chrisvoncsefalvay/vaers-outcomes huggingface dataset:
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if the patient received any prior vaccine in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 3rd of 40 adult patients.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
Swelling/knot at site of injection, mild itching. Appeared late in the day, nine days post-vaccination. No other symptoms currently.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Vaccine expiration date-01 April 2022. on 04 April 2022 vial was initially stored in refrigerator No temperature excursion. Treatment details was not reported by the reporter.
HIstory of Ocular burning and itching and drainage in past after flu vaccine- lasted 4-5 days. Recent flu vaccine resulted in similar symptoms within 24 hrs. Concern for possible occular respiratory syndrome associated with influenza vaccine
Vaccine exposure before pregnancy; This spontaneous report was received from a consumer, concerning to herself, an approximately 21-years-old female patient.  The patient's medical history was not reported. Her concurrent conditions included allergy to messenger RNA (MRNA) vaccines and egg protein allergy. The concomitant therapies were not reported.  On an unknown date in 2001, the patient received the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscularly (IM) (dose, lot #, and expiry date not provided) as immunization from hepatitis B.  On an unknown date in 2001, the patient developed right arm numbness after the administration of the vaccine (Hypoaesthesia) (captured on MARRS#2204USA006755), that lasted approximately one month. She stated that after she could not lift or move her arm or hold a pencil (Injected limb mobility decreased) (captured on MARRS#2204USA006755). The patient was in the college at the time and had to have someone take class notes for her. She also experienced pain at the injection site and the area still "felt like a bruise" at that time (captured on MARRS#2204USA006755). These symptoms happened after the administration of the vaccine. Furthermore, the patient reported that on an unknown date in 2021 (also reported as recently), she found out she was allergic to egg protein and had experienced anaphylactic (also reported as anaphalatic) shock by being close to people who had received Coronavirus disease (Covid) vaccine (captured on MARRS#2204USA006755), and she was allergic to all MRNA vaccines. It was reported that at the moment of the administration of hepatitis B vaccine (RECOMBIVAX HB) (manufacturer unknown) she was not pregnant, but currently she was 4-month pregnant.  The action taken with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was reported as discontinued, since after the administration of the first dose of the vaccine the patient did not finish the vaccination series.; Sender's Comments:  US-009507513-2204USA006755:
He got his vaccine, the following day he started to develop blisters on his hands, feet, legs and arms that would pop and weep.  It got to the point that his hands go so covered that he could not use them to work or function as they would pop..  He ended up getting a skin infection and had to see a doctor for that.  Then trying to figure out what it was, had biopsies and saw a dermatologist and informed it was extreme eczema that he still has on his hands and feet, and was prescribed Dupixent for it.  He has been out of work since January of this year and about 6 months last year due to the reaction.  He fought it for a month after getting the shot and worked wearing gloves to cover the blisters, and got to the point that it was too overwhelming for him.   He was also having symptoms of myocarditis and noticed this after he got sick.  He developed COVID on 1/30/22 and was out of work for that as well.  Since then he has fatigue greater than what he has ever experienced and has no endurance, believes possibly has long-COVID.  He is scared to get another vaccine due to his reaction to the first vaccine.   He was also given initially Betamethasone and Eucrisa creams and this did start to help to a degree and after that he was put on another cream and this year using Enopsalora but cannot seem to get rid of the blisters.    Prior to the vaccine he had no skin conditions of any kind.    He was getting regular vaccines to flu and never had a reaction to those.
pt seen for well pt & nl exam;recv vax t104 that evening;exam following day & no source of infect seen;site nl;remained febrile for 7 days;found to have OM;
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional said that the patient experienced an outbreak of shingles after the 1st dose of SHINGRIX. The healthcare professional said that the patient was needing to get her 2nd dose of SHINGRIX and healthcare professional was asking how long after a shingles outbreak could the patient be vaccinated with SHINGRIX.
Arm swelled up; Arm still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that, he/she got the shingles vaccine and his/her arm still hurt. The patient further added, his/her arm swelled up and was kind of scared to get the 2nd one then. The follow-up would not be possible as no contact details were available.
