chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/27/12 I received a call from clients parent stating that her daughter had had a possible reaction to TDAP vaccine. Vomiting, fever, pain/swelling. Parent advised to have her daughter seek medical attention and apply ice to the area. See attached note (please). I received a call at 11am from parent of patient. She went into an explanation of the reaction that her daughter experienced yesterday evening receiving the TDAP vaccine 11am on 3/26/2012. Vomiting, fever, pain/swelling at the site of the injection. I advised parent that she should seek medical attention for her daughter as soon as possible, also apply ice packs to affected area.
COVID arm - a red, raised, itchy bump developed at the site of the injection a week after I received the vaccine.
On 02/16/2021 at approximately 6 PM, patient, who usually uses a walker, fell while returning to her chair. Although she reports that she is not in any pain, since then she has been unable to walk more than 1-2 steps. She has also lost her appetite.
Extreme outer skin irritation like extreme skin irriration  Much more than itching... have been unable to sleep or rest for more than a week up to now 01_/25/2024...
10 day following immun pt devel fever, h/a, lethargy; fever 101-103; MD rx ATB & antipyretics;
Patient stated she had some localized pain and soarness starting the evening after the shot that lasted 2-3 days. The pain started to diminish a bit but was still there and 5 days after she noticed it was swollen and seemed warm to the touch. She went to see her physician who then prescribed the antibiotic Bactrim DS which happened today.
COMPLAIN OF PAIN AND FEELING WARM ON LEFT HIP.   LIGHTHEADEDNESS. PATIENT WAS ADVISED TO TAKE IBUPROFEN AND SEEK ADDITIONAL MEDICAL TREATMENT IF SYMPTOMS WORSEN.
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine lot # 069H21A met the 30-day thawed expiration on 2/20/22/administered on 28-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine lot # 069H21A met the 30-day thawed expiration on 2/20/22/administered on 28-Feb-2022) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination. The patient's past medical history included Kidney transplant. Concurrent medical conditions included Immunocompromised. On 28-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine lot # 069H21A met the 30-day thawed expiration on 2/20/22/administered on 28-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine lot # 069H21A met the 30-day thawed expiration on 2/20/22/administered on 28-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine lot # 069H21A met the 30-day thawed expiration on 2/20/22/administered on 28-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine lot # 069H21A met the 30-day thawed expiration on 2/20/22/administered on 28-Feb-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No vaccines given concurrently. No known history of COVID-19. No concomitant medications were reported. No treatment drugs were reported.
2 days later, she had diffuse joint pains, legs felt tight, still able to walk. She got second dose on 3/16. A few days after that, diagnosed by bilateral lower extremity DVTs
Initial report was received 24 August 2009 from another manufacturer (document number 45223857) who received the report from a health care professional. A 12-year-old female patient with a history of a milk allergy, had received an injection of MENACTRA (lot number, route and site of administration not reported), and an injection of "TDAP" (manufacturer, lot number, route and site of administration not reported) early on the morning of 05 August 2009, and an unspecified amount of time later that day, the patient began to have difficulty breathing and her throat began swelling. According to the reporter, after receiving the vaccines, the patient left the office. The patient then went to a fast food restaurant and had a cherry slushy and a burger and she began to experience difficulty breathing and her throat began swelling. The reporting physician did not believe the event was vaccine related because the patient had a milk allergy and the patient's mother had spoken with  a person at the restaurant who said that some milk could have gotten into the slushy. The patient's recovery status was not reported. No additional information was provided at the time of the report. Documents held by sender: None.
Pfizer Dose 1 1/26/21 (EN5318) Pfizer Dose 2 2/16/21 (EN5318) Pfizer Dose 3 11/4/21 (30145BA) COVID Positive 1/13/22  1/13/22: 93-year-old female with a past medical history of recurrent urinary tract infections, diabetes mellitus, hypertension, congestive heart failure presents after being found altered.  Patient's daughter was at bedside during the interview.  As per daughter the patient has been hospitalized multiple times over the last 2-3 months due to urinary tract infections.  This morning the patient appears to to have stroke like symptoms and was unable to respond to medical personal.  The daughter reports that this has been a common occurrence when the patient had been having urinary tract infections during this most recent period.  In the ED the patient did not appear to have any focal neurological deficits and CT head was clean.  Patient is positive for a urinary tract infection and appears to have left-sided pneumonia.  1/15/22: 2019 novel coronavirus detected  Acute UTI, Acute UTI  AMS (altered mental status)  Pneumonia, Pneumonia
On 9/8/2021, left arm pit swelling. 3 hours after vaccination, felt pain and then swelling. The Plan was to Ice, elevate, and return precautions discussed.
Muscle pain (next morning) extending down arm to fingers - around left shoulder blade.   Shortness of breath - red (hives) fever. Pt called MD.  Told to take BENADRYL.  Not better go to acute care or ER - Still on 12/19 - sore some swelling.
