chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022; No adverse event; Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent second dose of Moderna COVID-19 vaccine.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022).    This case contains information for the 2nd of 10th adult patients described by the reporter.  No concomitant information was reported. It was reported that monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-JUL-2022 and beyond use date was 05-AUG-2022. The unknown vial did not underwent any temperature excursions. 6 Patients received on 19-Sep-2022, 2 Patients 04-Oct-2022, 1 Patients on 06-Oct-2022, 1 Patient on 09-Nov-2022.  Live follow-up received it was reported that, Per Moderna CMC Lot analysis, regarding doses administered on or after 19SEP2022, 4OCT2022, 6OCT2022 and 9NOV2022: Moderna cannot guarantee patients received full protection against the COVID- 19 Virus Unless noted in previous AE. Age group Adult was selected as default as its required field. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2023: Live follow-up: Narrative updated. Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531: Master case ((1st Patient out of 12)
No side effects reported; HCP calling to report VAQTA was administered after it experienced a temperature excursion. No side effects reported. Excursion was supported. No additional information provided.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 27-JUL-2023, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliters as prophylaxis (lot number: 1971534, which was determined to be valid as syringe formulation, with an expiration date on 06-OCT-2024) (strength, route and anatomical location of administration).  The reported vaccine underwent a temperature excursion of 50 degrees Fahrenheit (F) for 1 hour and 40 minutes, excursion was supported. No previous temperature excursions were reported.   No additional information was reported.
Pain in lower part of left arm (not muscle), had trouble raising left arm above head for 2 weeks. Reports that her left arm is now feeling better and she had more range of motion with it now.
The patient's wife called to report that patient developed last night severe heartburn throughout the night. He developed also mouth and throat swelling. She reported this today at 12:29 pm. She states his mouth and throat swelling has stabilized. Recommended ER now. She agreed with plan and is taking him to the ER.
Arm swelled and turned red and itchy at and around the injection site. Patient followed up with primary care doctor who prescribed Prednisone, Hydroxyzine, and NORCO.
About 3 weeks following #2 COVID vaccine began having occasional skips of hearbeat. On the morning of 2/14/21 about 9 AM began having severe forceful heart contractions, with very frequent missed hearbeats, and severe dizziness. We were having a snowstorm, and I was not able to get down the stairs to the hospital. Being a nurse myself, and having just started the HCTZ, I knew I could be potassium depleted and this could be a cause. The triage nurse at my doctor's office agreed. I stopped the HCTZ. She advised to call 911 for any worsening symptoms. I finally fell asleep around 9 PM that night with continued symptoms, but when I woke at around 1 AM the contractions had stopped, but I was still very dizzy and extremely tired. The next day the triage nurse told me to call 911 if they started again. Because of the snowstorm, I was not able to have an EKG during the event, but my Monday I had an EKG at Dr.'s office that showed something had happened but it wasn't clear what. He was suspicious of the HCTZ and agreed with stopping it. (The dizziness and occasional arrhythmia continued for about a week). He ordered lab tests that were normal and a Ziopatch that showed SVT, sometimes with rate over 204 BMP, and referred me to Dr. in Cardiology. He ordered additional testing and prescribed metoprolol tartrate 25 mg BID PRN. When I do not take it twice daily, a minor arrhythmia resumes.
Onset of fever to 104.5 R several hrs p/getting DTP immun; had 2 minutes generalized convuls; exam in ER was normal x/fever; exam the following day was entirely normal;
Because of the Covid epidemic, I just got my 2nd Shingrix shot. But the time between shots was 2 years.; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years before the 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported The patient stated that he/she received the 2nd dose of Shingrix 2 years later due to Covid epidemic. The reporter stated the time between shots was 2 years and also stated that his/her doctor said that patient should get a 'third' shot because of the time elapsed between the first two. The reporter asked did he/she need another shot in 4-6 months and also asked was there any time that was preferred in the 2 to 6 month time-frame to get your second shingrix shot. It was stated that the patient was advised to talk to his/her healthcare provider about that guidance and patient's individual situation.
