chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient is not currently having any side effects; received MMRII live virus vaccine while patient is on Dupixent as it is an immunosuppressant; received MMRII live virus vaccine while patient is on Dupixent as it is an immunosuppressant; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and drug reactions or allergies were not reported. The patient's concomitant therapy included dupilumab (DUPIXENT).  On 05-APR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml (route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis, while the patient was on dupilumab (DUPIXENT) (contraindicated product administered, product use issue) which was an immunosuppressant. The reporter had contacted the patient's dermatologist for clarification and was told it was a recommendation not to give together but not a contraindication. Per the prescribing information, it was contraindicated to administer measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine while the patient is on immunosuppressants or immunocompromised. The patient was not currently having any side effects.
Terrible itching with no rash from top of head to tip of toes; Dose 3 administration: 29Sep2021 at 15:00; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 29Sep2021 at 15:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 29Jan2021 at 10:00 (at the age of 72-years-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 19Feb2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 30Sep2021 at 20:00, the patient had terrible itching with no rash from top of head to tip of toes. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event terrible itching with no rash from top of head to tip of toes which included treatment with unspecified steroids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event terrible itching with no rash from top of head to tip of toes was not resolved at the time of this report.
Myalgias, fevers, headache, shivering, abdominal pain, hives.
Vaccine had expired 4 days prior to administration.  Manufacturer contacted and confirmed vaccine still maintained potency to protect properly against Covid-19.
Patient had multiple joint pains and stiffness with some swelling in the hands to the point that she was unable to continue with usual life for a week.  Steroids helped a lot with the symptoms.  MMR was required by nursing school since her rubella titer was low.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 23-MAR-2017, the patient was inadvertently vaccinated with a dose of PROQUAD (rHA) lot# M043308, expiration date 24-APR-2018, along with VARIVAX lot# L034369, expiration date 08-SEP-2017 (dose and route of administration were not provided for both). The patient was scheduled to receive M-M-R II and inadvertently received PROQUAD because of human error. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
received 2nd dose after 2weeks; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that his/her doctor gave him/her GlaxoSmithKline Shingrix vaccine but he/she received 2nd dose after 2weeks. The patient  noticed 2-6 months was the usual. The patient asked was his/her vaccination invalid because his/her doctor did not wait 2-6 months for his/her 2nd dose. Additional supportive information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. The follow-up would not possible, as no contact, details were available.
Tinnitus.     Started on waking up day after vaccine.   Still have constant tinnitus 17 days later
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 29-SEP-2014 the patient was vaccinated with a dose of M-M-R II (route, strength, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Initial report was received 08 October 2008 from a consumer who is also the patient. A 47-year-old female patient with a history of pollen and dust allergies, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) and within two hours of vaccination (onset time not reported), she felt as if her throat was swelling, and complained of a sore raw throat, wheezing, headache, chills, a low grade fever of 99 degrees Fahrenheit, and her ears were plugged. The patient had no illness at the time of vaccination and she had not received any other vaccinations during the four weeks prior to receipt of FLUZONE. The patient self medicated with 25mg of BENADRYL and her symptoms resolved by 03:00 - 04:00am (date not reported). The patient had not been evaluated by a health care professional for the event. Concomitant medications included SINGULAIR 10mg q.d. and NECON q.d. At the time of the report, the patient reported that still continued to have symptoms of a slight headache and slight congestion and was not recovered from the event. No additional information was provided. Documents held by sender: None.
