chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My are has hurt since the shot, it hurts to lift my arm up and aches into the shoulder, have been nauscious and started vomiting on 4/11, have had a bad head ache. Body  Ache all over. Feeling very weak.
Developed a severe headache within 2-3 hours of receiving vaccine. Took 2 Tylenol. Headache abated but did not resolve. Within the next 2-3 hours felt tingling in my left upper lip. It grew worse and headache worsened. Lip felt like it was swelling but no change was seen. Then left side of face began to ache. Took 2 more Tylenol. Texted my primary care physician who recommended Benadryl in case it was an allergic reaction. Took Benadryl about 4:30 or 5:00.  Left work and went home. Had severe headache. Took my blood pressure. It was 185/68. Had some old Propanolol 10 mg from 2 years earlier and took one and a Prednisone 10mg. By 9:00 pm still felt bad with facial pain and tingling. BP decreased to 148/89. Took another Benadryl and went to bed. Face ant lip better in the morning. Arm sore for 2 days. Developed body and joint aches for the past 2-3 days. Slowly resolving.
This spontaneous report as received from a nurse refers to a 12-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was reported. On 20-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not provided). On 23-JUN-2016, the patient received the second dose GARDASIL 9. No adverse effect was reported. Additional information has been requested.
Pt vaccinated with Moderna (first dose) and was awaiting alongside the booth standing up and within a minute felt dizzy and was short of breath. Son at her side and assisted her to walk over to observation and felt weak all over, extremities and assisted in the wheelchair.   Complained of chest pain/pressure. EMS called and brought to ED.  In ED, EKG normal.  Trops 0.1, 0.04 then 0.01. Exercise Stress test normal Discharged to home with PCP followup.
Forty eight hours after receiving vaccine, pt broke out in hives on her legs. Mother reports red, raised spots in the area where her shots were given. A couple days later, pt was irritable and itching the rash. One week post vaccines, pt has bumps where the vaccines were given, itching, redness, and hives are no longer there.
rash, followed by severe joint;swelling & aches;mving from joint to joint-settled in wrist & hands
The pt received vax on 5/22/01 in left arm. Was seen in office on 5/24/01 with diagnosis of cellulitis at the injection site. The area was 18 x 14 inches with redness. Treated with Augmentin. Seen on 5/25/01 and the area had improved.
Fever MUSCLE ACHES, FATIGUE, DORENESS AT INJECTION SITE Narrative:  Other Relevant History:
Employee received 2 TDAP vaccines within a 2 year time frame. Reported severe local pain at injection site X 3 days.
This spontaneous report as received from a licensed practical nurse refers to an unspecified nurse, who on 05-AUG-2016, was attempting to administer a dose of GARDASIL 9 injection (lot # L024993, expiry dose 17-OCT-2017) to an unspecified patient. She did not attaché the needle to the syringe properly, and when she attempted to depress the plunger, the vaccine squirted out of the syringe hub and went into the nurse's eye. This resulted in a possible partial dose of GARDASIL 9 administered to the patient (captured in MARRS#1608USA004229). No adverse effect was reported. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
A couple of days after the vaccine I woke up with terrible brain fog, muscle soreness, unable to move well, difficulty sitting up, getting out of bed.  Right hand was swollen and stiff.
Patient received booster dose of Pfizer one month early.  Spoke with patient regarding being given vaccine too soon and educated patient on potential side effects of vaccine. Patient verbalized understanding. Patient observed in medical observation for 15 minutes. Patient left in own car following observation.
fast heart rate; dizziness; weakness; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (fast heart rate), DIZZINESS (dizziness), ASTHENIA (weakness) and DYSPNOEA (difficulty breathing) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, METFORMIN and LISINOPRIL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced TACHYCARDIA (fast heart rate), DIZZINESS (dizziness), ASTHENIA (weakness) and DYSPNOEA (difficulty breathing). At the time of the report, TACHYCARDIA (fast heart rate), DIZZINESS (dizziness), ASTHENIA (weakness) and DYSPNOEA (difficulty breathing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information was provided.
vaccine expired on 9/30/2022 but expiration written carton of vaccines was 10 weeks from date removed from dry ice which was 10/19/2022.  However, manufacturer has stated that stability and efficacy data shows that revaccination and patient notification is not required.
