chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in arm/Tender, can lift but if touches and pushes then arm still hurts; Dose 1, Dose 2 comirnaty and Dose 3 JANSSEN; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 30Aug2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 30Sep2021, when the patient was 52-year-old, for COVID-19 immunization; coviD-19 vaccine janssen (DOSE 3 (BOOSTER), SINGLE), administration date: 14Mar2022, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10Dec2022, outcome "unknown", described as "Dose 1, Dose 2 comirnaty and Dose 3 JANSSEN"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2022, outcome "not recovered", described as "Soreness in arm/Tender, can lift but if touches and pushes then arm still hurts".  Additional Information: The patient had booster shot on saturday evening and had soreness in arm. Right after the vaccination,, the patient experienced the events. Patient had first dose got in the states, then went back to a country, not sure at time of call which doses caller got where for the prior doses.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201372568 same reporter/drug, different patient/event;
p/vax started w/swelling, warm to touch & pain @ inj site;also w/white pimple that popped that white fluid came out of nauseated & dizzy;
DIFFICULTY IN SWALLOWING; VOMITING; LIGHT HEADNESS; FEELING OF SKIN VIBRATION; EXCESSIVE SLEEP AND FEELING OF TIREDNESS; BAD COUGH; CLOUDINESS IN THE HEAD; CRAMPING IN FORE ARM AND PINK FINGER OF LEFT ARM; LEFT ARM PAIN; SHARP PAIN AND PRESSURE IN THE LEFT SHOULDER THAT SETTLED AND SPREAD.; STIFFNESS IN WHOLE BODY; LESS SENSATION ON BODY; DIFFICULTY TO MOVE THE BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: smoker, and concurrent conditions included: alcohol user, and other pre-existing medical conditions included: Patient have not known allergies. patient did not had any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On 30-SEP-2021, the patient experienced stiffness in whole body. On 30-SEP-2021, the patient experienced less sensation on body. On 30-SEP-2021, the patient experienced difficulty to move the body. On 30-SEP-2021, the patient experienced cramping in fore arm and pink finger of left arm. On 30-SEP-2021, the patient experienced left arm pain. On 30-SEP-2021, the patient experienced sharp pain and pressure in the left shoulder that settled and spread. On 01-OCT-2021, the patient experienced light headness. On 01-OCT-2021, the patient experienced feeling of skin vibration. On 01-OCT-2021, the patient experienced excessive sleep and feeling of tiredness. On 01-OCT-2021, the patient experienced bad cough. On 01-OCT-2021, the patient experienced cloudiness in the head. On 04-OCT-2021, the patient experienced difficulty in swallowing. On 04-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, sharp pain and pressure in the left shoulder that settled and spread., left arm pain, stiffness in whole body, less sensation on body, difficulty to move the body, light headness, feeling of skin vibration, excessive sleep and feeling of tiredness, bad cough, cloudiness in the head, cramping in fore arm and pink finger of left arm, and difficulty in swallowing. This report was non-serious.
VanishPoint needle/syringe used to administer COVID-19 vaccine (Pfizer purple top). The needle retracted upon pressure into arm and vaccine spilled out onto skin. This was an isolated event with VanishPoint at the clinic.
Very tired, muscle aches, light fever for approximately 24 - 36 hours Arm was sore Two red splotches on my upper left arm beneath the vaccination site which lasted for several days
Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Given water.
This case was reported by a consumer via call center representative and described the occurrence of sputum bloody in a 67-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had shingle during holiday). Previously administered products included ZOSTAVAX (received in April 2015). On 28th February 2019, the patient received the 1st dose of SHINGRIX. On 1st March 2019, 1 days after receiving SHINGRIX, the patient experienced sputum bloody. On an unknown date, the outcome of the sputum bloody was not recovered/not resolved. It was unknown if the reporter considered the sputum bloody to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right deltoid and the next morning he coughed up blood. The condition repeated for the next to days and he was clear for the next 2 days. The symptoms returned and had occurred on various days since then. The patient also experience the symptom this morning. His healthcare professional said that his lungs sound clear, so he was ruling out pneumonia. The patient had a chest x-ray and it was negative.
