chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 24-JUL-2013, the patient was inoculated at a hospital (by an unspecified health care professional) with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the male patient subsequently contracted a persistent strain condition of herpes zoster. On or about 07-JUL-2015, the male patient was treated (by an unspecified healthcare professional) at a medical center, for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster.  On or about 20-JUL-2015, he sought subsequent treatment at the medical center for ongoing and worsening shingles-related pain, which was diagnosed as subacute neuralgia. The patient has been prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX.  Additional information has been requested.
Information has been received from a physician concerning a 16 week old female patient who on 28-OCT-2009 was vaccinated orally with first 2mL dose of ROTATEQ (lot number not reported).  The physician stated that on 28-OCT-2009, the patient came to the office for her 4 month well visit and was administered what they thought it was the second dose of ROTATEQ.  After looking at the patient's chart they realized that the patient had not been administered the first dose at 2 months old and that the dose given on 28-OCT-2009 was actually the first.  No adverse effect was involved.  Additional information has been requested.
fatigue; body aches; headache; fever of 100°F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever of 100°F) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever of 100°F). At the time of the report, PYREXIA (fever of 100°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.), UNDERDOSE (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.), UNDERDOSE (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.), UNDERDOSE (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and UNDERDOSE (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case was created for 19th patient of the 24 patients involved. Concomitant medication was not provided. An under dose bivalent vaccines was administered to the pediatric patients for either their 1st or 2nd dose. Patient received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial. The patients age was between 6 months to 5 years. Patient was contacted and revaccinated with correct dose. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
PATIENT DEVELOPED CELLULITIS OF INJECTED ARM (REDNESS AND SWELLING OF SKIN ONLY) EXTENDING FROM INJECTION SITE DOWN FOREARM OVER THE COURSE OF TWO DAYS FOLLOWING INJECTION. PATIENT TREATED WITH CEPHALEXIN 500 MG 1 CAPSULE TWO TIMES A DAY FOR UNKNOWN DURATION (LIKELY 7-10 DAYS), RESULTING IN DISAPPEARANCE OF SYMPTOMS.
Patient presented to the pharmacy with swollen shoulder, tenderness, redness and pain, patient states the pain  and tenderness started night of injection. 3 days later, the swollen arm expanded. Patient was instructed to take pain killers and apply ice on the tender arm and monitor for 3 days, We will call and follow up with patient everyday.
p/vax pt had large, swollen red mark on leg @ inject site; screaming & fever 104, x 1.5 days;MD called x2; 2/2/94 limp as rag doll;pt had bleeding from nose & high fever still;to ER-had convuls;speech delay until age 3; now mildly impaired
Diagnosed with pericarditis after suffering shoulder and chest pain and shortness of breath. Observed over night in hospital. Echocardiogram showed fluid in pericardium. Stress test normal. Treatment: ibuprofen (600mgx3 per day for two weeks), colchicine (0.6mg x2 per day for 3 months).
Pt came into office c/ R lateral upper arm - large area of erythema - blotchy, warm, mild swelling, indurated, nontender.
After getting the second shot, like at 1 pm I started having diarrhea and it lasted 4 days. I also had extreme fatigue and my body and feet hurt a lot, it felt like I was having Covid-19 again. I still have the fatigue and pain and I wake up very tired and with pain in my feet. I cannot do a lot of things because I get very tired very soon. 2 days after having the vaccine I woke up and I noticed some red spots in my arms and there was a really big one close to my elbow. I still have those spots. The next day they became blisters, and I went to the hospital because they were very itchy. They did a Covid test, but it was negative. They said the spots were because of the vaccine but there was no problem and if the blisters popped, I should return to the hospital. However, that did not happen. They gave me an injection, but I do not remember the name of it. They did not do any medical tests they only looked at it. I still have the spots but now they are black instead of red.
Initial report was received from a consumer, who was also the patient, on 22 October 2013. A male patient (age and date of birth not reported) had received an injection of Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a 100F fever for five days, white blood cells decreased and lower back pain. The patient will have his labs, including blood count, checked on 23 October 2013. The patient is scheduled to have a right total knee replacement on 07 November 2013. Concomitant medication was AUBAGIO 7mg. The patient had a history of IVIG therapy for an unspecified reason, left knee replacement in 2010, a normal body temperature of 97.2F and a month history of numbness in his feet. Outcome was not reported. Documents held by sender: None.
Bruising at the injection site  Arm is still bruised Injection was Feb 8, 2021.  Today is Feb 14 2021.
in bed sick for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (in bed sick for 4 days) in a 75-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (in bed sick for 4 days). At the time of the report, ILLNESS (in bed sick for 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-027829 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-027829:Crosslinked case
Pt developed Shingles after the second dosage. Symptoms started 9/4/18 as tail bone pain. This pain is the same pain as when she had Shingles in the past. She saw physician on 10/8/18 and the diagnosis was confirmed. Pt was started on Gabapentin 300 mg, Acyclovir 400mg and Hydrocortisone rectal suppositories.
