chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the 2nd dose of the Moderna vaccine, that evening I had a bad headache, felt like my head was getting squeezed I was also very tired and had no energy, this went on for a couple weeks, then contacted my Dr. An Mri was ordered, which showed a small stroke, from there I went to see a neurology Dr. on which I had a cardiac workup consisting of TEE, carotid ultrasound, 48 hour holter moniter , and limited exam by the neurologist. A repeat mri on august 18/2021  showed the stroke had healed
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Severe dizziness to the point of falling in home twice; Severe dizziness to the point of falling in home twice; This is a Spontaneous report from a Non-Contactable Consumer (patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: En6198), dose 1 via an unspecified route of administration on 23Feb2021 at 11:30 (at the age of 43-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included covid-19 on an unknown date. The patient's concomitant medications were not reported. Other vaccine received in four weeks was none. Patient had covid prior vaccination and was not tested for covid post vaccination. The patient experienced severe dizziness to the point of falling in home twice on an unspecified date. Patient did not receive any treatment for the event. Event resulted in the Doctor or other healthcare professional office/clinic visit. Outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Rash at the site of the injection; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE RASH (Rash at the site of the injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash at the site of the injection). On 22-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VACCINATION SITE RASH (Rash at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details include naproxen. Consented for follow-up from safety.Preferred method of contact phone
It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting; My fingertips and my fingers are like tingling; It is very uncomfortable; Her hand is numb; Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain; This time it is unbearably sore; She is also feeling a little nauseous; She is having headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb) and ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb), ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain), VACCINATION SITE PAIN (This time it is unbearably sore), NAUSEA (She is also feeling a little nauseous) and HEADACHE (She is having headache). At the time of the report, PAIN IN EXTREMITY (It ran all the way down to my hand/ whole arm is hurting/fingers are hurting/left arm is the one that is hurting), PARAESTHESIA (My fingertips and my fingers are like tingling), DISCOMFORT (It is very uncomfortable), HYPOAESTHESIA (Her hand is numb), ARTHRALGIA (Her wrist is hurting/ since her wrist was hurting so bad, is wondering if that is the joint pain), VACCINATION SITE PAIN (This time it is unbearably sore), NAUSEA (She is also feeling a little nauseous) and HEADACHE (She is having headache) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-435151, MOD-2021-435156 (Patient Link).
injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer (basal squamous)", start date: 2017 (ongoing), notes: 2 or 3 previous outpatient surgeries 1 recent radiation treatment (finally 20th treatment on 25Aug2022); "Prostate cancer", start date: Nov2019, stop date: Jan2020, notes: Surgical removal Jan2020; "Cholesterol" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6198; Anatomical location: Left arm; Route of administration: Intramuscular; Time of administration: 10:00AM Est), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "injection site soreness"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6208; Anatomical location: Left arm; Route of administration: Intramuscular; Time of administration: 10:00AM Est), administration date: 17Mar2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "injection site soreness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness".  Additional information: Patient did not receive any vaccinations within four weeks. Patient started Atorvastatin 4years ago and Omeprazole 3 years ago. Patient had skin cancer (Basal squamous), 2 or 3 previous outpatient surgeries 1 recent radiation treatment (finally 20th treatment on 25Aug2022).
Pain on the injected arm to which heat applied and it got itchy; Pain on the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Pain on the injected arm to which heat applied and it got itchy) and VACCINATION SITE PAIN (Pain on the injected arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LOVASTATIN, LEVOTHYROXINE, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Pain on the injected arm to which heat applied and it got itchy) and VACCINATION SITE PAIN (Pain on the injected arm). At the time of the report, VACCINATION SITE PRURITUS (Pain on the injected arm to which heat applied and it got itchy) and VACCINATION SITE PAIN (Pain on the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
15 YEAR OLD WAS GIVEN A BOOSTER WITHINT SIX MONTHS OF INITIAL SERIES COMPLETION
High Fever, Severe Allergic Reaction, Severe Swelling which is large round red and swollen and seem to be getting larger and larger everyday, dizziness until today 4/20/2014 with difficulty breathing while sleeping.
Rash redness hot to the touch and very itchy sometimes burning feeling under the injection site. On my right arm. Noticed it was really red and itchy april 4th 2021 I had received my vaccine March 27 2021
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE for Pain, VERAPAMIL, HYDROCHLOROTHIAZIDE, ATORVASTATIN, PANTOPRAZOLE, CITALOPRAM, AMITRIPTYLINE and BUTALBITAL for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
When Vacine was administered, I remember thinking it was given too high in the arm, and the administrator stated it was VERY hard to push in. About 17 hours after receiving shot I awoke to significant pain in the left shoulder, where I received the shot. Over the next day or so the pain continued but also seemed to worsen whenever I tried to use that arm-as in reaching across, over my head or behind me. After about a week and a half I went to the doctors- he told me just to watch it and take Aleve instead of ibuprofen. After another several days I called back as pain is not lessening-he recommended I go to muscle- skeletal doctor-as well as have x-ray and blood work done (both showed nothing). I was seen at ortho about 3 weeks to a month after administration of shot. That doctor said it was a probable rotator-cuff injury and to even double or triple my aleve intake as well as start PT.  (First appointment with PT tomorrow 12/27/18.) In the mean time I followed up with my PCP. (The first doctor I saw was at my PCP's office but not her.) My regular PCP- prescribed an oral steroid as my pain had not improved or lessened taking aleve or Ibuprofen. My understanding is PT and steroids and if the pain continues then we will do an MRI of the soft tissue. I have been unable to effectively use my left arm related to pain for over one month currently.