Information has been received from a health professional concerning an approximately 25 year old female with an allergy to Hydrocodone, who on 15-NOV-2006 was vaccinated with Gardasil. Concomitant therapy included ORTHO-CYCLEN. A short time after her second dose, she had a routine Pap which was positive for abnormal cells and positive for a high risk strain of HPV. No other symptoms were reported. Date of first vaccination not provided. Additional information has been requested.
arm swelling; redness at injection site; warmness at injection site; pain at injection site; itchiness at injection site; brown spot on skin at injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis and allergy.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced swelling arm, injection site erythema, injection site warmth, injection site pain, injection site itching and injection site discoloration. On an unknown date, the outcome of the swelling arm, injection site erythema, injection site warmth and injection site itching were recovered/resolved and the outcome of the injection site pain and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, injection site erythema, injection site warmth, injection site pain, injection site itching and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix experienced arm swelling, redness at injection site, warmness at injection site, pain at injection site, itching at injection site. Reporter consented to follow up.
Huge bruise with a knot.  Warm to touchArm pain to the point I couldn?t lay on it.  Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.
Patient has not been able to move her arm since vaccines given 10/31/2023. She says her pain and movements are better but still cause pain and they are restricted.
At one week after the vaccination, I developed urticaria of the left arm and fever.  I had previously had COVID in February 2020.
3 x 4cm redness and induration around the site of DTaP injection c/o itching.
Vertigo/Dizziness. Started about 36 hours after injection of Moderna 2nd shot. Still ongoing for 4 hours now. Only other side effect was being slightly tired day after 2nd shot.
Pt had a vasovagal syncopal episode and was unresponsive for about 15 minutes, slowly started responding after extensive fluids (water) and eating glucose candy. Last BP 96/60.
I got my 2nd vaccine shot  April 2 .  I felt OK the next morning, but later, when I got up from a chair & tried to walk, I couldn't.  I kept trying, but my knees kept buckling & I sank to the floor.  I had to go to the bathroom, so I hitched along on my butt, but when I got there, I couldn't haul myself up onto the toilet. Bad news.Was mostly OK the next day, just didn't have my normal strength back. Am sending this note as I understand that you want to hear about vaccine effects./
This spontaneous report as received from an office manager, refers to a 73 year old female patient with penicillin allergy. In November 2007, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On an unspecified date, the patient also received a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On 24-APR-2014 the patient developed prickling feeling on scalp and forehead. On 25-APR-2014, the patient was seen in physician's office and diagnosis of shingles was confirmed. As treatment, physician ordered GABAPENTIN, acyclovir and BENADRYL. The office manager reported that as the patient's condition advanced, physician ordered GABAPENTIN. Patient's condition has not involved patient's eyes. No lab diagnostic studies were performed. At the time of the report, the patient's outcome of shingles was unknown. Additional information has been requested.
A report was received from a health care professional on 10/6/03 concerning a female vaccinee of unspecified age who experienced a red, sore arm with swelling and frozen shoulder with muscle wastage, was considered medically significant an unspecified length of time after receiving Fluvirin on an unspecifieed date in October 2002. On an unspecified date the vaccinee experienced a red, sore arm with swelling which lasted 4 to 6 weeks. The vaccinee had an orthopaedic referral which diagnosed a frozen shoulder with muscle wastage. The outcome of the event was not reported. There was insufficient info to determine the reporter's causality assessment. Follow up pending.
Small redness around injection site then large red area 2-3 inches below injection site that is continuing to grow. Area is red warm and hard/swollen. Scratchy throat, rash on abdomen and back with no itch. Feel crappy.
