chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per company and FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and DHA instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes.
Patient reported chills, fever, muscle pains/aches, and fatigue for under 48 hours after receiving vaccine. Per her words, "could not get out of bed".
Information has been received from a pharmacist referring to a 49 year old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (19400 plaque forming unit (PFU), lot#, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and eye twitches. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced eye twitching. On 13-APR-2021, the subject experienced slight pressure on side of head. On 13-APR-2021, the subject experienced burning sensation in chest. On 13-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye twitching, slight pressure on side of head, burning sensation in chest, and shortness of breath. This report was non-serious.
Patient started to feel SOB, Chest tightness, mouth swelling, and generalized rash. Vitals taken, accessed by provider. Benadryl 25 mg IM ordered and administered. patient quickly started to feel better. subsequent vitals showed stable, SOB, chest tightness and mouth swelling  diminished. Patient reassessed by provider. Discharged home
6 inch local injection site reaction, hard, painful, red, and itchy for one week following the injection.  Patient had previously experienced 5 episodes of very painful shingles.  New episode started on October 19th following vaccination on October 8th.
Information has been received from a physician, author of the abstract title as stated above. Patients with inflammatory bowel disease (IBD) often receive immunosuppressive therapy (eg, thiopurines, methotrexate, tumor necrosis factor inhibitors) for prolonged periods of time. Although such medications maintain remission and improve quality of life, they put patients at risk for infection. Therefore, it is important to implement preventative care, including immunizations to minimize the risk of vaccine-preventable infections. In general, inactivated vaccines are considered to be safe in patients with IBD receiving immunosuppressive therapies. Two recent studies of the influenza vaccine demonstrated that the immune response in patients with IBD overall is good but that there may be a reduction in serologic response in patients receiving tumor necrosis factor inhibitors. However, there is a paucity of data regarding the immune response to the varicella vaccine in patients with IBD. Studies in other immunocompromised papulations (eg, oncology, chronic renal failure, human immunodeficency virus (HIV), transplant) show that varicella vaccine is generally well tolerated and immunogenic. We present a series of children with IBD receiving immunosuppressive therapy who were injected with varicella vaccine (manufacturer unknown), tolerated it without adverse events, and developed antibodies to the varicella virus. A 15 year old male was diagnosed at age 9 years in 2002 as having Crohn ileitis. He was given 6-MP shortly after diagnosis. Five years later, the family inquired about the varicella vaccine, given the patient's chronic immunosuppressed state. He was vaccinated with the primary varicella (manufacturer unknown) dose at age 6 years in approximately 1999. A baseline varicella titer was not drawn. After a discussion of risks versus benefits, the family decided to immunize the patient with varicella (manufacturer unknown) booster to prevent him from developing wild-type varicella in the setting of immunosuppression in approximately 2007 at 14 year old. He was receiving 6-MP (1.5 mg-kg-1-day-1, mesalamine, and ciprofloxacin at the time of vaccination. He tolerated the varicella booster without clinical manifestations of varicella. The follow-up titer was 0.90 IV (equivocal immunity) (A value of <0.89 IV indicates negative immunity) when patient was 15 years old in approximately 2008. The outcome of the event was unknown. A  copy of the published article as further documentation of the patient's experience. Additional information has been requested.
Left leg developed wheel with erythmatosis flare adjacent to site of vax, immediately after following vax in anterior thigh separated by 1 inch. Watched patient for 1 hour. No treatment given.
Patient presented to vaccine clinic for first Pfizer dose. Patient verbally stated that it was his first Pfizer dose. Upon further investigation after vaccine had already been administered, staff noticed that it was not actually his first dose. Patient had received Cansino last year on 4/6/21 and Astrazeneca on 1/12/22. Patient stated that they spoke to their provider today at his doctor's appointment and provider stated that it was okay to receive his first Pfizer dose today. However, no documentation was noted in his visit with the provider.
Patient's mom called pharmacy to report Hives breakout around injection site. Reported 2 days after shot.
11 YR OLD CHILD GIVEN PFIZER-BIOTECH COVID 19 VACCINE FORMULATED FOR CHILDREN 12 YRS OLD AND OLDER
Approximately 15 minutes following the first dose vaccination the patient began to complain of sudden onset bilateral blurred vision at at distance.  Patient denies any additional neurological symptoms.  Patient brought to the ED for evaluation.
Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Previously administered products included for Product used for unknown indication: Keytruda (Keytruda infusions). Past adverse reactions to the above products included No adverse reaction with Keytruda. Concurrent medical conditions included Endometrial cancer.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 10 milligram once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable..
