chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain on right arm; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on right arm), HEADACHE (headache) and FATIGUE (fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included mobic                                                          arthritis for Arthritis, duloxetine                                                     depression for Depression, protonix                                                       gerd for GERD.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain on right arm), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (pain on right arm), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-106488 (Patient Link).
Felt more tired than usual; Soreness on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt more tired than usual) and VACCINATION SITE PAIN (Soreness on arm of injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included Hiatal hernia. Concurrent medical conditions included Constipation and Diarrhoea. Concomitant products included CITALOPRAM, LOPERAMIDE HYDROCHLORIDE (IMODIUM) and LEVOTHYROXINE for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt more tired than usual) and VACCINATION SITE PAIN (Soreness on arm of injection). At the time of the report, FATIGUE (Felt more tired than usual) and VACCINATION SITE PAIN (Soreness on arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient reports that she underwent surgery for hiatal hernia "back in February", has since often experienced constipation and diarrhea. Patient received first dose of Moderna COVID-19 vaccine on "1st Saturday in April" (3Apr2021). Lot #016B21A (or 016BZ1A). Administered on left shoulder (nondominant side). At that time she experienced soreness on her left arm, and felt "a bit more tired than usual".   This case was linked to US-MODERNATX, INC.-MOD-2021-114597 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114597:dose 2
Large, red rash below injection site; hard, hot area got larger as time progressed  Took Tylenol, used ice pack.
not receiving second dose on time; he was unable to find stock of the vaccine for his second dose; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (not receiving second dose on time), PRODUCT AVAILABILITY ISSUE (he was unable to find stock of the vaccine for his second dose) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 PRODUCT ADMINISTRATION INTERRUPTED (not receiving second dose on time), PRODUCT AVAILABILITY ISSUE (he was unable to find stock of the vaccine for his second dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (not receiving second dose on time), PRODUCT AVAILABILITY ISSUE (he was unable to find stock of the vaccine for his second dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      No concomitant medications were reported. Patient only received 1 dose of the Moderna COVID19 vaccine because he was unable to find stock of the vaccine for his second dose and that happened two months ago. No treatment medications were reported.
This spontaneous report was received from a medical assistant and refers to a currently 5 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894, expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was unknown, which lot# was administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010333:Original Case : 1809USA008636, US-009507513-1809USA010334:Original Case : 1809USA008636, US-009507513-1809USA010336:Original Case : 1809USA008636, US-009507513-1809USA008636:Original Case : 1809USA008636.
Shot, got it, two weeks later got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 3-Sep-2022 Reporter's Comment: Reporter's comment: This case was reported by a patient via interactive digital media. The patients doctor said you need the shot ok patient got it two weeks later patient got shingles patient would not do anything.
shaking Chills severe muscle and joint pain 36hrs after the shot the skin on my palms turned white and peeled off.
Seemed like a head cold exactly a week later. Slight sore throat. Slight headache. Slight chest pain. Extreme pressure in the face, jaw, ears. Behind eyes. Extremely congested. All unable to lay down. Had to take two days off work. A week later, still a little congested, runny nose, Slight headaches, cough, Slight chest pain.
Patient is fully vaccinated. COVID + on admission to hospital on 2/3/2022. 58-year-old significant known history for diverticulitis, who presented to the emergency department secondary to abdominal pain with associated nausea/emesis.  Acute septic shock/hypotension, requiring pressor support. Colitis, leukocytosis, Treatment:  rocephin, flagyl, not a cadidate for remdesivir, on RA. HG 8.6; required 1 unit PRBC. Discharged home.
Coughing, wheezing, chest pressure, difficulty breathing, rapid heart rate. Received Albuterol via inhaler, 50mg Benadryl, Medrol 4mg.
Redness at injection site; lump under the skin; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 14:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidaemia, hypothyroidism, osteoporosis, arthritis and seasonal allergy. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and duloxetine (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 14:00 (at the age of 74-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 vaccination. On 05Apr2021 at 12:00, the patient experienced redness at injection site and lump under the skin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events redness at injection site and lump under the skin was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Headache-Mild
Information has been received from a registered nurse concerning a 14 year old female patient with no pertinent medical history and no known allergies who in July 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). On 06-FEB-2009 the patient was vaccinated with the second dose of GARDASIL (lot#659964/1978U) 0.5ml intramuscularly. There was no concomitant medication. One week after the second dose the patient developed nausea, vomiting, headache, fever, sore throat and runny nose. The patient has improved but continues with intermittent headaches and fever. Patient sought medical attention via a telephone call. No lab diagnostic studies were performed. Additional information has been requested.