Diagnosed with Guillain Barre Syndrome; Pain from low back up to armpits; Weakness in legs (worsened)/ losing strength in legs; Pain progressed to both legs, hospitalized for 3 days (worsened); Brought back to hospital, diagnosed with Bell's Palsy; Lost balance in legs; Pain at injection site; Redness at injection site; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On 31st January 2023, the patient received the 2nd dose of Shingrix. On 31st January 2023, several hours after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization), injection site erythema (serious criteria hospitalization) and injection site swelling (serious criteria hospitalization). In February 2023, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), radiating pain (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization), leg pain (serious criteria hospitalization), bell's palsy (serious criteria hospitalization and GSK medically significant) and loss of balance (serious criteria hospitalization). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and radiating pain were recovered/resolved and the outcome of the guillain barre syndrome and bell's palsy were unknown and the outcome of the lower extremities weakness of, leg pain and loss of balance were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, guillain barre syndrome, radiating pain, lower extremities weakness of, leg pain, bell's palsy and loss of balance to be related to Shingrix.     Additional Information: GSK receipt date: 10-FEB-2023, 13-FEB-2023 Reporter's comment: The reporter was the patient's son.  The reporter stated that his mom received 2nd dose of Shingrix in left arm. The reporter stated that patient had a history of high blood pressure.  The reporter reported that hours after vaccination patient experienced pain, redness and swelling at injection site and now resolved. The days later patient experienced pain from low back up to armpits. The day 7 after vaccine patient had weakness in legs and the pain progressed to both legs (more on left than right).  The patient was hospitalized for 3 days.  On day 20 after vaccine, patient was brought back to hospital and diagnosed with Bell's palsy. On day 22 leg strength and pain worse and she also stated that she had lost balance in her legs.  The reporter also stated that her oxygenation and her blood pressure had gone down.  The patient was diagnosed with guillain barre syndrome on 10th February 2023. The patient had an appointment with HCP(health care professional) today.  The reporter spoke per content. The medical disclaimer and MI phone number was provided. The reporter consent to follow up.
10/24/16 had flu shot, pt reports "given in subacromial space". 2 hours later had pain with any arm movement rates pain 8/10. ROCEPHIN given IM and placed on oral KEFLEX 500mg BID on 10/27/16 warm moist heat and ZYRTEC also. Today 11/7/16 rates pain 5-6/10. Awaiting MRI schedule.
MONDAY AT 1AM, PT WAS PARALYZED AND COULDN'T MOVE, SOME JOINT PAIN, HEADACHE, FEVER, SWEATING AND SHAKING. PT TOOK MOTRIN AND DRANK LOTSO FLUIDS. SYMPTOMS CONTINUED UNTIL THURSDAY 10/19
slightly passed out for 1 sec., blood pressure measured within normal limits, gave fluids and advised to eat
mRNA mixed series delivered - Pfizer on 3/24/21 and Moderna on 4/17/21
Bet 2-2:30pm day of 2nd shot: cramping in legs spread throughout entire body, pounding migraine, loss of taste, dizziness, blurred vision, lasted until Sunday late morning until around 11am, 9/12/21. Sunday pm felt a little better then debilitating migraine Monday am. 10/13: racing heart beat for 10 minutes twice in the day.  10/14 racing heartbeat would not stop. Went to ER.  All lupus symptoms inflammatory issues have gotten worse since 2nd shot and have not subsided including menstruations stopped suddenly.
Adverse event reported was herpes zoster to left side without ocular involvement that occurred one day after second dose of the COVID 19 vaccine. Treatment with Valtrex 1g TID with bactroban ointment to left side facial lesions.
I am deaf in my right ear and have had mild tinnitus since 2014 and no tinnitus in my left ear.  After the COVID vaccine the tinnitus was 200% worse, the noise went from a mild roar to a loud jet engine, blow dryer on high noise and the noise level does not change in my right ear.  AND I now have tinnitus in my left ear that does not ever leave, constant noise.
