chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingrix  Possible late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on January 13th 2023 or October 17th 2019).   On an unknown date, the patient did not receive  the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix  Possible late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:16-JUN-2023 The pharmacist reported that a patient received a dose of Shingrix on January 13th 2023 and was due for the second dose today (June 16th 2023, not administered). The insurance informed that patient had received a previous dose on October 17th, 2019, but patient does not remember the administration. Mentioned that due to covid situation probably was never administered.  Safety information on a possible The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Note: The date for 1st dose was not confirmed however by assuming 2019 2nd dose was kept as incomplete course of vaccination.
Initial pregnancy report received from a healthcare professional on 19 August 2013. A 29-year-old female patient, had received a dose of ADACEL vaccine (lot number: C4170AA, expiry date: 11/03/2014, dose number, route and anatomical site of administration were not reported) on 19 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was not reported and the expected date of delivery was reported as 06 September 2013. The patient did not experience any adverse event. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. List of documents held by the sender: none.
This spontaneous report was received from a pharmacist referring to a 43 year old non-pregnant female patient. The patient did not have pertinent medical history, drug reactions or allergies. On 01-FEB-2017, the patient was vaccinated with the first dose of VARIVAX (which had the lot # M002064, expiration date 12-JAN-2018), as routine varicella vaccination. There was no concomitant medication. The pharmacist reported that the patient called on 13-FEB-2017, to report that since 11-FEB-2017, the site was swollen, had a rash, and was painful to the touch "for the last couple of days". It was also reported that laboratory tests were not performed. The patient received treatment for the adverse events. And there was no product quality complaint involved. At the time of reporting, the outcome of vaccination site swelling, vaccination site pain and vaccination site rash was reported as not recovered. The causality assessment between the reported events and therapy with VARIVAX was not provided. Additional information has been requested.
Heat, swelling, from top of shoulder to mid arm. Ice pack, Tylenol, Benadryl.
Left arm 7 x 14cm area of localized redness without induration at site of injection. Fine discreet red papular rash left upper arm. No constitutional symptoms. No fever.
First, I had whole body muscle ache. wore off after 2 months. My muscles still ache randomly. About a week or so after the vaccine my hair fell off in patches.  Treated by dermatologist, said Alopecia. Then a few months later all my hair fell off, now Alopecia Areata.  Eyebrows, eyelashes, nose hair, ear hair ect... then he found immune system disorder on blood test. Referred me to Dr., she found protein in my body that was not right. she just referred me to a cancer doctor. Waiting now for appointment.
Unable to produce milk; headache; tiredness; woke up with dizziness; arm was in pain and sitll sore; body aches; I was breast feeding 5 month old  baby boy; hot and cold flashes; hot and cold flashes; A spontaneous report was received from a 42 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm in pain, dizziness, body aches, hot & cold flashes, headache, breastfeeding my 5 month old baby boy, unable to produce milk and still very tired.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.  On 24 Dec 2020, at 9:30 am  10am, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number unknown) in her left arm for prophylaxis of COVID-19 infection.    On 25 Dec 2020, at midnight, the patient stated that her arm was in pain and that she woke up with dizziness, body aches. She experienced hot and cold flashes (3 - 4 days after) and headache. Treatment included paracetamol.  The patient noted she was still experiencing dizziness and headache. The body aches were coming and going. Her arm was still sore. She was breastfeeding her 5-month-old baby boy, but was unable to produce milk at the time of this report, and was still very tired.  Action taken with mRNA-1273 vaccine was not provided. The events dizziness, headache, body aches, arm pain and sore, and still very tired were still ongoing and the outcome hot & cold flashes, breastfeeding her 5 month old baby boy, and unable to produce milk were unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with some associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Fever developed 3 days after flu vaccine given-seen in office at day 5 of having fevers, feet hurting and mouth ulcer-sent to ER for further eval.
The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 91-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 10-Feb-2023, 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 10-Feb-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 10-Feb-2023).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 29-Dec-2022. 2 patients received vaccine on 31-Jan-2023, 2 patients received vaccine on 02-Feb-2023 and 3 patients received vaccine on 10-Feb-2023. The vial did not undergo any temperature excursions.Was reported as 28-Jan-2023.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712785, US-MODERNATX, INC.-MOD-2023-712776, US-MODERNATX, INC.-MOD-2023-712783, US-MODERNATX, INC.-MOD-2023-712773, US-MODERNATX, INC.-MOD-2023-712771, US-MODERNATX, INC.-MOD-2023-712812 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712771:Same reporter US-MODERNATX, INC.-MOD-2023-712783:Same reporter US-MODERNATX, INC.-MOD-2023-712773:Same reporter US-MODERNATX, INC.-MOD-2023-712785:Same reporter US-MODERNATX, INC.-MOD-2023-712776:Same reporter US-MODERNATX, INC.-MOD-2023-712812:Same reporter
Patient received her first dose of pfizer COVID vaccine on 01/23/2021, her second dose was 02/13/2021. She became symptomatic with new loss of taste and smell, headache, nasal congestion, runny nose and fatigue on 04/03/2021. She reported to our facility on 04/07/2021 for COVID testing due to her symptoms.  Now rapid COVID and a PCR were obtained, the rapid returned positive. Her PCR is pending lab, they will run the sample upon receipt and instructions were given to send the specimen on ice to the health dept.
