chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalized body tingling at time of injection - current (getting less since lymphadenopathy) Painful, sore arm 8p (02/04/21) - current Lymphadenopathy left cervical (painful) 7:45p (02/05/21)- current
Localized arm swelling and inflammation from site to elbow - patient took TYLENOL and BENADRYL - ADVIL finally helped.
15 yo with brain tumor S/P VP shunt who  developed leg pain, muscle aching.
PATIENT RETURNED TO PHARMACY 30 MINUTES POST VACCINATION WITH RAISED, WARM INJECTION SITE.  SHE ALSO REPORTED SCRATCHY THROAT.  WE ADMINISTERED 25MG DIPHENHYDRAMINE AND APPLIED COLD COMPRESS TO SITE.  PATIENT WAS OBSERVED FOR ANOTHER 20 MINUTES AND SYMPTOMS HAD IMPROVED.  FOLLOW UP 4 HOURS LATER WITH PATIENT OVER THE PHONE.  PATIENT STATES ALL SYMPTOMS HAVE RESOLVED AND NO FURTHER ISSUES APPEARED
Pains in armpit; Swollen lymph node in armpit; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0172) via an unspecified route of administration in the arm left on 03May2021 at 09:00(at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) and loratadine (CLARITIN) from unknown dates and for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729)  via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 08:00, the patient experienced pains in armpit and  swollen lymph node in armpit. The clinical outcome of the event pains in armpit and  swollen lymph node in armpit were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
We only had a sore arm from the second shot; This is a Spontaneous report from a contactable consumer. This contactable Consumer(reporter's wife) reported for a 76-year-old patient(husband) that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) on an unknown date via an unspecified route of administration, as SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Historical vaccine included received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) on an unknown date via an unspecified route of administration, as SINGLE for COVID-19 immunization. On an unknown date the patient reported as had a sore arm from the second shot. Outcome of the events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042067 same reporter/drug/AE, different patients
This solicited report has been received from a consumer (also reported as "mother"), as part of a marketing research program, referring to a friend's daughter, a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient passed out after vaccinated with the third dose of GARDASIL (lot #, expiration date, dose and route were not reported). The outcome of the event was unknown. Additional information is not expected as the reporter did not consent for further follow up.
Dose 1 given 1/19/2021 Lot # 037K20A Moderna. Patient died from complications of MS, UTI, respiratory failure. Pt did NOT have Covid 19
This serious case was received from a health care professional on 06 November 2008, via another manufacturer (document number 45208302). A female patient (date of birth 13 July 1982) received a DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE as a child (manufacturer, lot number, and date of administration not known by the reporter). She subsequently experienced a seizure. The reporter had no other information about the adverse reaction, and the injection was administered at another location. The event was considered to be resolved. Documents held by sender: None.
6 hrs. after injection: achiness, bone shaking chills, by a.m. temp 103?,,nausea, headache, stabbing pains in leg muscles during sleep. 2 days later I now have slightly blurred vision and unsteadiness, trouble focusing on simple tasks. Soreness diminished.
Chills, Muscle Aches, Runny Nose, Sore Throat, Lost of Taste & Smell, Headache, Fatigue, Cough, Wheezing, Shortness of Breath, Abdominal Pain, Diarrhea
From initial information received on 4/15/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 14 year old female patient was administered a TD ADS ADULT booster dose, lot number U1014AA, administered in the left arm on 4/6/04 (route of administration not provided). Two days later the patient developed facial swelling, arthralgia, and a rash on arms and elbows. She also experienced fever, swelling of her lips, hives and rash. The patient called the doctor on 4/12/04 and upon examination on 4/14/04 she complained of a 101 degree F fever, lower lip swelling and generalized hives. The physician ordered Atarax. The rash was reported as persisting. From additional information received on 8/13/04 from the initial reporter, the route of vaccination was provided as IM. It was reported that the patient experienced an urticarial rash and the adverse event coding has been accordingly updated (hives and rash were changed to urticarial rash). The patient was seen by an allergy specialist on 4/22/04, who advised that the patient continue the Atarax. No labs were done at the specialist's office, however a CBC, metabolic panel, ANA, ESR, RF, urinalysis and C3 C4 complement were completed on an unspecified date and were within normal limits. On 5/10/04, the patient discontinued the Atarax and was started on Periactin 25mg three times per day, as her urticarial rash and swelling of body parts showed up in a limited way. Per the patient's parent, as of 5/9/04, the patient was free of rashes on Periactin and had no further episodes of rash or swelling. The patient recovered from the events. No further information is anticipated, this case is considered closed.
