chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness and swelling started on 2/10/21. size of half dollar. mom elevated the leg, iced it, did a warm compress on 2/10/21. nothing helped. fever of 100.7 taken tympanic.  measured on 2/11/21 - 4.2 in.
fever; Pain at injection site; fatigue; A spontaneous report was received from a consumer concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site, fatigue, fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028120A) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) pain at injection site, fatigue, fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain at injection site, fatigue, fever was unknown.
Information has been received from a consumer referring to unknown female patients of unknown age, There was no concurrent condition or medical history reported. The reporter stated that GARDASIL or GARDASIL 9 was killing and injuring girls. Lives were being irreversibly altered after vaccination. The outcome of the event was unknown. Additional information has been requested.
Pt came in for J&J COVID shot. She received her shot around 5:23pm. At 5:31pm, pt started exhibiting red pumps on her proximal left arm and 1-2 red spots on her distal right forearm. The husband stated that his wife tends to be sensitive to "this stuff." Pt. stated that she spoke with her doctor and allergy doctor and they both advised her to get the vaccine. She stated that she had an allergic reaction to the flu vaccine but she googled the J&J ingredients and she was allergic to none of them. At 5:37pm, she was provided 2tabs of diphenhydramine 25mg. I asked Pt to stay for observation till 6pm. I inquired if she felt any obstruction to the airway and she denied it. AT 5:58pm, her pumps went down and the redness was significantly reduced. She stated that she is feeling better ("less hot") and she is sleepy. I explained this might be due to the Benadryl.  She was advised to continue with Benadryl q4-6hrs and to go to urgent care next door to be assessed and to obtain an rx for EpiPen as she had none. She purchased Benadryl OTC. I explained what an allergic reaction would look like, that it could be delayed and she must call emergency services for any kind of reaction, even when in doubt.
The patient developed a small rash on her back within 24 hours of vaccination. This was not reported for 1 month.
S: Patient is a 53 y/o male c/o having dizziness and nausea while he is walking towards his car after 5 minutes of getting vaccine. Reports having high blood pressure. He did take his medication this morning. O:  1st reading vitals BP 150/70 HR 64 Oxygen sat 94 pain 0/10 resp. 18 2nd reading 130/80 Hr 68 oxygen saturation 96 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat.  Cardio: Negative for arm pain, back pain, weakness, palpitations  Neuro: Alert x4, negative for limb weakness, neg for slurring, neg  Medications: losartan 50 mg daily, carveidlol 12.5 mg bid, famotidine 20 mg every other day, simvasta
Soreness, mild swelling, scattered areas of redness which were hot to touch. Difficulty raising left arm v/x=99.2 po-84/20 120/70.
This spontaneous report was received from a medical assistant referring to a 16 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 20-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Vaccine was given subcutaneously instead of intramuscular.  2 days later developed swelling, redness, pain.  Treated with antihistamines and antibiotics.
vision loss; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 64-year-old female patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 19-AUG-2008, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) at a public health center. As a result of her receipt of vaccination, on unspecified date in 2008, the patient was treated for vision loss (blindness) and shingles including any and all its sequelae. It has been caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the time of the report, the patient's outcome was unknown, and the reporter considered blindness and shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered the event of blindness and shingles to be disabling.  Upon internal review, the event of blindness was considered medically significant.
DIED; HEART FAILURE; KIDNEY FAILURE; BLOOD CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned a 20 year old male of unspecified race and ethnicity. 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart failure due to blood clots, kidney failure due to blood clots, and blood clots. On APR-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated, "My nephew died after receiving the vaccine. Heart and kidney failure due to blood, he just turned 20 in JAN-2021. he died APR-2021". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died on APR-2021, and the outcome of heart failure, kidney failure and blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220236791-Covid-19 vaccine ad26.cov2.s-Died, heart failure, kidney failure and blood clots . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This case was reported by a nurse via call center representative and described the occurrence of alanine aminotransferase increased in a 75-year-old male patient who received HAVRIX for prophylaxis. Concurrent medical conditions included stroke. On 31st May 2018, the patient received HAVRIX. On 1st June 2018, 1 days after receiving HAVRIX, the patient experienced alanine aminotransferase increased and aspartate aminotransferase increased. On an unknown date, the outcome of the alanine aminotransferase increased and aspartate aminotransferase increased were unknown. It was unknown if the reporter considered the alanine aminotransferase increased and aspartate aminotransferase increased to be related to HAVRIX. Additional details were reported as follows: The healthcare professional reported that, the patient had a normal liver function test on 14th May 2018. The next day after receiving HAVRIX, the patient's alanine aminotransferase and aspartate aminotransferase were increased. No additional information was provided.
