chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "chronic asthma" (unspecified if ongoing), notes: other medical history: chronic asthma. Concomitant medication(s) included: XYZAL; ESOMEPRAZOLE; BACLOFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (23Dec2002) Positive, notes: By Dec 23 was testing very weakly positive,; (Dec2022) Positive, notes: Tested and was strongly positive; (23Dec2022) Positive, notes: though strongly positive earlier. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
On 1/7/21 this individual called in to report that after her vaccine on 12/30/20 she noticed a lump under her skin at injection site that eventually went away. A few days later it returned and she reports it's itchy, reddened, and continues getting bigger. She tried Benadryl and ice with no results. I encouraged her to call her family doctor to see if they had any further recommendations.
Chest pain/discomfort, Heart Palpitations/Abnormal Heart rhythm, Shortness of breath, Exhaustion, Lightheadedness and dizziness. Symptoms are ongoing and of intermittent intensity. Aspirin daily for chest pain. See below for diagnostic tests ordered.
Cold; COVID arm (red and swollen on the vaccination arm); COVID arm (red and swollen on the vaccination arm); Lymph node on neck; Felt achy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), MYALGIA (Felt achy), VACCINATION SITE ERYTHEMA (COVID arm (red and swollen on the vaccination arm)), VACCINATION SITE SWELLING (COVID arm (red and swollen on the vaccination arm)) and LYMPHADENOPATHY (Lymph node on neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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-Feb-2021, the patient experienced MYALGIA (Felt achy). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), VACCINATION SITE ERYTHEMA (COVID arm (red and swollen on the vaccination arm)), VACCINATION SITE SWELLING (COVID arm (red and swollen on the vaccination arm)) and LYMPHADENOPATHY (Lymph node on neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold) and LYMPHADENOPATHY (Lymph node on neck) outcome was unknown, MYALGIA (Felt achy) and VACCINATION SITE ERYTHEMA (COVID arm (red and swollen on the vaccination arm)) had resolved and VACCINATION SITE SWELLING (COVID arm (red and swollen on the vaccination arm)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NASOPHARYNGITIS (Cold) to be not related. No further causality assessments were provided for MYALGIA (Felt achy), VACCINATION SITE ERYTHEMA (COVID arm (red and swollen on the vaccination arm)), VACCINATION SITE SWELLING (COVID arm (red and swollen on the vaccination arm)) and LYMPHADENOPATHY (Lymph node on neck).    No concomitant medication reported
About a day after the vaccine administration, my chest was tight for 2-3 days and I would feel out of breath after going for a walk or lifting something moderately heavy like carrying grocery bags. After taking 200-400 mg of ibuprofen the tightness went away.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Products were reported. No Treatment information was reported. Date vial moved from freezer to refrigerator- 24-JAN-2022.
Information has been received form a consumer who is a office working concerning her approximately 18 month old daughter with no medical history or allergies who on 12-Mar-1999 was vaccinated SC in the "H" thigh with a first dose of varicella virus vaccine live (lot #629256/1850H). It was reported that the child was 12-15 months old at the time of vaccination. There was no concomitant medication. In September 1999 and in December 2001 the patient experienced breakthrough cases of varicella. No laboratory tests or diagnostic studies were performed. Both cases were described as mild by the mother. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No additional information was available. Follow up information from the consumer indicated that the child had a normal heart murmur and a sulfa allergy. The two episodes of chicken pox were reported to be in August 1999 and 12-Dec-2001. Medical attention was sought and the patient recovered. Additional information is not expected.
Within eight days of receiving the first of a two part dosage of SHRINGRIX vaccine I was diagnosed with Guillain-Barré syndrome. I write this on day forty nine of my hospital stay. I will return home tomorrow.
Pt received the 1st dose of the Moderna Vaccine and the next day developed a rash on his abdomen and back as well as slight tongue swelling. Denies difficulty swallowing, nausea, vomiting,  diarrhea, constipation or shortness of breath. No tongue swelling since then.  Did not seek further evaluation at the time, symptoms of tongue swelling resolved on their own.  Rash has improved slightly but is still somewhat persistent.
no strength in injection arm; very sore injection arm; tingling from injection to finger tips; cramping in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no strength in injection arm), VACCINATION SITE PAIN (very sore injection arm), PARAESTHESIA (tingling from injection to finger tips) and MUSCLE SPASMS (cramping in injection arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced ASTHENIA (no strength in injection arm), VACCINATION SITE PAIN (very sore injection arm), PARAESTHESIA (tingling from injection to finger tips) and MUSCLE SPASMS (cramping in injection arm). At the time of the report, ASTHENIA (no strength in injection arm), VACCINATION SITE PAIN (very sore injection arm), PARAESTHESIA (tingling from injection to finger tips) and MUSCLE SPASMS (cramping in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs included no treatment drugs included
Patient received two doses of Boostrix in the same day; Dispensing error; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z59N7, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device and not applicable after receiving Boostrix, the patient experienced accidental overdose and drug dispensing error. On an unknown date, the outcome of the accidental overdose and drug dispensing error were unknown.   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 reported as follows: This case was reported by pharmacy student. The reporter stated that, due to a dispensing error the patient received two doses of Boostrix on the same day. The reporter consented to follow up. The lot number and expiry date of Boostrix is for the 2nd dose given of the two. The reporter consented follow up.