Started with violent sneezing in week after 2nd Moderna Vaccine. Then on Friday, March 5, left ear started to feel clogged. Totally clogged on March 6. On Sunday March 7th, lost hearing in left ear around 7 PM.  On Monday , March 8, I was seen as an emergency visit at Ear Nose and Throat Dr. Hearing test was performed and doctor injected steroid into my inner left  ear canal. I was given a prescription for oral prednisone, which was started on Tuesday, 3/9. I continued this medication until Monday, 3/22. Since seeing him on 3/8 I have received three injections in my left ear and two hearing tests, the last one being told I have profound hearing loss in my left ear and continue suffering with ringing in the left ear.  My next appointment is tomorrow 3/25. I pray that my hearing returns.
received 2 Pfizer COVID injections, tested + for COVID, received monoclonal antibody.
Next day had severe muscle pain all over body (6/26/2021)  This was better the following day 6/27/2021) but had slight joint pain in knees and elbows.  Elbow joint pain subsided on 6/28/2021).  The knee joint pain has continued and the level of pain continued to increase.  Today's date is 7/1/2021 and the pain is to a level that it becomes difficult to stand for any period of time over 30 minutes.
19JUN98 diarrhea & temp low grade;20JUN98 vomiting q 20min;mom took to MD x2;21JUN98 cont vomiting(intermittently);
I got the booster, Pfizer shot; I got the booster, Pfizer shot; I am just not feeling great right now / I feel like I am having an adverse reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient reported "I got the booster, Pfizer shot" well, what considered to be booster on Friday and on an unspecified date "I am just not feeling great right now / I feel like I am having an adverse reaction" (further clarifications unknown). The patient stated "That's kind of sink when you get a shot on the weekend and you get a reaction, you got to wait till Monday to find out if that's what causing your problem. Is that so". The patient wanted to know whether this could be from the shot. The patient preferred not to probe further as patient was not feeling great. The patient was unwilling to complete the report. Further probing could not done. Hence, limited information was available over the call. The outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Headache; right shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Nov2021 13:15 (Lot number: FF2589) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 56 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:45 PM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Nov2021 20:00, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 16Nov2021 20:00, outcome "recovering", described as "right shoulder pain". Therapeutic measures were taken as a result of headache, arthralgia.  Additional information: Facility type vaccine was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. No Known allergies. No medical history. AE resulted in none of the above. The patient received Tylenol as treatment for the event.  No follow-up attempts are possible. No further information is expected.
About a week after injection I started to notice some itching at the injection site on my left arm. I didn't think anything of it until it continued for another day or two. It felt a bit warm and started to notice some redness. I then googled it and read about Covid arm.  On day 2/3 a small rash appeared and on day 4/5 it more than doubled in size and is rather itchy.
Vision impairment (seeing light/spots) Extreme headache. Difficulty catching breath.  Chest pain. Tightness in chest. Rapid heart rate.  Dizziness. Nausea.  EMS was called and Fire Dept. came to the home. Followed up with PCP Followed up with Heart specialist For 2 weeks dizziness, headaches, and nausea continuted.  Also intermitten chest tightness and rapid heartbeat. 4 months later and still have occasional dizziness and rapid heartbeat.  Headaches, lightheadedness.
Headache; fever; rash on forearms; tingling feeling on arms and back of neck; burning sensation on arms; irritability; General unwell feelings; Patient felt like the shot rendered his paroxetine hydrochloride useless for 5 days. Felt like he quit paroxetine hydrochloride cold turkey; This is a spontaneous report from a contactable consumer. A 50-year-old male patient to received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), via an unspecified route of administration on 13Jan2021 13:00 at single dose on right arm for covid-19 immunisation. The patient medical history was not reported.  Concomitant medication included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) at 30 mg daily for unknown indication. The patient previously took aspirin [acetylsalicylic acid] and experienced allergies. Patient experienced headache, fever, rash on forearms, tingling feeling on arms and back of neck, burning sensation on arms, irritability and general unwell feelings. Patient felt like the shot rendered his paroxetine hydrochloride useless for 5 days. Felt like he quit paroxetine hydrochloride cold turkey. All started on 13Jan2021 at 16:00. Nasal swab on 19Jan2021 was negative. No treatment was received. Outcome of the events was resolved. This case was reported as non-serious.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 08-JUL-2018 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degrees). There were also another excursions on unknown dates which lasted 100, 96, 24 and 24 hours with lowest recorded temperatures of 34 F (reported as 1.111111111 Celsius degrees), -1 F (also reported as -1 Celsius degree). 32 F (reported as 0 Celsius degrees) and 0 F (also reported as 0 Celsius degree), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 30.7F for 3 hours and 30 minutes and in 57.9F for 11 hours and 45 minutes) doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017; dose and route of administration were not reported). No adverse effects were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested.