This case was reported by a physician, via sales representative and described the occurrence of bulging fontalle in a 4-month-old subject of unspecified gender who was vaccinated with combined PEDIARIX. Previous and/or concurrent vaccination included Haemophilus influenzae tetanus conjugate vaccine; Sanofi; unknown given on an unspecified date; combined PEDIARIX; GlaxoSmithKline; unknown given on an unspecified date; Pneumococcal vaccine, unspecified; Wyeth. On an unspecified date the subject received 2nd dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced bulging fontanelle and fever (greater than 103.0). At the time of reporting the outcome of the events were unspecified.
Patient received an expired dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number J477y, expiry date 05-MAY-2023) for prophylaxis.   On 05-JUN-2023, the patient received Twinrix. On 05-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Patient received an expired dose of Twinrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter did not consent to follow up. The patient received a Twinrix which was already expired, which led to expired vaccine used.
First shot: lymph node swelling in armpit. Third shot: heart palpitations, chest pressure, pain (15 minutes) and shortness of breath.
took first shot of Shingrix in March, totally forgot to take it; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient totally forgot to took 2nd dose of Shingrix.
Light grade headache; Diarrhea, the loose bowels; Jittery feeling/the jitteriness; Sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. When she got her first shot she had quite a few side effects that was listed. When probed for side effects, consumer stated, just the normal one that had listed, On an unspecified date patient had light grade headache, the diarrhea, the loose bowels, the jitteriness, the jittery feeling and of course the sore arm but that she know everybody got that sore arm (further clarification unknown). But she was just wondering if that was all natural to get all of those. The outcome of events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
developed a case of Shingles in the eye after the 1st dose; was 3 months late for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and drug dose administration interval too long. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the ophthalmic herpes zoster and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. After 1st dose of Shingrix, the patient experienced Shingles in the eye. The patient was 3 months late for the second dose, which led to lengthening of the vaccination schedule. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015 19:12, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.5 and 2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
develop cancer quickly and die after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "develop cancer quickly and die after receiving the vaccine". The patient date of death was unknown. Reported cause of death: "develop cancer quickly and die after receiving the vaccine". It was not reported if an autopsy was performed. This case is reported as non-serious. The reporter stated, "my sister was going on and on about deaths related to covid injections" later clarifying she was speaking about the Pfizer-Covid19 vaccine. She stated, "We've had several friends up and die. she's had 4 friends develop cancer quickly and die after receiving the vaccine. This one lady didn't have cancer and she was dead in three weeks." Later adding "I think she's worried about long-term side effects" not those close to administration but "5 months later they got sick and died, people who had cancer and it came back quickly". She stated her sister had been doing a lot of research online, but she's not sure what sources she's reading. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: develop cancer quickly and die after receiving the vaccine
Received expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
extreme headache very different than  regular headaches, shooting stabbing pains up the back of my head that made my head feel like it was going to explode.  I still get  the pain up back of head and it will feel like I have been hit with a hammer. The other thing is my legs seize up. I am avid walker (yes there are other things you can do for prevention and exercise is one never mentioned) and now limited because they cramp or seize up at unpredictable times.
Vaccine was diluted using the incorrect diluent - bacteriostatic normal saline was used instead of preservative-free normal saline.
No adverse effects reported; The patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from an medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 16-JAN-2020, the patient was vaccinated with an improperly stored dose (product storage error) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lo number S023651, expiration date 26-JAN-2021(dose and route of administration were not reported). There was no adverse effect reported.
5mm knot @ inj site w/a patch of flat erythema measuring 10mm erythema;no active signs of cellulitis;tx ice & APAP to return if sx worsen or new sx-afeb @ this time
This patient received the Pneumovax 23 vaccine via IM injection in the morning on 07Aug2013. At 11:30 am on 07Aug2013 this patient started to experience redness and soreness at the site of injection, by noon symptoms progressed to swelling of throat, and shortness of breath and treated herself with a Ventolin (albuterol) inhaler. Symptoms continued to progress and by 7:30 PM the patients lips were swollen and burning, had blurred vision, dizziness, ear pressure, difficulty swallowing, site of injection had edema the size of softball and acute pain. At 7:45 pm the patient treated herself with 25mg of diphenhydramine, 10 mg of certirizine, 400mg cimetidine, albuterol inhaler and ice packs on injection site. At 8:00pm the swollen lips resolved and intensity of other symptoms improved. Patient contacted her PCP and was told to go to ER if symptoms did not continue to resolve and the Pneumovax 23 injection is not to be repeated due to severe allergic reaction.  Patient continues with resolving symptoms and treatment with diphenhydramine, albuterol, ice and cimetidine therapy.
Covid-19 like symptoms/possible Coronavirus infection; cough; shortness of breath; lethargy; achiness; This case was reported by a consumer via call center representative and described the occurrence of possible coronavirus infection in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced coronavirus infection, cough, shortness of breath, lethargy and pain. The patient was treated with steroids nos (Steroids) and azithromycin (Z Pak). On an unknown date, the outcome of the coronavirus infection, cough, shortness of breath, lethargy and pain were unknown.   It was unknown if the reporter considered the coronavirus infection, cough, shortness of breath, lethargy and pain to be related to Shingrix.  Additional details were provided as follows: Customer stating around January 2020 and February 2020 she had Covid-19 like symptoms of cough, shortness of breath, lethargy, achiness, all symptoms of Covid-19 except no temperature. She was not tested so she does not know if it was Covid-19. She was put on steroids and ZPAK. She would like to get her second dose of Shingrix as soon as possible.. Did not consent to follow-up.