chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse received via a sales representative. A 53-year-old female patient received PREVNAR 13, intramuscular in arm on 08Dec2015 at 0.5 ml, single and ZOSTAVAX, intramuscular in arm on 08Dec2015 at 1 DF, single. Both vaccines were given at the same time and in the same deltoid muscle. No other vaccinations were given within four weeks. Medical history and concomitant medications were not reported. The patient experienced cellulitis of arm and neck on Dec2015 with outcome of unknown. She stated that the vaccines were not supposed to be administered together and definitely not in the same deltoid muscle. The patient had gotten the two vaccines and that she went to the emergency room on 10Dec2015. She reported cellulitis of the arm that the vaccines were administered in. The cellulitis also went up into her neck. The patient was not hospitalized. She was prescribed an oral antibiotic from the emergency room, as treatment for the cellulitis.
soreness of arm; wasn't performing as well for a week; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness of arm) and MALAISE (wasn't performing as well for a week) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RITUXIMAB (RITUXAN) from 15-Jan-2021 to an unknown date for Multiple sclerosis, VITAMINS NOS (DAILY VITAMINS) for an unknown indication, DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE (NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE]).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness of arm) and MALAISE (wasn't performing as well for a week). At the time of the report, VACCINATION SITE PAIN (soreness of arm) and MALAISE (wasn't performing as well for a week) 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.   The patient took Nudexta for Pseudo Bulbar Affect( PBA).   Reporter did not allow further contact
also ankle swollen; When i got up today also left right side of thigh above the knee and knee on same side also ankle swollen; Injection site, pain on 2/26; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 25Feb2021 at 17:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Feb2021, the patient experienced injection site pain and on 27Feb2021 when she got up that day also left right side of thigh above the knee and knee on same side also ankle swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, left right side of thigh above the knee and knee on same side also ankle swollen were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a healthcare worker refers to three unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the three patients were vaccinated with improperly stored PROQUAD (Merck) (lot# L044058 and expiration date 02-MAY-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This case is linked to case 1603USA005789 (same reporter link). Additional information has been requested.
19 month old BM received single imm. left thigh. Mom notes swelling, warm and red anterior thigh starting at 29 hours. No limping physical noted for.
Fever of 103-104 degrees for 10-12 hours; chills; congestion with bloody mucous; congestion with bloody mucous; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 at 08:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included GERD and sleep apnea, both from unspecified dates and unspecified if ongoing. It was reported that the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported; however, it was reported that there were no other medications taken in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 27Dec2020 at 08:15 (at the age of 45-years-old) in the left arm for COVID-19 vaccination. On 16Jan2021 at 03:00 the patient experienced fever of 103-104 degrees for 10-12 hours, chills and congestion with bloody mucous. It was reported that the patient did not receive treatment for the events. The clinical outcomes of the events fever of 103-104 degrees for 10-12 hours, chills and congestion with bloody mucous were all recovered/resolved on unspecified dates in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a pharmacist via Pfizer Inc. and refers to a 59 year old patient of unknown gender. The patient was immunocompromised. No information about the patient's medical history and concomitant medications was provided. On unknown date in approximately 2005 (reported as at age 47), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (route, site of vaccination, dose, lot number and expiration date were not reported). On unknown date in approximately 2008 (reported as at age 50), the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (route, site of vaccination, dose, lot number and expiration date were not reported). The reporter wanted to know if the immunocompromised patient can be vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) before reaching 65 years of age. On an unknown date, the patient developed unspecified side effects. The outcome of the event was unknown at the time of the report. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Additional information has been requested.
The patient received a PPSV23 and flu shot on October 15, 2018 in the left arm and a SHINGRIX shot in the right arm. On October 18, 2018, she came back to the pharmacy to report that on the night of the 15th, she had started running a fever of 102 and her left arm began to present with redness and swelling. She ran a fever for 2 days, but is now fever free. She has been treating her arm with ice packs and TYLENOL and Ibuprofen. The pharmacist, advised her to continue with the ice packs and ibuprofen and acetaminophen. The patient was made aware upon the administration of the vaccine that an injection site reaction and fever are side effects of the vaccines, but that this is the body's immune response to an immunization. The patient reports that the swelling and redness has already begun to decrease. Pharmacist will follow up with the patient on Monday.
