chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 year old female student, who on 02-AUG-2007 was vaccinated with a first dose of Gardasil. No reaction was reported after the first dose. On 31-DEC-2007 the patient was vaccinated IM in the left deltoid with a second dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included Pneumovax 23, administered in the left deltoid. It was reported that "each injection site was spread apart from the other." On 01-JAN-2008 the patient experienced pain, swelling, and erythema in the left upper arm and was treated with unspecified antibiotics. On 02-JAN-2008 the patient was seen in the office. The patient recovered after a week and a half on approximately 14-JAN-2008. The physician considered the pain, swelling, and erythema of the left upper arm to be other important medical events. Additional information has been requested.
Blood running down arm during vaccination.  The vaccinator wiped my arm down to remove blood at least 3 times.  At the time, I thought she'd spilled some vaccine.  Wasn't until I later removed the bandaid and found it was completely saturated with blood that I realized she'd hit a blood vessel or vein.  The bleeding started immediately as soon as she began injecting me, but she did not remove the needle and start again.  I'm concerned that she injected the vaccine directly into a vessel or vein.
This spontaneous report was received from a pharmacist and referred to a 69-year-old male patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. The patient had no known drug reactions or allergies. On 18-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N010106, expiry date 15-NOV-2018) in the right arm (dose and route of administration were not reported), the indication was reported as "indicated in his age". On an unknown date in September 2017, the patient developed hives on both thighs. On an unknown date in September 2017, the patient was seen by a physician and treated with BENADRYL. On an unknown date in September 2017, the patient recovered from the event.
I started feeling sick on December 8th, these symptoms were runny nose. The I tested and I was negative and then tested again the next day and I was positive for COVID-19. I started having a fever, diarrhea, slight cough, fatigue and vomiting. I then reached out to the doctor and did a telehealth, and I was given a prescription for Paxlovid. I started to recover over the next few days, and I tested negative on 12/24.
16.5 weeks pregnant. Due Sept 11,2021. Received shot at 3pm and around 1:00am the first night I had a 101.5 fever, moderate to severe abdominal cramping, low back pain, calf pain, muscle aches, and a sore throat.
Felt like something was caught up under their upper gum; Normal arm hurt; Lips starting to get larger. one side of their upper lip has enlarged and half of upper lip is really enlarged; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (Lips starting to get larger. one side of their upper lip has enlarged and half of upper lip is really enlarged), GINGIVAL DISCOMFORT (Felt like something was caught up under their upper gum) and LIMB INJURY (Normal arm hurt) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Heart disease, unspecified: Isosorbide (Isosorbide for heart); for Blood cholesterol abnormal: Baby Aspirin (A medicine for cholesterol). Past adverse reactions to the above products included No adverse effect with Baby Aspirin and Isosorbide.   On 17-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 17-Oct-2023, the patient experienced LIP SWELLING (Lips starting to get larger. one side of their upper lip has enlarged and half of upper lip is really enlarged). On an unknown date, the patient experienced GINGIVAL DISCOMFORT (Felt like something was caught up under their upper gum) and LIMB INJURY (Normal arm hurt). At the time of the report, LIP SWELLING (Lips starting to get larger. one side of their upper lip has enlarged and half of upper lip is really enlarged), GINGIVAL DISCOMFORT (Felt like something was caught up under their upper gum) and LIMB INJURY (Normal arm hurt) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had received all Moderna previously: First dose on 07-Jan-2021 with batch no. 025L20A, second dose on 04-Feb-2021 with batch no. 032L20A, third dose on 31-Aug-2021 with batch no. 2C2119 and fourth dose on 04-Apr-2022 with batch no. 002M21A, fifth dose on 10-Jul-2022 with batch no. as 002M21A, sixth dose on 28-Oct-2022 with batch no. 013H22A. Caller reported that other than the normal arm hurt, patient felt like something was caught up under the upper gum, lips started to get larger. Patient woke up with one side of the upper lip enlarged and half of upper lip was really enlarged.  Treatment information was not reported.
Severe hives all over body. The worst day was January 20th, Thursday, I woke up at 2 am and then 4 am. I had large welts on my legs, near groin area and under arms. I was about to take myself to the hospital, but I took 2 pills of Benadryl and I was able to go back to sleep. The hives are on both arms, front and back legs, feet, lower abdomen, hands and back of neck. Feeling of wearing a very tight ring/tightness in middle finger of right hand and ring finger of left hand. Swelling outside of right arm; and swelling on top of right foot. Day after, I saw a doctor. Then next day at around 5 pm, I got swelling on the base of my left foot. I couldn't walk. It was painful. Today, my left ear feels hot and uncomfortable. My voice sounds differently and right arm feels weak and painful right now. I hope I don't get anymore signs or symptoms. I never had allergies to anything at all. I hope this goes away permanently. My right arm is aching as I'm writing this. In process of making appointment with allergist but they are difficult to make appointment.
