chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country; Interchange of vaccine product; Chills/got some shivering; Body aches; Tiredness; Low grade fever/fever; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches) and FATIGUE (Tiredness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA. Concomitant products included ATENOLOL, GABAPENTIN, CELECOXIB, IBUPROFEN and OXYBUTYNIN for an unknown indication.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever/fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Patient received the first dose of the Moderna COVID-19 vaccine after having received the Astra Zeneca COVID-19 vaccine in another country), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), CHILLS (Chills/got some shivering), MYALGIA (Body aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever/fever) 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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: New events added (lower grade fever, chills, tiredness, body aches). On 24-Aug-2021: Reporter details and new events shivering and fever were added.
improperly stored vaccine administered; no adverse effect; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S021925, expiry date : 15-JUL-2021) for prophylaxis. Other suspect therapies included sterile diluent(MERCK STERILE DILUENT). It was unknown if diluent used to reconstitute was stored at proper temperature.    It was reported that the vaccine experienced a temperature excursion total time in the range of 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees Celsius (C) to - 10 degrees C) for 30 minutes, 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) for 7 hours and 47 degrees F to 77 degrees F (9 degrees C to 25 degrees C) for 9 hours (product storage error). There was no previous temperature excursion and it was reported that this call was due to a digital data logger. The patient had no adverse events. There was no product quality compliant involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005586:Original Case : 2001USA005586
Warm sensation in left arm, developed sore throat and fever in evening. Symptoms subsided by next day.
Migraine all around my head; Dizziness to the point of falling down; Dizziness to the point of falling down; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 08Mar2021 13:30 (at the age of 53 years old) (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in right arm on 29Mar2021 13:30 (at the age of 54 years old) (Batch/Lot number was not reported), both as single dose for covid-19 immunization. Medical history included panhypopituitarism, hypothyroidism, bipolar 1, others. The patient had unspecified known allergies. The patient's concomitant medications in two weeks were reported as yes. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced dizziness to the point of falling down, migraine all around my head, extreme nausea on 29Mar2021 13:45, which were resulted in emergency room/department or urgent care. These events happened with both shots. The patient went to ER both times Treatment for events included migraine cocktail. Nothing for dizziness or nausea. The outcome of event was recovered with lasting effects.
mild cold like symptoms; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (mild cold like symptoms) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (mild cold like symptoms). At the time of the report, NASOPHARYNGITIS (mild cold 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 and treatment medications were reported.
Information has been received from a pharmacist concerning a female who on 14-AUG-2010 was vaccinated subcutaneously with a 0.5 ml dose of MMR II (lot # 665510/1146Y). On 17-AUG-2010 the patient presented with a raised, red rash on her face, neck and arms after receiving the vaccination. The patient did not sought medical attention. As of 18-AUG-2010 the patient had not recovered. Additional information is not expected.
She reports that the reaction started with a rash at injection site within an hour of receiving the vaccine. The site turned red. She called the pharmacy on 3/11/21 and spoke with the pharmacist to let them know she had "Covid arm" and to cancel her second dose. The reaction continued to get worse. By 3/20/2021 she had a red, burning, urticaric rash covering her torso and arms. The rash started to spread to the right side of her face and due to concerns about involving the airway, she went to Emergency Department on 3/20/21. She received steroids and was released after 3 1/2 hours with a prescription for oral prednisone. The rash resolved with the use of steroids and she has had no further symptoms.
cheek swelling; Swollen lymph node on right side; lock jaw; Fatigue after vaccination/fatigue increases; This is a spontaneous report from a contactable consumer (patient herself). A 31-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VAC-CINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in arm right on 05Jul2021 16:30 (age at the vaccination 31-year-old) as dose 1, single for COVID-19 immunization (pharmacy or drug store). The patient was not pregnant at time of vaccination. Medical history included pollen-food allergy from an unknown date and unknown if ongoing known allergies. The patient concomitant medications were not reported. On 05Jul2021 20:30, the patient had experienced fatigue after vaccination, fatigue increases, swollen lymph node on right side, swollen cheek and lock jaw. The patient did not receive treatment for the adverse event. AE resulted in doctor or other healthcare professional office/clinic visit. The reporter (health authority) considered the events as non-serious. 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 not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The outcome of the events was not recovered.  Information on Lot/Batch number has been requested.
