chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hard time raising arm; Pain in left arm and upper back left side that lasted few days; Upper back leftside; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease and allergy to penicillin and sulfa. 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 escitalopram oxalate (LEXAPRO), pravastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and lorazepam (MANUFACTURER UNKNOWN); all for unspecified indication and unknown start date. The patient previously took codeine (MANUFACTURER UNKNOWN) and methocarbamol (MYOCIN) and experienced drug allergy. On 01Apr2021, the day the patient received her 2nd dose, she had pain in her left arm and upper back left side that lasted few days. Pain in left arm never went away. Hard time raising arm or using arm and without pain still existed. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event she had pain in her left arm, hard time raising arm or using arm and without pain still existed was not recovered and she had pain in upper back left side was recovering at the time of this report.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
soreness in my arm; This is a spontaneous report from a contactable nurse (patient). A 52-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EH9899; expiration date: not known), via an unspecified route of administration on left arm on 15Dec2020 at single dose for covid-19 immunization, administered at hospital. Medical history included idiopathic epilepsy. The patient's concomitant medications were not reported. With first dose, the patient experienced soreness in his arm with no other symptoms on an unspecified date. The outcome of the reported event soreness in his arm was unknown. On 06Jan2021 10:45, the patient received second dose of vaccine. On 06Jan2021 at 17:00, the patient had fatigue two days after as well lymph node swelling in armpit of arm where second dose administered.
I have experienced severe episodes of nausea with some vomiting and feelings of near syncope. The near syncope resolved when lying down but returns when standing up. The nausea seems to be intermittent and also improved when lying down. Earlier this morning at approximately 3 a.m. I woke with chills and nausea which lasted an hour. When the chills resolved I began to feel very warm as if I had a fever but I did not get up to check my temperature.
Shot administered approx. 5:10 pm on 8/24/12, approx 20 mins later pt. felt to dizzy to drive or walk. Daughter came to pick her up. Pt. sat in waiting area for approx 1 hr. Also had headache in front. After approx. 3 hrs. pt. states HA went away and at 11 pm that night dizziness subsided. Next day noticed 2 inch radius of redness at inj site and gone in the afternoon.
redness surrounding site with raised lesions, warmth, and red streaks; fever to 100.6
Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.
Case number PHEH2014US003639 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. It was reported that this patient under 18-uears of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Patient received the Pfizer COVID-19 vaccine on 1/14/21 and 2/4/21 so was fully vaccinated when they tested positive for COVID-19 on 9/11/21. The patient was admitted to the Med/Surg unit at Hospital with a diagnosis of COVID-19.
Sweats- muscle tremor- chills-malaise-Fever decreased 102. Increased 102- nausea-diarrhea-"Black watery" urine-"Rusty". Arthralgia, myalgia.
Paxlovid as treatment for COVID-19; Paxlovid as treatment for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 at 12:00 as dose 1, single (Lot number: EL9265), in right arm, on 16Feb2021 at 12:00 as dose 2, single (Lot number: EN6200), in right arm, on 05Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FH 8 or 3), in left arm, on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989), in right arm and on 03Oct2022 at 12:00 as dose 5 (booster), single (Lot number: EL9265), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypo thyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: sulpha antibiotics" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 02Jan2023, stop date: 16Jan2023; LOSARTAN POTASSIUM, start date: 02Jan2023, stop date: 16Jan2023; ROSUVASTATIN, start date: 02Jan2023, stop date: 15Jan2023; VITAMIN D NOS, start date: 02Jan2023, stop date: 16Jan2023; D-MANNOSE, start date: 02Jan2023, stop date: 16Jan2023; VITAMIN C ACID, start date: 02Jan2023, stop date: 16Jan2023; CALCIUM 600 + D, start date: 02Jan2023, stop date: 16Jan2023; B-12, start date: 02Jan2023, stop date: 16Jan2023; ESTRADIOL, start date: Jan2023, stop date: Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid as treatment for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was received Paxlovid as treatment. treatment start date Jan2023, and treatment stop date Jan2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300040180 Same patient/drug, different dose, different event;
Approx 4 hours after receiving Flu vaccine patient started with increased pulse, chills, T.102 ax, diarrhea. 10/26/27/2009 hospital records for dates 10/12-10/19/2009. Patient with initial sx of: weakness, cough, fever, diarrhea, lethargy, dehydration, difficulty urinating, hypotensive. Tx: O2 per nc, IV rehydration, IV ABX. Dc Dx UTI w/sepsis, CHF.      ICD-9 codes: 780.60, 038.49, 995.91, 599.0, 276.51, v50.61, 403.90, 585.9, 428.0, 427.31, 453.51
HCP reported that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: X007358, Expiration: 9/; HCP reported that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: X007358, Expiration: 9/; Information has been received from a health care professional, referring to a 1 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-SEP-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #X007358, expiration date: 09-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided); and with an sterile diluent (STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, lot number reported as "W034712", expiration date: 19-JUL-2025 (strength, lot #, route of administration, and indication were not provided). No adverse effects were reported.  The vaccine had a temperature excursion of 13.2 Fahrenheit (F) during 5 minutes. It was confirmed that no previous temperature excursions occurred.
