chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sharp headache began in the afternoon after the shot and lasted all day. I also experienced nausea that has come and gone.  Eight days later, I suddenly had patches of intense itching on my left foot, injection site area of left arm and on my abdomen.  These continued throughout the afternoon. When I got home and looked at my left arm, I had a hard red welt the size of an orange around the injection site. The itching was fierce.  The next day, I only had itching on my left arm and it wasn't as bad.  After several days the hardness and the redness of the welt disappeared. On March 5, I had another bout of intense itching on my left abdomen area about the size of an orange.  When I looked at it, there were tiny purplish-red blood spots under the skin; the itching only lasted an hour or so and the blood spots are slowly going away. Also, I am a very freckled person and in the last few weeks, I appear to have loss of pigmentation in areas on my arms and on my face - nothing like that has ever happened to me before.
On the entirety of both my arms there had been little red blotchy bumps all over my arms.
Injection site pain for 3 days, headach 24 hours, chills 24 hours, fever 24 hours 101.8, Nausea 24 hours, feeling unwell 24 hours
received two doses of MENQUADFI. One at age 11 on 17Sep2022 and again yesterday 02Nov2023 at the age of 12 with no reported adverse event; Initial information received on 03-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who received two doses of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] one at age 11 on 17sep2022 and again yesterday 02nov2023 at the age of 12 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Sep-2023, the patient received Dose 1 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for immunisation. On 02-Nov-2023, he also received a Dose 2  of the same vaccine with an unknown batch number via unknown route in unknown administration site.  On 02-Nov-2023, the patient received two doses of Meningococcal A-C-Y-W135 (T Conj) Vaccine one at age 11 on 17sep2022 and again yesterday 02nov2023 at the age of 12 with no reported adverse event (extra dose administered) (latency: 1 month 16 days).   It was reported, HCP office pharmacy intern called to report a male patient received two doses of MENQUADFI. One at age 11 on 17Sep2022 and again yesterday 02Nov2023 at the age of 12. Are there any adverse side effects to look out for! Should the patient still receive the next dose at 16 years old! Caller is requesting a callback but would also like the information to be emailed, if available  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
He got his vaccine, he had a very, very bad headache.  About 3 weeks later his neck stiffened.  He developed a pain in his chest, stabbing in nature, down his neck, left arm, arm pit, down his side and through to his back and down his spine.   He also has had numbness in his hands.  He went to the ER because he thought he was having a heart attack, and they did a bunch of tests on him including a COVID test which was negative . They did a chest x-ray, EKG, blood work and possibly some others, and everything seemed to be OK, and could be a neuromuscular thing.  He then went to see his PCP the next day who reviewed the ER results, and he sent him to a cardiologist and he is in the process of having tests done with him.  He also has an APT set up with a neurologist and an Orthopedist as it has been 5 weeks since this started, and the pain is fairly severe.  He has an overall feeling of weakness, light headedness and nothing really relieves the pain and has been using Advil.  They told him to take Advil.  The cardiologist has not given  him any results yet.    He did ask his PCP and his cardiologist if they felt that it was due to the vaccine, perhaps a delayed reaction and they told him that they would not rule that out.
Fever FATIGUE, INJECTION SITE PAIN & SWELLING, TENDERNESS & SWELLING OF THE LOCAL LYMPH NODES ON THE INJECTION SIDE  Narrative:  Other Relevant History:
Patient experienced "tingly" and what she described as  a "weird" sensation on her tongue within minutes of receiving vaccine. Patient appeared flushed and nauseous.  Treatment was two 25 mg diphenhydramine tablets with water.  Patients symptoms resolved within 30 minutes of observation but patient was observed for 40 minutes total in clinic. Follow-up continued every 30 minutes to an hour over the phone with confirmed resolution of previously stated symptoms.
Patient was given a Moderna dose that expired on10/12/2021 Patient did not have any symptoms to our knowledge
Patient looked lethargic during her 15-minute monitoring period. She stated she felt like she couldn't breath, "she felt high."  Administered oxygen. Provider instructed to give EpiPen 0.3mL. Patient transported to hospital.
Narrative:  75yo male patient died on 11/11/2021 from pancreatic cancer. He had received 3 covid vaccines on 1/6/2021, 2/3/2021, 8/26/2021. Death is not related to covid vaccines.
COVID-19; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On 8th September 2021, less than 2 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with hyperimmune plasma covid-19 (Covid-19 Monoclonal Antibodies). On an unknown date, the outcome of the covid-19 was recovered/resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in July and had covid-19 in September. The reporter stated that the patient had received covid-19 monoclonal antibodies treatment on 08 September 2021. The reporter could not provide patient's information details as she only spoke to the nurse and not the patient himself/herself. she was not able to provide address when asked.  The reporter did not know the name of monoclonal antibody product the patient received and stated that she needed to assist a patient and would not be able to answer adverse event related questions at this time. The reporter stated that she would call back.  The reporter provided her personal phone number and was in rush to assist her patient. Follow-up consent was not obtained.