High pitched cry occurring p/pt was asleep for the night; crying lasted 2 hrs t99 taken to ER & examined; no tx given; crying subsided; pt OK since then;
Swelling, redness, itching of face. Predominantly around eyes and lips. Swelling started on 1/25, two days after vaccination.  First time this happened was after flu diagnosis. Took Benadryl and Xyzol.
fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 9809; Expiration Date: unknown) via an unspecified route of administration, in Arm Right on 09Feb2021 08:15 for COVID-19 immunization.The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 3247; Expiration Date: unknown), via an unspecified route of administration, in Arm Right on 19Jan2021 08:15 for COVID-19 immunization. The patient previously took Levaquin and bnt162b2.Medical history included neuropathy peripheral, rosacea, drug hypersensitivity to levaquin. Concomitant medications included vitamins (MULTIPLE VITAMIN), ciclosporin (RESTASIS), calcium and omega 3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 22:00, the patient experienced fever of 101.3, full body muscle pain, headache, vomiting. The patient underwent lab tests and procedures which included body temperature: fever of 101.3 on 09Feb2021. The outcome of the event was recovered.
This case was reported by a healthcare professional (nurse) and described the occurrence of facial flushing in a 34-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to eggs and multiple allergies. On 8 January 2013 at 10:45 the subject received a dose of FLULAVAL (.5 ml, unknown route, left deltoid). On 8 January 2013, 15 minutes after vaccination with FLULAVAL, the subject experienced facial flushing, increased heart rate, chest tightness and shortness of breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL at 11:15 on 8 January 2013. On 8 January 2013, at 12:00, the events were resolved. The nurse reported that the immunisation series was not delayed and was discontinued. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The subject had received flu shot in the past with a history of an allergic reaction with one previous influenza injection. Details in case A1007735B.
I GAVE THE VACCINE UNDILUTED.  SINCE THE ADULT VACCINES ARE NOW ALREADY DILUTED, I MISTAKENLY ASSUMED THAT THE CHILDRENS VACCINE WAS ALSO DILUTED WHEN IT CAME TO US.  I MADE THE MISTAKE AND GAVE THE CHILD AN UNDILUTED 0.2ML FO THE CHILDS VACCINE,  WE CHECKED WITH THE MOTHER LAST NIGHT AND THIS MORNING, THE CHILD HAS HAD NO ADVERSE EFFECTS SO FAR, WE WILL CONTINUE TO RECHECK WITH THE PARENTS.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Tnhe patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored VARIVAX (lot # L045956 with expiration date: 17-NOV-2017, dose and route of administration were not reported). NO adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of  several reports received from the same source. Additional information has been requested.
02/17/2021 I could not make all my movements with my right shoulder. "Frozen shoulder" 08/03/20021. I got a shot in my right shoulder and the pain went away. I am in PT for the range of motion.
headache; Fever/low grade fever; Chills; body aches; neck area where the tonsils are, it is swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration, in left arm on 11Apr2021 18:30 (at the age of 41-years-old) as dose 2, single for covid-19 immunization. The patient medical history (including any illness at time of vaccination) was none. Patient had not received any other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534 and Expiration date: 31Jul2021) via an unspecified route of administration, in left arm on 21Mar2021 (at the age of 41-years-old) as dose 1, single for covid-19 immunization. Family medical history relevant to adverse events were none. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Patient had not received any other vaccines within 4 weeks and had no adverse events following prior vaccinations. There were no relevant tests. On 12Apr2021, the patient experienced fever/low grade fever, chills, body aches and headache on 13Apr2021; neck area where the tonsils are, it was swollen on an unspecified date in 2021. The patient underwent lab tests and procedures which included a result of pyrexia was 100.4 on an unspecified date. Patient stated that after the 1st dose she was ok, but the next day after receiving the second dose she had fever, chills, headache, and body aches. She said after a couple of days was fine. Patient stated she started with chills, then had a slight fever of 100.4, then came the body aches and a headache. She stated that the headache started a little later and lasted for 2 days. The patient stated that after a week (2021) she noticed on her neck area where the tonsils were, it was swollen. She stated that it has been going on for around two weeks now. She states that it was there slightly, not going away and was a little concerned. She read that this was a side effect and she thought it was going away and then it was swollen again. She stated that it reduced and then it swelled back again. She says it appeared from nowhere. She woke up one morning and suddenly it was there. She wanted to know what was it and how to make it go away. Reporter stated that the adverse events did not require any emergency room or physician office visit. Therapeutic measures were taken as a result of the event fever and treatment included Tylenol. Patient stated her fever was a low-grade fever and so she did not take medication till the second day. Outcome of the events chills, body aches and fever were recovered on 14Apr2021; headache was recovered on 15Apr2021 and neck area where the tonsils were swollen was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Pt experienced a nose bleed that started at 3:30 pm adn continued for over 1 1/2hrs. Notification of nose bleed occurred at 4:45 pm. Instructed pt to seek medical attention. Called to follow up with pt on 12/3/09, 12/4/09 and 12/8/09.
