chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Transmission of drug via semen; This spontaneous report was received from the patient's and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was exposed to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) via his husband's semen(exposure via body fluid). ; Sender's Comments:  US-009507513-2101USA001097: US-009507513-2012USA013606:
Symptoms 4/19 diarrhea; 4/22-4/23 fever 99.5-101.3; 4/24 Morning temperature, rash appeared red dots on belly, back, neck; 4/24/17 doctors visit. Lack of appetite. Irritability. Clumsiness, loss of balance. As of 4/26 clumsiness, irritability. Cry bursts at night. Child seems to back to normal after 2 weeks.
On 4Jan2022 patient tested positive for COVID-19; On 4Jan2022 patient tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: EW0175) as dose 1, single and administration date 04Jun2021 (Lot number: EW0168) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 04Jan2022, outcome "recovering" and all described as "On 4Jan2022 patient tested positive for COVID-19"; OROPHARYNGEAL PAIN (non-serious) with onset 04Jan2022, outcome "recovering", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain.  Additional information: 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,  the patient has been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19  and the suspect drug BNT162B2 cannot be excluded.
This spontaneous report as received from a nurse refers to a 64 year old patient. Medical history and concurrent conditions were not reported. On 30-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Pt. reported "low grade fever" the evening of 6/19/09 -> reported warmth pain and redness at site of the PNEUMOVAX vaccination on 6/20/09. Reported 102 degrees F/oral temp on 6/20 and again on 6/21/09 when he was seen at clinic -> treated with Cephalexin. Pt. f/u on 6/22/09 confirmed diagnosis of left arm cellulitis -> antibiotic changed to BACTRIM DS (Temp 98.8).
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/4/21). Patient was admitted to the hospital on 4/9/21 for acute hypoxic respiratory failure and was ultimately diagnosed with PJP and HIV/AIDS. On 5/20 patient  had tested positive for SARS-CoV-2 and received treatment with monoclonal antibody.
she is not sure she really got vaccinated. Nurse student administered the shot felt that there was little resistance in the syringe and the administration was too fast as like there was nothing; she is not sure she really got vaccinated. Nurse student administered the shot felt that there was little resistance in the syringe and the administration was too fast as like there was nothing; She felt the needle stick but nothing else; she felt slightly sore in her arm; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), dose 2 via an unspecified route of administration on 23Mar2021 (at the age of 65-year-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on 02Mar2021 (at the age of 65-years-old) dose 1, single for covid-19 immunization. On 23Mar2021, the patient experienced felt slightly sore in her arm, she was not sure she really got vaccinated. She says that the Nurse student that administered the shot felt that there was little resistance in the syringe and the administration was too fast as like there was nothing. She did not know if she really administered her the vaccine, she did not know if there was something in the vial. She felt the needle stick but nothing else. The student nurse did not think she got any medicine in it and she was too afraid to get another shot. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The pain of the flu shot never went away. kept getting worse and worse. got really bad in december.  right after christmas she had to change her plans for holidays.  she contacted her doctor about the pain.  trouble sleeping at night.  cant lay on the left shoulder. cant do her hair. cant tuck in her shirt. painful doing so.
Headache, Fatigue, chills, injection site pain and swelling.  Narrative:
This spontaneous report was received from a nurse, referring to a male patient of unknown age. The patient's medical history, concurrent condition, concomitant therapy, drug and allergy history were not reported. On 09-JAN-2014, when the patient was 16 years old, was vaccinated with the first dose of GARDASIL injection and on 13-JUL-2015, he received the second dose. Vaccinations were for prophylaxis (administration route, lot numbers and expiration dates were not provided). No adverse effects were reported.  Additional information has been requested.
