chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had some aches and pain with the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (086396). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "not have a spleen." (Unspecified if ongoing), notes: Verbatim: not have a spleen.; "was having a problem with my thumb" (unspecified if ongoing), notes: prescribed Mobic once a day. Concomitant medication(s) included: LETROZOLE. Vaccination history included: Bnt162b2 (1st dose), administration date: Mar2021, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "had some aches and pain with the 2nd dose".  Additional information: Her oncologist told her booster shot since she was taking Ibrance and Letrozole. she was having a problem with her thumb and she was prescribed Mobic once a day. her doctor said she need to wait to get the booster during her week off of Ibrance. Patient husband added that she does not have a spleen. She was ok after the 1st dose but had some aches and pain with the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & felt lightheaded, h/a @ home & exp chest pain, severe h/a w/dizziness; was not able to move lt arm; exp pain w/movement;
This spontaneous report as received from a Certified Medical Assistant refers to an infant of unknown gender of 7 days old at the time of the report. Concurrent medications and medical history was not reported. On an unknown date, the patient was administered a dose of (Oka/Merck) VARIVAX subcutaneous injection (dose not reported) which underwent supported temperature excursions. Concomitant therapy was not reported. No adverse effects and no PQC involved. This case is cross referenced to MARR1505USA009906, MARR#1505USA013644, MARR#1505USA013645. Additional information has been requested.
Mother stated patient fell off exam table approx. 1 min. after receiving GARDASIL 9 vaccine. Pt nose began to bleed as he fell directly on his face. Another nurse saw pt. have seizure like movements, shaking extremities and eyes rolling back in his head. BP was 104/60 HR 50-60 O2 sat 99-100% RA.
Caller states she reported side effects form first  dose of the  Pfizer covid 19 vaccine./she is also allergic to a lot of foods that may not have set well in my system; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included she is also allergic to a lot of foods that may not have set well in my system. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced caller states she reported side effects form first dose of the pfizer covid 19 vaccine/she is also allergic to a lot of foods that may not have set well in my system. The outcome of event unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I did the second Covid vaccine and I have not gotten my periods; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated "I did the second Covid vaccine on the 5th and I have not gotten my periods, I am "93" (not clarified)." The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE EPILEPSY, GENERALIZED IDIOPATHIC STATUS EPILEPTICUS
Presented to ER evening of 11-19-19. Complaint of severe arm pain and altered mental status. Reports ER did not diagnose or treat as a reaction. Still has arm swelling pain, weakness improved. Client was reported to have altered mental status and weakness a few hours post vaccination 11-19-19. Client below 18 yr. age at time of vaccination. No previous history of reactions per screening check box. Also complained of (R) arm pain and swelling. Reports child has taken to ER night of 11-19-19. No treatment given, left without medication. Diagnosis was arm pain only. Weakness and mental status improved per family member. Mom not available, unable to discuss with other family member without release of information. Numerous phone calls to mother to obtain further info to complete VAERS 2.0. Unsuccessful in follow up re: condition after initial call Re: reaction. RN.
Pain in her left shoulder since getting her PREVNAR 13 injection on 5/22/18. Pain began the evening after the injection was severe. It persisted and she went to the doctor after hours 2 weeks later. She was given a steroid pack. She states her pain is more tolerable now, but it persists. She is unable to sleep on her left side at night. It is painful she raises her left arm to her side. It does wake her at night. On a regular basis.
