chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  The Lot Number of vaccine are as follows, 006C21A (10-10-2021), 026B21A (09-17-2021), 031B21A (9-22-2021).  The vaccines was stored in freezer, take out one to two vials and place in fridge each day as needed.
Pain in the joints, high blood pressure, lost of memory, swelling liver. Follow-up: joint pain, muscle pain, bone pain, vision disorder, severe fevers, high blood pressure, high blood cholesterol, aggressive, sleeping disorders, loss of memory, muscle cramps. 60 day Follow-up Information 23-OCT-2006: Symptoms still the same as I stated before. They have not improved at all. Some times I feel worst, some times the same. Antrax vaccine missing/administered on 22-FEB-03/Manufacturer: Bioport/Lot Number: unknown/Dosage 0.5cc/Previous Doses: 0/ Any questions feel free to call to the number I provided  before. Thanks.
On 12/07/2021 vaccines were picked up from the state department to be stored in the fridge and used by 01/07/2022. This patient received the vaccine 7 days after the vaccine use by date. This patient reported no known symptoms.
During 15 minute observation period patient stated that she had itchy throat and was not feeling good, she felt lightheaded.  She was given Benadryl and had a cold drink.  She stated that she felt a migraine coming on.  She had "kaliedescope eye" and sensed migraine aura.  She waited an additional 15 minutes and started to feel a little better, and had a friend pick her up and drive her home.
No additional AE; Five doses of varivax that underwent the temperature excursion were administered; This spontaneous report has been received from a physician  concerning a 4 years- old patient of unknown gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.  On 28-JUN-2020,  the patient was vaccinated with one of the five doses  that underwent temperature excursion of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection 0.5 milliliter once for prophylaxis.  Lot # reported as S026925 (Patient route of administration and expiration date was not reported). No additional adverse events were reported.  The storage temperature was reported  to have been at -9.2 celsius degrees (°C) and in between  -14 celsius degrees (°C) to -10 celsius degrees (°C) (-14.3) for 30 minutes.  There was digital data logger involved and  no previous temperature excursion was reported.  Lot #  S026925 is an invalid lot number for varicella virus vaccine live (oka/merck)  This is one of many reports received from the same reporter about related temperature excursion cases.; Sender's Comments:  US-009507513-2008USA011114:related case # 01687213 US-009507513-2008USA011596:Related case # 01687214 US-009507513-2008USA011552:Related case # 01687189 US-009507513-2008USA011473:Related case #01687223
RAISED RED ITCHY AND SCRATCHY, WELTS APPEARED AT INJECTION SITE 8 DAYS AFTER RECEIVING IMMUNIZATION
Pt calling stating that her arm where she received the shingles vaccine is very red and itchy. Pt states that there is no swelling or lumps and is only mildly painful. Pt denies any difficulty breathing/swallowing, fever, dizziness.
Reported Possible Anaphylaxis, possible respiratory failure and shock. Client was evaluated at Emergency Room and another Hospital.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The Patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot #: L004743, expiration date on 01-JAN-2017 (dose and anatomical location were not reported) which were stored in a temperature of 31F during 45 days. Concomitant therapies were not provided. No previous temperature excursion was reported. Other suspect therapies included an sterile diluent (lot #: K026419, expiration date: 19-OCT-2017, Lot #: L041248, expiration date: 27-JAN-2018), which were exposed with the same conditions. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Breakthrough admission after two vaccines 9/9/21 Moderna 052#21A 11/5/21 Moderna 071F31A
Moderate amt redness.& Itching to site and knot the size of a ping pong ball initially. At this time now the size of a marble with small amt itching.
3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of face.  Saturday morning (12/26/20) noticed left lymph node was swollen. Sought medical care-DX anterior cervical lymphadenopathy.
Child received VARIVAX, MMR, and KINRIX vaccine on 4-13-10 - came back in to office 4-16-10 with approximately 8cm x 7cm circular, erythemic hardened knot to left leg. Painful to touch. Child Dx with left leg cellulitis and Tx with OMNICEF 250mg/5mL-3 mL PO BID x 10 days with F/U in 1 week.
No adverse event at time of vaccine. It has been 13 days since I got the vaccine and yesterday my right arm became swollen and warm to the touch.  It looks a little red but that is all the symptons I have had so far. I don't know if that would be called an adverse event or a delayed side effect.
Mom called at 9:30PM to report swelling and redness at injection site, right arm as well as "4 or 6 bumps on her gums, some like pus". Gargling with salt water.  Recommended cool application as well as Motrin as appropriate for age to reduce pain and swelling. Call to mom 10:15 AM this morning, swelling improving "not as hard" after tx and Motrin, switching to warm applications later today. Child slept well during night.  Will see dentist today.
SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm; STIFFNESS; ENLARGED LEFT SHOULDER; SHOULDER PAIN; the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), MUSCULOSKELETAL STIFFNESS (STIFFNESS), JOINT SWELLING (ENLARGED LEFT SHOULDER), ARTHRALGIA (SHOULDER PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021, Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021 and Janssen COVID-19 Vaccine from 05-Apr-2021 to July 2021. Past adverse reactions to the above products included Leg pain with Janssen COVID-19 Vaccine; Numbness with Janssen COVID-19 Vaccine; and Tingling with Janssen COVID-19 Vaccine.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), MUSCULOSKELETAL STIFFNESS (STIFFNESS), JOINT SWELLING (ENLARGED LEFT SHOULDER), ARTHRALGIA (SHOULDER PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2). On 22-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the patient received additional  vaccine mRNA 1273 .Dose number in the series was 2) had resolved. At the time of the report, PAIN IN EXTREMITY (SUDDEN ARM PAIN/ It hurt very much when person received the shot,remained in constant pain,pain in arm), JOINT SWELLING (ENLARGED LEFT SHOULDER) and ARTHRALGIA (SHOULDER PAIN) had not resolved and MUSCULOSKELETAL STIFFNESS (STIFFNESS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, X-ray: results not reported Results not reported.         No Concomitant medications were reported. No Treatment mediations were reported.   Events related to historical Janssen COVID-19 vaccine severe leg pain, tingling in feel, legs, arms, hands and numbness  for at least 3 months had The patient  recovered from severe leg  pain, tingling in feet, legs, arms, hands, and numbness on an unspecified date in JUL-2021.
Client received CanSino COVID vaccine, no reaction. CanSino vaccine not approved by World Health Organization, Janssen given as an alternative on 09/15/21.
coughing bad; chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing bad) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing bad) and CHILLS (chills). At the time of the report, COUGH (coughing bad) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative. and (Positive) tested positive next day..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.
9-months female baby received HALF of Engerix-B adult dose; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 9-month-old female patient who received HBV (Engerix B adult) (batch number T254Z, expiry date 20th November 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (1st and 2nd dose received on an unknown date).   On 24th June 2021, the patient received the 3rd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 24th June 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child. On an unknown date, the outcome of the adult product administered to child 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 details were reported as follows : The patient received half of dose of Engerix B adult, which led to adult product administered to child. No further information was reported. The reporter consented to follow-up by email please in order to check information with Nurse´s supervisor.
4/8/21 Call from case to the Health Department to report symptoms she believes resulted from first COVID vaccination last week. Case states that she was vaccinated on 4/1/21 with the first dose of Moderna.  She states that the next day on 4/2/21 she developed nausea and fatigue. She felt better on 4/3/21. On 4/4/21 she went to a family celebration of a holiday and the fatigue and nausea resumed. The nausea and fatigue have continued to this day. She states she has an appointment made with her PCP for 4/12/21. The case states that she is recently returned home. She flew back home on 3/31/21. RN encouraged case to follow up with physician to report continued symptoms and to see if she can be seen sooner. RN also encouraged her to talk with physician about whether they feel she should be tested for COVID. Case agreed and will follow up with physician.
Large lymph node on collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Large lymph node on collar bone) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Large lymph node on collar bone). At the time of the report, LYMPHADENOPATHY (Large lymph node on collar bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Presented to ER on 11/17/21 with hypoxia noted at group home.  Caretaker at the bedside provides all the  history.  Patient was diagnosed with COVID symptoms that have been present for  approximately a week.  He has been coughing, chest x-ray does not show any  signs of infection.  He presented to another hospital, did not have much of a  workup.  Diagnosed with COVID on 11/17/21.  He drops down to below 90% on room  air. The patient was treated with dexamethasone for COVID treatment protocols ( was outside the window for remdesivir therapy); empiric antibiotic therapy with ceftriaxone and azithromycin was also added to preclude a bacterial component to his disease.    Patient improved over course of his hospital stay.   He was ultimately discharged back to his group home residence on 11/23/2021.
w/in 12 hrs p/1st vax, pt exp an inject site reaction which included swelling of the entire arm, erythema (7x5"), myalgias, arthralgias & fatigue; tx w/seldane, pramasone lotion & APAP; vax w/flu-imune previous wk;
swollen, red and itchy at injection site on Day 7 of first dose moderna covid 19 vaccine eua
On right leg, a 5 inch rash resembling chicken pox pimple like appearance, does not itch.
Initial unsolicited report received from a pharmacist  on 15 October 2015. This case involves a 5-year-old male patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI444AA, expiration date: 30 June 2016, expiration date and dose not reported) given intramuscularly on left deltoid on 13 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Previously patient received a dose of Influenza quadrival A-B vaccine on an unspecified date. Concomitant medication was not reported. On 14 October 2015, one day following the vaccination, the patient developed rash which was warm to touch. According to the patient's mother, the size of a post it note warm to touch (looks like a rug burn). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Patient came with his mother to the pharmacy to get a influenza vaccine. After few minutes (1 to 2 min) he got the vaccine, he feels dizzy, lost consciousness and passed out. I make the staff to call 911 and make him lay down and checked his pulse, breathing and for consciousness. His was breathing normal and got his consciousness quickly. Until paramedic arrive he stayed lay down and responsive. His mother states that patient have such symptoms every time he got a vaccine and mentioned as well as he did not  eat or drink since the night before  vaccination.
