chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slow onset of chest pain, shortness of breath, mild cough. Fever of 101 also present on day 2 post vaccination. Chest pain and SOB first occurred on day 3 post vaccination and gradually worsened until day 6. On day 7 symptoms seem to be slightly improving.
Ear fullness; Feels like fluid in ear; Ear is painful; Ear is / ringing; She had vertigo / eyes were not matching up with head; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, 1 days after receiving Shingrix, the patient experienced vertigo. On an unknown date, the patient experienced ear feels clogged, fluid in middle ear, ear pain and ringing in ears. On an unknown date, the outcome of the vertigo was recovered/resolved and the outcome of the ear feels clogged, fluid in middle ear, ear pain and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the vertigo, ear feels clogged, fluid in middle ear, ear pain and ringing in ears to be related to Shingrix.  Additional details were provided as follows: On 5th October 2020, the patient received the Shingrix shot in left arm then the next morning she had vertigo, her eyes were not matching up with her head. Vertigo had resolved. The patient still had ear fullness, feels like fluid in her ear, ear was painful and ringing. The ear problems had not resolved.  The reporter did not consent to follow up.
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L016427, expiration date 13-APR-2017; lot# L004754, expiration date 10-NOV-2016; lot# K020216, expiration date 17-SEP-2016; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Myalgia hip and arm pain x 2-3 days Narrative:  Woke up with severe hip and arm pain after 2nd dose 1/13. Reports feeling better today 1/21/21
This spontaneous report as received from a consumer refers to herself who was a 47 year old female patient, as part of marketing research program. Patient's relevant medical history included type 1 diabetes. On an unspecified date in October 2009 the patient was vaccinated with PNEUMOVAX23 (strength, formulation, lot#, dose, route and duration were unspecified). Concomitant therapy might included flu shot received at the same time. On an unspecified date in October 2009, after receiving shot, the patient experienced tennis-ball sac swelling on elbow and flu-like symptoms. Patient was treated with BENADRYL. The outcome of events was reported as recovered/resolved in 2009, "about 3 days after onset". Action taken was reported as "none". Reporter considered the events as non-serious and considered the events as related to the suspect therapy. Additional information has been requested.
Heart palpitation's -- increase heart rate followed by low heart rate and dizziness off and on for one week .
Trouble swallowing, chest pains, hard to breathe, muscle soreness. No treatment as no doctor can figure out what is wrong.
headache; a little diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and DIARRHOEA (a little diarrhea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-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 HEADACHE (headache) and DIARRHOEA (a little diarrhea). At the time of the report, HEADACHE (headache) and DIARRHOEA (a little diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Advil   This case was linked to MOD-2021-026067, MOD-2021-026020 (Linked Report).; Sender's Comments:  MOD-2021-026020:same reporter, different patient and event MOD-2021-026067:same reporter, different patient and event
Trainee received TDAP vaccination today instead of second dose of HEP B. Trainee received 1st dose of TDAP 7 weeks ago. Trainee was briefed on the error, expected side effects, the need to receive the HEP B vaccination in the next few weeks, and to seek medical attention for any medical concerns.
administered an expired dose of TENIVAC with no reported adverse event; Initial information was received on 24-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 75 years old female patient who was administered an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jan-2023, the patient received 0.5 of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6922AA and expiry 22-Jan-23) (expired product administered, latency same day) (formulation and strength: unknown) via intramuscular route in deltoid NOS for prophylactic vaccination.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired dose of tenivac with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had normal side effects at first. But this morning at work,(a week after vaccine), where I had the injection from the vaccine is red, swollen, and itchy. I spoke with my dr and he said it may be an allergic reaction to the vaccine and told me to report it here.
