chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received full 0.5mL 4th dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received full 0.5mL 4th dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2022, the patient experienced ACCIDENTAL OVERDOSE (Received full 0.5mL 4th dose). At the time of the report, ACCIDENTAL OVERDOSE (Received full 0.5mL 4th dose) outcome was unknown.            No concomitant medications were reported. Patient received 4th 0.5mL full dose in March 2022. Patient had no side effects after any vaccine dose. He was not a high risk patient. No treatment medication were provided.   This case was linked to MOD-2021-428648, MOD-2021-428659, MOD-2021-428660 (Patient Link).
Tongue swelling; Throat closed; Face swelling; A spontaneous report was received from a consumer concerning a 59-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue swelling, face swelling and throat closing  The patient's medical history was not reported.  Products known to have been used by the patient, within two weeks prior to the event, included Lisinopril, Simvastatin, Famotidine 150mg, Fluticasone Propionate, Vitamin C , Vitamin D , Fish Oil  all since an unknown date for an unknown indication and diphenhydramine hydrochloride  since 29 Jan 2021 for an unknown indication.   On 29 Jan 2021, approximately a few hours prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021, patient experienced tongue swelling, throat closing, and face swelling. where he  was hospitalized on same day(29 Jan 2021)  and was discharged on 01 Feb 2021.  Treatment for the event included Epinephrine, Prednisone Drip, Pepsin intravenously and Prednisone QD for 4 days.   The outcome of the events tongue swelling , throat closing, and face swelling were considered resolved on an unknown date in 2021.; 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.
Donor c/o hives on 3-1-08 bilateral ankles, antecubitals, wrists, lower back, and bottom feet.
Swollen red rash upper left arm, itchy lasted 5 days . Also experienced numb tingly feelings in both hands, arms & lips - still experiencing these symptoms to a lesser degree. Felt flush - like blood pressure was up ( FYI I have low blood pressure) and lite headed at times - a feeling of being a little off On the 3rd day had some sharp pains in my left are
Neck and Headache. Next Day (Oct. 28): Throbbing headache, nausea, and vertigo.
Patient remained at baseline until noted at 2130 unresponsive and abnormal VS. Sent to ED and patient passed away in ED
achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, expiration date: Mar2021), via an unspecified route of administration at the left arm on 05Jan2021 12:10 at a single dose for COVID-19 immunization in the hospital. The patient has not had any vaccines in four weeks. The patient has no medical history. There were no concomitant medications. The patient received the COVID vaccine on 05Jan2021 and confirmed that it was the first dose she received of the COVID vaccine. She clarified that she started to have dizziness, disorientation, nausea, achiness and headache. The dizziness, disorientation and nausea started about 8 hours after she received the vaccine, 05Jan2021 20:10. She stated that she was just trying to push through with the side effects. She woke up in the morning, 06Jan2021, feeling both achy and with a headache. She stated that she had the achiness that was regular and knew would normally come along with it. However, she also had a headache. The outcome of the events was not recovered.
Client was inadvertantly given a 3rd dose of HPV9 vaccine. Client had received their initial vaccination for the HPV series at 11 years old. Client did not need a third dose to complete the series. Upon reviewing Client chart the medication error was noticed. Client's list of vaccinations due indicated that HPV9 3rd dose was due along with  influenza, COVID-19 first dose, and MCV4. The vaccination forecast was incorrect and therefore client given a 3rd dose in the series. No other vaccinations given at time of visit. Client stated feeling fine and had no side effects. upon leaving the clinic.
tested positive for covid 19; tested positive for covid 19; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the female patient of an unspecified age (reported as 41, units unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After her first dose the patient was tested positive for covid 19 on 24Feb2021 (tested positive 2 weeks later for covid). The patient also stated that she still had a little bit of a headache but should complete isolation soon. Her second dose was schedule for 01Mar2021. Patient would like to know if it was safe for her to proceed with second dose and when she should receive her second dose, timing-wise, after having COVID-19 and that her doctor mentioned waiting 90 days after having COVID-19. The patient was called today (04Mar2021) to see when she should take her second dose or how she should go about getting vaccinated now. The outcome of the events headache was not recovered and other events was unknown.
Within 5 minutes of receiving vaccine I started to get a metallic taste in my mouth that has persisted for over 24 hours
3/19/2021 mid day arm was itchy, had on long sleeves, was at work & did not check til I got home  around 5pm. Arm had red circle around injection site, warm to touch & itchy.  3/20/2021 red circle was slightly larger, still warm to touch & itchy.  3/21-3/22 improved & was pretty much gone by 3/23.