Dizziness. Diarrhea. Prolong brain fog. Stomach pain. Heating effects in body. Swollen lymph node. Extreme tiredness. Dry mouth. Upset stomach. Loss of appetite. Heavy head. Fever. Chills. Jitters in body. Anxiety.
chills; sweats; tiredness; headache; eyes affected; nausea; joint pain; muscle pain; weakness in my legs and body.; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ENG6200TA), dose 1 via an unspecified route of administration, in left arm on 17Feb2021 at 10:00 (at 67-years age) as single dose for COVID-19 immunisation. Medical history included hypothyroidism, BPH, low iron, COVID-19 in 2020 and seasonal allergy. Concomitant medication(s) included clopidogrel, Tamsulosin, levothyroxine sodium, magnesium sulfate and ergocalciferol (VIT D) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have side effects until 8-10 hours after the shot. He previously had COVID last year, and it felt like he had it all over again. On 17Feb2021 at 18:45, the patient experienced chills, sweats, tiredness, headache, eyes affected, nausea, joint and muscle pain, and total weakness in my legs and body, but did not had fever. No treatment received for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.
14oct87 pt was apparently well;found under crib a few hrs later w/ cardiopulmonary arrest;autopsy including brain revealed no significant findings;COD attributed to SIDS;
Information has been received from a registered nurse concerning a 26 year old female patient who on 09-DEC-2008 was vaccinated with the first dose of GARDASIL, lot # was not specified. After being vaccinated, the patient passed out completely for 60-90 seconds. The nurse stated that 4-5 minutes after the patient came to, she did not make sense and her arms were moving about as if she was having a seizure. The patient reported to her nurse that she had bad luck when it comes to vaccinations (unspecified products and reactions). The patient was referred to primary care physician. Patient recovered. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a female consumer of unknown age and unknown demographics, reporting on herself. The patient's concurrent conditions or medical history were not reported. On 11-DEC-2013, the patient reported she took a pregnancy test at the doctor's office that showed up negative for pregnancy so then the patient was vaccinated with GARDASIL dose 1 (route lot and expiration date were not reported). Co-suspect or concomitant therapies were not reported. On 19-DEC-2013, the patient took an at home pregnancy test that showed up positive for pregnancy. The Last menstrual period (LMP) was in approximately 2013, and the patient's Estimated Due Date (EDD) was not provided. Additional information is not expected.
Received 4th Anthrax vaccine Tuesday 5/3/00. By Thursday of same week, injection site had redness, swelling, intense itching in an approximately 4 inch diameter welt. Saw physician 5/5/00 to determine reaction in medical records.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 12:39, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.0 and 0.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
The site of the injection was very sore when I went to bed at 10. In the morning I noticed that the area around the injection was red and swollen. I felt muscle pain all over my body, I was very fatigued and weak. I stayed in bed all day. I was feeling better the next day, though it was still red and sore at the site of the injection.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; vaccination date will be the start date of the event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (vaccination date will be the start date of the event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 6:01 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 6:01 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). 16-Nov-2021 at 6:01 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccination date will be the start date of the event). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (vaccination date will be the start date of the event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vial was stored in frozen storage which was in super cold freezer. On 19-Nov-2021 vial was went from super cold freezer to the refrigerator. 70 vials were still in the ultra cold freezer, 8 vials were in the refrigerator, so a total of 78 vials were affected. Vaccine vial state changes were noticed and vial was never refrozen. None of the vials were punctured before the event. Temperature excursion remained for 1 month.   No treatment medication was reported by reporter.   This case was linked to MOD-2021-402935 (Patient Link).
3/26 office appointment: New onset right and left sided chest pain with associated shortness of breath, fatigue and intermittent lightheadedness. Labs drawn. CT scan showed  Scattered small occlusive and nonocclusive emboli within small distal pulmonary artery branches bilaterally. Started on apixaban.  Has appointment with Hematology on 4/29
On 2/11/22 I had an acute onset allergic/anaphylactic reaction that mimicked allergic histamine reactions from my remote history - last one in 2001 before current allergy med regimen (H1, H2, and leukotriene blockers). I had rapid onset vomiting and diarrhea, lightheadedness, flushing, diaphoresis, hypotension, and then syncope. Reaction required transport to the emergency department and 2 Litres of IV fluids.
Mother states that 24 hours after the getting vaccines pt. began vomiting, headache and fever of 102.0F.  States this lasted for 24 hours.  States at this time pt has only a low grade fever of 100.0F and no vomiting.
Patient's arm was swollen and red.  She was at the dr office yesterday and he told her if worse overnight to goto an er. patient came in and said it spread over the night. told her to goto an er. she went and received cleocin for tx.
Patient's mother reported localized swelling and erythema to injection site 7 days after immunization given. Older sister with similar reaction 2 days after same vaccination received. Per mother, older sister had history of reaction to DTaP as infant so had not given any more doses, this was patient's 1st dose of DTaP.