chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/20/22 65 yr/o female who presents with cough congestion with associated sore throat nausea fatigue.  The patient recently had a COVID booster 3 days ago however has been gradually getting more sick over the last several days with associated fever at home.  Also has had some mild shortness of breath today as well. Review of Systems  Constitutional: Positive for chills, fatigue and fever.  Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative for dysuria.  Musculoskeletal: Negative for back pain.  Skin: Negative for rash.  Neurological: Negative for dizziness and headaches.  Review of Systems    Neurological: Negative for dizziness and headaches.  Psychiatric/Behavioral: The patient is not nervous/anxious.
Headache, Fever, SORE THROAT/STUFFY NOSE Narrative:
This was not an adverse event. Vaccine in freezer longer than 14 days. The patient advised to revaccinate.
38 mos p/vax pt devel chickenpox. pt had 5 spots on face, 3 on neck, 1 on knee, & some on arms. mom rpt spots started out looking like red spots & the one on the neck blistered.
Immediate pain in arm, felt that the injection was given higher/deeper than usual.  My arm felt "full" like there was a lot of fluid injected.  The pain became excruciating quickly, and I lost mobility in my arm.  When speaking to a different pharmacist at a different location when receiving my Covid vaccine in my other arm, he mentioned that I could have bursitis and to have it checked out by a doctor if it didn't resolve.  Saw primary care doctor in January 2023 who diagnosed frozen shoulder and prescribed OTC pain relievers and physical therapy.  In spite of physical therapy, the pain and immobility persist.  Have referral to orthopedic doctor in July 2023.
I went with my wife, whom we were more concerned about possible reactions to the vaccine given her history of anaphylaxis reactions to bee and wasp stings, has had to carry a Epi-pen always, so we stayed an additional 15 minutes for 30 minutes total before we left.  She was completely fine throughout, I however as we were walking out I began to feel a little ?Off?, not necessarily nauseous or dizzy, just a bit Off.  Told my wife that and that I wasn?t sure I should drive us home (I drove us there), so she drove.  About 15-20 minutes into the drive, it got worse and I passed out.  My wife says my eyes rolled in the back of my head with my eyes open but no responsive.  She says she kept hitting my chest but I didn?t respond. I came to about 2 minutes after passing out.  She asked me if I felt like I needed to goto the hospital, I told her I needed to eat, that I felt like what I needed was food, then we go from there.  I did eat breakfast, an English muffin at about 8am that morning, it was almost 12:30 by that point.  When I finally got food in me I felt much better and have had no adverse reactions since.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: pain and limited range of motion-Medium, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Per patient...his head was turned while vaccine was given, but complained to nurse that it hurt really badly and pain continued for next 48hrs and affected his sleep and daily activities. Now the pain is a 3 out of 10 (worst), but it radiates from his shoulder to his wrist even at rest. He has limited range of motion. He believes vaccine was given in shoulder nerves and not deltoid and nerves damaged. He wants $5K from pharmacy for his time for doctor visits he may need. He has not seen doctor yet.
Fever 101-102 x 3d. Red/swelling at site of vaccine - varicella.
Delayed hypersensitive reaction of itchy hives all over my body; Delayed hypersensitive reaction of itchy hives all over my body; Delayed hypersensitive reaction of itchy hives all over my body; This spontaneous case was received on 19-Oct-2020 from other health professional (reference number: SEQW20-03840), processed together with additional information received on 20-Oct-2020 and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed delayed hypersensitive reaction of itchy hives all over her body.  The outcome of events was not reported.  The reporter assessed events as related to influenza virus vaccine polyvalent. The patient had the exact same reaction to the 2016 flu vaccine.  The case is linked to 202005290 (the same patient).  Case updated on 27-Nov-2020: Correction made to information received on 19-Oct-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. Narrative and company comment amended accordingly.  Company comment: Type IV hypersensitivity reaction, urticaria and pruritus were associated with the use of the suspect product influenza virus vaccine polyvalent. The events occurred on an unknown time after vaccination. Chronology is unclarified. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as unlikely related due to unclarified temporality, biological plausibility and lack of other confounding factors. (unlikely related defaults to related for reporting purposes); Reporter's Comments: The reporter stated: I had the exact same reaction to the 2016 flu vaccine.; Sender's Comments: Type IV hypersensitivity reaction, urticaria and pruritus were associated with the use of the suspect product influenza virus vaccine polyvalent. The events occurred on an unknown time after vaccination. Chronology is unclarified. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as unlikely related due to unclarified temporality, biological plausibility and lack of other confounding factors. (unlikely related defaults to related for reporting purposes)
Diagnosed with COVID on 8/11/21, then developed low-grade fevers, weakness, and hypoxia. Patient admitted to hospital on 8/16/21.
