chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is to report reaction to the second series shot of the Shingrix vaccine.  The first was given on 2/5/19 with no side effect.   The second shot was administered in the morning on 4/7/19, by the  evening I developed a moderate headache and nausea.  At approx 2:00 in the morning I woke with severe alternating chills and hot spells, my legs were shaking, headache was increased and nausea was increased.  I tried to get out of bed as I was going to vomit and couldn't stand due my legs shaking and loss of lower muscle strength.  I crawled to the backroom where I did vomit and had vertigo with extreme cold chills.  My husband assisted me back to bed where the above side effects continued until mid morning (9 am).  I was then able to sit up with continuation of a headache, nausea, profound weakness and vertigo.  This continued throughout the day until the following morning.  I was not able to go to work the day of the reaction.   I have never had a reaction to any vaccine and I have had annual influenza and required pneumococcal vaccines in the past.
Vomiting until Mallory Weiss tear with bleeding led him to the ER for stabilization
shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about an unspecified date in 2008, the patient was inoculated by a pharmacist with the zoster vaccine live (ZOSTAVAX) vaccine at a pharmacy as recommended for the long-term prevention of shingles and other zoster-related conditions (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported). On an unknown date subsequently to vaccination, the patient was treated by a healthcare professional (HCP) for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). The patient claimed damages as a result of injury to itself, loss of consortium and loss of services. The outcome of the events was unknown at the reporting time. The reported considered the aforementioned events to be related to vaccination with zoster vaccine live (ZOSTAVAX).
pt recv vax & pt devel a rash;pt was told by MD in Guam that did not need a 2nd dose of varicella;
03/01/22 presents to ED for "shortness of breath". PMHx of "COPD, bronchiectasis, chronic infections with Pseudomonas"
A day after receiving the SHINGRIX vaccine, I experienced fever and fatigue. The fever went away within a few hours. The fatigue, which was severe on the first day, lasted 3 days, getting less severe as each day passed. My arm was a little more sore at the injection site than is usual with injections.
This is a spontaneous report from a contactable infectious disease pediatrician. This pediatrician reported similar events for five patients. This is the second of five reports. A patient (of 2, 3 or 4 years of age and gender unknown) received a dose of PREVNAR 13, on an unspecified date. Relevant medical history, concomitant medications and past product history were not provided. On an unknown date, following administration of the vaccination, the patient developed a skin reaction and skin swelling. The pediatrician further commented that one of their practices was seeing an increase in the amount of skin reactions to PREVNAR 13 in 2, 3, and 4-year-olds. The skin reactions were described as being greater than 2.5 inches in diameter and they were seeing approximately five children a week with this type of swelling. At the time of this report, the outcome of the events was unknown.
Fluttering; Increased heart beat; Heart beating out of my chest; Anxiety; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number was not reported), via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. Medical history included anxiety (She has had anxiety in the past related to perimenopause and this felt nothing like anxiety) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fluttering, increased heart beat, heart beating out of my chest, anxiety. The patient stated that 2 days after her first dose, she started getting an increased heart beat, it started out with a fluttering and then she could feel her heart beating out of her chest. She was resting on the couch. She said that this lasted continuously for about 2 weeks and then it improved slightly, however, it was still occurring on and off at times and her heart rate was higher than usual at times. She stated that she did see her doctor about this reaction and he told her that he felt like it was anxiety. The patient reported that she has had anxiety in the past related to perimenopause and this felt nothing like anxiety. She stated she know what anxiety feels like, she was not anxious or nervous. She was sitting on the couch resting and then all of the sudden her heart was fluttering and then beating out of her chest and she couldn't control it. With anxiety she can control it and calm down. This was totally different. She felt like her doctor just wrote her off. It was reported that her doctor performed an EKG and did blood work that was normal. Her doctor told her to proceed with the second dose. The patient stated that, she went back to the pharmacy on Friday 27Aug2021 to get her second dose and the pharmacist told her that based on her reaction to the first dose that she should not receive the second dose as it was not safe. The pharmacist told her that this reaction would happen again with the second dose and probably be more severe, therefore, the pharmacist did not feel safe administering the vaccine to her. The patient wanted to know if what she experienced could potentially happen again with the second dose and if it could be worse. The patient asked if she has any protection from receiving one dose of the Pfizer COVID-19 vaccine -Comirnaty. The AE required a visit to physician office. On an unspecified date in Aug2021, the patient underwent lab tests and procedures which included blood test: normal, electrocardiogram: normal, heart rate: increased (heart beat). Outcome of the events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Started with a tinkle in my throat and feeling bad. I had very little energy. I started to get cough and cold fevers. I went to the doctor, and I had a 102 fever. I had muscle aches, body aches, and cotton mouth. I had bad ear pressure. I had a lot of head pressure. I have back aches are bad. Loss of appetite and nausea. I am unable to taste like normal. I have been very sick. My throat the night before lasting it felt like something was stuck in my throat I could not get out. I would feel a little better and then I would go back to feeling bad. No fever anymore and I am taking Tylenol. I went to the doctor, and they tested me for COVID. I tested positive for COVID.
