chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; sore throat; Feverish; Rash; Redness; pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D28D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash), ERYTHEMA (Redness) and PAIN (pain). At the time of the report, HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash), ERYTHEMA (Redness) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported
redness, tenderness, slight swelling to left deltoid.  redness radiates upward in a triangular shape.  skin excoriated in shape of band aide, skin peeling off with band aid
Patient presented with rash/hives on injection arm from wrist to deltoid. Phoned approx. 6 hours after vaccination. I informed patient to take BENADRYL and seek treatment if worsens.
heart rising, and felted more when eating; A spontaneous report was received from a Consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events heart rising, and felted more when eating.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 012220A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the events heart rising and felted more when eating.   No treatment details were included.  Action taken with mRNA-1273 in response to the events was not reported.   On 3 Feb 2021 the outcome of events heart rising was resolved. On unknown date the outcome of events felted more when eating was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The described "heart rising" is likely a description of increased heart rate.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot# unspecified). Other suspect therapies included influenza virus vaccine (manufacturer unknown)(lot# unspecified). On an unknown date "immediately following" concomitant administration of GARDASIL and the unspecified seasonal flu vaccine on an unspecified date, the patient began to experience unspecified "joint issues" all over her body. The outcome of joint issues was reported as not recovered. The patient had sought medical attention via phone call to physician. Additional information has been requested.
On 7/7/04 pt was given DTaP#5 IM to Lt. upper deltoid 23g 1" needle,he was also given IPV#4 SQ to the Lt. lower deltoid given with 25g 5/8" neddle, pt. also received MMR#2 SQ 5/8" needle to the Rt. deltoid.  Pt also received PPd Mantoux 0.1cc to the Lt. for-arm intra-dermal.  Pt. returned on 7/9/04 for PPd reading and he also presented with Lt. deltoid redness, swelling, and pain, Lt. deltoid area hot to touch.  Pt. was examined by doctor and dx with Lt. deltoid cellulitis and pt. was discharged on cephalexin PO antibiotics.  A follow-up appt. was given and pt. was seen by another doctor on 7/12/04 and Lt. deltoid cellulitis had resolved and pt. was instructed to finish his antibiotics and pt. was discharged home and to return if any problems.
Information has been received from a nurse practitioner concerning a female patient who in approximately August 2009 (about a month ago) was vaccinated with a dose of GARDASIL IM and fainted. There was no concomitant medication. The patient recovered the same day. The patient sought medical attention by an office visit. Additional information has been requested.
Immediately after injection was received, patient felt extreme, throbbing pain at the injection site.  When she removed her shirt that evening, she notice 3 large, red, painful, and hot lumps around the injection site.    The next morning, the 3 large lumps had merged together to form 1 large lump that measured approximately 7 cm.  It was very firm, red, and hot to the touch.
Pt experienced a high fever of 103.4, restlessness. Fever broke in late evening. consequently acquired a viral infection which lasted 1-2 weeks (cold and cough). Child has never been ill prior to prevnar vaccine.
so dizzy like she couldn't see; having a hard time seeing; wanting to go back down since she was dizzy; fell two weeks ago and hit her behind; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (so dizzy like she couldn't see), VISION BLURRED (having a hard time seeing), ADVERSE REACTION (wanting to go back down since she was dizzy) and FALL (fell two weeks ago and hit her behind) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (so dizzy like she couldn't see), VISION BLURRED (having a hard time seeing), ADVERSE REACTION (wanting to go back down since she was dizzy) and FALL (fell two weeks ago and hit her behind). At the time of the report, DIZZINESS (so dizzy like she couldn't see), VISION BLURRED (having a hard time seeing), ADVERSE REACTION (wanting to go back down since she was dizzy) and FALL (fell two weeks ago and hit her behind) outcome was unknown.            Treatment information was not reported. Concomitant medications were not reported.
Patient came to ED with worsening symptoms of  cough and shortness of breath with Covid.  Patient was admitted to the hospital with Covid and treated with remdesivir.
PT. HAS DOCUMENTED CASE OF VARICELLA. SEEN IN OFFICE ON 06-24-2006 BY DR.
The injection site had developed this big redness around it; it itches a little bit; Patient states she received the first dose of the Moderna Covid-19 vaccine 6 days ago, and noticed yesterday the injection site had developed this big redness around it. Patient states it is not painful but it itches a little bit and the redness is starting to go down her arm Patient has not taken anything for this symptom. She is a 71 year old female who received the vaccine on her left arm. She takes Pantoprazole, Triamterene/hydrochlorothiazide, vitamins. Patient wants to know if this is normal, or a cause for reaction. Consent for safety to follow-up was received and consent to have this call documented was received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt who is a MD recv vax & devel inj site rxn of redness,swelling, tenderness & a lump. Tx w/antibiotic. 1 of 7 pt to exp rxn w/lot# 448455.
