chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 048C21A and 048C21A) for COVID-19 prophylaxis. The patient was never been diagnosed with/ tested positive for COVID-19. Concurrent medical conditions included Blood pressure high, Diabetes and Mental retardation. Concomitant products included: Lisinopril; Glimepiride; Vistaril [Hydroxyzine Embonate]) for an unknown indication. On 22-Jun-2021 at 2:02 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jul-2021 at 2:02 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jun-2022 at 1:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 1:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022). The vial did not undergo any temperature excursions. The used vial was placed in in the refrigerator on the same day of administration (07-Jun-2022). The reporter thought that Moderna had an extension like Pfizer, and it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 08-Jun-2022. Event did not cause the patient to seek medical care. It was unknown if there were any other potential causes and if patient experience similar events in the past. No treatment details were reported.
She got the vaccine, and had no reactions at all other than perhaps a chill.  About  2-3 weeks later on 3/7/21 she started experiencing what they are calling muscle confusions.  She feels a tapping sensation on her biceps and triceps and then starts with muscle cramps running down her right arm creating her fingers to cringe or come together or contract.  This then travels down to her right leg to her quadriceps which cramps and convulse and travels to her calves which tighten up like a Charlie Horse and down her toes to where they contract as well.  They are intermittent, scattered and sporadic.  Sometimes she will get 2-3 a day, and then none at all and then a few days later a couple more.   These contractions last 3-5 minutes.  She had COVID back in April of 2020 and was hospitalized until August of 2020 with that.  During that time she was on a ventilator for 60 days and on a breathing tube and coded and was out for about 30 minutes.  She had an EEG of her brain in September and told that she was fine.  her neurologist felt she should have another one due to these symptoms, and she had that and everything was normal.  The doctor prescribed 500 mg twice a day of Levetiracetam.   The seizures kind of regress a little and then they came back and he upped that medication to 1000 mg twice a day.  The seizures still continue and have continued but is still taking the medication.  He felt that she should know see an epileptic specialist and they have an APT for 5/27/21.   These episodes are exhausting and wear her out.   She was going to PT due to the weakness from being in the hospital for so long, and now she is fearful if she is going to fall and uses a walker and is having a setback in that progress.  She is to continue therapy at home for now and to follow up with the Epilepsy specialist.
Shingles; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 09:00 AM (Batch/Lot Number: EW0151) as dose 1, single for covid-19 immunization (at the age of 50-years-old). Medical history included hypertension from an unknown date and unknown if ongoing. The concomitant medications included unspecified medication (other medications uses in two weeks prior vaccination). The patient had no known allergies. Patient had no covid prior vaccination. The patient has not been tested for covid post vaccination. Patient had not received other vaccine in four weeks. It was reported that after receiving the dose of vaccine on the patient experienced shingles on 11Apr2021. Ae resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles with Valacyclovir. The patient was not recovered from the event at the time of report.   No follow-up attempts are possible. No further information is expected.
Redness and swelling around injection site including most of the upper arm.  Area is warm to the touch.
Swelling of lips and confusion, feeling of lip and cheek tightness. EMS called
diarrhea; This is a spontaneous report from a contactable nurse (patient's wife).  A 73-year-old male patient received bnt162b2 (BNT162B2) at single dose on 28Dec2020 for Covid-19 immunisation, because he was a physician.  Medical history included prostate cancer receiving radiation and having bowel issues and diarrhoea. The patient's concomitant medications were not reported.  The patient experienced diarrhea in Dec2020 after receiving the vaccine. He had prostate cancer and was receiving radiation so it was normal for him to have diarrhea. The nurse state it was not a good source to confirm if diarrhea is from COVID-19 Vaccine. She has not a chance to talk to her husband about his experiences. The outcome of event was unknown.  Information on the lot/batch number has been requested.
She got her vaccine, she had some muscle soreness and she took Tylenol.  Then as the time grew on when she lifts her arm her arm pops, as she moves it down it gets stiff and when she gets to shoulder level it pops.  She has not gone to her doctor for this.  It has not gotten any better, and is trying to get an appointment to see an orthopedist for this.  She has tired taking some more Tylenol and putting heat on it, and it did not improve.  She feels like it is in the shoulder joint itself.  She does take Gabapentin and she took that but that did not relieve her symptoms.    She did have her COVID vaccines and has not had any problems with that.
Patient noticed a fever as high as 101 degrees, in addition to headache and other flu like symptoms. She didn't go into much specifics and stated that she plans to get the second shot in the series to complete her prevention steps for avoidance of shingles. She had also suffered similar injection site challenges when she received ZOSTAVAX in the past.
