chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dry skin aggravated; Papule; Skin red; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry skin aggravated), PAPULE (Papule), ERYTHEMA (Skin red) and IMMUNISATION REACTION (Vaccination adverse reaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DRY SKIN (Dry skin aggravated), PAPULE (Papule), ERYTHEMA (Skin red) and IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, DRY SKIN (Dry skin aggravated), PAPULE (Papule), ERYTHEMA (Skin red) and IMMUNISATION REACTION (Vaccination adverse reaction) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No information on concomitant medication were reported. No treatment details were reported. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of DRY SKIN LIKE A RASH ON FACE/STARTED AROUND MOUTH, BUT NOW IT WAS MORE ALL OVER FACE/SOMETIMES RED AND RAISED unknown onset, DRY SKIN LIKE A RASH ON FACE/STARTED AROUND MOUTH, BUT NOW IT WAS MORE ALL OVER FACE/SOMETIMES RED AND RAISED unknown onset, DRY SKIN LIKE A RASH ON FACE/STARTED  AROUND MOUTH, BUT NOW IT WAS MORE ALL OVER FACE/SOMETIMES RED AND RAISED unknown onset and POSSIBLE REACTION TO COVID VACCINE with HUMIRA(ADALIMUMAB) was a reasonable possibility.This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Consumer received the first dose "2-3 months ago" has not received 2nd dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer received the first dose "2-3 months ago" has not received 2nd dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer received the first dose "2-3 months ago" has not received 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer received the first dose "2-3 months ago" has not received 2nd dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
No additional adverse effect; an expired dose of RECOMBIV AX HB that was given to a five year old child.; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-SEP-2021, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot number reported as 77BS9, expiry date reported as 22-SEP-2021, 0.5 milliliter (injection site and route of administration were not provided) for prophylaxis (Expired vaccine used). No additional adverse effect was reported.  Lot number 77BS9 is an invalid lot number for hepatitis b vaccine (recombinant) (RECOMBIVAX HB). Lot number 77BS9 does not match any Company product as confirmed by Lot Verification Team.
acute nephrotic syndrome  treating with high dose steroids symptoms included global edema/anasarca complications include pulmonary embolus and DVT
This 77 year old white  male received the Moderna Covid shot on  1/27/21    and went to the ED on  2/6/21     and was admitted  on 2/9/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident).
6/12/15 c/o sore arm and itchy rash around injection site some swelling. 6/13/15 Dx cellulitis Rt. arm. Pain in neck and Rt axilla. Rx with KEFLEX.
Patient came to the pharmacy on 09/25/2018 to receive PNEUMOVAX 23 as recommended by her primary care doctor. Patient received the vaccine at approximately 3:24pm in the afternoon and left ok. During the night, while at home she began to feel bad with muscle aches and fever. She followed up with her primary doctor the following morning on 09/26/2018. She was told by the doctor to get rest and take TYLENOL for fever/pain. Patient presented with a raised area on her left arm in the shape of a circle that was red and swollen.
Vaccines received in addition in same leg was dtap. Major swelling, and soreness in the injection site. This lasted 4 days until medication was given to stop the reaction.
pt recvd vax; devel some vesicular lesions; to hairdresser, broke out into chicken pox;
PATIENT RECEIVED THE VACCINE AT 5:30 PM. PATIENT FELT LIGHT HEADED, SWEATY, AND DIZZY AT 5:35 PM. THE PATIENT SAT DOWN IN A CHAIR AND ELEVATED LEGS. PATIENT CONTINUED TO FEEL DIZZY, SWEATY, AND LIGHT HEADED. THE AMBULANCE WAS CALLED PROMPTLY AT 5:40 PM TO THE PHARMACY FOR FURTHER ASSISSTANCE AND SUPPORT.  PATIENT'S STATUS IMPROVED AFTER A FEW MINUTES. PATIENT REFUSED TO BE TAKEN TO THE HOSPITAL FOR FURTHER OBSERVATION/CARE. PATIENT LEFT THE FACILITY AT 6:15 PM.
This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection (lot # L042835, expiry date 09-AUG-2018, therapy type digital data logger, temperature 32.8 F and time frame 20 hours). No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.
An 80 year old male pt was being treated with Oncotice since 10/10/2005. In Nov 2005, he experienced urinary frequency with burning, slow urine flow, fever and chills. The events were ongoing.
