to start her job which required that she be fully vaccinated prior to being able to start.
Patient was supposed to receive influenza vaccine and PREVNAR 20 (not Pneumovax), but MA accidentally gave Pneumovax because she did not check the orders first.
Became very ill in about 8 hours after booster (third) vaccination.  Symptoms of systemic nature included Chills, low fever, aches and pains, pain in neck and head area, eye muscle soreness, all over body tingling and skin sensitivity, followed several hours later by nausea, diarrhea, severe headache, neck glands tenderness,  profuse sweating, insomnia due to discomfort in bed, dryness of mouth and nose, nasal stuffiness,.  Diarrhea lasted for 48 hours.  Other symptoms subsided when I took one dose of Tylenol approximately 8 hours after first onset of symptoms.  Had sweating, stomach pains, eye muscle pain, and diarrhea for approximately 48 hours after injection.  I felt very ill for a24 hours after first onset of symptoms.
This spontaneous report was received from a healthcare worker refers to an unspecified patient of unknown age. On an unknown date, the patients were vaccinated with an improperly stored VAQTA (lot# L009445, expiry date 01-JUN-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (age at vaccination 51-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced lump on arm at injection site, little bit of swelling, her am is still sore. Reporter stated that he first of all he wanted to thank Pfizer. He stated that he and his wife got the first shot on Tuesday. While providing details about himself he mentioned his wife has a lump at the injection site and a little bit of swelling. Her arm was still sore. To him it seems like it was going down. He did not see a problem, and he was thinking that it will take 2 weeks for it to go away. He stated that it has not even been three full days, and they got the shot on Tuesday, and she just worried about that. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had syncopal episode approx 5-7 mins after vaccination. Fell down bed face forward, no head injury. pt was awake and aware within <1 min and stated that she felt dizzy
Patient received Moderna vaccines on 3/10/21, 4/9/21 Tested positive for COVID by PCR on 5/27/21. Patient is asymptomatic, tested due to upcoming appts at our facility.
initially fever of 104 hypotension 90/60 and tachycardia 128 at rest. tested for covid with pcr which was negative. hypotension lasted for a week and fever of 104 for 12 hours then 102 for 36 hours.
A non-serious, spontaneous report of papular itchy rash over his trunk was received from a nurse practitioner concerning a ten-year-old male subsequent to FLUMIST and H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Sep-2009 and H1N1, Intranasal on 06-Nov-2009. On the evening of 09-Nov-2009 the patient experienced a fine papular rash over his trunk. The rash was described as mildly itchy. The outcome for the event of papular rash and itchy rash was not reported.
persistent lower back pain; Bad shape and felt "just rotten"; Sore shoulder; Site of injection was painful; right shoulder swollen; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included spinal fusion (had lower back spinal fusion 30 years ago). Concomitant products included celecoxib (Celebrex).   On 16th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, swollen joints and shoulder soreness. On 17th July 2020, the patient experienced feeling unwell. On 21st July 2020, the patient experienced low back pain. On an unknown date, the outcome of the injection site pain and swollen joints were recovered/resolved and the outcome of the low back pain was not recovered/not resolved and the outcome of the shoulder soreness and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, swollen joints, low back pain, shoulder soreness and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the afternoon and had a sore shoulder and site of injection was painful both have resolved.   The patient was in bad shape and felt just rotten and persistent lower back pain and the only time was did not hurt was when the patient lying down with his knees pulled into his chest This where the persistent lower back pain was coming from. The reporter did not consent to follow up.
The day after Christmas I had a breakthrough of COVID-19 for about 3-6 days, I took Vitamin C but other than that my symptoms were really mild.
Shot given on Monday, July 28 - Wednesday, July 30 had seizures, high fever 104.6 (highest).  ER visit on 7/30 - febrile seizures - sent home.  Seizure/pain in belly.  7/31 doctor's visit - blood check - normal.  8/1 several seizures, back to ER, urine check, strep culture, ears - all o.k.  ER doctor gave valicon suppository if happens again.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients (demographics). The patient's pertinent medical history and concurrent conditions were not provided. On multiple unspecified dates, the patients were administered improperly stored doses of VAQTA (Lot # L023232; expiration date: 25-FEB-2017) (route not provided). The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 34.2 degrees F for 9 days (216 hours). No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
red blotch; vaccination site swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch) and RASH PAPULAR (raised red bump) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RASH MACULAR (red blotch). 11-Mar-2021, the patient experienced RASH PAPULAR (raised red bump). At the time of the report, RASH MACULAR (red blotch) and RASH PAPULAR (raised red bump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient developed two bumps on the inner area of left arm (not at the injection site). She described one was red blotch and the other one was raised red bump. These spots were not present until after she got the shot.  No relevant concomitant medications were reported.   Treatment information included, calamine lotion was provided.   Reporter did not allow further contact
Had muscle pain in the back and legs; Difficult for him to walk straight; This is a spontaneous report from a contactable consumer, reported for male patient (Uncle) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 vaccine, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Had muscle pain in the back and legs, and Difficult for him to walk straight. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Woke up with swollen eyes the following morning. Then, the nightmare began. Feet, ankles and legs (almost twice their sizes) were swollen. Extreme exhaustion and fatigued. Lack of concentration in class and after class causing me to do poorly in school. Dark rash under my chin and stomach. Medical Records received on 3/11/2005 states pain. Per follow up report received 06/10/2005:  Patient still has not recovered. 12/30/2009 I am still not back to normal. I am still experiencing problems with my memories. I must study the classwork material over, and over, and over again (and still there are times when I do not remember or comprehend what I have studied). The nightmare continues because I have problems remembering formulas and some complicated definitions. Please make certain what happened to me does not happen to anyone else. Thank you for caring.