Flu vaccine. Needle administered high in the arm near the joint. Immediate pain that persisted x2 weeks. Limited ROM. No sign of nerve injury. No signs of infection.   Evaluated at Occ med clinic: will treat conservatively with ice, rest, ibuprofen, gentle ROM MRI ordered to r/o soft tissue injury
Narrative: Patient felt slightly dizzy/lightheaded 2 minutes after vaccination. Pt given juice and pt reported feeling much better wIithn 5 minutes. Patient observed for 18 minutes then stated he felt fine and left the vaccination clinic.
This report describes the occurrence of Bell's Palsy in a 51 year old male pt who received Engerix B for prophylaxis. This report was received from a nurse. The pt's medical history included acute renal failure (cause not reported). Concurrent medications included Procrit, heparin, PhosLo, Protonix, Reglan, hydrocodone, Citracel, Vitamin D and Lotrel. On 29 May 2004 the pt received the second dose of Engerix B in the right arm. On 15 June 2004, 17 days post-immunization, the pt developed Bell's palsy. He was not hospitalized but was referred back to his primary care physician. At time of initial reporting, the event was unresolved. This case was assessed as medically serious (OMIC) by the manufacturer.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unspecified age and gender. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia, encephalitis, right eye vision loss (blindness unilateral), headaches and balance issues (balance disorder). As a result of these symptoms, the pt was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using this product. The pt sustained serious, severe, permanent, progressive and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, mental and emotional distress, loss of enjoyment of life, physical impairment and injury due to resulting physical limitations and seriousness of the condition. The pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered and causality was related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling. Upon internal review, the pt's encephalitis and blindness unilateral were determined to be medically significant events.
Nurse at clinic incorrectly diluted a Pfizer vaccine vial with 0.8 ml of sodium chloride instead of 1.8 ml of sodium chloride and administered 0.3 ml to the patient. The patient experienced 104 degree fever with vomiting, dizziness and extreme muscle joint pain. We explained to him that we noticed the dose he was given had been diluted improperly and he had received a slightly higher than normal dose.   I apologized for the incident and he said ?it?s ok?, and that now he knew why he was so sick.  He was very pleasant and appreciative of us trying to contact him over the weekend.   He was encouraged to contact us with any questions or if any new symptoms arise.   We also offered to have one of our providers contact him to discuss further, but he declined.
Vaccinate 7/12/04 Monday at 11:00. At 6PM vomited, again 8:00, fever at 100. 7/13-14/04 vomited, no fever, Left arm swollen and warm to touch. No problem retaining food or liquids.
Information has been received from a registered nurse concerning a approximately 50 year old female who on 10/18/2001 was vaccinated with a dose (lot # 636849/0944K) of pneumococcal vaccine 23 polyvalent. Subsequently, the patient called the physician's office and reported that she had developed an injection site reaction. The patient presented to the physician's office on 10/23/2001 with a small red indurated area at the site of vaccination. She was prescribed levofloxacin (LEVAQUIN) 500 mg and was believed to have recovered as of 11/26/2001. The physician requested a lot check because three patients (WAES #'s 01104540 and 01104569 (the patient's husband)) have had adverse experiences with the same bottle. The recordes of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was release. Additional information has been requested.
