chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm pain/right arm pain; shingles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain/right arm pain) and HERPES ZOSTER (shingles) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Left arm pain/right arm pain) and HERPES ZOSTER (shingles). At the time of the report, PAIN IN EXTREMITY (Left arm pain/right arm pain) and HERPES ZOSTER (shingles) outcome was unknown.            Treatment information was not provided. No concomitant medications were reported. Patient stated that she was fully vaccinated.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13 May 2021 included no new information.
Breathing problems Difficulty in taking a deep breath  He was given Motrin by the doctor.
High heart rate/Heart rate 130-140; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (High heart rate/Heart rate 130-140) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HEART RATE INCREASED (High heart rate/Heart rate 130-140) (seriousness criterion hospitalization). The patient was hospitalized from 13-May-2021 to 17-May-2021 due to HEART RATE INCREASED. The patient was treated with METOPROLOL TARTRATE ongoing since an unknown date at a dose of 25 mg; APIXABAN (ELIQUIS) ongoing since an unknown date at a dose of 5 mg and FUROSEMIDE ongoing since an unknown date at a dose of 40 mg. On 13-May-2021, HEART RATE INCREASED (High heart rate/Heart rate 130-140) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: 130-140 (High) 130-140.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEART RATE INCREASED (High heart rate/Heart rate 130-140) to be possibly related.    Concomitant product use was not provided by the reporter. Doctor stated that the event happened due to the vaccine.  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.
diarrhoea; Hardness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness at the injection site) and DIARRHOEA (diarrhoea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the injection site). On 12-Mar-2021, the patient experienced DIARRHOEA (diarrhoea). At the time of the report, VACCINATION SITE INDURATION (Hardness at the injection site) and DIARRHOEA (diarrhoea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.   No treatment information was reported.   Reporter did not allow further contact
Rash developed on 12/12/19 about 5:30 pm on his chest. Presented to the office 12/13/19 with confluent blanchable maculopapular rash to chest, abdomen, back, extremities, and faint to forehead. Per provider appears to be secondary to MMR vaccine.Provided education to parent re expected course of rash. No treatment needed at this time.
Information has been received from a mother concerning her then approximately two year old male with asthma and hypersensitivity who "some time" in 2002 was vaccinated with ATTENUVAX (dose, route and lot number not reported). There was no concomitant medication. The mother reported "about two weeks after receiving the vaccine", the patient had a high fever, diarrhea and then broke out in a rash and the patient was diagnosed with the measles. The patient was recovered in "unspecified date" and he sought medical attention at the physician's office. Additional information is not expected.
Reaction two weeks post injection which resulted in a red, itchy rash; Reaction two weeks post injection which resulted in a red, itchy rash; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH PRURITIC (Reaction two weeks post injection which resulted in a red, itchy rash) and ERYTHEMA (Reaction two weeks post injection which resulted in a red, itchy rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Reaction two weeks post injection which resulted in a red, itchy rash) and ERYTHEMA (Reaction two weeks post injection which resulted in a red, itchy rash). At the time of the report, RASH PRURITIC (Reaction two weeks post injection which resulted in a red, itchy rash) and ERYTHEMA (Reaction two weeks post injection which resulted in a red, itchy rash) outcome was unknown. Unknown      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.   No concomitant medicines were reported Reportedly, the patient was advised to take some diphenhydramine (Benadryl).
Pt received the COVID vaccine {Pfizer, lot # EN6202 and exp date 06/30/2021 at (1319)}. EMT observed patient return to observation area after completing required 15 minute observation period. EMT and RN co-lead responded when patient stated she felt, "shakey, flushed", had a "knot in her stomach", and her, "throat felt tight". Patient's vitals were immediately taken and had a BP of 138/82 with a HR of 106 bpm. As patient was still able to converse with staff, patient was given 50mg of PO Benadryl and was placed in the zero-gravity chair at 14:03. At 14:09 the patient's BP was 138/82 and was visibly less flushed. Then at 14:16 the  patient's HR was 89 bpm and her BP was 126/72 at 14:30. Patient verbalized feeling safe, was alert and oriented x3 and left with her husband who drove the couple home from the facility at 14:34. Throughout encounter patient was offered EMS several times and patient continually declined EMS services as her husband was, "on his way".
