chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; Nausea; extreme muscle fatigue; fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown., prev dose brand name unknown: COVID19 Vaccine), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown., prev dose brand name unknown: COVID19 Vaccine), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset Dec2021, outcome "unknown", described as "Nausea"; MUSCLE FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "extreme muscle fatigue"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "chills". Therapeutic measures were not taken as a result of nausea, muscle fatigue, pyrexia, chills.  Additional information: It was reported that, the 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, has the patient been tested for COVID-19 was reported as no. The reporter considered the events as non-serious. The device date was on 28Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney failure.....Total blockage of left lung. 9 inch clot in right ventricle.
Patient felt tightness in neck while still in office on afternoon 4/9/07.  Patient states that awoke next am c/o pain, redness, and warmth at injection site.  Pt later seen at emergency room with temp to 103 per her report to MD office 4/17.  Patient treated with antibiotics and diagnosed with cellulitis as well as allergic reaction.  5/9 patient seen in f/u my office and still had palpable 2 cm firm knot in left upper lateral arm.
Developed  significant widespread myalgias within several days of vaccine - and ongoing  myalgias in both hips and  right thigh
On March 8, 2005, I took my son for his 2 years well visit where he received the Pnewmococcal vaccine.  At approximately 8:00pm, I felt my som was very hot and I took his temperature which was 102.5.  I immediately called the doctor service and spoke with the doctor who gave me instruction to follow to reduce the temperature which I have followed.  My son had a fever range from 100 to 103.4 for 5 days.  On the six day, his temperature reached 104.4, luckily I was at the doctor's office and he gave an antiboitic injection, which reduced the temperature to 101.7.  On the 7th day, the doctor gave my son another antiboitic injection, which reduced the temperature to 100.  At this time his temperature is ranging from a 99.7 to 100.
Lightheaded,  blurring of vision . Paleness , diaphoresis Hypotensive and bradycardia.  Shock . Remained awake BP 58/30 Pulse 40 / min  Immediately sent to Emergency Department
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, adverse reaction and impaired work ability. On an unknown date, the outcome of the fever, adverse reaction and impaired work ability were unknown. It was unknown if the reporter considered the fever, adverse reaction and impaired work ability to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The reporter mentioned that after receiving SHINGRIX, many of his patients had complained to him about the unpleasant reactions. They complained of fevers and being out of commission for 24 hours. The reporter did not have any specific patients to mention, was just relaying information that he has heard from his patients.
Loss of amniotic fluid, was seen at medical clinic frequently, up until the shot, baby was measuring normally as well as fluids. Once shot was administered I started experiencing leaking (went to Labor and Delivery ER), however they could not determine if it was amniotic fluid. Follow up appointment June 19th was when I was told baby was not measuring as she should. Estimated due date was August 11th, she was born on July 17th, due to low amniotic fluid and preeclampsia. Birth weight was 5lbs 3onces
Cough; Wheezing; Problems breathing; Body aches; triggering of her asthmatic problems; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), WHEEZING (Wheezing), DYSPNOEA (Problems breathing), PAIN (Body aches) and ASTHMA (triggering of her asthmatic problems) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced COUGH (Cough), WHEEZING (Wheezing), DYSPNOEA (Problems breathing), PAIN (Body aches), ASTHMA (triggering of her asthmatic problems), PYREXIA (fever) and HEADACHE (Headache). On 25-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, COUGH (Cough), WHEEZING (Wheezing), DYSPNOEA (Problems breathing), PAIN (Body aches), ASTHMA (triggering of her asthmatic problems) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Narrative: COVID infection following COVID vaccine series 06/24, Pfizer, dose #1 07/14, Pfizer, dose #2 08/19 COVID swab, result: detected 08/19 SARS-COV-2 Variant Sequencing result: pending 08/20 pt cc: cough, rhinorrhea, exposure; unknown
Severe pain in joints and severe headache that lasted 48 hours, almost bad enough to go to ER.  Acetaminophen did not relieve.  Slight relieve with aspirin.
Increase in the level of Tinnitus.  This has been going on since the first shot of the Covid vaccine that was administered on February 26, 2021 but subsided after five or six days. The level of my tinnitus spiked up after the second shot on March 19th and I am still suffering from this side affect.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Expiry date was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included non significant information.
warm face; Nausea/vomiting; Nausea/vomiting; Chills; tachycardia; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), SKIN WARM (warm face), VOMITING (Nausea/vomiting) and CHILLS (Chills) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), VOMITING (Nausea/vomiting) and CHILLS (Chills). On an unknown date, the patient experienced SKIN WARM (warm face). At the time of the report, TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), SKIN WARM (warm face), VOMITING (Nausea/vomiting) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Heart rate: 115-120 (High) 115-120. On 14-Mar-2021, Oxygen saturation: 98 percent (Inconclusive) 98%. On 14-Mar-2021, Respiratory rate: 16 (Inconclusive) 16.     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.   Patient was monitored for 30 minutes by the onsite nurse.  No concomitant medications were reported.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: This follow-up was received on 24-MAY-2021 which updated historical condition, lab data, dosage details and new events.
This spontaneous report as received from a regulatory associate (also reported as health care worker) refers to a female patient of unknown age. On 19-OCt-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # J006242, expiration date 03-AUG-2014, dose, route not reported) for vaccination. On 19-OCT-2013 the patient experienced the area of injection was "swollen, red and hot". The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
About 5 hours after receiving the vaccine, I started to feel mild shoulders and body aches. At about 9:00pm, my temperature was 100.5, I have a moderate to severe shoulder and body pain, moderate to severe weakness, and fatigue. I took some Advil before midnight of 2/1/2021 but the symptoms remained the whole night. In the morning about 7:30am, my temperature was 100.9. Still having some chills and, shoulder and body pains. I took some Advil again, after a couple of hours, my temperature went down to 99.3,. My shoulder and body pains starts to subside. No headaches experienced.
Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.; No adverse event; patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 30-Aug-2021.).    No concomitant was reported. 40 patients received the Moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge. Vaccines were stored in the fridge on 30Jun2021, there are different administration dates, starting on 02Aug2021 until 20Sep2021 being the last one. Patients did not report any side effects.  The case reported for 21 of 31 patient.  No treatment detain was reported.   This case was linked to MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-698994:Master case
This spontaneous report has been received from a female pharmacist of unknown age, who was reporting on herself. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-DEC-2015, the pharmacist was splashed with an unknown dose of ZOSTAVAX (lot # and expiry date were not reported) in both eyes before administration; she experienced inadvertent vaccine contact with eyes. On the same date, she experienced mild burning in both eyes. The patient did not seek medical attention. The outcome of burning in both eyes was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
1/4/2022 arrived to ED with weakness, hypotension, +covid19 Patient reports cough that has been going on for a couple of "weeks" that has worsened and husband reported he had trouble waking up his wife, reports loss of taste/smell.
Generalized seizure (1st) < 24 hrs after DTaP, Hib, IPV and Prevnar.
Redness, itching, burning, hot on touch 1 week after shot administered. 4 inches in diameter.
Case number PHEH2014US024164 is an initial spontaneous report received from a health care professional on 01 Dec 2014. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A14030) intramuscularly at a dose of 0.5 ml on 18 Nov 2014. It was reported that the vaccine reached 0 to 1 degree C sporadically for 3 days when it was not reconstituted and was subsequently administered to the patient. The reporter stated that the vaccine did not freeze and it was the first occurrence. No adverse events were reported following the maladministration.
Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation concerning a male patient (age not reported) who was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 03-JUL-2012 at a clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused patient to contract a persistent strain of herpes zoster. On or about 06-JUL-2015, patient was treated by two physicians for a painful rash that was diagnosed as herpes zoster (shingles) with ophthalmic interference (in the eyes). Patient had been prescribed valcyclovir for management of his symptoms and outbreaks. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Upon internal review, ophthalmic interference (in the eyes) was determined to be a medically significant event. Additional information has been requested.
Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Generalized maculopapular rash on trunk and extremities, non itchy. Patient has no fever no other symptoms. Rash started 3 hours after receiving vaccines.
I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of my 9 hour shift I was very stiff in all of my lower joints from the hips down as well as uncomfortable from the achiness. I walked slowly and stiffly as I was leaving work. I felt extremely tired that night and decided to work a shorter shift the next day - 8 hours rather than 9 hours. I took ibuprofen prior to my second shift. I was still achy and stiff but it was a little better witht he ibuprofen. The next day at home on the weekend I was again achy and stiff and took ibuprofen. I woke up on 1/25 with swollen hands that were painful and stiff. I have since had daily swelling of both hands and achiness in wrists non
Information has been received from a physician concerning a 69 year old male who on 26-JUL-2007 was vaccinated with a single first dose on left arm of ZOSTAVAX (lot # 656858/0356U). Concomitant therapy included simvastatin, VERAPAMIL ER, WELLBUTRIN, hydrochlorothiazide, VICODEN, DEMEROL, ezetimibe and unspecified therapy. On 01-SEP-2007, the patient developed a bullous rash. The patient was seen at physician's office on 10-SEP-2007 to inform him of the issue and the physician treated the patient with ATARAX and a series of steroidal cream for the itching. The patient underwent biopsy. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the health professional who works in the lab who stated that the patient currently had vesicles on his hand. Additional information has been received from the physician who stated that the patient on 01-SEP-2007 developed vesicles that was described as vesicular rash with countless lesions on extremities. Follow up information was received from a nurse who reported that the patient had numerous fluid filled vesicles on all of his extremities and his trunk. The nurse reported that the patient had a biopsy done (date and location unspecified) of which the results were still pending. The nurse noted that the patient had not yet been assigned a diagnosis, due to the pending results. At the time of reporting the patient was "not totally better". Additional information requested. This is in follow-up to report(s) previously submitted on 12/21/07. Additional information was received from the physician. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The physician reported that on 25-OCT-2007, the sample was collected and arrived in the laboratory on 26-OCT-2007. Interpretation of the sample revealed inadequate specimen, negative for betaglobin no strain ID. No further information is expected.
Fatigue; Left arm was really hurting; Patient received a third full dose instead of a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Left arm was really hurting) and ACCIDENTAL OVERDOSE (Patient received a third full dose instead of a booster dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Left arm was really hurting) and ACCIDENTAL OVERDOSE (Patient received a third full dose instead of a booster dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), VACCINATION SITE PAIN (Left arm was really hurting) and ACCIDENTAL OVERDOSE (Patient received a third full dose instead of a booster dose) outcome was unknown.            No concomitant medications were reported. Patient received a third full dose instead of a booster dose and was not immunocompromised   This case was linked to MOD-2022-571007, MOD-2022-570986, MOD-2022-570966, MOD-2022-570982.
Redness spreading out over large area, itching, fatigue, very hot to the touch. Started almost 24 hours after administration
No additional AE reported; vaccines were previously short dated for 1 month after excursion and then were administered after the short date; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not provided      On 25-OCT-2021 (also reported as 1 month after excursion and after the short date), the patient was vaccinated with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, and anatomical location were not reported; lot number T032321, had been verified to be a valid number; expiration date 22-SEP-2022). The  temperature  excursion was at 55.9 degrees Farhrenheit on 15-SEP-2021 for a time frame of 30 minutes. No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA002247: US-009507513-2111USA002253: