chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on both feet; Spots on right arm; Huge hive on left elbow; Tiredness; Headache; Both sides of injected arm became swollen; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Huge hive on left elbow), URTICARIA (hives on both feet), PIGMENTATION DISORDER (Spots on right arm), FATIGUE (Tiredness) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, OMEPRAZOLE, AMLODIPINE, VITAMIN C [ASCORBIC ACID], CALCIUM and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (Tiredness), HEADACHE (Headache) and VACCINATION SITE SWELLING (Both sides of injected arm became swollen). On 13-Mar-2021, the patient experienced URTICARIA (Huge hive on left elbow). 13-Mar-2021, the patient experienced PIGMENTATION DISORDER (Spots on right arm). On 14-Mar-2021, the patient experienced URTICARIA (hives on both feet). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 at an unspecified dose and frequency. At the time of the report, URTICARIA (Huge hive on left elbow) and URTICARIA (hives on both feet) was resolving and PIGMENTATION DISORDER (Spots on right arm), FATIGUE (Tiredness), HEADACHE (Headache) and VACCINATION SITE SWELLING (Both sides of injected arm became swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16-Mar-2021, the hives were fading and getting better.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow-up received and added reporter information(email) On 10-Aug-2021: Follow up document received on 10 AUG 2021 contains updated reporter's name
I had a cough, runny nose and decided to test for COVID-19 once the came back positive I called my doctor and he prescribed me Paxlovid on June 28, 2022. I started taking it immediately, by the fifth day I was feeling better and every day since then I have been feeling better.
diffuse hair loss; This case was reported by a consumer via call center representative and described the occurrence of hair loss in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. In December 2022, between 1 and 3 months after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved.   It was unknown if the reporter considered the hair loss to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Jan-2023 Reporter's Comments: This case was self reported by the patient. The patient received the dose of Shingrix vaccine in the left arm. The patient experienced diffuse hair loss.  The patient was still experiencing the hair loss.  The reporter did not consent to follow up.
One day after vaccination, developed chest tightness and chest pain that is non-exertional. Self resolves, appears to be worsening. Advised ED referral for chest pain workup
Vaccine was received 6.2.21 at approximately 5:15 p.m.   Upon rising the next morning, 6.3.21, the patient noticed right hand cuticles were orange/brown.  Washed hands and it did not go away.  Color spread to her fingers and sides of her hands.  Two spots on the top center of her hand and are surrounded by white.   6.4.21 the discoloration is fading but she has blotches on her upper arm and foot.
Information has been received from a nurse concerning a 22 year old female with no know drug/reactions allergies and pertinent medical history reported who on 18-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot n. 663454/0672Y). Concomitant therapy included hormonal contraceptives (unspecified). The nurse reported that the patient received the first dose of GARDASIL on 18-AUG-2009 and developed vasovagal response. After administration the patient sat in the office for 15 minutes. She "seemed fine" but then began to feel "terrible". The patient laid down in the office and was given orange juice and peanut butter crackers. The pulse and the blood pressure were taken but no results were provided. The patient recovered in the office in the same date. Additional information has been requested.
tested positive for Covid; loss of taste; runny nose; bad headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid), AGEUSIA (loss of taste), RHINORRHOEA (runny nose), HEADACHE (bad headache) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid), AGEUSIA (loss of taste), RHINORRHOEA (runny nose), HEADACHE (bad headache) and CHILLS (Chills). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid), AGEUSIA (loss of taste), RHINORRHOEA (runny nose), HEADACHE (bad headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
I was positive for COVID-19 on 10JAN2023, I had a sore throat headache, body aches and a cough. I also, lost sense of taste. I spoke to my doctor and I took paxlovid, I started feeling better 2 days after. than I felt crummy again I thought it was over than 1 day later I started to feel much better.
Mirgiane and heaches on and off since the shot. Fever the firat 2 days, on the 3rd day my lymph nodes under my arm puffed out and the side of my neck as well. Exhusted, tonsils and whole neck swollen,  now 10days later i have horrid acid reflux and cant eat much.
