chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
From telephone contact from reporting physician's office stated that a patient (2 of 3) received a Trihibit vaccination and an IPOL vaccination on 6/22/01. Reportedly the patient developed a local reaction of swelling and redness at the injection site (site not specified). From additional correspondence received on 9/6/01, additional patient, vaccine, vaccine administrator and responsible physician information was provided. This case is closed.
Developed swelling/redness and itching at injection site (R) arm immediately by that evening, the area was hot and each morning since then the area of redness/warmth/pain and itching has increased. Yesterday, developed tingling sensation (R) med-thoracic dermatomal distribution and continues to have achiness, flushing/chills now has cellulitis of (R) arm.
I received my 2nd dose at 9:30 a.m. at 8:00 p.m my face felt hot and flushed, I started shaking and felt very cold. the tips of my finders were numb as well.  I went to bed and finally got warm but felt I could not move. When I tried to open my eyes all I saw was a slit of light then went back to sleep.  I slept until 2p.m today Sunday.  Felt week and tired but no longer cold, do not have an appetite.
Passed away; Positive result; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and passed away.    The patient's medical history was not provided. Concomitant product use was not reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient had a positive COVID-19 test.  On 18 Jan 2021, the patient passed away. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 18 Jan 2021. The cause of death was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced COVID-19 and passed away. The event of COVID-19 occurred 4 days after the first and only dose of the mRNA-1273 vaccine administered and death occurred 14 days after administration of the mRNA-1273 vaccine.  Based on the information provided and the known etiology of  COVID-19, it is unlikely to be associated with mRNA-1273 vaccine administration. With no definite information on the clinical details of the death, it is difficult to adequately assess a causal association with mRNA vaccine.  Main field defaults to possibly related'; Reported Cause(s) of Death: unknown cause of death
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: After patient went home, pharmacist contacted family and confirmed that the patient was doing fine and was no longer experiencing dizziness, blurred vision, and excessive sweating.
Moderna COVID-19 Vaccine  Soreness in arm , itching, fever, nausea and vomiting, chills, uncontrollable shaking, headache, weakness, fatigue
The first day about 10 minutes after I got the shot I had hives on both arms and an instant migraine.  The hives went away after an hour or two but the migraine was present for 3 days.  On March 31st I started having jaw and ear pain and April 1st hearing loss.  On April 3rd,  I went to the ER due to my ear canal closing completely, swelling and lots of pain.  I was put on amoxiccilan and ear drops to treat outer ear infection. I still cannot hear.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Concomitant medication, pertinent medical history, drug reaction or allergies were not reported. Cancer, overdose, hospitalization, life threatening, significant disability or incapacity were not reported. On 30-APR-2014 the patient was vaccinated with ZOSTAVAX, intramuscular, dose, anatomical location and lot unknown. On 30-APR-2014, the patient experienced pain, swelling and redness at the injection site after receiving ZOSTAVAX. Reporter stated that symptoms persisted and enhanced a few days after the injection. The representative confirmed the "therapy route" was an "intramuscular injection" which is other than indicated in the prescribing information. BENADRYL and hydrocortisone (both unspecified dose/frequency and manufacturer) were reported as treatment given for adverse events. Patient did not seek medical attention. Lab diagnostics studies were not performed. The outcome of events was reported as recovered/resolved on 04-MAY-2014. Relatedness between pain, swelling and redness at the injection site and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. the patient's concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursion of 24 hours each one. The lowest recorded temperature for one of the excursions was 33 F (0.555555556) and 34 F (1.111111111 Celsius) for the other one. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Chills, Fever, Myalgia, Rash, Hives, Lymphedema, and  Swelling
Dizzy: Patient states did not eat all day. Feels better after sitting. Patient released to self and refused hospital
Breakthrough Case of Covid-19.She received Positive Rapid test result on Dec 20 but is awaiting PCR confirmation.; Breakthrough Case of Covid-19.She received Positive Rapid test result on Dec 20 but is awaiting PCR confirmation.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in arm right, administration date 13Apr2021 10:00 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single, and intramuscular, administered in arm right, administration date 23Mar2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included High Blood Pressure (unspecified if ongoing); Chronic Eyeritis (ongoing). No covid prior vaccination. Concomitant medication(s) included AMLODIPINE; VITAMIN D; IRON. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Dec2021, outcome recovering. She received Positive Rapid test result on Dec 20 but is awaiting PCR confirmation. The patient underwent the following laboratory tests and procedures SARS-CoV-2 test (20Dec2021) positive, Rapid test; (20Dec2021) unknown, PCR. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Pain in injection site; Entire arm pain; Weakness; This case was reported by a pharmacist via call center representative and described the occurrence of pain injection site in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain injection site, pain in arm and weakness. On an unknown date, the outcome of the pain injection site, pain in arm and weakness were unknown.   It was unknown if the reporter considered the pain injection site, pain in arm and weakness to be related to Shingrix.  Additional details: The age group was not reported but it was selected as adult as per the vaccine indication.  The pharmacist reported that the patient after receiving Shingrix experienced pain in injection site, then experienced entire arm pain and weakness. The reporter consented to follow up. This was one of the 3 cases reported by same reporter.
