chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions; Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursion) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. The Nurse reported that patient had no adverse reactions or side effects to the Moderna Covid-19 vaccine. Nurse does not have any information on the first dose of the vaccine Treatment information was not provided
About 3 min after giving vaccine, pt was seen potentially having a seizure.  Unconscious for about 5 seconds.  Came to.  Hot, sweating, dizzy.  Dizziness continued for approximately 45 minutes.
Pt requested meningococcal and Varicella vaccines. Provider gave MMR. There were no adverse reactions from this. No treatment nec.
Numbness of all extremities, body wide pain, muscle weakness, Raynaud's phenomenon, paresthesia, fatigue, muscle spasms, muscle fasciculations, body wide pain, dysphagia, photophobia, tinnitus, headaches, nausea, loss of appetite, abdominal pain, muscle and joint pain.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from medical assistant (non health care professional). Global number: CO2018-00328. This case involves a patient (age and gender not reported) who was vaccinated with an incomplete dose of vaccine FLUZONE QUADRIVALENT (batch number: UT6261LA, expiration date: 30-Jun-2019, dose, route and site of administration was not reported) on 28 Sep 2018. The patient's medical history and concomitant medications were not reported. It was also a case of syringe issue as it was reported that vaccine leaked a lot between the needle and the hub. It was an actual medication error due to vaccine underdose which occurred as it was uncertain how much vaccine the child received. It was not known whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Due to known allergy to eggs, patient was offered the egg-free recombinant vaccine, FLUBLOK. Despite having an egg-free vaccine, patient had tingling in the entire arm down to the fingers and up to her neck on the side of the injection. This occurred within minutes of the vaccination. She also began to feel swollen in her neck and had some tingling in the other arm after a few minutes. Provider examined her and found that her hands were cold, but no other significant issues. Patient then took 50 mg of BENADRYL. Patient rested reclined for several minutes, but was talking. Patient reports that she was later was referred by provider to go to the ER since she was still not feeling well. Patient reports that she received epinephrine in the ER, and received prescriptions for Hydroxyzine and Prednisone.
Reaction to second shot:  redness upper right arm, itching, warm to the touch, spreading redness, swelling
Vision issue noticed November 1, 2021 left eye. Vision seemed somewhat distorted around 9AM EST. As days went on, vision became more abnormal, and began impacting right eye as well, but not as much as left eye. Also noticed drooping of area above right eye. On 11-08-2021 received MODERNA COVID-19 VACCINE (EUA), lot number 033F21A into left arm. On 11-08-2021 also received into right arm BOOSTRIX TDAP VACCINE SYRINGE lot number 224CG. Eye symptoms became worse as days went on, and began to experience severe double vision, weak neck muscles and could not chew food normally. Jaw became tired. Went to neuro optamologist who said to know for sure issue, a blood test is needed, as he thought could be 4th nerve palsy or the myasthenia gravis. Blood test from confirmed myasthenia gravis.
Trigger finger in right thumb; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot number: EL8982 and Expiration date: May2021), via unspecified route of administration in right arm, on 28Jan2021 at 04:30 PM, as single dose for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9261 and Expiration date was not reported), via unspecified route of administration in right arm, on 18Feb2021 at 09:00 AM, as single dose for COVID-19 immunisation. The patient was not pregnant. The patient's medical history included mild asthma. Concomitant medications included levothyroxine and meloxicam. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. The patient received other vaccine in four weeks. The patient received levothyroxine and meloxicam in two weeks. On an unspecified date in Feb2021 at 09:00, the patient experienced trigger finger in right thumb. The patient was not treated for adverse event. The outcome of the patient event was recovering.
suspected vaccination failure; so did I. Ive had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles and had a mild case. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR104430, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104430:comment response
Pt was in mass vaccination clinic.  Review of form  was not assessed by clerical personnel and sent to nurse to be vaccinated.  Mother was present with child.  Pt stature and body type appeared to be adult like.  He is approximately 6 ft tall and weighed about 200 lbs.  Event was discovered after vaccine was administered and information was entered .
Patient came to hospital with fever and chills with right leg pain/soreness and nausea, after being vaccinated with the Pfizer Covid booster. She gradually developed right leg weakness and then left leg weakness, progressing to the point that she was unable to walk.  She feels that both legs are weak although she states right leg seems worse than the left.  She attempted to go to the bathroom but fell due to the inability to walk. Patient is being worked up for Guillian Barre.
Narrative: Patient is a 67 yo man with PMH of schizophrenia, OSA, T2DM, HRN, HLD, oropharyngeal dysphagia, BPH, vaccinated against COVID who was brought in to Facility due to mild weakness. He lives at a nursing home. For the past week, there was an outbreak in his ALF and unfortunately people are unable to self isolate well. Patient was routinely tested for COVID19 and was tested positive on 9/10/2021. Patient was asymptomatic at the time and was instructed to come to the ED to get monoclonal antibody for treatment.
