chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose 2 was not on day 7 but will be today on day 9 with no A/E; Initial information was received on 06-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist under Inquiry Number: 00886590).  This case involves an adult female patient whose scheduled second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] was not on day seven but would be today on day nine with no adverse event (wrong schedule).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On an unknown date, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a potential medication error case due to wrong schedule.  It was reported "Pharmacist states he has a pharmacy tech who is going to school and is getting pre-exposure IMOVAX but is off her schedule. Caller wants to know what day she should take her last dose since she is 2 days late for the dose 2".  At time of reporting, it was not unknown if the patient received a second dose on day nine.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Severe pain in arm at site of vaccinations administration (both shots immediately next to each other), temperature of 101 degrees F, body aches and chills. Took 2 Tylenol pills the night of first symptoms, but symptoms came back next evening. Temperature of 99.8 on 11-24-2015 at 6 PM.
started 10 days after the injection, injection site arm is red, itching and very warm -- these reactions were not present in the 9 days immediately following  the injection.
Approx 2-3 wks p/recvd MMR pt devel shaking & tremors; allergist felt was a poss rxn to a new allergy med started p/shots; sx persisted & worsened even p/allergy med finished in OCT; pt falling due to severe tremors; continues to be weaker;
Chills (freezing), aches and  pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
She also got a fever yesterday; She is a little sore/Her arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She is a little sore/Her arm is sore) and PYREXIA (She also got a fever yesterday) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced PAIN IN EXTREMITY (She is a little sore/Her arm is sore). On 07-Dec-2021, the patient experienced PYREXIA (She also got a fever yesterday). At the time of the report, PAIN IN EXTREMITY (She is a little sore/Her arm is sore) and PYREXIA (She also got a fever yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
Information has been received from a healthcare worker who worked with 15 patients with no medical history who were vaccinated with a dose of MMR II.  The 15 patients became autistic within a year after administration of MMR II.  The parents of the patients reported a slow decrease in their vocabulary, eye contact, sleeping, eating, and social interaction.  Most behavioral changes occurred between the age of 2 and 3.  Unspecified medical attention was sought and the outcomes were unknown.  Upon internal review, it was determined that autism was serious as an other important medical event.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
40 min. after twinrix was administered pt. became dizzy, nauseated, pale, blurred vision, and had a headache. Vital signs were stable, breathing was non labored and even. Cool cloth on forehead. Laid down.
back pain; arm is sore; chills; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "back pain"; AXILLARY PAIN (non-serious) with onset 2021, outcome "not recovered", described as "arm is sore"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pneumonia; hearing loss; vision loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 17-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: pneumonia, hearing loss and vision loss. The outcome of pneumonia, hearing loss and vision loss were unknown.   Upon internal review, pneumonia, hearing loss and vision loss were determined to be medically significant.
This initial spontaneous case, was received from pharmacist on 10-Nov-2017, concerning a 23-year-old adult patient of unspecified gender. On 06-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195230, expiry date: May-2018). On the same day of vaccination, the patient experienced pain and soreness in the arm at the site of injection while sleeping in night. Pharmacist recommended analgesic. At the time of this report, the outcome of event was not recovered. The reporter assessed this case as non-serious. Non-significant follow-up received on 01-Dec-2017: The reporter confirmed that, the pain was in arm at injection site and not in leg.
Starting about 2 days after the injection she began experiencing symptoms consistent with the onset of menses (she has not had a menstrual cycle in a number of years). She also had bilateral nipple tenderness and severe left breast tenderness to the point where she needed to take Motrin. She also had what felt like menstrual cramps. The most significant symptoms lasted about 10 days, but are persisting at a lower level. She saw her GYN for a routine appointment and the GYN found masses in both breasts, more noticeable in the left, and uterine pain during the pelvic exam.
Patient was given flu shot in her right deltoid - she states she feels like the shot was given high in the arm. She states, she has had pain in the arm, can't raise the arm and can't sleep on her right side ever since the vaccine was administered. Advised her to see her HCP.
Approximately 7 days after the injection the upper arm around the injection site became red and welted.  It is about 3 in in diameter and has also affected the underarm area.  Both places feel hot, tight, and itch.
The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on23Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a female patient (daughter) of unknown age and race received TRUMENBA on unknown date at single dose for immunization. Medical history and concomitant medication were unknown. On unknown date the patient experienced headache and body ache. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Red dot next day-Graduale high in redness, swelling, heat until hard at site 4cm.  Improved now still slight swelling and redness.