Pt c/o swelling to cheeks, hives, and itchiness to face approximately 15 minutes after receiving Tdap. No difficulty breathing. Pt was seen by MD and was sent to ED. Pt stable. Returned and was recommended to take Benadryl PO for symptoms. No epinephrine was used.
PFIZER COVID VACCINE #3 GIVEN 8/24/21, LOT #FC3184; pt had a positive COVID test on 1/28/22; admitted from 1/30-2/4/22 for COVID pneumonia; admitted to 2/14/ - 2/18/22 for Klebsiella Pneumonia; sent home on O2; back on 3/6/22 with AHRF; worsening right malignant pleural effusion; increasing SOB; placed on NRB initially then able to wean to NC; ABX; DNI/DNR; pt's condition worsened and he passed away in the hospital
Pt felt dizzy/clammy just after receiving vaccine.  His wife said this is a usual reaction for him as he doesn't like needles.  Had similar response w birth of his children.  He laid on floor,  we applied cold compress and gave cold bottle of water. Symtoms improved in just several minutes.  He continue  rest of wait period and felt fine before leaving pharmacy.
Dizziness; Nauseous; Vomiting; This is a spontaneous report from a non-contactable consumer. A 19-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Apr2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced nauseous/vomiting for 4 days and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Apr2021, the patient underwent nasal swab test for COVID-19 and the result was negative. Therapeutic measures were taken as a result of nauseous/vomiting and included treatment with unspecified anti-nausea medication. The clinical outcome of the events nauseous and vomiting were recovered on 23Apr2021 while dizziness was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash appeared at site of vaccination. It was warm to touch and slightly itchy. 2 small spots appeared next to it. Rash lasted 5 days.
**Influenza Vaccine, Split non spec** Tingling in left arm, ring finger and pinky finger Employee Health clinic 11/7/2022 In the past 2weks pervious symptom's to include Tingling in entire left hand on and off throughout the day Neurology appointment  1/4/2023
mom recv vax 11FEB97 while pregnant;child born 15FEB97 w/no abnormalities;child devel testicular hydrocele which was unilateral;child hosp;testicular hydrocele had not reversed @ the time of the report;
SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 65 year old female. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness at injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210504555.
NUMBNESS IN LEG; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced numbness in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness in leg was not reported. This report was non-serious. This case, from the same reporter is linked.
26 y/o F received rabies vaccine 3/21 with hives/sore throat/feverish sensation noted AM of 3/22. Hives progressed, pt sought care in ED 3/25 & given ZYRTEC/BENADRYL/Prednisone with improvement.
Severe migraine for 3 days; severe joint pain for 4 days; extreme fatigue for 3 days (unable to stay awake from hours 9 to 25 after injection); severe diarrhea for 1 week; extensive opposite of injection arm pain.