BODY ACHES MOSTLY IN THE JOINTS AND ESPECIALLY THE ANKLES; COULD NOT SLEEP- WOKE EVERY 15 MIN; CHILLS-FREEZING; JOINT PAINS  WRISTS, SHOULDERS, HIPS, KNEES AND ANKLES; FEVER; SEVERE POUNDING HEADACHE; This spontaneous report received from a patient concerned a 47 year old. The patient's weight was 130 pounds, and height was 62 inches. The patient's concurrent conditions included percocet allergy, seasonal allergy, gluten allergy, alcohol use, nonsmoker, bile salt malabsorption -gi condition, anxiety, and vitamin d deficiency, and other pre-existing medical conditions included the patient reported no other relevant medical history. the patient had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. Concomitant medications included loratadine for allergies, sertraline hydrochloride for anxiety, colestipol for bile salt malabsorption, colecalciferol for vitamin d deficiency, and vitamins nos for vitamin d deficiency. On 06-MAR-2021, the subject experienced body aches mostly in the joints and especially the ankles. On 06-MAR-2021, the subject experienced could not sleep- woke every 15 min. On 06-MAR-2021, the subject experienced chills-freezing. On 06-MAR-2021, the subject experienced joint pains wrists, shoulders, hips, knees and ankles. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced severe pounding headache. Laboratory data included: Body temperature (NR: not provided) 103 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep- woke every 15 min, joint pains wrists, shoulders, hips, knees and ankles, and severe pounding headache on 08-MAR-2021, and chills-freezing on 06-MAR-2021, and had not recovered from body aches mostly in the joints and especially the ankles, and fever. This report was non-serious.  Additional information was received on 30-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter email, Patient demographic details( age, height, weight), age at time of vaccination, Patient history (seasonal, gluten allergy, alcohol use, nonsmoker, anxiety, vitamin d deficiency), events(could not sleep, joint pain, headache) Product batch no, therapy start date and end date, Concomitant medications.
Staff did not reconstitute the covid 6mo-4 year vaccine vial and drew up 0.3mL of the vial. Patient received COVID 19- 2023-2024 Pfizer formula without proper reconstruction
Respiratory infection; Information has been received from a lawyer via a case in litigation (# 1711USA002107) referring to a currently  69 year old female patient. Information about concurrent condition, medical history and concomitant medication was unknown. In 2016 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown, reported as Pneumonia vaccine) (strength, dose, route, lot# and expiration date not reported) for prophylaxis. On an unknown date, the patient experienced adverse reaction of respiratory infection. The outcome of respiratory infection was unknown. The reporter considered respiratory infection to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown, reported as Pneumonia vaccine).      Upon internal review, the event respiratory infection was determined to be medically significant.; Sender's Comments:  US-009507513-1711USA002107:
Developed about nine pimples, blisters at various parts of body including neck, trunk and arms. Evaluated 09/24/2010. No treatment required. Call to Dept of Health, Medical Director of Employee Health as well as Infectious Disease doctor.
Redness and swelling at injection site (L). pain and tingling traveling down to hand. Swelling of left index finger.
Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 2 received a dose of HEPLISAV-B. Details of administration was not provided.  On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This affected 5-10 patients, but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Fever, SkinRash, flu-like symptoms, red & flat rash on face and torso
I started feeling like I was getting a sinus infection on 02/05/2022. I started developing a temperature which got to about 100.2 and then I would keep taking it (a little above normal to about 100.2) but then after that day I never really had a temperature. I didn't have any tests to test myself with. So, when my cousin brought the mailed at home tests to the car port, I got one and tested myself either on Monday or Tuesday. which came out positive. So, I called my doctor and they sent me in some prescriptions. He sent in a Z-pack, nasal spray, steroids and a chest decongestant. I took the antibiotics, the chest congestion pill and the steroids. I did not do the nasal spray because I had never done one before. I took the steroids for 2-3 days then stopped because I couldn't tolerate them. I started feeling better Wednesday or Thursday that week. At first I thought the test was not accurate, but then it was like a switch was flipped and I lost my sense of taste and smell. That came back the next morning and would continue to fluctuate for awhile. I craved salt a lot at that time. I was more concerned about the loss of taste and smell, and the possibility of it migrating to my lungs. I was more scared of what could happen compared to how bad I felt. I ended up going back to work on 02/17/2022.
Chills - 10 hours after vaccine fever/rash/elevated heart rate - 20 hours after tiredness - 48 hours (lasted two weeks) rash lasted over 3 weeks and took almost 8 weeks to completely heal.
Swelling and pain of the arm and neck, redness on the arm and surrounding tissues. Nausea and vomiting once in the morning. Was given a steroid shot by the MD on 10/25/12.
