chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a consumer, concerns a 71-year-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced redness around the injection site, bumpiness around the injection site and itchiness around the injection site. The patient's medical history not provided. No concomitant medications reported. On Jan 18, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (batch/lot# 012L20A), via unknown route, for prophylaxis of COVID-19 infection. On Jan 25, 2021, patient experienced redness around the injection site, bumpiness around the injection site and itchiness around the injection site. Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events not reported. The outcome of redness around the injection site, bumpiness around the injection site and itchiness around the injection site-considered to be unknown. Sender's comments: Based on the information provided and the established safety profile of mRNA-1273 vaccine, a causal association between the event of headache and the product use cannot be excluded. Vaccination site redness, itching and swelling are consistent with the known safety profile of the vaccine.
Progressive swelling with mild tenderness and itching to rt deltoid x 2 days. Denies any respiratory distress. Pt advised to go to ER if resp. problems, and to RTC on 5/23/16 for eval of area. Spoke with mom on phone. Pt better by 5/22/16. Pt did not return.
This spontaneous prospective pregnancy report was received from a medical assistant (patient) via field representative, reporting on herself. The patient was currently 26 years of age. Information about patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were unspecified. On an unknown date, ten years ago, in approximately 2006, the patient was vaccinated with GARDASIL series. The patient experienced cervical cancer from an unknown date. She sought medical attention and went to her doctor. Thereafter, she underwent a loop electrosurgical excision procedure (LEEP) procedure on an unknown date and was currently being treated for the event (hence outcome of cervical cancer was considered not recovered). Patient was also pregnant with the last menstrual period (LMP) and estimated date of delivery (EDD) not reported. The pregnancy outcome was pending. Causality assessment was not provided. Upon internal review, the event cervical cancer was considered to be medically significant. Additional information has been requested.
I developed (possible) sudden sensorineural hearing loss 2 weeks after my second dose of COVID-19 vaccine on May 19, 2021. I started to experience a change of my hearing (reduced hearing) in the morning of May 19, 2021 in the left ear. No vertigo or dizziness, no fever, no discharge. The diagnosis is made by Dr. on May 20 2021. For completeness, I had a medical history of Guillain-Barre Syndrome in 2002, and Bell's Palsy in 2010. Both were mild cases and recovered with no sequela. I never took Flu shot because of the medical history. I am glad that I took the COVID-19 vaccine because I think it would be worse if this is a natural infection. It might be valuable if we can collect safety data for those who had GBS history,  so people know what to expect and they can be proactive if things happen.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Reporter stated that the vaccines were stored in freezer and they take out one to two vials and place in fridge each day as needed. Reporter stated that no treatment was given to the patients.
Pt has had chronically elevated liver enzymes since receiving Hepatitis B vaccine series. chronic hepatitis was not present before vaccine. Detected by blood donation - not sure when problem started. Diagnosed with severe allergic reaction. Per doc 212821, 60 day follow up, patient continues to have chronically elevated liver enzymes and is under constant treatment.
On 01/14/2021 - regular symptoms. When the injection went in,  I felt like the fluid went to my neck. I had chills, fatigue, the chills were much stronger than the 1st 2 vaccines.  I woke up Saturday morning, there was a lump under my arm, about the size of a dollar bill. The swelling is on my neck and my upper arm, and the swelling is preventing my arm from resting.  On Sunday afternoon, I felt perfectly fine. But the swelling increased in my skin like a 1/2 an inch or more. It feels like the medicine went to my neck and its swelling and it's uncomfortable. When the medicine was going in, I could feel like my heartrate changed. I could just tell when the injection went into my body it was different than the other 2 vaccines. My arm itched a bit on the left side after they injected the vaccine.  I am trying to get in to see my doctor today. If not today, I am going to try to get a telehealth today, 01/18/2022 I have not recovered from my AE, as of today, 01/18/2022, I still have the swelling on my neck. It is a slight swelling on my left arm, it is a swelling that is not normal.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-OCT-2007, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 29-JUN-2011, the patient was treated at a clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. She was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
1050 - Light headed, tight throat, tingle fingers, rush neck to ears, BP 139/81 pulse 101 1055 - tight chest, difficult to breath, unable to swallow. Benadryl liq 25/mg given Patient transferred to Emergency Department for evaluation.
Patient given Bivalent Booster (Pfizer) prior to primary series. No known adverse events thus far.
pt complained of tongue swelling and voice becoming hoarse, also said left pinky was falling asleep. hives also appeared on pt's left forearm and right upper thigh\
Stated "woke up could not close L eye and having R side facial paralysis. Also admits to h/a: after assessment with doctor now L side of face paralyzed. F/C, and LL lid drop. Sent for CT.
Immediate pain in left shoulder, pain has not subsided. Pain in joint and radiates down arm. Unable to perform functions over my head. Took a double dose of Medrol which helped but once steroid was complete pain returned. Unable to sleep on left shoulder, woken up at night to severe pain. Shoulder aches constantly. Heat, Cold, and Aleve are ineffective. Chiropractic adjustment ineffective in relieving pain. It has been almost 7 weeks and the pain is not subsiding. Tried biofreeze to the area, and also ineffective.
