chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms).    This case contains information for the 20th of 42 patients described by the reporter.  No concomitant drug was reported.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.  Vaccine was given to the patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms off 50% or more. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches.  No adverse reactions occurred.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Patient 20 out of 42
On June 4, 2008 in our immunization clinic, six children received their second dose of VARICELLA.  We are assuming one of them received a ZOSTAVAX instead of VARIVAX due to the count at the end of the day.  All parent of the children were reached by 06/11/2008.  None of the children had any adverse reactions, even a local one at the site of the VARIVAX.  Since were are not positive that one of these children received a ZOSTAVAX, we are only giving you the names and birthdays of these children as instructed by the state Immunization Program.  If you need more information, please contact me.  I called CDC on 6/11/08.  In response to this situation, there was no specific answer in the literature, but the "expert" that was consulted stated that the dose of ZOSTAVAX, if given, should be "counted". Follow-up Information:  6/4/08 Between 1-4 PM may have given Zostavax instead of Varivax. No adverse reaction.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Potential side effects from the vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Potential side effects from the vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION COMPLICATION (Potential side effects from the vaccine). At the time of the report, VACCINATION COMPLICATION (Potential side effects from the vaccine) outcome was unknown.        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.   The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
on the next day of his vaccines,he has a seizure go to the hospital they use resusitation and he stay for 1 month, when he open his eyes after 2 weeks in the hospital,he was blind,with epilepsy,encephalitis,and comes home permantly disabled.  2/26/09 MR received for DOS 10/22-11/19/1997 with no specific D/C DX given.  Seizure activity and Encephalitis type picture-likely viral noted.  Pt presented to ER following an episode of cyanosis, limpness and unresponsiveness on 10/22/97. Initially brought to PCP  where O2 was given and EMS called. Seizure activity noted in ER and during admission.. Pt had some bloody stool which resolved, as well as elevated LFTs and renal issues which also resolved. Pt noted to be blind by ophth consult. Later records 10/12-14/98 report dx of CNS reaction to Pertussis vaccine, now with blindness, microcephaly, significant developmental delay and seizure disorder. Seizures 1-2/day.
Rapid Heart Rate, Anxiety, High Blood Pressure. All began for the first time after vaccination. Approximately 10 weeks after vaccine
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6207), on 02Apr2021 as dose 2, single (Lot number: ER8734), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) and on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; DILTIAZEM; LOSARTAN; MONTELUKAST; ADVAIR; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; FLAX SEED OIL. Past drug history included: Sulfadrugs, reaction(s): "allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included treatment with Paxlovid started on 30Jul2022.  Clinical course: The patient Report about covid treatment and Vaccine received and Other medication used with in 2weeks. The Product COVID 19 Treatment Paxlovid was start date: 30Jul2022 and stop date 03Aug2022 The Other medication details were Escitalopram, Diltiazem, Losartan, Montelukast , Fluticasone, Advair, Vitamin C, Multivitamin, ascorbic, Vitamin D and Flax Seed Oil. The Adverse event Rebound after Paxlovid treatment from 30Jul2022 to 08Aug2022 .The Adverse event onset start date: 08Aug2022 patient Not recovered and no AE treatment. The Known has allergies with Sulfa drugs and Other medical history was Asthma .Device times tamp: 12Aug2022
Systemic: Hematuria-Medium, Additional Details: Patient complains of blood in urine the day after receiving booster shot. She says the urine has become darker and brighter each day. Patient is upset and insists that it is caused by the vaccine. She went to her clinic to get a urine analysis and is awaiting results. Patient says she did not experience this after the first and second Pfizer dose. She says she does not have any side effects around the injection site.
This spontaneous report was received from a 65 year old female patient reporting on herself. The patient did not have medical history, drug reactions included sulfonamide allergy. In approximately 2012, (reported as: "4 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, anatomical location, lot number and expiration date were not provided). Concomitant therapies included ZYRTEC. The patient stated that in December 2015, she developed a rash on her left side below her collar bone with migrated. In approximately 08-APR-2016 (reported as "a week ago"), she noticed 3 dots in a row in same area as in December 2015 (skin disorder). The patient received treatment for the adverse events. It was reported that a blood test an urine test was performed in August 2015 (results not provided). The outcome of rash was reported as recovered and the outcome of skin disorder was not reported. The reporter did not assess the relatedness between the event and suspect therapy. Additional information is not expected, since no consent to contact the reporter was provided.
Initial unsolicited report received from pharmacist via other company (Merck) on 27 May 2016. This case involves patient (age and gender was reported as unknown) who was vaccinated with dose of FLUZONE (batch number, expiry date, dose, and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination, patient lost the grip in his hands. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
LEFT ARM PAIN IS EXCRUTIATING, SAW PCP 03/13/13 OR 03/14/13.  PER MD IT WAS A SORE BACK MUSCLE AND HAD "ABSOLUTELY NOTHING TO DO WITH HER TETANUS SHOT." RESOLVED WITH IBUPROFEN AND FINE NOW. RECENTLY HAD STEROID INJECTION TO LT SHOULDER, HAS HX OF 2 PREVIOUS INJURIES IN 1990 AND 2010, CURRENTLY NOT IN ANY PAIN.