3RD DOSE MODERNA COVID VACCINE, GIVEN 1/24/22, #069H21A 4TH DOSE COVID VACCINE, PFIZER, GIVEN 6/16/22, #FM0173 8/25/22 pt had a positive COVID test; hospitalized and dc'd to home; returned 9/12/22 with SOB and worsening hypoxia; presents to ED with terminal care needs; failed to respond to curative tx; transferred to hospice, comfort measures; pt passed away in the hospital
This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a 76 year old female with a penicillin allergy who on 21-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # and dose were not provided). On 21-APR-2008, the patient was diagnosed with shingles when she visited her physician's office. The patient mentioned that she never had shingles prior to receiving ZOSTAVAX (Oka/Merck). The patient reported that she developed rashes and pain on her trunk. The consumer was seen by a medical doctor on 21-Apr-2008. No further information is available. Information has been received from a physician concerning a 76 year old female with a penicillin and KEFLEX allergy who on 21-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) subcutaneously in the right deltoid (Lot # 565607/01E3U). On 21-APR-2008 the patient developed rashes and pain on her trunk. On
H.D. FLUZONE admin 9-17-15, pt states "didn't feel that at all" aware of soreness up to 2-3 days post vaccination. As of 12-2-15; pt comes to clinic reports "flu shot still hurts my arm" states "like a toothache in that "spot" "no where else, no problems, no numbness, no weakness, no bruising, no knots, just aches off and on for days at anytime, awoke me lip and chins at 3 am. Took ADVIL. Very localized pain to spot where hot given. Been 2 1/2 months aching so thought I'd tell someone.
24 hours after H1N1 vaccine, patients R arm site hot to touch. Swollen from shoulder to hand with spreading redness. Not painful. MOTRIN, BENADRYL and ice as per pediatrician. MD visit on 11/21. Antibiotics ordered. No temp. Recovering. On 11/28 still red/swollen but improving.
Mom called on 8/12/05 and reported that the patient's left arm where the DTaP had been administered was red, hot and swollen to the size of a baseball.  Redness and swelling extending from shoulder to just above elbow.  Instructed mother to use Tylenol/Motrin and use cool compresses/ice to help with swelling.
I had a low-grade fever, fatigue, and like a really bad cold had come over me for about 4 days. By day 4, I was mentally unaware of my surroundings with extreme brain fog. I couldn't recollect anything I was saying on the phone or being done around the house while my sister was visiting at the time. My sister called the ambulance and had me taken to the hospital due to being incoherent. They took a chest x-ray, gave me fluids, COVID-19 test, and testing for a stroke. I was there for about 4-5 hours when they confirmed I had COVID-19 on 01/29/2023. They discharged me and didn't prescribe me anything due to my oncologist suggestion not to. I stayed home and rested until full recovery.  Unfortunately, I was in the midst of getting chemotherapy treatment when I contracted COVID-19 so I'm not sure if that's what affected my symptoms as well.
Fever of 104 less than 12 hours after administration. Tylenol given.
This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient (in her 60's) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, as single dose for immunization and influenza vaccine (MANUFACTURER UNKNOWN), via an unspecified route of administration, on an unspecified date, as single dose for immunization. The patient's medical history and concomitant medication was not reported. On an unspecified date, the patient experienced soreness at injection site, redness at the injection site and purplish bruise around the injection site. It was reported that the patient received the flu vaccine at the same time as the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), but it was unknown if they were administered in the same arm. The clinical outcome of experienced soreness at injection site, redness at the injection site and purplish bruise around the injection site was unknown.
The patient said his arm started to hurt 2 weeks after his vaccine. He said it feels like it is in the area that the vaccine was given. He said it only hurts every 2 to 3 days not every day. I recommended that he follow up with his PCP to have his arm checked.
pharmacist missed the deltoid and injected the vaccine into a nerve at the base of the deltoid. I cannot move the arm midline, lift my arm up  or lift heavy objects.  i cannot push doors closed with my right arm without intense , overwhelming pain. The pain radiates down to my wrist and fingers.
