chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The 6 vials of moderna were used to administer doses ot 9 patients between the dates 07 Oct 20121 to 22 Oct 2021; On date 06-Oct-2021 at 3. 30 pm Moderna vials were in refrigerator, and the refrigerator door was slightly open. Data logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (On date 06-Oct-2021 at 3. 30 pm Moderna vials were in refrigerator, and the refrigerator door was slightly open. Data logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes) and EXPIRED PRODUCT ADMINISTERED (The 6 vials of moderna were used to administer doses ot 9 patients between the dates 07 Oct 20121 to 22 Oct 2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for an unknown indication.     No Medical History information was reported.    On 22-Oct-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (On date 06-Oct-2021 at 3. 30 pm Moderna vials were in refrigerator, and the refrigerator door was slightly open. Data logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes). On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The 6 vials of moderna were used to administer doses ot 9 patients between the dates 07 Oct 20121 to 22 Oct 2021). On 06-Oct-2021, PRODUCT STORAGE ERROR (On date 06-Oct-2021 at 3. 30 pm Moderna vials were in refrigerator, and the refrigerator door was slightly open. Data logger showed that temperature was out of range at 10 degree Celsius for 1 hour and 20 minutes) had resolved. On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The 6 vials of moderna were used to administer doses ot 9 patients between the dates 07 Oct 20121 to 22 Oct 2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.
On 12/17/2020 approximately one hour after receiving vaccination patient reported experiencing excessive vomiting and uncontrolled shaking that lasted approximately 10 hours. The next day on 12/18/2020 patient was admitted to emergency room and received IV treatments. Patient was unable to recall treatment regimen while admitted in emergency room. Patient reported receiving treatment in ER for several hours, then given a choice by hospital staff to be admitted inpatient or discharged to recover at home. Patient chose to be discharged. On 12/22/2020 patient reported visiting primary care provider and conducted lab tests. Results of labs are currently pending.
Information has been received from a physician concerning a 17 year old female with no pertinent medical history reported and no known drug allergies who on 15-Apr-2009 at 11:30 am was vaccinated intramuscularly in the left arm with third dose of GARDASIL (lot number 661044/0548X). There was no concomitant  medication. The following day, on 16-Apr-2009 at 11:30, the patient experienced hives. The patient recovered from the event on an unspecified date. No lab tests were performed. The patient did not seek medical attention. Additional information is not expected.
Fever of 103°, bad lower back ache, very bad headache, tired, loss of smell and taste. Symptoms lasted approximately 7 to 8 days. Also developed a deep bronchial cough which did not go away after I tested negative with a home Covid test kit.Seek medical attention due to the continual bronchial cough and In ability to exercise. Was put on a steroid inhaler for a month and a rescue inhaler to be used while exercising. I have been doing that for two weeks and still continue with a cough but it has improved
Information has been received from a woman from a physician's office concerning a 54 yr old white female with a history of cellulitis who on the afternoon of 29Sep04 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647359/0740N). Concomitant vaccine therapy given IM in the left deltoid included a yearly dose of influenza virus vaccine (unspecified) (lot U1401BA). On the morning of 30Sep04 the pt developed a temp 101.5 and swelling and erythema over the shot site. Medical attention was sought and the pt's actual temp in the office was 99.9. It was reported that the pt received a 3 pak to prevent the reoccurrence of cellulitis. No diagnostic lab tests were performed. On 01Oct04 the pt recovered. No further information is expected.