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 01-AUG-2015, patients were vaccinated with ROTATEQ, (dose, frequency and route of administration were not provided), lot # K011948, expiration date 07-JUN-2016; lot # K020181, expiration date 24-JUN-2016 and lot # K024700, expiration date 30-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
patient describes next day whole body hurt and wanted to go to er.  Had pain, warm, redness at site of injection.  She still has significant pain at area of injection.
"I" had a severe headache this morning and it woke "me" up.; And "I" vomited 30 minutes after "I" woke up even though "I" didnt eat anything.; This is a spontaneous report from a contactable nurse. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 14Apr2021 at 15:15(at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received birth control pill (unspecified) every day within two weeks of vaccination. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 18Apr2021 at 06:30, in the morning the patient had severe headache and it woke her up. The patient vomited 30 minutes after she woke up, even though she did not eat anything. The patient asked that are these also the side effects of the vaccine. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache and vomited 30 minutes after 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.
Pt developed a rash on face, trunk and extremities. Had 15 - 20 lesions diagnosed with atypical varicella. Pt was treated with Tylenol and Benadryl.
I got my fourth dose of Moderna COVID-19 vaccine in October 2022. Sometime in November 2022, I started having pain and reduced range of motion in the left shoulder. I saw my PCP in January 2023, and he referred me to a physical therapist. On about 1/24/2023, I began seeing a physical therapist. At the time of this writing, I still see the physical therapist usually twice weekly. Since I have been seeing the physical therapist, I now have less pain and slightly more range of motion. At this point, there is no set time limit for me to receive the therapy, so the length of time is at my discretion. I have taken Tylenol from time to time to treat the pain when it's bad enough, but I usually don't find it necessary. I also saw an orthopedist on 3/30/2023. He took X-rays, and I was diagnosed with arthritis. He gave me a steroid shot. After the steroid shot, I had slightly more range of motion, but it didn't last long. On 3/17/2023, I underwent an MRI of the left shoulder. Bursitis and a partial tear of a ligament were detected. No recommendations have been made with regard to the treatment of those conditions, though I have called them and am awaiting a reply.
Approximately an hour after receiving my second vaccine, I developed an extensive rash across the backs of both of my legs.  I called my local emergency department and was referred to the poison control hotline for my area.  They instructed me to take a Benadryl, which cleared up the rash within about an hour.   Poison control continued to monitor me for the next 12 hours.
Patient received Moderna vaccine on 12/29/2020. Minimal discomfort the day after. Patient called today to report on 1/6/2021 she developed red, raised area at injection site. Warm to the touch and itchy. Today symptoms have improved. Patient reports she applied ice to injection site.
Nausea; Headache; Joint pain; Fatigue; This is a spontaneous report from a non-contactable consumer received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for covid-19 immunization and no reaction was experienced on previous exposure to vaccine. The patient experienced nausea, headache, joint pain, and fatigue after the second shot. The patient experienced the events for 24 hours and on the following day the symptoms resolved. It was reported that the events took place after use of product. The outcome for the events were recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
6/12/2022 noon - sore throat 6/13/2022 10 am - cough, headache, nasal conjestion 6/13/2022 4 pm - Took first dose of Paxlovid 6/14/2022 1 am - Chest congestion, heavy cough fever, tired 6/14/2022 4 am - felt better, eased cough, headache reduced not as tired 6/14/2022 10 am - second dose of Paxlovid 6/14/2022 1 pm - felt normal, slight fever, slight cough persists continued to take Paxlovid as directed, no change in symptoms to date: slight cough, slight fever.
The nerve on the backside of my leg was inflamed to the back of my knee; Outbreak of herpes; Tenderness in the nerve on the left side of my face; Occasional pain in my left ear; Sore arm; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 69-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:15 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included lumbar discectomy, low back pain with bilateral sciatica, degenerative disc from an unknown date and unknown if ongoing degenerative disc. The patient concomitant medications were not reported. Patient not had Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, did not patient been tested for COVID-19. The patient did not receive other medications in two weeks of vaccination. Other than a sore arm on 05Mar2021, I had no reaction on the Friday that I received the shot. I also have herpes which breaks out in the hairline of my forehead and on the back side of my right buttocks. The day after the vaccine on Saturday, On 06Mar2021 the nerve on the backside of my leg was inflamed to the back of my knee, I also had an outbreak of herpes in both areas and tenderness in the nerve on the left side of my face with occasional pain in my left ear. The nerve pain in my leg and face subsided by Monday, the bilateral sciatic pain thru my buttocks area on both sides has not dissipated as of yet. Patient visited doctor or other healthcare professional office/clinic visit. Treatment was received for the events (recommendation to hear, stretch and elevate). The outcome of the events was reported as recovering.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Pain 2 days post immunization radiated up (L) arm to shoulder to jaw. Also had pain in axilla with 1 lymph node enlarged x 5 days. Left sided headache.
