chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling about 2 inches down; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious Social media case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with swelling about 2 inches down after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious event of swelling about 2 inches down (swelling) (unknown latency) following the administration of influenza vaccine.  It was reported " I got my flu shot. The dr didn't put a band-aid on it and the next day I had swelling about 2 inches down. 3 weeks. Still there. I asked for the 65 and over. Never had a problem before. It doesn't hurt. Probably some crap so called vaccine ".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown
Patient was to receive moderna vaccine, instead received alfluria immunization. No signs of adverse reaction thus far.
sore arm lower than injection site on same arm. lasted 2 days with sore throat and low grade fever. 8 days later (1/23/21) woke with very painful swollen arm in the same area that i had the pain in the 2 days immediately following vaccination. Area hard, hot and red. Appears to be growing and is more painful today (1/27/2021) Have begun icing the area intermittently.
Initial unsolicited report received from a physician (pediatrics) on 13 July 2015 and follow-up information received from a physician (pediatrics) on 14 July 2015. A six-months-old patient (gender not reported), whose medical history and concomitant medication were not reported, had received a dose of PENTACEL (batch number, expiration date, dose, dose number, route and site of administration were not reported), with a dose of Rota (batch number, expiration date, dose, dose number, route and site of administration were not reported) and also received a dose of Pneumococcal (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced seizure. It was reported that, the patient experienced a seizure that did not occur in the office or witnessed by medical staff after Rota, Pneumococcal and PENTACEL were administered. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was not reported. Upon internal review, company assessed the event of seizure as serious and important medical event. List of documents held by sender: none.
Started sore and hot approx 4 hours post vaccination feelings of lethargy and general malaise; now resolving. Hive like rash from deltoid to elbow, now resolving.
Besides the tenderness, redness, and inflammation, I have experienced general malaise, lethargy, just feeling punky, on days 3, 4, and 5 after vaccination.  I?m am otherwise healthy and well rested.  My husband received his second shot of Shingrex at the same time, and also experienced the same general sense of malaise.
"Horrendous case of vertigo",; Cerebellar vertigo; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting). The patient was treated with SALINE [SODIUM CHLORIDE] for Vomiting, at a dose of UNK dosage form and MECLIZINE HCL for Vomiting, at a dose of UNK dosage form. At the time of the report, VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications were reported.
arm pain; foggy brain; tiredness; lymph node swelling under left arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "Known allergies: chocolate" (unspecified if ongoing), notes: known allergies:chocolate. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product; COVID 19 , Brand: Pfizer, Lot number: ER8733, Lot unknown: False, Administration date; 29Mar2021, Administration time: 08:30 AM, Vaccine location: Left arm), administration date: 29Mar2021, when the patient was 59 years old, for Covid-19 Immunisation, reaction(s): "arm pain".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm pain"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "foggy brain"; FATIGUE (non-serious), outcome "recovered", described as "tiredness"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node swelling under left arm". Therapeutic measures were not taken as a result of pain in extremity, feeling abnormal, fatigue, lymphadenopathy.  Additional information: No any other vaccine in four weeks. Shot 1 - arm pain - radiation up the back to neck. Last 6 hours. Shot 2 - 12- 48 hours - arm pain, foggy brain, tiredness. 3-7 days - lymph node swelling under left arm. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
I felt very down, lymph nodes appeared in my left clavicle. Very painful. I put ice on and take ibuprofen for the pain. Today 5 days later I feel better the lymph nodes and the pain have diminished.
Felt very nervous , jittery and shaky approx. 45 min after injection and lasted approx. 60 minutes. It went away and did not return.
PAIN RADIATED AND FELT ON RIGHT ELBOW.  PT WAS SHOPPING AND FOUND HIMSELF UNABLE TO PICK UP GROCERIES WITH RIGHT HAND.
Dizzy; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027AUA) for COVID-19 vaccination.     No medical history provided.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown. Not Provided      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 treatment information was provided.   Reporter did not allow further contact
I got my shingles shot and got shingles; I got my shingles shot and got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got his/ her shingles shot and got shingles so anyone could get shingles with or without the shot. The reporter's doctor was very surprised and so was he/ her.  The reporter guessed and asked he/ she was one of the lucky one. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
I have had a low grade fever. Minor headache. I have had severe body aches along with severe chills and then sweats. My arm is sore to the touch  and movement and today is very red.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Administered vaccine after 33 days in the refrigerator; Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
mom states pt was listless following vax;9PM vomited & became limp & ashen in color;seemed dazed-episode lasted over 1hr came out of it; mom phoned MD-was told to observe pt;about 1AM 7JUN pt seemed back to nl, mom reports;
Patient has had pain and discomfort in right arm since receiving flu vaccination. She states she has less mobility in right arm than left. She has been using pain relievers such as Motrin and Tylenol.
First shot: 7 hours after my first dose I experienced low fever 100.2 that last 2 days as well as chills. Severe pain in my left arm that subsided in about 24 hours. In addition , the first 48 hours I couldn't sleep. Slept 3 hours those nights despite feeling extremely tired. Brain fog and severe fatigue persisted for a full 7 days after the first shot.   Second shot: 12 hours after my second dose, around 10 pm that night sudden onset of fever, this time higher, rose to 101. Severe chills, nausea, diarrhea. These severe, flu-like symptoms lasted a little over 24 hours and then improved significantly. However, the stomach pains continued and the next morning (so about 24 hours after the second shot), I had heavy vaginal bleeding and cramping. This happened 21 days into my cycle and is highly abnormal for me. My cycle is regular and runs between 28 and 31 days, usually on the longer side. I track my periods, in the last 3 years it's never been 21 days and I've never had sudden onset of heavy bleeding like this, it always starts lighter and intensifies. Heavy bleeding continues as I'm writing this report. This is much heavier than usual for the full 6 days so far and seems to be getting heavier, not lighter as I would expect it to by day 6/7 certainly.
While administrating the COVID vaccine I felt a few drops running down my left arm. I was not looking and could not tell the exact amount that dripped down my arm and dripped off my elbow. Looking at the person administrating the vaccine she had a surprised and concerned look like something had gone wrong.  We discussed the incident and I told her I didn't see what happened and it was up to her to decide what we should do. After about 5 minutes she determined that I had received at least half the dosage and it should be OK. She did not feel I needed another dose ( I don't know if one was available, I did a walk in since I could not make my appointment at another pharmacy on Monday) . My concern is I am not sure she was that confident from her body language that I actually received at least half the dosage.
No adverse event; Maternal exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a patient family member or friend and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure before pregnancy) in a 36-year-old female patient (gravida 1) who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71708) for COVID-19 prophylaxis.     The patient's past medical history included Alcohol use (1-3 drinks/week) on 12-Jan-2023. Concurrent medical conditions included Food allergy and Food allergy.   On 21-Feb-2023 at 5:00 PM, 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. The patient's last menstrual period was on 06-Jan-2023 and the estimated date of delivery was 13-Oct-2023. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure before pregnancy). The patient received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) beginning around the  sixth week of the pregnancy.  At the time of the report, NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure before pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2023, Pregnancy test: Positive.   No concomitant and treatment medications were reported.  Patient's husband reported that patient was 6.5 weeks pregnant and had an appointment for a COVID booster at 5:00 PM that day.  Company comment: This spontaneous case concerns a 36-year-old pregnant female patient with no relevant medical history reported, who received the first booster dose of mRNA-1273.222 (BA.4/BA.5) vaccine and no adverse event was reported. Maternal exposure during pregnancy was reported at 6.5 weeks gestation. The patient's last menstrual period was almost 1.5 months before the vaccine and the estimated date of delivery was approximately 7 months after the vaccine. The outcome of pregnancy is pending at the time of report. There is no further clinical information provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: Follow up information received on 27-Feb-2023, contains significant information. Reporter details, patient demographics, medical history, lab data and suspect product details were updated.
Death; Herpes zoster; This spontaneous report was received from a lawyer and patient's spouse regarding a case in litigation referring to male patient who would be 76-year-old. No information was provided regarding medical history, concurrent conditions or concomitant medications. On an unknown date in 2013, at  approximately age of 70, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. On an unspecified date, the patient died. The cause of the patient's death is unknown. It is unknown if an autopsy was performed. The outcome of the event herpes zoster was not reported. The reporter considered the death and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: Death
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On an unspecified date, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 15-APR-2016 the patient was treated at a health facility for the onset of a painful rash, which was diagnosed as herpes zoster, or shingles. 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.
RN administered shot subcutaneously (versus intramuscularly as indicated).  By evening, patient with swelling, redness, warm & hard to touch at injection site, with pain.
Fainted; Dizziness; Heart racing; This is a spontaneous report from a contactable consumer reported for herself. A 22-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 15:45 at single dose in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), escitalopram oxalate (LEXAPRO), spironolactone and Birth control product. The patient experienced fainted morning after 1st dose with dizziness and heart racing on 22Jan2021 06:45 - had to go to ER. The patient received anti-nausea and heart monitor as treatment for the adverse event. Events outcome was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a pharmacist referring 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 03-JUN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly in the left upper leg (lot number and expiration date were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of RECOMBIVAX HB experienced the temperature excursion of 55 degrees Fahrenheit for 3 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006113: US-009507513-1706USA006114:
Received the shot on a Thursday. Had fever, body ache and chills, then Saturday lost my voice. Saw a Doctor on Tuesday. Dr told me to fill this out.
Information has been received from a consumer concerning her husband a 62 year old male with neuralgia from phantom limb pain who on 19-MAY-2009 was vaccinated with ZOSTAVAX vaccine (Merck) (Lot# not reported). Concomitant therapy included PPD. On 19-MAY-2009, since vaccination, the patient developed headache, achy, injection site red reaction with a 2.5 inch red area and may have a fever. It was reported that the patient was not recovered. Additional information has been requested.
Patient received 3rd dose (0.5ml) but should have received a booster as she was not immunocompromised at the time.
Vomiting, chills, headache, entire body ached, painful to move, lose of taste, sour stomach,