Pressure in ears / nose;   similar to when flying"   NKDA.   130/92, HR 83, talking, 99%
This delayed my period for a week.  The previous covid vaccine caused my period to be delayed for 2 cycles.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The consumer obtained the information from a website through e-mail with a link to an article on-line. The patient's current conditions and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL (unknown route and strength). Concomitant medications were not reported. It was reported that the patient experienced adverse event while on GARDASIL (unknown date). The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
developed nausea; had difficulty brushing her hair; tingling sensation all over her body / like pins and needles; This case was reported by a nurse via call center representative and described the occurrence of tingling sensation in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   The patient's past medical history included suicide attempt. Previously administered products included iodine. Concurrent medical conditions included attention deficit hyperactivity disorder, depression and anxiety. Concomitant products included lithium, citalopram, guanfacine, hydroxyzine hydrochloride (Hydroxyzine), methylphenidate hydrochloride (Methylphenidate) and ethinyloestradiol + levonorgestrel (Levonorgestrel 0.15, Ethinyloestradiol 0.03).   On 27th August 2020, the patient received Menveo .5 ml. On 27th August 2020, 1 hr 30 min after receiving Menveo, the patient experienced tingling sensation. On 28th August 2020, the patient experienced nausea and movement disorder. On an unknown date, the outcome of the tingling sensation, nausea and movement disorder were unknown.   It was unknown if the reporter considered the tingling sensation, nausea and movement disorder to be related to Menveo.  Additional details were provided as follows: The patient received Menveo vaccine and an hour 1/2 later developed tingling sensation all over her body, like pins and needles. The patient developed nausea and had difficulty brushing her hair. The patient had a history of to food, nut and iodine, shellfish and suicide attempts. The reporter consented to follow up.  The Nurse stated that Safety might reach out for additional information.
fever; chills; Lymphadenopathy; This is a spontaneous report received from a contactable consumer (the patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday at 17:30 (unspecified date). The patient stated she has experienced "every side effect", fever, chills, lymphadenopathy. Her fever was currently 102.5 Fahrenheit. She has been taking paracetamol (TYLENOL).  She asked at what point should she seek a healthcare professional. The outcome of fever was not recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Migraine type headache lasted most of day greater than 12 hours, slight fever 1 degree, chills, ache, lower back pain.
FEVER, CHILLS, BODY ACHES, NASUEA....DIDNT FEEL GOOD ENOUGH TO CHECK FEVER FRO SEVERAL HOURS  . WHEN FINALLY CHECKED IT AROUND 2 AM IT WAS 100.9   UNSURE IF THIS WAS THE HIGH OR LOW OR WHAT.......ALSO VERY SORE ARM BUT THAT WAS SAME AS FIRST DOSE ( 04/06/2021........)  ADVERSE REACTION WAS ONLY ON 2ND DOSE ( 04/27/2021)
pt devel an 11 cm by 11cm area of erythema, swelling, & itching @ the inject site of vax; aching of the arm was also noted; pt had full ROM in rt arm & radial pulses were intact; pt treated in ER w/DPH & cold compresses;
Pt complains of entire arm, shoulder to hand, aching and sore continuing to 15 days post vaccine. I examined arm and saw no bruising.  No pain at injection site per patient.
Dose was administered from vial outside of BUD labeled on product- dose was determined to be valid by Moderna.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. An adolescent male patient received the first dose of TRUMENBA at single dose for immunization, on unknown date. Medical history included severe food allergies. Concomitant medications were not reported. On unknown date the patient experienced fever, chills and stiff neck. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Case number PHEH2016US023708, is an initial spontaneous report received from a pharmacist on 14 Sep 2016. This report refers to a 63 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 165803) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. The pharmacist reported that, 2 patients received FLUAD vaccine that were not 65 years or older. No adverse event was reported following this administration error. The case was assessed as non serious by the pharmacist.
Appendicitis. Patient started to experience symptoms of RLQ abdominal pain on 3/3/2021 - she presented to ED on 3/5/2021 and found to have ruptured appendicitis.  She was hospitalized from 3/5/2021 - 3/7/2021.  Underwent appendectomy 3/5/2021.  Postoperative course was uncomplicated.
Patient notice soreness when went to bed on Sunday (01/27/2019) but no redness at area. Patient reported to pharmacy on Tuesday (01/29/2019) with redness and tenderness on right upper arm. Pharmacist recommended diphenhydramine and ibuprofen until patient could get in to see Physician. Pharmacist called Dr. office for patient and consulted with on call Physician who recommended patient come in to be evaluated on 01/29/2018. Patient agreed to go to Physician's office for evaluation.
