chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache; Nausea; Axillary Adenopathy; Fever; Malaise; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, and all previous Pfizer COVID-19-19 vaccines [Comirnaty]), for Covid-19 Immunization, reaction(s): "Severe headache", "Axillary Adenopathy", "Malaise", "Nausea", "Fever". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Severe headache"; NAUSEA (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Axillary Adenopathy"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MALAISE (non-serious), outcome "unknown".  Additional Information: It was reported that within 14 hours after administration of Pfizer COVID-19 vaccine, bi-valent (and all previous Pfizer COVID-19-19 vaccines [Comirnaty]). Name of Product: Pfizer-Moderna COVID-19 vaccine, bi-valent. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Awoke early in the morning (Oct. 23) after receiving vaccine at 5am with headache, sore throat, fatigue and body aches at 12:30pm had fever of 102.7 which responded to tylenol. Later in evening fever was 101.8 at 9pm and again responded well to tylenol. Symptoms persisted into the next day (Oct. 24th) until about 1pm. Had low grade fever 99.4 in the morning. Symptoms had significantly decreased by 2pm.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and allergic reactions were unspecified. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of PROQUAD dose 0.5 ml, subcutaneously (Lot # M043310 with expiry date 24-APR-2018) for prophylaxis. The nurse could not provide the lot number and expiration date for the properly stored sterile water diluent used to reconstitute the doses of the vaccine. The vaccines were exposed to a temperature 23 F for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. Digital data logger was involved.  No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA004916.
received only the diluent portion of the Menveo; received only the diluent portion of the Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received only the diluent portion of the Shingrix, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter mentioned no symptoms were reported. The reporter stated no lot number, expiration date or administration date were provided. The reporter consented to follow up via email.
2 days after receiving the vaccine pt started complaining of increased redness, swelling and itching around the injection site. Upon inspection, the deltoid muscle was warm to the touch and inflamed. He was given BENADRYL.
headache; body ache; temperature 99; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (body ache) and PYREXIA (temperature 99) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PAIN (body ache) and PYREXIA (temperature 99). At the time of the report, HEADACHE (headache), PAIN (body ache) and PYREXIA (temperature 99) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
At 11:47 patient notified monitoring personnel that she was not feeling well. She states her nose and sinuses are burning, she feels tired, her back is hurting, she is nauseous, the left side of her face and her left arms are tingling, her ear is hurting. Blood pressure is 120/74 and pulse is 88 beats per minute. 911 is called at 11:57 due to left sided numbness and tingling. Patient reports her ear pain is getting worse. Fire department arrives on scene at 12:06. Ambulance arrives for patient evaluation at 12:10. Patient refuses to be transported by ambulance and leaves with her mother at 12:25.
Diarrhea; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration in 22Dec2020 at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. Patient had the COVID vaccine on evening, 22Dec2020, and around 5:45am, morning of 24Dec2020, patient started having some diarrhea. Patient was wondering if that was a known side effect of the product. The outcome of the event diarrhea was unknown.   Information on the lot/batch number has been requested.
15 mins post vaccine pt had headache, lightheadedness.  Brought to aid station, BP120/81,  HR 90, 95% RA, complain of shortness of breath and given 2 puffs albuterol.  O2 sat increased to 98-100% RA, discussed epi and patient did not want to administer, patient continued to be diaphoretic, reported increasing lightheadedness and "feeling very tired", repeat BP 95/61, EpiPen administered and EMS called, Benadryl 50 mg PO administered.  Patient noted improvement in lightheadedness and BP 131/60, patient transported via EMS for further evaluation and monitoring.
5 patients administered vaccine after temperature excursion; 5 patients administered vaccine after temperature excursion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients administered vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (5 patients administered vaccine after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients administered vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (5 patients administered vaccine after temperature excursion). On 27-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients administered vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (5 patients administered vaccine after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-373513 (Patient Link).
