chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; Caller states that she has leukemia and has had a total of 4 Pfizer Covid19 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "has had "no problem" with any of the vaccines"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "has had "no problem" with any of the vaccines"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "has had "no problem" with any of the vaccines". The following information was reported: LEUKAEMIA (medically significant) with onset 2022, outcome "unknown", described as "Caller states that she has leukemia and has had a total of 4 Pfizer Covid19 vaccines"; ILLNESS (non-serious), outcome "unknown", described as "sick". Clinical course: Caller is a consumer/patient who is calling for information on the recommended schedule of Pfizer Covid19 vaccine doses for immunocompromised patients. Patient states that she has leukemia and has had a total of 4 Pfizer Covid19 vaccines, including the 1st and 2nd booster dose and has had "no problem" with any of the vaccines. Caller states that she was told by her pharmacy that she is not eligible for any more boosters. Caller states that she is "scared of the Covid variants" and is asking "isn't there another dose of the Pfizer Covid19 vaccine that I can get since I am immunocompromised". Warm transfer from (Name withheld) with Contact Center. He has a patient on the line and she basically stated one or two months she has leukemia and she was doing ok one or two months ago and a person with immunocompromised was not supposed to take more than one shot and she has had 4 shots of the vaccine.  Agent said he referred her to her doctor. She checked with the pharmacy and was told she cannot get any more shots of the Covid-19 vaccine and she wants a 5 shot. She said she has had 4 of the vaccines and she cannot have anymore per CDC.  She was told immunocompromised supposed to get boosters and she told them the booster was not enough and she needed more and the CDC only approved two boosters. She said she is a patient that is very sick and a few weeks ago she was told she has leukemia and she is looking for how many boosters she can have with an immunocompromised system.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt had bruising, shoulder pain, fever, swelling, and tenderness to touch at injection site of left arm/shoulder. Pt went to urgent care 06/24/22 and was given pain medications and has follow up appointment 7/1/22. Per pt, dr said that "vessel was hit."
Patient called to report heavy vaginal bleeding 24hours after vaccine administration, which lasted for 24hrs, and then subsided.
This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient was between 55 to 66 years of age. The age at vaccination was not reported, but the patient was adult at the time of vaccination. Office manager said that one of their patients experienced rash all over her body from the  trunk and below about 12 hours after administration of the first dose of SHINGRIX. The rash lasted for over a week. The patient did not experience rash on her face.
Patient got up immediately following the vaccination and then passed out in the hallway. He was easily revived and seemed okay.
This spontaneous report as received from a physician refers an unknown number of patients of unknown age. The physician reported that the unknown number of patients might have received improperly stored RECOMBIVAX HB from 21-JAN-2011 to present. No adverse event reported. This is one of several reports from the same reporter (Other MARRS# 1305USA009039, 1305USA010280, 1305USA010281, 1305USA010283). Additional information has been requested.
I had my vaccination on 10/12/2022. I started to have a sore throat on 02/20/2023. I tested COVID-19 negative from 02/20/2023 to 02/23/2023. The morning of 02/24/2023 I tested COVID-19 negative. I started to run a fever and have a very runny nose on that same day. I tested COVID-19 positive on the evening of 02/24/2023. I contacted my physician on 02/24/2023 and I requested PAXLOVID. I presently feel ok but I do still feel like I have brain fog and memory loss.
Patient received DTaP #5 07/08/2003.  Note pain to right upper arm with redness.  Area 11 cm x 9 cm red erythema.  Nonfluctuant.  Afebrile.  Motrin and cool compress.
Client states she had blister like bump inside of nose. No bump visable when examinded by RN.
Vaccine administered 7/12/07  Pt presented at clinic 7/19/07 with c/o of pain R shoulder extending into neck, down R arm, weakness of grip.  Dx tendonitis, tx NSAIDS, sling, recheck 3 days
2nd dose of Moderna vaccine administered on 22nd day; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered on 22nd day) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered on 22nd day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered on 22nd day) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
arm pain in his right arm, at the injection site; This is a spontaneous report received from a non-contactable reporter (consumer or other non-healthcare professional) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 62-year-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm right, administration date 27Jan2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm pain in his right arm, at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sickle cell pain crisis with acute chest syndrome; 4 separate episodes since dose #2 of the vaccine
patient was administered Moderna6-11Y/ 18+BOOSTER not Moderna BvlntBstr, denied any new symptoms
Chills; Diarrhea; Left arm pain about 2 hours after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in right arm on 24Mar2021 at 00:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma and had known allergy to sulfa drugs. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced left arm pain about 2 hours after vaccine, and chills and diarrhea 2 days after vaccine on 26Mar2021. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of events painful Left arm, chills and diarrhea was recovered on Mar2021.   No follow-up attempts are needed. No further information is expected.
