chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed an acute onset of shingles; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 07Oct2022 as dose number unknown, single. Vaccination history included: Moderna (Dose 1), for COVID-19 immunization, reaction(s): "fatigue", "headache"; Moderna (Dose 2), for COVID-19 immunization, reaction(s): "fatigue", "headache"; Moderna (Dose 3 (Booster)), for COVID-19 immunization, reaction(s): "fatigue", "headache". The following information was reported: HERPES ZOSTER (non-serious) with onset 21Nov2022, outcome "recovering", described as "I developed an acute onset of shingles". The event "i developed an acute onset of shingles" required physician office visit. Therapeutic measures were taken as a result of herpes zoster. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. Initial covid vaccines and 1st booster were Moderna. Patient's employer only had the Pfizer for her 2nd booster. With Moderna, patient did have some issues after the injections with fatigue, headache, etc but had nothing initially after the Pfizer. On 21Nov2022, she developed an acute onset of shingles and have never before and see that there have been several reported cases of shingles with this booster. AE treatment: NSAID, calamine lotion, analgesics.
PATIENT BECAME NAUSEATED AND BEGAN VOMITTING APPROX. 8 HOURS AFTER VACCINE ADMINISTRATION.  LASTED FOR 2 DAYS.  RESOLVED SPONTANTEOUSLY.
Post vax, the pt developed severe pain radiating up the back, including the head, eyes, jaw and very sensitive to light. He was afebrile and pain was controlled with ibuprofen which was needed through 10/29/00.
Received vaccine booster on 12/13/21, last night when patient was getting ready for bed, she noticed redness, warmth, swelling, purple/blueish area (not at vaccine injection site) but to the side of it. The site is itchy. She is concerned she has cellulitis. This nurse advised her to contact her PCP for a visit or telehealth visit, etc. Advised to use ice on/off, hydrocortisone/benadryl cream, benadryl oral for itching. No difficulty breathing, shortness of breath, tongue swelling, hives, etc.
(L) ear rash, face, chest, belly rash. Throat itching, took 4 days of BENADRYL 25mg.
Presented to Vaccine Clinic with known history of allergies and anaphylaxis events (although unsure what caused anaphylaxis in the past). States was advised to get Vaccine by Primary MD. Vaccine administered--within 10 minutes began complaining of itchyness, denied any airway compromise or difficulty swallowing.  Mild rash began--? hives, became more and more itchy. Benadryl offered but declined by patient.  Recommended EMS transport to ED, patient adamantly refused. Remained stable--sent to ED with family; evaluated in ED, treated with Epi-pen/steriods, monitored and released. Epi pen prescribed--recommended f/u with PCP
fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced HEART RATE INCREASED (fast heartbeat). At the time of the report, HEART RATE INCREASED (fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-103566 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103566:HUSBAND CASE
1st dose was last year; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The reporter enquired if he/she could repeat the Singrix dose as one of the patients received the first dose of the vaccine, so do they just give them one more dose or start over. The health care professional (HCP) disconnected the chat after asked for the contact information and before providing any additional information about the event. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt feeling lightheaded, BP 102/71; HR 79; RR 18. At assessment in observation pt hard to initiate a response, blankly staring & unresponsive to questions.  Eventually responded after 1 min & stated "I'm dizzy." Wheeled to bay, VS stable, AOx4, dizziness subsided per pt. Water given, BP 120/71 sitting, feels good to walk on own.
Was vaccinated. Got shingles on right arm anyway/Suspect vaccination Failure; Got shingles on right arm; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and got shingles on right arm. The patient stated the he/she understand the new vaccine was more effective. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Worst flu like symptoms; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Worst flu like symptoms) and FEELING ABNORMAL (Felt terrible) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 215M20A) for COVID-19 vaccination.     Concomitant products included BUPROPION for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Worst flu like symptoms) and FEELING ABNORMAL (Felt terrible). On 15-Feb-2021, INFLUENZA LIKE ILLNESS (Worst flu like symptoms) and FEELING ABNORMAL (Felt terrible) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.  Patient gave consent to safety for Follow-up.
Patient received vaccination yesterday morning. About an hour after receiving became shaky and felt flushed. States feeling did resolve after approximately 15 minutes. Woke up this morning with red bumps on the face that resembled small hives she has had in the past from allergens. Patient reports she did use a new facemask last night as well. Spots have gone down over the course of the morning. She used cold towel and topical benadryl and that has helped a little bit. Patient appears well and in good overall health no fever nausea or vomiting. Pt has no further concerns at this time.
