chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myelitis transverse; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or around 06-JUN-2012, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for it's intended purpose: the prevention of shingles (herpes zoster).  Shortly, after receiving Defendants' zoster vaccine live (ZOSTAVAX)vaccine, Plaintiff suffered transverse myelitis.   As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX)vaccine, Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), Plaintiffs sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, Plaintiffs suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiffs have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, transverse myelitis was determined to be a medically significant event.
received expired vaccine; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 35-year-old male patient who received HBV (Engerix B) (batch number P3ZF5, expiry date 5th July 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 15th October 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Engerix B which was expired on 5th July 2021, which led to expired vaccine used. No reactions were reported. The reporter consented to follow up.
High fever 104 degrees Loss of Taste Loss of smell Body aches Sore throat Nausea Chills Fatigue Shortness of Breath  - trouble breathing Headache runny nose
Pt  had high fever of 102.7 Saturday 03/29/2018. Then pt experienced left sided pain, level 10/10.  Pain to the left arm, left shoulder, neck and under left  scapula. Hurt to touch those areas. Pt able to move fingers and arm from elbow down. Hurts too much to move. Pt presented to the ER on Saturday 03.29.19 and was transported to med center and is currently admitted and obtaining physical therapy.
I had my vaccination on 01/05/2023. In 03/2023 I started to experience symptoms of diverticulitis. I am in pain in my gut area and being treated as if I do have diverticulitis. If the symptoms persist their going to a CAT Scan to determine if it is something else in 04/2023 or 05/2023.
This is a spontaneous report from a 40 year old male pt who on 6/1/99, the pt received his first treatment with Lymerix. Sometime, thereafter, he experienced a sore arm, headache, fatigue and flu-like symptoms. On 6/30/99, while the symptoms were ongoing, the pt received the 2nd dose of Lymerix. The pt was treated with Tylenol. The most recent information received on 7/1/99, reports the symptoms are ongoing.
When medical technician gave simultaneously MMR/varicella into L thigh SQ patient's hand was not secured and he pushed needle out of skin. Full dose of vaccine was not given.
The pt experienced redness and swelling at the injection site. The pt also experienced a raised, red, warm area which was non-tender on the right upper arm. Diagnosed as probable local reaction to immunization, possible cellulitis. Given Augmentin for 10 days.
2 days after receiving H1N1 injection noticed a flat rash on her chest and neck.  Started red in color then turned dark with a scab appearance.  Progressed to arms, stomach.  Rash is "getting better".  Denies rash below waist.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EKS730), in left arm, on 14Jan2021 at 12:30 as dose 2, single (Lot number: ELI283), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: TRIAMTERENE HCTZ; ATENOLOL; LISINOPRIL; LEVOTHYROXINE; VITAMIN C [ASCORBIC ACID]; ROBITUSSIN DM; IBUPROFEN; TYLENOL; ABREVA; OFLOXACIN; VISINE ALLERGY [NAPHAZOLINE HYDROCHLORIDE;PHENIRAMINE] taken for eye disorder; VISINE ADVANCED RELIEF taken for eye disorder; ALBUTEROL [SALBUTAMOL]; PINK EYE RELIEF taken for eye disorder. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Unknown results, notes: covid symtoms started. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included took paxlovid a.m. dose at 1700 on 18Jun22.  Clinical course: Patient called pharmacy at (pharmacy name withheld) to ask if this was ok, wanted to take the Paxlovid since started having increased cough. They said it was ok to. Patients covid symptoms started on 14Jun22 in the p.m. After patient took Paxlovid, immediately didn't feel right. Became horribly anxious and BP went up to 165/112, tried to relax. Took BP again and the machine wouldn't even read numbers. The cuff is of appropriate size for arm, so it's not that the cuff is too tight. Patient could feel a slight headache in right eye and became horribly anxious. The BP machine would reach over 200 mm/Hg when trying to read BP, that's when patient knew that she was in trouble. Patient made telehealth appt. NP said to stop taking Paxlovid. Brand was Paxlovid, treatment start date 17Jun2022, treatment top date 17Jun2022, Lot number GA3593, Indication was treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
At 11:23 pt began to c/o having a hard time breathing and that her chest felt "tight".  Doctor oversaw evaluation of pt. Vitals: 150/83; P-99-109; SpO2- 99% on RA. Pluse decreased to 81-82 as Doctor spoke to her.  Paramedics checked lung sounds- Clear.  11:36 vitals repeated: 145/83; P-87; SpO2- 100% on RA.  Vitals repeated at 11:48: 138/72; P-87; SpO2- 99% on RA.  Stated that she was feeling better.  Pt instructed to go to ER if s/s worsened; and encouraged to let her PMD know that she had noted s/s following her vaccination.
Hives occurred a few hours after vaccine administration on back, diaper area, chin and chest. No respiratory distress.  Pt went to ER. Given prescription for EpiPen. Hives resolved within 24 hours.
large red spot, itchy and very sensitive to touch, about 2 inches below injection site.    Spot is approx. 2.25" in diameter.
