chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIGHT NECK AND BACK WAS SORE; RIGHT NECK AND BACK WAS SORE; ARM SORENESS AT INJECTION SITE; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (RIGHT NECK AND BACK WAS SORE), NECK PAIN (RIGHT NECK AND BACK WAS SORE), NASAL CONGESTION (Nasal congestion) and INJECTION SITE PAIN (ARM SORENESS AT INJECTION SITE) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced NASAL CONGESTION (Nasal congestion). On an unknown date, the patient experienced BACK PAIN (RIGHT NECK AND BACK WAS SORE), NECK PAIN (RIGHT NECK AND BACK WAS SORE) and INJECTION SITE PAIN (ARM SORENESS AT INJECTION SITE). At the time of the report, BACK PAIN (RIGHT NECK AND BACK WAS SORE), NECK PAIN (RIGHT NECK AND BACK WAS SORE) and INJECTION SITE PAIN (ARM SORENESS AT INJECTION SITE) had resolved and NASAL CONGESTION (Nasal congestion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  On an unknown date, the patient experienced arm soreness at injection site/right neck and back was sore. In Sep-2021, the patient experienced nasal congestion. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
today actually it becomes worse; The other one is like blurred vision like around 2 weeks after I took my shot like I am watching you tube, I noticed that all the pictures was blur; sensation of throat tightness; feeling like I am really sick; I also hives on my throat; it something like itching on my throat; experience the heavy arm; I have an abdominal pain for 2 weeks and it does not go away/weird sensation in the belly button area; This is a spontaneous report from a contactable consumer or other non hcp. A 49-Year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0617), via an unspecified route of administration, administered on left arm on 09May2021 (at the age of 49-Years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   Patient had Pfizer first shot on 09May2021 and ever since then she had an abdominal pain for 2 weeks and it does not go away. Patient experienced abdominal pain about 5 hours after getting her first shot of the Pfizer BioNTech Covid-19 Vaccine, but went away after 5 minutes. She also mentioned that at night, she is experiencing a weird sensation in the belly button area and almost everyday when she wakes up, she is experiencing the abdominal pain which feels slightly stronger as days went by. She also mentioned that she has no preexisting issues. She wanted to know if it would be safe to get the 2nd shot of the Pfizer Covid-19 Vaccine because she is experiencing abdominal pain. The abdominal pain was like since about 6 hours after the shot it was like soft pain in her belly, then was just for few minute since then almost like daily, she felt abdominal pain near her belly button area and it would be like night time and day time it comes and goes and the day of reporting it actually became worse because ever since she woke up in the morning 8 O' clock it was like it doesn't go away. The pain is not is about like a 3 to 4 scale out of the 10. So it started on the belly button like the few days ago. When she was trying to push her hands like lightly on right side of belly button she felt the 'dull pain' in her abdominal area. Patient had abdominal pain besides other little ones that she won't mention like the minor one's they kind of already went away. The other ones are like blurred vision like around 2 weeks after she took her shot like when she is watching you tube, she noticed that all the pictures were blurred. Other than blur vision it was sensation of throat tightness, feeling like she was really sick and also hives on her throat, its something like itching on her throat and her arm which is normal and she thinks everybody experience the heavy arm for few days. Abdominal pain is one very much concern about. Treatment was reported as patient want to find out what she is going to do. The outcome of the events were reported as unknown.  Follow-up attempts are completed. No further information is expected.
Left elbow and forearm vesicular bulbous lesions spreading to left neck and head, spreading across midline to right forearm. No oropharyngeal lesions. No fever, chill. Good smallpox vaccine take. The pt is a 21 year old male , who received a smallpox vaccination, as well as PPD skin test, hepatitis A and B vaccines, influenza vaccine, anthrax vaccine and yellow fever vaccine on, or about Jan. 29th of this year. Two or three days ago, the pt developed left elbow and forearm vesicular/ bullous lesions. These subsequently appear on the left neck and head, and spread across the midline to involve the right forearm. The brachial areas were not reported. The pt has had no fever, chills, diarrhea, or vomiting. Infectious disease is consulted for eczema vaccinatum.
The patient was administered an improperly stored dose of VARIVAX; This spontaneous Non-valid report was received from a medical assistant referring to a patient of an unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided.  On unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S021926, expiration date on 15-JUL-2021 (strength, dose number, route and frequency were not provided). In addition, it was mentioned that the sterile diluent (manufacturer unknown) used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored. All therapies were used for prophylaxis.  The vaccines were improperly stored at a temperature of -14°C to -10°C during a time frame of 41 minutes. No previous temperature excursions and the call was because of a data logger.