1st dose face rash, and chest area for 2 weeks .   After 2nd dose, feeling always muscle weakness, fatigue, and unable to do active for long periods of time.  Still feel pain in injection site after this long time period. Over all just weak.
shortness of breath, happened after both 1 st shot and 2 nd shot.; This is a spontaneous report received from a non-contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UNKNOWN) in the right arm via an unspecified route on 26Feb2021 at 10:00 as DOSE 1, SINGLE (at the age of 57-years-old) for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Medical history included , covid-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Since the vaccination, patient had not been tested for COVID-19. The patient was allergic to lisinopril and losartan. Patient later received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UNKNOWN) in the right arm via an unspecified route on 19Mar2021 at 10:30 as DOSE 2, SINGL (at the age of 57-years-old) for COVID-19 immunisation. On 26Feb2021 at 20:00, the patient was having difficulty in breathing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Abuterol inhaler was given as treatment the for the event. The clinical outcome of the event difficulty in breathing was resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated narrative to reflect the Dose Description as DOSE 2, SINGLE, Lead sentence (a non-contactable consumer), medical history (COVID-19) and vaccination facility information was added.
exp euphoria x 2 hrs then in PM started w/stomach aches, burning, n/v; sx inc x 3 days; on 3rd day pt became depressed which became worse & stated had suicidal thoughts; called MD but they had no tx; sx peaked on day 4;
Pericardial effusion following first Pfizer COVID-19 vaccination. Treated outpatient and resolved. Patient received second vaccine and experienced chest pain, shoulder pain, shortness of breath. Found to have pericardial effusion and pleural effusion. Required pericardiocentesis with placement of drain and thoracenteais. Remains with residual pericardial effusion at discharge home.
Information has been received from an administrator, who also works as a medical assistant, referring to an unknown number of patients of unknown age and gender. Information about concurrent condition, concomitant therapies, drug reactions/allergies and medical history was unknown. From 02-JUN-2017 to 22-JUL-2017, the patients were vaccinated with improperly stored VARIVAX (dose, route and lot # were unknown) for prophylaxis. The reporter stated that if the VARIVAX were to go over 14 Fahrenheit (F), the patients who were administered the vaccines would need to be revaccinated (It was also reported that "no doses were administered" (conflict information)). No adverse effect was reported. The vaccines were under the temperature in the range of 6 F to 14 F: 6 F for 1 hour and 30 mins, 8 F for 5 hours, 5.6 F for 45 mins, 8 F for 7 hours, 8 F for 3 hours, 6 F for 1 hour, 9.7 F for 30 mins, 6.4 F for 5 hours. There was no previous temperature excursion. A data logger was used. On 06-OCT-2017, a call was placed to the medical assistant. The medical assistant stated that a patient (unknown age and gender) was vaccinated with an improperly dose of VARIVAX from lot# N000683 with expiry: 06-JAN-2019, on 22-JUN-2017. This is one of two reports received from the same reporter. Patient name, vaccination date and narrative updated. Sender's Comments: US-009507513-1708USA010189.
STREAKING AND "INFECTION" NEAR THE INJECTION SITE. STREAKING ABOVE THE INJECTION. BUMP FELT AT SITE.
This spontaneous report was received from a 57 years old male patient, reporting on himself. The patient had no pertinent medical history or drug allergies/reactions. Concurrent conditions and concomitant therapies were not reported. On 26-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 Intramuscular, and ZOSTAVAX intramuscular. Dose, dose number, lot number, expiration date and anatomical location for both vaccines were not provided. The patient stated that "the pharmacist informed him that there was no problem with getting both vaccines together and that the information in the prescribing information concerning drug interactions had been changed". The patient upon the suggestion of the pharmacist received both injection, and the next day began to experience a fever of 100.4 (no units provided), body and joint aches from his ankles up to his neck. The patient also experienced swollen glands under his arm pits, sore and red testicles, headaches, tiredness, and difficulty walking due to the joint aches. On 28-JUL-2016, the patient saw his physician, who prescribed TYLENOL for the pain. The patient stated that although it was "somewhat better" he was still experiencing the symptoms and therefore the outcome of the events was reported as recovering. At the time of reporting the causality assessment between the events and the suspect therapies was not reported. There was not a product quality complaint involved. Additional information has been requested.
T102-103.9 aux, diarrhea, anorexic, fussy, refused to sleep;rxn most severe day #1 & 2 then not back to normal behavior till 7 days;T103.9 went to ER;
Eye was swollen; Lips were swollen; Itching really bad to where it burned; Hives all over body; Two days later the welts continued; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 09:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient has no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) and trazodone (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 16:00, two days after the first dose of vaccination the patient experienced itching really bad to where it burned and that night had hives all over the body. On 19Apr2021, the welts continued and patient 's eye was swollen and that night lips were swollen. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with prednisone  (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), and famotidine (PEPCID)  till it cleared up. The clinical outcome of the event itching really bad to where it burned, hives all over body, the welts continued, eye was swollen and lips were swollen was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Erythema, induration, tenderness around site extending about 3 inches by 1 inch.