Lots of pain at injection area.  Severe chills lasting 3 hours, sharp pain in right hip.  Afterward, real tired and a little lethargic.
Modern a COVID-19 Vaccine EUA  On 9th day, I just got rash around the area where I got shot
heart problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001221 (Novavax).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems". The event "heart problems" required physician office visit.  Additional information: Patient age reported as 63 (no units). On 26Sep2023, it was reported that a patient started treatment on unreported dates with 3 doses of Pfizer BioNTech COVID-19 vaccine, primary series and booster, for COVID-19 immunization. It was reported the patient started having heart problems and did not have these problems before taking the vaccine. He started to see doctors.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
tachycardia; felt achy; She didn't feel good; injection site started to turn red; headache; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of heart rate increased, tachycardia, PAIN, MALAISE, and VACCINATION SITE ERYTHEMA in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and VITAMINS A & D for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced heart rate increased, PAIN, MALAISE, VACCINATION SITE ERYTHEMA, and headache. On 12-Sep-2021, the patient experienced tachycardia. The patient was treated with TYLENOL at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, heart rate increased, tachycardia, PAIN, MALAISE, VACCINATION SITE ERYTHEMA, and headache outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.  Patient stated that She started noticing increased heartrate next day after receiving 2nd dose. She had been monitoring heart rate on her Fitbit. After 2 days, heart rate started to settle down but it has never gone to baseline. On Sunday (12Sep2021), she went to ER because of increased heart rate. She wants someone to call from safety to follow up because she is concerned about tachycardia. She wants to know about compensation as she went to ER.   This case was linked to MOD-2021-317431 (Patient Link).
Within 5 minutes my son couldn't hear or see.  He thought he was going to black out.  He doesn't remember me taking him from hallway back to exam table.  It has been 5 hours since he was at doctors office and he is still suffering with a headache and dizziness.
Patient had Td on 06/19/2003.  Patient states developed swelling, slight tenderness, heat and redness at site on 06/21/2003.  Patient had left supraclavicular pain and up lymph node this area.  Td injection in left deltoid.  Soft lump, mild erythematous, hot and mildy tender, non-indurated.  4 cm diameter at left deltoid with enlarged and tender left supraclaulcer lymph on 06/26/2003.
Feb: defecation completely stopped; could no longer sense if constipated; extremely dry eyes Mar. :  Muscle and fatty tissue atrophy/wasting, myalgias, poor extremity circulation, twitching of muscles, skin atrophy, progressive worsening of vision especially near Continued worsening of all symptoms with no relief
FEELING ILL; This spontaneous report received from a patient 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 subject experienced feeling ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling ill was not reported.                        This report was non-serious. This case, involving the same patient is linked to 20210610903.
6 inch area of red, warmth area beginning day 3 after after injection, treated with BENADRYL.
Repeated, extreme nosebleed with large clots. I was unable to stop it and had to go to the ER on 4/16. They had to cauterize the site of the bleed. I do have a history of mild nosebleeds but this was unusual. I do not take any blood thinning medications. The silver nitrate did stop the bleeding. The ER ductus was not concerned that this was vaccine related but I thought it was unusual enough to report.
One week after receiving a the vaccine a large red welt appeared at the injection site (2-27-2021 first appeared). The welt was very hard at first, but is now back to normal skin density. The area feels very warm to the touch. The welt has expanded and is now itchy and approximately 7 inches in diameter.
Approximately 10 minutes after receiving the shot, I started to have a bit of swelling in my throat that was almost identical to the reactions I get from foods I am allergic to with my Oral Allergy Syndrome. Another 10-15 minutes later, it had gotten worse to the point where it was harder to swallow, plus I was a bit lightheaded and my mouth was itchy. The people monitoring the post vaccine waiting section didn?t want me walking around, so they sent someone to my car to get my liquid Benadryl, which is what I take for similar reactions to foods. I took about 50-75 mg worth and waited for an additional hour or so until the swelling had gone down mostly. Now (at almost 7 pm on the same day), I still have a tiny bit of swelling in addition to the ?normal? vaccine side effects, tiredness, soreness in my whole body, headache, pain at injection site.