Outcome "fine" p/ first 2 doses Engerix-B (Deltoid); Titer found inadequate response p/3rd dose. Will give 2 additional doses;
Latent RA became active and I have ongoing pain, swelling and hand issues a month or so after second Pfizer shot
inadvertently administered only half dose of Kinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced accidental underdose (Verbatim: inadvertently administered only half dose of Kinrix). The outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-JUL-2023 The reporter reported that a patient over 4 years of age was inadvertently administered only half dose of Kinrix which led to accidental underdose. The pharmacist inquired that how to proceed with the Kinrix dose and series and if there was need to give the other half or a full dose. The reporter stated this would have been the patient's final dose of Polio. The reporter was unable to provide vaccine and patient details. The reporter did not consent to follow up.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old female patient 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) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
feeling of congestion; difficulty breathing because of the congestion; fever of 99.4F; chills; She has experienced sweating the last two days; sleepy; She has lost her appetite; She feels like she has a head cold; she felt tired/exhausted; This is a spontaneous report from a contactable consumer (patient)  A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269) on 10Mar2021 at 16:30  at single dose via an unspecified route of administration  on arm right  for COVID-19 immunization. Relevant medical history included ongoing high blood pressure. On Saturday (13Mar2021), patient felt tired, exhausted, sleepy and lost her appetite and she feels like she has a head cold . The next morning (14Mar2021), she felt like she had a cold, feeling of congestion, difficulty breathing because of the congestion, fever of 99.4F and chills. These symptoms persisted for the next 2 days. She took 2 Tylenols for her symptoms. She said that her fever comes and goes (as such). Patient was concerning if these adverse events are normal after taking the vaccine. She was also concerning because the symptoms happened a while after and not immediate. At the time of the reporting the patient had not yet recovered from reported events.   No Follow-up attempts are needed. No further information is expected.
Hep B vac first approximately 3-12. 2nd shot 8-1-12. Within 14 days severe fatigue and warming sensation from top of head down to shoulders. Continued severely for 2 months. Then off and on for several more months. Now occasional.
The 2nd dose of the pediatric covid19 dose was attempted to be given to the patient. However, less than half of the content was injected due to administration error caused by the pediatric patient moving around. The pharmacist immediately contacted CDC for further instructions and was recommended to restart the dose. The pharmacist relayed the information provided by the CDC to the patient's father. The patient's father did not want to receive the shot here and will be going to the PCP office to receive the shot.  No adverse event was observed.
10/4/04- spv (primary, given alone)- no local/systemic problems 10/10/04- generalized mild headache 10/14/04- fever (temp not taken) and chills 10/15/04- awoke from sleep with worsening generalized headache, "chest tightness," and malaise- denies cp, sob, dyspnea, palpitations, n/v, cough, f/c, or diphoresis- throughout the day, ha slowly dissipated and the chest tightness progressively got worse 10/16/04- awoke from sleep with "pulsating" pain at the center of his chest  also c/o nausea- pain was "pressure-like," sharp, and constant (6 out of 10)- denies any radiation of pain or other cardiac sxs- pt. drove himself to the ER - he was given a dx of "viral myopericarditis" and he was admitted to the unit.  Throughout the day, he c/o mild headache and varied intensity of alternating chest pain (from "burning" pain to "pulsating pain" to "chest ache").   The patient states the he was given Naproxen for his pain and the pain gradually dissipated.   10/19/04- Pt. had remained chest pain/other cardiac symptom free for the past three days.  He was told his echocardiogram was "normal" and was discharged home in a stable condition with Lisinopril.  The final diagnosis he was given at discharge was "viral myopericarditis possibly vaccine related." 10/20/04- Pt. seen by his Case Manager - states he is now cardiac symptom free and has no medical complaints- he has a 6 wks f/u appointment. Medical Records received on 1/07/2005 states pt experienced a viral infection and myocarditis.
per patient 2-3 days post vaccine "almost flu like" "mild" fever (pt did not take temp). "chills" "felt weak" all sx x 1 day only pt. did not report this until 2 months later
Start with the normal sore arm continues on day five, normal headache two days. On the second day, very stomach pain so bad could not sleep now for three days.
Hypothyroidism  just diagnosed in September.  Have experienced fatigue since the vaccination.  Dr prescribed Levothyroxine 50 mg.
Approximately 1 mo. after receiving, developed "shingles" involving (L) facial and trigeminal nerve. Tx with - steroids, pain med. and Magic mouthwash. Fatigue and weakness persists.
Child not evaluated in office, but mother states wheezing, coughing, and fever 2-3 hours after the immunizations which continued for 3 days.
Scheduled for 2nd dose on 06Mar2021 but he missed it; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Scheduled for 2nd dose on 06Mar2021 but he missed it) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scheduled for 2nd dose on 06Mar2021 but he missed it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Scheduled for 2nd dose on 06Mar2021 but he missed it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Upon internal review on 24-May-2021, age was corrected to unknown.
Headache; Body aches; Sore throat; Rash all over torso; Fever 100-101; Injection site swollen; Injection site swollen and red and tender (3 diameter); Injection site swollen and red and tender (3diameter); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included valaciclovir (VALACYCLOVIR) for unknown indication from an unspecified date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Apr2021, the patient experienced  fever 100-101, injection site swollen, red and tender (3" diameter)". On 07Apr2021, the patient had  headache, body aches, sore throat and rash all over torso. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, vaccination site swelling, injection site redness, vaccination site tenderness, headache, body aches, sore throat and rash all over torso were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
has a frequent headache after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "has a frequent headache after the booster dose".  Additional information: The patient had the two doses and got the third dose because there was a lot of information about the effectiveness of the vaccine after 6 months so it was suggested to get a booster dose. The caller has had the booster as well but he didn't have any side effects. The caller clarifies that his wife is having more than frequent headaches. This could be a symptom from something else but he isn't sure if the vaccine exacerbated it or something.   The lot number for bnt162b2 was not provided and will be requested during follow up.