Severe arm pain all night.  Woke up around midnight with my entire left arm and hand numb and tingling like it had fallen asleep but I was not laying on it.  I moved it around until it finally stopped.  Pain continued all not.  On 3/24/21 was very tired and foggy.  On 3/25/21 have a headache and slight nausea.  I had an ophthalmic event where I saw lighting flashes in my right eye so it could be this causing instead of the vaccine.  I am fine just thought I should report these occurred.  Thanks!
Flu like symptoms for 2 days, not severe. 2 weeks later itchy rash back of head moving over two weeks to top of back, chest and legs. Rash was not easy to diagnose by dermatologist (3 total visits). After 3 weeks of undetermined rash, hives (clearly a urticaria rash) developed over 60% of body. Hives lasted 6 weeks. Treated with steroids, antihistamines to no effect. After 11 weeks skin is 90% clear with residual itch. Cannot find any other cause for urticaria and was the first lifetime hives outbreak. Cannot find any evidence of similar reactions and the vaccine was the only change to food, environment, etc.
Swollen Lymph Nodes; This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional information received were as follows: The pharmacist called in to question that whether there was any information on reaction of swollen lymph nodes after 1st injection of Shingrix. The patient received Shingrix on left arm. The patient experienced swollen nodes after injection. The adverse event was collected.  The healthcare professional was unable to provide lot and expiration of vaccine.  The reporter did not consent to follow-up.
pt passed out after receiving vaccine- revived shortly afterwards on her own and was found to have good color- normal pulse and was not complaining of any issues - ambulance called to assess pt
PATIENT IMMEDIATELY VOMITED AFTER RECEIVING THE FLUZONE QUAD.   SHE TOOK SOME DEEP BREATHS BEFORE AND AFTER THE IMMUNIZATION. SHE WAS GIVEN SIPS OF WATER AND A MOIST COMPRESS TO THE FOREHEAD.  SHE GOT UP AND LEFT WITHOUT INICIDENT AFTER ABOUT 5 MINUTES.
Extremely high fevers, large swollen lymph node under axillary on injection side.  Patient experiences chest pressure from upper chest as well as neck pressure, pressure feeling on carotid arteries, magnified pressure while bending over.  Pressure in head accompanied by headache, heart palpitations., shortness of breath,  as well as tooth sensitivity.
Pain on the chest on the side of the heart; Started to experience headache; Swollen lymph nodes; This is a spontaneous report from a Pfizer Sponsored Program from a contactable male consumer (patient) reported for himself. A male patient of unspecified age received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route on 06Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced headache, pain on the chest on the side of the heart and has swollen lymph nodes. He mentioned that the pain on the chest is getting worse and is in need of calling Emergency Services. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 4 (booster), single (Lot number: Gh9694) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild COPD" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Elevated PSA" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 24Jan2023 to 29Jan2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
(1) Enduring daily or intermittent limber joint pain originating @ (L) hip/groin area started after receiving STAMARIL vaccine (2) Occasional/weekly choking on saliva started ~ 1 month after receiving STAMARIL during speaking or breathing
4 x 6cm area of redness, swelling and localized warmth. Treated with Benadryl and with Keflex. Unclear if allergic vs cellulitis.
Narrative:  This being reported as a SUSPECTED POSSIBLE ADR: 83 y/o male came to agency Emergency Department 2/23/21 for first time having episodes of language dysfunction, described as expressive aphasia and possible right facial droop; pt was admitted for investigation. Patient had hx COVID vaccination on 2/16/2021. Pt had second episode of aphasia was one week later, discharged on 3/1/2021. MRI showed basal ganglia cerebral infarction due to thrombosis of middle cerebral artery.
Patient c/o itchiness overall her body. Patient is alert and oriented x 4, denied SOB, chest pain, or any respiratory distress. Vital signs stable. Administered 50mg Benadryl, IM injection at 10:29am. Patient stated the itchiness subsided at 11am. Patient was sent home at 12pm.
HORRIBLE REACTION TO J AND J FOR AN ACQUAINTANCE OF MINE; SCARY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced horrible reaction to j and j for an acquaintance of mine, and scary. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible reaction to j and j for an acquaintance of mine and scary was not reported. This report was non-serious.