Patient developed a fever of 102.6, chills, body aches and then significant swelling, pain and redness in her L deltoid. Recommended Ibuprofen by mouth and Ice to deltoid for 15 mins multiple times per day.
Had shingles vaccine and still got shingles/suspected vaccination failure; Shingles; Worst pain; Back bones felt like they were being twisted; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Worst pain) and bone pain (Verbatim: Back bones felt like they were being twisted). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and bone pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and bone pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and bone pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles. The patient stated that he or she had worst pain ever but did not break out. The patient stated that his or her back bone felt like they were being twisted. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, 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.
Have took the flu shots and still got the flu 4 or 5 times/Suspected vaccination failure; Have took the flu shots and still got; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced vaccination failure (Verbatim: Have took the flu shots and still got the flu 4 or 5 times/Suspected vaccination failure) (serious criteria GSK medically significant) and influenza (Verbatim: Have took the flu shots and still got). The outcome of the vaccination failure was unknown and the outcome of the influenza was not reported.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.     It was unknown if the company considered the vaccination failure and influenza to be related to Flu vaccine.   Linked case(s) involving the same patient:  US2023AMR089591   Additional Information: GSK Receipt Date: 20-JUN-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she received the flu shots, but still got the flu 4 or 5 times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The case had been link to the case US2023AMR089591 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR089591:Same patient
Moderna COVID-19 Vaccine EUA I noticed a small, kidney bean shaped blister appear about 24 hours after my vaccination.  It was off to the side of the actual injection site- but only by about an inch or so.  It didn't hurt, was not red.  It continued to swell throughout the next 12 hours, but did not increase in size.  To prevent it bursting, I did drain it, with a sanitized safety pin.  Liquid was clear.  Blister filled up again within 6 hours.  I left it alone.  Between 4 and 5 days after my vaccination, blister was flat, but turned a deep red/purple color- sort of like dried blood/old blood.  I continued to put first aid ointment and a band aid on it for another 24 hours.  As of yesterday, a week after vaccination, dead skin from blister has peeled off, and new skin seems fine.  I am continuing putting first aid ointment on it daily.  Still no pain on that location.  I did take a photo at the time I first noticed it.
Fatigue began day of vaccine, followed by chills, body aches, fever (101.7) and headache for the next approximately 36 hours. By the second or third day post-vaccine I developed hives on the back of my neck and shoulders and cold sores on my mouth and nose and continued to have a headache.  I was seen by my doctor on March 12th and was told that I had a sinus infection.  I was prescribed 100 mg Doxycycline Hyclate and began seeing improvements within 36 hours to the sinus infection.  The hives are still clearing up and were not treated.
lightheadedness; headache; pressure in head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 12:00 (Lot number: FF2587) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 27Sep2021, Time (24hr): 12:00 PM, Anatomical site of Location: Right upper arm, Batch/Lot number: Lot # FF2587), administration date: 27Sep2021, for Covid-19 immunization, reaction(s): "extreme pressure in brain / cranial area", "Brain just feels swollen", "headache", "dizzy spell", "migraine". The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "lightheadedness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "pressure in head". The events "lightheadedness", "headache" and "pressure in head" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, headache, head discomfort.  Additional information: Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Prior vaccinations: None. Concomitant drugs: None. Patients Medical History: None. As of 06Nov2021, patient still feel headache and pressure in head going to see neurologist. Specific relevant test for thromboembolic events with thrombocytopenia: None. Patient took the second vaccine on the opposite arm as worked for the government and was forced to take it. The second shot had a moment of lightheadedness but did not feel rush to head as did with the first shot. The pressure and extreme headache has been with me since the first shot and to this day has never left. patient did go to the emergency room 20Oct2021, where a CAT scan was done and they found nothing. They prescribed a headache medication Benzonatate which does nothing. Patient took Aleve, which elevated the pressure mildly for two seconds. As of today 29Nov2021 still suffering from the cranial pressure and headache.   No follow-up attempts are possible. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101342058 Same patient, different dose/AEs.
ACUTE ON CHRONIC RESPIRATORY FAILURE 8/24/2022 ACUTE UTI  ACUTE ON CHRONIC RESPIRATORY FAILURE 8/24/2022 HTN (HYPERTENSION)
This patient developed fever/vomiting and then had small bowel resection for intussusception at medical center.  6/19/07 Received vax record from PCP which confirms RO lot & dose as reported. 7/26/07 Received medical records from hospital via fax from CDC.  Records are primarily for ENT but IS mentioned on clinic note having been perfomed 6/1/07 w/resection of 5cm of bowel resected.  7/27/07 Received hospital medical records which reveal patient experienced nausea, bilious vomiting, fever & lethargy x 4 days.  Admitted 5/30-6/3/07. Tx w/IV antibiotics & taken to OR. Small bowel IS found at proximal mid ileum.  Did well post op w/o complications. FINAL DX: Intussusception; s/p exp lap & small bowel resection w/reanastomosis.  Records faxed to CDC.