Pt recvd vax & 3 days p/inject devel erythema nodosum;  pt was seen by MD; reporter indicated the event recurs in 20 day cycles & persists for 3 to 4 days;
On 1/25/2021 in the PM, had chills, muscle aches, fatigue x 3 hours. "It felt like I was hit by a bus." On 1/26/2021 - dry cough, nauseated, fatigue, muscle aches, right hip pain. Saw PCP on 1/27/2021- recommend Ibuprofen (Alleve) every 12 hours x 3 days. Also on 1/26/2021, "half size tennis ball" to right arm pit. Also, at injection site, red, hard, tender, and bruised. Per PCP, ruled out cellulitis and bacterial infection. On 1/27/2021, lymph node improving. "I'm still groggy and crummy." Right hip pain is resolved. As of 1/27/2021, still bruising, redness, and hard "in and around."
My sympmtoms lasted about 10 days. I took a at home COVID-19 test and it was positive. Sometimes headache, really strong lack of energy, several days I slept 12-16 hours. Those were the primary symptoms. I also couldn't taste anything, had slow thinking, nasal congestion on and off, a cough several times through the day. I missed the time frame to get on Paxlovid so I didn't take anything.
Developed fever to 103 F at 8pm.  Began Tylenol and Motrin alternating Q3H.  Peaked at 105 F 10pm-1am.  Defervesced to 100-101 at 1am.  Still with low grade fever 48 hours out, continuing Tylenol/Motrin rtc.
Local reaction to varicella vaccine.  5cm x 7cm redness and moderate swelling immediately at site of injection.  Benedryl given and patient watched in office for 20 minutes.  Swelling and redness did decrease and improve before patient discharged to go home.
Chest pain x2-4 days.  Admitted 2/19 - 2/21/22 with acute right pulmonary embolism with large clot burden now on Eliquis.  Hospitalized on oxygen, discharged home without oxygen.  Returned to ED same day as discharge with a panic attack.  Now home again.
LUE pain and hives, (L) arm and hand pain. Generalized body aches, fever, RUE erythema and pain. B/L shoulder pain.
High fever (101°F), chills, fatigue, and burning eyes 12h post-injection. 1000mg acetaminophen would reduce fever to ~99°F within 1.5h of dosing, only to return to the high 100/low 101°F range once it starts to wear off. Fever broke in the early am hours of 4/22/21, with the chills going away as fever was gone. The burning eye sensation and tiredness were no longer present upon waking am of 4/23/21.  Itchy skin and hives on feet around noon on 4/21/21. Hives on feet disappeared on their own by early pm of 4/22/21. Itchy and sensitive skin persists as of time of this report in early pm 4/23/21. Shallow breathing (normal and deep breaths were painful), wheezing, and feeling like I'm breathing through a sponge and that there is concrete (serving as weight) in my chest every time I inhaled began early am 4/21/20. I began producing mucus from deep coughs as of late pm 4/22/21 and that also continues to the time of this report, accompanied by wheezing and slightly deeper (but still shallower than normal) breathing.
I did not have an adverse reaction to the vaccine. In 02/2021, I had joint pain in my right shoulder that lasted for about six months. I wasn't able to lift my arm very high due to the pain. I also experienced the pain in other joints too. I used a topical medicated cream to help with the pain. I also did light exercises to help with mobility. As of today, I do not have the joint pain.
the muscles in my neck got sorer; Diarrhoea; my legs were really red; flushed; Dizziness; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 11:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included irregular heartbeat, known allergies to sulfa drugs, wheat, dairy, eggs, and beans. Concomitant medication included metoprolol and gabapentin. It was reported that, on 26Feb2021, she received the shot about 11:30 AM she had to use the restroom and noticed that her legs were red and flushed at that point. She did not notice any rash. She had a couple of waves of dizziness which were short lived over the next couple of hours. she ran errands and ate lunch. She was fine after that. On 27Feb2021, she slept well and woke up OK. However, after breakfast, she was quite dizzy. She was able to walk around and when she dropped something on the floor, she was able to pick it up. she did have to pay attention to do these things. As the morning progressed, the muscles in her neck got sorer and sorer. she also had some diarrhea, which was not unusual for her. she called her doctor and spoke to a nurse, who said these mild reactions are not unusual and instructed her to document the symptoms. If they got worse, she was to call again, of course. All day, she was spacy and a bit dizzy; but she did take her dog for a mile walk. She has been under the weather all day. No fever, no rash and tired. The patient experienced my legs were red, flushed and dizziness on 26Feb2021, the muscles in my neck got sorer and diarrhoea on 27Feb2021. Outcome of the events was recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Patient had no other adverse effects; A patient in their practice received a dose of MMR II intramuscularly rather than subcutaneously; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 05-APR-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter, one dose, intramuscular route (Incorrect route of product administration) lot number T029549 (rHA) expiration date 10-SEP-2022 administered as prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) 0.7 milliliter once lot number U015344 expiration date 23-SEP-2023.  No other adverse event was reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2204USA003586:
Topic: Acute Illness >> Jun 2, 2021  9:18 AM: Pt states she has a sinus infection.    Pt sxs include, sore throat, burning in throat, coughing, head congestion, nose drainage, yellow mucus.    Pt states provider has prescribed her medication in the past that has helped alleviate her sinus symptoms.