Seizure one day after having flu shot. Awoke the day after shot feeling unwell. Bad headache and vomited breakfast. No fever. Slept until 2 PM. Unable to respond to questions and absent stare for approximately 10 minutes. Reported bad headache after seizure ended. Advil administered and he slept more. Neurologist suggested possible link to vaccine since seizure was not the typical type he experiences and he is controlled on medication. By the next day the headache was gone and he had a normal day. No more seizures since.  He did not have a similar reaction to the seasonal FluMist vaccine given on 9/23/2009 10/30/09 and 11/2/09 vaccine records received for date 9/23/09.  bhp 11/3/09 Medical records received from Neurologist most recent date of service 9/22/09. F/u appt. mentioned pt missed dose of seizure med and had three episodes of seizures and eval. at hospital. Recovered no complications except small laceration on forehead from seizure activity.
Event 1: Cold sore on outside of lip, noticed 02/13/2020 (approx.).  Ran its course 7 to 10 days, no treatment. Event 2: Peeling, bleeding inside both nostrils, noticed 03/06/2020 (approx.). Ran its course about 14 days, no treatment. Event 3: Peeling, burning, base of both nostrils, noticed end of May 2020. Treated with Eucerin. Event 4: (Major Flare 1) Outside weeping, then burning blister on outside of lip 06/05/2020; 06/07/2020 multiple bleeding sores (ulcers) above left eye and on both lips and sore under tongue. Treated with Abreva OTC and 1000 MG Lysine. Started on Valacyclovir 1 GM and Sulfameth/Trimethoprim 800/160 MG; ran its course until 06/16/2020. Event 5: (Major Flare 2): Weeping, then multiple bleeding sores (ulcers) on both lips 07/11/2020 and sore under tongue. Treated with Valacyclovir 1 GM and Sulfamethoxazole/Trimethoprim 800/160 MG and Mupirocin 2% ointment; ran its course until 07/19/2020. Event 6 (Major Flare 3): Multiple bleeding sores (ulcers) on both lips 08/23/2020 and sore under tongue. Treated with Valacyclovir 1 GM and Sulfamethoxazole/Trimethoprim 800/160 MG and Mupirocin 2% ointment; ran its course until 08/30/2020. Event 7 (Lesser Flare 4): Multiple bleeding smaller sores (ulcers) on both lips 09/21/2020. Treated with Valacyclovir 500 MG (current dosage) and Dexamethasone 0.5 MG/5ML elixir for internal mouth ulcer; current course in progress for 3 months; experiencing some inflammation on lips and reddish scar tissue where ulcers were appearing. Also treating lips and nostrils with EUCERIN for comfort.
Patient was given varicella vaccine for pre employement on May 10th 2018 and had positive pregnancy test on May 17th 2018.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 9:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 9:38 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 76.85 years.  Concomitant products were not provided.  On 11-Jan-2021, Excursion time were at 02 PM, temp was 35, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vial was moved to clinic. Vaccine BUD date was 07-Feb-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Hands turned red with slight swelling. Face and chest with red blotches.  Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol.   I drank water and it got better in an hour.  At night, my scalp was itching all nite.  My scalp was red on the right side only which was the site of the vaccine.  It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.
Information has been received from a registered pharmacist concerning a female patient "over 60 years of age", who was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported) 0.65ml subcutaneously. One day after the vaccination, the patient developed a localized zoster-like rash at the injection site. Patient sought medical attention via a telephone call. No lab diagnostic studies were performed. The rash lasted 2 days and then the patient recovered. No further information is available.
Patient called on 2/15/2016 and said she was having difficulty with arm movement had injection on 2/1/16 and I referred her to primary care physician.
Although arm was red and sore for days after vaccine, on day 8 it became itchy, large (at least silver dollar sized) hard lump, swelling of lump area and surround, redness, tenderness and warm to the touch. Worse the following morning (more swollen, more red, more warm) day 9 (today). Outcome. I am watching this closely (RN) as I am trying not to take antibiotics due to my Celiac Disease. If it worsens, will seek medical care.
Pain in upper left arm and shoulder, worsening to limited range of motion within 24 hours. Sustained for at least 7 days (to present).  Treated with acetaminophen with minimal resolution.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender. On 25-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse regarding a female patient of an unknown age. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. On an unspecified date in March 2016, the patient was vaccinated with first dose of GARDASIL, (lot number/expiry date and dose not reported). On 10-AUG-2016 (today), the patient would be vaccinated with her second dose of GARDASIL. No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
injection site was swelling; injection site was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was swelling) and VACCINATION SITE PRURITUS (injection site was itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included RALOXIFENE HCL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swelling) and VACCINATION SITE PRURITUS (injection site was itchy). On 16-Feb-2021, VACCINATION SITE PRURITUS (injection site was itchy) had resolved. At the time of the report, VACCINATION SITE SWELLING (injection site was swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Left arm  swelled, pain at injection sight all the way down outside of arm stopping at wrist, then traveling up inside of arm to arm pit. pain subsided but arm is still swollen as of today 03/16/2021.