There was NO adverse event reported.  The patient presented to the pharmacy requesting a second vaccine of HepB.  It was determined she was given Engerix-B 20mcg/ml indicated for 20 years and up. She was 19 at the time of administration on 1-7-2023.
t99.7, rash, local adenoapthy, general adenopathy, allergic event, hives;
pt recv vax;lt arm red,swollen & hot at site of inject w/ aching;16jul95 fever 101 to 104,neck swelling,HA,earache & n;17jul95 sharp pain at site of inject;20jul95 hosp;still has red whelp measuring 4 1/2 cm w/ tenderness;
10Pm the evening of vaccination, arm pain, chills, sweating, burning sensation on patient's side, chest, and back. Patient took Tylenol. Then Migraine headache starting around 5AM the morning after and ending around 11AM.
About a week after receiving the 1st Pfizer Covid vaccine, I started experiencing heart palpitations and difficulty walking up stairs and/or hills.  I visited the ER the following day because I did not have a doctor nearby.    I was referred to a local doctor, who I visited May 6, 2021.  He dismissed the notion that anything was caused by the vaccine and put me on a low dose (5mg) blood pressure medicine and a 81mg aspirin.  Around 3-4 days after visiting the doctor, I started to feel normal again.  Since then I have felt 100% and back to healthy eating and exercise routine.  Nothing like this has happened to me before, and it was an abnormal situation.  I have not received any other vaccines in many years.
Horrible Headache.  I couldn't hold my eyes open for 36 hours.  Generally feeling lousy.
Dose #1 - mild pain at injection side and mild fatigue Dose #2 - I awoke at 3 a.m. with severe muscle and joint pain  in my entire body (11 hours following injection).  I have had fibromyalgia for years but have never experienced this level of pain.  Pain and stiffness is extremely severe at night or after sitting resulting in inability to walk upon rising due to pain in my legs and hips.  The pain subsides to a tolerable level upon stretching and moving throughout the day but is still significant.    Climbing stairs is painful and unstable and pain in upper body arms, neck, back inhibits my usual exercise and daily routines.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: menstrual cycle changes-Medium, Systemic: Nausea-Medium
I was having a very bad headache from the afternoon of the shot, and I started having stomach pain and body aches. I called my doctor and did a visit with doctor on the May 13th, and he said if I didn't feel better by the Monday to come see him, but by that Sunday I was in severe pain with my stomach, so I went to the emergency room. When I got there, they sent me from that to the hospital so I could get a CT scan and they diagnosed me with a bacterial infection in my stomach and gave me a lot of antibiotics to take. To this day my nose just constantly runs and it's not allergy season. The runny nose started after my vaccination, and I never had Covid to my knowledge.
Received MMR, DTaP and IPV on 8/4/06. Mom states on 8/6/06 the area started becoming red,"itchy" area cont. to increase in size w/ice. seen in office 08/07/06, area red and swollen over site of MMR adm.
Swelling of left arm SC, cephalecin 125mg/5ml QD x 7 days was given by hospital. Pediapred 5mg/5ml 5ml po QD x 4 days # 20 mc NR Motrin PRN, ice site, RTO PRN
(?)MAY21 Bloodwork abnormal (?); (?)MAY 23, different bloodwork, Polymyalgia Rheumatica.
chills/tremendous chills; has been coughing for a couple of day; he was really cold when he came to bed. He was really freezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sinus issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Unknown Manufacturer), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills/tremendous chills"; COUGH (non-serious), outcome "unknown", described as "has been coughing for a couple of day"; FEELING COLD (non-serious), outcome "unknown", described as "he was really cold when he came to bed. He was really freezing".  Additional information: Wife of patient called and wanted to know if chills was a side effect of the Pfizer COVID-19 Vaccine 3rd booster dose. Patient received the vaccine at 9:30AM and had extreme chills that night. Caller had to turn up the heat at night and put extra blankets on the patient. Caller mentioned that the patient has been coughing for a couple of days maybe due to the allergy season. Caller mentioned that the patient has sinus issues during allergy season. Further reported that husband was given the third booster of the Pfizer shot and she doesn't know if her husband is getting a side effect but her husband had tremendous chills last night. Which her husband doesn't normally have. Had the shot at 9:30 in the morning then at midnight, 1am, or 2am he was really cold when he came to bed. He was really freezing. Thought it was a side effect because it was kind of unusual.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
still took the 3rd injection; bleeding; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; COVID-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "still took the 3rd injection"; HAEMORRHAGE (medically significant) with onset 2021, outcome "not recovered", described as "bleeding". The event "bleeding" was evaluated at the physician office visit. The patient took the third vaccination, and the patient was bleeding and he was probably going to die.  There was nothing more the doctors could do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. developed a non-itchy non-painful rash at site of immunization. It covered approx. 2x4 inches w/ blisters. Started w/in 3 days and blisters went down over time. Discoloration remains after 2 1/2 months.