This medically confirmed spontaneous report (initial receipt 09-May-2012) concerns a female patient 17 or 18 years of age. On 01-Apr-2008 the patient received her first dose of GARDASIL vial (batch number: #1978U) via injection at a dose of 0.5 ml. Fairly quickly after the first dose of GARDASIL (received on 01-Apr-2008), the patient developed ITP (idiopathic thrombocytopenic purpura) and was referred to children's hematology. Her ITP was thrombocytopenia. The doctor at first said that she wasn't convinced it was from G (GARDASIL), but hematologist said it may have been. They went through her past medical history and saw nothing out of the ordinary. On 28-Sep-2009 the patient received her second dose of GARDASIL at a different clinic. On 09-Mar-2010 the patient received flu vaccine (batch and manufacturer unspecified). On the same day, the patient also received her third dose of GARDASIL (batch number: #1378Y). She finished the series (of GARDASIL injections). Flu vaccine was reported as a concomitant medication. It was unspecified if other vaccines were given with previous doses of GARDASIL. The patient's platelet levels were going up and down. Her platelet levels got as low as 20 (which was her lowest), it was unspecified when this count was taken. Her platelet count went up to 114 at some point, and the last checked count was at 85. The patient became very fatigue and was followed up by hematology, but she was never hospitalised. The symptoms were still continuing. The event improved after stopping GARDASIL therapy. Rechallenge with influenza vaccine was not performed.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.            Concomitant product use included birth control medication.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.
Patient presented to the ED and was subsequently hospitalized for Toxic encephalopathy related to Keppra within 6 weeks of receiving COVID vaccination.
The patient stated that after the shot he experienced 2 days of flu like symptoms including nausea and headache. On the third day after his shot, he had intestinal flu like symptoms, including severe diarrhea and upset stomach. He recovered after the third day and has had no further issues.
I was told patient had redness, warmth and swelling at injection site. Patient antibiotics and sent home from Urgent Care.
Fever of 100.2; Chills; Headache; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 at 10:30 (at the age of 30-year-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received ceftriaxone sodium (ROCEPHIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Jul2021 at 09:30 (at the age of 30-year-old) as a single dose for COVID-19 immunization. On 08Aug2021 at 02:00, the patient had fever of 100.2, chills, headache and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 08Aug2021, the patient body temperature was measured and result was 100.2 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 100.2, chills, headache and muscle pain were not recovered at the time of this report.
aches and tiredness about 1 day after shot. lasted about 1.5 days
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 14-AUG-2017 the patient was vaccinated with the first dose of GARDASIL. On 23-OCT-2015 the patient was vaccinated with the second dose of GARDASIL (lot # L014415  with expiration date on 24-JUL-2017, dose, strength and route unknown). No adverse effect reported. Additional information has been requested.
Dizziness still to this day; Tingling in body /pins and needles; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date Mar2021 (Lot number: Er2613) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [ERGOCALCIFEROL]. Vaccination history included: BNT162B2 (Dose 1, Single, Batch/lot number : EN6202, Anatomical Location:Arm Left, Time: 04:00 PM), administration date: Feb2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Dizziness still to this day"; PARAESTHESIA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Tingling in body /pins and needles". The events "dizziness still to this day" and "tingling in body /pins and needles" were evaluated at the physician office visit and emergency room visit. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
A report was received from a nurse on 27.Jun.2011, and concerns a 41-year-old female patient who, on 17.Jun.2011, received the first dose of VIVOTIF (batch number and expiry date unknown). The patient's medical history and concomitant medications were not provided. At unspecified time after VIVOTIF administration, the patient developed a rash on her face. The patient took BENADRYL. On 19.Jun.2011, the patient took the second capsule and, at an unspecified time later, the rash spread from her face to her arms, legs and ears. The rash was itchy but was not raised. The patient discontinued taking the vaccine. At the time of reporting, the patient had not yet recovered. The event was considered non-serious. Follow-up information received from Crucell, on 01.Aug.2011 stated that no further follow-up information had been available.
On the above date, I had quiche for breakfast.  Shortly after, I developed nausea, vomiting, and diarrhea.  I spent several hours vomiting and feeling nauseous.  I received 2 liters of 0.9% Normal Saline via I.V.  I also received 2 4mg doses of Zofran.  I felt sick the rest of the day.   Two days later, I again had a dish with eggs in it and developed the same symptoms.  This continued for the next two weeks, with also development of abdominal pain, heartburn, and bruising look around my eyes.  The skin around my eyes also became scaly and sloughed off. After the 2 weeks, I realized I was feeling this way every time I had eaten eggs.  I subsequently stopped eating eggs, and followed up with my physician.  She sent me for allergy testing which showed an allergy to egg whites. I have had previous allergy testing (in 1995) and did not have this allergy then.  I also had been eating eggs for all my life with no difficulty.
