chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weak when woke up. Fell 2 times was then paralyzed on that Sunday A. M. went to ER was Dx with GBS . Guillan Barre Syndrome. Hospitalized. Now in rehab hospital
Patient was Hospitalized for two months DUE to COVID; The window for the second dose is missed; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient was Hospitalized for two months DUE to COVID) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-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 COVID-19 (Patient was Hospitalized for two months DUE to COVID) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (The window for the second dose is missed). The patient was hospitalized for 60 days due to COVID-19. At the time of the report, COVID-19 (Patient was Hospitalized for two months DUE to COVID) and PRODUCT DOSE OMISSION ISSUE (The window for the second dose is missed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab results included patient had a positive SARS-COV-2 test on an unknown date, after the first vaccine was administered. Treatment include patient received the antibodies and was hospitalized for two months due to COVID-19.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Unlikely that the events are related to the vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Unlikely that the events are related to the vaccine.
Muscle aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-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 on 29Apr2021 at 16:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Apr2021 (at the age of 49-years-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 30Apr2021 at 06:45, the patient experienced muscle aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events muscle aches and fatigue were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
It started about a week after I had my second dose.  I woke up like I had slept funny and my right shoulder was sore and really bothering me.  Within a few days I was in excruciating pain.  My range of motion in my right shoulder was really hindered and I had extreme difficulty reaching behind my back.  Despite me being right handed, I had weakness in my right arm.  Just getting dressed was difficult and unbelievably painful.  I considered going to Urgent Care  several times, but just tried to rest it, and the extreme pain did subside but then seemed to move into my neck. Upon my next Dr. appointment with my primary, I complained about my shoulder and neck.  She said it was probably bursitis and said PT, and ice and heat were all we could do. I started chiropractic treatment to try to get relief.  I was having daily, debilitating pain in my neck and right shoulder that worsened with any activity that required my arms outstretched, bearing weight.  As a mother of two and a professional potter for an occupation, I can tell you 90% of my daily activities aggravated my symptoms, and the symptoms would get progressively worse as the day went on. I begged my chiropractor for an mri which showed just a slight spinal cord compression, but nothing that would explain the symptoms.  I then saw a spine surgeon  Rothman who referred me to a sports medicine Dr who put me on gabbapentin. He just referred me to Relieve us for acupuncture.
Moderna vaccine side effect 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Moderna vaccine side effect 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna vaccine side effect 2nd dose). At the time of the report, VACCINATION COMPLICATION (Moderna vaccine side effect 2nd dose) had resolved. Not Provided          Treatment information was not provided by reporter.   This case was linked to MOD-2021-026594 (Patient Link).
I heart palpitations on and off. I went to the ER and they took a whole bunch of test and nothing came up. I wore heart monitor and nothing came up except for heart arrhythmia. I don't have the date of the tests . I still have heart palutations. I had the flu vaccine on the other other but I cannot remember which arm.
lightheaded, dizzy, nausea, vomiting, tingling in the hands and face, diaphoretic, tachycardia
Left eye, I started losing vision. Then I went to my ophthalmologist. He said my left ratio was swollen. This started end of March and I had surgery on it. But I am still having issues with it.
Pt states left arm pain 2 weeks after shot. States it hurts to raise left arm. He states he received his flu shot in the left arm. Our records show he was given SHINGRIX in left arm. He was advised to see his doctor who prescribed Lidocaine patches. Still has pain.
Banging head on crib rails that evening and for a few days after vaccine. Decrease in speech that day and for a few days later. His behavior resumed back to normal about a few days after vaccine.
This spontaneous report was received from a nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB whit Lot # M034189 and an expiration date of 23-OCT-2019 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit degrees (°F) to 77 °F range, for a time frame of 3 hours and 30 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002379: US-009507513-1705USA002378:
Approximately 10 days after first  Pfizer vaccination , severe outbreak of HSV-1 infection occured. Diagnosed with HSV-1 approximately 6 years ago. Only very very mild outbreak since first diagnosis. This outbreak is very severe and very painful, debilitating and not getting better my the day but worsening after each day goes by. Did get prescription of Valcyclovir.
nauseous; Sick; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 05Mar2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Mar2021, the patient experienced nauseous and sick, after receiving the vaccine. The clinical outcome of the events nauseous and sick was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Pt states when she received the PNEUMOVAX around 4pm today and it was painful and burned.  She called me around 850pm and said when she went home the pain continued and went up to her neck and all the way down her right side to her hip. She says the pain is severe and she is not able to move very much. I advised her to ice the area and take some TYLENOL. She stated if the pain does not get better or worsens she will go to the ER.