Case number PHEH2014US022238 is an initial spontaneous report received from a pharmacist on 04 Nov 2014. This report refers to a patient of over the age of 55 years old and of an unknown gender. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 Nov 2014. The patient was administered MENVEO outside of age guidelines. No adverse event was reported. No further information was provided.
This was my second booster for hepatitis B I got on March 16, 2016. I got the first shot on February 17 and was told to get this one one month later. Soreness in hip and leg joints started after the first shot, particularly on the lower right side. Strange pain in middle of my back started about 3 days after the booster. Then, starting March 22, I started to feel sharp pains down my back, and a general feeling of unwellness. On March 26, burning sensations across my back started, felt sharp pain in my lower spine and my legs and arms started to tremble so I went to the emergency room. I got an EKG, they checked my O2 levels and both were fine. I explained that I was having some sort of nerve reaction to the hep B vaccine. The doctor did a reflex test to test for Guillain Barre and said I was okay. Said to take ibuprofen for any inflammation. March 28 I still feel burning sensation, now in my legs. Also I have periodic chills and sweats.
Headache, NauseaVomiting, FATIGUE AND MUSCLE ACHINESS Narrative:
Arm was heavy; Her pain level was 3; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm was heavy) and PAIN IN EXTREMITY (Her pain level was 3) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history provided.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm was heavy) and PAIN IN EXTREMITY (Her pain level was 3). At the time of the report, LIMB DISCOMFORT (Arm was heavy) and PAIN IN EXTREMITY (Her pain level was 3) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not do any treatment. No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Live follow up received on 21-Apr-2021: Patient said she was doing fine but not sure about getting 2nd dose. She did not want further follow up.
pt found unresponsive in home by daughter; EMS called; daughter instructed to give CPR; pt did not respond and passed away in her home; COD:  cardiopulmonary arrest due to recent COVID 19 infection; unknown date of positive COVID test: PCP is unknown
Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccination), severe chills and fever of 105. Took 800 mg of Ibuprophen and 50 mg of Benadryl. Temp down to 102 by midnight. Fevers persisted, especially at night with extreme night sweats for 11 days often requiring a change of clothing up to 6 times through the night. No further respiratory symptoms past initial presentation. Night sweats have persisted but with less severity as of Day 15. Please note, I am also a healthcare provider and infectious disease epidemiologist, hence enterring my own VAERS.
Had Fluarix vaccine 11/14/05 in AM. On 11/15/05 while driving home noticed vaccinated arm felt tired. Better in AM but symptoms return as day progressed. Continued to have these symptoms.
small rash around injection site; hives only at injection site that were red, raised, and itchy; hives only at injection site that were red, raised, and itchy; hives only at injection site that were red, raised, and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (small rash around injection site), VACCINATION SITE PRURITUS (hives only at injection site that were red, raised, and itchy), VACCINATION SITE URTICARIA (hives only at injection site that were red, raised, and itchy) and VACCINATION SITE ERYTHEMA (hives only at injection site that were red, raised, and itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (small rash around injection site), VACCINATION SITE PRURITUS (hives only at injection site that were red, raised, and itchy), VACCINATION SITE URTICARIA (hives only at injection site that were red, raised, and itchy) and VACCINATION SITE ERYTHEMA (hives only at injection site that were red, raised, and itchy). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (small rash around injection site), VACCINATION SITE PRURITUS (hives only at injection site that were red, raised, and itchy), VACCINATION SITE URTICARIA (hives only at injection site that were red, raised, and itchy) and VACCINATION SITE ERYTHEMA (hives only at injection site that were red, raised, and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Injection arm still painful when laying down; Mismanagement of dose, received 2nd Vaccination 43 days after 1st Vaccination; Injection arm, shoulder and back painful; Injection arm, shoulder and back painful; Injection arm, shoulder and back painful; Injection arm, shoulder and back became stiff; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Injection arm, shoulder and back painful), BACK PAIN (Injection arm, shoulder and back painful), MUSCULOSKELETAL STIFFNESS (Injection arm, shoulder and back became stiff), PAIN IN EXTREMITY (Injection arm still painful when laying down) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mismanagement of dose, received 2nd Vaccination 43 days after 1st Vaccination) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Injection arm, shoulder and back painful), BACK PAIN (Injection arm, shoulder and back painful), MUSCULOSKELETAL STIFFNESS (Injection arm, shoulder and back became stiff), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mismanagement of dose, received 2nd Vaccination 43 days after 1st Vaccination) and ARTHRALGIA (Injection arm, shoulder and back painful). On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Injection arm still painful when laying down). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Injection arm, shoulder and back painful), BACK PAIN (Injection arm, shoulder and back painful), MUSCULOSKELETAL STIFFNESS (Injection arm, shoulder and back became stiff), PAIN IN EXTREMITY (Injection arm still painful when laying down) and ARTHRALGIA (Injection arm, shoulder and back painful) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mismanagement of dose, received 2nd Vaccination 43 days after 1st Vaccination) had resolved. Not Provided          No concomitant medication was reported.