Eyelids became swollen and itchy for 48 hours. Improved with Claritin. Site of injection was swollen and red for 72 hours.
8/13/15 at 12:22 p.m. pt and mother noticed redness, swelling and itching the size of quarter. 8/14/15 at 0908 mother describes the redness has increased to the size of an adult fist. Pt sought medical care at local urgent care who states this was allergic reaction to Tdap. (Lt) upper thigh.
An adult female consumer called to report she was vaccinated with H1N1 somewhere between 21-Oct-2009 and 23-Oct-2009 (manufacturer specified as CSL but lot unknown); see related case 2010025896.  The mother received the vaccine at a clinic (name unknown to reporter) when she was knowingly 4 months pregnant, after her pediatrician's office refused to vaccinate her.  The baby was born with no apparent issues, however she now has concerns that he moves his right arm rapidly which she does not notice with the left arm.  Based on recent publications regarding the safety of the seasonal flu vaccine, she is concerned about neurological damage to her baby.  Awaiting further information.  The company considers events unassessable to the suspect drug, H1N1 vaccine.  Information derived from this AE report does not change the current safety of the profile.
The patient reports that 1 week after the administration of the vaccine, she presented redness, itching and swelling in different areas of the body (face, legs, arms and neck).
Hives, top lip swollen. Urgent care given adrenalin shot and corticosteroid medication. Returned to Hospital ER at 1201 AM on 10/10/2014 throat constriction admistered epi shot.
The patient presents with COVID-19. Pt states she tested positive for COVID-19 x 10 days ago. Pt states she was in in another State and she was at the walking clinic when she was prescribed prednisone for three days and diagnosed with bronchitis, and her a COVID test done. Pt states her results came back positive but she had to come back home since she was visiting. Pt states she is having cough, congestion, runny nose, and diarrhea but denies fever, HA, chest pain, abdominal pain, N/V.  The onset was 10  days ago.  The course/duration of symptoms is constant. Risk factors consist of immunocompromised patient.
17 years old and got first dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and got first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and got first dose). On 10-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and got first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not provided. Treatment information not provided.; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # 29A21A  with no associated AEs
petechiae and husband wondered if this could be related to the co-administration of Arexvy; This non-serious case was reported by a other health professional via call center representative and described the occurrence of petechia in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Arexvy, Flu vaccine and COVID VACCINE. On an unknown date, an unknown time after receiving Arexvy and Flu vaccine, the patient experienced petechia (Verbatim: petechiae and husband wondered if this could be related to the co-administration of Arexvy). The outcome of the petechia was not resolved.   It was unknown if the reporter considered the petechia to be related to Arexvy and Flu vaccine.   It was unknown if the company considered the petechia to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 18-OCT-2023 The case was reported by patient's husband. The patient received Covid, Flu and Arexvy vaccine at the same time.  It was unknown if the reporter considered the petechia to be related to covid vaccine. The patient now noting onset of petechiae and husband wondered if this could be related to the co-administration of Arexvy with the other vaccines.
Right arm noted with redness, warmth, states she thinks it has gotten worse since it has started. Was initially noted 2 hrs post administration, applied vics mentholatum then ice pack. States she did not notice any other symptoms for the next 2-3 days as she was sleeping due to the excessive fatigue from the vaccine as well.advised pt to see physician or to go to ER to seek treatment if her physician is not available for the redness on her arm.
Body chills then a fever  Body aches  Diarrhea  Headache  Feeling very unwell
pt recv vax 31JAN97 & 16JUN97 pt devel a chickenpox eruption w/minimal itching & less than 50 lesions;pt recovered;
Patient received dose and after a few minutes of standing up from the chair leaned on his sister and felt lightheaded and we helped him down to the floor where he came back to. His face/lips were pale and after a few minutes of sitting on the floor he felt good enough to get up and sit back on the chair. I gave him a cold bottle of water. He was able to drink the water. It was hard to get specifically what the patient was feeling or experiencing because he did not speak English and also was mentally challenged. The paramedics were called and when they came they took the patient's blood pressure and pulse ox and everything was normal. After about 15-20 minutes they helped him to the car to make sure he was feeling better. We called later in the afternoon to see how he was doing and the sister said he was doing much better.
fever for about 12 hours starting about 10 hours after receiving vaccine, lethargy started about 6 hours after vaccine and lasted for the next 24 hours, sore arm for about 36 hours after receiving vaccine
PATIENT WAS HERE FOR FLU VACCINE BUT COVID 19 6 MONTH TO 4 YEAR VACCINE WAS GIVEN INSTEAD.