Significant hearing loss, resulting in hearing aids in late 2021.  Also, regular blood labs taken on May 21, 2021 showed a rise in Alkaline Phosphatase to 175 (from 71 on May 14, 2020).  These increases continued and got as high as 506 on May 24, 2022.  I am seeing a liver specialist, whose tests show significant liver scarring.  Research indicates that there have been a number of other cases stating that the vaccine cause liver damage.
A report was received from a healthcare professional concerning a female vaccinee of unspecified age who experienced a rash and itching on her whole body 2 days after receiving Fluvirin on 10/21/2003. On the 23 October 2003, the vaccinee experienced a rash and itching on her whole body.  The vaccinee recovered approximately 5 days later. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional concerning a 37 year old vaccinee who experienced a generalized itchy rash on her arms, trunk and back on 17 October 2003, 2 days after receiving Fluvirin on 10/15/2003. According to the reporter the event is most likely resolved. No follow up pending, no further information available.
Subsequently, the pt experienced chickenpox. Another pt was reported who experienced lesions following vax, after exposure to this pt.
Moderna COVID-19 Vaccine EUA.   Second Injection -Within 4 hours of injection, large red, swollen, painful lump appeared on left arm.  This was followed by a 101F fever all night.  This morning, slight fever is still evident.  No energy.  Fever caused entire body to be in unusual pain.  Spasm shooting pains in left groin area and right neck area.  First injection there was no problem until 7 days after injection and then it was the large red swollen itchy bump on left arm.  This went away after about 4 days.  No fever.
Patient presented to hospital with SOB and swollen and weeping legs. He was found to have bilateral edema and pleural effusions. Thoracentesis was preformed to remove fluid and 1500ML was removed.
Body aches for 5 days, low fever for 2 days (100 degrees), fatigue (stayed in bed for 2 days and low energy for the next 3 days), swelling and pain in armpits, swelling and rash at injection site.  I took tylenol, increased hydration, limited activity, and increased sleep . Symptoms started Thursday afternoon. I was in bed from Thursday afternoon until Sunday morning.
This spontaneous report as received from a pharmacist via a company representative, refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date, reported as long time ago, the patient experienced shingles. On an unspecified date, the patient recovered from the event. The relatedness between shingles and the suspect therapies was not provided. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007879:
fully vaccinated last march, had a positive case in August; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (fully vaccinated last march, had a positive case in August) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (fully vaccinated last march, had a positive case in August). At the time of the report, COVID-19 (fully vaccinated last march, had a positive case in August) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Company comment: This case concerns a patient of unknow age and gender with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred approximately 4 months after the second dose of mRNA1273. As reported, the patient was fully vaccinated last march, had a positive case in August. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA1273  in not affected by this report.?; Sender's Comments: This case concerns a patient of unknow age and gender with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred approximately 4 months after the second dose of mRNA1273. As reported, the patient was fully vaccinated last march, had a positive case in August. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA1273  in not affected by this report.
Information has been received from a nurse practitioner concerning four patients who were vaccinated with Gardasil (yeast). Subsequently the four patients experienced a fainting episode. At the time of the report, it was not reported if the four patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
No additional adverse event; Caller reports that lot expired on 10/22/22 and was administered to adult patient on 11/18/22.; This spontaneous report was received from a medical assistant and refers to a 28-year-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 18-NOV-2022, the patient was vaccinated with a expired lot of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter, lot #U024378, expiration date: 22-OCT-2022, administered for prophylaxis (strength and route of administration were not provided). No additional adverse event was provided.
Typical side effects, nothing extreme or noteworth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Typical side effects, nothing extreme or noteworth) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Typical side effects, nothing extreme or noteworth). At the time of the report, VACCINATION COMPLICATION (Typical side effects, nothing extreme or noteworth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided No treatment details were provided.   This case was linked to MOD-2021-400021, MOD-2021-400021 (Patient Link).