Patient administered vaccine that has possibly expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator- 02-OCT-2021 The vial  doesn't  undergo any temperature excursions  Concomitant medication were not reported.  Treatment information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow-up received and had no significant information. A query has been raised about expiration date extension of vaccine LOT#033B21A
bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 6 (booster), single (Lot number: GH9693) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing), notes: Other medical history: CTCL (Cutaneous T-cell lymphoma); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: bee venom" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (DOSE 4, SINGLE, Lot number: 33130BA), administration date: 31Mar2022, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 3, SINGLE, Lot number: FF2590), administration date: 13Oct2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955), administration date: 25Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 1, SINGLE, Lot number: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose"; Bnt162b2 (DOSE 5, SINGLE), for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The following information was reported: TINNITUS (non-serious) with onset Oct2022, outcome "not recovered", described as "bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose. Evaluated by ENT and audiologist. MRI ordered, no causes identified.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/product/event, different dose;
Shot given on 6/16/11, became red on 6/16/11. 6/17/11 redness increased and was warm to touch, applied ice. 6/18/11 site became worse. Had CBC and started prednisone on 6/18/11, 600mg ibuprofen and 50mg BENADRYL. Arm looking better on 6/20/11.
PT MISTAKENLY RECEIVED A 12 & UP DOSE. PT IS 11 YEARS AND 3 MONTHS OF AGE.
This case was reported by a consumer via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patients experienced fever, influenza-like symptoms, fever, influenza-like symptoms and condition aggravated. On an unknown date, the outcome of the fever, influenza-like symptoms, fever and condition aggravated were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the fever and influenza-like symptoms to be related to SHINGRIX. It was unknown if the reporter considered the fever, influenza-like symptoms and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per product indication. The reporter and her husband were both on the phone. They mentioned that, they had several friends who got the SHINGRIX vaccine and that the side effects of fever and flu-like symptoms were worse after the second dose versus the first dose of SHINGRIX. This case was linked with case US2019001668, reported by the same reporter.
Initial report received from a pharmacist on 13 December 2006. A female patient (age not reported) experienced sharp, stabbing pain at the injection site after she received Fluzone (lot number, route and site of administration unknown) on 28 November 2006. It was reported that she 'can't lift her arm" and she had the pain since vaccination. The patient's recovery status was not reported.
Roughness feeling at site of injection; Starting to itch on red patch; Red patch(circle) at site of injection and below; Red patch(circle) at site of injection and below; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Roughness feeling at site of injection), VACCINATION SITE PRURITUS (Starting to itch on red patch), VACCINATION SITE RASH (Red patch(circle) at site of injection and below) and VACCINATION SITE ERYTHEMA (Red patch(circle) at site of injection and below) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LANSOPRAZOLE (PREVACID) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DRY SKIN (Roughness feeling at site of injection), VACCINATION SITE PRURITUS (Starting to itch on red patch), VACCINATION SITE RASH (Red patch(circle) at site of injection and below) and VACCINATION SITE ERYTHEMA (Red patch(circle) at site of injection and below). At the time of the report, DRY SKIN (Roughness feeling at site of injection) outcome was unknown and VACCINATION SITE PRURITUS (Starting to itch on red patch), VACCINATION SITE RASH (Red patch(circle) at site of injection and below) and VACCINATION SITE ERYTHEMA (Red patch(circle) at site of injection and below) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included unspecified High Blood Pressure Medications.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
On July 2, 2022 we noticed a small red bump at the vaccine site. On July 3, 2022 we noticed the red bump had gotten bigger and her arm was swollen and also had a rash, the swelling went down some but we took her to a walk-in clinic as it was a Sunday. The doctors at the clinic said it looked like what they were seeing as a delayed reaction to the Moderna vaccine. Give it until Wednesday to see if it would subside some or go away all together. By Wednesday it was completely gone.
3" x 3" erythema muscle hot to touch x 2 days after vaccine injection.
red, circumscribed rash at the site of injection, treated with zyrtec 10mg BID x 7 days
Diarrhea in the form of very loose stools every day all the time since the moment of receiving the second shot.