chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after an hour I had diarrhea/ it's coming back again, the diarrhea; runny nose last night; small knot on my arm; my arm is sore; Did not take her 2nd shot and doesn't want to take it; vomit started coming out of my throat; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (after an hour I had diarrhea/ it's coming back again, the diarrhea), RHINORRHOEA (runny nose last night), LIMB MASS (small knot on my arm), PAIN IN EXTREMITY (my arm is sore) and INTENTIONAL PRODUCT USE ISSUE (Did not take her 2nd shot and doesn't want to take it) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (after an hour I had diarrhea/ it's coming back again, the diarrhea), RHINORRHOEA (runny nose last night), LIMB MASS (small knot on my arm), PAIN IN EXTREMITY (my arm is sore), INTENTIONAL PRODUCT USE ISSUE (Did not take her 2nd shot and doesn't want to take it), VOMITING (vomit started coming out of my throat) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, DIARRHOEA (after an hour I had diarrhea/ it's coming back again, the diarrhea), RHINORRHOEA (runny nose last night), LIMB MASS (small knot on my arm), PAIN IN EXTREMITY (my arm is sore), INTENTIONAL PRODUCT USE ISSUE (Did not take her 2nd shot and doesn't want to take it), VOMITING (vomit started coming out of my throat) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. 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.   No concomitant medication were provided  patient had diarrhea; vomit started coming out of patient throat. Patient had runny nose last night until today, it's coming back again, the diarrhea.  Patient feel kind of small knot on his arm, arm is sore, redness at the injection site.  Patient stated that she was recovered from all the events (diarrhea, Vomiting, rhinorrhea, runny nose last night, diarrhea 2nd time, Axillary mass, pain in the extremity and Vaccination site erythema). She did not take her 2nd shot and doesn't want to take it.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09-May-2021 and included significant information such as outcome of the events were updated to recovered/resolved and New Event Intentional product use issue was added.
patient described that she had tingling in her ring finger, which was the same arm the vaccine was given
Rash, fever, chest tightness. Pt reported this to us on 11/10/15.
Severe inflammation and itching at the site 7 day severe inflammation and itching at the site 7 days after the vaccinations after the vaccination
noticed a red patch about the size of the palm of her hand, lower than the injection site, close to her bicep. The rash has become hot and itchy. She called her clinic and was advised to put cold packs on it; her provider did not think it was serious.  has "long haul" COVID with symptoms still lingering since she had the virus in October 2020. Her neurologist gave her the go-ahead to get the vaccine.
On 1/28/21, developed Shingles on left midriff. Dr. contacted on Friday, 1/29/21. Diagnosis was confirmed. Medication prescribed : Acyclovir 400 mg; 2 tablets (800 mg total) 5 times per day. Plus Acyclovir 5% ointment, apply to affected area as needed. Subsequently, developed severe pain in the affected area on 1/31/21. Prescribed Gabapentin, 100 mg. Dosage: 3 capsules ( 300 mg) 3 times per day. As of 2/16/21, developing numbness and tenderness in affected area.
10"x10" warm erythema area on rt. arm extending from deltoid to elbow. no blisters. extends around arm. Client has red hair and very fair skin.
On 2/7/21 pt woke up to rash/hives below  injection site on left deltoid. The site was a  few inches below the injection site above the  elbow on 2/8/21 The pt called her Dr who treated the rash as cellulitis with an antibiotic since the rash spread and was warm to the touch.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-566676 (Patient Link).
Hardness at injection site; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included rheumatoid arthritis.   On 25th January 2020, the patient received the 2nd dose of Shingrix. On 26th January 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema. On 30th January 2020, the patient experienced injection site induration. On an unknown date, the outcome of the injection site erythema and injection site induration were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site induration to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient was around 70 years of age. The reporter stated that the patient received the second dose of Shingrix and noted an area of redness at the injection site approximately 1 inch in diameter. Five days after receiving vaccination, the area of redness now felt hard, and was approximately 2 inches by 5 inches in diameter. The reporter consented to follow up.
08/12/2005 Friday pm c/o itching to left arm, mom noticed a 3x3 red spot. no fever child scratching. 08/13/2005 Saturday morning right arm swelled. red feverish shoulder to elbow. seen in ER started on amoxicillin 400mg and Clavulanate KCL PO.
Patient called and notified pharmacy at 9:00 am on 10/12/17 about an adverse event she attributed to the PNEUMOVAX 23 vaccine. She described flushing, fever, high blood pressure and general flu like symptoms the night before 10/11/17. She also had arm pain and itchiness/hardness at the injection site. The patient stated that some of the symptoms had resolved by morning 10/12/17  but  arm pain was still present. I advised the patient to use tylenol or ibuprofen and a cold compress at the injection site. At the time of this report she was unsure of seeking medical treatment. I will follow up with her in the afternoon.