Painful rash/ rash has improved slightly; Warm to the touch rash; Pinkish/red rash / rash has improved slightly; Arm soreness/ arm soreness is ongoing; Chills; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 559H5, expiry date unknown) for prophylaxis.   On 16th December 2022, the patient received the 1st dose of Shingrix. On 17th December 2022, 1 days after receiving Shingrix, the patient experienced chills, fatigue and nausea. On 18th December 2022, the patient experienced pain in arm. On 19th December 2022, the patient experienced painful rash, skin warm and red rash. On 17th December 2022, the outcome of the chills, fatigue and nausea were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the painful rash and red rash were recovering/resolving and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the chills, fatigue, nausea, pain in arm, painful rash, skin warm and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The patient had received the first dose of Shingrix at a retail pharmacy, in the left arm. The patient had reported experiencing chills, fatigue, and nausea on Saturday morning, the patient had reported chills, fatigue, and nausea had resolved at the night of 17 December 2022.  The patient had reported experiencing left arm soreness starting on Sunday, 18 December 2022. The patient had reported arm soreness was ongoing at the time of reporting. The patient had reported she had noticed rash on left arm on Monday, 19 December 2022. The patient had reported that the rash was 2-3 inches below injection site and the rash was painful, warm to the touch, red and in a linear pattern. The patient had reported width of rash was approximately one and a half to 2 inches wide. The patient had reported rash had improved slightly, at the time of reporting had more pinkish, as opposed to red, appearance. The reporter consented to Follow-up.
both shots, very bad case of shingles/suspected vaccination failure; bad case of shingles; left leg and foot numb, through stomach and bowel; lost 30 lbs; can't eat right; pain for a month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, numbness, pain, weight loss and unable to eat. On an unknown date, the outcome of the vaccination failure, shingles, numbness and weight loss were unknown and the outcome of the pain was recovered/resolved and the outcome of the unable to eat was not recovered/not resolved.   The reporter considered the vaccination failure, shingles, numbness, pain, weight loss and unable to eat to be possibly related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comments: This case was reported by a patient via  interactive digital media. The patient had both shots and had very bad case of shingles. The patients left leg and foot were numb from it, and numb through his/her stomach and bowels.  The patient was in pain for a month, lost 30 lbs, still could not ate right. The patient thought vaccines were poisonous. Additional supportive information:This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Breakthrough case after 2 vaccines Moderna 1/14/21 Lot# 032H20A;  Modern 3/11/21 Lot# 032H20A
Rendess, swelling and pain to left upper arm-large local hypersensitivity reaction
Mom reports temp at 9:00pm on 12/8/16 was 99.9 and she gave TYLENOL by wt. At 4:00am eyes rolled back and began shaking. Called 911. When paramedics arrived temp. was 105 degrees and cold clothes applied. In ER temp was 103.9 degrees rectally and Ibuprofen given. Discharged on cefdinir. Dx febrile seizure.
Shortly after the shot I felt a little odd.  I felt like I had a fast heartbeat or extremely high anxiety.  Felt like I had 20 cups of coffee.  I was really hyper the night of the shot.  Only got (4) hours of sleep.  The symptoms continued for approx 24 hours.  I had shortness of breath at times which could be from my heartbeat flucuating or I had anxiety.  I am also very irritable.  No other reactions.  Other than that I feel back to normal after about 48+ hours.  Praying I don't have any heart damage or lunch damage from what was injected into my body.
After receiving vaccines I began to fell unbalanced accompanied with 24/7 dizziness. Have seen a multitude of doctors & specialists without a firm diagnosis. This has become very disabiliating.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided   This case was linked to MOD-2021-395985 (Patient Link).
I had a temperature up to 102.0; muscle aches, fatigue, congestion, sore throat and flu like symptoms. The temperature lasted for about 4 days and then on the 5th day my temperature was normal. It wasn't until Monday I reached out and spoke to my doctor and they wanted to give Paxlovid, but I was told I may have a rebound if I took that medicine. I decided to just treat the symptoms and I did just that. The fatigue lasted 4-5 weeks and I was weak and exhausted.
