chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weak; fatigue; feels out of it; injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included shoulder pain.   On 16th October 2019, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 16th October 2019, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site pain. On 17th October 2019, the patient experienced weakness, fatigue and feeling abnormal. On an unknown date, the outcome of the injection site pain, weakness, fatigue and feeling abnormal were unknown.   It was unknown if the reporter considered the injection site pain, weakness, fatigue and feeling abnormal to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: On 14th October 2019, the patient received Steriod injection in her left shoulder due to pain. The patient received Shingrix in her right arm and  flu vaccine in the left arm. The reporter did not knew the name of the flu vaccine she received. The patient experienced soreness at the injection sites but on the day of reporting, the patient was weak and felt out of it. The patient asked about the use of shingrix with the steriod injection, but was told by the pharmacist so long as she was not taking it, she would be fine. The patient also asked about receiving the flu vaccine at the same time, if that could also be causing the weak feeling.  The patient was referred to discuss these issues with her physician but also shared the side effect of fatigue from the clinical trials and use with GSK flu vaccine of Fluarix.
he is bedridden with fever, tremors and pain; he is bedridden with fever, tremors and pain; he is bedridden with fever, tremors and pain; Initial information received on 29-Oct-2021 regarding an unsolicited valid social media serious case received from a consumer or non-healthcare professional via social media via Digital Media.  This case involves a 74 years old male patient who is bedridden with fever, tremors and pain (Pyrexia, tremor,pain) after  receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient was bedridden with fever, tremors and pain (Pyrexia, tremor,pain) (unknown latency) following the administration of INFLUENZA VACCINE.   All events were leading to disability (bedridden).  Additional information was reported as healthy 74 year old uncle took that flu shot against his wife's advice and now he is bedridden with fever, tremors and pain. This is an atrocity. And by the way, its the shedding from the flu shit that causes flu season as it gets on everything and makes everyone in contact susceptible. Stop this quackery and virtue signaling now.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.; Sender's Comments: This case involves a 74 years old male patient who was Bedridden with Pyrexia, tremor, pain after the vaccination with INFLUENZA VACCINE . Time of onset is unknown. Further information regarding medical condition during vaccination, previous vaccination and tolerance, other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.
pt recv vax & devel an inj site rxn characterized by swelling, redness & inflammation;pt tx w/ice packs to the site;
Fever, had similar fever after 12 month Varicella, PCV7, DPaT & purulent URI.
I felt/feel wheezy. Like I was experiencing asthma so I used my inhalers more than usual and I took benadryl regularly to minimize the wheezing.
Stiffness; Lethargic; Headache; Intense muscular pain in the lower back (left side) laying down flat on back sent shooting pain; Shooting pain/bit sore; Mild flu; Seasonal allergy type feeling; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 11:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR), clonazepam (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), naltrexone (MANUFACTURER UNKNOWN) and loratadine (LORAT); all taken on unknown dates for unknown indications and unknown if ongoing. On 17Apr2021 at 23:30, 12 hours post shot, the patient experienced mild flu/seasonal allergy type feeling. On 18Apr2021 at 15:00, the patient experienced stiffness, headache and was lethargic. The symptoms progressed throughout the day, some were lessening, others were worsening. On 18Apr2021, about 36 hours after shot, the patient experienced the worst effect - intense muscular pain in the lower back (left side). The patient laid down flat on back which sent shooting pain. The patient had a high pain tolerance and it was intense and the patient was eventually able to find a comfortable position in bed, fetal on right side with head at odd angle. On 19Apr2021, next day the patient was still sore but the intense shooting pain had passed and was able to sleep. The patient reported that it was still a bit sore/stiff. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events mild flu, seasonal allergy type feeling, headache, and lethargic were recovered on an unknown date in Apr2021. The clinical outcome of the events intense muscular pain in the lower back (left side) laying down flat on back sent shooting pain, shooting pain/bit sore and stiffness were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt called 6/27/13 to be seen for adverse reaction to Tdap given 6/21/13. Left arm red, warm to touch, swollen.
acute hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. In or around 26-MAY-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than two months after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered and was diagnosed with acute hearing loss. As a direct and proximate result, the zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, acute hearing loss was determined to be medically significant and disabling.