Chills, body aches, and fever 102.5 more than 24 hours. Redness and swelling to injection site numbness and tingling down Left arm.
Developed stomach pain/cramps on the evening of Dec 10th.  The following morning was followed by fever, flushing, body aches, with nausea/vomiting which persisted approximately 36 hours.
Patient reported that his left arm was feeling numb and he felt like the fingers on his left hand were slightly swollen. He reported to the vaccinator these symptoms approximately 10 minutes after his vaccine was administered. He was given an ice pack and diphenhydramine and asked to extend his wait time for further monitoring. at 30 minutes he reported his symptoms were improved.
Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS.
Patien experienced tightness of chest, shortness of breath, diziness, trouble breathing; administered 1 epi-pen @ 1447
Pfizer covid 19 vaccine given instead of Moderna. Reports she has been getting sick often after she got the Pfizer shot: GI symptoms, muscle aches, headaches ,ear pain
3 weeks apart/Second dose was received 3 and half months ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks apart/Second dose was received 3 and half months ago) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks apart/Second dose was received 3 and half months ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks apart/Second dose was received 3 and half months ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided No treatment medications were provided; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated adverse events reported. Reportedly, the patient received both doses of Moderna COVID 19 vaccine three weeks apart. The company causality for inappropriate schedule of vaccine administered is not applicable.
This spontaneous report received from a consumer concerned a 22 year old male. The patient's weight was 135 pounds, and height was 66 inches. The patient's past medical history included: born premature, and many complications/surgeries early in life, and concurrent conditions included: bee stings allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 18-JUN-2022) dose was not reported, administered on 10-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced moody/agitated/short tempered than normal. On 11-MAR-2022, the patient experienced nausea, vomiting, and tiredness. On 12-MAR-2022, the patient experienced lower throat-lower chest tightness/discomfort for breathing, pale in color, dizziness, super achy, hot/cold/chills/cold sweats, off and on headaches, and ears ringing/weird sounding. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower throat-lower chest tightness/discomfort for breathing, and ears ringing/weird sounding, and the outcome of nausea, hot/cold/chills/cold sweats, pale in color, moody/agitated/short tempered than normal, off and on headaches, dizziness, super achy, vomiting and tiredness was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 68 years old female patient with no drug reactions/allergies. On 14-MAY-2013 (also reported as an unspecified date in May 2013), the patient was vaccinated with a dose of ZOSTAVAX (lot # j000494, expiry date was 14-APR-2014, route and dose were not reported) in the unspecified arm. On an unknown date in May 2013, the patient was diagnosed with cellulitis in the unspecified arm in which ZOSTAVAX was administered. The patient had sought medical attention for the same. The patient was treated with an unspecified antibiotic. The outcome of cellulitis was unknown. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 26-JAN-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by medical providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pain in L deltoid area X 2.5 months that started after the vaccine. Pt declined pain med. Will refer to PT for RC tendonitis.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 17-AUG-2016, the patient was vaccinated with improperly stored VARIVAX lot # L049534, expiry date 08-DEC-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. On 17-AUG-2016, the patient was vaccinated with M-M-R II, rHA, (lot # L030162, expiry date 11-AUG-2017), intramuscularly instead of subcutaneously, 0.5 ml. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Myalgia, Fever, NauseaVomiting,  soreness around injection site
Approximately baseball-sized area of left axillary lymphedema.  Edema and subsequent pain was first noticed just under 24 hours after vaccine dose and was completely resolved by the 5th day following the vaccination.
MMR given 9-23-2004 at patient's home (Amish). Prior to giving the MMR, all appropriate questions were asked regarding allergies,etc. Mother had stated child has no know allergies and is able to eat eggs. 3 hours after shot given patient developed a few hives on body. No other symptoms. 3-4 hours later that evening, more hives developed. Patient's mother called to report symptom of hives as instructed on the VIS. She was told to watch for further hives and call her Dr....Patient's mother called this RN at 11AM on the following day 9-24-2004 stating the hives were now all over the child's body. Child still has no other symptoms..no problem swallowing, or breathing.. no fever.. no other symptoms. This RN advised patient's mother to call her Dr. right away to seek advice and any treatment that he might order  (IE: benadryl,etc.) Patient's mother stated she would call her Dr. as soon as she hung up the phone from talking with this RN.
Red rash, warm to touch, soreness on lower part of upper arm approx. 4 inches below area of injection.
