chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller reports that they had a temperature excursion 31-MAR-2023 for VARIVAX and was administered on 03-JUL-2023; Expiration date of 30-JUN-2023; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 31-MAR-2023, the reporter stated they had a temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) (from 6°F up to 14°F for 4 hours; from 14°F up to 46°F for 4 hours; and from 47°F to 77°F (50°F) for 3 hours and 57 minutes giving a total excursion duration of 11 hours and 57 minutes).   Later, on 03-JUL-2023, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W031816, expiration date: 30-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided). According to the reporter, the lot # involved was "short dated" and a new expiration date of 30-JUN-2023 was given (expired product administered, also reported as original expiration date was 05-OCT-2024 and confirmed upon system validation; conflicting information).  This is one of several cases received from the same reporter.
Patient received the Pfizer Bivalent vaccine as an initial dose instead of the monovalent.
bad pain in my left arm  where shot was given &  enlarged lymph nodes .Have hard times sleeping due to the pain
He experienced weakness and dizziness first. About 20 minutes later, trouble breathing, ran outside to get fresh air. 15 minutes later, he vomited 1x.
Patient reports fatigue for 5 to 6 weeks following vaccination, then 2-3 days of progressive weakness at time of admission. He reports prior to this he was working out 5-6 times weekly but had lost stamina and had to cut back.  Work-up unremarkable for inflammation, infection, autoimmune disorder, or demyelination. Concern for functional neurological disorder, but work-up of other causes in process
Awoke 3/12 with pain in left back covering an area about 8" by 8", all on the ribs. Would not have thought it was related to the vaccine, except that the exact same pain showed up 2 days after I got the first vaccine,  and I have never had it before. Lasted 3-4 days-faded away. (Did not report at that time - thought I had strained something.) Very painful, does not appear to be muscular, heat does not help. Hurts much worse with breathing in deeply, any movement. Also have pain in left ankle radiating up the inside of the leg, which I also had with the first shot and at that time attributed to new shoes, which had also gone away weeks ago.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 02-MAY-2012 the patient was vaccinated with VARIVAX (Merck) (dose, route and application site were unspecified) (lot # reported as H01551, exp date: 16-AUG-2013) instead of ZOSTAVAX. The physician reported that the patient will be notified that day that the incorrect vaccine had been administered, along with the time period in which follow up is required for the administration of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Fever, body aches, chills, muscle ache. I developed bruising that is still there. Saw my doctor and they did a clotting blood work but everything came back normal
Hepatitis B surface antigen positive.  This case was reported by a physician and described a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) and subsequently tested positive for hepatitis B surface antigen.  The subject was a dialysis patient. On an unspecified date prior to receiving the Engerix-B dosing series, the subject had a negative hepatitis B surface antigen blood test.  On an unspecified date at the end of September 2006, the subject received the 3rd dose of Engerix-B. On either 04 or 05 October 2006, a titre was drawn which showed a positive result for hepatitis B surface antigen. No other information was reported.  At the time of reporting, the outcome was unknown.
about 2 weeks after receiving the shot I had severe muscle spams to right leg ( I received injection on right dorsal gluteus) for over a week. However,  spasms are less and less everyday.
Day following vaccine she developed malaise, myalgias swelling, redness, heat, pain at injection site and fever to 101 orally. The next day neck pain; head pain and cervical and axillary lymphadenopathy. Sx all resolving on day 6.
I started getting fatigue, headache, muscle aches, and sore throat. I took an at home COVID-19 test that was positive. I developed a bad out of control cough.  I contacted my doctor and I was prescribed Paxlovid and a cough medication. I took 1 dose of Paxlovid and could not handle the side effects so I stopped taking it. My symptoms lasted for 5 days. I did also lose my sense of taste for a short period. I had lingering effects of cough and fatigue.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 17-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting 488 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Screamed and cried and was basically inconsolable for almost a week - seen in primary doctor's office and emergency room - normal lab work.
Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 20-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
was back for the second dose today; 1st shot on Jun2021, had shingles on April; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not received the 2nd dose of Shingrix. In April 2022, between 9 and 11 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comment: The reporter stated that the patient received Shingrix vaccine and experienced Shingles. The reporter stated that the patient was back for the second dose today (on the day of reporting). Additional supportive information: Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination.
Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old male patient who developed petechia 11 days after receiving his second dose of PREVNAR. The patient received the second dose on 15-Feb-2007. The patient developed petechia 11 days after receiving his second dose of PREVNAR on 26-Feb-2008. The outcome is unknown. No additional information was available at the time of this report.
lymphatic back up; fatigue; brain fog; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have a history of chronic lyme (in readmission)" (unspecified if ongoing), notes: I have a history of chronic lyme (in readmission),; "cancer" (unspecified if ongoing); "joint replacement" (unspecified if ongoing). Concomitant medication(s) included: LASIX [FUROSEMIDE]. The following information was reported: LYMPHATIC DISORDER (non-serious), outcome "unknown", described as "lymphatic back up"; FATIGUE (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Additional information: 2 of the patient's doctors agree it is probably related.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bleed under skin easily; Taking more naps than usual; Hair stared falling out; Been tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual), ALOPECIA (Hair stared falling out) and FATIGUE (Been tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A, 0U4A21A and 033L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PREDNISONE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual), ALOPECIA (Hair stared falling out) and FATIGUE (Been tired). At the time of the report, SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual) and FATIGUE (Been tired) outcome was unknown and ALOPECIA (Hair stared falling out) was resolving.            No treatment medications were reported.  The patient has underlying conditions and got third Moderna boost. The patient tends to bleed under skin easily. The patient reported that a cat bumped leg and blood went all the down front of leg and was black.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAR-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the 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. Additional information has been requested.
Throbbing head ache, difficulty breathing, lips numbness, chest discomfort, upper back, lower legs, fingers tingling/numbness, high blood pressure 148/83, underarm sweating, feels weak
HAIR FALLING OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced hair falling out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair falling out was not reported. This report was non-serious.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that The box of vials was received on 10/14/2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
diarrhea; vomiting; upset stomach/really upset; felt nauseous; Stomach ache; not feeling well; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: unknown), via an unspecified route of administration on 27Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, patient received first dose BNT162B2 (Lot number and expiration date: unknown), via an un-specified route of administration on unspecified date as single dose for covid-19 immunisation (first one, went through it was really nice). The patient got the covid Pfizer vaccine dose 2 on 27Feb2021 (Saturday), the first day was okay, on 27Feb2021 night (Saturday; that night) the patient had an upset stomach and felt nauseous. The patient was suffering and didn't know what to do. He called the doctor, but they won't get back to him till 24-48hrs hours. The patient could only eat crackers and ginger ale since 28Feb2021 (Sunday) morning, and on 01Mar2021 (Monday afternoon) diarrhea started, and vomiting started on 01Mar2021 (last night), the patient only vomited one time. His stomach was really upset. The reporter didn't think the patient needed to go to the hospital for this. Since getting the second covid 19 vaccine, he had upset stomach, stomach aches (start date: 2021), and diarrhea. He had only eaten crackers, saltines and ginger ale. The patient did not want to be transferred because he was not feeling well (start date: 2021). The reporter asked how long these symptoms might last, were they normal side effects, what can the patient do, and the patient was wondering if he should see a health care provider about this right now and what he can do. The outcome for all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Client's R arm sore after immunizations on 12-7-07.  On 12-8-07 p.m. client's back started hurting.  R arm getting very sore and flu-like symptoms.  Client had to take 2 extra strength Tylenol then and later as needed.  On 12-9-07 Sunday night, client noticed that her R arm had a 3" x 5" to 6" long raised, warm and rough to touch, red hives which was following her bicep & it was itching at and around injection site.
This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. The nurse reported an unspecified number of patients received improperly stored M-M-R II (lot#, strength, dosage, frequency and route unknown) on an unspecified date. No adverse effects reported. The outcome of the events was unknown. This is one of two reports from the same reporter. The other report is MARRS# 1411USA002360. Additional information has been requested.