The patient developed a rash at the injection site which spread over several days to her neck, throat, chest and back. Two to three days later, the patient felt cold and her BP was lower than usual, 101/50. The patient developed a sinus infection 4-5 days after the injection. The patient was treated with an antibiotic.
Pt recvd vax on MAY92 & exp generalized pruritus; seen by MD, treated w/Pred & DPH;
Pain; Discomfort at the injection site; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date unknown) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site discomfort and lethargy. On an unknown date, the outcome of the injection site pain, injection site discomfort and lethargy were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site discomfort and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving 1st dose, the patient experienced pain around the injection site, discomfort at the injection site and lethargy which dissipated after two days. For tolerence of 2nd dose, refer case US2020011363.
felt tired; felt off; trouble sleeping most of the night; body aches from head to toe; aching legs / aching arms; aching back; chills; lethargy; headache on the top front of the head / is getting worse; she would not be able to get out of bed; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 18th October 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular). On 18th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and bedridden. On 18th October 2020 22:00, the patient experienced tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy and headache. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain, tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy, headache and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy, headache and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix in left deltoid. After vaccination patient felt tired, felt off, had trouble sleeping most of the night, body aches from head to toe, aching legs, aching back, and aching arms, pain at injection site all theses symptoms were ongoining till the time of reporting. The patient also had chills, lethargy and headache on the top front of the head all of these were ongoing at till the  time of reporting and the headache was getting worse. Patient reported she took Motrin for the headache and body aches but it did not resolve the issues. Patient reported she would not be able to get out of bed if she did not take the Motrin. Patient preferred not to give any additional personal information. The reporter did not consent to follow up.
Initial report received from a health care professional on 04 Jan 2010: This patient, with an unknown medical history was inadvertently administered FLUVIRIN, intramuscularly on 04 Jan 2010. The outcome of the event was not reported. No other information was provided.
10:10 Vaccine given for booster on 6/14 was drawn up in syringe in refrigerator since 6/11.  Unknown to nurse giving vaccine.  Primary vaccination nurse alerted this nurse to situation.  Notified Agency Director who advises to offer new vaccine.  Situation explained to patient and husband(other patient). Consent to new vaccine injection (same lot). Asked patient to call if any problems or concerns. Contacted AGENCY.
Patient received vaccination without any issues.  Asked him to stay the 15 minutes after vaccination to make sure that he doesn't have side effects. A few minutes after he sat down, he got my attention and said he was not feeling well, dizzy. Had him sit down, drink water. Took his blood pressure which was 148/105, repeated in 10 minutes and it was 146/108 via electronic cuff.  Switched to manual to ensure correct values and manual pressure was 145/105.  Called 911 to evaluate
Breakthrough case admission after 2 vaccines Pfizer 3/10/21 lot# EN6207;  Pfizer 3/31/21 lot# ER8734
Extreme body aches, skin hurt to touch, extreme feeling of being cold unable to get warm, stiff joints and joint pain, sleeplessness, all over burning sensation
Client came to our local office of health to receive the second dose in her Varicella series. Series was started years ago but never finished. Came in to clinic, filled out the screening form. No contraindications noted. Vaccine was prepared upon client arrival to clinic using aseptic technique, dose of 0.5ml administered in subcutaneous tissue the left arm. No complications during administration. Client tolerated well. She stayed in the office for 15 minutes of observation per protocol and was without complaint at time of leaving office. She called the office the next day 6/8/18 to report that she had experienced a local reaction and possibly a systemic reaction to the vaccine. She reported local redness/swelling at injection site "egg size" per client. She also reported that at 2-3pm the same day of the vaccine she had experience fatigue followed by nausea, vomiting and diarrhea. On the same day as receiving the varicella vaccine at our clinic she had also received a Tdap from an occupational health clinic, she went back to the occupational health clinic the next day 6/8/19 and at that time she reported to the practitioner the reactions from the previous day (fatigue, N/V/D). She reports during the assessment 6/8/19 she was still found to have a mild temperature (99f) and slightly low blood pressure (96 systolic). Client reports that the clinician told her to notify our clinic regarding the systemic reaction so that a report could be filed and that the occupational health clinic would also file a report as she had received a Tdap from them the same day at 9am.
6/15 39y.o. female who presented from home with a chief complaint of wound infection on the scalp. She also complained of abdominal pain on admission. Patient was given pain control and small IVF bolus. She was started on CS. Covid-19 returned positive, though deemed likely from a previous infection versus new infection.
patient was post pfizer covid vaccination about 5 minutes seated in chair. fainted and appeared to have a seizure of around 1 min. his mother and I were trying to revive/wake pt during this time. called 911. pt was disoriented upon awakening and vomited about 5 times. emt arrived in about 7 mins. pt left in ambulance.
