chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of an adult patients who received SHINGRIX for prophylaxis. Co-suspect products included FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patients received SHINGRIX (intramuscular) and FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, 2 days after receiving SHINGRIX and FLULAVAL QUADRIVALENT 2018-2019 season, the patients experienced influenza-like symptoms, chills, headache, feeling bad and sickness. On an unknown date, the outcome of the influenza-like symptoms, chills, headache, feeling bad and sickness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, headache, feeling bad and sickness to be related to SHINGRIX and FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The reporter reported that when some patients receive FLULAVAL and SHINGRIX in different arms while at the pharmacy, they come back and say they got sick 2 to 3 days after. The patients experienced flu like symptoms including headache, chills and feel bad for a day or 2. The reporter reported that physicians had also experienced these symptoms when they got vaccinated with both the vaccines. Some patients who received SHINGRIX at the Medicine Doctor (MD) office then came to the pharmacy that same day to get FLULAVAL and vice versa where these symptoms has happened to them as well. Some patients were opting not to get the second dose of SHINGRIX as a result. This had been ongoing for a couple of months. The reporter cannot quantify and had no further patient or product details. The reporter stated that this was just a general question regarding co-administration. The reporter did not consent to follow-up. This case has been linked with case US2019GSK066451, reported by same reporter.
Right upper arm with redness and swelling with pain. Redness 6 inches in length and around entire upper arm
Almost immediately after injection pt felt dizzy and asked for water. Within 10 minutes she developed tightness in her throat when swallowing and developed a cough. Denied SOB. After 20 min she had developed nausea with wretching and was sent to the emergency department.
Large 4 x 5 cm erythematous and indurated lesion, mildly pruritic, conservative treatment with antihistamines and ice advised.
Swelling of the lymph nodes; Arm soreness got worse; Arm  soreness; A spontaneous report was received from a  Consumer concerning a 55-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, arm soreness got worse, swelling of the lymph nodes .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.  On 7 Jan 2021, the patient experienced the event arm soreness,On 8 Jan 2021, the patient experienced the event arm soreness got worse,On 13 Jan 2021, the patient experienced the event swelling of the lymph nodes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm soreness, arm soreness got worse, swelling of the lymph nodes were ongoing.
Patient has mild dementia.  The night of the day he was injected with his second shot, he was extremely confused, could not find familiar places,.....this was a marked decline from the way he had been before he received this second shot.  Then EVERY day after, he was VERY confused during the day, was seeing things that were not there, and delusional.  It was like the vaccination had accelerated his dementia enormously.
fever of 102.5 F persisted 2 days; 3" wide band of skin that was reddened & warm to touch above left elbow persisted 4 days - looked and felt like a sunburn or fluid-less blister
Narrative:  C/O PAINFUL ERYHTMATOUS LESIONS THAT DEVELOPED AROUND SITE OF PNEUMOVAX ON RT UPPER ARM on 1/20/22..
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, an unspecified patients were vaccinated with doses of ZOSTAVAX (dose, route, and lot# were not reported) which were exposed to temperatures outside of the recommended range. No adverse experienced reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same source. Additional information has been requested.
Patient came to see me and stated she had her Pfiser vaccine at her pharmacy on Nov 13 2021 and two days later her knees both started hurted very badly. It lasted a few days, went away and then came back again in December. Now it is January and the pain alternates from right to left knee randomly. I am just reporting what the patient relayed to me. We did not give her this vaccine in our clinic.
Information has been received from a physician concerning  a patient who was vaccinated with zoster vaccine live (Oka/Merck) ("lot # 0829U") and three weeks later presented with chicken pox. At the time of reporting the patient was still recovering. Additional information has been requested.
Erythema, indurated grape fruit sized cellulitis at left upper arm. Pain, red, swollen.