It started with a strong headache the day after the second dose which went to the back of the neck and later I started feeling tingling on the left side of my face, I went to the clinic and the doctor told me it was facial paralysis.
Scenario: Pharmacist administered immunization and patient  had immediate reaction to imz. The patient has multiple health conditions such as lupus, cerebral palsy, and is currently on dialysis. She indicated on the PQCF that she had never had an adverse reaction after a vaccine but after the incident, her husband indicated this was normal and not uncommon.    SIG: Pharmacist Administered Immunization   What happened (Describe in detail, what occurred)? * The patient came in for a covid vaccine; this was the first of a 2 series of Pfizer. * The pharmacist injected the immunization and a few minutes afterwards the husband called for the pharmacist to come because his wife didn't feel well. She immediately became unresponsive and her eyes rolled back into her head but she came to. She was responding somewhat to questions but she was also slightly mentally impaired at baseline due to her co-morbidities. She never fell to the ground or wanted to lie down, so not a true faint. * The pharmacist offered to call 911 but they both declined. The patient was given water and a banana and taken to a private area to recover until she fell well enough to leave.  How did it happen? * The Pharmacist administered an appropriate, routine vaccine per protocol. *Patient had an somewhat immediate reaction (~4 minutes) after the vaccine. *The pharmacist followed the adverse event protocol. CPR was not administered nor benadryl.  Why did it happen (Root Causes)? * Unknown; patient has no known allergy to the vaccine but has had adverse reactions to different procedures in the past.  Plan of Action * Make sure all pharmacists are refreshed and aware of the adverse reaction protocol. *Document reaction as a SCRT and with VAERS. What specific task will take place to prevent future recurrence? *N/A. Who: * Pharmacist Where: * clinic When: *All pharmacists at location must review by 3/20.
Information has been received from a physician concerning a child who was vaccinated with a dose of ROTATEQ (lot# not available) orally. Child developed rotavirus after receiving the vaccine and was hospitalized. This is one of two reports from the same source. Additional information has been requested.
Patient did not take the second dose of vaccine.; Nausea; Vomiting; Dizziness; Diaphoresis; Near syncope; Spinning room; BPPV; Mild tinnitus; This spontaneous case was reported by a physician and describes the occurrence of Dizziness, Diaphoresis, Near syncope, Vertigo, and BPPV in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (HTN), Foramen ovale patent (PFO), and Adrenal disorder (Overactive adrenal gland).    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced Dizziness, Diaphoresis, Near syncope, Viertigo, BPPV, Tinnitus, Nausea, and Vomiting. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine). The patient was treated with MECLIZINE at a dose of UNK dosage form, ZOFRAN, at a dose of UNK dosage form; Physical therapy (Vertigo exercises (Epley maneuver)) for Vertigo and Physical therapy (Vertigo exercises (Epley maneuver)) for Vertigo positional. In May 2021, Dizziness had not resolved, Diaphoresis, Near syncope, Vertigo, BPPV, Tinnitus, Nausea, and Vomiting had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) had resolved. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taken to Emergency Room and was discharged on the same day. Patient prescribed for vertigo exercises, Epley maneuver. Concomitant product use was not provided.   This case was linked to MOD-2021-276754 (Patient Link).   Most recent FOLLOW-UP information incorporated above included on 06-Aug-2021: Follow-up received on 06-Aug-2021 and included non-significant information.
Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown dates, the patients were administered improperly stored PNEUMOVAX 23 (lot# and expiration date, strength, dose, frequency and route were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Received TDAP. Arm began swelling. Presents 5 days later with 6cm erythematous raised swollen over deltoid. Denies med or vaccine allergies.
Information has been received regarding a case in litigation from a administrative assistant concerning a 26 year old female with no relevant medical history or allergies who on 15-APR-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot number and injection site not reported).  On 17-JUN-2008, the patient was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (lot number 660553/0070X) (injection site not reported).  Concomitant therapy included birth control pills (unspecified brand).  After the vaccination, the patient became lightheaded.  Her eye rolled back and she seemed to have a severe vasovagal response.  According to the reporter, it seemed like the patient was going to have a seizure.  The patient was sent to the emergency room.  The patient was observed there and released on the same day fully recovered.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Morning after immunizations, child had red, swollen left deltoid.  Also c/o HA & burning throat & not feeling well.  Parent took child to Dr. on Fri, 3-20-09, & she was given antibiotic.  Unsure if reaction was R/T immunization.
swelling of the lymph nodes on his neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling of the lymph nodes on his neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling of the lymph nodes on his neck). At the time of the report, LYMPHADENOPATHY (swelling of the lymph nodes on his neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Site pain swelling. Extreme shivering for 3 hours. Thick mucous. Chest heavy from nipple line up
As soon as I received it within a couple of hours, my face started tingling and that lasted for an hour after that. I noticed that I started to become very heat sensitive. Every time the weather was hot, I would get electric shocks or in the shower with hot water, there would be electric shocks until my body gets accustomed to it. And when there?s hot weather, I still get a rash from the last time So when it?s hot outside, I get the rash. Currently rash is under control because it is cold, but recently had another rash because of the heater. Rash has always been there, just comes and goes.