Received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Moderna COVID-19 vaccine that was refrigerated for more than 30 days was administered to the patient. The vaccine was defrosted in 30-Aug-2021 and it was administered on 01-Oct-2021.   This case was linked to MOD-2021-358921, MOD-2021-358735, MOD-2021-358779, MOD-2021-358800, MOD-2021-358865, MOD-2021-359032, MOD-2021-359764, MOD-2021-359183, MOD-2021-358799, MOD-2021-358841, MOD-2021-358753 (Patient Link).
Client complained of aura and had seizures. While on site client had 3 seizures lasting up to 3 minutes. EMT and MD on site. Given Versed x1 IM.  EMS called. Client was taken via ambulance to emergency room.
Patient had red patch (warm to touch) extending 5 to 7 inches below injection site. Primary care doctor treated with cephalexin and infection resolved.
Severe headache, stomach cramping/pain and fatigue 11/14/20/22. Severe stomach cramping/pain and fatigue-missed work today. Slept ten hours last night. Still feeling tired this afternoon.
Patient was nervous before the shot. She felt fine after the shot but a few minutes later started feeling lightheaded and turned pale. Patient then lost consciousness for a few seconds and was shaking but regained consciousness. She was pale and nauseated. We gave her an ice pack and just had her remain sitting in her chair. 911 was called and we were told not to move her. The EMTs arrived within 10 minutes of the incident and took over patient's care.
Broke out in hives all over my body.   Taking Benadryl, went to urgent care and given Benadryl shot.
3-4 days post vaccine dysesthesia right lateral lower leg and foot in distribution of sural nerve.  No motor loss or progression
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe
Received injections on 03/23/05. TD given IM in the left deltoid. IPV and Havrix given in right deltoid. Also given oral Typhoid. On 03/25/05, noted slight itching with slight reddened area below TD injection site. Admits to scratching vigorously at times throughout the next week. Returned to clinic on 03/30/05 for HBV #1. Showed left arm to RN. Slightly red area noted below injection site with dry skin. HBV # 1 given in right deltoid. Called office on 03/31/05, stating that left upper arm had an area the size of a grapefruit below injection site of TD, continued itching and hot to touch. Had appointment with doctor that afternoon, asked to call clinic with update after appointment. At doctor's office, she states the entire left arm was red, swollen and hot to touch. Given Zyrtec and cream to apply to arm. At present arm is less red and less itchy. Will call in 3 days for follow up. Patient recovered on 04/04/05.
Have been having trouble breathing and chest pain on and off since the vaccine.  Finally went to the ER almost a year later and that pain (heart attack type pain) it was diagnosed as inflammation of the heart and lungs.  Extreme fatigue when this happens.  I could say this has happened to me about 8 times through out this year.  I have four elementary and younger children and work from home .  It?s been a very difficult year with this happening.  Doctor at the ER rules out heart attack and told me to take it easy and take anti inflammatories for three days.
This spontaneous report was received from a nurse via company representative who is the mother of the patient (child) of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in SEP-2016 (reported as 3.5 weeks ago) the patient was vaccinated with GARDASIL 9, intramuscular. On an unknown date in September 2016, the patient experienced unspecified visual disturbances, depression, fatigue and dizziness. The patient was scheduled to have unspecified testing done to help diagnose vertigo. The patient had received 3 other unspecified vaccines on that same day. It was not determined if GARDASIL 9 was the source of the symptoms experienced by the patient. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
This is a spontaneous report from a contactable physician communicated to a sales representative for two patients, this case is for the first patient. A female patient in her 80's of an unspecified ethnicity received  PREVNAR 13, via an unspecified route of administration at 0.5ml single dose in arm on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received PNEUMOVAX over one year before.  The patient experienced  arthus with redness of upper arm 3-4 days later on an unspecified date with outcome of unknown.; Sender's Comments: A possible contributory role of suspect product cannot be excluded for the event arthus with redness due to 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,Linked Report(s) : US-PFIZER INC-2017188837 same reporter drug event different patient.
I have started to discharge trace amounts of vaginal blood during non-period times.  This has not ever been an issue for me before.  I have always before had regular periods contained within a 5-7 day window.
I experienced COVID-19 after my vaccine. It started in 11-19-2022. I thought I was having allergy problems, itchy nose, runny eyes and by Sunday I was sneezing violently and I wore a mask. My symptoms had been cold symptoms, started with heavy congestion and sneezing. by Monday I can stay it stopped. I have been dealing with a bit of congestion, slight headache, I did not have a sore throat and fever. I am also kind of sleepy at times. I did take an at home COVID-19 test on 11-19-2022 and it was positive and my husband test was negative. At this time, we are masking at home, following CDC recommendations. I tested again yesterday and I am still positive.