This spontaneous report as received from a healthcare worker refers to a 20 month old patient of unknown gender. On 29-AUG-2008 the patient was vaccinated with first dose of M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown) 0.5ml subcutaneously. No concomitant medications were reported. On 01-APR-2009, the patient received second dose of M-M-R II since the office was not aware that the patient had received the first dose on 29-AUG-2008. No adverse event was reported. The action taken with the therapy with M-M-R II was unknown. Additional information has been requested.
a huge swollen lymph nodes under her left armpit on the same side where she received the injection; This is a spontaneous report from a contactable Pharmacist(patient). A female patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 16Jan2021 at single dose, in left arm for covid-19 immunization. The patient received first dose of BNT162B2 on 26Dec2020 for covid-19 immunization. The lot number from her first dose was EL0140. The patient's medical history and concomitant medications were not reported. She got the second shot on 16Jan2021. The next day she experienced a huge swollen lymph nodes under her left armpit on the same side where she received the injection and she still had them. She was asking what she should do. The patient was wondering if she should be concerned if her lymph node was still swollen after 10 days. The outcome of the event was not recovered.    Information on the Lot/Batch Number has been requested.
rash and welps on neck and chest, pcp prescribed steroids , goes away but comes back when it wears off
The initial pain at the injection site turned into long-standing pain throughout the deltoid muscle and the entire rotator cuff. Muscle and shoulder joint soreness. Often accompanied with muscle weakness, particularly lifting arm above head, moving arm from in front of midline to right side (abduction, but from raised arm position most painful & most weakness). As of 5/20/21 this pain & weakness has not subsided. No treatment attempted.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 31-JAN-2014 (it was also reported as 13-JAN-2014), at 09:00 pm, the 25 year old female patient was vaccinated with the third dose of GARDASIL (lot # reported as J005661) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Got shingles.; Got shingles.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
03/17/2021 Night of the vaccination fatigue for the week and aching, fever of 102. developed the following week and lasted two weeks, taste was off, was able to control the fever with Tylenol but if she went too long with out Tylenol the fever returned. In person visit for  blood, chest ex-ray to check for pneumonia, urine and stole test and while blood count enzyme's and liver enzymes was up, function up. Went in once a week for three weeks for three weeks for blood test. Was tested for bacteria infection in stomach.
Sxs onset 7/17. Moderna-1/21 and 2/18. Admitted to hospital 7/18 to 8/09. Died on 08/09 due to COVID related death per Disease report. Never admitted to ICU. Was in Step Down unit when he passed away
14DEC97 began w/redness, head, extending down from deltoid in lt arm towards elbow;patchy type, raised rash;
rashes; This is a spontaneous report received from contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious), outcome "unknown", described as "rashes".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
developed hives, and scratchy throat. Was give 50 mg of po benadryl at 3:30pm. Hives and scratchy throat were gone by 5:30 pm
Case number PHEH2015US022366, is an initial spontaneous report received from nurse on 29 Oct 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUVIRIN (batch number: 1515101) at a dose of 0.5ml subcutaneously on 21 Oct 2015. On the same day after vaccination patient had an injection site reaction. Outcome of the events was reported as unknown. Events were reported to be non-serious and causality of the events was not reported.
19MAY94 swollen gland rt side of neck, fever x few days, tired; rx Duricef; 21MAY93 gland 5cm hot red, fixed, pt cranky fretful; fever @ home; adm to hosp;
Urticaria with mild angioedema (lips). Started with full body pruritis. Then I started to have had random patches of hives that come and go on various parts of my body. Hydrocortisone cream and Claritin are helpful but rash continues.
61 yo male who developed shoulder & upper arm pain (left) after receipt of IIV at flu drive. He states he was sitting and the vaccinator was a nurse, and she was standing. He states the injection site was higher than usual and he felt an immediate 'shock' electrical like pain from his shoulder to his fingers. He states it resolved but 1-3 days later he developed a dull ache in the shoulder and down the upper arm to his elbow, but does not radiate further. There was point tenderness at the upper deltoid/ lower shoulder, posterior portion in the soft tissue. It has improved over time and is now intermittent. It does not affect sleep. He has normal ROM and strength. This is his nondominant arm and he has no history of injury.
