chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at injection site; Headache; General tiredness; Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 at 14:15 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19.  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced soreness at injection site, headache, general tiredness and flu like symptoms. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events injection site, headache, general tiredness and flu like symptoms was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
A report was received from a health care professional on 11/28/03 concerning approximately 40 vaccinees between the ages of 4-9 years and of unknown gender, who inadvertently received 0.24ml of Fluvirin between 10/6/03 and 11/21/03. Between 10/6/03 and 11/21/03, the vaccinees inadvertently received 0.25ml of Fluvirin. It was reported that no adverse events had occurred as a result, at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
I learned that my mother started feeling ill the day after the shot in the evening and then went to bed. On Saturday, January 23rd, she was exhausted and unable to get up. We learned this from a friend of hers who had called us back after both my brother and I were unable to reach her by phone.  This was about 3:15 pm and we drove to her apartment and found her semi conscious in her bed. We awoke her but she was unable to talk or get up. We then called 911 and emergency paramedics came and took her to hospital.
Dizziness, nausea. BPs 139/84 (pulse 105), 128/76 (pulse 93). O2 sat 100%.
Patient recieved expired vaccine with no reported adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Regulatory authority (00794863).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ565AB and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "Caller stated they administered vaccine to two patients and realized the vaccine expired 30Jun2021. Caller asking if there any safety issues and should the patients receive the updated version vaccine for this year? Caller declined to provide email."  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore left arm; Right ear stopped up; Ear pain; Loud ringing in ears; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            Concomitant medications was not provided. Treatment medications was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
field of vision narrowed, episodic syncope over 45 minute period, confusion, diaphoresis, disorientation, exhaustion, prolonged light-headedness.
Patient received her 2nd dose of covid-19 Pfzier vaccine drive thru @ 0819. Patient c/o severe headache, dizziness, nausea, palpitations.  0821 BP164/100, denied shortness of breath, no respiratory distress noted.  0828 BP 160/98, O2 sat 98 %. HR 115, c/o nausea, severe headache, face flushed.  0831 BP 145/83 HR 99, o2 sat 100%, c/o severe headache, vomited x 1. 0832EMS activated.   0833BP 143/91 HR 95. 0835 Fire Department on site,  0838 BP 182/102 HR 125 O2 sat 98% (by the Fire Department) 0839 Patient c/o severe headache, nausea, vomited x 1 0841 Blood glucose 173 (by the Fire Department) 0848 EMS arrived  0850 BP 180/99 HR 105, patient c/o severe headache, nausea and dizziness. 0901 Patient transported to Hospital. Pt was alert and oriented x 3 @ all time, no respiratory distress noted.
Abdominal pain and cramping after taking last pill. No diarrhea or vomiting.
extremely fatigued; experience nerve sensations that felt like electrical shocks all over her body, in her abdomen, calves, thighs, toes, back, hands, everywhere; fever 102 degrees F; slight rash on the arm that vaccine was given; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 14 years old female patient who experienced extremely fatigued, nerve sensations that felt like electrical shocks all over her body, in her abdomen, calves, thighs, toes, back, hands, everywhere, fever 102 degrees f and slight rash on the arm that vaccine was given, while she received vaccines MMR, HEPATITIS B VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included MMR. The patient's past medical history, medical treatment(s) and family history were not provided.   On 07-Aug-2019, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On 07-Aug-2019, the patient received a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On 07-Aug-2019, the patient received a dose of suspect MMR not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On 13-Aug-2019 around 6 pm or 7 pm, the patient developed a non-serious extremely fatigued (fatigue) 6 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, HEPATITIS B VACCINE and MMR.  On 13-Aug-2019 about 10 pm, 11 pm, or midnight, the patient developed a non-serious experience nerve sensations that felt like electrical shocks all over her body, in her abdomen, calves, thighs, toes, back, hands, everywhere (paraesthesia) and fever 102 degrees f (pyrexia) 6 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, HEPATITIS B VACCINE and MMR.  On 13-Aug-2019, the patient developed a non-serious slight rash on the arm that vaccine was given (vaccination site rash) 6 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, HEPATITIS B VACCINE and MMR.  (Other relevant tests included no lab data.)  Final diagnosis was slight rash on the arm that vaccine was given, fever 102 degrees f, experience nerve sensations that felt like electrical shocks all over her body, in her abdomen, calves, thighs, toes, back, hands, everywhere and extremely fatigued.   The patient was treated with two PARACETAMOL (TYLENOL [PARACETAMOL]).  The patient was Recovering from fever and fatigue and outcome of the other event was unknown.  Information on the batch number was requested.  Documents held by sender: none.
