chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen hand and it is the opposite arm; This is a spontaneous report from a contactable consumer (primary consumer-husband and secondary consumer-wife). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 20feb2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in Feb2021, patient experienced swollen hand and it is the opposite arm. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
PNEUMOVAX23 administered on 8/31/16, 2 hrs later her arm was swollen and hurt, tender to the touch, no mark at immunization site. Dissipated after 48 hrs.
After months one day my eyes were bleeding and I had to go the doctor and they didn't give me any medicine or anything.
Patient received tetanus shot on 10/3/02. Went to emergency room 1 week later with huge cellulitis covering her arm.
She got her vaccine, mother called and said she had fever within an hour of getting the vaccine.  She also had arm pain, nausea, vomiting, visual changes, stridor.  Mom was advised by the clinic by one of the doctors, who reassured the mother that these were reactions to the vaccine, fever can last up to 2 days, but should be better by tomorrow.  Patient should hydrate, take Ibuprofen and advised to take to ER if she was having swelling of throat, and other symptoms.  Mom voiced understanding.  The symptoms resolved as far as the clinic is aware.  The arm pain did continue until 6/29/23 when they saw her in the clinic for that.  Was told to use Ibuprofen or Tylenol for pain or a topical patch. The clinic did not get any other calls after that.
swollen, heat, pain, and vesicles at injection site.  Vaccine received on 7/8 and that night injection site is red and raised small patch.  Saturday morning, site is more swollen and red.  Sunday morning, vesicles appeared.
intense pain in the injection site; fever; Cough; upset stomach; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 14:45 (Lot number: Ew0172) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Other medical history: Adhd.; "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder. Past drug history included: Amoxocillin, reaction(s): "known allergies; amoxicillin", notes: Known allergies: Amoxocillin. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "intense pain in the injection site"; PYREXIA (non-serious), outcome "recovering", described as "fever"; COUGH (non-serious), outcome "recovering", described as "Cough"; ABDOMINAL DISCOMFORT (non-serious), outcome "recovering", described as "upset stomach". Therapeutic measures were taken as a result of vaccination site pain, pyrexia, cough, abdominal discomfort.  Additional information: After receiving each dose Patient was sick for 3 days with a fever, cough, and upset stomach with intense pain in the injection site that traveled up to neck and down to left side. Patient couldn't move neck completely, but the side effects subsided after day three. Patient was advised to take antihistamine as a treatment of adverse events. No other vaccine in four weeks. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Rash on my trunk, some on arms. Started with one spot, spread from there. Went to the dr, she diagnosed me with pityriasis rosea and prescribed a topical steroid. The rash continued for the following 12 weeks and started fading on 10/1/2021.
Patient is a resident in a LTC facility.  Patient was COVID positive in October. Patient received the 1st  Moderna  COVID 19  vaccine on 1/11/2021 lot # 027L204.  Patient received the 2nd Moderna vaccine on 02/8/2021 with Lot # 037K20A.  Abbot rapid COVID 19 anitigen test were performed on patient on 2/9/2021, 2/11/2021, 2/15/2021, 2/18/2021, & 2/22/2021 all with negative results. Res had a general decline of fatigue, decreased appetite and foley catheter complications and was sent to ER on 2/25/2021. It was reported to our facility on 2/26/2021 from a nurse contacting the Dr. about another resident that patient had a COVID 19 PCR obtained in the ER and was positive.