This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) and VACCINATION SITE PRURITUS (On day 3 it started itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) and VACCINATION SITE PRURITUS (On day 3 it started itching). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff muscle/3 x 4 inches south of vaccine injection) and VACCINATION SITE PRURITUS (On day 3 it started itching) outcome was unknown. Not Provided          No relevant concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-067352 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24 Jun 2021 contains no new information On 15-Jul-2021: Follow up received on 15 Jul 2021 contains no new information
This spontaneous report as received from a physician assistant via company representative refers to 4 patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the 4 doses of improperly stored PNEUMOVAX 23  due to being "in transit for 7 days" were administered to 4 unspecified patients. No adverse effects reported. The outcome of reported events is unknown. No product quality complaint was involved. This case is linked to the case 1503USA013841 via same reporter link. Additional information has been requested.
Information has been received from a pharmacist concerning an adult female employee who "about a month ago" on approximately 19-AUG-2006 was vaccinated with her first dose of Varivax and experienced a generalized rash. She missed one week of work but had since returned to work. As of 19-SEP-2006, the patient's rash resolved and no lesions were present. Additional information has been requested.
My bottom right lip is swelling and the skin is turning yellow. There is sharp pain, pins and needles, and loss of feeling in parts of the lip area. The inside of my mouth is slightly tingly.
This spontaneous report as received from an about 38 year old male consumer with no pertinent medical history refers to himself. The patient had drug reactions/allergies to RONDEC and penicillin. The reported stated that he had first dose of the hepatitis A vaccine, inactivated (manufacturer unknown) (lot# J005680) injection (dose, strength, route and site of administration not reported) on an unspecified date in approximately August 2013, reported as about 2 months ago and a second dose of hepatitis A vaccine, inactivated (manufacturer unknown) (lot#reported as: J005680) injection(dose, strength, route and site of administration not reported). was on 28-OCT-2013. Both doses were administered for employment requirements. It was reported that on unspecified date, in 2013, an unspecified test performed after the first dose of hepatitis A vaccine, inactivated (manufacturer unknown) showed a good level of immunity but the patient elected to get a second dose because of being informed by an unspecified technician that it would not hurt and that it would be for longer-lasting immunity. The reporter stated that, immediately following the first dose of hepatitis A vaccine, inactivated (manufacturer unknown), an unspecified technician told him to wait about 5 minutes and because he felt fine he was released from the clinic. The reporter stated that he felt "a little weird" while travelling back to his work location, but he recovered from the feeling within about an hour of its onset (onset and stop date for the event approximately in August 2013). After receiving the second shot on 28-OCT-2013, the patient felt lousy and experienced dizziness, a foggy head, chest tightness, shortness of breath, and racing heartbeat. When he reported those reactions to his work supervisor, he was sent to be evaluated at the Emergency Room (ER). At the ER, the patient's vitals were taken and, afterward, the patient was sent home from work for the rest of the day. The patient reported that, since receiving the second dose of hepatitis A vaccine, inactivated (manufacturer unknown) on 28-OCT-2013, he had missed work from being sick at home. The patient reported that he himself had been staying mostly in bed with no energy, head pressure, and dizziness. adverse events. The patient did not recovered from the adverse events. The relatedness between hepatitis A vaccine, inactivated (manufacturer unspecified) and the events was not reported. This report is linked to the report:# 1310USA014976, which refers to coworker who was vaccinated with the hepatitis A vaccine, inactivated (manufacturer unknown) with the same lot# and experienced similar adverse events. Additional information has been requested.
Sudden onset gait instability, tinnitus and decreased hearing left ear at 4PM 11/09/06.
Information has been received from a consumer concerning her 1 year old daughter with a murmur and no drug reactions/allergies who on 15-NOV-2007 was vaccinated with a third dose of PEDVAXHIB (lot# 655546/0075U) injected in her leg.  Concomitant therapy on 15-NOV-2007 included PEDIARIX and (therapy unspecified) "PCV vaccine" (manufacturer unspecified).  On 15-NOV-2007 the patient experienced swelling of both legs twice the normal sized and a fever after receiving the third dose of PEDVAXHIB.  No further information was given.  Additional information is not expected.
patient received product that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307319, 2019SA307320, 2019SA307321 and 2019SA307322 (same reporter).  This case involves a 88 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] which had undergone delayed shipping transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ290AB, expiry date- 09-JUN-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Debilitating fatigue; Extreme chills; Headaches; Joint pain; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; both for COVID-19 immunisation. The patient's medical history included COVID from Dec2020 to an unknown date. Concomitant medications were not reported. On an unspecified date, the patient experienced: debilitating fatigue (non-serious), extreme chills (non-serious), headaches (non-serious), joint pain (non-serious), loss of taste and smell (non-serious). The clinical course was reported as follows: The reporter wanted to give an update from a patient who had contracted COVID last Dec2020 and experienced symptoms of debilitating fatigue, extreme chills, headaches, joint pain, loss of taste and smell for three weeks, and had experienced most of these same symptoms after being inoculated three times with the vaccine.  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
pt recv vax 18JUN97 & there was no concomitant med;15min p/vax pt exp lt shoulders, elbow & wrist pain;felt better & as soon as started using the arm felt worse;no swelling or discoloration was noted;