chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sciatica; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatica) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SCIATICA (Sciatica). At the time of the report, SCIATICA (Sciatica) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications included Prednisone.; Sender'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.
it is possible the dose was given subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35AD3, expiry date 23-JAN-2025) for prophylaxis.   The patient's past medical history included shoulder operation.   On 10-OCT-2023, the patient received Arexvy (subcutaneous, right arm). On 10-OCT-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: it is possible the dose was given subcutaneous).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that the patient came in for Arexvy vaccine on reporting day. The reporter reported that intended to administer in the right deltoid muscle, but patient stated that it felt like the needle did not go in very far and she hit something. Afterward the patient told reporter that she had shoulder surgery on that side and had some metal there. The reporter stated that it was possible that the dose was given subcutaneous, which led to intramuscular formulation administered by other route. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Following receipt of anthrax vaccine #4, which he received with the typhoid vaccine in his right arm, patient recalls experiencing pain and swelling within 4 hours of vaccine receipt. The swelling and pain extended from his shoulder to his wrist. The circumference of his right upper arm increased significantly to the point that his shirtsleeve had to be cut open to relieve the pressure. Patient sought evaluation and was treated with an IM steroid injection and released on a prednisone taper. The pain and swelling lasted about 3 weeks and when the pain resolved, patient experienced persistent numbness and tingling in his right 4th and 5th fingers. This was evaluated by neurology and patient reports significant damage to his ulnar nerve. Patient had an EMG/NCV studies, but results are not visible to the clinic. The patient continues to experience paresthesias of his (R) arm with some accompanying weakness demonstrated by not always being able to grasp things tightly or his grasp giving out. Patient's medical records include an ER note dated 6 April 2000 which noted a subcutaneous nodule over triceps and lists (R) 4th and 5th digit paresthesias. Patient denies angioedema, dyspnea, wheezing, difficulty swallowing or breathing, GI symptoms flu-like symptoms associated with receipt of vaccines. Patient is allergic to morphine --> hives, iodine - -> irritation, and trazodone - - > priapism. He has no food allergies or allergies to insect bites/stings. Patient does not recall anything out of the ordinary with regard to vaccine administration of his 3rd or 4th anthrax vaccine. He denies any trauma or injury to his right upper extremity prior to receipt of anthrax vaccine #4. He has no history of previous vaccine reactions.
Experienced worsening of fever this morning; Experiencing chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Experienced worsening of fever this morning), CHILLS (Experiencing chills) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunisation.     The patient's past medical history included Stroke.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (Experienced worsening of fever this morning), CHILLS (Experiencing chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Pyrexia and Chills, at an unspecified dose and frequency. At the time of the report, PYREXIA (Experienced worsening of fever this morning), CHILLS (Experiencing chills) and HEADACHE (Headache) was resolving.            Concomitant medication list was not provided. The patient also mentions a limited functionality on right arm due to health history therefore only receives vaccination and so on to her left arm.
Information has been received from a health professional concerning a female who on 08-JAN-2008 was vaccinated with her first dose of GARDASIL (lot number unspecified). About two weeks after being vaccinated, on approximately 22-JAN-2008 the patient experienced heavy menstrual periods, and severe cramping which was causing her to have difficulty in walking. Patient is now visiting a specialist, but specifics unknown. The patient's heavy menstrual periods and severe cramping and difficulty walking persisted. Additional information has been requested.
Patient states that left arm has been experiencing shooting pain since administration of vaccine. Range of motion is also limited. Patient has not sought medical treatment, but has self-medicating with OTC ibuprofen.
Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 04-APR-2019, the patient received a first dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscularly, (lot # and expiration date were not provided) for prophylaxis.  On 24-JUN-2020, the patient received another dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA002536: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
raised red rashes bileateral lower legs and L forearm. Rash remains at this time on 2/8/21.Sent to Medical clinic.
Mentrual cycle is significantly heavier, more painful and period is starting 7-10 days earlier than usual.
