chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose; person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine; Sored arm; Chills; Fever; Body is tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Body is tired) and ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR45048, 7006320005, 7006320010 and 7008121001) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2.5 milliliter. On 14-Jul-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine). In July 2022, the patient experienced PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Body is tired). At the time of the report, PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Body is tired) had not resolved and ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine) outcome was unknown.            Patient did not had any allergy. Patient and her 3 children accidentally received doses of 2,5 ml of the Moderna Covid 19 vaccine. No concomitant medication were reported by the reporter. Treatment medication included painkiller for symptoms.   This case was linked to MOD-2022-609068 (Patient Link).
1st shot - no symptoms, only slight sore arm. 2nd shot -  sore arm, very fatigued second day 3rd shot - sore arm, very fatigued after the shot. Extreme fatigue and dizziness for three days. On the fourth day (today) still feeling dizzy. Can?t seem to shake the dizziness and lightheaded mess even with lots of sleep, hydration. Getting worried that this will not go away.
rash; shingles; hurts; This case was reported by a consumer and described the occurrence of rash in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included painful rash (experienced couple years before the reporting).   In June 2019, the patient received the 1st dose of Shingrix. In August 2019, between 2 and 3 months after receiving Shingrix, the patient experienced rash, shingles and pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir Hcl). On an unknown date, the outcome of the rash, shingles and pain were unknown.   It was unknown if the reporter considered the rash, shingles and pain to be related to Shingrix.  Additional information received were as follows: The patient started to experience rash on rear about 5 days ago from the reporting date. The patient blamed it on adult diaper rash because the patient had been outside sweating a lot on the weekends. On Wednesday, the patient decided to get 2nd dose of Shingrix. On Friday, on the reporting date, the patient finally went to the doctor and he looked at my rash.  The patient told him it did not itch, it hurts, and had something like this a couple years ago, which took about 3 or 4 weeks or more to heal, though did not go to the doctor for it years ago.  On the reporting date, the patient was diagnosed with Shingles. The patient was put on Valacyclovir HCl 1gm tablet, every 8 hours, for 7 days. The patient know that it is not supposed to get a Shingrix shot when you have Shingles. But the patient did not even know that the patient had Shingles. The patient asked that would being on the Valtrex (Valacyclovir), reduce the effectiveness of my second Shingrix shot. The patient asked whether do need to consider getting a third shot when the patient do not had Shingles.
Some very common words I have started to forget. It takes me quite a few minutes to recall it in my memory.
This spontaneous report as received from a vaccine coordinator via field representative refers to an unknown number of patients. On an unknown date, the unknown number of patients was vaccinated with MMR II (dose and frequency were unknown). It was reported that the MMR II vaccine shot was more painful that the PROQUAD (Oka-Merck). It was not specified what she meant by more painful. It was reported that the patients completed the dosing regimen. The reporter did not specify when she noticed the pain on the specified patients. The patient sought medical attention and no treatment was provided for the event. The outcome of event was reported as recovered/resolved. The causality of the event was not reported. Additional information has been requested.
acute dyspnea rquiring 10L simple facemask. DC from hosp yesterday, neg COVID during that admission. Did not swab in ER. Malodorus urine, CT chest shows large bilat effusions.  O2 6L NC and lasix, acute CHF. COPD, exacerbation. RRT called, transfer to PCU, placed on bipap. thoracentesis done 1400 ml fluid removed.  pt continued to declined, +COVID test 11/17. dexamethasone, singulair, Vit C&D, zinc. no toci d/t bacteremia. PT DNR. maxed out on bipap. Pt continuously pulling bipap off, then desats. Pt found with bipap off, unresponsive, ambu bag, bipap replaced, sats not above 65%.  palliatvie care on board, care withdrawn.
Chills, nauseous, low grade fever over night. Symptoms lasted for 10 hours.
2-3 inch area around site of injection red and sore. Benadryl cream applied.
aching all over, wheezing, having trouble taking deep breath, eyes very blood shot, chills, fever, vomit (mucus), watery stools, yellow mucus, sticky in eyes;
Information has been received from a physician and someone at the physician's office concerning a 5 year old white male pt with a history of jaundice at birth who on 05Aug03 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination that day, 05Aug03, at 8:30AM included a SC second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 645402/0130N). The physician reported that the pt received the varicella virus vaccine live and the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  concomitantly. On 08Mar04 at 8:45AM the pt experienced break through chicken pox. The pt's case of chickenpox was mild. The pt recovered on 15Mar04. The physician stated that It was interesting since 3 or 4 other students who attend the same school also developed chickenpox. Additional information has been requested. The physician also reported that the pt's brother experienced breakthrough chickenpox following concomitant vaccination with varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (WAES0404USA01731) (someone at physician's office confirmed that WAES0404USA01731 pertains to the pt's brother.