71-year-old female with a PMH significant for COPD (3 L NC O2 dependent in HS/w activity), emphysema of the lung, L-VATS s/p emphyema, hyperthyroidism, former tobacco dependence, vaccinated x2 Moderna who presented to the ER for evaluation of worsening SOB, 89%/2L NC O2 sat last HS, sore throat and generalized weakness onset 12/31. Yesterday 1/1, she began taking Cipro and increased prednisone to 10 mg-per Pulmonary. This morning she felt nauseous, sweaty, "like I was passing out" with O2 sat 90-92% at rest down to 89% w activity an HR in the 150s. Denies any sick contacts but she is "active in the community" has been socializing without a mask at times. In the ER, her O2 saturations have been ranging between 92-100% on RA. HR better controlled 80-90s, afebrile. CXR read as negative for acute cardiopulmonary disease. Labs unremarkable, inflammatory markers pending
Client reports Dizziness, Headache and Nausea but no vomiting.
Warm to the touch; Rash; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment provided include diphenhydramine tablet and cream.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Report
Initial report received from a healthcare professional on 08 December 2008. An adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) and a first intramuscular left deltoid injection of FLUZONE (lot number U2761AA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, fever and sore arm. No diagnostic tests or lab data were performed. The patient received treatment symptomatically and recovered. No additional details were reported. Follow-up information received on 09 February 2009 from a health care professional. The injection site swelling was approximately one inch. According to the reporter, the events resolved in five to seven days.  Follow-up information received 16 March 2009 from a health care professional. The reporter verified that the patient's right arm had been sore. ADACEL had been administered in the patient's right deltoid and FLUZONE was administered in the left deltoid and it had been greater than two years since the patient last received a Td booster. Corrective treatment consisted of a compress and exercise. No further information was provided. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03925, 2008-03926 and 2008-03923, all from the same reporter.  Documents held by sender: None.
pt recv vax 14AUG95 & pt devel immed redness @ the site of inj & itching;tx w/ice packs & recovered;
injection site red; injection site burning; injection site swelling; injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site burning), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itching) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included MELATONIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site burning), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itching). At the time of the report, INJECTION SITE PAIN (injection site burning), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itching) outcome was 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.   patient was taken treatment DIPHENHYDRAMINE HYDROCHLORIDE IN NIGHT Treatment included Benadryl
The patient fainted after receiving the vaccination.  He stated he had fainted before when given other vaccines, stated he was beginning to feel lightheaded and decided to lie down.  For a couple of seconds he was unresponsive but then recovered.
I received my first shot March 18 , I am concerned because my second shot was August 6; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (I received my first shot March 18 , I am concerned because my second shot was August 6) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 044a21a) for COVID-19 vaccination.     The patient's past medical history included Heart attack (patient had a heart attack on the past). Concurrent medical conditions included Diabetic, High cholesterol, Hypertension, Walking pneumonia and Drug resistance.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (I received my first shot March 18 , I am concerned because my second shot was August 6). On 09-Aug-2021, INTENTIONAL PRODUCT USE ISSUE (I received my first shot March 18 , I am concerned because my second shot was August 6) had resolved.            Concomitant product use was not provided by the reporter.  Vaccination date of the second dose was ambiguosly reported as August 6 and August 9.  It was reported that the patient was concerned because second shot was August 6 and he would die if he would got Covid because he had walking pneumonia from 15. Patient had bad kidney pains in left kidney which he did not report or go to the hospital because he had no insurance.  Patient was grateful about the vaccine and made several comments regarding masks and people's behavior regarding the pandemic but blamed the Moderna COVID19 vaccine affecting his life because of the numbness on his hands and the pain in his kidneys.  It was reported that the patient did not get the second shot till August because he was trying to research if he would have that problem again which he did not for the second shot or vaccine shot.  Patient made the following statement: with the 2nd shoot everything was fine.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Follow up received included new event (Hypoesthesia) was added, reporter details, patient details, suspect product details, event verbatim of renal pain and I narrative was updated.