Information has been received from a physician concerning her child who was vaccinated with varicella virus vaccine live. The physician reported that her child developed a chickenpox breakthrough. She described the child's case as severe with several hundred lesions on the body and in the mouth. The reporter indicated the pt may have been treated with acyclovir. No other information was available at the time of this report. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested. The physician also mentioned that there have been a large number of chickenpox breakthrough cases in children who have been vaccinated with varicella virus vaccine live.
I have started to have abdominal issues in April of 2022, I thought that it may have been a hernia, which showed symptoms when I was lifting things I would have pain in my ovary area and started on ones side and then both sides. It started to get worse over the past two three weeks and decided to go to the doctor. I would begin to get twinges around my abdominal area of pain, and pressure and discomfort under my rib cage and whole abdominal area. I went for a Sonogram and as they were pushing under my rib cage I started have a really bad pain and I am now extremely sore in the right area under my rib cage. There are certain times when I am okay however these past few weeks have been every day. I feel fatigued which is abnormal for me. I go back to the doctor in week and at that time they will discuss a plan for my pain.
Extreme fatigue. Had to sleep.  Slept 2 hour nap, 9 hour night, then two more two hour naps.   (6-7 hours is normal sleep time for me) Groggy and dizzy during that same time when awake.  Resolved within 32 hours.
Narrative:  COVID infection following COVID vaccine series 03/19, Pfizer, dose #1 04/09, Pfizer, dose #2 12/21 CXR impression: Good aeration of the lungs. Stable cardiac and mediastinal contours. Degenerative changes of the visualized spine. Overall, no acute cardiopulmonary disease. 12/21 COVID swab, result: detected 12/18 pt cc: cough, diarrhea, fatigue, myalgias, sore throat, loss of taste or smell, rhinorrhea exposure: unknown 12/28 clinically resolved
Patient developed fever, abdominal pain, vomiting and diarrhea on 12/27/21. Was evaluated in the ED on 12/29, underwent imaging for appendicitis which was negative. Diagnosed w/presumed viral gastroenteritis. Symptoms persisted and then he developed conjunctivitis on 1/1/21 as well. Due to worsening of his symptoms he returned to the ED on 1/2/21. Found to be hypotensive. Received fluid boluses.  Admitted w/suspected MIS-C. Treatment started with IVIG and IV steroids  on 1/2/22 with improvement in vital signs and clinical status.
Vaginal bleeding. My last period was 12/03/21-12/09/21. I started bleeding late the night after I received the vaccine. It started light, became heavy two days later, and finally started to slow down two days ago. I am still bleeding but it seems to be coming to an end. Have felt fine otherwise. I am due to start my normal cycle in five days.
Hospitalization due to COVID 19  Reported per Pfizer COVID-19 Vaccine EUA
On 1/15/14 patient's daughter informed me that patient was diagnosed with ADEM (acute disseminated encephalomyelitis) secondary to Fluzone HD. He was admitted on 12/1/13 and now is in a hospital.
Moderna COVID-19 Vaccine EUA Headache, nausea, no appetite, very tired.  Began when I woke the day after the injection which was a Saturday and lasted approximately 1  1/2 days.   By Sunday afternoon my appetite returned, the headache was gone, the tiredness was gone.   There was no treatment other than to sleep and put ice on my head for the headache.
