chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt became diaphoretic, dizzy, tinnitus 5 minutes after immunization. Pt was sitting down and had a syncopal episode, urinated on himself. Lasted 30-45 seconds. Pt was disoriented afterwards. Didn't fall. After water and sitting down, pt became oriented and started feeling better. Pt is stable.
Booster dose given at less than 6 months after initial series; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient did not experience any adverse events.  No treatment details were reported.
(L) thigh, redness, swelling, warm to touch 4 in. x 4 in.
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 06-DEC-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Shingles on back. Extreme itching on right side of back, right torso and right side of chest for 5 days. Blister patch on middle of back on day 6. Started 1 week of anti-viral medication on day 5 of itching. Blisters still present but not painful or itching following treatment.
Information has been received from a registered nurse concerning a 6-year-old female who with no pre-existing allergies, birth defects or medical conditions who on 29-NOV-2001 was vaccinated in the left leg with her first dose of VARIVAX (lot # 636565/0922K). There were no illnesses at the time of vaccination. On 17-OCT-2007 the patient developed multiple vesicular lesions on arms, legs, face, neck and back, as well as a fever and no appetite. On 01-NOV-2007 varicella titer was ordered and the results were not back at the time of reporting. The patient was treated with ZOVIRAX 600 mg PO every 6 hours for five days. On an unspecified date the patient recovered from all adverse events. Multiple vesicular lesions on arms, legs, face, neck and back, as well as a fever and no appetite was considered to be an other important medical. Additional information is not expected.
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 64-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that no adverse reactions were reported by patient.  No concomitant medications were reported.  No treatment information was reported.
I woke up a little afraid 2:00 AM with a headache, body chills and vomiting.  It is now 6:57 AM, I still have the headache, chills and get hot.  I have no fever.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients (age and gender were not reported). Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored doses of ROTATEQ (lot # K009753, expiration date 28-APR-2016) route default as oral (dose, strength and frequency were not reported). There was no concomitant medication reported. The reporter stated that no adverse experiences were reported. Additional information is not expected.
10/27 - Evening chills and shivers, intense headache, upset stomach, rash on arm 10/28 - Stayed in bed most of day - only had 1/2 banana, water, crackers - chills gone, but still intense headache and upset stomach, rash on arm 10/29 - Starting to feel better, ate 3 regular but smaller meals, napped in afternoon (not normal for me), still felt warm, headache and stomach upset more mild, rash smaller but still itchy 10/30 - Feeling more normal - headache about gone but still some "brain fog" The first 2 regular doses gave me rash on arm, very mild headache and very mild stomach upset so surprised that this half dose had such adverse reaction.
I wake up with a fever of 100 as the day went on my temp got to 101...I had pain in all my joints, excess tireness, fever broke around 8:00 p.m. that same day.
Contracted pneumonia for the entirety of November 2021 Required 3 visits to PCP for shots plus antibiotics and steroids
After vaccination, I had a low-grade fever, nausea, and my arm was swollen.
Diagnosis of Varicella 08/23/06 vaccine given 5/30/01.
c/o numbness left side of body; dissipated until it was just the left side of her face 2 days later.   H/O Bell's Palsy; team member advised to f/u with her PCP; unk. if she did seek medical treatment.  She also reported HA, fatigue, fever, chills.
This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 18-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 injection, lot # N000508 and expiration date 19-OCT-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). On an unknown date following the administration, the patient developed cellulitis. It was unknown by the reporter if the patient sought medical attention, if treatment was given for the adverse events or if lab diagnostics or studies were performed. The outcome of the event cellulitis and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. Upon internal review, cellulitis was considered to be medically significant. This is one of several cases from the same reporter.; Sender's Comments: US-009507513-1802USA002517: US-009507513-1802USA001892:
Pt reports fever within 2 hrs post vaccine 101.6F, lasted 6 days. Also severe malaise, joint pain, nausea and vomiting, diarrhea. Injection reaction.
Some of the vaccine spilled on patient's arm; A spontaneous report was received from a pharmaist concerning a 63-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the vaccine spilled on arm/ accidental underdose.  The patient's medical history included blood pressure, thyroid and acid reflux. Concomitant product use was not provided by the reporter.   On 23 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 23 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 23 Mar 2021, the patient experienced some of the vaccine spilled on arm.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The event, some of the vaccine spilled on arm was considered resolved on 23 Mar 2021.; Reporter's Comments: This report refers to a case of accidental under dose for mRNA-1273, lot # 030M20A with no associated AEs.
Pt received COVID-19 J&J vaccination on 4/29/2021.  Pt began having symptoms of COVID around 5/8/2021, worsening to the point of needing hospitalization on 5/15/2021.  Diagnosed with COVID pneumonia.  Hospitalized for 3 days, symptoms improved enough to discharge.
Persistent stiff neck on left side occuring the day following vaccination and continuing to present day/time (4/19). Minor relief with acetaminophen or ibuprofen. No other strenuous activities or events could account for stiff neck.
3FEB93 glands behind ears swelled & pt c/o jaw hurting; later same day devel hives & whelping rash that really scared mom; pt taken to ER dx hives & poss react to immun; dx ear infect, bronchitis & flu; allerg rxn, conjuctivitis, runny nose
Patient was very nervous and has passed out in the past. The first time she came I told her she should come back with a parent so she came back with mom, dad and grandma. Mom was there to help she passed out about 3 minutes after the shot. Her family knew exactly what to do with her because it has happened before. Dad came and helped get her lying down.
Pneumonia shot early morning (along with flu shot). 10-28-02 by afternoon could not lift right arm. Continued to swell, by Wednesday twice normal size. Hot and achy. Friday swelling began to decrease. Last pneumonia shot 11/95 no problems.
pt recvd vax; extreme swelling  and cellulitis of lt arm; keflex  for 10 days; Tigan for n & darvocet for pain
I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 4/11/2023 ACUTE ST ELEVATION MI, UNSPECIFIED    DM 2 W RENAL MANIFESTATION I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 4/11/2023 ACUTE ST ELEVATION MI, UNSPECIFIED    DM 2 W RENAL MANIFESTATION
Red area extending down the right arm, warm to touch, sore to move arm, first day worse but now better movement.
patient got sick, had a fever, and Aseptic meningitis; This spontaneous report has been received from a physician, concerning a 1-year-old patient of unknown gender. Information about the patient's pertinent medical history, concomitant therapies and past drug reactions or allergies were not reported.  On an unknown date in 2015 (reported as January or February), the patient received a measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) vaccination (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis.  On an unknown date in 2015 (reported as two weeks after receiving measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) vaccination), the patient got sick: experienced aseptic meningitis with fever. Titers were ordered, however results were not back at the time of reporting. The outcome of aseptic meningitis was not reported.  The causality assessment between measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and the occurrence of aseptic meningitis was not reported.  Upon internal review, aseptic meningitis was determined to be a medically significant event.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant and treatment medications were reported.
Information has been received from a licensed visiting nurse concerning a 5-year-old male with no pertinent medical history or allergies who on 11-OCT-2007 was vaccinated subcutaneous in the right arm with a second 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 658375/118U). There was no concomitant medication. On 12-OCT-2007 the parents of the child called the office stating the patient had redness and swelling above the injections site. The patient was seen in the office on 13-OCT-2007 and had 2 inches of swelling and redness above and below the injection site. The patient was treated with over the counter oral diphenhydramine hydrochloride (BENADRYL). No diagnostic labs were performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Vomiting; Nausea; Spontaneous report received on 14FEB2020.  A caregiver (consumer's mother) reported that her 23-year-old daughter had nausea (PT: Nausea) and vomiting (PT: Vomiting) while being on Vivotif for immunisation. On 07FEB2020, the consumer took first dose of Vivotif and felt nauseated on the same day. On 13FEB2020 at approximately 05:00 pm, she took the last dose of Vivotif and vomited at 11:00 pm approximately. Moreover, she had not vomited again. Action taken with Vivotif with respect to the reported event nausea was dose not changed while, with respect to the event vomiting was not applicable. She had recovered from the event vomiting while the outcome of the event nausea was unknown.  Past medications included meningitis vaccine (meningococcal vaccine), polio vaccine and yellow fever vaccine, which were received on 21JAN2020.  She was concomitantly taking medication for birth control.  Company Comment: A consumer felt nauseated (nausea) after taking first dose of Vivotif, and then she had vomiting within a few hours of taking last dose of Vivotif. Vomiting was resolved and the outcome of nausea was unknown. Considering the events occurred after taking Vivotif and the potential of Vivotif to cause both these events, the causality of nausea and vomiting is assessed as possible with Vivotif.; Sender's Comments: A consumer felt nauseated (nausea) after taking first dose of Vivotif, and then she had vomiting within a few hours of taking last dose of Vivotif. Vomiting was resolved and the outcome of nausea was unknown. Considering the events occurred after taking Vivotif and the potential of Vivotif to cause both these events, the causality of nausea and vomiting is assessed as possible with Vivotif.