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves three 5 years old patients (gender not reported) who received a dose of vaccine PENTACEL lot number not reported on an unknown date, instead of vaccine POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer lot number not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error as Wrong vaccine administered. It was reported that, this would be for the DTAP fifth dose and Polio fourth dose. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
The pt experienced chronic extreme pain in ribs, joint and muscular pain, fatigue, nausea. Treated with Prozac and Darvon. Pain symptoms still persist.
This spontaneous report as received from a physician via company representative refers to unspecified number of male patients of unknown age. No concurrent conditions, medical history or allergy/drug reactions were reported. Physician reported that he had already been administering GARDASIL 9 (dose, frequency, lot number not reported) in boys older than 15 years of age, way before new indicated age (that included boys 16-26 years of age) was approved. No concomitant medication was reported. No adverse effects were reported. Number of patients was unspecified. No additional information was provided. Additional information is not expected as the reporter did not wish further contact.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and general body pain after 1st dose received in May 2018, refer linked case US2019GSK037063). On 20th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, leg pain and general body pain. On 20th February 2019, the patient experienced drug dose administration interval too long. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills and leg pain were not recovered/not resolved and the outcome of the muscle pain, general body pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the fever, chills, muscle pain, leg pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The patient received the 2nd dose of SHINGRIX later than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced muscle aches, fever, chills and the patient founded it painful to sit. The patient was having body aches all over. The reporter did not consent to follow up.
Patient came into the pharmacy complaining of right shoulder joint pain on 4/8/21. He expressed that the pain started 4 days after his first Moderna Covid19 vaccine on 2/12/21 and has not subsided. He has lost range of motion and expresses that the pain shoots down to his elbow joint. Pain is surrounding the joint, area is not visibly inflamed or red. He reports that vibration massage, heat and Tylenol help. He did not have this problem with his second vaccine on the left shoulder. Could potentially be caused by SIRVA, recommended that the patient takes ibuprofen on top of his current regimen and talk to his PCP.
2 hours, post vax, while pt was home, mom had just fed the baby, burped and then laid her down and a few minutes after, the baby turned red and was not breathing, lasting 30 seconds. Mom picked baby up and baby started crying. Baby was seen back at the office again and was fine. She was alert and active and was discharged home on Apnea Monitor.
fever x 1 day p/vax;soreness, redness, pain @ inj site;
devel rt sciatic neuralgia severe 25OCT92 hosp eval nl x/pt w/severe pain @ sciatic distribution; rx Analges; resolved sxs in few days;
Redness, swelling, itching, discomfort at site of injection. Body aches, headache. Seen 6/26 in ER - diagnosed allergic rxn - MEDROL dose pak and hydroxyzine prescribed.
Pt recvd flu vax & devel redness @ the inject site, joint pain in the shoulder & SOB;
A immunocompromised patient on his 3rd dose received only 0.25mL.; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (A immunocompromised patient on his 3rd dose received only 0.25mL.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced UNDERDOSE (A immunocompromised patient on his 3rd dose received only 0.25mL.). At the time of the report, UNDERDOSE (A immunocompromised patient on his 3rd dose received only 0.25mL.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. The patient received 3 Covid-19 vaccine doses. He was coming in for his fourth dose.  No information on treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up information received includes no newmedically significant information.
Information has been received from a medical assistant concerning a female patient who was vaccinated with the first dose of GARDASIL and fainted. Unspecified medical attention has been sought. The patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Severe mid and low back pain with radiation to BILATERAL legs and tingling in toes. Pain then into groin 3 days after injection.
Felt the injection unexpectedly. Upper arm and shoulder were sore the first week. Same arm/shoulder was stiff, limited range of motion with pain. Primary care Doctor recommended not rubbing and giving it time. Finally, Doctor prescribed NSAID because the symptoms continued.