Shot given in the top of the right shoulder, pain started around 4:30. Called pharmacy talked to pharmacist who gave the shot told her I was having pain and she suggested Tylenol and Ice. Tried this and pain got progressively worse until no longer could stand the  pain. Went to ER that evening. They gave me a shot for pain, X-rays and blood work. They thought the pain was probably caused by the injection given into the tendon. I have seen my primary care doctor and they suggested seeing an orthopedic doctor. Also have seen a Chiropractor and received Myofascial Acoustic Compression Therapy. Starting physical theropy today. Have had very little use of right arm in the past two weeks.  No pain in this arm or shoulder prior to this shot.
Severe depression.   Depression began getting worse shortly after receiving the vaccine.  Got to the point where I was constantly crying, could not get out of bed for weeks, sleeping 18 to 20 hours a day.
At 6:30PM, I developed a headache and took acetaminophen. It didn?t subside after taking that, and progressively got worse as the night went on. I began feeling chills and feverish before I went to bed. I woke up sweating in the middle of the night multiple times with my headache getting even worse. At 5:30am, I woke up and it was as its worst, with a 101.2° fever, sweating, chills, and an even worse headache that felt like a migraine.  The  headache lasted until the next morning and lingered throughout the entire next day, although not as intense as it was at 5:30pm. I?m still struggling with some on and off fatigue from the vaccine, and my arm is still sore.
Pt reported a red circle 3 inches in diameter at the injection site that appeared 3 days after administration.  Pt also stated that he had laboratory results that included a low platelet count value reportedly around 100,000 on 4/25/2023
After immunization, patient experienced upper shoulder pain when moving her arm.  Hoped it would resolve, but it did not.  Contacted the pharmacy for help.
Had sore throat & some mild swelling in glands and low grade fever for 24 hours.
Information has been received from a nurse practitioner via company representative  referring to a female patient of unknown age. On an unspecified date the patient was vaccinated with ZOSTAVAX vial (lot #, dose and route were not provided). On an unspecified date the patient was diagnosed with shingles. The shingles lesions were papular and painless. The distribution of the lesions was not provided. The patient visited the office to seek medical attention. No treatment was given for the events. The outcome of shingles was unknown. Additional information has been requested.
Rec'd vaccines 2/27/13 -> MMRV & Hep A. Developed hives on 2/20/13.
I had no adverse effects of the time of taking the vaccine. I had some stomach issues but that was about it. On Christmas Day, I was feeling sick, I took a Covid-19 test and it came back positive. I had a fever, a raging headache that lasted 2 weeks, congestion like I never had before, I had stomach issues, and a runny noise. I still have headaches and my nose still runs. At the time I got sick, they were not even seeing people at the office due to omicron outbreak. I had to talk to an on call doctor who I explained I had no anti bodies with any of the vaccines. Which they found weird. I was confused, with 3 doses of the vaccines I should not have been this sick. And after 3 months the antibodies have gone again. All my relatives who had it were not as sick as I was and all of them are vaccinated. The vaccines were just not very effective at all on my behalf. I did not go to the hospital, I will give it that, but I was tempted to go to the hospital but my oxygen never went below 90. I am someone who has a long history oh pneumonia and bronchitis and I was terrified the whole time that it would go into my chest, and it didn't. I am still coughing to this day, a deep throat cough and still have headaches and runny nose, and it is nowhere near what it was for the 2 weeks during Christmas, but I am still experiencing these symptoms. I do not consider myself to have long Covid-19 due to no longer being in bed rest. I am still very fatigued, but to my sons wishes and my doctors orders, I keep busy to keep myself out of bed.
Initial report received from healthcare professional on 03 October 2013. A 43-year-old female patient whose medical history and concomitant medications were not reported, received FLUZONE (lot number UH898AA and expiration date 30-Sep-2014) intramuscularly in left deltoid (dose was not reported) on 27-Sep-2013. On 27-Sep-2013 by 4:30 pm on day of vaccination, patient began having symptoms, her left arm felt heavy and she had numbness. Patient reported that she didn't felt right. Numbness progressed down the left side of her body. She went to emergency room (ER) and was given FLEXERIL, DECADRON and MOTRIN. Spent 4.5 hours in the emergency room and was sent home. The numbness has resolved except for a localized area on the left arm. The patient also developed a black and blue mark the size of a thumbprint below and to the right of the injection site. Laboratory investigation was not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none.