Severe pain in left arm that became almost unbearable throughout 24 hr after injection (much more intense than any vaccination I have ever had).   This pain was not at the injection site, but throughout the arm.  Arm pain has continued until today (14 days later) albeit much less intense.  Pain increases upon some arm movements. Treated with Advil.
felt sick to the gout; stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,; feel a pressure in their stomach; diarrhea.; a little of a  rash in their face/rash around the eyes/little rash in  their feet,; feels like through up; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.) and RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042s21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Throat sore and Cold. Previously administered products included for Product used for unknown indication: Johnson & Johnson on 04-Feb-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Asthma and Blood disorder NOS. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 19-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.), RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) and NAUSEA (feels like through up). At the time of the report, GOUT (felt sick to the gout), SWELLING (stomach, face  neck and back was swollen,stomach was swollen and could get no easy/cant fell their eyes and they are swollen and puffy,), ABDOMINAL DISCOMFORT (feel a pressure in their stomach), DIARRHOEA (diarrhea.), RASH (a little of a  rash in their face/rash around the eyes/little rash in  their feet,) and NAUSEA (feels like through up) outcome was unknown.            No treatment medication was provided Patient reported concomitant product for blood pressure
pt recvd vax on 9AUG93 & 18SEp93 exp paralysis of lt leg & was dx as having transverse myelitis; pt was hospitlaized;
Fever, shaking, disorientation, delusions were experienced the evening after receiving her vaccinations. Husband took pt to ED. Per husband pt was given BENADRYL in the ED.
PT RECIEVED VACCINE AT THE COUNTY 3/18/2003-VARICELLA, WAS SEEN AT PEDIATRIC OFFICE 3/20/2003. PT AT DAYCARE WOKE UP FROM NAP WITH A UNBALANCED GAIT,NORMAL SPEECH AND ALERTNESS. DOCTOR DIAGNOSIS WAS ACUTE ATAXIA.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. In March 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
After receiving the second dose of the Moderna COVID-19 vaccine, I had two periods in four weeks. This has never happened before and has not happened since.
Patient received a dose of Pfizer COVID-19 Vaccine formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
128PM pt c/o feeling lightheaded. Stated was going to faint. Placed on the floor with legs elevated on chair.  Doctor in clinic 128p  BP 83/42 P56  131P  BP 107/59 P62 PO2 98 percent. 132P sat pt up   134  P 111/56 P89 PO299  136PBP 113/620P77 PO2 99  percent139P B P 103/62 P79 141P sat in chair.   147 Pt states feels better. Walked to car by Doctor.
Extreme chills in hands and toes, body aches, arthralgia (joint pain), muscle aches (mostly larger muscles, quadriceps), some vision loss (lights are dim), nausea, gall bladder pain
I experienced about one week or so after the vaccine, my right arm was vey itchy. I had the size of soft ball lump, was red, hot to touch. I took temperature of my right arm and it was 102.9F.  I started also getting hot flashes on my face. To this day,  I still have soreness to my right arm since my first dose vaccine.  I also had a telemedicine visit with a doctor due to my symptoms.   I do not have my vaccine card to provide my lot#.
I tested positive on 5/17/22. I went to urgent care and received monoclonal antibodies and chest x-ray. They confirmed my positive test result with a PCR test. It basically is a severe cold. I have had congestion, low grade ever, cough, sore throat, a lot of phlegm. I have had symptoms for four days so far.
severe abdominal cramping; high  fever  (102.9); chills;  severe  body  aches; headache; dizziness;  body  aches
Extreme itchiness throughout body and a blister on face. Severe soreness at injection site, fever and muscle soreness. Fatigue, joint pain.
Received second Covid booster. Am reporting side effects due to bivalent not finishing clinical trials. Side effects included fever, extreme fatigue, extreme body aches, sore arm at injection site, chills.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Immune thrombocytopenia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; HYDROXYCHLOROQUIN; PREDNISONE; MYCOPHENOLATE. Vaccination history included: Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax & 30NOV94 & w/in 24hr p/vax exp a fever greater than 102;fever resolved w/o treatment;
GROIN PAIN; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced groin pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.t The patient had not recovered from groin pain. This report was non-serious.