Pt presents as standby stating that left arm is swollen, red, painful and itching due to MMR vaccine given on 5/16/22. Pt was in good spirits, humor and disposition. Pt states that itching began immediately after the injection and a few hours later "a warm lump that is itching and painful started forming". Pt rates pain on left arm as an 8/10. Pt states she cannot hold baby on left arm. RN observed pt's arm and noted a red lump on pt's left subq under arm area. The lump measured 2" wide by 3.5" long. RN noted that  the lump was warm to the touch. Pt denies fever, dizziness, confusion, facial swelling, lymph node soreness, joint stiffness, and notable tachycardia. RN reviewed ED precautions in detail and pt stated understanding. RN suggested use of Benadryl to manage localized allergic response as well as warm and cold compresses and ROM. RN scheduled a telephone follow up for 05-19 at 0900 and completed a VEARS report. All questions answered.
Lots of redness, approx. 3" diameter bump. Tenderness and very painful. Noticed bump same day, but got worse. It even felt hot to touch. We visited Dr.'s office on 9-10-09 and Dr. prescribed my daughter CEPHALEXIN 500 mg capsules. Daughter has a follow up appt. on 9-17-09 at 15:50.
Weakness all over, questionable orthostatic hypotension at home. None noted at office.
PT BECAME DIAPHORETIC PALE AND VOMITED X1 5 MINUTES AFTER RECIEVING THE VACCINE
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. Concurrent medical conditions included asthma. On 5th April 2018 18:00, the patient received the 1st dose of SHINGRIX. On 5th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th April 2018, the patient experienced injection site swelling. In April 2018, the patient experienced skin discoloration and pruritus. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site swelling, skin discoloration and pruritus were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling and skin discoloration to be related to SHINGRIX. The reporter considered the pruritus to be related to SHINGRIX. Additional details were provided as follows: The caller was physician, who was good family friend to the patient. The patient received SHINGRIX in left arm and experienced pain at the injection site the first evening, but nothing too significant. The next day 1 day after receiving SHINGRIX, the patient experienced large swelling of the full deltoid muscle. Less than a week after receiving SHINGRIX, the patient experienced a 4cm x 3.5cm area that was pink in color and itching. The pain was worsened. The patient was directed by physician to take an antihistamine and he notes the swelling was decreasing. The physician was not aware of the dose or how the product was given or the lot number she had received. The patient called for inquiring if she should receive the second dose or not based on her localized reaction. The patient was transferred to the Medical Information Scientist to discuss.
Approximately 9:00 PM, experienced severe chills, after having zero side effects all day.  She went to bed, and could not get warm.  She was unable to use body muscles, could not stand without help, and was conscious, but was unaware of her surroundings.  She started regaining muscle control about 12:30 AM, but still no awareness of things around her.   Next morning, she was fine, with no remaining side effects.  It should be noted that she had a small glass of red wine about 30 minutes before experiencing chills.
Patient stated she received second dose of Moderna 2/26/2021. She stated she had some seide effects for a couple days and that was it. She stated she now has discomfort at the injection site. RN asked if she tried Tylenol or Advil and she stated she did but it did not help. RN reviewed trying acool compress at the site.
After giving the 3 vaccines, I was by the door leaving the room and  I heard the child's  mom screaming for help because the patient faint. I turned around and saw patient lying on the floor, he was bleeding from his gums and lips , I hold him while the Dr went into the room with the other nurse. Dr did an examination to the patient vital sign were steady. We put some gauze into child's mouth to stop the bleeding. We gave water to the patient while he was sitting down. We observed him for 1 hour, vital signs were steady  and we release him to go home.
Information has been received from a pharmacist concerning to her 21 year old daughter with allergic reaction to cefaclor (CECLOR) and ovarian cyst, in the last year (in 2007) was vaccinated with three doses of HPV 4L1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included duloxetine hydrochloride (CYMBALTA) and lamotrigine )LAMICTAL). The patient developed fibromyalgia and more severe migraine headaches after received three HPV 4L1 6 11 16 18 VLP vaccine (yeast) injections "last year" (date unspecificed). The fibromyalgia was diagnosed in February 2008. Blood studies performed (results not provided). The patient was prescribed cyclobenzaprine HCL (FLEXERIL), gabapentin (NEURONTIN) and eletrptan hydrobromide (REPLAX). At the time of the reporting the patient was not recovered. The patient sought medical attention in office visit. There was no product quality complaint. Additional information is expected. 11/11/08-records received for DOS 10/9/07-C/O migraines times 1 week, body aches. Stress at school. Received 1st Gardasil vaccine 10/9/07-second dose 12/17/07 and 3rd dose 4/22/08-
dizzy; doesn´t feel good; she was going to throw up; diarrhea; chills / shivering; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019, refer case US2019201110).   On 29th October 2019, the patient received the 2nd dose of Shingrix. On 29th October 2019, 8 hrs after receiving Shingrix, the patient experienced chills, headache and nausea. On an unknown date, the patient experienced dizziness, feeling unwell, vomiting and diarrhea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, headache, nausea, dizziness, feeling unwell, vomiting and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache, nausea, dizziness, feeling unwell, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: On 29th October 2019, patient received dose of Shingrix at around 10 am. By 6 pm on the day of vaccination, the patient had chills, shivering, headache and nausea. By 8 pm, the patient went to bed and could not get ou of bed untill 3 pm the following day. Less than a week after vaccination, the patient had dizziness, feeling unwell and vomiting. The patient would get dizzy and felt as if was going to threw up. Several days later, the patient had diarrhea everithing she ate. Till the time of reporting, th patient still not feeling good but was able to get up and move around.
I now have tinnitus. I believe it started in November or December of 2021, so possibly coinciding with the Moderna booster following two Pfizers.
Left arm was red and swollen and Mom states redness went across chest. Mom took child to local urgent care the next day and was given ATB and steroids. She was told the client had cellulitis. She came in on Monday and reported the reaction to the Nursing Director who observed his arm and did see redness and swelling but NO redness across chest.
8 1/2 hours post vaccination I started with a headache and fatigue. 10 1/2 hours post vaccination severe chills vomiting and extreme feeling of cold. Fever broke at 13 hours post vaccination. Then body aches fatigue and joint pain and continuation of headache. Lasted until 36 hours post vaccination.
Pt given 4 vaccines on 3/11/2010: see below. Initially - parents report fussy crying x 3 days (3/11 - 3/13) followed by hoarseness since that time. Seen in office today.
The day after immunizations, the pt developed fever to 103F and had a 3-4 minute, generalized seizure. Nine days, post vax, she had recurrent otitis, fever to 102F and a seizure for 2-3 hours, on and off. Started seizure med and given antibiotics.
In 5/00, the vaccinee received her 1st injection of Lymerix. Beginning in 6/00, she began to experience numbness and tingling in her left leg, numbness of the fingertips on her left hand, loss of equilibrium, lightheadedness and veering toward the left on ambulation. The vaccinee subsequently, received her 2nd and 3rd injections of Lymerix in 6/00 and 6/01, respectively. On an unspecified date, a neurologist mad a dx of CNS demyelinating process. As of 3/13/02, the event was ongoing. CNS demyelinating process is considered to be "Medically Serious". The most recent information was received on 4/23/02. The reporting neurologist considered the events to be possibly related to Lymerix administration. The events were worse as of 4/23/02. The follow up states she smoked one pack of cigarettes per day for thirty years, and used alcohol (especially). She had no adverse expereinces following receipt of previous immunization. MRI of the thoracic spine performed on 3/1/02 was normal. MRI of the cervical spine performed on 3/1/02 showed "several plagues consistent with demyelination." The most recent info was received on 4/25/02. The reporting neurologist considered the events to be possibly related to LYMErix administration. The events werre "worse" as of 4/27/02.
p/vax pt lt upper arm @ inj site red, firm & itchy;no resp distress, no hives;T97.8;advised to alternate advil w/APAP;hydrocortisone cream applied to inj area to dec pruritus;redness resolved;