Intestines inflammation, not being able to eat, Daily, nausea, headache and fever.
rotator cuff inflammation; This case was reported by a pharmacist via call center representative and described the occurrence of rotator cuff tendinitis in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date unknown) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced rotator cuff tendinitis. On an unknown date, the outcome of the rotator cuff tendinitis was unknown.   It was unknown if the reporter considered the rotator cuff tendinitis to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in an unknown deltoid. The reporter stated that the patient experienced rotator cuff inflammation after their first does of Shingrix. The reporter consented to follow up.
Red, swollen night arm. Warm to touch. Pt. did take Tylenol.
Heart rate went to low 40s so went to ER at  hospital and follow up with , Cardiologist
Information was received on 25-AUG-2017 from a 41-year-old female consumer via voicemail who received a dose of MMR II vaccine for prophylaxis on an unknown date (Lot # and expiration not reported). Concomitant medications and medical history were not reported. The patient reported she had an unknown reaction to MMR II vaccine when she was 18 months old. Patient recovered from the event. Causality were not reported. Additional information has been requested.
Lack of effect (vaccine did not provide coverage against infection and illness for at least 3 full months). Symptomatic 08Mar2023 and positive at-home test on Friday 10Mar2023; Lack of effect (vaccine did not provide coverage against infection and illness for at least 3 full months). Symptomatic 08Mar2023 and positive at-home test on Friday 10Mar2023.; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Raynaud's Syndrome" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: PATANOL; ATROVENT; ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]; ADALAT. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 08Mar2023, outcome "recovering", described as "Lack of effect (vaccine did not provide coverage against infection and illness for at least 3 full months). Symptomatic 08Mar2023 and positive at-home test on Friday 10Mar2023"; COVID-19 (medically significant) with onset 08Mar2023, outcome "recovering", described as "Lack of effect (vaccine did not provide coverage against infection and illness for at least 3 full months). Symptomatic 08Mar2023 and positive at-home test on Friday 10Mar2023.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Facility type vaccine: Pharmacy or Drug Store. AE treatment: Motrin, Tylenol, Sudafed, Atrovent. Patient did not have COVID prior vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.
Breakthrough case admission after 3 vaccines Pfizer 1/19/21 Lot# EL3249;  Pfizer 2/9/21 Lot# EL9267;  Pfizer 9/25/21 Lot# FF2588
Information has been received from a nurse and concerning a patient of unknown age and gender. There was no information about patients' concurrent conditions, medical history or concomitant medications. On 16-MAR-2017, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # L033549 and expiration date of 05-JUN-2017, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celsius degrees (11.25 Celsius degrees) for 24 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source.
15 minutes post shot, started feeling light headed, dizzy, weak legs.  EMTs on sight took BP and pulse.  196/147 and 169 pulse.  Normal BP and pulse is 105/65 and 74 pulse.  30 minutes after shot, BP at 157/83 and pulse at 110, also nausea started and still shaky, light headed, dizzy.  At 45 minutes after shot, decision made to transport me to hospital because BP/pulse not coming further down, and nausea getting worse.  At ER, given saline IV, Zophran for nausea (which is now over a 10 on 1-10 scale), blood work and ECG tests.  Zophran did not touch escalating nausea, so a second med was added.  1st dose of that did not help, second dose of second me 5 hours after shot finally got nausea to a 6 (1-10 scale) which was way more tolerable.  BP and pulse still not lower than 140/84.  Was sent home after 5 hours in ER (6 hours after shot).  3 days later still nauseous, light headed, not feeling 'right' or good, not going anywhere, just resting, hydrating, eating.  Prior to shot I was well hydrated and had eaten regularly that day and was feeling well.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at an outpatient clinic administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider at the outpatient clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
difficult breathing,shortness of breath.; 2nd dose, night sweats, mid morning since  04/26/2021 to prevent.  Today 4:00 am sweats; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 at 12:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included renal transplant, hypotension, glaucoma, rubber sensitivity (known allergies: Latex (Rash)). The patient's concomitant medications were not reported. The patient had dose 1 of bnt162b2 on 05Apr2021 at 12:00 AM (lot Number: EP7533, vaccine location: Left arm). The patient experienced 2nd dose, night sweats, mid morning since 26Apr2021 to prevent. today 4:00 am sweats on 26Apr2021, difficult breathing,shortness of breath on 27Apr2021 at 04:00. Outcome of both the events was unknown.  No follow-up attempts are needed. No further information is expected.
This child was feeling tired, run down, no energy. Had sore throat, indigestion, tingling in her arms, blurred vision, nausea, constant abdominal pain, anorexia, esophageal reflux, Episodes of (ongoing) gas. Hair loss, quarter size swollen cervical lymph nodes, bumps on her scalp leaving multiple bald spots with 3 inch circle in the crown of her head, still warm to touch. Still has to see the MD. Ongoing visits to the doctor as of 08/20/01.