Pt recvd 3 doses of Engerix-B, 3rd dose given 1NOV91? (1990) & it was determined that pt did not convert to protective surface antibody level;
This spontaneous case was reported by a consumer and describes the occurrence of MEDICAL DEVICE SITE JOINT PAIN (Joint pain in artifical joint) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MEDICAL DEVICE SITE JOINT PAIN (Joint pain in artifical joint). At the time of the report, MEDICAL DEVICE SITE JOINT PAIN (Joint pain in artifical joint) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Got 1st round on 3/7/2023 and the 2nd round on 3/28/2023 and started feeling numbness and tingling and burning feeling in both feet and lower legs around the middle of April 2023. It is now June and it has gotten worse, despite my doctor putting me on nerve medication
Patient was administered moderna covid-19 vaccination on 3/12/2021, patient has not reported any type of adverse reaction, however patient was not 18 at the time of administeration of the vaccine
Sudden onset of vomiting lasting over 25 minutes and resolving with no further stomach issues
Positive for covid; Positive for covid; Pneumonia; Depressed/ "feel's discouraged; This is a spontaneous report from a contactable other hcp. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 74 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included asthma, rheumatoid arthritis. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication. It was reported that after taking the therapy, noted improvement in rheumatoid arthritis symptoms. However, in the past month a lot of joint pain all over the body feels miserable. Pain level 8/10 missed doses a couple of times due to mail in her area is slow no adverse effects mention due to missed doses. It was reported that the patient received covid 19 vaccine dose 1 on Mar2021 however, before receiving the second dose was positive for covid 19, hospitalized for one night only, unspecified  date May2021 . The patient was diagnosed with pneumonia however, she said it was her asthma, prescribed with antibiotics. no missed doses. While receiving the covid 19 vaccine. (unknown if the therapy was held due to covid 19 positive, taking antibiotics). Generally, it's been hard for her to cope with rheumatoid arthritis and sometimes she feels discouraged and/or depressed, feel's discouraged. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Covid 19 and Pneumonia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
6x6 inch area of bright red, slightly raised spots on her back w/in 3 hours of shot, dulled to normal color and were gone within 12 hours of administration.
Patient's caregiver/relative, called and stated parent had a 3 inch rash on injection site and a 1 inch tender bubble. Per immunizing RPh were injection correctly (IM) suggest patient take Tylenol for pain cold compress. if no relief see doctor who prescribed antibiotics
Client fainted after injection given and bandaid was applied to injection site. No injury.  Supportive treatment until awoke from faint.
2 year old child came to Arvada site clinic.  Received DTAP in left deltoid and MMR in right SQ arm.  Mother of child called concerned about redness, swelling and warm to touch in left arm.  Child also fussy.  Child was administered shot on 11/18/2003, went to bed early 11/19/2003 was very fussy and complained of left arm soreness.  Mom treated with Tylenol, cool compresses, swelling resolved 10/21/2003.
Approximately 8 hours after vaccine administration, patient reportedly had apneic, cyanotic episode from which she recovered fully after minutes.  1/26/06 Review of 6-page d/c summary D/C diagnosis was stated as adverse reaction to pertussis vaccine. Described as fussy initially and later limp with shallow breathing, blue lips, and pallor. Father stated the child had a similar, but less severe episode after her first DTaP (positive rechallenge). Review of 5-page medical record confirms acute life-threatening episode following DTaP vaccine.
Left eye twitching; Left eye vision problems; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: QW0177) via an unspecified route of administration in the left arm on 12Jun2021 at 10:00 (at the age of 53-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 06Jul2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, blood pressure high (high BP), depression, anxiety and neuropathy. The patient received unspecified concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took methotrexate (MANUFACTURER UNKNOWN) for psoriatic arthritis (discontinued for 2 weeks after both doses), INDERAL LA and hydralazine (MANUFACTURER UNKNOWN) for blood pressure high (high BP), WELLBUTRIN and ABILIFY for depression and anxiety, gabapentin (MANUFACTURER UNKNOWN) for neuropathy all were taken from unknown dates and unknown if ongoing. On 13Jun2021 at 12:00, the patient experienced left eye twitching and left eye vision problems after receiving first and second dose, problem went after two weeks on first dose, still experiencing symptoms since receiving second dose on 06Jul2021(as reported). The adverse events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events left eye twitching and left eye vision problems was recovering at the time of this report.
had 2 shingles shots, this was on feet and hands, suspected vaccination failure; this was on my feet and hands; symptoms are blisters; crack skin; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and skin cracked. On an unknown date, the outcome of the vaccination failure, shingles, blister and skin cracked were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and skin cracked to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comments: The patient self-reported this case. The patient was taken pictures of the bottom of his or her to show his or her symptoms  physically.  The patient had at least 2 shingles related shots and he or she thought that this was what this was on his or her feet and it was also a little bit on his or her hands but according to the symptoms were blisters and this was crack skin. The patient said he or she keep feet and he or she really good so did have any idea was this another form of she knows he or she did not think so but could help him or her with this. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The event shingles and vaccination failure were coded conservatively since the narrative stated that this was what appeared on their feet and hands'. Follow up would not possible, as no contact details were available.