DIZZY, DIAPHORETIC, EYES FLUTTERING, SYNCOPE, SEEN BY PARAMEDICS, BP 171/90 HR 97, BS: 99. PT HAS NO HX OF SYNCOPE, REFUSED TRANSPORT, AMA SIGNED.
Patient was underage at vaccination time for both doses of Moderna. Vaccination facility attempted to reach out to patient using phone number on file-no contact made.
redness at the injection site/her arm was red around the injection site and then today it's like spreading out further on the injection site; This is a spontaneous report from a contactable consumer (patient mother) or other non-healthcare professional. A 13-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 08Aug2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included anxiety. Concomitant medications included fluoxetine hydrochloride (FLUOXETINE) taken for anxiety, start and stop date were not reported. On an unspecified date in Aug2021, the patient experienced redness at the injection site/her arm was red around the injection site and then today it's like spreading out further on the injection site. Reported that her daughter received the first dose of the vaccine on 08Aug2021. She observed redness at the injection site but the redness has spread, from 09Aug2021 to 10Aug2021. She was wondering if this is normal and if her daughter should receive the second dose. It was reported that she got the vaccine on Sunday afternoon and on Monday, noticed that her arm was red around the injection site and then today it is like spreading out further on the injection site so, she was not quite sure. As per reporter, there is something redness that is associated with it but she was not quite sure how much and how long it would be it will be irritated. She is suffering from redness from COVID vaccine but she does takes medications. She had the Covid vaccine Sunday. She had redness on her arm since Sunday. The reporter stated that she has read that is just for last 24 hours. This is supposed to last for little bit longer seems like it may be possibly spreading. So that is a common side effect. Do we need to worry about it.  She wanted to know what needs to be done. Do she get the second dose. Reporter was not willing for further probing, further probing could not be done. Hence, limited information available over the call. The clinical outcome of the event was unknown.  Information about batch/lot number was requested.
Extreme muscular weakness in my arm. Increased pulse in palm of hand and radiating elbow.  A pronounced lateral thoratic atery (top half and bottom half) . a sharp pain from under my right breast that trail up under my shoulder blade into my arm pit and down my torso on my side about 1/3 of the way. The vein (after about 2 weeks) has since not been as visible. I still have issues with limited movement in regards to reaching and grabbing. I was told that it has not do with a chiropractic issue upon visiting an urgent care. I do not agree. I was in a car accident in 2014, and never had these issues. I had a period of 10 days where my circadian rhythm was out of whack and it was like I couldn't sleep enough. Lack of hunger. Increased thirst.
Information has been received from an office manager in a physician's office, concerning a 26 year old female patient with unspecified allergies but no drug allergies, and a history of one seizure in childhood, who on 27-FEB-2008 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot #659655/1486U). Concomitant therapy included ALLEGRA-D. On 27-FEB-2008, 5 minutes after the vaccination, the patient experienced a grand mal seizure. She was transported to a local emergency room (ER), but it was unknown if she was admitted to the hospital. No further information was available regarding treatment in the ER. The patient was "seeing a neurologist." Upon internal review, grand mal seizure was considered to be serious as an other important medical event. Additional information has been requested.
After approximately 5 minutes of receiving vaccination, my heart rate increased. I notified the pharmacist and she took my blood pressure. Blood Pressure was a little high so she had me wait 10 minutes and took blood pressure again. Second reading was higher at 170/107.
Chills began approx 1:30am on 3/12 (13 hrs after dose), mostly resolved 46 hours after dose  inflamed lungs / coughing - began approx. 9pm on 3/11 ( 8 hours after dose), mostly resolves by 1am 3/13 (36 hours after dose) Body aches - began approx 9am on 3/12 (20 hours after dose), greatly improved 4:30pm 3/13 (52 hours after dose), took naproxene 3/12-3/13 Headache - began approx. 9am on 3/12 (20 hours after dose), greatly improved by 9am 3/13 ( 52 hours after dose), took naproxene 3/12-3/13 Nausea - began approx 9am on 3/12 (20 hours after dose), continues, not resolved
This spontaneous report as received from an unspecified reporter via an online media refers unspecified number of female patient's aged 18 to 45 years, in the period from October 2006 to July 2013. Information on pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with GARDASIL (strength, dose, route, anatomical location lot#, expiry date were not reported) for prophylaxis. The online article did  not specify whether the HPV vaccine in question was GARDASIL or CERVARIX. On unknown dates, the patients experienced coeliac disease (gluten intolerance). The outcome of the event was reported as unknown. Causality assessment was reported as unknown. The reporter considered the event to be medically significant.