Injection given in L tricep area with no unusual symptoms at time of administration. But the next day, a noticably firm, reddened, oval shaped lump about 2.5 inches in diameter was noticed. It was slightly painful, which progressed to mild, intermittent itching. At the second day, there was a reduction in lump size but a substantial increase in the affected area, about 6 inches running between the shoulder and elbow. Itching intensity increased substantially. Application of topical BENADRYL, lidocaine, betamethasone and oral BENADRYL were mostly ineffective, with the aerosolized BENADRYL giving the most relief, partly due to its cooling effect. On the third day, itching was reduced, but the redness spread to almost the entire back of the upper arm, to an area about 8 inches by five inches. It would appear the adverse event has begun to diminish, and there are no other sequelae to report.
Around 8 weeks from my second dose I noticed a lump on my neck towards the left side my left breast was very tender and after 3 days it got worse and it was painful to the touch if I would move my arm I went to the Doctor and she said there is fluid around the area and she said I have fluid in my breast.
redness at injection site; swelling at injection site; pain at injection site; rash around the arm; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 14th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain and rash. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced red, swollen and painful injection site on the arm and he had developed a rash that goes around the arm at injection site down to the elbow.  The reported batch number G723ZD was corrected to G72ZD as per sales data sheet.
Fast heartbeat, felt like it was beating out of my chest, unable to sleep, shortness of breath   Also fever, chills, headache, etc.
death I61.9 - Cerebral parenchymal hemorrhage (CMS/HCC)
Severe joint pain in both shoulders and both hips. Pain medications don't help, however, Prenizone relieved the pain for a week, and then the pain came back . Blood tests showed inflamation.
Patient came into the pharmacy on 12/14/19.  She said her flu shot was very painful.  She said she has had  nerve pain in her right arm since receiving immunization.
site sore; tiredness; headache; chills; nausea; feeling unwell; dizziness; weakness; This is a spontaneous report from a contactable consumer (reporting for himself). A 73-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiration date: unknown), via an unspecified route of administration in his left arm from an unspecified date at single dose for covid-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD). Concomitant medications were not reported. The patient previously took codeine and sertraline and experienced allergy. On 22Jan2021 at 16:00, the patient experienced site sore, tiredness, headache, chills, nausea, generally feeling unwell, dizziness and weakness. The outcome of the events was recovered on an unspecified date. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Sore left injection site arm after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm after first vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm after first vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm after first vaccine) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-374448 (Patient Link).
This initial non-serious spontaneous case, received on 02-Mar-2018, reported by other non-health professional, concerns an adult female patient of unspecified age. On an unspecified date (5 years ago), the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, after the administration of vaccine, the patient experienced nausea, vomiting and diarrhoea. At the time of this report, the outcome of the events was not reported.
Redness at site of injection; Papule / persistent light pink 5x7cm rectangular papule; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) 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 23rd October 2020, the patient received the 1st dose of Fluarix Tetra 2020-2021 season (intramuscular). On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 29th October 2020, 6 days after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema and papule. On an unknown date, the outcome of the injection site erythema and papule were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and papule to be related to Fluarix Tetra 2020-2021 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 provided as follows: The age at vaccination was not reported. The patient received Fluarix QIV and several days later, could not be specified by reporter, the patient presented a papule (5 by 7 cm) and some redness at site of injection it was not itchy.  The papule was persistent and had not cleared up. The reporter consented to follow up. This case US2020230710 is duplicate of case US2020230712 and all information submitted in case US2020230710.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020230712:FU1 deleted
Frozen shoulder/limited range of motion without severe pain, not at all like the pain from a normal shot or even my first covid dose. Treated with ibuprofen about 730pm and got no relief.
Patient felt extremely lethargic, could not get out of bed and very nauseated to 24 hours. She had a large red, hardened, itchy area approximately 1 inch below the vaccination puncture, I was shown this 3 days later and still very visible. Red area is approximately 3 inches long and 1.5 inches wide. It subsided around day 5  lightening up but still visible.
pt came infor shots only-returned 45-50min later w/hives covering entire body;pt was given DPH & remained in office 40 -45 minutes;
around the injection site  It is hard; around the injection site  It is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (around the injection site  It is hard) and VACCINATION SITE ERYTHEMA (around the injection site  It is red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (around the injection site  It is hard) and VACCINATION SITE ERYTHEMA (around the injection site  It is red). At the time of the report, VACCINATION SITE INDURATION (around the injection site  It is hard) and VACCINATION SITE ERYTHEMA (around the injection site  It is red) outcome was unknown.            Concomitant medications details not available. Treatment details was not reported by the reporter.