It effected my RA where it cause me to have episodes one joint as a time starting at the Right Shoulder (site of injection) and normally not one of my joints effected by my RA and made the complete rounds to all my joints. I've since have new sites of RA joints involved mainly in my upper body (both shoulders, elbows and wrist). Not sure if this was a result of this reaction or just my progress of the RA. I declined the second dose to the vaccine as I did not want to cause any other interaction with my RA. Not sure if this was reported by another else. But I thought that it should be reported so that if there are others that maybe we can prevent others from possible reactions.
Redness around site of injection; marked improvement as of 8/11/2016 approximately 3PM.
Heart palpitations while sitting at desk lasting about 3 minutes one hour post vaccination Sharp, stabbing pain in chest about 5 days, 13 days and 19 days post vaccination. These all lasted less than one minute.
Patient experienced fever, chills, body aches, loss of appetite, and vomiting. Patient also experienced diarrhea later in the next day. Patient also had soreness/redness at the injection site. The site was also warm to the touch.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Arthritis.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow up : patient is putting ice on affected arm
PATIENT FAINTED APPROXIMATELY 5 MINUTES AFTER RECEIVING SHOT. SHE REGAINED REGAINED CONSCIOUSNESS SHORTLY THEREAFTER (WITHIN 1-2 MINUTES). PT HIT HER HEAD AS SHE FELL CAUSING A LACERATION APPROXIMATELY 1/2 TO 3/4" IN LENGTH. PT WAS TAKEN TO A LOCAL URGENT CARE CENTER FOR TREATMENT.
I received the shot and was told to sit in a chair and wait for 15 minutes. After about 5-10 minutes I began to feel faint/lightheaded/clammy. I do have a history of these from shots I have had in the past. I got the pharmacists attention and told her I was feeling faint and asked for some water. Once she left, breathing in my throat felt significantly constricted. I had a reaction to clear my throat a few times but that didn't not affect anything. The pharmacist came back with water and an ice pack that she held against my neck. During this episode I was able to drink water still. The severity of the breathing issue leveled off and eventually I was able to breathe normally again. The whole thing lasted 1-2 minutes. It felt longer thinking back on it but I don't think it lasted as long as my impression of the episode.  After that I felt tingling followed by shakiness in my extremities which was more typical of the fainting side effects ive had in the past. I've never experienced breathing issues with other shots I've received in the past. The pharmacist kept me there to monitor me for 30-45 minutes. No additional medication was administered
Rec'd 5y IMM. on 12/07/16 at 4 y/o WCE in office fever x 1 Day (12/08/16) -> 101.8 max; seen for S/S on 12/09/16 -> (RT) upper arm with 5x6 cm area erythema. No induration. TX with PRN BENADRYL. Call if S/S increased.
Don't know if these are adverse events -- they are described in take home information as "General side effects:"   Chills, headache, joint ache, muscle ache, extreme fatigue -- lasted about 36 hours.  No treatment required other than ibuprofen and sleep (lots of the latter).
This spontaneous report was received from a registered nurse referring to a 23 month old White male patient with no illness at the time of vaccination. No information about the patient's medical history or concurrent conditions. The patient was not taking any concomitant medications. On 04-NOV-2016 at 04:45 pm, the patient was vaccinated with the first dose of M-M-R II injection, (lot # M010426), intramuscularly in the right thigh, for prophylaxis (strength, expiration date and frequency were not provided). The patient had none relevant diagnostic tests and laboratory data performed. This is one of two reports from the same reporter.  Additional information has been requested.