We got what we assume was the booster/September 29th would be the time for booster, but got it one month earlier.; This case is considered invalid as there are no indication that patient experienced an event under the suspect drug (bnt162b2).  This is a spontaneous report from a contactable consumer or other non-health care professional from a Pfizer-sponsored program, via medical information team.  A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0202), via an unspecified route of administration on 16Aug2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included, Diabetes, triple heart bypass, cancers including prostate. Patient previously received Pfizer Covid 19 Vaccine (COMIRNATY, Batch/Lot number: EN6206), via an unspecified route of administration on 08Mar2021 as DOSE 1, SINGLE and Pfizer Covid 19 Vaccine (COMIRNATY, Batch/Lot number: ER8732), via an unspecified route of administration on 29Mar2021 as DOSE 2, SINGLE for covid-19 immunization. The patients concomitant medications were not reported. It was reported that reporter and her husband both had Pfizer COVID 19 vaccine in March and received a call that they were eligible for a third dose after getting first doses on 19 March 2021 and a second dose 29 March 2021, and then August 16th they went and received a third dose they assumed was booster. Agent reports patient didn't know if it was a third dose or a booster and believes her husband called to get the third dose because he has diabetes and had a triple heart bypass in the past and cancers including prostate cancers and he is 76 years old. Agent reports the third dose was earlier than recommendation of six months for a booster, six months would be September 29th, so they got their dose earlier by a month and a few days, at least a month earlier since they got their third dose in August. Agent clarifies that reporter and her husband got the third dose of the vaccine not knowing if it was a third dose or booster, because they were thinking he has got comorbidities. Agent reports she was able to answer the caller's question about a third dose and booster dose and for how long if it did increase protection, and how long with booster. Agent reports caller asked would he need to get a booster dose, and she notified caller it was only recommend by Pfizer at this time for three doses. She says for the third dose only they provided an EXP date, which was 30 Sept for that dose. She says for the third dose it also says VIS version date 12 Aug 2021. Patient wife reported that she did the paperwork stating third dose thing was that in March it had initial vaccine number 1 and 2 in March, then 5 months later third dose. She says the reason she was calling was to find out how long they are protected and if third dose was a booster, and if they don't need a booster after all of that. Follow-up attempts are completed. No further information Was expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reassessed the case as invalid.
About a day after the vaccine injection, I started breaking out in a slightly raised, flaky, itchy rash around my neck and some dime sized spots on my right arm.
Hospitalized (9.13.21);  COVID-19 positive (9.13.21);  Deceased (9.22.21);  Fully Vaccinated  Admission Date: 9/13/2021 Discharge Date: 09/22/2021   Discharge Diagnoses: Severe COPD COVID-19 positive GAD  CKD3 DISCHARGE INSTRUCTIONS Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY Hospital Course: Patient is a 81 y.o. male with PMH of O2 dependent COPD, GAD, CKD3 who presented 9/13 with chest pain/pressure and SOB. He was discharged 8/23 after hospitalization for COPD exacerbation and had loose stools, SOB, and cough. He tested positive for COVID-19 and was on baseline O2. He was having trouble sleeping due to anxiety and SOB.    He was treated with Decadron for COVID-19 which was transitioned to methylprednisolone when COPD seemed to be more of his underlying problem. Initial chest x-rays and CTA were unremarkable for underlying pneumonia or blood clot.    Patient's symptoms were difficult to assess as underlying anxiety, respiratory status, or both. Patient remained on home O2. He was treated with frequent nebulizer treatments, and PRN Ativan and hydroxyzine added for underlying anxiety. He was started on antibiotics for possible underlying bacterial pneumonia on 9/17 although clinical suspicion was low. The patient did not improve symptomatically and discussed goals of care with Dr. At that point, he transitioned to comfort care on 9/19. Comfort measures were initiated and patient passed overnight 9/21-9/22.