The vial was initially stored in the refrigerator on 02-Jun-2022 and was administered on 12-Jul-2022; (Moderna) Vaccine was given beyond the refrigeration use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2022 and was administered on 12-Jul-2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2022 and was administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2022 and was administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The vial was initially stored in the refrigerator on 02-Jun-2022.  The vial did not undergo any temperature excursion.  No treatment medication was provided.
Digestive problems; Temperature of 100°F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Digestive problems), PYREXIA (Temperature of 100°F) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DYSPEPSIA (Digestive problems), PYREXIA (Temperature of 100°F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) on 24-Mar-2021 for Fever, at an unspecified dose and frequency. On 24-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, DYSPEPSIA (Digestive problems) and PYREXIA (Temperature of 100°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Aches in joints, then extremely cold, followed by extremely hot with severe body sweats starting around 9PM and lasting until 6AM.
Chest pressure/tightness - persistent for approximately 3 weeks and  now continues intermittently.
patient received an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 12th August 2022, the patient received Havrix. On 12th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: A clinic manager reported that a patient received an expired dose of Havrix on 12th August 2022. The Havrix expired on 09th August 2022. The clinic manager did not have any patient details at the time of report but consented to follow-up via email. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Chest pain; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Chest pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.            Concomitant medications was not reported. The patient had chest pain after receiving the Moderna primary vaccine as well as a monovalent booster. Treatment medications was not reported.   This case was linked to MOD-2023-703403 (Patient Link).
Suspect COVID breakthrough case Incidental COVID positive finding (asymptomatic)- admitted for abnormal labs (metabolic acidosis
My eyes were extremely strained and were burning. I couldn't focus and it was giving me a bad headache. I returned to my doctor. Two days later I developed cold symptoms, a cough and sore throat and on 1/24/2010 I had muscular pain in my neck, it's very stiff and painful and all my lymph nodes seem sore; under my arms, my groin and my neck. I returned to the doctor. He tested me for strep because of the sore throat, it was negative. He prescribed over the counter remedies for pain and discomfort.
Effecting my eyes; This case was reported by a other health professional and described the occurrence of eye disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eye disorder. On an unknown date, the outcome of the eye disorder was unknown.   It was unknown if the reporter considered the eye disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported , however captured as adult as per vaccine indication The patient received shingles shot and it was effecting the patient's eyes. The patient was very concerned and asked to get help.
Injection was given in left arm and within seconds after the injection the patient began complaining of a strange salty chemical taste in her mouth followed by tingling on the roof of her mouth and a intense hot feeling, described as if like scolding the roof of her mouth with hot liquids.  The same feeling then began to ravel to the back of her neck.
Following vax, the pt developed swelling of lip and inside the mouth and a rash that is on-going since administration. No further information was available at the date of this report.
101.7 temp, fever for two days, cold soaking sweats on 3rd day with no fever. Entire upper arm red and itchy. Dehydrated and dizzy on morning after shots.
Received vaccine on Friday Oct 27 - Saturday red rash covered my left arm, swelling and fever, hearing was distorted. Hearing grew worse over next day - called doctor for treatment. Later to specialist - lost my hearing.  3/21/08 Reviewed PCP medical records 10/26/07-3/11/08. FINAL DX: none provided Records review patient experienced swelling or left arm w/rash & oral thrush.  On 10/26 received PCV & flu vaccines.  10/30 dx w/injection reaction & tx w/steroids & antihistamine.  TM/s were normal but having vertigo & hearing problem.  Noted to have retraction right TM.  Tx w/continued steroids & decongestant.  Note of 3/11 does not address hearing or vertigo status.   3/25/08 Received ENT medical records of 11/07-11/30/2007. FINAL DX: right sided sudden sensorineural hearing loss. Records reveal patient noted rash, n/v & right ear hearing loss day after pneumo vax.  No improvement w/tx.  Exam revealed dull right TM w/fluid in right middle ear.  Dx: right serous otitis media & possible mixed hearing loss.  Tx w/antibiotics & steroids.  Returned for audiogram 11/16/07 which was abnormal.  Referred for MRI.  Returned 11/28/07.  No improvement.   Referred for hearing aids.
After sitting for 5 minutes, patient stood up and walked 8 feet to her father. Patient was standing next to father, fell forward into him, then lost control and fell backwards. Patient did not lose consciousness at any time.