It hurt for about 5 or 6 days and then the pain disappears; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It hurt for about 5 or 6 days and then the pain disappears). The outcome of the pain was resolved (duration 6 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084567   Additional Information: GSK Receipt Date: 09-JUN-2023 This case was reported by the patient via interactive digital media. The patient received 1st dose and had pain for 5 to 6 days and then the pain disappears, the patient stated that the first vaccine hurt more the second and almost not but if it hurts a lot. put patches of warm water and everything would be fine. The follow-up could not be possible as no contact details were available. For tolerance of 2nd dose refer case US2023AMR084567, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR084567:Same patient
Pt received her first dose of ENGERIX-B, Hep B vaccine left deltoid on 6/8/10. She c/o pain in (L) deltoid at injection site approximately 4 days later that began to radiate to (L) shoulder, reported difficulty lifting (L) arm, pain progressed x approximately 3 wks and now wk of 7/16/10 states it is resolving but still has pain (mild) when raises (L) arm at injection site in (L) deltoid.
Mother states patients arm was swollen and red where injection was administered and will give Benadryl for further treatment.
This case was reported by a healthcare professional and described the occurrence of inappropriate route of vaccination in a 4-month-old female subject who was vaccinated with ROTARIX (Glaxosmithkline). Previous and/or concurrent vaccination included PENTACEL (non-gsk), manufacturer unspecified, unknown given on 15 September 2009; PREVNAR (non-gsk); manufacturer unspecified given on 15 September 2009. On 15 September 2009 at 11:00, the subject received 2nd dose of ROTARIX (intramuscular, right thigh) and experienced inappropriate route of vaccination. The lot number was as "A41SA802A". A 4-month old female subject was administered ROTARIX intramuscularly on 15 September 2009. No additional information was available. Follow up information was received on 20 October 2009. It was reported that the vaccine was diluted on a vial and withdrawn in a regular syringe with a needle. The medical assistant stated she had not given ROTARIX before and assumed it was intramuscular injection. The lot number was A41FA802A. On 15 September 2009, the subject experienced fussiness. On 16 September 2009, the subject experienced redness on both thighs. The outcome of the events was unspecified.
Bell's Palsy-left side of face, slowly progressing paralysis of right side- diagnosed with Guillain-Barre Syndrome. Symptoms developed within 24 hours of second vaccine. Requiring IVIG treatment for the next 5 days.
Information has been received from a  healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-APR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Slight tingling sensation of the arm of site of vaccine administration. monitored for 30 minutes, stable. Follow up with PCP, V-Safe, ER precautions
Patient came into the pharmacy and showed me her arm which was swollen and red from the site of administration (the deltoid) all the way down to near the elbow. She complained of itchiness but no pain. I recommended hydrocortisone 1% cream for her and to go to an urgent care clinic if symptoms don't approve after a couple of days. Vaccine was administered properly at the appropriate site (IM at deltoid). Patient even confirmed that she remembered me giving her the shot that way. No further information such as treatment outcome is known as of today (12/22/18). As for the result of the adverse event (item 21), she came into the pharmacy, told me the story, showed me her arm, and asked me for advice which I gave to her as stated above. Patient did NOT die. Item 21 is forcing me to put a check mark in a box for patient's date of death. At least that's what it looks like to me.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 05-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 10-DEC-2015, the patient was treated by a physician, for a blistering vesicular outbreak, which was diagnosed as zoster keratitis. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, zoster keratitis was considered to be medically significant. Additional information has been requested.
Pt recvd booster dose of MMR on 2JAN92 & the following morning pt noted localized redness & swelling @ inject site & mild fever which subsided in approx 24 hrs; 8JAN92 pt devel stomach pain, sore throat, joint pains & flu-like sx;
Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild Brachial Neuritis; probably with autonomic neuropathy component, producing orthostatic hypotension; probably with autonomic neuropathy component, producing orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotension, weakness right side of the body, arm and leg; paresthesia, probably post vaccinal mild brachial neuritis, probably with autonomic neuropathy component, producing orthostatic hypotension on 13Apr2021 16:00. The patient was hospitalized for a day on unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Apr2021. The outcome of the event was recovering.  Information about lot/batch number has been requested.