chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rippling effect down her neck; Pain in her upper shoulder; This spontaneous case was reported by a patient and describes the occurrence of RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 20-Jan-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 RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder) had not resolved.        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.   Concomitant product use was not provided by the reporter. The patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had received 5 doses of the Moderna COVID-19 vaccines on: Dose 2: 17-FEB-2021, lot number 016M20A Dose 3: 1-NOV-2021, lot number 939904 Dose 4: 12-MAY-2022, lot number 004M211A. Dose 5: 14-NOV-2022, lot number 060F22A Following the first dose of the vaccine patient noticed a rippling effect down to neck and onto the shoulder without pain. That did not occur with doses 2-4 however it had returned following dose 5.  That rippling effect was now associated with pain for patient in upper shoulder which had continued since April. Initially patient took treatment medication such as Aleve and Tylenol for the symptoms which seemed to not be helped. Patient stopped treatment medications and started using the ice pack two times daily on shoulder to help with the pain. Currently patient took Aleve treatment drug before patient goes to sleep to help with the pain. Patient consulted with HCP and HCP seemed unfazed by patient symptoms. Because that had persisted so long, they agreed to schedule an MRI for October.   This case was linked to US-MODERNATX, INC.-MOD-2023-738080 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738080:Same patient (Dose 5)
Side effects from first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects from first dose) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (Side effects from first dose). At the time of the report, VACCINATION COMPLICATION (Side effects from first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
101 F fever; Aches; Headache; Chills; Sweats; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730), via an unspecified route of administration in the right arm on 03Apr2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6206), via an unspecified route of administration in the right arm on 12Mar2021 at 17:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 03Apr2021 about 12 hours after the injection, the patient experienced a 101 degrees Fahrenheit fever, aches, headache, chills and sweats. The events did not result in 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 experienced. The clinical outcome of the events 101 degrees Fahrenheit fever, aches, headache, chills and sweats was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Mom reported fever 103 + irritability all night. Offered an appt by myself and Doctor. Mom refused appt X 2.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to --8 degrees C for an estimated total time out of range of 14 hours. On 01-MAR-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -14 degrees C for an estimated total time out of range of 10.5 hours and on 03-MAR-2012 at 11:30 it was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 07-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Pt vaccinated with DTP/OPV/MMR began vomiting & diarrhea around 830PM. Temp to 104. Mom call ER & MD, but did not take child to either.
03/30 - 11:00am - Current: Sore around injection area 03/30 - 5:00pm - Current:  headaches, swollen and red arm around injection area. 03/31- 12:00am - 5:00pm: Chills, total body ache, extreme fatigue, body sensitive to touch.
I had a sudden and extreme loss of calcium.  My face was tingling and I went into a sever case of tetany.  I took my forteo and calcium abs waited.  It took a good hour or so to get over the attack.  It was definitely from the shot and for some reason it messed with my calcium levels.  The next day I was very achy fever chills and pain.  But that was more normal  reaction s. The calcium was very sudden abs s about 5 hours after injection.
arm automatically felt heavy and hot. immediately started coughing. then after that I started feeling tight in my chest and airways. I waited and it progressively got worse. it felt like I had phlegm stuck in my throat that I could not get out. nurses at the drive offered to call 911 but I was close enough to an Urgent care/ER that I decided to drive myself over there. they took me in, started an IV and gave me 50mg of epinephrine and Benadryl, steroids and Pepcid. they prescribed an EpiPen. They told me to continue taking Benadryl because the allergic reaction could resurface. cough is still present and I have body aches.
Patient (RN who works at hospital) complained of jaw tightness about 15 minutes after the vaccination. Diphenhydramine 50mg IM x 1 was administered.  Patient then developed a rash across her chest and stated that she was not feeling well.  EpiPen x 1 IM was given at 11:17 and Code Blue was called per hospital policy. Patient's vitals were BP 175/99, HR 129, Oxygen 100%. Patient was alert and oriented but anxious. Patient was sent to ER at around 11:20 for observation
shortness of breath; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX support.   A 90-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 90-year-old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced shortness of breath on an unspecified date. The event was considered serious as medically significant. The outcome of unknown.  He decided to skip second dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tired; Achy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 56 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) at the age of 56 years, as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 02Mar2021, outcome "recovered" (03Mar2021), described as "Tired"; PAIN (non-serious) with onset 02Mar2021, outcome "recovered" (03Mar2021), described as "Achy". Therapeutic measures were taken as a result of fatigue, pain. Additional information: Treatment included ibuprofen (ADVIL). The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 4/5/21 I got nausea and chills for about an hour. I woke up on 4/6/21 and my right eye and all bone structure on the left side were very painful. It did get worse throughout the day. I woke up on 4/7/21 and the same symptoms with my face and eye but appear to be lessened. But as I am trying to fill out the form it is starting to hurt a little more. Slight swelling in the left eye.
and has some heart conditions that may be exasperated by maybe taking the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "and has some heart conditions that may be exasperated by maybe taking the vaccine".  Additional information: Caller was asking about the safety of the Pfizer-Biontech Covid19 vaccine for her daughter who was already perfectly healthy, already had covid, and has some heart conditions that may be exasperated by maybe taking the vaccine"? She stated that her daughter was "otherwise healthy" and has "already had covid" and "her cardiologist doesn't really recommend it [the vaccine] since she's already had covid". She also noted that  personally shehave known children her age, from friends, who have had some heart issues after receiving the vaccine. Quite frankly it's kind of very disturbing how any little child could be having these issues and how this is being forced on everyone and anyone to take it". She wants to know "if the scientists at Pfizer feel it was safe for children with heart conditions?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.-
Sore throat, sinus pain, headache. Continued throughout the day after the vaccination. Still feeling symptoms as of the date of reporting, however keep in mind it has only been two days.