Anaphylactic reaction with bronchospasm and angioedema. Epinephrine SQ. Xopresis nebulizer treatment. Benadryl PO and Solumedrol IM.
minor soreness near the injection site; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL3247 and Expiration date: unknown), via an unspecified route of administration, administered in left arm on 30Jan2021 at 13:00 (at the age of 72-years-old) as dose 1, single for covid-19 immunisation. Medical history included sarcoidosis and depression. The patient's concomitant medications were not reported. The patient previously took biaxin and experienced allergy. On 30Jan2021 at 14:00, the patient experienced minor soreness near the injection site. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. Outcome of event was recovered on an unspecified date.   Follow-up (17May2021): Follow-up attempts completed. No further information expected.
3RD PFIZER VACCINE GIVEN AT 4 WEEKS INSTEAD OF 8 WEEK INTERVAL
The day folowing pt developed cellulitis in triceps area. by 6/18/07 cellulitis on antecubital area and forearm.
The patient had a brain stroke after getting the medicine. one of the arteries in the brain had small blood clots to form. Patient had a vaccine shot on 30th September 2022 at 12:30 p.m. Immediately she had some tingling  in her neck which she ignored. Then next day, she started to see "blackouts". After following day, she started seeing colors. At that time, she was admitted to the Emergency. Patient mentioned to the doctors about Covid vaccine - however all the doctors (whether ER, ENT, Neurology) ignored and did not want to make this as Covid Vaccine adverse reaction. Patient was put on two blood thinners (one - Plavix for 3 months and second - Aspirin for life long). Because Doctors did not want to admit this as a adverse effect of Covid Vaccine, they assumed that this was because of Heart. Put a monitor to monitor any irregular heart beat. Doctors did not put any follow up after three months (when the blood thinner Plavix will be stopped).  Patient flew. Patient got another brain stroke on 8th Feb and the DOctors at Hospital conducted CT Angioscan of Brain and Neck, Holter Test, and other test to rule out any other cause. Now doctors confirmed that this was an ischemic stroke. Patient has now the right side of cerebral artery is 80% blocked and right side is 30%.  Patient is so frustated that now she may need a strent to unblock the arteries so the blood can flow in brain.
Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after 1st dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (Fatigue after 1st dose). On 08-Apr-2021, FATIGUE (Fatigue after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Birth control pills.   This case was linked to MOD-2021-118764 (Patient Link).
COAGULOPATHY, UNSPECIFIED TYPE 11/13/2021 BILAT ACUTE OTITIS EXTERNA  ACUTE RESPIRATORY FAILURE 11/14/2021 BILAT ACUTE OTITIS EXTERNA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/13/2021 BILAT ACUTE OTITIS EXTERNA  COAGULOPATHY, UNSPECIFIED TYPE 11/13/2021 SEPTIC SHOCK  ACUTE RESPIRATORY FAILURE 11/14/2021 SEPTIC SHOCK  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/13/2021 SEPTIC SHOCK
Headache, Arthralgia, Fatigue, chills, injection site pain and swelling, tenderness and swelling of lymph nodes on the injection side Narrative:
A spontaneous report was received from other healthcare professional concerning a 54-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lost sense of taste and smell, sore in arm, covid, a little fever and runny nose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient experienced the a little fever and runny nose. On 12 Jan 2021, the patient was diagnosed with covid. On an unknown date, the patient had lost sense of taste and smell and in the areas the patient touched, the next day sore in arm. The patient did not receive any treatment for the events sore in arm and covid and treatment information for the events lost sense of taste and smell, a little fever and runny nose was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events lost sense of taste and smell was recovering (gaining back taste and smell). The outcome of the events a little fever and runny nose was recovered on 17 Jan 2021. The outcome of the events sore in arm and covid was not provided.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported event- vaccination site pain and the administration of the mRNA-1273 cannot be excluded. However, the event of Covid-19 is Unlikely related to mRNA-1273 and a very limited information regarding the event (anosmia, ageusia) has been provided. However, the events- rhinorrhea, pyrexia might be explained by the concurrent COVID-19. Further information has been requested.