Red blotchy face about 15 min after shots almost looked likes hives but we undressed her and it was not on rest of her body and seemed to fade after 30 min.
Tiredness; Chills; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction (no medical history reported). Concomitant products included HCTZ and METFORMIN for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site). On 26-Mar-2021, FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (batch/lot number and expiration date were not reported) as an unknown dose number, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced heavy menstrual cycle bleeding after receiving the COVID-19 vaccine on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
I woke up feeling like I had a cold. I was starting to cough a little bit and had nasal congestion. The symptoms got worse. I was coughing a little more and had a little bit of a headache. The next day, I tested for COVID-19 at home. The result was negative. I thought I just had a bad cold. I was coughing and my nose was running a lot more. On day four, I tested for COVID-19 again. The result was positive. I called my doctor. He prescribed PAXLOVID. I started it the same day. I was told to take it for five days. The medicine seemed to calm my cough, but it didn't go away completely. The nasal congestion just stopped. The medicine tasted metallic. I took another COVID-19 test at the end of the fifth day of taking the medication. The result was still positive. I took another COVID-19 test on March 18, 2023. The result was negative. I still have a lingering cough. I took another COVID-19 test on March 22, 2023. The result was still negative. I have a cough in the morning and when my throat is dry.
Pt recv vax on 10/28/97 & 12/2/1997; post vax had idiopathic epilepsy, Dr does not think it is related.
Pt who experienced the severe (albeit within the normal expected range of possible side effects per manufacturer and CDC guidelines) went with his wife to get their second in their two-dose series. By evening male recipient who had marked rxn began to "feel bad" with tiredness, arm pain, and fatigue with the onset of headache. By midnight the wife was screaming for me (the son) to come help. The pt was shivering so bad he couldn't walk. He was in severe pain along with his headache.  He experienced rapid onset nausea which despite oral tablet 12.5mg of Phenergan around 9:30 PM and was given 25 mg of liquid oral promethazine (20ml).  He held down the liquid promethazine for approx 15 minutes and violently threw it up.  During this time a large hot bath was drawn in the whirlpool tube which he stripped and entered. He was also made some hot tea with honey and given two glasses of that to help with internal GI warming.  A heating pad was placed in his bed under the sheets for when he exited to aid in the warming process. Once out of the bath, warmed, in warmer clothing - and having held down the tea he was given 8mg Zofran ODT which was well tolerated. Pt was observed from approx midnight to 6 AM when he got up and was able to perform his normal household morning "rituals" under his own mental faculties without assistance. **IN regards to question 21 below** the person making this report now - is a critical care paramedic, FF, instructor, and has a background in field and trauma medicine as well.  Outside of working 20 years on an ambulance/fire truck I also worked in the clinical medical setting with an extension of my license in family/internal medicine, rheumatology and immunology, and pediatrics. I had spent years giving vaccines, entering data into state systems after administration of vaccines, as well as using the VAERS systems when there were "adverse events." Diagnostics devices were here at the house for temperature, blood pressure, blood sugar, O2 saturation, etc.  There is a local hospital 1 mile away. I felt QUITE comfortable treating the patient at home with my skills - and if at any point I felt there had been a significant adverse si/sx emerge I would have ensured the pt went to a higher level of care.  Also how I am able to remember and provide certain details in this report. I have left the pt's name and the majority of his identifying information out BECAUSE "he doesn't trust government databases."
Patient described injection site reaction of swollen bump that he experienced after receiving the shot. Patient decided to call pharmacy at 09/15/2015 around 4:45pm describing bump is still there. Advise patient to apply a cold compress to the site for approximately 15 minutes if soreness and swelling of injection site. Also recommend analgesic (i.e. NSAID/APAP) if no contraindications to it for pain. Also, to seek medical attention if it gets worse.
Breast, right: Ductal carcinoma in situ nuclear grade 1, Stage 0
There is something or pain in the left neck area.; Pain went up to her jaw and to her left temple; She felt like she had to throw up, and she still feels that way.; Massive headache; Something in the muscle between arm and neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (There is something or pain in the left neck area.), PAIN IN JAW (Pain went up to her jaw and to her left temple), NAUSEA (She felt like she had to throw up, and she still feels that way.), HEADACHE (Massive headache) and MUSCLE DISCOMFORT (Something in the muscle between arm and neck) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (a couple of heart procedures last year.). Concurrent medical conditions included Diabetes and Cancer.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced NECK PAIN (There is something or pain in the left neck area.), PAIN IN JAW (Pain went up to her jaw and to her left temple), NAUSEA (She felt like she had to throw up, and she still feels that way.), HEADACHE (Massive headache) and MUSCLE DISCOMFORT (Something in the muscle between arm and neck). At the time of the report, NECK PAIN (There is something or pain in the left neck area.), PAIN IN JAW (Pain went up to her jaw and to her left temple), NAUSEA (She felt like she had to throw up, and she still feels that way.), HEADACHE (Massive headache) and MUSCLE DISCOMFORT (Something in the muscle between arm and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Patient consented to safety follow up through her phone or email. She consented to safety follow up to her doctor.
