chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have arm pain at the injection site where I got the Pfizer shot; She had previously had two shots and two booster doses of Moderna. She got the last one as a Pfizer Booster because Moderna didn't make that last booster per the caller; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna covid vaccine (DOSE 1, SINGLE, Lot Number: 007B21A), administration date: 10Apr2021, when the patient was 57-year-old, for Covid-19 immunization; moderna covid vaccine (DOSE 2, SINGLE, Lot Number: 038A21A), administration date: 07May2021, when the patient was 58-year-old, for Covid-19 immunization; moderna covid vaccine (DOSE 3 (BOOSTER), SINGLE, Lot Number: 013F21A), administration date: 01Dec2021, when the patient was 58-year-old, for Covid-19 immunization; moderna covid vaccine (DOSE 4 (BOOSTER), SINGLE, Lot Number: 0510M21A), administration date: 07Jun2022, when the patient was 59-year-old, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Dec2022, outcome "unknown", described as "She had previously had two shots and two booster doses of Moderna. She got the last one as a Pfizer Booster because Moderna didn't make that last booster per the caller"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "I have arm pain at the injection site where I got the Pfizer shot".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient received dose from punctured vial after 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Client experienced throat swelling, itchiness, mouth swelling and flushing either 4 hours after vaccination or the next day.  The client doesn't remember when it started exactly.  Client states that she took Benadryl for it and the symptoms abated.  She denied experiencing symptoms with her second dose.
Pt only received the diluent part of the mcv4; Pt only received the diluent part of the mcv4; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient only received the diluent part of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine. The reporter consented to follow up. No other information was reported.
This case was reported by a consumer via call center representative and described the occurrence of hives in a 32-year-old female patient who received HAVRIX for prophylaxis. On 18th June 2018, the patient received the 1st dose of HAVRIX. On 21st June 2018, 3 days after receiving HAVRIX, the patient experienced hives, pruritus and erythema. The patient was treated with SINGULAIR, ATARAX and Topical Steroid. On an unknown date, the outcome of the hives, pruritus and erythema were unchanged. It was unknown if the reporter considered the hives, pruritus and erythema to be related to HAVRIX. Additional details were provided as follows: The patient developed reddish itchy hives all over torso, neck, breast, stomach and lower back after receiving GlaxoSmithKline (GSK) hepatitis A vaccine. The patient also reported she went to the physician on the day of reporting to report the reactions after which she received prescriptions for a topical steroid, SINGULAIR and ATARAX. The patient initially called in wanting to speak to a representative on how to proceed with 2nd dose in series after the adverse reaction from initial dose. The request for call back was being forwarded to Global Response Center (GRC) for consumer call-back per the follow-up patient request. The patient was okay with GSK safety further contacting the pharmacy for further information regarding product details and adverse reaction. No further information was reported regarding the event.
After injection had soreness at injection site.  This soreness progressed and spread from her shoulder down into forearm.  Also developed limited range of motion.  Saw her pcp on Feb 2, 2022  and was sent for an xray completed on 02/18/2022.  Then saw a physiatrist on March 2, 2022. She was then referred to physical therapy, first visit  was on 03/11/2022.  On 03/15/2022 she received a steroid injection with xray guidance.  Next appt with PT is on 03/25/2022.  Video visit with the physiatrist is scheduled May 2, 2022. She has continued with ROM home exercises throughout this time. Pain has decreased but is not eliminated.  Range of motion slightly improved.
Fever, abdominal pain, severe diarrhea starting 7 days after vaccine.
This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with VAQTA. Concomitant medications were not reported. It was reported that the VAQTA vaccine was exposed to 11 degree Celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of VAQTA are administered consistently throughout the period of January 2014 to May 2014. No adverse effects were reported. The outcome of administered vaccine exposed to 11C for 84.5 hours and then for -2.5C for 47 hours and no adverse effects was unknown. This case was linked to 1406USA000152, 1406USA000392, 1406USA000393 and 1406USA000394 (same reporter link). Additional information has been requested.
7SEP93 devel fever 104.8 which has cont over past 2 days temp has gone down p/APAP then rises again; mom giving APAP 4 hrs & cool baths; 9SEP93 noticed fine red rash on stomach;
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 17-OCT-2008, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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 of herpes zoster. In February 2016, the patient was treated at a medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ (lot#, dose unknown) oral. The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored ROTATEQ were administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of lip swelling (swollen lips) and eye swelling (eye became swollen and shut) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced lip swelling (swollen lips) and eye swelling (eye became swollen and shut). At the time of the report, lip swelling (swollen lips) and eye swelling (eye became swollen and shut) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Most recent follow-up information incorporated: On May 19, 2021: Non-significant follow-up received on May 19, 2021; no new information.