After the 2nd dose, I began experiencing a headache about one and a half hour later. About  3-4 hours after the vaccine, I felt fatigue and pain at the injection site as well. The following morning, about 16 hours after the vaccine, I also had chills and a fever (up to 100.2 F) and about 18-20 hours after the vaccine, I had generalized myalgias.  These symptoms began to subside around 26 hours after the vaccine and after 36 hours, I was without these symptoms. About 40 hours after the vaccine however, my arm at the injection site started itching slightly and I noticed it was red. Those symptoms subsided by 72 hours.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Lot number: GJ3275), in left arm and on 27Mar2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single as dose 3 (booster), single as dose 4 (booster), single; VENLAFAXINE, start date: 03Nov2008; LISINOPRIL, start date: 06Jun2003; LAMOTRIGINE, start date: 15Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: home Covid test was taken in afternoon & revealed a very positive band; Negative, notes: negative test was seen 1-2 days before. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Pateint took Osteo Bi-Flex joint health from Laila neutroceuticals and One-a-day multiple vitamins from bayer with batch/lot number reported as NAAARD8. Patient was treated with Paxlovid from 18Jul2023 to 22Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300261400 same reporter/patient, different drug/AE;
Information has been received from a medical assistant concerning a 15 year old female patient with no allergies or pertinent medical history who was vaccinated with a first and second dose of GARDASIL on 27-APR-2009 and 29-JUN-2009 respectively. (Lot # 661953/1130X). The patient experienced fatigue, dizziness, and nausea for 3 days after vaccination with her second dose of GARDASIL. Three days after vaccination, on approximately 03-JUL-2009, the patient recovered. No lab diagnostics were performed. The patient has sought medical attention at office visit. Additional information has been received from the medical assistant concerning this 6 year old female student. It was confirmed that on 29-JUN-2009, the patient received a second dose of GARDASIL (Lot # 661953/1130X). The same day the patient experienced dizziness and feeling sick for 3 days after vaccine was given. The patient recovered from adverse events on 03-JUL-2009. Additional information is not expected.
Reported advers event 11/2/2016. Stated began being itchy within 6 hors of vaccine. Stated that she was taking benadryl and had used her daughter's inhaler on 11/1/16. When seen in clinic on 11/2/2016, had itchy red rash, eys were red and watery and was clearing throat frequently. Complained of wheezing. Was escorted to the Emergency Department.
Arm itch; Red; Hot; swollen; A spontaneous report was received from a consumer who was also a 74-years-old male patient who received Moderna's COVID-19 vaccine and experienced events like arm started to itch, it was  swollen, red and hot,around the arm on deltoid.   Patient's medical history  and concomitant medicines was not provided.   On 12-JAN-2021,patient received Moderna's COVID-19 vaccine on his left arm intramuscularly at a drive thru vaccination site  Around the 18-JAN-2021 or 19-JAN-2021, her arm started to itch. On the 20-JAN-2021 it was swollen and on 22-JAN-2021  there was no itching but it is red and hot, around arm on the deltoid.   Treatment actions was not provided.  Action taken with mRNA-1273 was not reported.  The outcome of the events, arm started to itch was recovered/resolved, and  it was  swollen, red and hot,around the arm on deltoid was unknown.
Extreme fatigue and body aches the day after the injection, pain at site of injection for two days after injection.
Chills, high fever (up to 103.1 24 hours after administration of vaccine, body aches and joint stiffness (both arms, hands, left shoulder blade, hips),  intense headache.
Pt. states she woke up Thursday (01/22/15) AM with headache and fever (approximately 104 degrees). She took Ibuprofen with no relief of headache, fever. On Friday night she decided to go to hospital. She was seen at Medical Center. She states spinal tap done and told had "bacteria". She was given morphine for headache with no relief of headache. She was discharged at 6 AM on Saturday (01/23/15) with rx. for TYLENOL. This nurse spoke with patient on 01/26/15 at approximately 10 am after friend called clinic concerned about patient. The above is what the patient stated over the phone. Patient states she continues to have headache and fever, feels very light sensitive. Does not want to take TYLENOL because she states that TYLENOL "makes my headache and fever worse". Pt. was counseled to return to hospital to be checked again. Pt. expressed that she did not want to go back to hospital. Encouraged patient to get follow up since her symptoms persist. Pt. states she will think about it.
Pt was given 0.3 ml instead of 0.5 ml dosage.