lymph nodes swollen; lymph nodes were painful; fatigue; pain in collarbone area, aunder arms and from shoulders to elbows; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 16:00 (Lot number: ER8735) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Wheat" (unspecified if ongoing); "known allergies: animal dander" (unspecified if ongoing); "anemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Hypothyroid/hashimotos" (unspecified if ongoing); "Hypothyroid/hashimotos" (unspecified if ongoing); "known allergies: hay fever" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VENTOLIN [SALBUTAMOL]; SINGULAIR; SUPER B COMPLEX [VITAMIN B COMPLEX]; D3; LORAZEPAM; MAGNESIUM; VENOFER. Past drug history included: Hydrochlorothiazide, reaction(s): "known allergies: hydrochlorothyazide". Vaccination history included: Bnt162b2 (dose 1, Lot number: EN6206, Administration time: 04:00 PM, Vaccine location: Left arm), administration date: 18Mar2021, when the patient was 22 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Apr2021 12:00, outcome "not recovered", described as "lymph nodes swollen"; LYMPH NODE PAIN (non-serious) with onset 20Apr2021 12:00, outcome "not recovered", described as "lymph nodes were painful"; FATIGUE (non-serious) with onset 20Apr2021 12:00, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 20Apr2021 12:00, outcome "not recovered", described as "pain in collarbone area, aunder arms and from shoulders to elbows". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, fatigue, pain.  Additional information: If other vaccine in four weeks: No. On 20Apr2021 patient noted all lymph nodes in neck, arms and chest were swollen and painful. Over the next few days lymph nodes continued to grow in size and become more painful. On 30Apr2021 while she had slightly less swelling, lymph nodes were incredibly painful and still enlarged. She also fatigued easily. Patient experienced the most pain in collarbone area, under arms, and from shoulders to elbows. She had to miss several days of work due to this reaction.   No follow-up attempts are possible. No further information is expected.
Patient was administered incorrect dosage of Pfizer (0.1).  Vaccinator notified site leader in regards to the above.  Site  leader contacted patient and advised the patient to return to facility to receive the remaining dosage of 0.2.  0.2 was administered and patient was fully vaccinated with the correct dosage of 0.3.
pt recv vax 11AM & 5PM had sz & presented to ER in status epilepticus, hypothermic, hyponatremic;stabilized, intubated transferred to another hosp;
24-26 p/vax low grade fever, gen muscle aches, malaise, sl dec appetite;treating self w/APAP & aleve w/relief of sx;
My son has a red rash all over his body.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 11-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 06Dec2021 at 18:30 (Lot number: FK5127) at the age of 11 years as dose 2 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot number: FK5127, vaccine location: left arm, Administration time: 18:15), administration date: 15Nov2021, when the patient was 11 years old, for COVID-19 immunisation. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 07Dec2021, outcome "not recovered", described as "My son has a red rash all over his body". Therapeutic measures were not taken as a result of rash erythematous.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shortness of breath, Blood pressure elevated and elevated Heart rate. Duration: 30+ minutes.
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Woke up 1/19 covered in full-body hives, continued x5 days (still not fully resolved). Relieved with anithistamines. Continue to have red blotchy spots all over body that come and go, without itching.
vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4JUN2023, Expiration date 30MAY2023).    Concomitant medication was not reported. Vial was initially stored in the refrigerator on 04-Jun-2023. Vial did not undergo any temperature excursions. Treatment medication was not reported.  This case was for the 42nd patient out of 50 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case (Patient 42)
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
22MAY96 pt recv vax 345PM & 5min later mom was driving home pt had 4-5 sz lasting about 30sec & were tonic clonic in nature;eval @ PMD office which was nearby;
This case was reported by a other health professional via call center representative and described the occurrence of fainting in a adult male patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On an unknown date, the patient received HAVRIX 1440 adult (intramuscular) 1 ml. On an unknown date, 1 min after receiving HAVRIX 1440 adult, the patient experienced fainting and pseudoseizure. On an unknown date, the outcome of the fainting and pseudoseizure were recovered/resolved. The reporter considered the fainting and pseudoseizure to be unrelated to HAVRIX 1440 adult. Additional details were provided as follows: The age at the vaccination was not reported. The patient received HAVRIX 1440 adult in the left deltoid. The patient fainted 1 minute after getting the vaccination and fainted again 6 hours later. The patient was taken to the emergency room where it was determined that it was not related to the vaccination.
hospitalized for COVID-19 infection, tested positive on09/10/2021; Signs and symptoms: SOB, headache, body aches cough
1110 Was leaving facility after second dose Pifzer vaccine. She complained of tingling of body, shakiness of hands, and not feeling right. BP 128/72 P82 R 18 Pulse ox 98%. Denies difficulty breathing or sense of swelling of face 1115 Given Benadryl 25 mg per request but requested to take with yogurt as cannot swallow pills with water. No difficulty swallowing or further complaints.  1120 BP 133/78 P70 R20 Pulse ox 97%. States feels tongue is thick but feels secondary to biting tongue. Shakiness has improved slightly. Hands cool to touch, skin warm and dry.  1140 BP 138/78 P 70 R 20 Pulse ox  97%. States feeling better and ready to go home. Denies further complaints. Anxious to be discharged. Ambulated to bathroom with no dizziness and escorted to car with husband.
Pain to left arm, difficult to lift or touch, fever, chills, body aches.  Symptoms improved within 24 hours. No treatment given.
patient was administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine), with no reported adverse event; patient was administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine), with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 6 months old female patient who was administered the liquid component (dtap-ipv) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] without being reconstituted with the powder component (lyophilized acthib vaccine), with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar); rotavirus vaccine live reassort oral 5V (Rotateq) and influenza vaccine (INFLUENZA VACCINE) all for Immunisation.  On 13-Sep-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml total (lot UJ641AAA, expiry date: 28-Feb-2023) via intramuscular route in the thigh nos for immunisation.  On 13-Sep-2022 the patient was administered the liquid component (dtap-ipv) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine without being reconstituted with the powder component (lyophilized acthib vaccine), with no reported adverse event (product preparation error, single component of a two-component product administered, latency: same day for both). Reporter also wanted to know where to find the 0.4% NaCL diluent to mix with the ACTHIB portion.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.