I had an itchy and later rash on my upper chest. And that evening I started getting an internal itch, I only experienced that with my eczema as a kid. I had a physical at my doctors and by that time I had tried Benadryl and other anti-histamine. My doctor prescribed some steroid cream and prednisone to help with the eczema.  It only took about a week to recover after the medicine.
Extreme body aches, extreme bones hurt, muscles hurt, extreme fatigue, nausea, -all for 2 full days Day 3 was fatigue
T 99.0, lt arm has arthritis, nausea, upset stomach /w much gas
Headache, Myalgia, fatigue Narrative:  flu-like symptoms causing employee to miss one day of work
ill; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) .  This case involves patient (unknown demographics) who experienced ill (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.
Redness and swelling 2 inch x 3 inch area redness + swelling Augmentin 600 1 tsp BID x 10 days. Doubt cellulitis but starting Augmentin for otitis
Arm was killing her; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included hysterectomy.   In November 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced arm was killing. The reporter consent to follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2021AMR011486.
Phone call from patient. Stated woke up "Sore all over last night. Didn't want to get out of bed". Reported chills (unsure if had fever). States also had stomach upset. Reports took ibuprofen with some relief today. (Felt better today.)See MD if persists or worsens
This spontaneous report was received from a healthcare worker and refers to a 3 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JUL-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K023534, expiration date: 22-MAY-2016, orally. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a 12 month old Caucasian female no past medical history and no immune problems who on 9/13/02 was vaccinated with a dose of varicella virus vaccine live, (lot # 643126/0547M). The patient had otitis media at time of vaccination. The physician noted that there was no immediate reaction to vaccine. Treatment of otitis media with amoxicillin clavulanic acid was initiated on 9/19/02 and discontinued on 9/24/02. The physician had been contacted by the patient's parent, who reported that the child developed a severe urticarial rash 8 to 10 days post vaccination on approximately 9/21/02 (also reported as 9/13/02). On 9/20/02 the patient had a low grade fever. On 9/24/02 the patient had diffuse urticaria and eyelids were puffy. The patient's feet, knees and hands were reportedly swollen, and the patient won't walk. The patient had skin testing and showed positive to pre-pen, RAST test was positive to pen G and pen V. The patient was diagnosed with serum sickness secondary to penicillin. The patient also had a low C4 level and IgE 243u/mL. The patient sought unspecified medical attention. It was reported that the patient recovered on 9/30/02. The reporter considered serum sickness to be an other medical event. No further information is expected. The follow up received on 4/30/03 states
About forty minutes after receiving vaccine the patient noticed numbing starting in her pinky finger. The numbing radiated up her whole arm up to her jaw. This lasted about two hours and then stopped. Patient did not seek any additional treatment. No numbing has continued or started since the first incident.
Cardiac issues. Elevated blood pressure elevated heart rate. Severe chronic fatigue, increased unbearable body pain. Difficulty doing activities of daily living. I am undergoing cardiac evaluation now and should have the results in A couple of weeks. I am a former nurse practitioner and strongly believe this vaccine caused me to have high blood pressure, an extremely elevated heart rate and the symptoms mentioned above. I have never had high blood pressure or a problem with my pulse?Except one time and that was due to a thyroid crisis several years ago.
It was reported that a female pt received a TD vaccination on 6/4/99. Reportedly, sometime after the vaccination, the pt developed cellulitis at the injection site. The pt was seen at a physician's office.
Dizziness lightheaded sweaty blurred vision  Pt laid down on bench until he felt better
I am in treatment in the Center.  Stomach problems, nausea, vomit, skin problems (rash).  Chronic depression.
Severe nausea, a burning sensation on my back, felt like icy hot was poured all over my left back and shoulder.
pt recvd MMR vax on 6SEP91 & immed following vax pt devel redness @ inject site on arm; next day pt devel a fever of 101.7, warmth & 4+ edema @ the site; tx w/DPH & APAP & pt recovered; no further details were provided;
Runny nose, chills, fever, took Day Quil. 11/24 lymph nodes and ear swollen, hard in excruciating pain. 11/26 when woke up lip huge, bumps under lip.