NEEDLE SEPARATED FROM SYRINGE DURING ADMINISTRATION. IT IS UNKNOWN WHAT VOLUME OF VACCINE ENTERED PATIENT AND HOW MUCH WAS LOST.
Headache, Arthralgia, Fatigue, chills, Injection site pain and swelling, tenderness and swelling of the local lymph nodes on the injection side Narrative:
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
BlurredVision, Myalgia, Fever, CoughWheeze & Palpitations  Narrative: tested for COVID-19, InfluenzaA&B, RSV on 7/31- it was the earlies he would come in Test Negative
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ lot # M042821, orally for prophylaxis. No adverse event reported. The vaccines were exposed to a temperature between 32-35 Fahrenheit degrees for a timeframe of 32 hours. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA004021:
Pt states initial Moderna vaccine given at health dept.   verified at least twice with pt and he states he received Moderna as his initial dose.   Moderna dose given.  Pt came back later and actually had Pfizer vaccine.  The handheld did not alert that the initial dose was Pfizer.   Pt was inadvertently given Moderna as second dose.  He has access  and reports no ill signs/symptoms.
cellulitis devel @ site of inj & spread over majority of arm;lasting approx 7 days;treated w/Keflex
The next day after the flu shot he developed a rash on the injection site, wheezing, runny nose and hoarse. He had a temp of 100 degree on Friday A.M. he was seen by physician and prescribed steroids and advised to Not have another flu shot.
3rd Dose of Pfizer vaccine given without knowledge of the previous doses provided.  Patient has been monitored for and adverse symptoms.  Doctor was advised.   No adverse symptoms have been reported due to the 3rd dose provided.
Vaccine Error. Patient was given vaccine at 11 years of age, when should not have been given until atleast 12
Feeling flushed; Feeling warm; hives on chest, arm, face, and thigh; Itchiness of the skin; Nauseous; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FLUSHING (Feeling flushed), FEELING HOT (Feeling warm), URTICARIA (hives on chest, arm, face, and thigh), PRURITUS (Itchiness of the skin) and NAUSEA (Nauseous) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FLUSHING (Feeling flushed), FEELING HOT (Feeling warm), URTICARIA (hives on chest, arm, face, and thigh), PRURITUS (Itchiness of the skin) and NAUSEA (Nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 milligram; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK dosage form; METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at a dose of UNK dosage form and FAMOTIDINE for Adverse event, at a dose of UNK dosage form. At the time of the report, FLUSHING (Feeling flushed), FEELING HOT (Feeling warm), URTICARIA (hives on chest, arm, face, and thigh), PRURITUS (Itchiness of the skin) and NAUSEA (Nauseous) was resolving.        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 concomitant medication reported.      Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: follow up information received, stating that Patient is fine, has not presented any sequalae's, everything is fine, and all previous symptoms have resolved and there are no ongoing symptoms.; Sender's Comments:
About 6 hours post vaccine, I woke up with fever, chills and shaking.  I took ibuprofen and Tylenol .  I could not go to work and stayed home.  These symptoms lasted about 48 hours.  About a week after the vaccine, I started having angioedema.  I notice my tongue started to swell.  I also noticed my lips and the inside of my mouth was swelling too. It would start from the left inside of my mouth and migrate to the right side.  I took Benadryl.  The swelling lasted for about 4 days and started to slowly go away.  About a week later, I started getting body rashes on random parts of my body.  It  had it on my ears, underarms, under my breasts, thighs, hands, legs and  trunk.  The rash would randomly appear and dissapear and could last from 12 hours to several days.  I went to se a doctor and was prescribed Allegra, Zyrtec and steroids.   I got another 2nd opinion with Dr and got blood work done.  I still am suffering from random rashes and notice it will flare up when I don't take my antihistamine medications. The rash is very red, blotchy, can be raised, itchy, painful and very uncomfortable.  I never know when I would get them or how severe it may be.
Egg yolk allergy -> rash. Approved by her allergist to receive influenza vaccine 2010. Reports that 5 hours after influenza injection, developed a "knot," edema, erythema to injection site. The following day, had symptoms extending the length of upper arm. 11/20/10 developed bilateral hand swelling requiring her jewelry to be "cut off" in ED. Treated in ED with BENADRYL. Had received influenza vaccine 12/15/09 without problems.
Received Pfizer vaccines on 4/14/21, 5/7/21.  Tested positive for COVID-19 on 7/21/21.  Admitted to hospital on 7/20/21. Patient is s/p C-section and bilateral tubal ligation on 06/04/2021 admitted under the obstetrical service with severe right upper quadrant abdominal pain with leukocytosis, tachycardia with CT chest abdomen and pelvis showing some mild ground-glass opacities without any clear foci of infection, and possible evidence partial small-bowel obstruction that is now improving with bowel movements. At time of vaccination, patient was pregnant, G5P3104, delivered at 38 weeks via C-section on 6/4/21 d/t partial placenta previa w/ hemorrhage.  EDD was 6/18/21 determined by LMP. Birth weight was 2.89 kg.