Beginning on Day 2, nausea on and off sustained now through day 25 Today). Loss of appetite as a result. Extreme muscle pain on day 10 (just day 10). Extreme Fatigue now through day 25, with headache. Dizziness and head pain beginning week 3 after shot. Unable to function properly.  Symptoms are not constant, come and go from mild to extreme.
ActHib administered on 7/21/21 expired on 6/8/21.  No adverse effects noted from the patient as of this time.
sore arm with mild swelling, feeling tired, muscle aches/pain, headache, shivering, insomnia related to sore arm and shivering
PATIENT SAID HAD PAIN & SWOLLEN SAME EVENING IN RIGHT ARM AND NEXT MORNING IT WAS RED, SWOLLEN AND PAINFUL (NOT AT SITE OF INJECTION BUT AREA BELOW AND ABOVE ELBOW). ON 09/14/17 MORNING WENT TO URGENT CARE, THEY DIDN'T HAVE FACILITY TO TEST SO SEND THE PATIENT TO ER, WHERE SHE WAS ADMITTED AND TREATED FOR CELLULITIS AND RELEASED FROM HOSPITAL ON 09/23/17 SATURDAY AFTERNOON. WITH TWO RXS FOR ANTIBIOTICS DOXYCYCLINE AND CEPHALEXIN.
HA, chills, anxiety, tongue and fingers go numb during anxiety attack 4-24-21ER was told she had a panic attack
I had a very light sensation in my hands the evening of the vaccine (like a slight numbness). I also experienced intense, almost crampy pain in my right forearm/wrist area. It lasted maybe 20-30 minutes at the most and then went away. I haven?t had anything like it since, and have had no other symptoms except for the soreness on the left arm where the injection site was. (Note, my dominant/writing arm is the right.)
ACUTE DVT, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
Rotator cuff issues, hurts to sleep on, get dressed, etc. Patient said she felt pain immediatly upon receiving shot.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PMDD" (ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYCYSTIC OVARIES (non-serious), outcome "unknown", described as "PCOS". Therapeutic measures were taken as a result of polycystic ovaries. Additional information: Patient stated, "As a patient with PMDD I spent three days on bedrest coping with PCOS I developed as a result of having gotten the COVID-19 vaccine from Pfizer, but I likely would have ruptured my ovaries if I had gotten Moderna's version of the vaccine. This is why I can ask that you please fare well during the lawsuit from Moderna knowing that your company is doing humane work. Thank you, from my heart." The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax 30JUN90 & reporter indicated that various liver function tests went up p/booster dose; Engerix-B was given because titers had dropped p/vax;
Dizziness, light-headed. Happened before with ear piercing. Given water. BP 86/50 (pulse 72), then 113/64 (pulse 80). O2 sat 99%.
At approximately 1 AM I woke up to chills and sweats. Had a fever of approximately 102°F, body achiness from head to toe a severe headache, slight cough and general muscle fatigue. Slight pain at injection site.
Six newly drawn doses were added to a tote containing 3 expired doses (expired around 10 hours before). The patient received one of these 9 doses.
She developed a raspy cough and a fever. We took her to urgent care, and they ran some test that all came back negative. She did have an ear infection though. They prescribed amoxicillin, and dexamethasone. We also gave her infant TYLENOL to reduce the fever.
LT DELTOID MACULAR RASH,MILD SWELLING, WARM TO TOUCH. CLARITIN RX/BENADRYL RX. RETURN IF NOT IMPROVED.
Dose was placed into the refrigerator initially on 4-MAY-2023 and was administered between 6-JUN-2023 to 9-JUN-2023.; No adverse event; Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and was administered between 6-JUN-2023 to 9-JUN-2023.) 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and was administered between 6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and was administered between 6-JUN-2023 to 9-JUN-2023.) 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 Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.) and PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and was administered between 6-JUN-2023 to 9-JUN-2023.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient did not report other symptoms and no additional doses medications or treatments administered in response.  The case contains information for patient 5th out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case
She took first doze COVID vaccine on Friday 4pm. Then she began to feel pain and aching arm on Saturday morning, which was normal. She began to feel very strong reactions on Sunday morning. She woke up around 9AM on Sunday morning and felt dizzy, nausea and vomiting. She managed to bathroom to vomit but could not get anything out. She saw everything red in front of her. Her face became pal and then dark blue, which has never happened before. We managed to put her into bed and let her rest. We also measured her finger pulse oxygenation. The finger pulse oximeter showed 98% an 97% on two fingers. We also let her lie down in bed and let her rest. Then gave her a cup of warm water. She then felt much better 30 minutes later. She was back to normal one hour later.