very difficult concentrating; couldn't drive for 6 months; Confusion; hard to talk because confuses the words or have to talk slow so don't confuse the words.; 1st Seizure episode; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (1st Seizure episode) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 028A21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced SEIZURE (1st Seizure episode) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (very difficult concentrating), IMPAIRED DRIVING ABILITY (couldn't drive for 6 months), CONFUSIONAL STATE (Confusion) and SPEECH DISORDER (hard to talk because confuses the words or have to talk slow so don't confuse the words.). At the time of the report, SEIZURE (1st Seizure episode), DISTURBANCE IN ATTENTION (very difficult concentrating), IMPAIRED DRIVING ABILITY (couldn't drive for 6 months), CONFUSIONAL STATE (Confusion) and SPEECH DISORDER (hard to talk because confuses the words or have to talk slow so don't confuse the words.) had not resolved.            Treatment for the events were not provided.  Company comment included This is a spontaneous case concerning a 36-year-old female patient with no reported medical history, who experienced the serious (medically significant) expected event of special interest seizure . The event occurred approximately 20 days after the third   dose of mRNA-1273 and repeated again 23 days later. Very limited information was provided regarding medical history and events. Further information has been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403022 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 36-year-old female patient with no reported medical history, who experienced the serious (medically significant) expected event of special interest seizure . The event occurred approximately 20 days after the third   dose of mRNA-1273 and repeated again 23 days later. Very limited information was provided regarding medical history and events. Further information has been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.
no adverse effects reported; Patient was administered GARDASIL 9 while pregnant; Patient was administered GARDASIL 9 while pregnant; This spontaneous prospective pregnancy report was received from nurse concerning a 36-year-old female pregnant patient, with a pregnancy gestation of 21 weeks and 5 days.  The patient's concurrent conditions included genital herpes, and papilloma viral infection (HPV). The patient had past drug reactions / allergies to latex and metronidazole benzoate (FLAGYL). The patient did not take concomitant medications.  On 08-APR-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose not provided) lot # reported as R024264, date of expiration: 29-OCT-2019, intramuscular as routine vaccine, while pregnant (exposure during pregnancy, product use issue. The patient did not received treatment for the event, and she did not seek medical attention. There were no diagnostic / studies performed. No adverse effects were reported. There was no additional information at that time. Product quality complaint (PQC) was not filed. At the time of report, the pregnancy outcome was pending.
Maculopapular rash started over acute orbital forearm , then face, chest, back, whole arm and legs.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. In December 2016, the patient was vaccinated with an unspecified improperly stored dose of GARDASIL for prophylaxis (lot number K011562 with expiration date of 08-APR-2017) (strength, dosage schedule, route of administration and anatomical location were not reported). No concomitant medications were provided. No adverse effects were reported. The dose of the vaccine experienced a temperature excursion of 35.4 degree Fahrenheit (F) and 34.9 F for 96 hours and 72 hours. The aforementioned temperature was no identified due to a data logger. There were no previous temperature excursions. Furthermore, no product quality complaint was involved. Additional information has been requested.
Arm under injection site turned red and itched a lot. Doctor gave  me cephalexin 500mg for 7 days. I am also taking benedril. Redness is better and itching is much better.
Very bad pain in in the arm in which I received the 2nd dose of the Pfizer Covid Vaccine. It feels like the bone in my arm hurts terrible. I did have pain after the 1st shot but it wasn't 6 days later. This pain has me worried.
Difficulty breathing, Hoarseness, Dizziness, Weakness, rapid heart beat.
Itchy eyes at first then numb upper lip and swollen eyes and cheeks; tired next day after swelling went away.
Vaccinations administered on 7-9-12. Patient seen in ER on 7-22-12 with reaction that started the previous night. Reported reaction was itching and rash/hives that continued despite Benadryl (taken at noon). Pt given 60 mg Prednisone orally in ER and discharged with prescriptions for Prednisone and Benadryl.