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a five months old male patient who experienced low grade fever, while he received second dose of vaccine PENTACEL. The patient's medical history not reported and concomitant medications included ROTATEQ for Immunisation. The patient received 0.5 ml first and second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE on 21-Nov-2018 and 03-Dec-2018 respectively (lot C5527AA and Exp. Date 04-OCT-2019) via intramuscular route in the left thigh. It was an actual medication error case due to inappropriate schedule of vaccine administered. On an unknown date, the patient developed non-serious event of low grade fever following the administration of second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. As per reporter, no medical intervention was necessary. On an unknown date, the patient had recovered from low grade fever. 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. List of documents held by sender: none.
acting ill on day of rxn-then had focal febrile sx (t104.0F) lt arm shaking x 5mins-then became limp & pale & somnolence x 5 more min
Anaphylactic reaction Swelling in face and throat Passing out feeling Rapid eyelid movement  Trouble breathing, trouble swallowing
By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.
Pt was inadvertently given a Moderna 0.5mL vaccine for her first dose.  Pt is 16 years of age.  As of 11/18/21 when this was brought to my attention, the patient had not experienced any adverse event.
On 10/19/05, pt received flu vaccine at 11 am; at noon face burning, scratchiness in throat, SOB.  Went to ER-given iv fluids, iv benadryl, iv pepcid, iv solumedrol, & sc epi .3 ml 1:1000.  Discharged with medrol dosepak, & scripts for allegra & pepcid.
pt recv vax & exp chest tightness which resolved p/2min;pt also devel an inj site rxn characterized by swelling & redness;the vaccine provider said this event may represent & allerg rxn to thimerosal;
Post vax, on 05/09/00, this pt experienced herpes zoster on the right arm and palm, and underneath the arm to the armpit. There was no recent exposure to chicken pox or shingles.  He also experienced right arm hand and pain, fatigue, increased sleeping and decreased appetite. He had scattered lesions on the right arm and hand, some pinpoint bumps and some vesicles. He was dxed with low grade astrocytoma on 03/02/00. He had been treated with carboplatin and vincristine since that date. On 05/14, he reported recovered form the adverse event but remains on chemotherapy regimen.
Fully vaccinated with Moderna. Second dose given on 3/12/2021. Tested positive for COvid on 12/18/2021. Admitted to Hospital on 12/27/2021. Patient expired on 01/02/2022 while still hospitalized.
Pediarix on Friday fever of over 100 deg Sat & Sun-well on Monday-On Tuesday or Wednesday evening had a seizure. Mom states child afebrile-went to ER at hospital
72 hrs after immunization W/MMR, employee developed severe migraine, nausea, fever and rash
Information has been received from a physician concerning a 71 year old female patient with history of chicken pox and hypertension and no recent exposure to chicken pox or shingles who on 15-JUL-2010 (also reported as 16-JUL-2010), was vaccinated with a dose of ZOSTAVAX (Merck) in her deltoid at a local pharmacy. It was reported that on 16-JUL-2010, shortly after receiving vaccine live (Merck), the patient developed a rash on her chest, back and arms, the rash was reported as urticarial rash. The patient saw the physician on 19-JUL-2010, and the physician said that the rash was two or three centimeters in size and the patient had itching as well. The patient had 7100 lesions distributed on her chest, abdomen, hands and arms. The patient was using calamine lotion but the physician provided a steroid pack on 19-JUL-2010. Additional information has been requested.
Itchy throat, tingling lips, chest tightness. Benadryl 50 mg given. BP 128/73 (pulse 67), 100% O2 sat.
No adverse event; called us back and said they had made a mistake and gave him the monovalent, instead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (called us back and said they had made a mistake and gave him the monovalent, instead) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A, 045L21A, 035C21A, 036A21A and 013M20A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (called us back and said they had made a mistake and gave him the monovalent, instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (called us back and said they had made a mistake and gave him the monovalent, instead) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that patient received first and second dose as full doses.  On 22-Oct-2021, the patient received first booster dose.  On 01-Apr-2022, the patient received second booster dose.  On 14-Sep-2022, the patient received third monovalent booster dose.  Treatment information was not provided.
Rash on lower legs, arms - itchy. Mom applied hydrocortisone cream before bringing into office. Provider advised ZYRTEC 3/4 tsp. QD.
7 pm 1/15/21 : arm soreness and slight headache  11pm 1/15/21: moderate chills and headache increase, arm increasingly sore  12 am 1/16/21: Tylenol 9 am 1/16/21: excruciating headache, arm soreness around 7/8 on a scale and moderate chills  9:10 am 1/16/21: Tylenol and Advil  12pm 1/16/21: headache decreased chills subsided. Got up from bed and showered  3 pm: chills returning and headache returning. Arm stays consistently sore around a 6 4 pm 1/16/21: took Tylenol and Advil  4:30 pm 1/16/21: mild headache , mild headache mild soreness. No fever 10 pm 1/16/21:took  Advil  11pm: sleep with mild headache and mild arm soreness. No fever 9 am 1/17/21: Tired and weak. Slight chills and slight headache 11am 1/17/21: took Tylenol and advil
Redness; soreness; This is a spontaneous report from a contactable consumer. An 81-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 27Feb2021 at 16:00 (at the age of 81-years) as dose 1, single for covid-19 immunization. The patient medical history included diabetes, cardiac failure congestive, hypertension. The patient had penicillin allergy. The patient had not received any other vaccine within 4 weeks. The patient had received other medications in two weeks. On 28Feb2021 at 08:30, the patient had redness that spread from 1 inch to 3 inches wide, and 8 inches long; soreness which was same as her flu shot; which lasted for 6 days. Patient received no treatment for the events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
It was reported by the pt's parent that a four year old female pt received IPOL< a fifth dose of Infanrix and a dose of MMR II on an unspecified date in January 2002. The lot numbers, routes and sites were not reported. Later that same day, the pt experienced four seizures within a 24 hr period. On an unspecified date, the pt was seen by a physician and prescribed an unspecified anticonvulsant. The parent reported that the pt had no further seizures, however, she continued to take the anticonvulsant as of 7/14/03. Reportedly, the pt recovered from this event. Seriousness criteria-other medically significant (OMIC).