Pain in most of the leg and part of the glute; Pain in most of the leg and part of the glute; Numbness in the left thigh/couldn't feel left thigh; Felt like nerve type of pain; Upset stomach; Minor headache; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in most of the leg and part of the glute), MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute), HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh), NEURALGIA (Felt like nerve type of pain) and ABDOMINAL DISCOMFORT (Upset stomach) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Minor headache) and NAUSEA (Nausea). On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in most of the leg and part of the glute), MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute), HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh) and NEURALGIA (Felt like nerve type of pain). The patient was treated with PARACETAMOL (TYLENOL) on 26-Feb-2021 for Headache, at an unspecified dose and frequency. On 26-Feb-2021, ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Minor headache) and NAUSEA (Nausea) had resolved. On 11-Mar-2021, HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in most of the leg and part of the glute) was resolving and MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute) and NEURALGIA (Felt like nerve type of pain) 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.   No relevant concomitant medications were reported.  The patient reported that he went to get evaluated with chiropractor. They couldn't figure out what was wrong.
Pt received smallpox vaccine 1/16/08. Returned 1/23/08 with major reaction, on 1/25 noted pustules forming arms, neck, lip and back seen in office 1/28. Body aches, fatigue. Diag: generalized vaccine reaction. Plan Levaquin 750mg PO Qd #5, Reevaluated 2/4/08 pustules scabbed over - SX resolved (pics taken).
Patient has redness around injection site about the size of a quarter and then a separate, much larger area of redness near her bicep and completely separate from injection site, but on same arm. It is pink and warm. Onset began the day after injection and is still persisting 4 days post-injection. Patient saw PCP who instructed her to take Benadryl at night, any allergy antihistamine in the morning, and Benadryl or hydrocortisone cream if there's any itching.
Pt started persistent unconsolable crying 3 hrs p/DTP/OPV/HIB; crying lasting over 3 hrs;
Had light temperature both times; Swelling on the right breast bellow the arm; Swelling was on glands in the left side on the neck; This spontaneous case was reported by a patient and describes the occurrence of BREAST SWELLING (Swelling on the right breast bellow the arm), LYMPHADENOPATHY (Swelling was on glands in the left side on the neck) and PYREXIA (Had light temperature both times) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ONJ2OA or O11J2OA) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced BREAST SWELLING (Swelling on the right breast bellow the arm) and LYMPHADENOPATHY (Swelling was on glands in the left side on the neck). On an unknown date, the patient experienced PYREXIA (Had light temperature both times). At the time of the report, BREAST SWELLING (Swelling on the right breast bellow the arm) and LYMPHADENOPATHY (Swelling was on glands in the left side on the neck) had resolved and PYREXIA (Had light temperature both times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Had light temperature both times.         Concomitant product use was not provided by the reporter.  Patient received first dose on the left side of the arm and second dose on the right side.  It was reported that patient had swelling in the glands from the vaccine. After the first dose swelling was on glands in the left side on the neck and on the right breast and below on the arm. Occurred after few hours after she came home. After the second dose patient got swelling again but was not as bad as the first dose.  Patient had light temperature both times.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-738115 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738115:Same patient (Booster dose)
Patient received Moderna vaccine after review. Approximately 5 minutes after receiving the vaccine they came to the drop off area stating that they felt warm and the lights seemed brighter. They explained they didn't know if it was just a random feeling or a reaction to the vaccine. I had them sit down, gave them an ice pak and cold bottled water, advised that they stay longer (around 30 minutes total) After about 10 minutes the patient felt better but they stayed the wait time. I called to check on them in the afternoon but they did not answer
Had covid, took Paxlovid, 07Jun -11Jun.  Tested antigen and PCR sputum negative 11Jun & 17Jun; Had covid, took Paxlovid, 07Jun -11Jun.  Tested antigen and PCR sputum negative 11Jun & 17Jun; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ49E9) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Feb2021 at 01:00 as dose 1, single (Lot number: 032L20A), in right arm, on 02Mar2021 at 13:00 as dose 2, single (Lot number: 032L20A), in left arm and on 26Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 071F214), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "Had covid, took Paxlovid, 07Jun -11Jun. Tested antigen and PCR sputum negative 11Jun & 17Jun. Husband became covid positive with symptoms 17Jun. I tested positive home test and PCR sputum test on 19Jun"; COVID-19 (medically significant), outcome "recovered", described as "Had covid, took Paxlovid, 07Jun -11Jun. Tested antigen and PCR sputum negative 11Jun & 17Jun. Husband became covid positive with symptoms 17Jun. I tested positive home test and PCR sputum test on 19Jun." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) UNKNOWN RESULTS, notes: Had covid,took Paxlovid, 07Jun -11Jun; (19Jun2022) positive, notes: I tested positive home test and PCR sputum test on 19Jun; (23Jun2022) negative, notes: I tested negative home test on 23Jun; (11Jun2022) negative, notes: Tested antigen and PCR sputum negative 11Jun & 17Jun; (17Jun2022) negative, notes: Tested antigen and PCR sputum negative 11Jun & 17Jun; (19Jun2022) positive, notes: I tested positive home test and PCR sputum test on 19Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient dad covid, took Paxlovid from 07Jun to 11Jun. Tested antigen and PCR sputum negative 11Jun & 17Jun. Her husband became covid positive with symptoms on 17Jun. She tested positive home test and PCR sputum test on 19Jun. No symptoms. She tested negative home test on 23Jun. Her husband was still positive and became symptom free on 25Jun.