Allergies; experience bleeding (she reports "a lot") from his nose a lot; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunization and rivaroxaban (XARELTO VASCULAR) via an unspecified route of administration from unspecified date for atrial fibrillation. Medical history included atrial fibrillation. The patient's concomitant medications was not reported.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 for COVID-19 immunization. He received his first Pfizer Covid vaccine dose on 09Feb2021 and his second on 02Mar2021. On 03Mar2021 he started to experience bleeding (she reports "a lot") from his nose a lot then stopped for 10-15 mins, then 04Mar2021 same thing occurred in the morning. On 06Mar2021, she took him to emergency room. He is on Xarelto for atrial fibrillation. The bleeding stopped and they told them to put vaseline in his nose. He was treated by his PCP 09Mar2021 - and was told this was not a side effect of the vaccine but could possibly be allergies and was prescribed allergy medication. She states that after 2 days the bleeding returned. She was instructed by the MD that if the bleeding comes back then XARELTO needs to be stopped, which he did, then he restarted it because is worried about having a stroke. Now the bleeding has returned. The action taken of rivaroxaban in response to events was unknown. The outcome of the event bleeding (she reports "a lot") from his nose a lot was not recovered and the outcome of the event allergies was unknown.  Information on the lot/batch number has been requested.
Unproductive cough, shortness of breath with prostration - referred to ER to rule out DVT.
Pain in right shoulder after flu vaccine that resulted in limited range of motion. Progressively became worse. Vaccine given high in arm. MRI - shoulder impingement syndrome.
Shingles; Rash to R Flank; This case was reported by a nurse and described the occurrence of shingles in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Concurrent medical conditions included pruritus and burning sensation.   On 24th September 2019, the patient received FluLaval Tetra 2019-2020 season. On 26th September 2019, 2 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced shingles and rash. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported having itching and burning symptoms the week prior to diagnosis of shingles. The patient received gave an employee a FluLaval Tetra 2019-2020 season in left deltoid and was found to have a rash to right flank and diagnosed with shingles. The patient was started on Acyclovir. The reporter asked if the Flulaval vaccination interfere with her current treatment with antiviral medications for shingles.
The night of the vaccine (about 8 p.m.) I had chills and could not sleep due to body aches.  I experienced profound thirst and also urination.  I finally fell asleep around 5:00 a.m. on Sunday morning.  When I woke to care for husband (he is a stroke victim), I was feeling some better but now had a crackling sound in my head whenever I moved by body, head, or just eyes.  I notified my physician, but assumed it was from the vaccine since # 2, #3 also gave me weird after-effects.  Cracking is some better today (3/21) but still present.  It sounds like the pilot light trying to ignite a gas stove in my kitchen.
Elevated temp, dizzy, and nauseated on 08/23/01. On 08/27/01 in the AM, this patient came into the office complaining of nausea, diarrhea since the evening of 08/23/01. He was seen in the ER on 08/26/01, due to weakness and diarrhea. On 08/27/01, phone call, patient was seen by the doctor due to severe weakness, nausea, and diarrhea this PM.
Swelling at injection site, 1.5 cm oval area, non-tender to light touch, no loss of ROM.
After vaccine was administered the patient stated she felt dizzy and as I was helping her to lay on the floor she seemed to faint. Her body went face-down and fully straight on the floor. After 3 seconds, her body shook briefly and she rolled over onto her back with her eyes open. She smiled and said she was just "a little disoriented". I had her stay on the floor with her feet elevated and a cushion under her head while she hydrated. After 15 minutes she sat up on the floor for 15 more minutes. We then helped her into a chair for 15 additional minutes while she continued hydrating for a total of 3 water bottles. Her 2 sons drove her home, stopping for food along the way at restaurant. I then called at 8pm and suggested she see her physician the following day which she said she may go to the Urgent Care. Her main complaint after the event (while laying on the floor) was that her right ear was ringing and she was unable to hear out of it normally.
About 4 days after immunization rash began on ankles and wrists. Within 1 day spread up extremities, buttock and back. Temp 99.5. Malaise. Swollen lymph glands. Significant malaise persists as of 9/9/03. Rx: allergy med and Atarax - no relief. Steroid injection. No benefit.
arm pain, headache, rash on face neck and chest, fever greater than 101F, fatigue
Patient called and said her arm was still sore 10 days after vaccination.  Started about 4 days after the vaccine.  She stated her arm was not red, swollen or hot.