POSSIBLE CONCUSSION; EXPIRED VACCINE ADMINISTERED; SEIZURE; HIT HEAD REQUIRING STAPLES; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not had any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 22-MAR-2021) dose was not reported, 1 total, administered on 06-OCT-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, after vaccination, patient went to wait the 15 minutes in his car but came back into the pharmacy. The patient did not look good according to the technician who approached patient. Patient was began to speak then went down (passed out) and hit his head and did not seem to be breathing and one of the pharmacists went to give cardiopulmonary resuscitation (CPR) when patient gasped for air. Patient had labored breathing and had a seizure at that time for which he was taken to emergency room. It was stated that the patient was fine when he first came into the pharmacy to get the vaccine. On the same day, as per reporter, the patient and his mom came into the pharmacy and at that time patient did have some staples put into his head because he hit his head when he went down. Patient received expired vaccine on same day. On 07-OCT-2021, patient had a headache, nauseous and was resting. As per reporter, patient might have a concussion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hit head requiring staples, and seizure, had not recovered from possible concussion, and the outcome of expired vaccine administered was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211015018-COVID-19 VACCINE AD26.COV2.S-Seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Fever; This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever after injection. The clinical outcome of the event fever after injection was unknown at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated primary reporter information, patient details (country) and added Vaccination Facility Country.  No follow-up attempts are needed. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "lymphatic leukemia on no therapy (LGL)" (unspecified if ongoing), notes: lymphatic leukemia on no therapy (LGL). There were no concomitant medications in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive, notes: Home test positive x 2 on 02Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details: COVID 19 Treatment, Paxlovid, from 19May2022 to 25May2022, Oral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
I had significant whole body aches, elevated temperature, sweating and weakness.  It started around 11 pm and lasted until 8 am.  When I got out of bed at 6 am, I was weak and unsteady on my feet.  When I checked my blood pressure at 8:30 am, it was SBP 97/ DBP 60 with a pulse of 96.  I felt weak and had a bad headache through out the day.  As the day progressed I felt better.
Head ach; dizziness; stomach issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:00 (Lot number: ER8730) at the age of 61 years as dose 1, single and administered in arm right, administration date 19Apr2021 (Lot number: EW0162) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Head ach"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach issues". Additional information: The patient had headache, dizziness and stomach issues for all three shots.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : 202101766389 same reporter/product/ patient, different dose, similar event
Tested positive today runny and stuffy nose fever chills fatigue no appetite stomach pain diarrhea
Redness to surrounding tissue, warm to touch. Tx: PO ZYRTEC, Ice pack.
Adult dose was given at 1.0 ml instead of pediatric dose of 0.5 ml.
vaccine doesn't work,  wife has shingles/Suspected vaccination failure; Has Shingles right now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Nov-2022 Reporter's comment: The case was received from the patient's husband via  interactive digital media. The patient's husband reported that nice try, the vaccine did not worked, the patient has had shingles right now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt complained of dizziness and loss of vision. Then eyes rolled back and she began having jerking motions lasting a few seconds. She remained at the vaccination location for approx one hour to be monitored before leaving on her own.
pt recv vax 5NOV95 & exp chills, low grade fever (99) & rt sinus infect beginning 13NOV95;took Lorabid for 10 days but sx persisted for 6 wk;pt was never hosp;MD feels the sx were related to flu vax;
Patient was given the 2nd Pfizer Vaccine 6 days before the recommended time between the 1st and 2nd dose.   Patient has been notified of the immunization error.
This case was reported by a other health professional and described the occurrence of swelling arm in a adult patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 29th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In October 2018, less than a week after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced swelling arm, erythema of extremities, skin warm and raised rash. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and raised rash were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and raised rash to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The reporting medical assistant was a patient herself. The patient's arm was swollen, red and warm to touch. The patient also had tiny bumps covering the area. The patient called to report the adverse reactions she was having, but no one answered so she decided to email.
Arm Soreness; This non-serious case was reported by a pharmacist and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm Soreness). The outcome of the pain in arm was resolved (duration 4 days).   The reporter considered the pain in arm to be related to Shingrix.     The company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR081796   Additional Information: GSK Receipt Date:09-JUN-2023 The patient thought he might have an infection in his arm. The follow-up could not be possible as no contact details were available. For tolerance to the 2nd dose, refer case US2023AMR081796.; Sender's Comments:  US-GSK-US2023AMR081796:Same patient, same reporter, second dose, different events