Presents with a 2 week history of worsening left lower extremity paresthesias and weakness with increasing difficulty ambulating; admitted for lumbar disc herniation with discussion of potential surgery; preprocedure COVID-19 swab positive; pt w/o symptoms.
Began with severe sinus issues, turned into migraine symptoms, light sensitive. Took an at home Covid-19 test kit, it showed positive. Went to the Medical clinic, they did a rapid Covid-19 test, it came back positive. Headache lasted several days, felt extremely exhausted, small cough.  Symptoms began to clear up after a week.  No problems since.
Diarrhea; Stomach cramps; Stomach pain; Body ache; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), ABDOMINAL PAIN UPPER (Stomach pain), MYALGIA (Body ache) and VACCINATION SITE PAIN (Pain at injection site) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), ABDOMINAL PAIN UPPER (Stomach pain), MYALGIA (Body ache) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), ABDOMINAL PAIN UPPER (Stomach pain), MYALGIA (Body ache) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient did not receive treatment.
Swelling on arm. Placement lower than deltoid, 4 cm. treated with corticosteroids, antihistamines
administration error.   vaccine in refrigerator past expiration date by 3 days past  the 10 week expiration date from when vaccine taken out of  ultra cold storage.  patient experienced no adverse  events or side effects.
Experienced complete Loss of bladder control, twice, 5pm and within a couple hours after that.  There was no indication of urgency for either event. Assessed for UTI, negative.
Patient developed shingles on rt side of face after receiving Shingrix vaccine at her pharmacy on 8/25/20.  Symptoms started on 9/3 with a blister between eyebrows and progressed down to tip of nose and into scalp on right side.  She continues to have severe neuralgia.  Treated with Valtrex and opiates.
Dizziness, mild nausea, fatigue 8 PM. Home to bed 11 PM with body aches, fatigue, some nausea, possible fever. 06/23/2012 10 AM fever 100 degrees, extreme headache, no appetite, slept all day, nibbled at only one bowl of cold cereal. 06/24/2012 Headache receding, fever receing, extreme exhaustion, no appetite until mid-afternoon, ate some spaghetti and meatballs around 5 PM but didn't finish meal (a rare event for this young man). 06/25/12 achy all over (maybe from laying around for two days), still too tired to get up and walk around.
Patient has episode of vasovagal syncope approx 2 minutes after administration of HPV #1 in office. No fall or injury. Out for approx 10 seconds. Vitals stable with noted low BP.
This case was reported by a nurse via sales rep and described the occurrence of syncope in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, immediately after receiving BEXSERO, the patient experienced syncope, weakness, light headedness and presyncope. On an unknown date, the outcome of the syncope, weakness, light headedness and presyncope were unknown. The reporter considered the syncope, weakness, light headedness and presyncope to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO within previous few weeks from reporting date (specific date unknown). The field representative reported on behalf of healthcare professional and marked as follow-up because reporter stated that she had reported to Novartis (unclear if event was then forwarded to GlaxoSmithKline).
Contusion and quarter-size lump at injection site. Next day fever of 99.5, red, itchy, raised, fluid filled rash on chest, sides, and scalp. Actual pox developed.
Heavy vaginal bleeding with large clots.  After 7 days, it wasn't letting up and I was having difficulty breathing.  Consulted gynecologist and bloodwork, which revealed the blood loss caused iron deficiency and very low red blood cells.   Doctor did testing, including internal exam and ultrasound.  Unable to identify why this was happening and had never happened to me in my life.  Prescribed Medroxyprgesterine and  later norethindrone, progesterone IUD as well to try to slow the blood loss.  This lessened blood loss, but I was still bleeding.  She later prescribed premarin, which still didn't stop the bleeding.  This lasted for 6 MONTHS!  I just had a D&C and an ablation procedure - outpatient surgery.  The surgery was a little over a week ago.  So far bleeding has stopped.  Still healing.