Breakthrough case admission after 2 vaccines Pfizer 3/12/21 Lot# En6207;  Pfizer 4/7/21 LOt# ER8727
Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: Health Center Manager stated that an expired dose of Pediarix was administered to a patient today (on the day of reporting). The reporter consented to follow-up via postal. Additional Supportive Information:  The patient received a dose of Pediarix which was already expired on 5th September 2022, which led to expired vaccine used. This case has been linked with case US2022128918, reported by the same reporter.; Sender's Comments:  US-GSK-US2022128918:Same reporter
Severe arm pain, fever, achy joints, muscle aches,  headache,  upper back muscle weakness, faintness. Lasted for 30 hours.
swelling; redness at site of inj; fever at site; palm size; no streaking-Dr. looked at site and Rx Keflex 250 TID x 7 day
Hot red rash first appeared behind knees, then on elbows, the on knees and shins, then by sitting bones and then ankles over the course of a week.  Prednisone was prescribed and helped.
Diarrhea, gas, distended stomach. pain. Started within 4 hours of dose and continued for 8 hours (took sleeping pill)
pt recvd vax;2 days later, exp eyes swollen shut, face swollen, fine raised rash on face & cheeks red; tx w/ dph; sxs have not subsided;
Site: Swelling at Injection Site-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient came to pharmacy with slightly swollen arm at site of injection, warm to touch and a swollen lymph node slightly red in appearance, warm to touch on the left side of patient's body near the neck. Patient was instructed to take benadryl and to draw a circle around both sites of swelling to monitor. This started about 24 hours post-vaccination. Patient was instructed to seek help at Urgent Care or ER regarding further treatment if swelling did not go away.
mom states pt devel severe h/a 1/2 hr p/shots; states also had vomiting & t103.4; pt taken to hosp 8DEC92 to 10DEC92;
Information has been received from a health professional concerning a 46 month old male, with no known allergies or medical history who on 12/28/2000 was vaccinated with the first dose of varicella vaccine SC in the thigh. On 05/29/2001, the pt developed chicken pox which was described as 10-20 lesions, mostly on the trunk of the body. The pt did not have a fever or any other symptoms. There was no known exposure to wild type chicken pox. The pt sought unspecified medical attention. Subsequently, he recovered on 06/03/2001. No additional info is expected.
had redness on his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "had redness on his arm".  Additional information: Caller stated she was calling about the Pfizer vaccine for coronavirus and stated they had a little bit of confusion and she called her husband's internist office and inquired whether or not he should get the 2nd booster vaccine and the last one he had was his 2nd booster and that was in September; stated she asked because the patient had an appointment with his endocrinologist so she called the endocrinologist because he has two physicians and the endocrinologist called her back and said the patient could wait for the 2nd booster dose or until there was a surge to get the 2nd booster or he could get it now. Caller stated she heard what the endocrinologist said and that HCP managed the patient's health and the internist's office got back to her yesterday and said that yes the patient should go ahead and get the 2nd booster now and because there was a surge now and the question they have also was when the office got back to her and said the patient should request the new FDA approved vaccine, she was not sure and the patient called his pharmacy this morning and she wanted to ascertain does someone have a new vaccine out for the 2nd booster as it was approved by the EUA and now the FDA; caller clarified the patient has not gotten the 2nd booster vaccine yet. Caller awared that Pfizer unable to offer medical advice or treatment recommendations. Caller stated her husband also said he had redness on his arm after the vaccine and she told him well everyone has redness on their arm. Caller stated she would have to go get the vaccine cards as it was not with her at this time and asked if she could do the reports online at a later time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chest pain approximately 5 minutes post vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: FD0809, Expiration Date: 10Jan2022) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 07Jan2022, outcome "unknown", described as "Chest pain approximately 5 minutes post vaccination".  Additional information: The reporter stated that vaccine was administered at one of their specific fixed vaccination site and that particular day, 3 of their individuals between ages of 14 and 16 had adverse reaction, 3 which were 'about the 10% reactive' for that day'. The reporter stated the vaccine was administered for provision not for treatment. Further stated that 1st patient was a 14 years old female which reported chest pain approximately 5 minutes post vaccination. The reporter stated that immediately after vaccination on 07Jan2022, these vaccines were pulled '"from use" to "for do not use". The reporter stated that 2 of the 3 did seek emergency room care and was unaware of the outcome and for evaluation yes for the 2 that had chest pain for both of them.  Follow-up attempts completed. No further information is expected.