Initial report received 23 February 2009 from a health care professional.  An 18-year-old male patient had received a first dose, left arm injection of ADACEL, lot number UF455BA (Sanofi Pasteur Ltd lot number C3004) and a first dose, right arm injection of MENACTRA, lot number U2817AA on 24 October 2008 and on an unspecified day during December 2008, he developed pain on the right side of his head and constipation.  Concomitant medications included PRILOSEC.  The patient had no known allergies and had no reported illness at the time of vaccination.  The patient's recovery status was reported as unknown; however, at the time of the report, it was reported that their previous symptoms continued and the patient had an additional symptom of an itchy area at their waist and the right side of their head.  No further information was provided.  Follow-up information was received from the health professional on 27 February 2009. The patient complained of a tight, stiff stomach, constipation, and wider hips and thighs one week post-vaccination. He also complained of headache, itching, rash, tight jaw, and muscular stiffness. The reporting physician stated that she would complete a VAERS form when more information was availble. Follow-up information was received 21 March 2009 from a local health care professional. The patient was female (previously reported as male) and she ahd mild reflux at the time of vaccination. The patient also reported that she felt like her bones were expanding. She had received DUAC and RETIN A concomitantly at the time of vaccination (not PROLOSEC as previously reported). The patient's health care professional was informed about all of the reported symptoms during an office visit on 23 February 2009. The patient also stated that her mother experienced a similar reaction to ADACEL vaccine. At the time of the report, the patient was not recovered.
Breakthrough case admission after 2 vaccines Pfizer 9/8/21 Lot# EW0183;  Pfizer 10/4/21 Lot# FE3592
Evening of vaccination, pt. experienced soreness in arm and flu-like symptoms and fatigue that progressed. Had swollen area described as size of a tea cup, sensitive to touch, warm to touch. Flu like symptoms and localized reactions were self-resolving after several weeks. Pt. did say 3 weeks after vaccine, experienced tingling in arm that just resolved 3-4 days ago. Also says still feel like her arm is "popping" with movements. Did not contact PCP or pharmacy of any adverse reaction B/C thought was somewhat expected. She admits to bruising easily and didn't feel need to notify health provider. Only found out about reactions when pharmacy called to remind of second dose and schedule vaccination. Pt. has not had chicken pox or shingles. Was only getting vaccine as recommended by PCP for age. Contacting GSK to see if advising to D/C vaccine series and check immunity status.
48 hours after receiving the Moderna booster, I broke out in hives, red angry splotches  and very itchy. Took Benadryl, Called doctor the next day, got on prednisone for 6 days. When finished, hives were back. Doing Allegra once a day in the morning, Pepcid twice a day one in morning one at night, and one Benadryl at night before bed. Hives, angry red splotches and itchiness is still an issue.
swelling; malar edema; This spontaneous case was reported by a health care professional and describes the occurrence of SWELLING (swelling) and OEDEMA (malar edema) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 SWELLING (swelling) and OEDEMA (malar edema). At the time of the report, SWELLING (swelling) and OEDEMA (malar edema) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicines include steroids and antihistamines. Concomitant medicines were not included. Upon internal review on 04-Aug-2021, the age was corrected to 60 years.   Action taken with mRNA-1273 in response to the event was not applicable.
terrible hives which started at the injection site and is now spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (terrible hives which started at the injection site and is now spreading) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (terrible hives which started at the injection site and is now spreading). At the time of the report, VACCINATION SITE URTICARIA (terrible hives which started at the injection site and is now spreading) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unkonwn age. On an unspecified dates, the patients were received PNEUMOVAX 23 (dose/frequency and lot # were unknown), which had been stored improperly. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Pt came to pharmacy on 4/21/17 showed are inside of arm near elbow was swollen, red and hurt not near the injection site. Pt went to dr they said it was cellulitis and may or may not have been from the injection said there is many possible reasons that it could have occured. pP got rx for keflex on 4/21/17.
Approx 3 minutes after injection I experienced flushing, tingling in my tongue, throat esophagus and stomach. It started in the back of my throat and spread quickly. Through my upper torso. I had no pain, no apparent swelling, no difficulty breathing. Just stinging/tingling throughout my upper torso, throat and mouth. It gradually subsided after about 30 minutes. I had no reaction at all to the first shot. I am now 48 hours out from the second injection and have a very sore arm, headache, body aches and low grade fever. All are relatively mild and are resolved with Tylenol.