Flu like symptoms-fever, congested, sinus headache, sweating, sore throat, ear ache, diarrhea which lasted for over 2 weeks.
Severe headaches - 5 days + nites bad headache - 4 days, very - very tired  - 9 days arm still aches.
This spontaneous report was received from a Registered nurse regarding --- patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On ---, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. Sender's Comments: US-009507513-1804USA005153.
died from heart problems; suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of heart disorder in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles when he was 8 years.).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced heart disorder (serious criteria death), vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the heart disorder was fatal and the outcome of the vaccination failure, shingles and pain were unknown. The reported cause of death was heart disorder.   It was unknown if the reporter considered the heart disorder, vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The patient received shingrix in his early 80s and he ended up  with shingles. The patient had bad pain until he  died from  heart problems.; Reported Cause(s) of Death: Heart disorder
Imovax was given less than 24 hours after the expiration date, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse .  This case involves a 20 years old male patient who was vaccinated an expired dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included TYPHOID VACCINE (TYPHOID).  On 29-Oct-2019, the patient received expired dose of suspect RABIES (HDC) VACCINE lot number not reported (exp date: 28 Oct 2019) via intramuscular route in the left deltoid.  It was actual medication error due to Expired vaccine used.  No adverse event was reported.  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 was requested.
Pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 12-May-2020 and the estimated date of delivery was 16-Feb-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy.  On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2020, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported. Previous pregnancy end date was 09 OCT 2018 with outcome live birth.   This case was linked to MOD-2021-015597 (Patient Link).; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
w/in 24 hrs p/vax pt had gen urticarial rash-resolved p/tx w/DPH; no rash present 2nd morning p/vax;
Client stated two days after 1st dose of Hep. B was give that he developed very small little red dots on his arms/hands/legs/back...stated they caused minor itching and that when they currents bumps would heal new ones would arise.
During dose administration, some vaccine leaked from the base of the syringe, amount unknown; Some vaccine leaked from the base of the syringe; During dose administration, some vaccine leaked from the base of the syringe, amount unknown; A spontaneous report was received from a physician concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and during dose administration, some vaccine leaked from the base of the syringe, amount unknown.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown).   On 24 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 24 Feb 2021, during dose administration, some vaccine leaked from the base of the syringe, the amount was unknown. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, during dose administration, some vaccine leaked from the base of the syringe, amount unknown were considered unknown.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # Unknown with no associated AEs.
Itching all over her body; tongue was numb; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 03Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/lot number: EL8982) via an unspecified route of administration in the left arm on 28Jan2021 15:55 (at the age of 68-years-old) as a single dose for COVID-19 immunization. The patient medical history included allergy to all antibiotic and eggs. The patient had no family medical history relevant to event. Concomitant medications were not reported. The patient previously received flu shot in Sep2020 for immunization in which she had no reaction. The patient did not administered additional vaccines on same date of the Pfizer suspect. On 28Jan2021, half an hour after the vaccination, the patient experienced a bad reaction-itching all over her body and her tongue was numb. She was still itching but was better; she has taken Zyrtec and all kinds of things for this event. The patient did not visit emergency room and physician office. The numb tongue had gotten better but then Monday it was numb again. She took more Zyrtec and it was better today. No relevant tests performed. The caller said she was really upset because her doctor told her that she cannot take the second vaccine due to her reaction. She wanted to know if she has any protection from just one dose. The outcome of the events was recovering.
Tested positive for Covid 19 on 11/11/2022.  No treatment given.  Symptoms are runny nose, headaches, cough, sinus drainage.  Told to take over the counter flonase and tylenol for symptoms and isolate for 5 days.
Breakthrough case admission after three vaccines Janssen 4/2/21 Lot# 1805020;  Moderna 3/2/22 Lot#042J21A;  Moderna 8/31/22 Lot# 011B22A;
10 days after getting my 3rd dose (booster) of the vaccine I ended up in the ER in excruciating abdominal pain.   I was having crippling pain on the right side of the abdomen (lower pelvic area and upper under ribs).   I was given 2 ultrasounds.  The trans-vaginal ultrasound revealed I have an ovarian torsion that required emergency surgery.  I was transported to another hospital immediately to have the surgery.   The ER had also done an ultra-sound of my gallbladder and found gallstones.  I had another surgery to have those removed on 1/19/22.