1015AM immed p/vax area of erythema appeared on pt lt arm;w/in 5min red area extended 6inches from inj site;ice was applied to site;BP 102/78;P104 1035AM;BP 108/78, p100;pt alert & states feels fine;
Scratch OT rough. Rash all over body. In her ears also. Right eye closed. went to hospital. Medicine given Cetirizine 1/ml lg 120m
received the first dose of Moderna and the second dose of Pfizer; received the first dose of Moderna and the second dose of Pfizer; a lot of leg pain/his legs hurt a lot; walks with a lot of difficulty; a lot of abdominal pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist). Other Case identifier(s): MDES22-00040 (Moderna), 132485 (Moderna). A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (First Dose), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (disability), INTERCHANGE OF VACCINE PRODUCTS (disability), outcome "unknown" and all described as "received the first dose of Moderna and the second dose of Pfizer"; PAIN IN EXTREMITY (disability), outcome "not recovered", described as "a lot of leg pain/his legs hurt a lot"; GAIT INABILITY (disability), outcome "not recovered", described as "walks with a lot of difficulty"; ABDOMINAL PAIN (non-serious), outcome "recovered", described as "a lot of abdominal pain". The patient underwent the following laboratory tests and procedures: investigation: possible intestinal occlusion, notes: that was then ruled out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product bnt162b2 to the reported events cannot be totally excluded based on a plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Headache; severe joint pain; flush face; snow chills; injection site pain; This is a spontaneous report from a contactable consumer. This 49-Year-old female consumer (Patient) reported that:  A 49-years-female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration, administered on left arm (age at the vaccination was 49 years) on 22Feb2021 02:45 PM at single dose for COVID-19 immunisation. Patient previously had first dose of bnt162b2. Patient medical history included Hypothyroidism, migraines and  knee/foot surgeries. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Patient concomitant medications included Tylenol, Excedrine and ibuprofen, prescriptions. On 23Feb2021 10:00Am, patient had experienced headache, severe joint pain, flush face, snow chills and injection site pain (Vaccination site pain).. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in 2021, the outcome of the events were recovered.  Follow-up attempts completed. No further information expected.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053c21a and 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Pharmacist reported that they had more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  The lot number for the monovalent vaccines with their corresponding BUD dates were 027C21A (BUD - 21-May-2021), 053C21A (BUD - 01-Jul-2021), 939902 (BUD - 02-Sep-2021), 011F21A (BUD - 04-Nov-2021), 012H21B (BUD - 23-Dec-2021), 056M21A (BUD - 12-May-2022), 082B22A (BUD - 08-Sep-2022).   The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A (BUD - 17-Nov-2022), dates of administration 18-Nov-2022 to 28-Nov-2022, 023H22A, (BUD - 15-Dec-2022), dates of administration 16-Dec-2022 to 20-Dec-2022. It was reported lot 042J21A should had been reported with a BUD of 17-Feb-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live  significant Follow-up contains narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
got an expired first dose of the vaccine/just noticed the expiry date was 01Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got an expired first dose of the vaccine/just noticed the expiry date was 01Oct2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got an expired first dose of the vaccine/just noticed the expiry date was 01Oct2021). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (got an expired first dose of the vaccine/just noticed the expiry date was 01Oct2021) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-456443 (Patient Link).
Pt recvd dose 1&2-Sept97&Nov97;Sept97 approx 2 wk p/vax Pt devel macular erythematous generalized rash. Nov97 after recvd 2nd dose, Pt rash "got much worse";Unable to control w/steroids; pt not yet recovered
Patient states a rash has developed on the arm she got her SHINGRIX vaccine in. There are no other symptoms and it is not painful.
Tinnitus in both ears, noted the morning after second dose and fairly constant since then (4 days).  Loud enough to interfere with sleep at night. I hope it goes away!
Patient was given an MMR-V and PNU vaccines Thurs. evening between 4-6:00/pm on 3/1/-7. According to history from her mother, pt was first noticed to have a "few spots on her front and back" Sunday evening 3/4/07 By Monday 3/5/07 she had lots of spots. Tuesday AM 3/6/07 she was covered with a rash from her knees to her armpits Tuesday they took her to see their doctor and were informed it was from her immunization-a reaction. Blood work was ordered and completed. Her temperature peaked at 100 deg. Rash continued for a week, then had purple bruising that faded gradually but could return occasionally. Within 2 wks, all symptoms were gone. Mother said two medications were given.
light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (light headedness). At the time of the report, DIZZINESS (light headedness) outcome was unknown. Not Provided          Concomitant medication use was not reported.  Treatment information was not reported. Patient experienced Elevated blood pressure.   Reporter did not allow further contact
Moderna COVID-19 vaccine not deferred for at least 90 days after receiving Bamlanivimab infusion antibody therapy (monoclonal antibodies)
got the shots I was horribly sick; Initial information was received on 06-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional via social media.  This case involves adult patient with an unknown demography details for whom it was reported that got the shots and was horribly sick (illness), while being received vaccine influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.    On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient was horribly sick  (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
Covid symptoms started 05/23/22; tested positive on 05/27/22. I did have a negative test either Monday or Tuesday. Symptoms were mostly the cough and I started taking Levalbuterol and it would clear it up and I'd be OK the rest of the day. Thursday night/Friday morning around 2 AM I woke up because I couldn't breathe and I use a CPAP machine and I had to take the mask off. The next morning I was stuffy and my mucous seemed different so I took 3 tests and they were all positive. I called my Doctor and she said it sounded like a very mild case and she gave me Paxlovid and I took one dose Friday night and then decided not to take it because there were a lot of risks involved. Since then I did do another test on 05/30 and it still came back positive and the biggest symptom is the cough but I feel OK and feel I could resume normal daily activities.