35.5 weeks pregnant and just received my first dose of your vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (35.5 weeks pregnant and just received my first dose of your vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 an unknown date and the estimated date of delivery was 21-Feb-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (35.5 weeks pregnant and just received my first dose of your vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 22-Jan-2021, EXPOSURE DURING PREGNANCY (35.5 weeks pregnant and just received my first dose of your vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
VACCINE ADMINISTRATION ERROR: The vaccine was given subcutaneously causing cellulitis. (redness, heat, swelling) In addition, several drops of the vaccine were seen and felt running down the patient's arm, therefore the full dose was not administered. I did not experience any of the adverse symptoms as I had with the first two vaccines and based on an article by agency, I do not feel this dose will be effective.
pt recv vax 4SEP97 & 13SEP97 pt exp approx 6 pustular lesions on the vaccinated leg;
Quickly after the vaccine, I had a funny taste of medicine. Also a migrant headache which continued the next day (Tuesday-04/13/2021) together with my bones aching and arm swollen and sore. I did not go to work and will not go to work again on today, Wednesday-04/14/2021. My body hurts.
Vaccines MMR, varicella & Prevnar administered 9/19/07.  On 9/23/07 pt had fever & a seizure.  Temp not taken until fever started to come down, was 103.6 at that time.
I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 ANEMIA R57.9 SHOCK, UNSPECIFIED 9/3/2021 ANEMIA I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 ANEMIA R57.9 SHOCK, UNSPECIFIED 9/3/2021 ANEMIA I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 CANCER METASTATIC TO LIVER R57.9 SHOCK, UNSPECIFIED 9/3/2021 CANCER METASTATIC TO LIVER I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 SYNCOPE R57.9 SHOCK, UNSPECIFIED 9/3/2021 SYNCOPE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 CANCER METASTATIC TO LIVER R57.9 SHOCK, UNSPECIFIED 9/3/2021 CANCER METASTATIC TO LIVER I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 HYPOTENSION R57.9 SHOCK, UNSPECIFIED 9/3/2021 HYPOTENSION I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 ANEMIA R57.9 SHOCK, UNSPECIFIED 9/3/2021 ANEMIA I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 ANEMIA R57.9 SHOCK, UNSPECIFIED 9/3/2021 ANEMIA I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 ACUTE POSTHEMORRHAGIC ANEMIA R57.9 SHOCK, UNSPECIFIED 9/3/2021 ACUTE POSTHEMORRHAGIC ANEMIA I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 UPPER GI HEMORRHAGE R57.9 SHOCK, UNSPECIFIED 9/3/2021 UPPER GI HEMORRHAGE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/1/2021 ANEMIA R57.9 SHOCK, UNSPECIFIED 9/3/2021 ANEMIA
pt recv vax 11AUG95 & pt failed to seroconvert;no further details were provided;
No adverse event. Patient requested pneumonia vaccine. Stated last pneumonia was at age 61. State website had no vaccine information. Faxed family physician after vaccination. They stated that they had given PREVNAR 13 on 6/7 and had told patient to get Tdap. No adverse reaction at site of administration on 6/16/17. Patient had no ill effects.
she had pruritus after taking the first dose.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced she had pruritus after taking the first dose on 18Feb2021. Patient was asking how to make an appointment for today's second dose schedule. Also the patient is reporting that she had pruritus after taking the first dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (PRD/SRD 12May2021): Follow-up attempts completed. No further information expected.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported for two patients. This is the first of two reports. A 16-year-old male patient of an unknown race received TRUMENBA for immunization and MENACTRA on 07Aug2017 at single dose. On an unknown date the patient experienced a high fever of 104 degrees and had to be taken to the Emergency Room. It is unknown if he was admitted. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017360781 same reporter/product, different patient/event.
Mild nausea 11/30/2009, all day. Patient vomited at 6am 12/1/2009 and nausea abated after that time.
pt was given expired lot. lot expired on 06/01/23 and shot was given 06/16/23
Patient stated feeling hot after vaccination.  Mother states patient anxious before vaccine.  Transported to observation with help from paramedic.  1st vitals: BP 152/109, P 121, Resp. 19, O2 95%, 15 years old BS 85.  Shaking and crying.  No complaint of pain or difficulty breathing.  Second vitals: BP 138/86, P 107, T 98.7.  Mother decided to call for transport and observation.
14DEC92 pt called c/o lt foot bloating & swelling 1 wk p/flu shot; lt foot to mid calf nubness, lt hand squeezing & burning, spastic pain; seen by MD but did not indicated that thought was from flu vax;
Patient received the booster dose approx. 2 months early. She has had no adverse effects from the early dose.
Pulmonary embolism symptoms felt April 12, 13.  Pulmonary infarction felt night of April 15th forward.  Blood test was positive for possible clots done April 16th.  CT/CTA chest scan done at hospital (also April 16th) confirmed the above embolism and infarction.  Blood thinner via shots, then via tablet (Xarelto) until discharge on April 17th.  Continuing on Xarelto.