Fever; A spontaneous report was received from a consumer concerning a 76-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever (pyrexia).  The patient's medical history was not reported. Concomitant products included chemotherapy.  On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Feb 2021, next day of receiving vaccine, the patient developed fever and was taken to the emergency room and subsequently admitted on 02 Mar 21 for the fever. Treatment for the event included were antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event is not applicable.  The outcome of event, fever was considered as 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 event, a causal relationship cannot be excluded.
Diarrhea started 4 days after the vaccine and is ongoing, now 16 days later.
I was doing some construction in my house, lifting something very heavy, felt like an abdominal muscle strain bothering me for a few weeks. I had my annual physical in the end of October 2022. My doctor thought it was a muscle strain. It was very uncomfortable and very painful and as months went by, the first of the year, started to become more intense and I went back to see my doctor and complaining of continued abdominal pain. They did an CT scan of the abdomen on 01/25/2023 and referred me to a gastroenterologist. He diagnosed me with mesenteric bacterial infection due to abdominal trauma. I also had an ultrasound as well. I have recovered from my symptoms today.
Muscle/body ache, chills, weakness, tiredness, sore arm.  Treated with acetaminophen.  Symptoms dissipated by 1:00 pm on 10/27/21. Symptom duration was 19 hours.
Received Half the Vaccine Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received Half the Vaccine Dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced UNDERDOSE (Received Half the Vaccine Dose). At the time of the report, UNDERDOSE (Received Half the Vaccine Dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe headache x3 days. Intially headache was over entire forehead, on day 2 and 3 radiated to right side of head with severe pain to right eye x3 days; Severe headache x3 days. Intially headache was over entire forehead, on day 2 and 3 radiated to right side of head with severe pain to right eye x3 days; Severe headache x3 days. Intially headache was over entire forehead, on day 2 and 3 radiated to right side of head with severe pain to right eye x3 days; On day 3 developed hives on right buttock which later spread to left buttock; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 25Aug2021 10:00 (at the age of 43 years old) as dose 2, single, dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0127, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 04Aug2021 (at the age of 43 years old) as dose 1, single for covid-19 immunisation at Pharmacy or drug store. Medical history included hypertension. Concomitant medication(s) included amlodipine besilate (AMLODIPINE). Known allergies included Ace and arbs. No other vaccine received in four weeks. Other medications received in two weeks included Amlodipine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache x3 days. Initially headache was over entire forehead, on day 2 and 3 radiated to right side of head with severe pain to right eye x3 days, on day 3 developed hives on right buttock which later spread to left buttock on an unspecified date. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 32 year old female who on 15-NOV-2006 was vaccinated with the first dose Gardasil 0.5 ml IM. On an unspecified date the patient received the second dose Gardasil. On 16-MAY-2007 the patient received the third dose of Gardasil 0.5 ml IM. On 17-MAY-2007 the patient experienced pain, swelling and tenderness at the injection site of the right deltoid muscle. The physician also mentioned that the patient had trouble lifting her arm due to pain. The physician prescribed ibuprofen (Motrin). The patient was examined by the physician on 05-21-2007 and the symptoms were resolving. Additional information has been requested.
Information has been received from a female consumer (demographics unknown) who on 09 JUL 2001 was vaccinated with the first dose of hepatitis b vaccine recombinant (yeast) (Lot # 0327C - invalid). Approximately one half hour later, the patient developed an extreme headache, paine, felt weak, was very sensitive to light, and reported that her body felt like it was in slow motion. She reported that the physician gave her a shot, for pain, in the hip and that "this did help with some of the pain". She requested information about the vaccine and whether or not she should receive the next dose. The patient sought unspecified medical attention. Additional information has been requested.
Pain in shoulder and surrounding muscles - tricep, bicep, deltoid. Felt pain through the night and into the next two to three days. Realized the pain was going on too long. Pain spread to pectoral muscles and was affecting range of motion and sleep. Took Aleve and Tylenol, didn't help much. Saw chiropractor who massaged it - it felt better for about 4 hours, pain returned. Tried taking Arnica tablets and using Arnica cream. Helped some but wore off. Generalized pain and stiffness in areas of right shoulder and arm, still affecting sleep. General malaise and agitation.
Got the shot one time and was so sick after; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020. This case involves a patient of unknown demographics reported that got the shot one time and was so sick after (Illness), while the patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported that got the shot one time and was so sick after (Illness) unknown period of time after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Bell's Palsy diagnosed 2-2-10. Acyclovir and prednisone prescribed.