Started with HA and soreness, developed fever. Over the next couple days had two emergency room visits for ha and vomiting, second visit lead to admission to hospital 11-6-18 with suspected meningitis.  Final diagnosis probable viral meningitis, but no positive cultures.
Severe headache and body aches- not relieved by Max dose of OTC Tylenol,  ibuprofen or codeine.- 2 days  (L)Axilla pain and swelling  onset 12 hrs later- still present day 4 Back pain day 1 to present  Dizziness and nausea, feeling "off" still persists and interferes with daily function day 4
patient experienced syncope reaction after having vaccine.  he was just slouched over in the chair.  came out of fainting pretty quickly and started sweating.  we gave him an ice pack for his neck to cool off and some water.  i checked on him this morning and he's perfectly fine.
Rash on torso, red swollen itchy Came on day ten after moderne vac and is growing  Cortisol cream not effective  Under breast and u shaped around Left hip spread across lower abdomen avoiding pubic hair region Lasting three days now and maybe more
rapid heart rate; an allergic reaction; This is a spontaneous report from a contactable consumer (patient herself) and via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown), dose 1 via an unspecified route of administration on an unspecified date of Jan2021 as dose 1, single for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. Consumer stated that she took the Pfizer COVID-19 vaccine in January. She was experienced a rapid heart rate, immediately. The heart rate was 130 or higher. That was deemed an allergic reaction. She was then advised to not take the second dose. She was called today for more information after having had a reaction and getting the 2nd dose. She states Pfizer advised her not to take it. Also advised not to take Moderna as well. She stated that she knows there was something in the Pfizer product she may be allergic to but unsure if the ingredients are different in the "J&J" vaccine. She had an AE of a very rapid Heartbeat and was told not to take the second dose as a result; she could not take the second dose of the vaccine. Consumer stated for the reason of no lot number, she had no idea. She did not think she was going to be able to get that because she did not even know that they even gave her a vaccination card, so she was not even sure what information, she did not have that with her. On an unspecified date, the patient experienced rapid heart rate and an allergic reaction. The patient underwent lab tests and procedures which included heart rate: 130 or higher on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow up (03Aug2021) This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Starting at 2am had the worst fever, shivers/shakes, headache, aches, and felt weak. Shaking/shivering uncontrollably all night. Tylenol helped but when it wore off I recorded a high 103-low 104 degree fever. Tylenol and a bath helped bring it down, rest of day just headache  and weakness, sweating. By 4pm next day started feeling a bit more normal. The night/morning of was the worst fever/sickness I can remember feeling.
Information has been received from a RN concerning a 3rd grade female who on 05/27/97 was vaccinated with a dose of varicella vaccine live. In mid December 2004 the student developed  chicken pox. According to the  school nurse 58 other students when in mid December 2004 34 of them had been vaccinated with a dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no information regarding the present stats of the 3rd grade student / no product quality complaint was involved. Additonal information has been requested.
Headache, Myalgia, Arthralgia, Localized pain; rigors, photophobia, flushing, chills, fatigue Narrative:
pt recv vax 9OCT95 & pt devel redness @ the inj site;no tx was necessary; pt recovered;
Received vaccine in morning on 2/2/2021.  No noted reaction.  Next morning 2/3/2021, patient started vomiting blood/coffee ground emesis.  Sent to ER.  Hospitalized.  Recovered and readmitted.
Case number PHEH2014US003792 is an initial spontaneous report from the pharmacist received on 21 Feb 2014 with follow-up received on 24 Mar 2014. This report refers to a 64-year-old male patient. The patient was vaccinated with MENVEO (batch number: A11052) at a dose of 0.5 ml intramuscularly into left deltoid on 28 Sep 2013 at 13:43. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration). Follow-up received from a pharmacist on 24 Mar 2014: Patient's demographics, site and time of vaccination updated. Batch number was amended.