Patient was given the pediatric dose .25ml of COVID 19 bivalent vaccine . not the adult dose of .50ml
Had an infected saliva gland. Amoxillin for 7 days. Cleared up
felt awful for 4-5 days; fever; muscle ache; headache; This case was reported by a physician via call center representative and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lung cancer (on therapy for lung cancer).   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful, fever, muscle pain and headache. On an unknown date, the outcome of the feels awful, fever, muscle pain and headache were recovered/resolved.   It was unknown if the reporter considered the feels awful, fever, muscle pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination were not reported but adult has been selected as age group according to the vaccine. The patient stated to physician that he/she felt awful for 4 to 5 days with fever, muscle ache, headache. The patient was on therapy for lung cancer. The reporter consented to follow up. This case is 1 of 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178096:same reporter US-GLAXOSMITHKLINE-US2020178097:same reporter US-GLAXOSMITHKLINE-US2020178099:Original Case : US2020178099 (same reporter)
17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
Followed up with patient after 24 hours of incident. Confirmed no adverse reaction. Patient got overdiluted dose of vaccine.
I have had 3 doses of the pfizer covid vaccine/ I started testing RAT positive again; I have had 3 doses of the pfizer covid vaccine/ I started testing RAT positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I have had 3 doses of the pfizer covid vaccine/ I started testing RAT positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested PCR positive for COVID-19; Negative, notes: I started testing RAT negative; Positive, notes: My symptoms returned and I started testing RAT positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I was prescribed Paxlovid the day I tested PCR positive for COVID-19. My symptoms gradually improved and I started testing RAT negative. Three days later, my symptoms returned and I started testing RAT positive again. My doctor said to report this to Pfizer so that it would be counted. I didn't see anywhere else to report, so I am reporting it here. For context, I have had 3 doses of the Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a nurse via a company representative and refers to an 11-year-old male patient. The patient had no concomitant medications, pertinent medical history or known drug reactions and allergies. On 02-AUG-2018, the patient was vaccinated with GARDASIL 9, intramuscularly (dose, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). On the same date, within 5 minutes after receiving GARDASIL 9, the patient experienced dizziness and lightheadedness. The patient sought medical attention, no lab diagnostics were performed and the patient was treated with cold compress, drinking water and a popsicle. The outcome of the event was reported as recovered (on the same date, 30 minutes later). Causality assessment was not provided by the reporter.
severe uncontrolled muscle pain despite medication, loss of muscle control, muscle weakness, loss of appetite and 25 pound weight loss over 3 months, development of a pronounced essential tremor in hands, arms, head, and lower extremities
Arm was slightly itchy, so I scratched it. Within a few hours, I looked at it and it was red and slightly raised. I experienced pain, itchiness, swelling and redness at the injection site. I emailed my doctor on 2/2/2021, and she said to take Benadryl and put cortisone cream on it. I began taking Benadryl and put calamine lotion on the site.  The itchiness, swelling and pain subsided after 2-3 days, but I still feel a slight irritation at the site and intermittent itchiness.
Next day :pt felt achey, felt bad 08:00 p.m. had extreme pain and flashes in back of eye, felt concerned but let it go, following saturday  04/10/2021  taking shower , noticed that part of vision in eye that cannot see. calls eye dr, and has retinal detachment, immediate  surgery, had complications, 2 weeks later had detachment in left eye. severe anxiety in patient .