Swelling and red. Amoxil for 5 days. Topical BACTROBAN.
immediately after injection, pt bacame dizzy, lightheaded, nauseated, and vommited.  Pt became pale. Vitals stable.
9MAY96 circular erythema @ inj site;rt anterior thigh;approx 4x4cm;warm to touch;redness noted immed p/inj given;swelling appeared later;
C/O itching ears/neck within 10 min of administration. Generalized itching/redness, face and neck. Monitored x 30 minutes - no respiratory involvement. Sent to urgent care clinic (primary md).
awoke @ 4AM 24OCT97 itching all over body;noticed swelling/rash on both legs below knees;rash did extend farther up leg on 25OCT & 26OCT but as of 27OCT AM rash & itching are resolving;used DPH for itching;rash was red, raised not hives;
neck was tender to touch on the left side; could not move her neck; It looked like she had mumps on 1 side and she thought it was a bug bite, The nurse said she had seen this (neck swelling); sore arm/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (neck was tender to touch on the left side), MUSCULOSKELETAL STIFFNESS (could not move her neck), SWELLING (It looked like she had mumps on 1 side and she thought it was a bug bite, The nurse said she had seen this (neck swelling)) and MYALGIA (sore arm/sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL and METFORMIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced MYALGIA (sore arm/sore arm). On 23-Feb-2021, the patient experienced HYPERAESTHESIA (neck was tender to touch on the left side), MUSCULOSKELETAL STIFFNESS (could not move her neck) and SWELLING (It looked like she had mumps on 1 side and she thought it was a bug bite, The nurse said she had seen this (neck swelling)). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form and IBUPROFEN for Swelling, at a dose of 1 dosage form. On 10-Feb-2021, MYALGIA (sore arm/sore arm) had resolved. On 08-Mar-2021, HYPERAESTHESIA (neck was tender to touch on the left side), MUSCULOSKELETAL STIFFNESS (could not move her neck) and SWELLING (It looked like she had mumps on 1 side and she thought it was a bug bite, The nurse said she had seen this (neck swelling)) had resolved.
RED WELCH MEASURING 6CM X 6 CM, SOME ITCHING. PATIENT WAS GIVEN METHYIPREDNISOLONE4MG TABLET DOSE PACK AND TRIAMCINOLONE ACETONIDE 0.1% TOPICAL OINTMENT
received vaccine @ 4:25pm within few mins noted red flush across face, neck extending to collar bones.  No SOB, difficulty swallowing, hives, rash nausea  BP 142/80 HR 64 O2 Sat 97% 15mg of liquid Benadryl @ 4:35pm resolved in 1 hr
After my first dose injection, I experienced a dental infection. I went to see Dr who performed dental work.  I do not know if this is related to the Moderna vaccine. I also had my second dose injection on 01-23-2021 and have no adverse event symptoms to report.