Pt called 9/13/19 with chills, headache and muscle aches.  Pt advised per office to take Advil. Left 2 messages and sent pt message for follow up post vaccine. No follow up from pt received.
This happened to me after cancer and a shingles shot; Suspected vaccination failure; Cancer; This happened to me after cancer and a shingles shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: This happened to me after cancer and a shingles shot; Suspected vaccination failure) (serious criteria GSK medically significant), cancer (Verbatim: Cancer) (serious criteria GSK medically significant) and shingles (Verbatim: This happened to me after cancer and a shingles shot). The outcome of the vaccination failure, cancer and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, cancer and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, cancer and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by the patient via interactive digital media. The patient reported that this happened to him/her after cancer and a Shingles shot. This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
First noticed tinnitus in 12/22, followed that month by sudden loss of hearing in right ear (robotic sounds, loss of hearing, unable to distinguish speech in a group, some balance issues that I noticed because I am a dancer).  1st doctor's visit 1/13/ 2023, tuning fork test showed loss of hearing on right side.  Referred to audiologist but could not get appointment till 3/6/2023.  Confirmed loss of lower tones in right ear.  Phone appointment with ENT specialist, Dr, who prescribed prednisone 60 mg. for 7 days (for inflammation) and ordered MRI to rule out tumor, etc.  Tests showed inner ear normal, no tumor, brain normal.  Recommended Flonaise for possible blockage of eustachian tube.  Steroids didn't help, sense of fullness has intensified, as has tinnitus and increasing hearing problems.  Can no long sing with a group because I can't hear my voice because of the tinnitus and compromised hearing.  Visit to my regular doctor 4/25/23 confirmed  problem likely being eustachian drainage.  My only options right now are continuing the Flonaise/Ipratroprium treatment and/or a steroid injection through the eardrum to reduce inflammation,  The onset of all of this was sudden and has quickly changed my lifestyle and activities.
Headache, Myalgia, Arthralgia, Fatigue and flu like symptoms Narrative:  Other Relevant History:
Pt presented with persisting right leg pain that seemed to spread to the hip. Pain appeared approximately 1 day after receiving second dose of Pfizer COVID vaccine. Second dose received on 4/29/2021. Additionally, the patient experienced fever, chills, and fatigue, which had resolved by her presentation to the clinic on 5/3/2021. Pt noted the pain was partially positional, but was constant and found little relief with tylenol purchased over the counter. On physical exam, swelling of the lower extremity was noted with decreased hip ROM. Pain was ellicted on palpation of the calf. No erythema was noted. Pt was sent for Venous Duplex Ultrasound of both legs which was positive for deep vein thrombosis in the right leg.
Pt became limp and unresponsive within 2 hours of vax, had a fever of 102 within 6-8 hours lasting 2 days. Pt remained limp (flaccid) for approximately 16 or 17 hours. Pt experienced a rash with fever and difficulty with nursing for 2 days.
Redness, minor swelling and warmth noted on (L) upper arm surrounding injection site of flu vaccine.
Low humming noise in head.  Very hard to sleep and stay asleep. Finally visited doctor (my doctor was out of office) on 3-30 to discuss and see if ok to get 2nd dose. He called CDC and came back saying they said ok and looked at ears and routine checks and said ears looked fine, referred me to ENT. 2nd vaccine on 4-8-21.  Later same day humming changed to a loud high pitch noise 24/7. Visited doctor ENT on 4-14-21, he put me on 24 days, starting at 80 mg daily for 5 days with slow weening off of Prednisone.  Finished medicine with no changes but experienced awful side effects from steroids.  Next visit to doctor will be 5-24-21. Will also have a hearing test same day.  I have also been having dizzy spells.
c/o soreness, swelling, warmness from Td given 8DEC97;area red w/swelling noted, warm to touch lt arm;MD assessment all signs inflammation, redness, warmness, swelling,pain;