The patient developed shortness of breath with activity. The following day she spoke with me, her primary care provider, and I sent her to ER whereby she was found to have submassive pulmonary embolism.
Enlarged knuckles; increased arthralgia in knuckles; This case was reported by a consumer via call center representative and described the occurrence of finger arthritis in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than 2 weeks after receiving Shingrix, the patient experienced finger arthritis and arthralgia. On an unknown date, the outcome of the finger arthritis and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the finger arthritis and arthralgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: The case was self reported by the patient.  The patient received first dose of Shingrix on right arm. The patient reported that while removing wedding ring from ring finger on right hand because it felt snug approximately a week to a week and half after receiving dose.  The patient reported that when they attempted to put their wedding ring back on, they were unable to get it past the middle knuckle due to the knuckle being enlarged.  The patient reported that they were trying to put on ring on the left ring finger and noticed the left middle knuckle was also enlarged.  The patient located rings purchased for index finger to see if it would go past the middle knuckle on index finger.  The patient confirmed ring for index finger would not go past the middle knuckle on their right hand.  The patient reported the rest of their fingers are not swollen; only the middle knuckles.  The patient would take wedding ring into jewelry to confirm the size, which was size 6.  The patient reported jewelry confirmed size and measured around middle knuckle and advised size was now 6 and three quarters.  The patient reported that the weigh was less than they did when rings were purchased, so they feel know the enlargement of their middle knuckles was not due to weight gain.  The patient visited to seeing a rheumatologist a couple of months after receiving first dose of Shingrix.  The patient did not have rheumatoid arthritis.  The patient reported that increased arthralgia in the knuckles, since receiving first dose of Shingrix.  The reporter did not consent to follow-up. This case has been linked to the US2022AMR146029 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR146029:Same reporter
suspected vaccination failure; had shingle flare ups; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. The patient never had shingles but through the advice of their doctor because of his/her age got the Shingles vaccine. Since receiving Shingles vaccine, the patient had shingles flare ups. The reporter stated that, like any other vaccine, if effects each person differently due to a lot of variables. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This is 1 of 4 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR184304:Same reporter US-GLAXOSMITHKLINE-US2021AMR184294:Same reporter US-GLAXOSMITHKLINE-US2021AMR184332:same reporter
Horrible pain in shoulder, ":robbed of a night's sleep" , and cannot raise her arm all of the way. She also states she worked for a physical therapist and knows about rotator cuff injuries. Has had a rotator cuff injury as a child.
She reported achy muscles (especially legs), chest tightness and a productive cough. This began on 1/11/2021. I told her she could take Tylenol for the aches. She is going to monitor the other symptoms and if they progress or get worse she will call her primary care doctor. She thinks it is just the start of a cold.
On 13May91 pt recved 2nd dose of vax but was inadvertently admin a 2 ml dose of hep B vax instead of 1 ml.Devel rxn & stayed 1/2 hr.During noc became feverish (102 F) & devel diarrhea,achiness & sl sore throat.Took meds & sxs lasted 16May91
Information has been received from a physician concerning a female who was exposed to her mother who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX. On 31-MAY-2008, the patient developed a disseminated vesicular rash. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
I started to have  pain in my arm and headache. I felt my arm was hot. After some days taking ibuprofen and putting some ice to the arm It went away. on day 8th of the vaccine my arm pit started to hurt a lot (lymph nodes) and I got a rash in my arm were the vaccine was given. This became itchy and hot too. today 3/7 after 5 days these other reactions started I am better from the arm pain and arm pit pain it still itches a little and feels a little tender.
Patient had both vaccines given in his left arm. Within 24 hours developed an edematous, pruritic, erythematous 4.5 cm x 5cm circular lesion
Medical assistant calling to report administered vaccine temperature excursion on multiple patients.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 13-JUN-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 injection, lot # 1780867, expiration date was reported as 20-AUG-2023, upon internal validation established as 08-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the vaccine went out of range on 13-JUN-2022 (reported as "yesterday") and it was not discovered until the morning on 14-JUN-2022 when checking the data logger.  This is one of the cases reported by the same reporter. ; Sender's Comments:  US-009507513-2206USA004511:
I had pain in the left arm for several days after first shot. Expected that. After the second shot I had the same pain but it spread into my left breast. The pain is worse this time, constant throughout the day and going into week 6 with no change. The arm pain has subsided but not the breast and under arm pain.