Noted entire left arm with swelling reddness warm and painful to touch on Saturday. Sent for follow up with provider
Three hours after receiving the vaccine she began experiencing swelling in the uvula.  Some mild difficulty breathing.  It took several days for the swelling to return to normal.
Arm red, warm, swollen, and very sore.  Treatment-MOTRIN, ice.
Patient states on Saturday he developed a large red circle that eventually turned into an itchy knot at injection site. Itchy rash appeared from her shoulder to her elbow. No anaphylactic rxn. 4 days later and it is still itchy. She hasn't taken anything to treat the reaction.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 25-SEP-2017, the patient was the patient was inadvertently administered a dose of VARIVAX lot # L015047 which expired on 29-APR-2017 (dose and route of administration were not reported). No adverse effects was reported. Product quality complaint was not reported.
Dizziness; Paraesthesia; Dysgeusia; Extra menstrual cycle; Dizziness; face tingling; tasting metal; This spontaneous case was reported by a non-health professional and describes the occurrence of the first episode of DIZZINESS (Dizziness), PARAESTHESIA (face tingling), DYSGEUSIA (tasting metal), OLIGOMENORRHOEA (Extra menstrual cycle) and the second episode of DIZZINESS (Dizziness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine since 1995 and Thyroid cancer since 2015. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and IBUPROFEN for an unknown indication.    On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced the first episode of DIZZINESS (Dizziness), PARAESTHESIA (face tingling) and DYSGEUSIA (tasting metal). On 25-Apr-2021, the patient experienced OLIGOMENORRHOEA (Extra menstrual cycle). On 12-May-2021, the patient experienced the second episode of DIZZINESS (Dizziness), PARAESTHESIA (Paraesthesia) and DYSGEUSIA (Dysgeusia). On 14-Apr-2021, PARAESTHESIA (face tingling) and DYSGEUSIA (tasting metal) had resolved. On 28-Apr-2021, OLIGOMENORRHOEA (Extra menstrual cycle) had resolved. On 13-May-2021, last episode of DIZZINESS (Dizziness), PARAESTHESIA (Paraesthesia) and DYSGEUSIA (Dysgeusia) had resolved.        This case was linked to US-MODERNATX, INC.-MOD-2021-077893 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077893:Dose 2
Intermittent tingling/numbness on one side of mouth/lips, "lightheaded" lasted 3 days post-immunization.
1st dose pfizer 5/15/21 2nd dose 6/5/21 Booster 12/9/21. Received Covid booster on Thursday afternoon at 11am within 2 hrs started to feel ill with generalized body aches/fatigue/ That evening had severe weakness and developed temp 103, was unable to sleep and body aches were so severe she couldn't even open a bottle of water. ON Friday felt worse with same symptoms, had to stay in bed, continued with fevers/chills/body aches and fatigue. Did not take mpap or ibuprofen. On Saturday when moved in bed felt sharp pain in chest but did not radiate and had no SOB/n/v, pain came and went. On Sunday felt chest discomfort once or twice but it came and went, was a dull ache. Monday had same problem a couple of times, Tues had a couple of episodes. Today has had no episodes of chest pain but continues with upper back pain and lymph node swelling along with severe fatigue. Last time she had a fever was Sunday. On Sunday noticed swelling under left armpit. Chest pain episodes from SUN/MON/TUEs were more of a dull ache that is on the left side of chest and also has pain between both shoulder blades. Has not had any dyspnea. Temperature:  96.6. Pulse (sitting):  94. Blood Pressure (sitting): 145/82. Respirations: 18
Pain and tingling in hands and feet, lasting approx. 2 weeks.  These symptoms recurred after her 2nd dose on 12/03/2021, and they lasted  4 weeks before resolving. Again, parents did not seek care.
immune thrombocytopenic purpura (ITP); This spontaneous report as received from a consumer referring to a currently 25-year-old female patient. The patient concurrent conditions, concomitant therapies were not reported. The patient's medical history included Sulfa antibiotics allergy and allergy to nuts and shellfish.  On 20-DEC-1997, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration, formulation, lot number and expiration date were not reported.) for routine vaccination.  On the same date, after the administration of the suspect vaccine, the patient experienced immune thrombocytopenic purpura (ITP) "reaction from the vaccine". The reported mentioned that the patient was hospitalized for 3 nights and was treated with immunoglobulin (unspecified). It was not reported if the subject sought medical attention. On 24-DEC-1997, the subject was recovered from the event.  The causal relationship between the suspect vaccine and the event was not reported