chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; itchy face; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face). At the time of the report, PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Med Info Agent: Staff
CERVARIX wsa given to a male patient, while it should be given to the female patients only.
Information has been received from a physician concerning a 17-week-old female who on 25-MAR-2008 was vaccinated orally with a second dose of ROTATEQ ("lot # 0618X").  Concomitant vaccines included a dose of PEDVAXHIB (manufacturer unknown), PEDIARIX and PREVNAR.  On 25-MAR-2008 the patient experienced gagging, developed a rash and diarrhea, post vaccination.  It was noted that the gagging would not subside.  It is unclear how long the patient "gagged" post vaccination.  On 01-APR-2008 the patient was examined in the office and was reported to be recovering.  A product quality complaint was not involved.  Additional information has been requested.
Noticed nickel-sized redness in am of 12/01/02. By pm, 12/10/02, swelling of redness increased. Site.(L thigh) warm to touch. Treated with Augmentin.
After my 2nd COVID19 vaccine, about 3 weeks later my both hands broke out in an itchy red rash
8/16/07 - Fever 102, stomach ache, diarrhea and headache. Called HC. Referred to FMD. On 8/17/07 stomach ache and headache gone. In the evening (R) upper arm swollen "big as a baseball. No fever. 8/18/07 Referred to FMD who advised ice packs  every hour and Tylenol. 08/19/07 - no swelling. To see FMD 8/21/07.,
No symptoms or additional adverse effects reported.; Office manager reporting patient inadvertently received expired first dose in VAQTA immunization series.; This spontaneous report was received from an office manager referring to a 69 years old patient of unknown gender. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On 08-JUN-2020, the patient was inadvertently received expired first dose in hepatitis a vaccine, inactivated (VAQTA) (lot# S001832, expiration date 12-MAY-2020; dose detail, route and strength were not provided) immunization series for prophylaxis (expired product administered). No symptoms or additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
April 28 to April 30, 2021: low fever, chills, aches, exhaustion, watery diarrhea, fuzzy-brained. "Fuzzy-brained" equals (1) inability to process thought, pull words from the air, tie thoughts together into a cogent sentence, be able to tie different memories together to form a full thought. For instance, I could not recall the names of people plus the projects each was working on and the current status in order to provide a cogent report to my work colleagues -- I could not form any level of complex thought into a sentence, paragraph, or discussion. "Fuzzy-brained" also meant (2) I was unable to form short-term memories. Due to others' observations of me over a period of days, we realized that I did not form any memory of what happened to me on April 29-30, 2021. I, in fact, overdrew my bank account by making a one month error in writing the check for the bill pay, then borrowed money from my son to cover the deficit, then forgot entirely about the episode until reminded today (17 May 2021) that I owed him several hundred dollars. May 8 to May 9, 2021: low fever, chills, aches, lack of appetite, inability to sleep (insomnia). Yeast infection in my female parts. May 17 and May 18, 2021: watery diarrhea, inability to sleep (insomnia).
Reaction occurred on upper arm on bicep, not at injection site. Redness, hard to the touch, warm to the touch, approx. 1 or 1 1/2 inch diameter.
Erythema (1 1/2 x 2 1/2 cm) with induration (1 x 1 1/2 cm) and mild tenderness with palpation --> recommend cool compresses and ibuprofen prn.
This spontaneous report was received from a Medical Assistant referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M045101 and expiration date on 10-NOV-2018 reconstituted with a properly stored sterile diluent (reported lot # K012930, expiration date 26-JUN-2017) for prophylaxis. M-M-R II was involved on a temperature excursion if 9 °C to 25°C for 1 hour 11 minutes. Information was provided due to a data logger. No adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA011887.
The pt walked into the clinic on 1-8-14. She stated she had soreness and itching after receiving the flu vaccine on 1-3-14. The pt had a reddened area on her (L) arm. The area was in the shape of a bandaid. BENADRYL (q 6-8 hrs) and ibuprofen (1) (tid) treatment advised. Pt to call back 1/9/14 if no improvement.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chills-Mild, Additional Details: Patients mother called to report her daughter had to go to ED on the night of the 24th to receive care for anaphylactic shock after having difficulty breathing and swollen tongue at home. She reports common side effects earlier on (chills,sweats,etc). cost of care on ed were ~$1000+ and she wants the company to be responsible for administering the vaccine. reports RPH didnt scan the doctor's orders, which were specific to what had to be administered.
