chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 at 13:00 as dose 2, single (Lot number: EL8982) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Sep2022) Negative, notes: positive test result, after a negative test, after taking PAXLOVID; (Sep2022) Positive, notes: positive test result, after a negative test, after taking PAXLOVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2 weeks. The patient received Paxlovid from 08Sep2022 to 13Sep2022 for the Treatment of COVID-19. Rebound symptoms and positive test result after a negative test, after taking PAXLOVID. The patient did not have an any allergies.
The doctor convinsed my daughter to take 3 shots (Tdap, MCV4 and Varicella - chickenpox) in same time.  After 5 hours of vaccine, she started fever 99.8 F at 5:00 pm on 7/23, 101.6 F at 7:54 am, 10:02 am 102 F, 100.5 F, 99.2 F at 5:00 pm.  I gave her pain relief (Acetaminophen).  She slept 2 days, pain and dizzy.
Information has been received from a physician concerning an 11 year old female with no drug allergies and no medical history, who on 12-JUL-2007 was vaccinated with a first dose of Gardasil (Lot# 658100/0525U).  Concomitant therapy included ADACEL.  On 13-JUL-2007 the patient experienced confusion, dizziness, nausea and pain at the injection site.  The patient received each of the vaccines in different arms.  It was reported that she only experienced pain in the arm she was vaccinated with Gardasil.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Rotavirus given on 11/8/22, patient has aged out of vaccine by 2 days
Within 15 minutes of injection, rash, tingling of tongue/ lips and wheezing developed. Pt has asthma and was on a medrol dose pak. Given po Benadryl total of 50mg with improvement within 30 minutes got worse take to ER intubated and on ventilator x 2 da. Now home and OK. Throat remains sore due to respirator. Discharge summary states vomiting, sweat, apnea, facial edema. msv
After the COVID-19 Vaccines, this has caused her so much pain; much pain, she is on the max dose of Gabapentin she can get for her neck; she couldn't move her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 1, single (Lot number: FD8448) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "had 4 C-Sections and never needed pain medicine." (unspecified if ongoing), notes: had 4 C-Sections and never needed pain medicine. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "After the COVID-19 Vaccines, this has caused her so much pain"; NECK PAIN (non-serious) with onset 2021, outcome "unknown", described as "much pain, she is on the max dose of Gabapentin she can get for her neck"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2021, outcome "unknown", described as "she couldn't move her neck". Therapeutic measures were taken as a result of pain, neck pain, joint range of motion decreased.  Additional Information: After the COVID-19 Vaccines, that had caused her so much pain, she was on the max dose of Gabapentin she can get for her neck. If she didn't have that, she couldn't move her neck. Had none of these conditions until after the COVID-19 vaccines. It was a big series of medicine because she was in so much pain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101728832 same patient/drug, different event/dose;
Per patient on phone. Received injection on Thursday 1/26/12. Muscle weakness in arm & legs started Friday AM. Became worsening throughout day. Unable to walk or get up from sitting. Started using a walker. Can grip walker but rest of arms weak. Today Mon 1/30/12 - still weakness "slowly improving".
chills, body aches primarily in my torso and back, and a headache. Then a fever the following day.
EXTRA DOSE ADMINISTERED; This case was retrieved during the monitoring on 11-Apr-2022 with the following reference number: 2189860-1. The original narrative from the sender is as follows:  Two Hib containing vaccine were given to patient on the same day. Vaxelis (DTaP+Hib+IPV+HepB) and PedvaxHib were administered on 02/12/2022 by on-call MA. Vaxelis was given in left thigh and Hib in right thigh.  Adverse events after prior vaccinations included redness on Right thigh injection site.
Covid 19 Bivalent Pfizer 0.5 ml administered instead of 0.3 ml. Monitored for 30 minutes. No adverse reaction noted at this time. Instructed daughter on what symptoms to observe for.
I gave the GARDASIL shot, asked patient to sit down for fifteen minutes. Noticed he looked passed out and started convulsing. Did not respond to me I gave him an epinephrine pen. He responded afterwards. He fell from his chair. Call 911. Ambulance came, I walked him out.
pt says she had bad migraines after taking the vaccine.  Her left arm is still sore, red and inflamed at the injection site. (it has been months)  Then she had itching all over.  She took a shower and then noticed she had a bump on chest, then on her arms, and her both legs, stomach, back, and breast.  These bumps appear like little blisters and then burst and scar her skin like a cigarette burn.  Most are small but there are some larger ones.  She says like look the measles.  She went to her PCP Dr.   She was told she was having a reaction to the vaccine and to come back if it got worse.  Pt will reach back out to her doctor for medical advice.
Diarrhea; right arm pain; fatigue; This is a spontaneous report from a contactable nurse.  A 27-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular at right arm on 16Dec2020 at 08:15 at single dose for immunization. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) for headache. On 16Dec2020 at 09:00, the patient experienced diarrhea, right arm pain and fatigue. The patient outcome of the events was recovering.