Cramps; Body aches; arm soreness; MUSCLE PAIN; soreness in knee right joints; A spontaneous report was received from a nurse a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness/pain in extremity, muscle pain/myalgia, body aches/pain, cramps/muscle spasms, and soreness in knee joints/arthralgia.   The patient's medical history, as provided by the reporter, included a positive COVID-19 test. No relevant concomitant medications were reported.    On 29 Dec 2020 at 7:30 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 29 Dec 2020 the patient received the Moderna Covid-19 vaccine. After a few hours, she started to feel symptoms. She experienced arm soreness, muscle pain, body aches, cramps, and soreness in her knee joints. Per the patient, the soreness moved all around her body through the day. Her condition improved with treatment. Treatment for the events included ibuprofen for the pain.   Action taken with mRNA-1273 in response to the events was not reported.     The events, arm soreness, muscle pain, body aches, cramps, and soreness in her knee joints, were considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
No adverse reaction. However, the vaccine was accidentally administered one month earlier than the recommended 2-6 months interval.
Every bowel movement since vaccine has bee diarrhea. Pt is having a movement a couple times a day, this frequency is same as before vaccine
1st dose about 2 years ago, 2nd dose February 27, 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number FA277, expiry date 27-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, the patient received their first dose about 2 years ago).   On 27-FEB-2023, the patient received the 2nd dose of Shingrix. On 27-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose about 2 years ago, 2nd dose February 27, 2023). The outcome of the drug dose administration interval too long was not reported.   Additional Information: GSK Receipt Date: 28-FEB-2023 The patient never had returned for their second dose until 27 February, 2023. Information about the vaccine and patient were given. The vaccine administration facility was the same as primary reporter.  The reporter had consented to follow-up. The patient had received the second dose of Shingrix vaccine later than the recommended interval, which had led to lengthening of vaccination schedule.
Immediate sharp, non-radiating neck pain after receiving second COVID-19 vaccination. Associated with headache and weakness. No changes in vision, no chest pain, no syncope. Took ibuprofen 400 mg x1 which provided mild relief.
Extreme weakness, shivering, fever, swollen lymph nodes and feet that feel bruised on the bottom. Feeling of tiredness and lethargic for over three days. My arm where the vaccine was given continues to feel swollen and can hardly be moved.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient developed linear large welts immediately on neck and had systemic itching. given 25mg benadryl & 20mg famotidine oral. pt advised to follow up with pcp.
I have a frozen shoulder.   It started on March. I have limited ROM on my left arm.   I'm in pain when I sleep on my arm.    It's been a while now.  I'm so upset and sad
Red, papular eruption locally and down right arm below where HAVRIX was given. Also complained of a "burning sensation" locally for about 20 min 5 hours after vaccine given.
tingling from bottom of feet to heaD ON RIGHT SIDE, THROAT CLOSING, bp 200/101
Vaccination site is pink; Vaccination site is worm; Vaccination site itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Vaccination site is pink), VACCINATION SITE WARMTH (Vaccination site is worm) and VACCINATION SITE PRURITUS (Vaccination site itching) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site itching). On 13-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Vaccination site is pink) and VACCINATION SITE WARMTH (Vaccination site is worm). At the time of the report, VACCINATION SITE DISCOLOURATION (Vaccination site is pink), VACCINATION SITE WARMTH (Vaccination site is worm) and VACCINATION SITE PRURITUS (Vaccination site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment was received.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Between 12-1am on 6/18/21 Complaints of extreme hypersensitivity of skin, felt ?weird? for her clothing of bed sheets to touch her resulting in uncontrollable crying. Also fever of 101.3 Administration of ibuprofen by mouth for fever once able to calm the emotional reaction. Water intake & sleep.  Awoke after 9am on 6/18, fever reduced, symptoms resolved except for tiredness.
L arm pain, HA, body aches/chills starting 12/29/2020. Chest pain, SOB, cough, fevers starting 1/3/2021. Hemoptysis 1/7/2021 with worsening SOB and positional cough. Multiple PEs found on chest CT 1/10/2021 and hospitalized on heparin drip for >24hrs. DVT found on lower leg US 1/10/2021. Remain on DOAC for anticoagulation.
Sore arm at injection site that became more sore as time went on. Resolved to little pain inn less than 24 hours.
Chemical taste in mouth, Redness and heat in neck, ears, face, chest and forearms.  Drank lots of water. Lasted 2 hours.
2ml of normal saline was used to reconstitute the vaccine instead of the recommended 1.8ml. No adverse effects reported.