COVID vaccine breakthrough. Moderna 03/25/2021 010A21A, 04/22/2021 043B21A and 12/15/2021 058H21A
Severe GI cramping; diarrhea; nausea; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 10Feb2021 12:15 (Batch/Lot Number: EN6201) (at the age of 40-years-old) as single dose for covid-19 immunisation. The patient medical history included none. The patient had no known allergies. There were no concomitant medications. 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. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Right on 20Jan2021 11:00 (Batch/Lot Number: EL-9261) (at the age of 40-years-old) for covid-19 immunisation. On 12Feb2021 03:00, the patient experienced severe GI cramping, diarrhea and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included 2 litres of fluids, IV, IM and po medications. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and know drug profile a  contributory role of BNT162B2  to the reported severe GI cramping, diarrhea and nausea cannot be totally excluded. Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
went blind; This serious case was reported by a consumer via market research programs and described the occurrence of blind in a patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   On an unknown date, the patient received Hz/su + AS01B. On an unknown date, an unknown time after receiving Hz/su + AS01B, the patient experienced blind (Verbatim: went blind) (serious criteria GSK medically significant). The outcome of the blind was not reported.   The reporter considered the blind to be possibly related to Hz/su + AS01B.   The company considered the blind to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt date: 03-Apr-2023. This case was reported by a consumer via market research programs. Reporter stated that a friend went blind after getting the vaccine. The reporter think that the event might have been related to the product/device. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR049411:same reporter - reporter´s case
Pt was administered flu vaccination when fainted, fell to floor, airway patent, became alert within 30 seconds, pallor, P-108, weakness, swollen area on back of head after fainting. Observed for 40 minutes, took fluids, alert and oriented. Sent via EMS to ER for further evaluation.
Sore arm; 17 year old daughter received the 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the 1st dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the 1st dose). On 31-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the 1st dose) had resolved. On 02-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: On 24-MAY-2021, ADR form attached, Patient demographics was updated, product details of dose #1 was added.
July 8th when I was eating dinner my throat was hurting. I went to bed I woke up with a runny nose, sore throat and sneezing. And on Sunday it was the same thing i tried drink a lot of water. on the 11th I didn't feel any better. On the 12th I called my doctor and I called and told her and she gave me antibiotics. By the 15th I started to feel better and by Monday the 18th I felt fine and it was gone. But I was still really tired.
My eye sight is rapidly changing; Double vision/Seeing double up close and far away; Goop like substance in eyes; trouble focusing; Joint pain; This is a spontaneous report from a contactable consumer. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:00 (Lot Number: Er8727) at the age of 44-year-old as single dose for covid-19 immunisation. The patient had no known allergies. Other medical history reported as none. The patient previously received first dose of BNT162B2(lot number=En6208) on 23Mar2021 12:00 PM at the age of 44-year-old as single dose, in Arm Left for covid-19 immunisation. There were no concomitant medications. The patient had no covid prior vaccination, No covid tested post vaccination. The patient experienced "my eye sight is rapidly changing", double vision, trouble focusing, goop like substance in eyes, seeing double up close and far away, Joint pain on 20May2021 12:00 PM. Events serious as disability or permanent damage. No treatment received for the events. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Morning developed rash over entire body and face and by the afternoon had a Febrile Seizure.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received SHINGRIX. In February 2019, several hours after receiving SHINGRIX, the patient experienced shivering, general body pain and stomach pain. On an unknown date, the outcome of the shivering, general body pain and stomach pain were not recovered/not resolved. It was unknown if the reporter considered the shivering, general body pain and stomach pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated she had the SHINGRIX vaccine at 5:30 afternoon in the right arm and around midnight she started to experience shivering, body aches and stomach pain which had continued through today. The reporter did not give consent to follow up. The patient did not currently have a physician.
Patient stated on 3-21-14 arm was still sore and numbness and tingling at times, on 3-24-14 employer of patient called stating pt had to go to ER due to she still was not feeling well. ER stated she had a infection at injection site.
Localized reaction to injection area.  Unknow time of when it started.  Red and raised area approximately 8 x 10 cm.  Patient states it itches and burns at times.
Headache arm pain, flushing and chills Narrative:  employee states: experienced arm pain, headache, flushing, and chills the day after first injection