Information has been received from a physician concerning a 7 month old female with history of renal anomaly who on 21-SEP-2007 was vaccinated PO with her third dose of Rotateq (lot # 657660/0972U). Concomitant vaccinations administered on that day included a dose of PEDIARIX, a dose of PREVNAR, and a dose of influenza virus vaccine (unspecified). Other concomitant drug therapy included prophylactic antibiotics and BACTRIM. On that same day, the patient experienced vomiting of blood and vomiting. The patient was taken to the ER and was subsequently sent back to a hospital for further observation. Subsequently, the vomiting and vomiting of blood resolved quickly and the patient was recovered. There was no product quality complaint. Additional information has been requested.
Had severe migraine with apraxia  (which has never occurred before) along with neuropathy of lower extremity (which has never occurred before either) that lasted about 10-15 min. All symptoms (headache, numbness) eventually subsided about 1.5 hrs after onset. Saw PCP about 2 weeks later and no interventions needed at that time.
Headache for multiple days, body aches for 24 hours, lymph node in arm pit of injection site swelling and soreness on day 2, injection site soreness, swelling and hardness, chills and fever for 36 hours
Extreme fatigue followed by muscle aches, mostly in upper thighs and knees, headache and fever reaching 102 Began at approximately 15:00 on 3/9/21 lasting approximately 12 hours. No adverse effects since
Admission date 8/9/21. First dose of Moderna vaccine on 8/5/21. Presented with generalized weakness, necrotic toe, and fever. COVID test positive on 8/9/21. Diagnosed with early sepsis, UTI and AKI in setting of acute COVID infection. Treated with COVID-19 protocol. Discharged 8/11/21.
Within a month after receiving my Bivalent vaccine, I came down with two different health issues. The first incident occurred around October 03, 2022. I thought I had contracted a UTI. I was getting up in the middle of the night to urinate about five times. I've never had a UTI in my life. I made an appointment with a Nurse Practitioner. They performed a Urinalysis. The result came back negative. They prescribed an antibiotic anyway. The antibiotic did not clear it up, so I made an appointment with my regular doctor. He repeated the Urinalysis and ran a blood test for STIs. I am not sexually active, but he still wanted to rule it out. Those results came back negative as well. He referred me to a Urologist. The Urologist also ruled out a UTI and that it had something to do with the muscles surrounding the prostate. My PSA number is very low, so it is not cancer. The prostate is not enlarged. He put me on tamsulosin HCL and that has made it very manageable. I continue to take one capsule per night. The second incident occurred around October 28, 2022. It was an ear infection. I've had ear infections on and off in my lifetime, but I haven't had one within the past 15 years. The periodic ear infections stopped when I received my Pneumonia vaccination. The infection is in my left ear. I saw a Nurse Practitioner at urgent care. I was prescribed amoxicillin and FLONASE. Over the 10-day course, my symptoms got about 90% better. I stopped the medication believing it would clear up, but it came back again. I was put on another antibiotic. I had a reaction to the medication, so I stopped taking it. I was also put on prednisone. Neither one of those medications helped. At that point, I went to an ENT. They removed some ear way from my left ear and indicated it was probably a result of the infection. They confirmed the infection was gone. They recommended a nasal wash. I used it for about a month. The pressure in my sinuses and left ear never abated. They decided to do a CT scan to rule out anything unseen. The scans came back clean. I was advised to monitor it. I don't feel the pressure a longer, but my sinuses are still impacted on my left side. It slowly seems to be abating, but I'm not yet through it. I was told that I could consider a Myringotomy if they symptoms don't resolve, but I have not done that at this point. I'm going to wait another month or two to see if the symptoms resolve.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "thyroidectomy" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid from 29Dec2022 to 03Jan2023.  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.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events Covid-19 and drug ineffective are related to BNT162b2, BNT162b2 omi ba.4-5 administration cannot be excluded. This case will be reassessed should additional information become available.
Receive flu shot on 9-30-09. C/O arm soreness for 2 days which lessened over time. Approx 1 week after shot she noticed increased soreness especially when moving in certain positions. This continues for 3 more weeks until now, when she presents at the clinic.