I was pregnant with a Due date of 12/13/2021  Around 4/23 the pregnancy was deemed non viable (blighted ovum)
Myalgia LIGHTHEADEDNESS, TIRED, FATIGUE, SORENESS AT INJECTION SITE Narrative:
2 days after injection, patient noticed raised red line from injection site towards elbow. Patient went to see urgent care, diagnosed with cellulitis and given KEFLEX. Patient doing well after 2 days on antibiotics.
shortness of breath; not feeling well/  kind of off; weakness in legs for 3 weeks; low appetite; her arm was sore for a day; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), MALAISE (not feeling well/  kind of off), ASTHENIA (weakness in legs for 3 weeks), DECREASED APPETITE (low appetite) and VACCINATION SITE PAIN (her arm was sore for a day) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE, DULOXETINE, METOPROLOL, CALCIUM, MENAQUINONE-7 (VITAMIN K 2), CURCUMA LONGA, PIPER NIGRUM (TURMERIC & BLACK PEPPAR), RESVERATROL, FISH OIL, ROSUVASTATIN CALCIUM (CRESTOR), MACROGOL 3350 (MIRALAX) and MAGNESIUM for an unknown indication.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (her arm was sore for a day). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), MALAISE (not feeling well/  kind of off), ASTHENIA (weakness in legs for 3 weeks) and DECREASED APPETITE (low appetite). At the time of the report, DYSPNOEA (shortness of breath), MALAISE (not feeling well/  kind of off), ASTHENIA (weakness in legs for 3 weeks), DECREASED APPETITE (low appetite) and VACCINATION SITE PAIN (her arm was sore for a day) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
The injection area formed a sore like area which formed a deep scab about an inch in diameter. The color was purplish.
Tired; Achy joints; This is a spontaneous report from contactable physician (patient) via a Pfizer sales representative. A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 11Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included overweight. The patient's concomitant medications were not reported. On 12Jan2021 (the following day after administration of vaccine), the patient was tired and had achy joints. Events took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Constipation; Anemia; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), ANAEMIA (Anemia) and VACCINATION SITE PAIN (Vaccination site pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Arthritis rheumatoid and IRON for Anaemia.    Concurrent medical conditions included Anaemia.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and IRON (unknown route) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced CONSTIPATION (Constipation) and ANAEMIA (Anemia). At the time of the report, CONSTIPATION (Constipation), ANAEMIA (Anemia) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medication was provided. It was reported that patient for anemic and for took Iron for that and experienced constipation.  The causality for the all events reported with respect to RINVOQ not reported and causality for the event with respect to Iron was probable for constipation and for vaccination site pain and anemia was not reported.  It was unknown if the patient was enrolled in COVID-19 vaccine trial.  No treatment medication was provided.
NONE. Patient due to a clerical error received his first set of shots at 1 month of age instead of 2 months. Patient had no adverse reactions and was informed of the error. CDC also consulted and recommended to give the next set of shots at interval of 8 weeks.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
2 hours after shot, joint pain increased 10 fold. I became exhausted, headache temp of 101. Started to get tight in chest. Felt the same as when I started with COVID in Oct of 2020
Tested IgM positive for mumps.  He received his first MMR on 9/3/98 and the second MMR on 6/23/01.  Specimen was collected 2/7/06 and reported IgM positve for mumps on 2/15/06. Doctor saw him in his office on 2/07. He presented with swollen parotid glands x 1day and complained of sore throat and cough. He was afebrile.
Several hours after receiving flu vaccine, developed headache, then back ache, a feeling being close to vomiting. On 11/16, developed diarrhea.
As soon as Hep A was given IM on right arm, turned really pale and got dizzy.  Color eventually came back but dizziness persisted for at least 30 minutes.  The following day had headache and dizziness.
Complained of L arm pain and tingling about an hour after administration but stated this was a reaction he had in past to flu vaccine. Several hours later he complained of chest pain and feeling short of breath. Visibly shaking and tearful. Able to speak in full sentences. Emergency services was called. O2 sat was normal. No hives/rashes. He was sent to an urgent care via emergent transport (fire dept) where he was monitored for several hours. He was told he had a panic attack with dehydration and syncope. Today, 10/26 he is only complaining of usual symptoms of increased fatigue and muscle aches.  He is working today.
Got and adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got and adverse reaction) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got and adverse reaction). At the time of the report, VACCINATION COMPLICATION (Got and adverse reaction) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), in Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "rls" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received no other medication in 2 weeks. Patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
pt stated that she woke up next day 2/6 and her left arm hurt.  It was hot and hard around the injection site.  She walks daily and started having bad leg cramps.  Later that day she had chills and 102 fever.  On 2/7 she stated she woke up dizzy, light headed with headache and fatigue.  Pt took Advil and Tylenol to help with fever and thought she may have to go to the ER or Urgent care but fever finally broke. On 2/8 her arm still has a 4x4 red, swollen, itchy mark around the injection site.  Pt has not contacted her PCP at this time she is feeling better.