Initial unsolicited report received from a consumeron 10 December 2016. This case involves a female patient (age not reported) who was vaccinated with INFLUENZA VACCINE (Flu shot) (dose, dose in series, batch number, expiry date of product, route and site of administration were not reported) on an unspecified date (reported as this week). It was reported that the patient never had a low blood sugar. No further information regarding the patient's medical history was reported. Concomitant medications included METFORMIN HYDROCHLORIDE (Metformin), SITAGLIPTIN PHOSPHATE (Januvia) and glimiperide. On an unspecified date and duration following the vaccination the patient had enlarged lymph nodes. Laboratory data and corrective treatment were not reported. The patient had not recovered from the event at the time of reporting. List of documents held by sender: none.
Redness and swelling noted. Advised to apply ice and may take Tylenol for discomfort.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2011, the patient was treated by a physician at a medical center/health care facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a nurse refers to two unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported.  On 03-AUG-2017 the patients were vaccinated with improperly stored VARIVAX (Incorrect product storage) from lot # M039317 expiry date 20-SEP-2018. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT) (unknown lot number and expiration date) used for reconstitution was properly stored. No adverse effects reported. The vaccine was exposed to temperature -14"C to-10"C (-9.9"C) for a time frame of 15 minutes. No previous temperature excursion was reported. The call because of a "data logger". No further information provided. No PQC involved.
upon discovery from the administrator of the shot, and errant dose of Pfizer-BioNTech COVID-19 vaccine with a LOT of FP7137 instead of the Bivalent Pfizer Booster
Entire arm (past elbow) was red, swollen, and warm. Painful to patient, but improving.
Within a minute tasted mentally a bit foggy then fine within an hour. Luis and tongue felt puffy and swollen a bit tingly and irritated. Arm not sore until second day but didn?t run or ice it this time.  Day 2 whole body feels puffy like lots of water retention feels like. Tongue and lips still affected
COVID symptoms returned; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms returned) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Naproxen and all muscle relaxers (Naproxen and all muscle relaxers). Past adverse reactions to the above products included Allergy with Naproxen and all muscle relaxers. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 26-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (COVID symptoms returned). At the time of the report, COVID-19 (COVID symptoms returned) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2022, SARS-CoV-2 test: positive (Positive) COVID symptoms returned after paxlovid and tested  positive again.         The patient took any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. No treatment medications were reported. Company comment: This spontaneous case concerns a 40-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The date of onset of the event was not specified in respect to the administration of second dose of mRNA-1273, hence latency could not be assessed. There was no information regarding the first dose. On May 6, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The date of onset of the event was not specified in respect to the administration of second dose of mRNA-1273, hence latency could not be assessed. There was no information regarding the first dose. On May 6, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Runny nose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No Treatment medication was provided.
TOOK TWO DOSES OF UNREFRIGERATED VIVOTIF; This spontaneous case (PVX2019-1516) was received from a consumer on 11-Jun-2019. It describes a 53-year-old adult female consumer who "took two doses unrefrigerated Vivotif ". The consumer was receiving oral Vivotif (one capsule every other day) (lot number: 3003272) for typhoid prophylaxis.  Case report: The consumer left Vivotif doses at room temperature (80 to 90-degree Fahrenheit). Then, she took two doses on 09-Jun-2019 and 11-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses unrefrigerated Vivotif " was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses unrefrigerated Vivotif " was considered as not applicable.
This spontaneous report as received from a physician refers to a 72 year old female patient. The patient had none pertinent medical history and none drug reactions or allergies. Concomitant therapies included CRESTOR, NORVASC, vitamin D (unspecified) and vitamins (unspecified). On 23-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L040181, expiration date 18-AUG-2017) 0.5 ml (route not reported). On the same day, about an hour and a half after receiving the vaccine the patient complained of arm swelling (unspecified arm), redness and itching around injection site. The patient had hives on both arms, on face and numbness and tingling of hands, feet and tongue, since an unspecified date in May 2016. The reporter stated that the patient could not eat, was very uncomfortable and was not able to drive. The patient was seen in the office. No labs were performed. The patient was treated with hydroxyzine 50 mg and MEDROL pack. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Severe  body ache muscle spasms for 2 months and slowly improved over next 2 months .Extreme fatigue, needed to stay in bed.improved over next 3 months.Sciatica 5 days after the first inj. oin feb 21 and persistent and severe after the  second vaccine .Fine after cortisone   injection .in june of 21.MRI showed spondilolisthesis  and believed that was the cause. but after the booster developed severe sciatica immediately again. Improved but still have persistent issues with it.