I have a history of migraines, but since starting emgality injections in september, had been doing much better.  I only had 1 migraine in November an hasn't had any in Dec until 12/30 (6 days post vaccine). I took my rescue medication (ubrelvy), and the migraine came back again the next day, so I took my medication again. On 1/1 the headache was really bad and the medication did not work. All I could do was sleep and when waking up from a nap I took my medication again, and it didn't help again. This is the first time my migraine has not responded to my medication. I still had the headache on 1/2.
A report has been received from a Health Professional concerning a 7 month old, male subject, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on 11-Dec-2014. A registered nurse with the county health department called the information center to find out any information available about what happens if a 6 month old receives a FLUMIST vaccine approved for ages 2 years and up. Registered nurse stated that it was discovered through an audit that a 6 month old erroneously received a FLUMIST vaccine on 11DEC2014. Registered nurse was unaware of any events resulting from this medication error. Registered nurse stated she already reported this event through the Vaccine Adverse Event Reporting System, but did not have a confirmation number yet. The outcome of the event of 6 month old received the FLUMIST vaccine is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 28-Aug-2015 from health professional via spontaneous source: Reporter details updated. Start date of event updated. Narrative updated.
1st dose: given at 4:45pm. Mild fever, and severe body aches, chills, very tired. Pain at injection site. Most symptoms started at 8pm and lasted for several hours. Most problems were gone by next morning.   2nd dose: given at 3:30pm.  3:00am is when the major symptoms started: Mild fever, SEVERE body aches and chills--unbearable pain, had to take a lot of advil and alternated with Tylenol and still felt terrible. Headache, dizziness, stomach pain, very tired, but couldn't sleep for the pain and discomfort. It's been almost 24 hours and I still feel as terrible as I did this morning.
Pt was seen for well child exam 09/28/2001 at 10:30 am. Mother f/u with me on 10/01/2001 and related that Gustano developed that same afternoon about 4 pm, respiratory distress, angioedema, of the lips and face and an urticaual skin rxn. Pt was treated and released from the hospital, for an anaphylactic reaction to unknown trigger. Continue oral course of Benadryl and Epi-Pen JR. ER states non reactive to vaccine. Has an upcoming appointment with Allergist 10/24/2001 for further testing to determine hypersensitivity trigger.
Patient experienced syncope shortly after administration of vaccine. Was still at the pharmacy. Layed patient flat on floor and waited for him to regain consciousness. He regained consciousness shortly thereafter. Had him wait at the pharmacy until blood pressure stabilized.
Allergies: Pneumococcal 13-valent conjugate; Rash; Nodule at site of injection; This is a spontaneous report from a contactable physician. A 63-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), rash, and nodule at site of injection on an unspecified date. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Refused food and water for 6 hours, lethargy, spacing out, fever for 24 hours.
I developed a cold, runny nose, cough. My symptoms lasted 5 to 6 weeks. I took a COVID-19 antigen test on 01/03/2023 and it was positive. I phoned my doctor and they gave me PAXLOVID. I took the PAXLOVID for five days. I have recovered from my symptoms some what, but still feel lethargic at times. I still have dizziness that comes and goes.
Sores on tongue 1 week after vaccine booster, same thing happened on initial vaccine 8/26/21 reported to Vaers as well
Pt felt like she will faint after her flu vaccine, she was lowered to the floor with eleveted legs. She started feeling better in couple minutes, pt mentioned that she had episodes like this in a past
This case was reported by a consumer via interactive digital media and described the occurrence of rib pain in a female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced rib pain, painful cough and cold. On an unknown date, the outcome of the rib pain, painful cough and cold were unknown. It was unknown if the reporter considered the rib pain, painful cough and cold to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient commented on here before about her experience that she and her daughter just survived this over the summer. The patient caught it and went undiagnosed after seeing 3 doctors who said it was a cold. The doctors did not recognize it anymore, and unfortunately the patient's 4 week old baby caught it from her. The patient's child was in pediatric intensive care unit for 14 days. The patient even received TDAP vaccine at the hospital the day her child received it. The patient experienced cough which was very painful, and was in the worst pain of her life, and she cracked her ribs coughing. The patient told to be vigilant.