Six inch wide red slightly swollen area at injection site, warm to the touch, did not appear until several days after injection.
Swelling at site, redness, pain, warm to touch, fever of 100, itching x 3 days.
After the vaccination, the patient was asked to wait at the Waiting Area for at least a few minutes. He was with his father that time and they were seated at the Waiting Area. After a few minutes, the father saw the patient looking somewhat pale and he asked if he is doing okay and he seemed to become unconscious for a brief moment then he started shaking for a few seconds. While this happened, pharmacy called 911 and attended to the patient. His color came back after maybe 5 to 10 minutes, but still had sweats on his forehead. His palms were warm the whole time, no clamminess. 911 came and they attended to the patient and took him.
flu like synd w/gen myalgias, arthralgias sinus congestion fever, chills, & yellow/white phlegm
This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 39-year-old male subject had received an injection of ACAM2000 (lot number not reported) on 10 March 2011. The subject had a normal troponin I on 10 March 2011. The subject's ECG, echocardiogram and MRI of the heart results were not available. The subject was diagnosed with other, chest pain on 10 March 2011. Medical history was not available. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Patient presented with chest pain on 3/18/21, was found to have NSTEMI and underwent cardiac catherization on 3/19/21 that found high-grade left anterior descending disease with 2 sequential lesions.  There is moderate disease in the mid circumflex and the right coronary artery. He received PCI to LAD with DES and was discharged home on ASA and plavix on 3/20/21.
Patient told the vaccinating pharmacist he had a history of fainting after receiving vaccinations. Patient was feeling okay after vaccination and went into waiting area. Pharmacist was called over because patient fainted. By the time we got to the patient he was awake, alert and sitting upright. He knew who he was, where he was, and that he just received a covid vaccine. The patient said he felt light headed. We offered water and an ice pack as the patient was sweating but he did not say he was hot. The patient was able to get up after a few minutes of sitting and sat in a chair. After another few minutes, the patients head went backwards and he was making a snoring sound. I tried to talk to the patient but he didn't respond. We called 911. We placed the patient on the floor and turned him on his side. After about 1 minute he was with it again. He knew where he was and thought he fainted again. Upon speaking with the patient we received details about his history of seizures due to alcohol withdrawal. He also confirmed the last time he drank was that morning and he had "a few shots and was cutting back."  Patient told us he was not on any medications but did take 50 mg of benadryl around 12:00pm that day. The paramedics arrived and took him to the hospital.
Patient requested RSV but vaccines entered for flu and covid.  Pharmacist did say I have your flu and covid.  After the vaccines were administered patient says "Was that was my RSV?"
Low back pain; Shingles; Drug effect incomplete; Painful hips; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Low back pain), HERPES ZOSTER (Shingles), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), ARTHRALGIA (Painful hips) and VACCINATION SITE PAIN (Vaccination site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced BACK PAIN (Low back pain), HERPES ZOSTER (Shingles), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), ARTHRALGIA (Painful hips) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, BACK PAIN (Low back pain), HERPES ZOSTER (Shingles), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), ARTHRALGIA (Painful hips) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant drugs not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the events of of vaccination site pain, painful hips, drug effect incomplete, shingles and low back pain was not provided with Humira (adalimumab).  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
and is shaking; she is having fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (and is shaking), PYREXIA (she is having fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (and is shaking), PYREXIA (she is having fever) and HEADACHE (headache). At the time of the report, TREMOR (and is shaking), PYREXIA (she is having fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was provided.
warm to touch; little itchy; it is swollen; reddish; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (it is swollen), VACCINATION SITE ERYTHEMA (reddish) and FATIGUE (feeling tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 012M20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced FATIGUE (feeling tired). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (it is swollen) and VACCINATION SITE ERYTHEMA (reddish). The patient was treated with Manual therapy (Applied ice pack) for Vaccination site warmth; Manual therapy (Applied ice pack) for Vaccination site pruritus; Manual therapy (Applied ice pack) for Vaccination site swelling; Manual therapy (Applied ice pack) for Vaccination site erythema and Manual therapy (Applied ice pack) for Fatigue. On 05-Nov-2021, FATIGUE (feeling tired) had resolved. On 07-Nov-2021, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (it is swollen) and VACCINATION SITE ERYTHEMA (reddish) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-378334, MOD-2021-378309 (Patient Link).