Took first dose in February and second in september; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose in February and second in september) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight and Smoker (With health issues).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose in February and second in september). In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose in February and second in september) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Soreness and swelling in injection arm - 1/2 hour after shot continuing to present  1:00pm 3/17 (26 hours after shot):  unexpected low blood sugar readings throughout the afternoon  7:00pm 3/17 (32 hours after shot):  slight fever (100.1), muscle soreness, body aches
My symptoms started around 4 pm the day I got the vaccine.  The fever started first, then body chills.  My nausea was mild and happened mostly the next morning when I first woke up, then subsided. My headache started soon after the fever and lasted until around 2 pm the next day. The body zaps started in the evening of the day I got the vaccine, and the brain zaps happened 3 times while I was sleeping, waking me up each time.  I fell asleep at 9 pm and got up at 4:30 am.   fever (101 degrees) chills nausea - no vomiting headache brain zaps - it felt like short bursts of lightning in my head body zaps - every time I moved it felt like lightning was in my body/joints sleep problems - I woke up every hour for the first few hours, then I started waking up every 15 minutes for the last couple of hours of sleep around 2 am.   All my symptoms disappeared by evening, 6 pm, the day after the vaccine. So, just over 24 hours of duration.
Note from ED: Patient was receiving her Covid vaccine and immediately after getting the vaccine, she started to develop palpitations. Patient monitored, labs normal, stable, continue further observation at home.
Gave Flublok Quadrivalent to an underage patient. No adverse reactions or symptoms.
Swelling, redness and discomfort at the injection site, mother reports onset of symptoms after 24 hrs post immunization. Application of warm soaks pre MD. Swelling resolved in 2 days.
pain at site, joint pain next day (wrist& ankles), shingles like rash on neck face and side by saturday.
Tiredness, aches, headaches, and fever for much of the day. Fever broke in the evening. Feeling fine the next day (two days after vaccination) Only medication I took was to alleviate fever.
Chronic uticaria (hives) presented about 2 weeks after covid booster all over body, especially back, sides, hands, feet and underwear lines. Has continued for 3 months. Still continuing. Treating daily with Zyrtec and Benadryl.
Bruised almost immediately. Day 2 bruises run along vein lines. I have pictures. The vein bruising (2 veins) are approximately 2 inches per vein.
Anthrax Lot #FAV110 Administered after expired date due to administrative oversight.  No adverse reaction at this time.  Report submitted per Milvax direction.
Racing heart, itching throat.  Heart racing resolved in 45 minutes, Itching throat never worsened and resolved after taking Benadryl and sleeping.  Woke up 12/17 feeling fine, but also has a golf ball size knot and redness at injection site.
vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2007, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
with hives, urticaria multiforme.  additional Benadryl here in the clinic. Started on some Orapred. Follow-up if not improved in the next 24 to 48 hours, or symptoms worsen. 1. Allergic urticaria prednisoLONE (ORAPRED) 15 MG/5ML solution, diphenhydrAMINE (BENADRYL) 12.5 MG/5ML elixir; 12/18:  Labs are normal today.  Will await the respiratory panel.  Will call mother with results tomorrow.  If the RRP is negative then will report to VAERS as adverse reaction to the influenza vaccine. Will increase the steroids to BID for 5 days.  Increase the benadryl to 10 mg every 6 hours. She should start zyrtec 1 tsp PO daily.
Pt reported that he was immune compromised  at the time of his vaccination. CMA checked with provider to see what dose should be given and was instructed to give full 0.5cc dose of moderna. It was later realized that pt should have received booster 0.25 dose.  No side effects reported at the time of vaccination
PREVNAR 13-reaction loss of arm movement. JARDIANCE-lactic acidosis.
This is a spontaneous report from sales representative on behalf of an Other Healthcare professional (the receptionist who was calling on behalf of physician) for a patient. This is the first report of three reports.  A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. The patient developed ring of welt at the injection site on an unspecified date with outcome of unknown.
pain, redness, swelling and tenderness at injection site.  Systemic tiredness, chills.
Patient received Pfizer COVID vaccine on 2/7/21 and 2/25/21. On 1/14/22, patient admitted to our inpatient med/surg unit for acute respiratory failure with hypoxia due to COVID19 pneumonia, AKI, and acute metabolic encephalopathy in setting of dementia due to COVID19. As of today (1/18/22), patient is still admitted in our med/surg unit.
04/06/21 experienced rash on the face. 04/07/21 went to ED for funn body rash/redness and was admitted to hospital.
Patient started to experience numbness, pain in her right foot 2 weeks after her Moderna vaccine. It is uncomfortable, but she can still walk on it.
Developed Shingles on opposite arm within 24 hours of SHINGRIX injection. No reaction in injected arm.
Swelling of left upper arm. Received IVP and MMRV on 06/16/2016 at 4:26PM and noticed swelling since then Reports Erythema and warmth in area. Denies fever.
Patient received Moderna mRNA 1273; 015M20A on 2/3/2021 as FIRST COVID-19 vaccination. He received his SECOND vaccination today at different location as Pfizer ER2613 on 3/24/2021. He has had NO symptoms or adverse events associated with this mixing of vaccines.