hives; itching; lumpy hives all over her body; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (lumpy hives all over her body), URTICARIA (hives) and PRURITUS (itching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M201) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for Neck pain, PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN), DOXEPIN, MONTELUKAST SODIUM (SINGULAIR) and OMALIZUMAB (XOLAIR) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced URTICARIA (lumpy hives all over her body). On 03-May-2021, the patient experienced URTICARIA (hives) and PRURITUS (itching). At the time of the report, URTICARIA (lumpy hives all over her body), URTICARIA (hives) and PRURITUS (itching) outcome was unknown.        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.   This case was linked to MOD-2021-024679 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: follow up received addition of two events hives and itching and addition of concomitant medications
9 or 10 days after receiving my Moderna booster vaccine at the pharmacy, I began to develop a raised pink rash. The rash started on my shoulders but would move every hour or so. Though the rash has gotten a little better, 9 months after I am still experiencing the effects of this. The rash appears at night and morning and is accompanied by intense itching. I have tried everything from cortisone lotions, calamine lotion, Benedryl, ice packs, and many other treatments.  The rash still persists.
Starting 07/05/2022, I had a very bad sinus headache and fever (the highest it ever went was 100.7). I tested positive with an at-home COVID-19 test that same day. Other symptoms that I experienced were fatigue, sore throat and cough. On 07/06/2022, I called the doctor and, after reviewing my symptoms, told me to just take some over the counter medications and told me, if it got worse, to call back. The fever started going down and was gone by 07/07/2022. I took Tylenol for it. The headache was gone by then. I was just left with a cough, nasal congestion and fatigue. Today, 07/12/2022, I still have fatigue, a mild cough and congestion. The last time I tested myself was 07/10/2022 which was positive.
she had cancer treatment last August all the vaccines have been wiped off her body, she is now asking if she has to start with the primary series again?; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (21Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "she had cancer treatment last August all the vaccines have been wiped off her body, she is now asking if she has to start with the primary series again?". Clinical course: Caller mentioned that his wife had the primary series as well as the two booster doses of the Pfizer Covid-19 vaccine however she had cancer treatment last August and the Covid-19 vaccine's immunity are all gone and they're having a hard time scheduling for the primary series again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt required emergency care after receiving flu and Pneumovax in her right arm.  Got fever, chills and extreme pain in her arm that ultimately prompted her to go to Emergency room. Treated her symptomatically and sent her home. She went to the local Urgent care the following day because symptoms escalated and her arm became more swollen.  At this point she was diagnosed with a bacterial infection with cellulitis and she was treated with antibiotics.
Pain in arm; Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). In November 2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report was received from a medical assistant regarding a 18 months old patient of unknown gender. There was no information about concurrent condition and historical medication. On 23-FEB-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L19128, expiration date 27-MAY-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 8F, Time frame- 3 hours and was back in range. There was no previous temperature excursion before and yes call was because of the data logger. No PQC (product quality complaint) was involved. This si one of several reports received from the same reporter. Additional information has been requested.
Abnormally heavy bleeding during the menstrual period following the vaccination, including a large blood clot (also abnormal)
Child had redness and swelling at site of injection 5 in long 6 1/2 in wide raised and warm to the touch.
Fatigue; muscle fatigue; fever; This is a spontaneous report from a contactable consumer.A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On unspecified date, the patient experienced fatigue, muscle fatigue and fever with second shot of COVID 19 vaccination. Events took place after use of product. At the time of this report, the outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
onset on symptoms near midnight on 10/4/23 that lasted until 6:30 am on 10/5/23. Experienced unbearable fever/chills, joint/muscle pain and burning and insomnia. Feels better today.