I caught COVID-19 during a trip, possibly on a flight. I took a home antigen test on 2/7/2023 and got a negative result. When I took it again on 2/10/2023, it was positive. I experienced fever, cough, and headache. The fever lasted four days. The cough lasted seven days. The headache subsided the same time the fever did. I treated my symptoms with OTC MUCINEX nasal spray, ADVIL, and TYLENOL, which helped somewhat. My sister is a nurse, and she suggested that I alternate the MUCINEX spray, ADVIL, and TYLENOL. On 2/16/2023, I took another home antigen test and got a negative result.
Woke up feeling achy all over in my body.  Stood up to go to kitchen to prepare my morning routine - Suddenly Felt faint, weak - then  lost consciousness.  Pramedics arrived after 5 minutes...feeling headache all day so slept most of the day.  Next morning, I was feeling better, felt the bump on the back of my head...had my annual PE and Dr. inspected the site...no blood, still had headache --- he said that is normal for a few days.
This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, (reported as "before 12-AUG-2016"), the patients were vaccinated with improperly stored M-M-R II, lot number K011188, expiration date 12-AUG-2016, and lot number L003858, expiration date 05-FEB-2017, (route, anatomical location and frequency were not reported), for prophylaxis. The temperature was 8.7 Celsius degrees, time frame 1.5 hours without previous temperature excursions. Digital data logger was involved. No adverse effects were reported and no product quality complain was involved. This is on of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007299.
SPORADIC NOSE BLEEDS; LEG CRAMPS IN CALVES LIKE CHARLIE HORSE; CONSTANT HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced sporadic nose bleeds. On APR-2021, the subject experienced leg cramps in calves like charlie horse. On APR-2021, the subject experienced constant headache. On APR-2021, the subject experienced extreme fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headache, and the outcome of sporadic nose bleeds, leg cramps in calves like charlie horse and extreme fatigue was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Pulmonary embolism; severe body aching; Chills all over.; This serious case was reported by a physician via sales rep and described the occurrence of pulmonary embolism in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid vaccine (patient had been vaccinated for Covid).   On 02-NOV-2023, the patient received the 2nd dose of Shingrix. In NOV-2023, immediately after receiving Shingrix, the patient experienced pulmonary embolism (Verbatim: Pulmonary embolism) (serious criteria hospitalization and GSK medically significant), general body pain (Verbatim: severe body aching) and chills (Verbatim: Chills all over.). The outcome of the pulmonary embolism and chills were not reported and the outcome of the general body pain was not resolved.   It was unknown if the reporter considered the pulmonary embolism, general body pain and chills to be related to Shingrix.     It was unknown if the company considered the pulmonary embolism, general body pain and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-Nov-2023 The reporter reported that the patient received Shingrix vaccine and experienced severe body aching and chills all over, this was started immediately.  The patient thought maybe he was sore from working in the yard but they did not improve.  The patient was admitted to the hospital on 6th November 2023 with pulmonary embolism.  The patient finds it odd that it started immediately after getting the vaccine. The reporter did consent to follow up.
unsure if the HCP injected her in the right location; blood dripped down; yellowish bruise near injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (unsure if the HCP injected her in the right location), VACCINATION SITE HAEMORRHAGE (blood dripped down) and VACCINATION SITE BRUISING (yellowish bruise near injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (unsure if the HCP injected her in the right location), VACCINATION SITE HAEMORRHAGE (blood dripped down) and VACCINATION SITE BRUISING (yellowish bruise near injection site). On 05-Apr-2021, PRODUCT ADMINISTRATION ERROR (unsure if the HCP injected her in the right location) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (blood dripped down) and VACCINATION SITE BRUISING (yellowish bruise near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided. Treatment activities for event was done with ice, topical CBD (cannabidiol).
Patient experienced bumps all over head, neck, and face on 4/19/13 in the evening. Mother called and reported to immunization RN. Patient denies itching, redness, fever (temp 97.9 fever by mother) or warmth. RN instructed mom that this is not a common reaction to MENVEO and to follow up with PCP.
Hives at injection site; Redness and hive at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Sep2021 17:00 (Lot number: EW0173) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Batch/lot number : EW0182, Vaccine location : Left arm, Time: 16:30, Route of administration: Intramuscular), administration date: 19Aug2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE URTICARIA (non-serious) with onset 11Sep2021 20:00, outcome "recovered" (12Sep2021), described as "Hives at injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Redness and hive at injection site". Therapeutic measures were taken as a result of vaccination site urticaria, vaccination site erythema.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was application of cold compress and Zyrtec (Centirize HCl) via oral route and they cleared completely next day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Prior vaccinations (within 4 weeks) were none.  Follow-up attempts are completed. No further information is expected.