Information has been received from a mother concerning her 16 year old daughter with no known medical history or allergies who on 01-DEC-2007 was vaccinated (route unknown) with a first dose of Gardasil (Lot # unknown).  Concomitant therapy included hormonal contraceptives (unspecified).  Two to three days after vaccination, on approximately 02-DEC-2007, the patient experienced hives on her back, stomach, chest, legs, & arms.  "Some areas are spotty and some places it looks like big welts".  The patient has been taking steroids on and off since December.  The last steroid she took was prednisone, and the hives came back when the medication was over.  The physician also put her on ZYRTEC. The patient's hives on her back, stomach, chest, legs, & arms persisted.  It was reported that the patient visited the doctor's office.  Unspecified blood work was performed, and no results were provided.  No product quality complaint was involved.  Additional information has been requested.
Caller states she became sick and started getting sick; Booster; congestion; cough; sore throat; fever; diarrhea; she thinks no appetite.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF2588) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, lot number:  PF EN6207), administration date: 17Mar2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 02, lot number: EW0162, Anatomical Location of Administration of Pfizer vaccine considered as suspect: left upper arm), administration date: 05Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "the 2nd dose she got was diluted too much and was recommended to get revaccinated for the 2nd shot", "the 2nd dose she got was diluted too much and was recommended to get revaccinated for the 2nd shot". The following information was reported: IMMUNISATION (non-serious) with onset 19Oct2021, outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "she thinks no appetite."; ILLNESS (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Caller states she became sick and started getting sick". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (21Dec2021): This is a spontaneous follow-up report from same contactable Consumer. This 49-year-old female patient reported for herself that:  Updated information: Reporter information, Patient information, Relevant Medical History, Historical Vaccine, Lab data, Suspect product information and Event information were added  No follow-up attempts are possible. No further information is expected.
Headache; Metallic taste; Fever; Confusion; Muscle pain; Unusual organ pain; Hot feet; Dizziness; Fatigue; hot hands; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EAU206) via an unspecified route of administration in the right arm on 30Apr2021 at 10:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy (ligonberries). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), estradiol (ESTROGEN) and progesterone (MANUFACTURER UNKNOWN); all for unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 10:15, the patient experienced headache, metallic taste, fever, confusion, muscle pain, unusual organ pain, hot feet and hands, dizziness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, metallic taste, fever, confusion, muscle pain, unusual organ pain, hot feet and hands, dizziness and fatigue were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling of arm, redness @ site of inject & t100 noted 16APR92; tx Keflex, Ibuprofen, & DPH;
Day following vaccination completely unable to abduct left arm. Severe pain deep in left shoulder. No pain to palpation of left deltoid. Pain with range of motion of shoulder.  Over the subsequent week the pain and limited range of motion has persisted. The pain is worse when I sleep and wakes me up at night. I am unable to do my normal activities now at 9 days since vaccination.
Breathing became labored, felt like throat was closing, vomited, heart palpitations, felt tight, flushed Used epi pen immediately, taken down the hall to the Emergency Dept.  Given another course of epi and IV, able to go home after 4 hours.
This spontaneous report was received from a medical assistant and refers to a 52 year old female patient. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 30-JAN-2017, the patient was vaccinated with a dose of RECOMBIVAX HB 5 Microgram (0,5 ml) injection lot # M003658, expiration date 02-JUN-2018 (route was not reported). The patient was mistakenly vaccinated with a pediatric dose of RECOMBIVAX HB as a result of confusion. The reporter stated that the error occurred because "the doses of RECOMBIVAX HB looked similar. No adverse events were reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 4 year old female patient. None pertinent medical history was reported. The patient's concurrent conditions included penicillin allergy. On 27-MAR-2017, the patient was vaccinated with a dose of PROQUAD (lot # M018635, expiration date 11-OCT-2017, subcutaneously in the thigh; dose was not reported for prophylaxis. Concomitantly, on the same date, the patient was vaccinated in the other thigh with a dose of KINRIX. In March 2017 (it was reported that the patient's mother noticed the reaction on 29-MAR-2017), the patient developed swelling, redness, tenderness and warmth to the touch at the PROQUAD injection site. The patient sought medical attention via physician office visit. The reporter stated that ibuprofen and warm compresses were suggested for treatment of the symptoms. None lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and PROQUAD was not provided. Additional information has been requested.
Patient experienced a syncopal episode after receiving the COVID-19 vaccine. Patient transferred to the emergency department. Upon arrival to the emergency department, patient was awake and alert with GCS of 15. Patient did state she felt a little dizzy. Patient denied any nausea, vomiting, or abdominal pain. Patient received IV fluids. Patient was reassessed and stated she felt significantly improved. Patient discharged at 1300 on 12/23/2020.