Information has been received from an unspecified reporter referring to a patient of unknown age and gender without previously having chickenpox. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # were not reported). Later, on an unknown date the patient developed Parkinson's Disease. At the time of the report, the outcome of the event and the causality were not reported. Additional information is not expected as there was no contact information provided.
Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.
Patient came to a covid clinic to receive a vaccine. The nurse at the facility, RN, took her covid card to copy it and I thought she was able to receive her bivalent vaccine. I thought the facility nurse looked at the card and verified she was eligible. When the facility nurse came back, she handed me her covid card. I realized that she had received her second Pfizer on 9/27/22 and I had already adminstered her vaccine.  She wasn't eligible until 11/27/22. We monitored the patient for thirty mintues. She verbalized no complaints.
9MAY94 devel bumps on the back of head, rash & a fever; MD reported devel myalgia & a rash; however, was not examined by MD; No further details were provided;
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist  reported similar events for two patients (husband and wife). This is the 2nd of two reports (referred to the wife). This female patient of an unspecified age, race and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced localized redness and swelling that lasted a few days. Patient referred to Urgent Care physician office and she was treated with diphenhydramine hydrochloride (BENADRYL).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017502081 same reporter/drug/event, different patient.
throbbing headache; injection site pain; enlarged lymph nodes under left arm; moderate flu like symptoms; difficulty processing things two days later - neurological; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14May2021 (Lot number: EW0183) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot Number:  ER8731, administrator route: Intramuscular, vaccination Location: Left arm, Dose : 01), administration date: 23Apr2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 16May2021, outcome "recovered" (2021), described as "throbbing headache"; VACCINATION SITE PAIN (non-serious) with onset 16May2021, outcome "recovered" (2021), described as "injection site pain"; LYMPHADENOPATHY (non-serious) with onset 16May2021, outcome "recovered" (2021), described as "enlarged lymph nodes under left arm"; INFLUENZA LIKE ILLNESS (non-serious) with onset 16May2021, outcome "recovered" (2021), described as "moderate flu like symptoms"; NERVOUS SYSTEM DISORDER (non-serious) with onset 16May2021, outcome "recovered" (2021), described as "difficulty processing things two days later - neurological". Therapeutic measures were not taken as a result of headache, vaccination site pain, lymphadenopathy, influenza like illness, nervous system disorder.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-NOV-2012 18:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax;w/in mins,exp diff walking,weakness & SOB;c/o numbness of tongue & fingertips,became stuporous & difficult to arouse;shaking & chills;O2 adm, observed in er;devel periorbital edema;final dx:allergic rxn;discharged on po dph
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have received doses of PEDVAXHIB (dose, route and lot # not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Shortly after inoculation, I began to feel irritable, achy, my skin felt sensitive to touch, my joints hurt, i felt slightly nauseated, my heart rate was faster than usual, I was sleepy but couldn't sleep, and I felt tingly in my hands and body. Eventually I felt light-headed and fuzzy.  The next day the inoculation site developed a redness 1/2 inch across and became swollen 2 1/2 inches across. I developed a headache and called clinic to see if I should be seen at a clinic. They said if symptoms got worse to come to the emergency room. They didn't. The redness at the inoculation site became patchy and began to travel down my arm for about 3 inches. . I began to feel better that night. I woke up on the morning of the 21st feeling much better and the redness at the inoculation site is disappearing.
NO Adverse Drug Event to report, however, the incorrect Covid-19 vaccine was drawn up and administerd.  The wrong dose was administered.  Patient had received the Moderna vaccine for dose #1  and was appropriate for second dose in primary series.  Moderna vaccine (0.5ml) was ordered, but erroneously, 0.5ml of Pfizer vaccine was drawn up and administered.  No adverse reaction or event reported.  Nurse notified.  Prescriber will be notified. Patient will be notified.
PT REPORTS CHILLS, ACHING JOINTS, SLIGHT WHEEZING, FREQUENT BOWEL MOVEMENTS
hives weeks later for only 24 hours.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives weeks later for only 24 hours.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), LEVOCETIRIZINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA (hives weeks later for only 24 hours.). On 04-Feb-2021, URTICARIA (hives weeks later for only 24 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.   This case was linked to MOD-2021-354848 (Patient Link).