Itches every now and then; Red ring at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches every now and then) and VACCINATION SITE ERYTHEMA (Red ring at injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itches every now and then) and VACCINATION SITE ERYTHEMA (Red ring at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itches every now and then) and VACCINATION SITE ERYTHEMA (Red ring at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03 Jun 2021 contains non-significant information: Updated reporter information.
Erratic heart rate two weeks after 1st Pfizer vaccine, lasted for two weeks. This was followed by additional two weeks of constant stabbing headache, and  after that passed, four weeks of extreme fatigue. Recovery from first Pfizer took six weeks.  Same heart rate issues  but more severe after second Pfizer dose. Lasted eight weeks this time
1515 While patient was waiting her 20 minutes after receiving her TdAP Immunization in the lobby, the receptionist  informed me that the patient did not look right and that she was holding onto her brother for support while walking.  Noted that the patient was attempting to leave the facility.  I walked out to the lobby and asked the patient and her father to return to the front clinic nurse 2.  I grabbed the emergency kit and removed the Epinephrine 1mg/ml.   I asked the patient's father her last weight and he informed me that she weighed 120 lbs.  I obtained the patient's vital signs.  The patient stated,  "It feels like my throat is closing".  The patient appeared to be pale and her lips were cyanotic.   I asked someone to call EMS for ambulance transport to the local hospital.   1518 the patient was given  Epinephrine via right thigh.   CNAAA placed ice pack on the patients forehead.   1525EmServ ambulance arrived.  The patient independently ambulated to the ambulance with the paramedic. I completed the documentation for emergency and gave a copy to the EMS driver.   1530 I informed Office manager of the current situation.   1539  ambulance left the Health Department.      Called the patient's father on 7/10/2023 to inquire about the patient's current status.   Informed per the patient's father that they observed his daughter for 3-4 hours and sent her home with a prescription for steroids and an Epi Pen.   The patient's father also informed that they will follow up with her pediatrician but they have not made the appointment yet.
Vomiting, Cold Chills, Body Aches, Itchy at Injection Site, Fatigue
Developed extremely sensitive and painful skin over specific area of body. Two days later, multiple red skin lesions and blistering appeared. Diagnosed by dermatologist's office as shingles likely caused by COVID vaccine.
pt recvd Engerix-B & exp nausea, vomiting, & diarrhea;
Pt had onset of facial droop and difficulty speakin gon 3/20/21, diagnosed with acute right corona radiata stroke by MRI at A Medical Center on 3/23/21
Right hand has muscle weakness and is difficult to do normal tasks like buttoning things, typing, any things using my right hand for certain things
Patient was administered the incorrect dose / volume for the Moderna Booster.  Patient was administered 0.5 mL (rather than 0.25 mL) no adverse reactions or side effects reported.
Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.; No adverse event; 3 patients received Moderna Covid-19 vaccine past its 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine past its 30 day use by date), PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, 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 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine past its 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine past its 30 day use by date), PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.) 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 (3 patients received Moderna Covid-19 vaccine past its 30 day use by date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.).    No concomitant medications were reported. Previous Moderna Covid-19 booster doses were First booster dose 8-DEC-2022 029H21B Second booster dose 19-MAY-2022 059M21A. No other adverse reactions reported. The adverse event was reported with Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture and dose was given in the 18th hour. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2022: Live significant follow-up received contains product storage error event added.
Symptoms began evening of 08/16/04-started with chills, sweats-lasted about day and a 1/2-saw MD, prescribed ATB. Site reddened and swollen.
Pfizer-BioNTech COVID-10 Vaccine EUA. Possible Atrial Fibrillation  detected using Kardia EKG application. Event started at 11:30 pm. First EKG taken at 12:00 am and measured 156BPM. I took one baby aspirin (81mg), drank cold water and did controlled deep breathing technique .
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-JUL-2017, the patient was vaccinated with M-M-R II (rHA) lot # L008684 for prophylaxis. On 27-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. Additional information has been requested.
pneumonia; Diagnosed with COVID after getting the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (reporting for himself). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on his right arm on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Jan2021, the patient was diagnosed with COVID after getting the first dose of the vaccine and experienced pneumonia. The outcome of the event was unknown.  Information about batch/lot number requested.