No additional clarifying statements or details were; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug allergies or previous drug reactions, and concomitant medications were not reported.  On 04-NOV-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, with a default oral route of administration (strength, dose, vaccination scheme frequency and anatomical site of application was not provided; lot number 1879858 that was verified to be valid with an expiration date reported and established as 21-OCT-2023) for prophylaxis (product storage error).   The administered dose of vaccine was stored at a temperature excursion of 47.83 degrees Fahrenheit (°F), during a time frame of 0 hours 10 minutes with 0 seconds.There was no previous temperature excursion.  No additional clarifying statements or details were provided (no adverse event).
RECEIVING VZV 0.5ML SC/SQ AND HEP A 0.5ML IM ON 01/03/2011.  MOTHER APPLIED ICE/COLD COMPRESS ON 01/03/2011.  DENIED ANY FEVER OR PAIN AT THAT TIME.  STARTING ON 01/04/2011 PT DEVELOPED SOME SKIN REDNESS AT THE LEFT ARM, MOTHER GAVE CHILDREN MOTRIN 7.5ML PO X 2 TO THE PT TO REDUCE DISCOMFORT.  ACCORDING TO THE PT'S MOTHER THE VACCINE SITE GETTING WORST ON 01/05/2011, AND DECIDED TO BRING THE PATIENT BACK TO THE CLINIC.  01/05/2011 AT 12:00 PM: PT ALERT, ACTIVE, DENIED ANY PAIN. LEFT ARM SKIN REDNESS AND SWELLING ABOUT 15CM X 20 CM WITH BLISTERING IN THE CENTER ABOUT 2 X 2 CM.  NO TENDERNESS.  NO LEFT AUXILLARY NODE ENLARGEMENT OR TENDERNESS.  REPORTED TO CLINICIAN, CLINICIAN ADVISED APPLYING WARM COMPRESS TO THE SITE, KEEPING CLEAN TO PREVENT INFECTION AND RETURN TO THE CLINIC ON 01/07/2011 FOR FOLLOW UP.  NO MEDICATION PRESCRIPTION GIVEN AND  IF S/S GETTING WORST PARENT WILL BRING PT TO ER.
Tinnitus around June 6th and I still experience these symptoms. In both ears, but mostly in my left ear. When it's at its worse, it's worse ears. No treatments. Started getting hair loss as well. That started around a month prior to getting Tinnitus about mid-May.
have not adverse event.  He received the second dose incorrectly.  Had to be Pfizer for 12+ but he received Pfizer 5-11 years
Outgoing call to patient's mother to discuss incorrect dose amount of Moderna 23/24 6m-11 given on 10/24/2023. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. Additionally, a message sent to patient's PCP informing them of error.
Received 1s dose of SHINGRIX, Hours after vaccine at injection site, patient noticed redness, slight swelling and warmth at and around injection site. Redness, soreness and warmth persisted for about 5 days before resolving. Patient stated they used ice on affected arm to control side effects.
This spontaneous report has been received from a nurse and concerns of an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were unknown. It was stated that on unspecified date, an improperly stored dose of VARIVAX (Merck) lot # L032391, expiry date 26-AUG-2017 (dose and route were not reported) and other lot number reported as L034268, expiry date 08-SEP-2017 (dose and route were not reported) were given to unspecified number of patients. It was reported that the vaccine was at 6 Fahrenheit of temperature and its time frame was 4 hours, there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. this is one of two reports from the same source. Additional information has been requested.
headaches; headache was not that bad, it was kind of a tension headache; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization. The patient received her second dose of the Covid vaccine and was told not to take Tylenol. She was not told anything of what not to take on the first dose. She was currently having headaches and wanted to know what she can take since she was told not to take Tylenol. The patient informed that her headache was not that bad, it was kind of a tension headache. The patient did not think it was involved with the vaccine. Her headache was not that bad and she can live with it. The patient just wanted to know if it was not recommended to take Tylenol. The patient was advised to contact healthcare professional. The events was considered non-serious.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect BNT162B2 to the events headache and tension headache cannot be totally excluded.
Patient came from nursing home to the ED with cough and chest congestion.  Patient admitted to the hospital for Covid and treated with remdesivir.
The first symptom I had was a stuffy head which I thought was a head cold. I took the test that evening and it was positive. The stuffy head was the only symptom I had at that time. I contacted the doctors office and was prescribed Paxlovid. I started taking the medication yesterday. I had a little bit of a headache and a sore throat. The symptoms are about the same. I took a nasal spray to try to open my head up and that has helped significantly.