Hives and itching reported on 8/19/2018 advised BENADRYL and to monitor reaction.
This spontaneous report was received from a Registered nurse and refers to multiple patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, and drug reactions or allergies. On unknown dates, the patients were vaccinated with multiple doses of improperly stored PROQUAD (rHA) (lot number reported as N002916, expiration date 24-JUL-2018) (dose, frequency, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine was exposed to a temperature of -14 to -10 Celsius for 24 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse effects were reported. There was no product quality complaint involved. No further information provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA012618.
- Resident had H/O COVID-19 (+) nasal swab on 12/23/20. The resident received/completed the COVID-19 vaccination (Dose 1 on 1/25/21 and Dose 2 on 2/15/21. Resident tested (weekly) and on 4/7/21, his COVID-19 nasal swabbing (PCR) came back positive again. - Resident is asymptomatic
Patient was given FLUZONE HD and PNEUMOVAX 23 in the left deltoid muscle on afternoon of February 1, 2019. She received FLUZONE HD last year and did not have any reaction. The next day she noticed red rash, warm to touch and arm a little swollen. She says the swelling is not at injection site but lower on arm. She took BENADRYL and ADVIL. She called pharmacy 2 days later and says still sore and rash. I told her to put cold pack on arm and continue to take BENADRYL and ADVIL. I will check up with her tomorrow.
DIZZINESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included dizziness, and pure autonomic failure.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 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 09-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) 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 information was reported.
Ringing in the ears started two days after the shot.  Still have it five days after.  No other symptoms.
site of vaccination in left arm is still sore after 2 weeks.  In addition to soreness it causes slight range of motion limitations.
Patient becomes sick to her stomach and has cramps after eating eggs. She has had no previous reaction to eggs before.
Swelling of right arm and large hematoma developed about 6 inches below injection site.
This non-serious spontaneous case, initially received on 30-Mar-2018, reported by other health professional and concerns a female patient of unspecified age. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported). On an unspecified date, after the administration of vaccine, the patient experienced erythema, swelling and warmth at the site of injection. The outcome of the events was not reported.
CHIEF COMPLAINT:   Nausea & vomiting since 1/31  No abd pain  Was seen at walk in 2/1 Was given zofran Last dose 11pm last night.PCP gave her abo -in case of infection Vomited @4am Did not take anything since. Throat & tongue sore. body aches low grade temp Covid 3wks ago   HISTORY OF PRESENT ILLNESS:     Patient is a 48-year-old female with past medical history of radiated thyroid, currently on methimazole, who presents complaints of nausea and vomiting for the past 5 days associated with sore throat, mild headache, mild neck pain.  She reports myalgias, low-grade fevers.  Denies any chills.  Reports some mild abdominal discomfort but denies any diarrhea, constipation or urinary complaints.  No chest pain, shortness of breath, cough.  States that she feels unwell and reports significant malaise and weakness.  No focal paresthesias or weakness or vision changes.  No history of recent trauma.
pt recv vax 21APR98 & 30APR98 pt devel a rash;
A non-serious, spontaneous report of administration of expired product was received from a registered nurse concerning a 6-year 11 month old male. Neither medical history nor concomitant medications were reported. On 29-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 23-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 10-Mar-2009. The reporter confirmed that no delayed adverse events resulted from this error. Additional information was received on 09-Apr-2009: product complaint investigation results.
Mother states that he got his vaccine and they informed him that he might get a fever.  He got really sweaty, it was an extreme fever to her.  She did not take him into the doctor as it was his first vaccines, and she felt it was normal.  He was sick for a few days.  She was contacted this past Thursday that he was given a 4-6 year vaccine instead of a 4 month old vaccine.  She was informed to keep an eye on him, and that he was now "super protected".    He has not had any other problems other than the initial reaction after the vaccine.
Patient was walking around the store with his dad when he started to get tunnel vision. This has happened before so he knew what was coming and told his dad and his dad was able to ease him down to a sitting position. He was sweaty and light-headed but it subsided in about 10-15 minutes. He drank a bottle of water and then stood up slowly and felt better and was able to leave the store with his dad.