pt was dizzy, he said head was not feeling well, stiff hand, sweating. he said legs are tingly .  right arm was tingly (even tho pt had vaccin in left arm)... after 20 mins pt said he is feeing better
Information has been received from a certified medical assistant concerning a 19 week old male who on 12-DEC-2007 was vaccinated with a dose of PedvaxHIB (Lot# 657387/0995U). Concomitant suspect vaccinations included Rotateq. Other concomitant vaccinations included Prevnar and Pediarix. On 13-DEC-2007 the patient experienced fever and diarrhea. The nurse practitioner's office was contacted. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
received his first dose yesterday and had experienced sting on his arm and they gave him a topical steroid. He's wondering if the steroid will not interfere with the efficacy of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "received his first dose yesterday and had experienced sting on his arm and they gave him a topical steroid. He's wondering if the steroid will not interfere with the efficacy of the vaccine". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Any medical questions addressed by this program forwarded/referred to Medical Information was reported as yes: Customer and/or medical inquiry forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 65-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). Concurrent medical conditions included blood pressure high. Concomitant products included ZESTRIL and hydrochlorothiazide. On 13th October 2016, the patient received FLULAVAL QUADRIVALENT 0.5 ml. On 15th October 2016, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site redness and swelling. On an unknown date, the outcome of the injection site redness and swelling were recovering/resolving. The reporter considered the injection site redness and swelling to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This patient received the vaccine between 2 to 4 pm and experienced swelling which was located at the bend of her elbow and on two small places near her wrist.
Quadracel in the left thigh instead of the intended vaccine which was Pentacel with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: UTR, expiry date: unknown), via unknown route in the left thigh, on 11-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the wrong product administered. It was reported that the quadracel in the left thigh instead of the intended vaccine which was pentacel with no ae (wrong product administered).  At the time of reporting, the patient had no 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 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.
Patient stated feeling nervous and lightheaded suddenly lean forward unresponsive for a minute.  Patient was unaware of passing out.  BP 110/70, Pulse 64, Oxygen 92.  06:45PM EMS paramedics were called
Information has been received from a physician concerning a child (demographics not provided) who on an unspecified date was vaccinated with hepatitis A virus inactivated. The physician reported that the child developed erythema multiforme. The patient sought unspecified medical attention. Further information has been received from the physician concerning this 16 year old male who on 07-MAR-2007 at 4:00 PM was vaccinated with the first dose of hepatitis a virus vaccine in the deltoid (Lot# 656993/0001U). Two days after, on 09-MAR-2007 the patient had started with hives. The patient went to the physicians office on 12-MAR-2007 and was diagnosed with erythema multiforme. The patient was given prednisone for five days. It was reported that the patient was getting better two days after this. The patient recovered as of 18-MAR-2007. No further information is expected.
Within ten minutes of the shot in the left arm, I experienced paresthesia (numbness, burning, and tingling) of Cranial Nerve VII as well as a feeling as if a cotton ball had been inserted toward the front of my ear (no hearing loss or pain, just an odd feeling of fullness). As this was not a reaction I had been told to watch for, I thought I must be imagining it, and did not report to onsite personnel. When it was still happening fifteen hours later, I called the OHSU COVID line for advice.
Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nodule (Not verified if cancer), Stroke, Venous stenosis and Hypertension (For ten years.). Concomitant products included METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ADALIMUMAB (HUMIRA) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported.
Nausea was the first symptom. Chills & fever lasted all night, took 1 Advil.  Arm soreness continues. Fatigue continues. Random sharp pains in chest lasted several hours throughout the night.
Patient died of influenza A on 2/10/09. 3/16/09-preliminary anatomic diagnoses received-Influenza A infection with Staphylococcus aureus superinfection and septic shock. Bilateral hemorrhagic bronchopneumonia. Staphylococcus aureus isolated on postmortem lung culture;antibiotic sensitivity pending. Influenza A virus identified by PCR testing on antemortem tracheal aspirate. Bilateral adrenal hemorrhage Waterhouse-Friderichsen syndrome). Coagulopathy widespread glomerular microthrombi. Congestive organomegaly, lungs, liver, kidneys and spleen.  Admitted 2/10/09.
Received flu shot on 10/28/14 9:30 am, arm hurt around 10:30 am - could not sleep on it, push door open, lift it, get dressed etc. Called after 1 week, 2 weeks, got PT script after 3 weeks. Injection was high in arm. I am a thin female. Its been 5 months, improved but still some discomfort at injection site.