Headache; chills; body aches; low grade fever; diarrhea - symptoms lasted about 12 hours
Red bumps on legs up to buttocks.  Diagnosed as HSP Vasculitis.
Patient had received primary series with a dose of Johnson and Johnson COVID vaccine. Per CDC recommendations, patient was eligible to receive COVID bivalent vaccine as a booster, but received Pfizer COVID monovalent vaccine
Development of urticarial rash on face within 10 minutes of receiving vaccine, while still in office. Benadryl given in office and monitored for difficulty breathing, vomiting, other symptoms. Urticaria resolved, no further symptoms developed. Sent home with instructions to watch for signs of anaphylaxis.
coagulation; after the first series the IgM went to 58; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003731 (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1), administration date: 14Mar2021, for COVID-19 Immunization. The following information was reported: BLOOD IMMUNOGLOBULIN M INCREASED (non-serious) with onset 2021, outcome "unknown", described as "after the first series the IgM went to 58"; COAGULOPATHY (non-serious), outcome "unknown", described as "coagulation". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported the patient experienced the following: after the first series the IgM went to 58, and after the 4th booster the IgM was at 94.5 and they reported it should be around 10. They reported the mRNA is causing coagulation. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A spontaneous report has been received from a Health Professional concerning a 2 year old, male patient. The patient had medical history of premature birth and twin. Patient received FLUMIST quadrivalent (intranasal), 0.2 milliliters. The patient experienced hives which started on 09-Oct-2015. Action taken with FLUMIST quadrivalent was unknown. The patient recovered from the event of hives on an unspecified date. The report was considered to be non-serious company physician.
Administration error: Patient received 18 micrograms of 1st Pfizer dose 01/03/2022.
Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received includes: Updated batch number, expiration date and added new reporter.
This spontaneous report as received from a pharmacist refers to a 73 year old male patient with diabetes and no drug reactions/allergies. On 26-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H021941, expiration date 11-JUL-2014, 0.5 ml, intramuscular in the right arm). There was no concomitant therapies reported. On 26-SEP-2013 ("at an unspecified time later in the day"), the patient experienced tenderness at the injection site on his right arm, fever and chills. The patient then returned to see the pharmacist on 27-SEP-2013 ("today"), to inform that he was experiencing severe pain at the injection site and extremely limited mobility of his right arm. There was no treatment given for the events. No lab test was performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
p/vax evening bad h/a, stiff neck, arm, chills, dizziness @ times fatigue, hives, blotchy rash neck area;6/14/99 round ring & rash @ inj site;rash covers entire deltoid area;6/18/99 itchy rash nape of neck;
Pt reported to Medical facility at approximately 3:30 PM stating he felt like he was developing hives and becoming harder to breathe. Nurse in Charge of Immunizations, Medical Director, and the Nursing Services Superintendant evaluated patient. MD cofirmed patient was experiencing a reaction of some type, ordered treatment with a emergency Epi-Pen. Patients symptoms began improving immediately after Epi-Pen administration. MD ordered patient to be transported to local ER, accompanied by NREMT and an additional Epi-Pen to be evaluated and monitored. Patient stated that he had eaten lunch after receiving vaccination and prior to onset of symptoms.
104 degree temperature. Tachycardia at 229. Body very hot. Extreme fussiness.
Approximately 21 hours post injection I had lower abdominal pain that resulted in diarrhea lasting approximately 8 hours.   I started a diarrhea medication about 5 hours after onset of symptoms and that has helped.   Waiting for a response from my primary care physician to determine which medicine I should to (as a diabetic) if the symptoms continue.
Initial report received from a physician on 05 September 2014. An 87-year-old female patient, with a history of idiopathic jaundice (resolved), received a left deltoid injection of FLUZONE HD (lot number U4997AA) on 27 August 2014. One day post-vaccination, on 28 August 2014, the patient experienced a fever up to 101.6 degrees Fahrenheit, still ongoing at the time of the report. The patient had been seen by her physician, and laboratory testing including CBC, urinalysis, and blood cultures, had been obtained (results not reported). No additional information was reported. Documents held by sender: None.
3/23 Arthritic flare up w/ painful numbness. NSAIDs, Voltaren, referred to Rheumatologist, Physical therapy.