Approximately 15 hours after vaccine, developed muscle aches, chills., elevated Temperature to 99.2 F. No true fever.  Muscle aches, fatigue, and chills persisted for approximately 24 hours.  All moderate intensity and with some response to tylenol/advil as needed.  At 40 hours post vaccine, no  remaining symptoms
The pt states that on 4/14/01 he developed itching, red whelps that began on torso and spread to the head, arms legs. Referred to his PMD. He was seen and given medication. The diagnosis was hives. Probably not due to vaccine.
unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swelling and pain progressively worsening; right leg swelling; This is a spontaneous report from a contactable consumer (patient). A 29 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:00 (Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of BNT162B2 on 29Dec2020 at the age of 29 years old for COVID-19 immunisation. Medical history included pleural effusion w/ thoracentesis x2 (5 years ago), known allergies: penicillin and sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included armodafinil taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the workplace. 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 has been tested for COVID-19 (nasal swab): negative on 28Jan2021. On 28Jan2021, the patient presented to the ED with right leg swelling and pain progressively worsening over the past week. Subsequently diagnosed with unprovoked right leg DVT and bilateral PEs, admitted overnight and given anticoagulation therapy. Labs ordered and reviewed with hematology consult 1 week later and found to be Factor V Leiden positive (hetereozygous). Treatment plan therapeutic dose of Eliquis twice a day for 1 year, prophylactic dose indefinitely after that. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events were reported as life threatening illness as patient was in immediate risk of death from the events. The patient was hospitalized for 1 day. The events was recovering. The events was treated with anticoagulation therapy, pain medicine and stockings.
Contracted a case of shingles about 6 days later, lasted about 3 weeks.
lymph node swelling and a small rash at the site of her Moderna injection; lymph node swelling and a small rash at the site of her Moderna injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lymph node swelling and a small rash at the site of her Moderna injection) and VACCINATION SITE RASH (lymph node swelling and a small rash at the site of her Moderna injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node swelling and a small rash at the site of her Moderna injection) and VACCINATION SITE RASH (lymph node swelling and a small rash at the site of her Moderna injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node swelling and a small rash at the site of her Moderna injection) and VACCINATION SITE RASH (lymph node swelling and a small rash at the site of her Moderna injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided.
arm hurt; diarrhea; knees hurt; cold; had a temperature; Lightheaded; tired; Memory was worsened; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269), via an unspecified route of administration on 13Mar2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Following second dose vaccination on an unspecified date, the reporter states that the patient was fairly normal but had experienced arm hurt, diarrhea, knees hurt. The patient felt cold, had a temperature which was just the fay after and was gone. However, the patient had felt lightheaded, very tired for a day or two and then alright for a while, memory was worsened mare than before. The reporter wanted to know if other people were having some of these same things. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-2021688836 Same reporter/drug/events, different patients.
Four days after vaccine I started experiencing neurological symptoms. I was having dizziness, tingling, drooping of right side of the mouth, internal tremors. I also had hypertension (first blood pressure done at ER was 182/112). I also experienced migraines and numbness in extremities. Two days later after being released from hospital, experienced facial numbness, burning in neck and  shoulders, burning in ears and still having numbness and tingling and internal tremors are worse.
Information has been received from a registered nurse for the Pregnancy Registry for GARDASIL, concerning a 22 year old female who on 22-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot #658560/1062U).  There was no concomitant medication.  On an unspecified date, the patient found out she was pregnant (LMP = 28-JAN-2008).  The patient sought unspecified medical attention via an office visit.  No adverse experience was related to this event.  No further information is available.  Follow up information has been received from a registered nurse on 02-APR-2009.  It was reported that the patient delivered a normal baby girl on 23-OCT-2008 at 38.2 weeks gestation.  The baby was 5 pounds and 14 ounces.  She was 19 inches long.  Prenatal care included pregnancy induced hypertension, which did not resolve after delivery.  The patient's last visit to the office was on 05-MAR-2009, and she was started on hydrochlorothiazide at that time.  She also received her third dose of GARDASIL on 05-MAR-2009.  Additional information is not expected.
PROBLEM SPEAKING; COMPLAINT NOT CONFIRMED; This spontaneous report received from a consumer 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 (suspension for injection, route of admin not reported, batch number: Unknown, expiry: 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 problem speaking, and complaint not confirmed. The action taken with covid-19 vaccine was not applicable. The outcome of the problem speaking and complaint not confirmed was not reported. This report was non-serious.
Administered HIb vaccine diluted with sterile water diluent instead of diluent that came with vaccine. No adverse Sxs. reported. Informed DON. Mother was notified to repeat vaccination in one month.