Information has been received from a certified medical assistant (C.M.A.) concerning a "66 year old" female who on 28-SEP-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23. On 29-SEP-2010 the patient's injection site got swollen and tender to touch. The patient had a hard time lifting her left arm. The patient sought unspecified medical attention. As of 30-SEP-2010 the patient was recovering. Follow-up information was received from a physician concerning a 66 year old female with allergic reaction to alendronate sodium (MSD) and NAPROSYN, who at 11:04 on 28-SEP-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665925/0932Z) in the left arm. In the evening of 28-SEP-2010 the patient experienced redness, swelling and difficulty moving arm. She was given prednisone and KEFLEX. The patient was improved on exam on 30-SEP-2010. No further information is available. The patient has a history of drug hypersensitivity while on prior therapy with alendronate sodium (MSD) (WAES 1010USA03131).
This case was reported by a nurse to a sales representative and described an adult male patient who tested positive for hepatitis B antigen after receiving Energix-B.    The patient's past medical history included renal failure (cause not specified) regarding hemodialysis.    On an unspecified date, the patient received the fourth dose of Energix-B.  Approximately one year after the administration of Engerix-B, on an unspecified date, "a hepatitis B panel was positive for hepatitis B antigen,"  The reporter was unsure if the antigen was "hepatitis B antigen or hepatitis B antigen positive"  At the time of initial reporting, it was not known if the serology had been repeated.
The left side of my face was numb for three days. My hand and left side of my face became numb within thirty minutes of being vaccinated. The numbness in my hand went away, but the feeling in my face didn?t fully return for a couple of days.
Area around injection site started to become red, swollen with accompanying rash. C/O severe itching and buring at site. Area of involvement is expanding. Currently extends from top of shoulder to elbow. Patient is a paramedic and was seen by doctor informally who told him it looked like cellulitis. Member told to see someone professionally but declined at this time but will see someone if condition worsens. Pt states he will take OTC Benadryl.
TIGHTNESS IN THROAT, TINGLING IN EARS, LIPS, MOUTH, THROAT, CHEST - PT DID NOT LOSE CONSCIOUSNESS, 911 CALLED, EMT ARRIVED
Headache; Bad sweats; This case was reported by a consumer and described the occurrence of headache in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included depression and anxiety. Concomitant products included fluvoxamine maleate (Luvox).   On 28th October 2019, the patient received Shingrix. On 28th October 2019, less than a day after receiving Shingrix, the patient experienced headache and sweating. On an unknown date, the outcome of the headache and sweating were not recovered/not resolved.   It was unknown if the reporter considered the headache and sweating to be related to Shingrix.  Additional details were provided as follows: The patient was on 150 Luvox for depression and anxiety an the shot did not go with Luvox so she had to win off Luvox. The patient experienced headaches and was sweating terrible. The reporter said that they had nothing to stop the side effects.
Information has been received from physician concerning a female patient who was vaccinated with a 0.5 ml dose of GARDASIL vaccine. The patient experienced shortness of breath 24 hours after receiving GARDASIL vaccine. At the time of reporting the patient was recovered. The patient sought medical attention. Additional information has been requested.
Right leg is red, large area 5 X 6 in diameter, extending from groin area to knee area, raised and warm.
After receiving Td and Pneumovax IM, patient stated "I can't breathe".  BP=120/70, P=88,R=20.  No redness, no hives or respiratory distress noted.  Gave 50 mg Benadryl IM per protocol.  Monitored VS, all within normal limits. Discharged at 12:05.  Left clinic with friend. Followed up with phone call late afternoon.  No problem voiced.
Breakthrough case admission after 2 vaccines Moderna 8/12/21 lot# 052E21A;  Moderna 9/7/21 lot# 043B21A
vaccine is later than 6 month after first dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 17th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received shingrix vaccine later than 6 months after 1st dose. Additional Supportive Information: The patient received 2nd dose late which led to lengthening of vaccination schedule.