A report was received from a healthcare professional on 10/02/2003 concerning an unspecified number of vaccinees under the age of 4 years who were inadvertently administered Fluvirin between 09/26/2003 and 10/01/2003.  Between 09/26/2003 and 10/01/2003 an unspecified number of vaccinees under the age of four years inadvertently received Fluvirin.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.
UTI  after second dose; Sweats; Unable to walk; Fever; This spontaneous report was received from a consumer concerning a 73-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Urinary Tract Infection, fever (pyrexia), sweats (hyperhidrosis), and unable to walk (gait inability).  The patient's medical history and concomitant medications were not reported.  The patient received the first of two planned doses of mRNA-1273 (Lot/Batch number: 007MZ0A) on 30 Jan 2021.  On 27 Feb 2021, prior to onset of symptoms, the patient received the second of two planned doses of mRNA-1273 (Lot/Batch number:  013A21A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after first dose of vaccine, the patient felt sick with fever, had sweats and was unable to walk.   Post second vaccination administration, the patient experienced same symptoms of feeling sick with fever, had sweats and was unable to walk. After second dose, the patient also experienced Urinary Tract Infection (UTI) and was hospitalized for three days. The patient reported that the people at facility were not wearing gloves when she received both doses.  Treatment for the events was not reported.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome for the events, Urinary Tract Infection, fever, sweats, and unable to walk was unknown.; Reporter'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.
Injection site pain,  tiredness,  chills, joint pain,  fever 103.4,  nausea.  All side effects resolved themselves within 24 hours.
Monday April 5th I started bleeding.   I thought it was my normal period.    Tuesday I started having major abdomin pain.   It was so bad I couldnt walk.   The pain would subside and then I would bleed alot.    Then the pain would start again.  The pain would subside and I would start bleeding alot again.   This was like labor.  Wednesday I had a lot of tissue come out of me so I realized this must be a miscarriage.   My doctor told me to take a pregnancy test and sure enough it tested positive  I was about 5- 7 weeks pregnant. As far as pregnancy history, I also miscarried February 11th.  (went in for the ultrasound and fetus wasnt moving around 9 weeks).   Had first child at 35 and 2nd at 40.   My instincts tell me the vaccine had something to do with  my 2nd miscarriage (April 5th).
Case number PHEH2013US012281, is an initial spontaneous report received from a nurse on 04 JUN 2013 with the follow-up received on 28 JUN 2013. This report refers to an 18-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO  (batch number: X11042) intramuscularly in left deltoid, without being reconstituted with Men A component on 28 May 2013 at 18:00 PM. No adverse reaction was reported following this administration error.  Follow-up received from nurse on 28 JUN 2013: Updated batch number, vaccination site and time.
Feeling unwell; Chills ensued; Temperature began rising continuing to 104.1; Nausea; Vomiting; Headache; Fatigue; Various aches throughout body; Stress; Vein on forehead popped out from the stress; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an intramuscular route of administration in the left arm on 08Apr2021 at 08:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included bundle branch block left. The patient was allergic to shellfish. Concomitant medications included paracetamol (ACETAMINOPHEN) and loratadine (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an intramuscular route of administration in the left arm on 16Mar2021 at 09:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 20:30, within 12 hours, the patient began to experience feeling unwell, chills ensued, her temperature began rising, which continued to 104.1, had nausea, vomiting, headache, fatigue, various aches that began then stopped throughout her body, the vein on her forehead popped out from the stress. Headache, fatigue and nausea were still continued the second day post vaccine. 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 event feeling unwell, chills, temperature began rising continuing to 104.1, vomiting, various aches throughout body, stress and vein on forehead popped out from the stress were resolving. The clinical outcome of the events nausea, headache and fatigue were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Generalized rash with itching onset approximately early November 2013. Treatment included Antihistamine BID, 12 day course of Prednisone, topical steroid.