Approximately 3 hours after the injection, a cough with wheezing began.  This worsened over the course of 15 minutes which began to increase the labor of breathing.  Fortunately, I had a left over albuterol inhaler (pro air respiclick) from a respiratory illness a few years ago.  Administered 2 metered doses with near immediate resolution.  No further symptom recurrence.
Pt developed swelling in his left arm that happened overnight. His arm was red, very warm to touch and firm feeling. The area of induration went from shoulder to mid-arm. Tylenol and warm packs were suggested as treatment.
8/18/12 Swelling and pain in left arm. Patient went to see MD. Patient Dx cellulitis. Patient was given a rx for cephalexin 500mg on 8/18/12 - rx filled on 8/19/12.
Per mother at 4 AM 3/23/2018 pt had a seizure call 911, pt was evaluated by paramedics was told reaction from immunizations, febrile seizure. This is the 1st episode of seizure.
Fetal exposure during pregnancy; Pre-term birth; This is a serious retrospective pregnancy study case, initially received from other health professional on 26-Aug-2019, concerning a neonate, male subject.  The mother was a 35-year-old female, enrolled in a  prospective observational safety study.   The mother's medical history was not reported. Concomitant medications included prenatal vitamins.  The mother's obstetrical history included one previous pregnancy of full term live birth. Also, the subject's mother had no maternal or paternal history with major congenital malformations. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was on 06-Dec-2018 and the pregnancy was singleton. The estimated delivery date (EDD) and the corrected estimated date of delivery (CEDD) were both on 12-Sep-2019.  On 29-Jan-2019, at gestation age of seven weeks, the subject's mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, at a dose of 0.5 ml, batch number:252675, expiration date, route of administration, and anatomical location: not reported] (explicitly coded as foetal exposure during pregnancy') for influenza immunisation.  At gestational age of 36.1 weeks, the mother vaginally delivered a normal male neonate (explicitly coded as premature baby'). The neonate's birth weight was 2637 g, his head circumference was 34.3 cm and length 48.3 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.  This case is linked to 201904507, corresponding mother case.  Company Comment: Reportedly, the male neonate subject was delivered as premature baby 6 months and 18 days after foetal exposure during pregnancy with the suspect product Flucelvax QIV (influenza vaccine). Chronology is plausible. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related and as related for the event premature baby.; Reporter's Comments: Reportedly, the male neonate subject was delivered as premature baby 6 months and 18 days after foetal exposure during pregnancy with the suspect product Flucelvax QIV (influenza vaccine). Chronology is plausible. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related and as related for the event premature baby.
Patient developed a right lower extremity DVT and a large saddle pulmonary embolus 1 month after his Moderna booster shot.
Fever, muscle pain and stiffness all over, nausea, dizziness, joint pain all over, malaise
1st dose 06Feb2022, 2nd 10Feb2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose on 6th February 2022).   On 10-FEB-2023, the patient received the 2nd dose of Twinrix. On 10-FEB-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 06Feb2022, 2nd 10Feb2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Apr-2023 The patient did not get the second dose until 10th February 2023.  The pharmacist called to inquired that how to proceed with Twinrix series. The reporter reported a patient did not follow the dosing schedule for Twinrix.  The patient was in pharmacy now with interest in the third dose.  The reporter asked that how should they proceed. The reporter unable to provide past vaccine details. The reporter consented to follow-up. The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-APR-2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 31-MAY-2016, the patient was treated by a health professional for a severe vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, 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. Additional information has been requested.
No adverse event; they should not have gotten a second Bivalent dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXTRA DOSE ADMINISTERED (they should not have gotten a second Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7172B and AS7163B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Lot 001M21A) in April 2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (took 3 shots of Pfizer). Past adverse reactions to the above products included No adverse event with Moderna and PFIZER BIONTECH COVID-19 VACCINE.   On 25-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jan-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (they should not have gotten a second Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (they should not have gotten a second Bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (they should not have gotten a second Bivalent dose).    No concomitant medication were reported.  Reporter and her husband have been taking vaccines all the same dates except for the beginning. They took 3 shots of Pfizer and then in April-2022 they took Moderna for the first time and then 25-sep-2022 they also took Moderna.  When they took it in September they forgot vaccine card. They went with their card so they could enter the 25-Sep-2022 Bivalent shot and were told that they were up for a new shot. They went and took another shot today which was the Bivalent booster on 19-Jan-2023. Reporter said they have taken 6 shots. Caller says the woman at Pharmacy was wrong and they should not have gotten a second Bivalent dose. They were told that they needed another one but they didn't have any spots available so caller got the vaccines at a different location. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-700859 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700859:Female case
I had pzier vaccine, 4th shot, second booster on . I already have problems with my neck and shoulder muscles becoming so tight that I take several muscle relaxers everyday. After the shot, that night my shoulder muscles got so tight and hurt badly, even after I took multiple muscle relaxers that normally help. This time, nothing worked. I tried to sleep and woke up from the pain in my neck and shoulders, I was crying from the pain. pain radiated down  my right arm (I was vaccinated on left arm) also. I stayed in bed the next day, still hurting quite a bit despite taking multiple doses of muscle relaxers. I went to bed that night, still hurting, but not as bad as the night before. I woke up the next morning and it was better. I?ve never experienced such pain before from my muscles without medicine or therapy at least lessening the pain until this vaccine.  It felt like my muscles  were glued together, and not in a good way.