temperature excursion; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the incorrect storage of drug to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On 27th September 2021, the retail pharmacy called GSK medical information to obtain temperature excursion data because their wholesaler had contacted them to inform them that there had been a temperature excursion. Wholesaler asked pharmacy to quarantine the product. The product had already been administered to the patient. On 27th September 2021 the pharmacy did not yet have the specifics of the temperature excursion. They did not yet know whether the product had been stored above or below refrigerated temperatures nor did they know for how long. On 04th October 2021 GSK employee (Director for GSK, retail) learned the specific details of the temperature excursion. The product was shipped from GSK to the wholesaler via, but the shipment was lost and was sitting on a loading dock unrefrigerated for 2 weeks. The wholesaler then put the Fluarix product back in the refrigerator and subsequently shipped it to the pharmacy. Fluarix Quadrivalent (Influenza Vaccine) injectable suspension was available in 0.5 mL single-dose, disposable, prefilled Tip-Lok syringes (packaged without needles). GlaxoSmithKline (GSK) employee (Director for GSK, retail) called GSK response center on 6th October 2021 to report that the patient was vaccinated with Fluarix (FLU.QIV PRTC X10 CT FS US NH21, NDC: 59160-0887-52) which had been stored outside of the refrigerator for 2 weeks, which led to incorrect storage of drug. The pharmacy correctly stored the product in the refrigerator and unknowingly administered 1 dose to the patient. The GSK employee (Director for GSK, retail) did not have any specific patient information (example: gender). This is 1 of the 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208518:same reporter US-GLAXOSMITHKLINE-US2021208229:same reporter
The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.it was about the size of a gold ball; Dizziness and lightheaded ness started.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 16Jan2021 at 14:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and migraines. The patient had no known allergies to medications, food or other products. 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 vaccination. Concomitant medications included folic acid (MANUFACTURER UNKNOWN) and carbamazepine (CARBATROL) for unknown indication from an unknown date unknown if ongoing. The patient received the shot on Saturday 16Jan2021. Tuesday 3 days later, on 19Jan2021 at 08:00, the patient experienced dizziness and light-headedness. Symptoms had continued none since then. Also, 1 week later, on Saturday 23Jan2021, the injection site became inflamed, irritated, red, swollen and hot. It was about the size of a gold ball. That lasted approximately 3 days and did not return. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events dizziness and light-headedness which included treatment with vestibular therapy at the time of this report. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site became inflamed, irritated, red, swollen, and hot. It was about the size of a gold ball was resolved on an unknown date in Jan2021; while that of the events dizziness and light-headedness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient was admiited to the hospital on April 9, 2021 complaining of tightness in her chest was noted to be clammy with blue tinted lips and fingertips.  Vital signs were  BP 114/72, Pulse 135, Respirations 20, O2 Room air 80% Shortness of breath.  While at the  hospital she was diagnosed with a saddle embolus of the lungs and also a DVT on her left leg.  She was sent back on hospice and is being treated with Eliquis
Patient was undergoing treatment for kidney cancer with axitinib and pembrolizumab.  He was his usual self until the day that he received his Covid vaccine.  He was noted by his wife to be lethargic and confused 3 hours later, and this worsened over the course of the next day.  He presented to the ED for evaluation, where he was found to be disoriented with difficulty responding to questions and ambulating. He was hospitalized for 12 days.  Underwent an extensive workup for his symptoms including brain imaging, infectious workup, laboratory testing which were negative for other causes of his neurological symptoms.  He gradually recovered with physical therapy and returned to his baseline.  His symptoms were attributed by some to his cancer therapy, but he subsequently resumed his cancer therapy (axitinib and pembrolizumab) which he tolerated well without recurrence of severe neurological symptoms, strengthening suspicion that his acute neurological changes were due to the Moderna COVID19 vaccine.
severe joint pain  shoulders and inside hips       body stiffness   those were the first symptoms that started within 2 days of the shot. polymyalgia Rheumatica was diagnosed several weeks later.   and as of today...things have gotten worse as  pain is worse and other areas affected as well...jaw , knees. i have also had 2 carpel tunnel surgeries since and now hands and wrists are in pain.  prednisone has been prescribed and i am still on it and my pain is getting worse.
Redness at inj. site silver dollar size, shoulder and neck pain for one week with tingling on left side of face Date of Onset: 1/5/2021  Patient took tylenol, no follow-up with provider