Crying off & on all noc 3Feb92.Crying am 4Feb92 approx 6-9am nonstop.Instructed to take pt to MD for eval.
body aches; sore throat; dry cough; Headache; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer reported that she received bnt162b2 (BNT162B2, Solution for injection, Lot# EM9810), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:45 (Batch/Lot Number: EM9810) as SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications was not reported. On 08Feb2021 the patient experienced headache, body aches, sore throat, dry cough. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
Information has been received from a registered nurse concerning a 13 year old female who on 06-OCT-2008 was vaccinated with GARDASIL as her first dose.  Subsequently the patient experienced nausea, dizziness and sweating 5-10 minutes after receiving the 1st dose of GARDASIL.  The patient lay down for 30 minutes at the office and got better.  The patient sought medical attention at the office.  Additional information has been requested.
I received the Pfzr shot in April 2021 and May 2021. In Aug 2021, I began to feel weak in my left arm, where I received the shots. My hand grip was also significantly weak. I also noticed muscle atrophy in the bicep and overall arm. My ring finger and pinky were impacted the most. I also experienced muscle twitching throughout my body. I also began to notice my left leg feeling weak but not as weak as my arm.  As of Jan 2022, my arm remains to feel weak. The area of impact include bicep,  deltoid, shoulder and supraspinatus. My ring and pinky are not functional properly. Weakness in arm still remains.  I have not been in any accident, trauma or injury in the past. I am healthy 41 year old male, weight is 167 lbs, 5'9. I do not smoke, drink or do any type of drugs and live a pretty healthy lifestyle. My cholesterol, sugar, blood pressure are normal and not on any medications.
Pt. had visible swelling and tenderness on inner arm (opposite of where vaccine was administered).
second dose 10 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10 days after first dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016c21a and 020b20b) for COVID-19 vaccination.     Concurrent medical conditions included Cramps, Arthritis and Acid reflux (oesophageal).   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10 days after first dose). On 30-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10 days after first dose) had resolved.            Concomitant products include pills for cramps,pills for arthritis and acid reflects. No treatment information was provided.   This case was linked to MOD-2022-436032 (Patient Link).
pt recv vax; post immun local erythema & swelling (3"x1/2");
After a few hours of the shot I was really tired and had a headache but I still went to work. Around 3 I started seeing red rashes appear on my chest and when I got off of work around 6 my face and chest were covered in red bumps and rashes.
developing white patches on face where there was depigmentation. developed vitiligo on right side of face. lost most pigmentation on right side of face. diagnosed with segmental vitiligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 2, single (Lot number: ew0270) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 18Jan2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EW0164, Location of injection: Arm Right), administration date: 02Aug2021, for COVID-19 immunisation. The following information was reported: VITILIGO (disability) with onset 01Oct2021, outcome "not recovered", described as "developing white patches on face where there was depigmentation. developed vitiligo on right side of face. lost most pigmentation on right side of face. diagnosed with segmental vitiligo". The event "developing white patches on face where there was depigmentation. developed vitiligo on right side of face. lost most pigmentation on right side of face. diagnosed with segmental vitiligo" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: post vaccination; (18Jan2021) Positive. Therapeutic measures were not taken as a result of vitiligo. Clinical course: Oct2021 started developing white patches on face where there was depigmentation. Around Dec2021 to Jan2022 patient developed vitiligo on the right side of face. Patient had lost most pigmentation on the right side of face. Patient was diagnosed with segmental vitiligo.
Erythemic rash on the right breast approx 2 - 1 x 2 cm and 1 on right at waist line - did not follow dermatome.
Initial case was received from a health care professional on 17 December 2013. A 39 years old female patient had no medical history reported, received a dose of Tdap on an unspecified date (Route, Site dose and batch number Not reported). Patient had not reported concomitant medication. It was reported that on unspecified date patient had developed erythema nodosum within 48 hrs after receiving a dose of Tdap vaccine. No laboratory investigation and corrective treatment was reported. At the time of reported the outcome of event was unknown.
PATIENT PRESENTED TO THE ER HERE AT THE HOSPITAL WITH RIGHT MOUTH DROOP; WAS EXPEREINCING SEVERE HEADING STARTING THE NIGHT AFTER RECEIVING 2ND DOSE OF MODERNA VACCINE.
pt recvd vax about 3PM 10JUL92 & was given APAP & took a nap soon as got home; when pt awoke about 7PM rt eye was completly swollen shut; no fever;
Redness and Rash on injection site; Redness and Rash on injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history information was reported.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history information was reported.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.
covid arm; sore muscles; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (covid arm) and MYALGIA (sore muscles) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm) and MYALGIA (sore muscles). At the time of the report, VACCINATION SITE REACTION (covid arm) had resolved and MYALGIA (sore muscles) outcome was unknown.            no concomitant and treatment medications are provided by the reporter. patient want to know whether about to get booster dose.   This case was linked to MOD-2021-365141 (Patient Link).
pregnant after receiving 1st dose of Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant after receiving 1st dose of Moderna COVID-19 vaccine) in a female patient of an unknown age 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant after receiving 1st dose of Moderna COVID-19 vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant after receiving 1st dose of Moderna COVID-19 vaccine) had resolved.        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 details was reported.  No treatment medication details was reported.