Local DTaP reaction, swollen left arm 16 x 13cm around injection site. Benadryl 1 tsp tid.
he most painful vaccine he's ever gotten - arm hurts a lot; felt heavy; tired; This is a spontaneous report from a contactable consumer (patient's wife) A 64 year-old  male patient received  bnt162b2 (BNT162B2) , via an unspecified route of administration on 16Dec2020 at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  The patient  felt heavy on 16Dec2020 with outcome of unknown , tired  on 16Dec2020 with outcome of unknown , arm hurts a lot  on 17Dec2020 with outcome of unknown.   The patient stated this was  the most painful vaccine he has ever gotten.   Information on the lot/batch number has been requested.
Information has been received from a physician via telephone call about a conversation he heard concerning a teenage female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not reported).  On an unspecified date the patient had a stroke.  At the time of the report, the patient's outcome was unknown.  Upon internal review strokes were considered to be an other important medical event.  It was unknown if the patient sought medical attention.  This is one of several reports received from the same source.  Additional information is not expected.
I RECEIVED MY VACCINATION ON FRIDAY, JANUARY 28, 2022 BETWEEN 9:30 AND 9:40 AM. ON SUNDAY, FEBRUARY 6, 2022, AT ABOUT 3:30 PM, I DEVELOPED A BILATERAL SORE THROAT ORIGINATING IN MY LYMPH GLANDS AS WELL AS DOUBLE EARACHES. I SAW MY DOCTOR'S PA, AND SHE CHECKED EVERYTHING AND SAID SHE BELIEVES THE PAIN WAS CAUSED BY THE VACCINATION AND TOLD ME TO WAIT A FEW DAYS AND IT WOULD RESOLVE ON IT'S OWN, WHICH IT DID 1-2 DAYS LATER.
Vaccine was thawed at Cmh on 4/12/21.   Vaccine received by clinic on 4/30/21 and placed in freezer. Vaccine thawed again on 5/12/21 and injection given to pt on 5/13/21 Question viability of vaccine and if needs to be repeated?
Pt was give two TDAP within 5 month of each other. Dr contacted pt told pt to call if she had any problems.
pt admitted to hosp w/DTP rxn aseptic meningitis, p/1 day hx of fever & irritability;
Red patch on his arm; Hot patch on his arm; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced localized erythema and localized feeling of warmth. On an unknown date, the outcome of the localized erythema and localized feeling of warmth were unknown.   It was unknown if the reporter considered the localized erythema and localized feeling of warmth to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient for himself. Age of patient calculated by reported date of birth of patient and date of vaccination. Reporter stated that after receiving the 1st dose of Shingrix patient had experienced a red-hot patch on his arm. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix because of the Covid pandemic. The patient did not had the virus but did not got an appointment for the second Shingrix dose. All information was not available. The reporter consent to follow up. For 2nd dose refer linked case id US2021AMR094040.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094040:Same reporter. US-GLAXOSMITHKLINE-US2021093365:Same reporter. Wife's case. 1st dose. US-GLAXOSMITHKLINE-US2021AMR094049:Same reporter. Wife's case. 2nd dose.
I did not have an adverse reaction from the vaccine. I began to not feel well on 06/02 and my symptoms where elevated fever, runny nose and coughing. I was exposed on either 06/01 or 06/02. I tested positive for COVID-19 with a PCR test.  I took a home test on 06/04 which was positive. The PCR  test came back positive on 06/06. I was not eligible for Paxlovid due to one of my heart medication.  I took Mucinex to help with my symptoms.
Dizziness; Wheezing; Rash on the side- under her armpit on both sides; achy and severe; Nausea; Severe joint pain; Extreme fatigue; Headache; Arm pain; Injection pain on the left arm; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first dose of vaccination, the patient had a reaction after leaving the vaccination site. The patient experienced nausea, severe joint pain, achy and severe, extreme fatigue, headache, rash on the side- under her armpit on both sides, wheezing, dizziness and arm pain or injection pain on the left arm. The patient also mentioned that all symptoms were severe. It started later in the evening which lasted about 6 days. The outcome of all the events was recovered.  Information about lot/batch number has been requested.
Nursing Discharge Disposition Patient was brought in by older sister today. Verified what IZ's were going to be given (FLU and HEP A according to records). She agreed with plan. Mom called after patient had arrived home and said that patient had received flu shot at the community flu clinic on Wed 12/08/21. 12/14/2021 @430pm called mom to follow up on how patient was doing. She states that he started with arm soreness and fever that night that lasted about 3 days (did not take temp, he felt warm and was not feeling good). She gave him Tylenol/Ibuprofen and he was OK with that. He is feeling better now although still c/o of some mild arm soreness
This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), FATIGUE (Very exhausted) and CHILLS (Chills). At the time of the report, EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), FATIGUE (Very exhausted) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient felt malaise following the immunization; it lasted for about one day. Patient also experience 'ringing in the ear'; it was significant and lasted for about five days.