Can't lift the arm,  Huge pain; A spontaneous report was received from a (Consumer) concerning a  55 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (Can't lift the arm and Huge pain) list.      The patient's medical history was not provided. Concomitant medications include Vit D, Mg2+ and K.      On 10-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.    On 10-FEB-2021, The patient experienced the events list (Can't lift the arm and Huge pain).     Laboratory details was not provided.    Treatment details include 1200mg ibuprofen.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the event(s)(Can't lift the arm and Huge pain was unknown.    The reporter assessed the event(s), [Can't lift the arm and Huge pain], as related to study drug.  Based on comment, (Can't lift the arm and Huge pain) was changed to vaccination site pain, listed.
Pt recvd vax & exp hive-like eruption, itching w/occasional pain in hands; sore throat, fingers swelling, joint tenderness; urticarial, hypersensitivity reaction, arthralgia; nausea, ASO titer elevated; pos IgG and neg IgM; sl chest pain;
injection site pain; tiredness; headache; joint pain; chills; muscle pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male consumer reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on15Feb2021at single dose for COVID-19 Immunization. Medical history was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date. Concomitant medication included lisinopril. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines (10Feb2021) in right arm within 4 weeks prior to the COVID vaccine. The patient was tested for COVID-19 since the vaccination after the nasal swab test. On16Feb2021 02:00 AM, patient experienced Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. On16Feb2021 02:00 AM, patient experienced Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The patient did not receive any treatment for events. Reporter assessed the events as non-serious. The outcome for the events was recovering  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable physician. A physician reported a 3-year-old male patient received PREVNAR13 on an unspecified date via an intramuscular route of administration in the left vastas lateralas. On 16JAN2011 the patient developed injection site swelling, painful, arm to the touch, and erythematous 5x10 cm. The patient was seen on 20JAN2011 with several local reaction to vaccine. At the time of this report, it is unknown if the patient recovered. No serious criteria were reported by the physician.
5 days of fever, anorexia oral and nasal desquamation/sores
04/04/2003:  Right shoulder upper 1/2 of arm swollen and hot to touch x 2 days. 05/02/2003:  Hives palm size moving around trunk x 2 days.  Decreasing prednisone treatment x 4 days.
Information has been received from a RN concerning a 5 year old female with a history of "reaction to albuterol" who on 01/30/04 was vaccinated in the left arm with a dose of MMRII (Lot # 646118/0614N). On 01/31/04 the pt developed a generalized body rash. The pt's mother had called the doctor's office stating that the pt had a very red arm and the body rash, but no fever and no pain. No lab or diagnostic testing was performed. No treatment was required. Unspecified medical attention was sought. The pt's outcome was not reported. Additional information has been requested.
Fainted after shot.  when up in clinic, decribed feeling that her throat felt tight.  Benadryl po given with resolution of symptom
No additional AE; HCP called to report inadvertent administration of VARIVAX after a temperature excursion. Limited patient demographics provided. No additional AE/PQC.      ?    Names of vaccines involved (including lot/exp): VARIVAX W039697 12/13/2024        ?; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 14-AUG-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W039697, expiration date was reported and validated as 13-DEC-2024) as prophylaxis, after a temperature excursion (product storage error). No additional adverse event (AE).  The vaccine experienced a temperature excursion of 7 degrees Fahrenheit (F) for 2 hours and 11 minutes. There was no previous temperature excursion.
PATIENT REPORTED FEELING FLUSH AND HER "HEART GOING FASBP 170/60 PULSE 88 98%RA OBSERVED FOR 30 MIN 146/76  FELT BETTEREDUCATED ON WHEN TO CALL/COME IN
Client called to report that the night that he received the vaccine he noticed a small red rash around mouth and nose. Reported that he took Benadryl at that time. On 2/21/2021 he reported elevated B/P and  rash has continued but now the redness is on face and jaw line.
He got his vaccine, He could feel a muscle jumping in the back left side of his neck.  This has continued since the vaccine.  It has not gotten any better or any worse, but it is constant and just stays the same.  He has never had this type of reaction in the past.  He did not speak with his doctor.  He started to read his paperwork and decided to call and report it, but will call his doctor.
Due to v-safe tool text links not working to date (March 13 - March 15), I'm using VAERS to report history back to the date of injection.  To date, all side effects are Mild, so I have not needed to notify my physician.  March 13, 2021:  In addition to mild pain and mild swelling at injection site immediately after injection, I developed some mild itching (but no redness or rash) at the injection site around midnight (about 12 hours after the injection).  March 14, 2021:  Mild pain and mild swelling and mild itching at the injection site continues.  No additional side effects.  March 15, 2021:  Minor pain (much less than yesterday) but mild swelling at injection site continues.  No itching.  No additional side effects.
Pt. with productive cough, sore throat, occassional chest tightness (Hx  ashma), headache, runny nose, and fatigue