Swelling of lymph node in left axilla; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 15:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety/despression" (unspecified if ongoing), notes: Other medical history: Anxiety/depression. Concomitant medication(s) included: WELLBUTRIN; TOPAMAX; HYDROXIZINE. Vaccination history included: Bnt162b2 (Dose: 01, Lot unknown: True, administration time=12:00 PM, vaccine location=Left arm), administration date: 30Jan2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 22Feb2021 16:00, outcome "not recovered", described as "Swelling of lymph node in left axilla". The event "swelling of lymph node in left axilla" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of lymphadenopathy. Additional Information: Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Patient received medications within 2 weeks of vaccination were Wellbutrin, topamax, hydroxyzine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. Device Date : 19May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was in the post vaccination waiting area for about 10 minutes when I noticed that he and his daughter got up in a hurry. I came out to see what was wrong, they stated he was having an allergic reaction.  They moved toward the health clinic.  I retrieved the cart and met them in the health clinic where the patient stated his tongue was swelling up. I asked the staff in the health clinic to contact the ambulance.   The patient was drinking water.  I observed the patient and determined that his tongue was swelling and delivered one dose of epinephrine 0.3mg to the left lateral thigh.  I waited approximately 5 minutes and the patient requested benadryl.  I dispensed 25mg of diphenhydramine liquid.  The patient requested another dose of diphenhydramine in about 10 minutes (because he says he normally takes 2 pills when this happens).  I dispensed the 2nd dose for a total of 50mg of diphenhydramine.  Meanwhile the patients vital signs were being taken intermittently.   The ambulance arrived and tended to the patient.  The patient ultimately came back into the store and thanked us for helping him with his response and was inquiring about his second dose of vaccine. The patient was referred to his doctor for further guidance.
5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.
Patient reports tingling, reddened area from upper arm to mid-forearm. Stiffness and swelling. He reports it is getting better.
Pt says her Arm still is sore 16 days Later. She has "shooting" paiNs and trouble sleeping on Arm. SHe says she is still ABle to Lift ARM and do work
THE DAY AFTER RECEIVING THE FIRST DOSE OF MODERNA I HAD INTENSE DIAHHREA.  I ALSO HAD A DULL HEADACHE, MUSCLE ACHES AND CHILLS BUT NO FEVER.  THE DIAHHREA CONTINUED AND IS CURRENTLY PRESENT SINCE MARCH 6, 2021.  I STARTED THE  BRAT DIET AND SEEN SOME IMPROVEMENT.  MY STOOLS WERE LOOSE BUT SOMEWHAT FORMED.  AS I CONTINUED THE BRAT DIET I NOTICED A PATTERN OF DIAHHREA, LOOSE STOOLS, A LITTLE MORE FORMED STOOLS THEN BETTER FORMED STOOLS, BUT NEVER RETURNED TO MY NORMAL.  AS SOON AS I WENT SLOWLY BACK INTO MY REGULAR DIET THE DIAHRREA STARTED ALL OVER AGAIN.  I FINALLY CONTACTED MY PCP ON MARCH 11, 2021.  I HAD TELEPHONE CONTACT WITH MY PCP WHO RECOMMENDED CONTINUE WITH THE BRAT DIET AND TAKE IMODIUM.  I HAD TAKEN ONE TABLET OF PEBTO BISMAL ON 3/10/21.  I HAD NOT TAKEN ANY OTHER ANTI-DIAHRREAL MEDICATION.  FINALLY ON 3/18/21 MY PCP ORDERED TESTING.
It started that same day of vaccination. It started at the injection site, pain, headache and inflammation. That was followed by 5 days of flu like symptoms.
I was diagnosed with MS in Dec 2018 at 34 yrs old. In April 2019, began preventative treatment with IV infusions of a drug called Ocrevus every 6 months to prevent my immune system from attacking my brain and spinal cord (aka demyelination ). Ocrevus eliminates my B cells found in my bloodstream among other things. So I am on an immune suppressant bc my immune system is overactive.  I had been relapse free with no new numbness for 2 years exactly - since beginning Ocrevus. I got my first Moderna vax 3/11/21 and second 4/8/21. On may 4 I noticed new numbness on my left toes. (My initial relapse in 2018 was my right lower extremity.) my neurologist ordered MRIs and a new lesion on my cervical spine was found. It is my belief that the vaccination activated my immune system and caused me a new lesion on my spine. It should be noted that people who are suppressing their immune system intentionally, so that it doesn't attack their Bodies, should NOT take a vaccine that activates it.