Patient complained of pain and swelling under the injection site, approximately the middle of the upper arm. Area was large and inflammed. Patient did not report any vaccination allergies before administering the shingrix shot, however, when she came in today to inquire about the side effect, she stated that she has had an allergic reaction to the flu shot perviously and had forgotten about it.
Sick feeling (fever, chills, body aches, painful swollen arm, unable to lay on it.  Quite bad until 10/23/2016 in morning.
Pt was sitting in chair by desk, TD given IM rt arm,Hep B give IM, pt says "I feel sick", paleness developed, non- responsive for few seconds. Left arm was drawn upward Pt came to, ambulated to exam table to lie down, pt reported being nauseated. B|P 120/86, pulse 80, LOC minutes, B/P 110/80. PMD notified Pt under observation at his office.
received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number MR75G, expiry date 13th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th December 2021) and Shingrix (received 2nd dose on 4th March 2022).   On 28th May 2022, the patient received the 3rd dose of Shingrix. On 28th May 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.       Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: The pharmacist reported patient received 3 doses of Shingrix.  The reporter consented to follow up. Additional Supportive Information: The patient received 3 doses of Shingrix which led to extra dose administered.
I noticed a light pink bump on my left wrist by the veins that looks like a mosquito or insect  bite a little over an hour after getting the Pfizer Vaccine.  The bump itches like an insect or mosquito bite.  I?m putting hydrocortisone ointment in that bump and taking Benadryl.
Constipation since vaccine, has had only 3 bowel movements in 3 weeks & those were after suppository. Before vaccines, BM's were daily.
received an extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in an unspecified number of patients 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 extra dose administered (Verbatim: received an extra dose). The outcome of the extra dose administered 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: 28-Mar-2023 The reporter reported that anonymous report made about numerous patients getting an extra dose of kinrix. The reporter denied to follow-up. The patients received an extra dose of Kinrix, which led to extra dose administered.
PATIENT WIFE SAID THAT THE PATIENT ENDED UP HAVING SEIZURES AND HAD TO REPORT TO THE ED.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 10:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.37.  No concomitant medications were reported.  Batch number 031L20A administered on 12-Feb-2021 with temperature 35 degrees Fahrenheit. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021. Excursion time was 10am to 11am.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pt reports having double vision and vision being blurry. Pt was seen by Fire rescue which  took patient's vital signs and were all stable. Pt reported he had an episode of this three days ago. Pt was asked if he wanted to be sent to the ER and reported he did not. Pt's wife drove him home and reported he has dementia and she would contact his PCP and Opthalmologist.  Pt's vision had cleared up by the time pt was assessed by EMS.
She was administered MMRII and on a later unspecified date, had "titers" checked for an unspecified reason and the results showed "no developement of immnunity to measles".; This spontaneous report was received from a nurse prescriber of unknown age, reporting to herself. The patient's medical history, concurrent conditions, previously drug reactions, allergies, and her concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 1 dosage form for prophylaxis (frequency, route of administration, lot number and expiration date were not reported), which was reconstituted using an sterile diluent (MERCK STERILE DILUENT) (it was not reported that the sterile diluent was expedited or poorly stored).  On a later unspecified date, the patient had an antibody titer test, for an in unspecified reason and the results showed: "No development of immunity to measles" (measles antibody negative).   The outcome of the event measles antibody negative was unknown. The causality relationship with the reported event and the therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), was not provided.
Right arm moderately swollen, warm, tender , firm, swelling and tenderness lasted 3 days.
Redness, warmth, bruising adjacent to the injection site. Itching started 4 days post injection.
Swelling reaction right deltoid.  2.5x2 inch localized swelling, no erythema, no induration, no limitation of movement right shoulder.
Breakthrough case admission after 2 vaccines; patient expired Moderna 1/14/21 lot# 012L20A;  Moderna 2/11/21 lot# 039K20A
Circular erythematous area on left thigh approximately two weeks after first set of immunizations. (Child previously immunizes). Treated with mupirocin ointment.
SEVERE Fibromyalgia-like symptoms, constant fever of 101, achy muscles, brain fog, exhaustion, tender and sore joints.
Fever chills, severe headache. Body aches sweats swollen neck glands. Swelling at injection site.