Bruising was starting to form from the scratching; Itching / Rash with an itch on lower extremities; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itching / Rash with an itch on lower extremities) and CONTUSION (Bruising was starting to form from the scratching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. M0D012M0A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Urticaria (Autoimmune urticarial (skin infections)), Drug allergy (sulfa, most antibiotics and codeine), Latex allergy, Gastroparesis, COPD, Coronary artery disease, Hypercholesterolaemia and Skin infection. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, DUPILUMAB (DUPIXENT) for COPD, Eosinophilia and Urticaria, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL TARTRATE and LOSARTAN for Coronary artery disease.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced RASH PRURITIC (Itching / Rash with an itch on lower extremities). On an unknown date, the patient experienced CONTUSION (Bruising was starting to form from the scratching). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE) for Itchy rash, at a dose of UNK dosage form; DIPHENHYDRAMINE for Itchy rash, at a dose of UNK dosage form and METHYLPREDNISOLONE (MEDROL DOSEPAK) for Itchy rash, at a dose of UNK dosage form. On 22-Feb-2021, RASH PRURITIC (Itching / Rash with an itch on lower extremities) had resolved. At the time of the report, CONTUSION (Bruising was starting to form from the scratching) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient developed a rash with an itch on her lower extremities about 48 hours after vaccination. After a few days of scratching bruising started to form. The patient contacted her dermatologist and requested treatment with prednisone but her dermatologist denied to prescribe the drug due to a contraindication with the vaccine and instead recommended treatment with levocetrizine and diphenhydramine. When that regimen did not work the patient presented to her general practitioner and was prescribed Medrol-dosepak and the symptoms resolved.   This case was linked to MOD-2021-089738 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Added second dosage details. On 26-Apr-2021: Added patient demographics, medical history and concomitant medications, event, treatment medication and updated second dosage details. On 21-Jun-2021: No new information was received.
Little soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness in arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prophylactic vaccination.    Previously administered products included for Prophylactic vaccination: Influenza vaccine (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE). Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.   On 29-Jan-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Feb-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PAIN IN EXTREMITY (Little soreness in arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little soreness in arm) outcome was unknown.            Patient took the primary doses of Pfizer vaccine initially, and then on 20FEB2021, took the Moderna booster. She reported a little soreness in her arm on 28SEP2021, following the administrations of the vaccines.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This spontaneous report was received from a physician referring to a 89 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. In September 2017, the patient was vaccinated with PNEUMOVAX 23 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. Subsequently, the physician reported that the same patient received a 2nd dose of PNEUMOVAX 23 on 22-JAN-2018, and that the female patient had no adverse effects after either of the doses.
pt became ill w/vomiting on 18APR96;fever 102 oral;tx w/APAP;fever 103 on 19APR;red rash over back, chest & genitalia on 21APR96;seen by MD 23APR96;dx viral infect
Client presented to the vaccination site on 12/29/21. The client's mother reported that he received a 1st dose of Pfizer COVID vaccine on 12/7/2021. Client was then vaccinated with Pfizer for 5 through 11 years of age (lot # FK5618) at 10:44 by RN. RN then alerted lead RN. Lead RN submitted a medical consult via text message to  Coordinators. Per  Coordinators client is to return in 5 months to receive Pfizer for 12 years of age and older booster dose. The client did not report any symptoms during the 30-minute observation period. Lead RN educated client's mother on possible adverse reactions, when to seek medical care and to register with V-Safe. Client's mother verbalized understanding. The client left the vaccination site at 11:20 with a steady gait.
extreme severe sinus headaches, sore throat, for over 3 weeks, I have  loss of smell still & very  fatigue still.
Admitted for GI symptoms in setting of IBS-D. Dx with COVID infection and GI symptoms "likely worse with COVID". No specific therapy for COVID as no respiratory symptoms. Discharged home.
Headache, Arthralgia, Fever, chills, jaw pain, ear ringing
i'm an ophthalmologist with paroxysmal afib.  very fit, play tennis at the national level 2-3x/week.  usually have 2-3 brief bouts of afib per year.  since being vaccinated (got second shot on 1/9/2021) have had at least 5 bouts lasting minutes to hours, some apc's also.  incidence decreased after the first shot, and seems to be occurring same way after the second shot.
Headache first 3 days after dose 2; Upset stomach; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovering", described as "Headache first 3 days after dose 2"; ABDOMINAL DISCOMFORT (non-serious) with onset Apr2021, outcome "recovering", described as "Upset stomach"; PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "body aches". It was unknown if therapeutic measures were taken as a result of headache, abdominal discomfort, pain.  Additional information: Other vaccine in four weeks was unknown, treatment received for AE was unknown, COVID prior vaccination unknown, COVID tested post vaccination unknown. Clinical course: Headache first 3 days after dose 2 Upset stomach and body aches as well.  Follow up (09Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The Updated information include: Upon Query awareness date of events response by reporter was 07Apr and Report on 08Apr.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a major headache. I felt drained and exhausted. Overall, I had no energy. I could not shake my headache. My arm was tender, swollen and hot to touch. I had shortness of breath.
Big welt/rash on arm that is spreading  size of the welt 8 inch circle   Rash is hot and itching