This spontaneous report as received from a medical assistant via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of improperly stored oral, ROTATEQ (lot# L008578, exp.date: 14-DEC-2016) (route and frequency were not reported). The temperature of the storage was 50 Fahrenheit degree for 24 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
left upper arm got extremely red/hot/sore and swollen from site of injection almost down to 2 inches above where elbow angles.  this started 4 days after injections given.  Patient went to physician on 9-14 -20 for reassurence.   physician prescribed antibiotic for patient just in case.  Patient did not experience swollen lips/tongue or any other anaphylaxis type symptoms.    Patients arm has started to improve as of today.  rph
Lymph nodes hurting/burning pain on chest and breast area/ Her Lymph nodes are tender on the Left Side, it goes down the breast arm; This is a spontaneous report from a contactable consumer reporting for herself. A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (arm right) on 26Jan2021 at SINGLE DOSE for COVID-19 immunization, at 92 years old. Medical history lung cancer 12 years before from 2009, breast cancer on an unspecified date, and a lump already on the breast from the surgery and she usually get pain there from an unspecified date. She is a cancer survivor. She had surgery for breast cancer on same side, that's where the pain was. She also had a stroke and speech is slurry from an unspecified date. The patient asked to bear with her as she had a stroke in the past and her speech is slurry. She lost the COVID card, she did not even know they gave a card, until somebody told her that they had their card. She lives in a Senior citizen facility, and she does not remember any card. They just gave her information sheets. It was reported that the patient had the vaccine and she was having a lot of pain on the left side, however she got the vaccine on the right side. She had surgery for breast cancer on same side, that's where the pain was, however the vaccine was on the other arm. Patient stated that she thinks it was the lymph nodes, she does not know what to do about it, since she is a Cancer survivor. The patient requested the call handler to talk slow, she is 92 years old. She cannot call the doctor because he is retired and so she does not have a doctor. The patient expressed that its especially in the Lymph nodes, she read the papers that she got, she thought this is common. Her First Dose was on 26Jan2021, probably around 9:30AM or 10AM. The Lymph nodes began hurting on 26Jan2021, it was a burning pain on chest and breast area. She took a Vicodin and it went away and did not bother her for the rest of the day, but it was bothering her this morning and it woke her up. She has a lump already on the breast from the surgery and she usually get pain there, but this is not the same pain today. As of reporting time, it was different, it was a stronger pain, it goes down the breast arm. Her Lymph nodes are tender on the Left Side which is the same side she had surgery on in the past. She got the vaccine on the right arm. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Patient received Fluzone HD and Pneumovax 23 on 9/28/2020. She called on 10/3/2020 and said she is very sick with a fever and has been in bed for 5 days. She said the arm of the flu shot is sore and warm to touch but now it itches so it is healing. Recommended she see an MD or go to hospital in case it is infected. She said the itching means it is healing and she isn't going to call MD. Recommended multiple times at least calling MD and she said no maybe if she feels better Monday she will.
The day after the shot, the patient experienced severe headaches, fatigue and nausea.  This lasted one day.  The 2nd day after the shot patient was feeling better and went to work.  While there he had one episode of fainting where he was unconscious just momentarily.  Pt slumped and DID NOT hit his head.  Followed up with healthcare provider.  Provider felt things were good and told pt to return if anything changed.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster (The patient had a history of shingles outbreaks.). On an unknown date, the patient received the 1st dose of SHINGRIX and the 1st dose of SHINGRIX. On 31st March 2019, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in late December 2018 or early January 2019. The patient received 2nd dose in late February or early March. The patient did not experienced any events after 1st dose. The patient experienced shingles on her tail bone and buttock 2 days after after receiving 2nd dose and shingles got resolved. The patient again experienced shingles in the same area. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
6 days after the vaccine I experienced sharp stabbing pains on right side under ribs followed closely by skin blisters in same area with severe nerve pain since that day. It's been more than a month now.
Three months after vaccine, started feeling heart fluttering; Went to emergency room and had an EKG test; Advised to go to Cardiologist and was diagnosed with Atrial Fluttering.
Neurological Lyme Disease symptoms of headache, confusion, memory loss, visual difficulty, cognitive dysfunction, degenerated hand writing, "brain fog". Symptoms are because hasn't responded to antibiotic treatment; both oral and IV. In 4/00, I visited my optometrist for my vision problems and he prescribed reading glasses which did not solve my problems and as my symptoms progressed, I saw my PMD, 2 infectious disease specialists, a neurologist, an ophthalmologist and finally a rheumatologist. I was dx'd in 7/00 with Lyme disease. I am left with seemingly untreatable neurological symptoms that have robbed me of my ability to reason and filled my mind with never ending depression and hopelessness.
Edema on both legs from feet to knees after 2nd dose; Fever; Shivering Chills; Severe Headaches; Fatigue; Nausea after 2nt dose; Vomiting after 2nt dose; This spontaneous case was reported by a nurse and describes the occurrence of OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches), FATIGUE (Fatigue), NAUSEA (Nausea after 2nt dose) and VOMITING (Vomiting after 2nt dose). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (Edema on both legs from feet to knees after 2nd dose), PYREXIA (Fever), CHILLS (Shivering Chills), HEADACHE (Severe Headaches), FATIGUE (Fatigue), NAUSEA (Nausea after 2nt dose) and VOMITING (Vomiting after 2nt dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-338733 (Patient Link).