a few hours  Pt states after getting shot had very bad diarrhea dehydration & colon infection & UTI went to ER on 2/21/21-
About 4-5 hours after the vaccine: Tightness of throat - lump feeling at the level of the larynx, some coughing, really itchy runny red swollen eyes, numbness in the back of the mouth/oropharyngeal area, mild swelling of lips, fever/chills for about 8 hours. I took a CLARITIN 10mg tab, used an asthma inhaler - albuterol, and used allergy antihistamine eye drops and went to bed, the throat tightness took about 3 hours to resolve, my eyes and lips are still swollen about 12 hours later but are no where near as itchy, the chills have resolved, my head now hurts a little and my sense of taste seems to be affected.
Patient became lethargic about 3 minutes after receiving vaccine.  Patient could not keep eyes open but did not lose consciousness. Patient slow to answer questions. Skin was cold, clammy, capillary refill was sluggish. Patient placed in reclined position in parent's lap with feet elevated. Epi-Pen given by RN about one minute after initial assessment. Child was responsive to pain from EpiPen and symptoms improved. About 10 minutes later, child was evaluated by PA & deemed safe to return home.
Patient was admitted to hospital admitted as inpatient on 9/5/21 due to SIRS (systemic inflammatory response syndrome. Patient was tested for COVID-19 and was positive on 9/5/21.
High blood pressure 160/109 ten minutes after shot.  Still elevated at 154/94 on recheck 5 minutes later.  Patient reports a "pounding" heart.  HR was also elevated.  Patient reports this happened last time as well.
Patient complained of R arm numbness and "needles in my throat". Hives in throat area noted. Patient was administered epinephrine via auto injector and transported by EMS to hospital for further evaluation.
Extreme Tremors and twitching  Gait difficulty Headaches Fatigue Diagnosed as Functional Neurological Disorder by Dr. I missed a lot of work and considered suicide since I'm the provider for my family. I have been to lots of doctors and therapy. I have a lot more good days now but I still have bad days like today.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/29/2021, expiration date is 10/13/2021, administered on 11/9/2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/29/2021, expiration date is 10/13/2021, administered on 11/9/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/29/2021, expiration date is 10/13/2021, administered on 11/9/2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. Date the vial was placed in the refrigerator was 29-OCT-2021. There was no temperature excursion. The reporter reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. The patient did not experience any adverse event. No treatment information was provided by the reporter.
SYMPTOMS BEGAN APPROXIMATELY 12 HOURS AFTER INJECTION. SYMPTOMS WERE GONE AFTER APPROXIMATELY 36 HOURS. TREATMENTS ~ IBUPROFEN AND REST SYMPTOMS: INJECTION SITE PAIN TIREDNESS HEADACHS MUSCLE PAIN CHILLS FEVER INJECTION SITE SWELLING FEELING UNWELL DECREASED APPETITE ARM PAIN
Rash break out on both forearms, just above and below both knees in the back of both leg; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021(at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 from unknown date. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), tizanidine (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) and ga (as reported); all for unspecified indication and from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, the patient experienced rash break out on both forearms, just above and below both knees in the back of both legs. The patient underwent lab tests and procedures which included polymerase chain reaction test on 30Mar2021 and tested negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the event rash on legs and arm was not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Expied Daptacel vaccine was administered with no AE; Initial information received on 09-Mar-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp (Office Staff).  This case involves a patient of unknown demographics who received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Lot- unknown, expiration date- 30-Jan-2020) via an unknown route at an unknown administration site on 05-Mar-2020, for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Laboratory details were not reported.  It was an actual medication error due to expired vaccine administered.  Patient had no adverse reactions at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number is requested.
Large red patch (about 5 inches in diameter) appeared overnight on 3/4 at sight of injection, itchy, slightly sore, hot.  On 3/8 the patch started diminishing but still itchy and by 3/10 the side effects were mostly gone.  I treated the itch with a cortizone cream.