Left armpit and shoulder swelled significantly; Left armpit and shoulder swelled significantly; Lymph nodes were painful to movement or touch; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history (reported as not applicable (n/a)) and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified birth control medication (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 23:30, after second dose, the patient's left armpit and shoulder swelled significantly and lymph nodes were painful to movement or touch and reported that took several days for swelling to subside. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left armpit and shoulder swelled significantly and lymph nodes were painful to movement or touch was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
9/1/11 entire upper arm red and hot to the touch.  Swelling at site - raised area. 9/2/11 bumpy rash at injection site and area surrounding it.  Extreme itching. 9/6/11 Extreme itching on arm.  Small raised red, itchy bumps on other parts of body (e.g. hands, backs of knees, legs, underarm area, other arm)
The injection itself was quite painful (and I've had many vaccine shots in my life). Felt completely fine until around 4pm when I felt a dull headache. Around 5pm, my head was throbbing so much that I couldn't leave my bed. Around 6pm, I felt muscle pains starting around my neck, slowly moving to my shoulders, chest, and upper back. Without taking any medication, I slept and woke up around 8pm. I was sweating, felt so cold but hot at the same time. The muscle pains were intense, and my head hurt so much that I took a single capsule of 200mg Advil. The pain became more manageable around 30 minutes later. Was still sweating, and muscle aches continued. I slept again at around 2am (May 26, 2021) and woke up at 10am. Head was no longer hurting, but muscle aches were still lingering. Currently, 1:04pm on March 26, 2021, I feel weak and tired with muscles pains around my upper body, but overall feeling much better than yesterday.
Swab collected/ positive COVID. Came to ED with Cough / SOB/ fever/chills
Facial swelling to right cheek, blanching, erythema to right cheek with trace, localized swelling, onset approximately 2 hours after typhoid injection. Given acetaminophen 325mg TID x 3 days, diphenhydramine 25mg BID x 2 days, hydrocortisone 1%.
12/01/21 presents to EC ED for "headache, shortness of breath, fever, chills, and loss of taste and smell". PMHx of "DM, HTN, HLD, asthma, neuropathy, obesity".
I had what felt like was a neurological response. I was sitting at my desk and my whole body turned inward with a shudder. It went all at once and my arms and shoulders bilaterally turned inward. I have never experienced anything like it. I am a former ICU nurse and know what a neuro response is.
Flushing, hot flashes, elevated heart rate and high BP (never have a problem with that), Evaluated at the ER and received Benadryl immediately.  After coming home (discharged around 1:30), felt fatigued and started with a mild headache. Also joint pain in my hips and my knees.  Woke up this morning pretty fatigued and with headache feeling better this afternoon. Still have a mild headache.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2013, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Additional information has been requested.
Initially had localized reaction with redness and induration. Then developed large blister (approx 3-4 cm) in area.
C/O worsening SOB X 3 days, dry cough. Dx w/ acute hypoxemic resp. failure secondary to Covid pneumonia. Tx w/ Decadron, O2, Remdesvir.
SERVICE MEMBER GIVEN ATHRAX 0.1 ML INSTEAD OF TST.
soreness of the right arm; Headache; Nausea; body aches; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the right arm), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (body aches) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical history reported.).    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness of the right arm), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (body aches) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, PAIN IN EXTREMITY (soreness of the right arm), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (body aches) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) 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 provided.
transient global amnesia - started within hour of receiving vaccine - pt became lost driving, was subsequently admitted and had amnesia that lasted approx 24 h then resolved, negative CVA workup
Patient received Infanrix and Pedvax HIB on 7/9/2019 at his 6 mo WCC He had neve rbeen vaccinated before due to parental refusal. On 7/10 afternoon, he was brought to clinic by his Mother because he developed vomiting. Diarrhea and listlessness that morning. (i.e. morning after receiving immunizations). Patient was seen in clinic, assessed to be at risk for Dehydration and was admitted to hospital for IV fluids, work up and monitoring.
tested positive for COVID-19; He experienced redness/streaking in the arm that received vaccination.; streaking in the arm that received vaccination.; This spontaneous report was received from a the patient's grandmother and refers to a 12-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions included  asthma. Concomitant therapies were not reported.  In July 2022 (reported as "about 3-4 weeks ago"), the patient was vaccinated with the first dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (dosage regimen, route of administration, lot #, and expiry date were not reported) as prophylaxis.  On an unspecified date in July 2022, the patient experienced redness and streaking in the arm that received vaccination. The reporter stated that the pediatrician stated it was a localized reaction from injection and no cause for concern. On 23-JUL-2022, the patient tested positive for COVID-19, with no symptoms. At the time of report, the outcome of the events was not known.   The causal relationship between the events and 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) was not provided.
9NOV91 abdominal cramps;  10NOV01 vomiting; rx w/liquid diet admitted to hosp ICU dx dec NA & K; 11NOV -15NOV91 still weak-anorexic, depressed;