Patient received Johnson and Johnson covid vaccine on 5/28/21. We later discovered that she had already received two doses of Pfizer COVID vaccine  on coit and legacy  on dates 4/16/21 and 05/07/21.
Patient was given a dose of meningococcal conjugate instead of the scheduled HPV dose. No adverse effects reported.
Sore arm; lump in lymph node under arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: FE3590), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years, ago,; "SVT" (unspecified if ongoing); "mastectomy" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years, ago,. Concomitant medication(s) included: LETROZOLE; ATORVASTATIN; METOPROLOL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9269; Anatomical location: Arm Right), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "Sore arm", "lump in lymph node under arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6204; Anatomical location: Arm Right), administration date: 06Mar2021, for COVID-19 Immunization, reaction(s): "Sore arm", "lump in lymph node under arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lump in lymph node under arm". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: Adverse events lasted a couple days. AEs did not result in physician office visit or Emergency room visit. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201373781 Same Reporter/Patient AE; Different Vaccine Dose;US-PFIZER INC-202201373782 Same Reporter/Patient AE; Different Vaccine Dose;
Mom called 10 AM 01/26/05 stating noticed child's arm red and swollen from elbow to shoulder.  Child examined in office by Dr. Area marked, Augmentin started and F/U appt in AM. Warm compress ordered.
Starting 05/13/2022, I started not feeling well and thought it was another sinus infection. The headache lasted 3-4 weeks. I worked that week and on 05/20/2022 my employer told me to go home and get tested. I tested myself at home on 05/20/2022 which was positive. On 05/22/2022. I went to the ER per my employer's request (the hospital) to get tested and I was positive. When I went and followed up with my doctor, they put me on a Z-Pak and prednisone and that had no effect. I went back to doctor and he gave me doxy and prednisolone. I still have a cough to this day and am coughing up phlegm. When I went back recently to the doctor, they did a chest x ray (which I'm waiting for the results of) and gave me an albuterol inhaler. I went back to them yesterday and they gave me a TRELEGY inhaler. Today, I am following up with my pulmonologist.
Hugging the toilet; Really bad side effects; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Hugging the toilet) and ADVERSE EVENT (Really bad side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VOMITING (Hugging the toilet) and ADVERSE EVENT (Really bad side effects). At the time of the report, VOMITING (Hugging the toilet) and ADVERSE EVENT (Really bad side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.   This case was linked to MOD21-088258, US-MODERNATX, INC.-MOD-2021-114635, US-MODERNATX, INC.-MOD-2021-114755 (E2B Linked Report).; Sender's Comments:  MOD21-088258: US-MODERNATX, INC.-MOD-2021-114635: US-MODERNATX, INC.-MOD-2021-114755:
At 8 days post vaccination, severe itching at injection site, along with slightly raised and warm rash. Rash has traveled to a larger area on the upper arm and continues to be itchy, raised, and warm to the touch 12 days post vaccination. The itching is no longer severe, but the rash continues to travel on the upper arm.
severe reaction; This spontaneous report as received from a consumer who is the patient's grandfather, concerning a 15-year-old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, vaccination schedule, anatomical site, lot# and expiration date were not provided).  On an unknown date, the patient experienced a severe reaction (vaccination complication).  The outcome of vaccination complication was unknown.  The reporter considered vaccination complication to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Diarrhea for 1 and 1/2 days following; Fatigued the next day; Large swollen area (3 1/2"), very sore and painful, very itchy.
Intermittent nystagmus, dizziness, "foggy" feeling in the brain, intermittent faint nausea
Just a raised red rash on my arm that the vaccine was given in. It does have some heat to it.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: patient passed out in chair-Severe
Pt received vaccines 1/24/07. On 1/25/07 the injection site to the left leg started to swell. On Friday 1/26/07 pt came to the office to have leg checked. Area was swollen and red, warm to touch. 0 fever, 0 other complaints. Leg was assessed by nurse practitioner, instructions given (Benadryl, Motrin, cool compress to area), voiced understanding.
Pt tired and achy all over body. Displaying flu like symptom. Been taking APAP for pain.
Seizure Activity after receiving 4mo immunizations at PHD in DTaP, HIB, IPV, Prevnar. Abnormal head movements.
The pt's parent states that child had too many vaccination upon her birth, which greatly compromised her immune system. She started having head tremor at age of 5 to 6 months of age which caused her regression. She developed severe developmental delays plus seizure disorder and autism. 60 day follow-up states the pt is non-verbal and badly constipated.
Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 28-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-Aug-2021. On 12-Jan-2021 at 12:00 PM, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 12-Jan-2021 at 12:00 PM, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.