Mother states that her son received the varicella vaccine in 1995 and came down with the chickenpox on 1/17/01. Mother states that her son had over 120 pox.
had bad site reaction on her arm, "physician's" arm was badly swollen; This spontaneous report was received from a pharmacist (conflicting information also reported as a "physician"), who was also the 65-year-old female patient reporting from herself via a company representative. Patient did not know her pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications.    Five to ten years ago, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown).  About 5-10 years ago, patient had a bad site reaction on her arm, it was badly swollen (injection site swelling) and she sought medical attention. It was unknown if patient received any treatment for the adverse experience but she recovered on an unknown date. Patient was, at reporting time, scheduled to get pneumococcal 13v conj vaccine (CRM197) (PREVNAR13) vaccine and was wanting to know if she should expect the same reaction.  The causality assessment was not reported.
My shoulder swelled up initially to the size of a softball. It then moved down my arm and stayed swollen for a week. I went to the emergency room only to be told to see my doctor on base.
Next day after 2nd shot: Chills, fatigue, head ache, slight fever.   They went away by end of 3rd day.  About 1.5 weeks later all those side effects reemerged at a much greater amplitude.  Also, I had trouble breathing and was very weak.  I went to PCP and had low O2 at 92%.  He thought I had COVID,  but rapid test came back negative and chest x-ray was normal.  Based on his recommendation and my O2 staying low, I went to emergency room 2 days later.  The doctor there thought symptoms were consistent with COVID. I got another chest x-ray . It was normal.  They performed a lot of blood analysis and found nothing acute and abnormal.  They gave me a PCR test and it came back negative.  I got diarrhea constantly for about a month. I slowly got better with my O2 returning to normal range and diarrhea  over with.
The day after the first injection my right arm shoulder area, biceps and triceps were aching and sore. Left arm where shot was administered no pain. My right shoulder had a joint replacement and tendon repair on May 3rd 2021. Saturday on May 28, 2021 I noticed my lower back having pain from my Sciatic nerve as the next 4 days progressed it got worse affecting both my right leg and left leg. I had been dealing with the pain hoping it would lessen. it did not. I received my 2nd shot on 9-16 The following day my lower back pain amplified. I have a previous back problem so I thought nothing of it. Until I researched on possible side effects of the Vaccine.
Injection at 3:25 Pm. Waited 40 min and left.  At 6 Pm my throat was closing up and breathing was shallow.   Took 2  Benedryl caplets  and in approx 20 minutes things started to get  better.   At 9:30 Pm I took 1 more Benedryl caplet.   Also left arm is sore at injection site.
Large red welt at the injection site. Was there for about 48 hours then went away. Came back today and is more swollen and itchy.
From initial information received on 11/11/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a one year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1095AA, administered intra-muscularly in the right thigh on 11/07/2003.  30 minutes later, the patient developed a generalized rash.  Oral Benadryl was given and the reaction was gone within one hour.  The patient recovered from  this event.
Patient was sleepy after 1st vaccine on 3/16.  Waited 30 min after 2nd vaccine with no complaints.  Went to her car and son brought her back to clinic with complaints of jaw tightness and difficulty understanding things.  Gait was shaky.  BP 156/87, O2 sat 98%, resp 18, HR 69, temp normal.  O2 sat decreased to 81%, but increased to normal on own.  Later, BP 142/82, HR 70, O2 sat 97%, respirations 16 - 20.  Felt better and refused ED visit.  Improved.
I went to the emergency room on 18th for treatment, they described that I had hypotension, diarrhea, and the Addison's crisis.  I had to much stress that my body could not handle it.  They gave me a injection, and  other medications to help. They were also monitoring my blood sugar and also my cardiac.  They did a medication review.  They did not feel like I had COVID or anything.  My body was completely wiped out and could not handle it.  They also did not feel like I had an illness.  They ran blood work multiple times.  I feel even though I was pushing my body to go my body was not having it.