adverse reaction for 9 days; Stiff neck which was extremely painful and was on entire right side all the way down to foot; Stiff neck which was extremely painful and was on entire right side all the way down to foot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck which was extremely painful and was on entire right side all the way down to foot), NECK PAIN (Stiff neck which was extremely painful and was on entire right side all the way down to foot) and ADVERSE REACTION (adverse reaction for 9 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included LIRAGLUTIDE (VICTOZA), GABAPENTIN, LEVOTHYROXINE, LISINOPRIL, TOLTERODINE, SIMVASTATIN, OMEPRAZOLE, FENOFIBRATE, METOPROLOL and VITAMINS NOS for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck which was extremely painful and was on entire right side all the way down to foot) and NECK PAIN (Stiff neck which was extremely painful and was on entire right side all the way down to foot). On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction for 9 days). The patient was treated with ACETAMINOPHEN for Stiff neck and Neck pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck which was extremely painful and was on entire right side all the way down to foot), NECK PAIN (Stiff neck which was extremely painful and was on entire right side all the way down to foot) and ADVERSE REACTION (adverse reaction for 9 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history information was provided.
1) 1-day after felt tired, no bruising  2) 4th day after woke up with moderate-to-severe joint pain, large hematoma at injection site, multiple 3-4 very small hemotomas on other parts of body: right arm, stomach, no fever in am, low grade fever in afternoon 3) 5th-8th day mild to moderate joint pain, hematoma remains, no fever
Warm feeling; This case was reported by a other health professional via call center representative and described the occurrence of feeling of warmth in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020 03:00, the patient received the 1st dose of Shingrix. On 28th October 2020, several hours after receiving Shingrix, the patient experienced feeling of warmth. On an unknown date, the outcome of the feeling of warmth was recovered/resolved.   It was unknown if the reporter considered the feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was a medical science lisaon. The patient had received first dose of Shingrix day before the reporting date at around 3; and within a couple hours began to develop a warm feeling. The warm feeling reportedly resolved approximately 12 hours later. The batch number was not known. The reporter consented to follow up via phone. No health care professional consent was provided.
Got Hives Day After Shot and they lasted 5 days She took Benadryl She tells me and got better each day
red blotchy rash under arms, abd, thighs, hips, vesicles 4 chest, 3 lt leg, 2 rt leg, 2 back;
pt recvd vax;on 1dec94 started feeling lethargic, on 4dec94 v x 2; ha, very lethargic, achy joints; 9dec94 feeling better;
Red and Itchy at the injection site (arm).  Started day after vaccine.  Still is itching 2 days later.
Patient is 5 days younger than the recommended age of 18 yrs for Moderna.
First one caused rash / on her arm for a few days; First one caused / redness / on her arm for a few days; First one caused / a warm feeling on her arm for a few days; This case was reported by a consumer via patient support programs and described the occurrence of rash in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received the 1st dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced rash, erythema of extremities and skin warm. In March 2021, the outcome of the rash, erythema of extremities and skin warm were recovered/resolved.   The reporter considered the rash, erythema of extremities and skin warm to be unrelated to Shingrix.  Additional details were provided as follows: The reporter reported for herself. The reporter stated that, 1 week ago received Shingrix shot and had rash, redness and a warm feeling on her arm for a few days. The reporter asked if s could have 2nd shot of Shingrix as 1st shot caused adverse reaction. The reporter consented to follow up.
Patient developed anaphylactic reaction to FLULAVAL. She became red and had trouble breathing within a couple minutes of vaccination. She's had prior flu vacc. without any incidents in previous years. EPIPEN 0.3mg was administer and patient vital/physical signs normalized.
On Nov 15th my rheumatoid Dr. drew my blood. I noticed a red spot that lingered for a few days. I saw my PCP and they treated me for cellulitis and treated it for several things and didn't get better. Send me to another dermatologist on 12/16 and they tested me and it confirmed Lyme disease. After a week of treatment the rash went away but I'm still testing positive for Lyme disease.
About 4 hours after the vaccination the patient got agitated and did not know who I was and went next door and told the neighbor to call the police to get me out of his house.  His memory of me came back about 4 hours later. 4 days later it happened again only more agitated.  His memory came back again, but not for several hours. The 3rd episode happened 4 days after that and the agitation escalated into total psychosis and he tried to stab me with a steak knife.  The police took him to the hospital and the doctors have been trying to adjust he meds to keep him from getting violent.  He has been in a month now. Prior to the vaccination on February 20th things were normal, went out to lunch, he knew who I was.
Shot did not work for me/Suspected vaccination failure; Shot did not work for me; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shot did not work for me/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shot did not work for me). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that shingles shot did not work for him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.