Very sore deltoid for 2 1/2 days. Early morning on 2/3 had headache, very tired and didn?t feel well. No fever or chills. Lasted until 2/4 and I felt fine 2/5. Symptoms decreased with Tylenol.
Pt. states that after receiving the 2nd dose of vaccine 05/11/2021, started experiencing symptoms 05/12/2021 of shortness of breath, asthma attacks, and weakness of the body. Still continuing currently.
MMRV is supposed to be administered subcutaneously; however, my daughter had the vaccine administered intramuscularly.  About 26 hours after vaccination, the injection site is very hot to the touch, red, and swollen. This covers the top 2/3 of my daughter?s upper arm.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patients pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-AUG-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 24 hours, with the lowest recorded temperature of 24 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Site of shot was red raised and itchy right after shot then for 3 days. That part went away then came back yesterday. Along with fever, chills, nausea, diarrhea, headache, neck pain, dizziness, and fatigue.
Within 3 minutes of flu shot administration patient complained of tingling lips which appeared to be swollen. Symptoms progressed to tingling hands and hives over five minutes. Patient was given one BENADRYL 50mg capsule at 11:50AM and taken to the emergency room.
Dizziness; headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (headaches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (headaches). At the time of the report, DIZZINESS (Dizziness) outcome was unknown and HEADACHE (headaches) had resolved.        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.
THE PATIENT WAS SUPPOSED TO RECEIVE THEIR SECOND MODERNA VACCINE, BUT RATHER RECEIVED PFIZER'S  COVID-19 VACCINE. THE PATIENT WAS INFORMED AND HAS EXPERIENCED NO SIDE EFFECTS FROM THE PFIZER VACCINE.
Temp 100.2, crying severely, rectal core tmep of 92 was noted; Pt lethargic, poor responsive to stimuli, irritability, shivering, deep tendon reflexes are hyperactive; Admission dx: poss sepsis meningitis, shock, hypothermia; sz activity;
Received MMR/Varivax on 7/8/05. Cough and low-grade fever x 2 days. Viral exanthem.
chills; Headache; This is a spontaneous report received from a contactable consumer reported for his wife. A 75-year-old female patient received BNT162B2 (Solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 10:30 (at the age of 75-year-old) as single dose for COVID-19 immunization. The patient medical history included positive for covid on an unspecified date in Jul2020. The patient's concomitant medications were not reported. Prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine was reported as none. No history of problems with vaccines in past. No additional vaccines administered on same date of the suspect. About 24 hours later (on 30Jan2021), the patient had headache and chills that probably lasted for 24 hours. The events did not require a visit to emergency room and physician office. The outcome of the events was reported as resolving.  Follow-up attempts are completed. No further information is expected.
On 2/22/07 pt had half-dollar sized red area with white center & pain. 2/23/07 pt had red area size of a raquetball.  2/24/07 she had itching at the site but was smaller.  2/25/07 it red area was quarter-sized.  2/27/07 the redness is gone and swelling gone.
Generalized weakness, dizziness drowsiness, cannot move (stable) body temp. high.
Received call from parent with c/o starting 11/23/14 noticed redness, swelling and whensite touched child pulled away, signifying "pain" site R thigh.
This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient's husband). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for pneumonia vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient had a pneumonia vaccination that hurt the patient's arm a lot. It was also reported that the patient has been hospitalized twice in the last few years with serious pneumonia. The outcome of the events was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained.
Patient received Shingrix vaccine at offsite vaccine clinic, but is below recommended age. Patient has not reported adverse signs and symptoms.
Right after administering shot, patient said that she didn't feel quite right. Then she started feeling chest tightness and then a strange taste in her mouth. This was followed by dizziness. Then she said that she felt pain shooting down the middle of her back. She stated that she would not have been able to stand up at that point.
From telephone call received at manufacturer on 1/8/02 it was reported that a 44 year old female patient received a Fluzone SV 01-02 vaccination administered on 10/30/01. Somtime after the vaccination (date not specified) the patient developed pain that continues in deltoid area; interferes with range of motion. This event is unresolved.
FIRST DOSE 4-9-21. SECOND DOSE 5-26-21. OUTSIDE OF 6 WEEK RANGE BY 5 DAYS. NO SIDE EFFECTS AT THIS TIME
Usual symptoms: fever, aches, pains headache and tiredness  Unusual symptoms: swollen and painful lymph nodes under left arm
Patient reported severe left arm soreness that was so bad she could not move arm or sleep on that side. The pain radiated down the arm over the next 4 days and on the 5th day the patient called our pharmacy because she had a red swollen "pillow" on the top of her left hand that was slightly warm to the touch. Patient stated that while the arm was very sore it was not swollen or red. Patient does have a history of gout in her wrist, but states that this pain is different and on the top of the hand and not in the wrist. Patient received FLUZONE in the left arm which is where all the pain has occurred. Of note, she received PREVNAR-13 in the Right arm on the same day and she reports no reaction/pain or swelling in the right arm since the vaccine.