This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL9265, expiry date: unknown) at the vaccination age of 57, via an unspecified route of administration, in left arm, on Feb 5, 2021, at 16:30, single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (high blood pressure). Additional information: patient diagnosed with high blood pressure 3-4 years ago. The only medication he takes is for high blood pressure. No additional vaccines administered on same date of Pfizer suspect. The patient's concomitant medications not reported. He did not receive any other vaccine within 4 weeks. On Feb 6, 2021, at 06:45, patient had leg dragging, heaviness in leg and his legs gave out from under him. Reportedly, patient had a weird experience after his first dose of COVID-19 vaccine. Patient said he was due to get his second COVID-19 vaccine shot later today (Feb 26, 2021). In the morning after his first COVID-19 vaccination, as he was walking to the bathroom after waking up, his legs felt heavy. He felt he was dragging his legs. All of a sudden, his legs gave out from under him. He slid down the wall and ended up on the floor. A minute later, he was able to stand up. Patient reported he did not have any other issues. He was not sure if what happened was related to the COVID-19 vaccine, or if his legs giving out was an anomaly. Patient said he wanted to get his second COVID-19 vaccine shot today and would like to know what Pfizer recommended. Patient did not visit emergency room/physician office as a result of events. The outcome of events recovered on Feb 6, 2021, at 6:46. No follow-up attempts needed. No further information expected.
Localized reaction with a 5 inches tall x 4 inches wide redness area to right arm. Patient received this within 24hours the localized reaction.
This spontaneous report was received from a registered nurse refers to a 12 months old patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # L008272, expiry date 11-MAR-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Myalgia, Fever, Tachycardia, TEMP 101.4, BODY ACHES, INTERMITTANT TACHYCARDIA AND FATIGUE Narrative: TEMP 101.4, BODY ACHES, INTERMITTANT TACHYCARDIA AND FATIGUE requiring loss of work.
I had rash/hives after the first and the second doses. This time (booster) is worse. Rash/Hives on lower body and belly. The next day My face was swollen with itchy and redness. I still get some weird rash/hives sometimes.  I got severe dermatitis at midnight on Sunday and Monday. I had to go to a dermatologist and was told it is Perioral (periorificial) dermatitis. I have never had skin issues before the covid vaccine. My skin was healthy. I am 5'0 and 104#. It is not fair to get the same dose from someone big body frame.
pt recvd vax 20 mcg hep B Engerix-B (twice the normal dosage) rt thigh; no adverse effects noted or reported by mom
This spontaneous report wad received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 0-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 26-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset and were narrative updated.
Acquired fever 2 days after MMR. Fevers persisted for more than 1 week. Causing dehydration. All lab/diagnosis negative. Diagnosed with Kawasaki disease.   The medical record states rash and edema. Diagnosis of Kawasaki disease was confirmed. The 60 day follow up received on 9/24/03 states pt was diagnosed with Kawasaki's.
Mentally disabled man and his sister came to pharmacy to get flu vaccine. All questions asked prior to admin. Administered vaccine and 20 min later his sister returned and said he received a flu shot 3 weeks prior (according to a different family member). No adverse rxn reported.
Within minutes I became very dizzy and could not move my head or my eyes without feeling like I would faint or fall over.; blood pressure was checked and found to be 155/110; This is a spontaneous report from a contactable healthcare professional (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 25-year-old, via an unspecified route of administration, administered in left arm on 09Mar2021 15:45 (Lot Number: EN6206) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), atrial septal defect, obsessive-compulsive disorder (OCD), depression, post-traumatic stress disorder (PTSD), and was normally hypotensive with an average of about 100/50. The patient has no known allergies. No COVID prior vaccination and no COVID test post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included fluvoxamine (FLUVOXAMIN), valaciclovir (VALACYCLOVIR), and hydroxyzine; all taken for an unspecified indication, start and stop date were not reported. On 09Mar2021 15:45 (also reported as within minutes), the patient became very dizzy and could not move her head or eyes without feeling like she would faint or fall over. Her blood pressure was checked and found to be 155/110, and she was normally hypotensive with an average of about 100/50. Her blood pressure dropped, and the dizziness went away within 1-2 hours. The patient received EMT treatment/monitoring for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of dizzy and blood pressure increased due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
Deep red circle about the size of an orange appeared on arm; The area was hot to the touch; Very itchy; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 17Apr2021 at 13:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included high Blood pressure, high cholesterol and obesity. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC) and calcium/ magnesium (CALCIUM MAGNESIUM SUPPLEMENT), all taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 21Apr2021, about 4 days after the shot, the patient experienced a deep red circle about the size of an orange appeared on her arm. The area was hot to the touch and very itchy. The events did not result in doctor 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. No therapeutic measures were not taken as a result of events. The clinical outcome of the events deep red circle about the size of an orange appeared on arm, the area was hot to the touch and very itchy was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.