Started with low abdominal pain and diarrhea. Then had chills and fever to 100.8 and severe muscle and joint pain, and tiredness, and left deltoid soreness. Shoulder joints and neck felt like they were burning. Lasted two and half days and gradually subsided.  Treatments included ibuprofen for fever, sleeping and ice packs on shoulder and neck on the third day when the burning began. Felt so bad took a Vicodin for the burning sensation on third day. On fourth day almost back to normal with mild abd pain but had a normal bowel movement.
I was paralyzed; every bone of my body hurt; every joint hurt; my entire vertebrae hurt; I was in such pain /my entire body, every bone of my body hurt, every joint hurt; I could not get out of bed; I was in terrible shape; I was so sick; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 89 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I had a kidney stone" (unspecified if ongoing), notes: I remember I had a kidney stone past one time (History) and that is very painful. Concomitant medication(s) included: FAMOTIDINE; ALLOPURINOL; PRIMIDONE; TAMSULOSIN HYDROCHLORIDE; LANSOPRAZOLE; LEVOTHYROXINE SODIUM; SUCRALFATE. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization; Bnt162b2 (Dose:02), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 18Nov2021, outcome "unknown", described as "Booster"; PARALYSIS (medically significant) with onset 19Nov2021, outcome "unknown", described as "I was paralyzed"; BONE PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "every bone of my body hurt"; ARTHRALGIA (non-serious) with onset 19Nov2021, outcome "unknown", described as "every joint hurt"; SPINAL PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "my entire vertebrae hurt"; PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was in such pain /my entire body, every bone of my body hurt, every joint hurt"; BEDRIDDEN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I could not get out of bed"; FEELING ABNORMAL (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was in terrible shape"; ILLNESS (non-serious) with onset 19Nov2021, outcome "unknown", described as "I was so sick". The patient underwent the following laboratory tests and procedures: blood test: unknown results. Therapeutic measures were taken as a result of immunisation, paralysis, bone pain, arthralgia, spinal pain, pain, bedridden, feeling abnormal. The patient was taking Ibuprofen along with some other pain medication (Unspecified medications) to ease the pain and still the patient was not right.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Suffered a major heart attack on 09/06/2021 and expired on 09/07/2021 on hospice.
I was fine all day, very active actually. But as soon as I stopped moving- 10pm- & sat down for the first time since my shot, I immediately started feeling chills. They rapidly got worse until my teeth were chattering and my skin was hurting and I couldn?t get warm. Didn?t have energy to walk across the room.  Brain got foggy, I started to panic, head pounding. I took two took my temp at 10:30, 101.3, and I nevvver run a fever. Tylenol before 11pm. With multiple blankets, gloves, and hat on I fell asleep. Woke up at 2am crying and dreaming I was on fire, burning up hot. And then started puking. That lasted only 30 minutes or so. From there, I was drained, soooo sore, tired, clammy, chills on and off throughout the next 24 hours or so. Woke up this morning feeling better. Thank God & medicine. It sucked, but better than dying from Covid. God Bless
This was my booster dose (had j&j shot in April) Have had significant adverse menstrual irregularities beginning the next cycle after booster dose. My menstrual period (bleeding) historically was 3-4 days of light and medium bleeding. Since having the booster dose it has been 6-7 days of heavy bleeding. Prior to the booster dose, I never soaked through tampons and now I am soaking through and bleeding onto my clothes within 2-3 hours of changing a tampon. I also have been having cramping, which I never had before.
In order: March 26,2021 at 2.05pm, 2nd injection of Moderna :     30min. after injection, left eyeball, then left temple; then right eyeball and then right temple; then moved to top of my head and all was aching and starting to throb.  Then moved to all my cervical neck bones.  This all took place within 30 min after injection.  Once home started to ache all over.  Started with low grade fever of 99.7 and eventually till it got to 101.4  I did not take any medication.  Just let it run its course.  Upon waking up this morning my left eyeball has a busted blood vessel in it and looks bad.  But as day goes on, it is slightly fading.  I am no feeling fine.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # 023232, expiration date 25-FEB-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient complained of pain in right arm and redness at injection location. No swelling, no drainage, no other symptoms. Pain began this morning, just noted redness about 2:00pm.
About a couple of days later starting to feel weakness in left arm. Feels heavy. Worsening. No redness or bruising or swelling. No systemic illness.