The patient called an hour after receiving the shot stating she could feel her throat swelling slightly and having a feeling of numbness throughout her throat and tongue. She said she had no trouble breathing, swallowing fluids or any chest pain. It was recommended to take 2 benadryl tablets now (4:45pm) and 2 tablets before she goes to bed. I had the father get on the phone as well, tell educate him on monitoring her breathing. She was urged to see a doctor or call 911 if breathing issues start or swelling gets worse. I asked her to call the store first thing tomorrow morning when we open to see if there was any relief from the benadryl or if symptoms got worse.
- patchy, itchy rash developed. Diagnosed by dermatologist as shingles  - 1 year old daughter had received chickenpox vaccine on 3/12 as well
Patient developed diffuse mild vesicular rash on both anterior thighs approximately 10-15 lesions each thigh.  Thought could also be a contact dermatitis secondary to a lotion/topical agent but no specific histy.
This spontaneous report was received from a physician via a company representative refers to a 50 year old female patient. On 12-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K000326, expiry : 27-FEB-2015) in the left arm. Nurse reported that patient was seen in office 10 days post vaccination on 21-AUG-2014 and presented to the office with a rash on the left arm where the injection site was and also on the right arm. Physician added that she would not have reported this symptom because the rash looked more like a raised heat rash to her. Patient sought medical attention and was seen in the physician's office. Treatment given included hydrocortisone cream on both areas as needed. Because the patient stated they believed it was vaccine related, the physician's office decided to report it. No PQC was reported. The outcome of rash on the left arm where the injection site was and also in right arm was unknown. Therapy with ZOSTAVAX was not discontinued. Causality by the physician was not reported. Additional information has been requested.
12,13th day, fatigue; 12,13th day joint pain; 10th day following dose 1, rash on back of both arms; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Apr2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included many supplements (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 16:00, 10th day following dose 1, the patient experienced rash on back of both arms. On 26Apr2021 and 27Apr2021, 12th and 13th day, the patient experienced joint pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on back of both arms, joint pain, and fatigue was not resolved 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.
Caught COVID after possible exposure on 5/18/2022.  Started with sore, scratchy throat on 5/20/2022, then fever of 103 for 24 hours on 5/22/2022 with head cold symptoms with nasal congestion and cough.  Symptoms are mild so far.  Today is 5/25/2022 and nasal congestion is minimal and cough is subsiding. All-in-all symptoms were mild to date.
Information has been received from a physician concerning a 17 year old female with coeliac disease and no drug allergies and a history of headaches, who, on 08-NOV-2007 was vaccinated with a first dose of (previously reported as a second dose) on Gardasil. Concomitant suspect therapy included cyproheptadine hydrochloride (MSD), tablet for the treatment of headache (duration and dose not reported). On 09-NOV-2007 (previously reported as 08-NOV-2007 later in the day) the patient experienced bilateral calf pain. It was reported that the patient "couldn't walk." On 12-NOV-2007 (also reported as 4 days later) the patient was seen in the office with bilateral calf pain, marked calf tenderness, and difficulty getting out of bed. There was no treatment prescribed. Laboratory diagnostics were performed with the following results: complete blood count was normal, sedimentation rate was 3, c-reactive protein was normal, antinuclear antibodies were less than 80, chemistry profile was normal except serum aspartate aminotransferase which was 75, and creatine phosphokinase was 2739. A component C3 test was performed with no results provided. On 14-NOV-2007 the patient recovered. No product quality complaint was involved. The physician considered the bilateral calf pain and difficulty getting out of bed/couldn't walk to be disabling. Additional information has been requested.
7 days after routine td boaster client experienced extreme soreness (awaken by soreness X 3 nights), itching, swollen and hot x 3-4 days, and pinpoint rash (start) to large redden blotch area x 4 inches below injection site (4 X 3 size area) X 3 weeks, relieved with ibprofen and ice packs X 4 days, per advice of private MD (telephone)
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of VAQTA injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature between 32 degrees Fahrenheit (F) and 36 degrees Fahrenheit (F), with the lowest temperature of 33 degrees Fahrenheit (F), for unknown period of time. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000338: US-009507513-1702USA009503: US-009507513-1703USA000335: US-009507513-1703USA000336:
Chills; fever; body aches; stomach ache; Dizziness; Weakness; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had drug allergy to augmentin and sulfa drugs. Concomitant medications included escitalopram (MANUFCTURER UNKNOWN) within 2 weeks of vaccination for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 13Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 23:30, the patient experienced chills, fever, body aches, stomach ache, dizziness, weakness and diarrhea. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event chills, fever, body aches, stomach ache, dizziness, weakness and diarrhea were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Nurse reported that the patient was not a patient of the office but called to the office for medical advice. On an unknown date, the patient was vaccinated with two doses of GARDASIL injection, (dose and route of administration not provided), over the age of twenty six. No concomitant medications were reported. No adverse effects reported. Nurse asked if there was any data regarding the efficacy of GARDASIL after only two doses, what was the long term efficacy and if they should administer the third dose to a patient who was 30 years old. No Product quality complaint was involved. The outcome of events was unknown. No further information was provided. Additional information has been requested.