COVID-19; COVID-19; Dose 3: Moderna; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 19:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13May2022 at 19:00 as dose 4 (booster), single (Lot number: FK9729), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2021 at 19:00 as dose 3 (booster), single (Lot number: 038C21A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RAD" (unspecified if ongoing);" pulmonary disease" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing); "remote history of breast cancer" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL], start date: Apr2010; SYMBICORT, start date: Apr2015; VIT D [COLECALCIFEROL], start date: Feb2018; VIT B 12, start date: Apr2018; MAGNESIUM, start date: Jan2001. Past drug history included: Anzemet, reaction(s): "Known allergies: Anzemet"; Scopolamine, reaction(s): "Known allergies: scopolamine"; Zofran, reaction(s): "Known allergies: zofran". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13May2022, outcome "not recovered", described as "Dose 3: Moderna"; 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was received other medication in 2 weeks. She took Paxlovid from 09Jan2023 to 13Jan2023 for the treatment of COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
No adverse reactions noted - Vaccines BUD date was 12/28/2022 - Vaccine given on 01/03/2023 5 days past BUD date
One and a half hour after the vaccine, the headaches began.  They lasted during the next day.  I treated them with acetaminophen. The next day of the vaccine, my left arm turned red around the vaccination area (about a lemon in size), it got swollen, and itching. I put ice on the area and it improved, but the redness continue.  Then, eight days later it got worse, the redness area increase in size, it got swollen again (more than previously) and the itching was back.  Also, the area seems to have a fever (when touch).  I took Benadryl for two consecutives days and applied ice to the area.  The swollen and the itching improved; but it has been 11 days and I still have the redness in my arm (bigger than a lemon in size).
Instant pain at injection site. Nerve type pain down to elbow. Followed up with pt today and he stated that his arm/muscle was sore (like he lifted heavy weights) which lasted about a month. Symptoms have resolved as of today 11/28/18.
more than 42 days for administration of second dose after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose after 1st dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose after 1st dose). In July 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included high blood pressure medicine.  Treatment information was not provided   This case was linked to MOD-2021-375405 (Patient Link).
J96.00 ACUTE RESPIRATORY FAILURE 7/14/2022 EXPRESSIVE APHASIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/15/2022 EXPRESSIVE APHASIA J96.00 ACUTE RESPIRATORY FAILURE 7/14/2022 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/15/2022 HTN (HYPERTENSION)
Pt. claims  left upper arm pain at injection site immediately after injection.  Developed progressive upper arm pain with reduced range of motion.  Seen by ER and diagnosed with bursitis one week after injection.  Referred to specialist who diagnosed her with tendinits/bursitis and injected her with steroids locally.  Has regained full range of motion and pain has resolved.  Has not had previous reactions to vaccine, no allergies.  Never developed fever or other systemic symptoms.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 28-DEC-2022 Reporter's Comments: The nurse reported expired Havrix had been administered to a patient. The health care professional (HCP) did not provide information of the patient due to patient privacy. The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired Havrix vaccine, which led to expired vaccine used.
One week after vaccination, I had to all 911 and was put in the hospital, I had a stroke, I had a blood clot in my brain, and severe abdominal pain, and terrible headache where the clot was, I couldn't see, my legs weren't working right. My head was sensitive on the right side, like a tingling and sore to touch, then the headache started in the center of my head. I stayed in the hospital for 3 weeks. I'm home but have slurred speech and I use a walker now.
few people in my church started getting Covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (few people in my church started getting Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced COVID-19 (few people in my church started getting Covid). At the time of the report, COVID-19 (few people in my church started getting Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that even though vaccinated few people in his church got COVID-19 and none of them had to be in Hospital.  No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This spontaneous report concerns patients of unknown age and gender with no relevant medical history who experienced non-serious AESI event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. The reporter stated that the patients were vaccinated, however still contracted COVID-19 infection. Re-challenge is unknown as there is no information on the vaccine doses. The benefit-risk relationship of mRNA-1273 is not affected by this report. Based on the available information, the case has been classified as invalid.
Patient had turned red on his face and arms and hands 5 minutes after receiving vaccine, (1045am) holding his chest, lips were blue. Looked lethargic, Benadryl 27.875 mg given of a 12.5mg per 5 mls at 1102am.
Tight chest, fever, body aches, swollen lymph nodes in neck, sore throat, indigestion.
received 1st dose of Covid vaccine last Tuesday and then tested positive for Covid on Friday; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 29Jan2021, the patient was tested Covid positive. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt was given vaccine beyond 12 hour beyond use date/time after initial vial puncture.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of Rotateq. Subsequently "after the fourth month dose" the patient experienced intussusception and was hospitalized. It was reported that the patient was in the hospital but the length of stay was not provided. On an unspecified ate, the patient recovered. No product quality complaint was involved. Additional information has been requested.
I had a little bit of low grade temperature and then I had fatigue and some GI upset and a headache.
This case was received via VAERS on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VOMITING (Vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized on 17-Mar-2021 due to VOMITING. At the time of the report, VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was vomiting , she was on the floor, and she called the EMS twice. The second time was taken to the hospital. Action taken with mRNA-1273 in response to the event was not applicable.  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.; 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.
Patient became diaphoretic and pale, c/o some nausea approx. 10 min after receiving vaccination in clinic. Denied rash itching or shortness of breath. B/P was 80/40 pulse 55. O2 Saturation was 99 to 100 %. Was escorted to nearby Emergency room for evaluation
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/24/21 2nd dose 04/14/21 Diagnosed covid positive:08/17/21 Symptom onset:08/11/21 Exposure:community Symptoms:cough, fatigue,loss of smell/taste, runny nose.