Adacel given for 76 years old patient with no reported adverse event; Initial information received on 11-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 76 years old and unknown gender patient who had received vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, 76 years old patient received an 0.5 mL dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot number: not reported) (with unknown strength, expiry date) via unknown route in unknown administration site for immunisation (product administered to patient of inappropriate age) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event adacel given for 76 years old patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After the vaccination, her arm started to swell up about 1 cm immediately. Benadryl was offered but the patient refused. After a couple minutes, the patient was lightheaded and dizzy. After two minutes the patient became unconscious, was not breathing, and was turning purple/blue. She then began having a seizure and was placed on to the ground. One dose of EpiPen was given to her and she regained consciousness.
Left shoulder rash itchiness, redness and warm. Chill and fever since 12/8/2016 to 12/11/2016.
Headache, Myalgia, NauseaVomiting, chills, injection site pain, night sweats Narrative:
Sore joints and muscles. On 10/23 went to ER at hospital due to pain in muscles.  Had blood work taken and urine specimin collected.  Taking Tylenol and Loritab as prescribed by ER doctor with follow up with family physician.  Still sore one week later after receiving flu shot.
On 09/15/2021 she was admitted to the hospital diagnosed with COVID-19 pneumonia. She stayed three days and was sent home. She progressively got worse she was admitted back in the hospital on 09/28/2021 and is currently still there. She was moved from that hospital to long term care hospital because her oxygen levels will not level out. She had a blood clot in her lungs and right leg.
Patient is a 92-year-old female who presented with weakness. The patient has a history of HTN, CKD 3, GERD. In the ER the patient was found to be COVID positive, she is fully vaccinated. She did not have any hypoxia. Her labs showed hyponatremia with sodium of 126, AKI and hypomagnesemia. The patient had a CXR which was negative. She was admitted for further management. The patient was agreeable to monoclonal antibody therapy and this was completed on 9/12. She was given some IVF and her renal function normalized. On the morning of discharge she was feeling much better. Her sodium level had improved. She worked with OT who recommended home with home health PT/OT and nursing. The patient's daughter agreed to stay with her initially and make sure things were continuing to go well at home. Care management helped arrange home health care for the patient. The patient was advised to follow up with her PCP after discharge and discharged home in stable condition with her daughter.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 13-OCT-2015 the patient was vaccinated with M-M-R II lot # L009213 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II. Sender's Comments: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002373: US-009507513-1708USA002369: US-009507513-1708USA000870.
After 3rd dose in series, patient experienced fever, chills, headache, abdominal pain, shortness of breath and general malaise.
Heart palpitations; Other reactions; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions). At the time of the report, PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions) outcome was unknown.            Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-363323 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contained: Added reporter details - Email id;
Patient was given first Moderna dose which is not approved for age frame. Patient was contacted by the pharmacy and there were no side effects from the vaccine administration and no symptoms.
got positive after getting the vaccine; got positive after getting the vaccine; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients. This is a 1st (wife's report) of 2 reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient got positive after getting the vaccine. The patient was scheduled for her second dose on 05Apr2021 (more than 21 days). She wanted to know if she can still get the second dose vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test result: positive in Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021328802 same reporter/product/event, different patient
Pt developed a diffuse maculopapular rash throughout the body, the morning after the vaccines where given. Pt also was very irritable with temperature up to 101.5 the day after the vaccines were given. Pt was seen by MD one day post vax for those signs/symptoms and was given Cedex, Benadryl and Tylenol. Alternate with ibuprofen.
I had symptoms of fever, tiredness, weakness. I did an at home COVID-19 test that was positive. My symptoms lasted for 3-4 days.
Chills  comes and goes but not like it was Exhaustion still prolonging Stabbing head pain for the most part has resolved Sensitive teeth