Patient was given flu shot 10/13 in clinic. Later that day she began to notice redness at the injection site and a rash developed. Over the weekend the rash began to spread and became itchy. Today 10/16 she came to clinic on the advice of her cardiologist who thought it looked infected. The rash was measured in clinic and it was 9x9 cm and red in color and warm to the touch. Patient reports that she noticed pus coming off the rash today in the shower. No fever in clinic, temp was 97.9 Fahrenheit orally. Dr. examined patient and diagnosed with cellulitis. Was started on a 7 day course of BACTRIM.
When I received my vaccine, The nurse jabbed it in my upper arm much higher compared to my first dose. I had pain in my arm swelling at the injection site, red and hot to touch lasted two weeks. I still do not have full range of motion or mobility and the injection site still feels tender. I also at my annual mammogram they noticed a swollen lymph node  arm pit of the left side.  I did 6 weeks of Pyhsical Therapy , they recommended more but my insurance does not cover it.
COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METFORMIN, ATORVASTATIN and INSULIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include blood pressure medication. Treatment for the event COVID-19 include antibody infusion.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.
eyes rolling & starring; eyes glassy; body tense & stiff; sweating, cold & clammy skin when pt woke; by evening pt fine;
I (patient) developed swollen and painful lymph nodes in the underarms on both sides of my body. They began on the side of the injection but spread to include both arms. In addition, two similarly swollen and painful lumps have appeared, though I am not sure if they are lymph nodes given their locations. One is along my the line of my waistband in the front of my body, not in the traditional groin area where most charts ascribe lymph nodes to be. One is directly below my areola on my right breast. Along with these lumps, I developed a rash made up of several small, inflamed hives that range from painless, to itchy, to painful. They are concentrated along my bra line, particularly around my breasts, but are spread everywhere from below my neckline to above my ankles. These symptoms began approximately 7 days after my second dose of the Pfizer-BioNTech vaccine and are continuing at the time of this report.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not reported. On 06-Dec-2021, they placed LOT 012H21B vials in the refrigerator, upon receiving.  Between 06-Jan-2022 and 11-Jan-2022, there were a total of 69 administered doses of LOT 012H21B. Of these, 68 doses were boosters and 1 dose was a first dose.   This case was linked to MOD-2022-448109 (Patient Link).
This is a spontaneous case, initially received from pharmacist on 19-Nov-2018, concerning a 69-year-old, female patient. On 16-Nov-2018, the patient subcutaneously administered FLUAD (TIV) [egg-derived, MF59, dose: 0.5 ml, route of administration: subcutaneous, batch number: 250783, expiry date: 30-Apr-2019 and anatomical location: not reported] with a needle size of 5/8 (explicitly coded as inappropriate route of vaccination). No adverse events were reported after vaccination. The reporter assessed the case as non-serious. This case was considered as lost to follow up as the reporter did not give consent for follow up.
At around 6:30 pm patient felt very dizzy, lightheaded, and nauseous. He also felt hot, had cold sweats, pale face, and blue lips. He started shaking as well. At 6:35 pm his blood pressure was 126/78, his heart rate was 69, and his oxygen saturations were 95%. We called EMS and they arrived around 6:45 pm. He was already feeling much better by the time they arrived. They checked him out and said he was good to go and he left at 6:55 pm.
RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non alcohol use, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201ALIA expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced right arm pain. On 21-JUN-2021, Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain. This report was non-serious.
This spontaneous report was received from a registered nurse and refers to a 24 year old patient. On 12-JUL-2017, the patient was vaccinated with PROQUAD lot # M010477. Other suspect therapies included sterile diluent. No adverse effects was reported. Additional information has been requested.
rash dots on back of both hands/rash on shoulders and mid-back/rash on upper legs/rash on lower legs and arms; This is a spontaneous report received from a contactable nurse (who is also the patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EH9899), intramuscular in left arm, on 17Dec2020 13:00, at single dose, for COVID-19 immunization. Medical history included ulcerative colitis diagnosed in 2002, and "Allergies to medications, food, or other products: Sulfa medications - cause rash". The patient is not pregnant. Concomitant medication included mesalamine, lithium, lamotrigine and an unspecified birth control pill. It was reported that on 23Dec2020 15:00 (also reported as 17:00, pending clarification), she noticed rash dots on back of both hands. On 26Dec2020 15:00, she noticed rash on shoulders and mid-back. On 28Dec2020 17:00, she noticed rash on upper legs. On 29Dec2020 17:00, she noticed rash on lower legs and arms. On 01Jan2021, she went to urgent care for evaluation and was treated with methylprednisolone dose pack. The patient did not receive any other vaccines with 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering. The reporter assessed the report as non-serious.
Patient complained of left facial itching. Swelling and Hives noted. Patient was transferred to ICC for immediate assessment and treatment by Dr. Benadryl IM given to patient and she was discharged home accompanied by family. Patient to follow up with her MD. Patient instructed to  go to the ER if condition worsens.