Headache; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Muscle ache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HEADACHE (Headache) and MYALGIA (Muscle ache). At the time of the report, HEADACHE (Headache) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was reported as none. Treatment information was not provided.   Reporter did not allow further contact
Patient called patient relations in January of 2022 to report that she experienced pain when she was given her flu vaccine but did not report it in the moment because her children, who were going to receive their vaccinations, were with her.  Saw her PCP on 02/23/22 who diagnosed her with right shoulder pain following vaccine administration.  Patient reports she thought the vaccine was given too high and had extreme tenderness and decrease ROM for the first week which slowly resolved but still with decreased ROM and significant pain when reaching across her chest or picking up a jug of water.  PCP ordered xray of shoulder, done on 03/08/22, which was unremarkable then MRI, done 03/10/22, which showed changes in proximal humerus suspicious for osteomyelitis.  CT guided bone marrow bx done 03/14/22 - pathology report indicated few cutibacterium acnes on culture. Patient notified of result, had PICC line placed on 03/18/22 and started 6 weeks of IV Ceftriaxone 1 gram daily on the same date.  Start date 03.18.22, last dose will be on 04.28.22.
tested positive for Covid vaccine after receiving the first dose of vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. There was no patient medical history. There were no concomitant medications. The patient stated that on 01Feb2021 that she had her first vaccine and on 08Feb2021 tested positive for Covid. Stated that she is supposed to go back on 22Feb2021 for her second dose. Stated that she was told that she could go back to work. She wanted to know if she could get a second dose or if it was a waste of time. It was reported that the 2nd dose is scheduled on 22Feb2021. Caller said she tested positive for Covid after 1st dose. She can go back to work on 18Feb2021. Caller is asking if she can take the 2nd dose on the 22nd. It was reported that the reason why the patient took Pfizer Covid vaccine was school teacher so symptoms are lighter for Covid. Stated that she went through the health department. Outcome of the event was unknown.
A report was received from a health professional on 12/10/01 concerning an 11 year old male patient who experienced an asthma attack, resulting in hospitalization, the morning after receiving Fluvirin on 11/13/01. The patient has had asthma for an unknown duration and takes unknown concomitant asthma medication orally on an ongoing basis. It is not known whether or not the patient has been previously exposed to Fluvirin. On 11/13/01, the patient received a Fluvirin injection IM on the left deltoid muscle. On the morning of the next day (11/14/01), the patient experienced an asthma attack. He was admitted to hospital for the treatment of the asthma attack on 11/15/01. The reporter provided no information on the inpatient therapy regimen. The patient was discharged from hospital on 11/19/01 and has recovered. The reporter assessed the relationship of study medication to the event as possible, also stating that the event may have been contributed to by the patient's medical history.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2015, the patient was vaccinated with VARIVAX (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported) for prophylaxis and on 16-MAR-2015 with M-M-R II for prophylaxis. On an unknown date, the patient experienced inappropriate schedule of drug administration. The outcome of the event and action taken with suspect vaccines was unknown.
only really tired and continued to be tired even through the 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (only really tired and continued to be tired even through the 2nd vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 028Az1A) for COVID-19 vaccination.     The patient's past medical history included Nausea and Fever.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced FATIGUE (only really tired and continued to be tired even through the 2nd vaccine). At the time of the report, FATIGUE (only really tired and continued to be tired even through the 2nd vaccine) had not resolved.            No concomitant medications reported by investigator No treatment medications provided by the reporter.   This case was linked to MOD-2021-136663, MOD-2021-042717 (Patient Link).
Patient had pain around his heart; Patient started having pain in his arm about a day after the shot, and it lasted about a week; Gas; Burping; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Patient had pain around his heart), PAIN IN EXTREMITY (Patient started having pain in his arm about a day after the shot, and it lasted about a week), FLATULENCE (Gas) and ERUCTATION (Burping) in a 76-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 3). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Diabetes (under control) and COPD (mild).    On 29-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Oct-2023, the patient experienced FLATULENCE (Gas) and ERUCTATION (Burping). On 30-Oct-2023, the patient experienced PAIN IN EXTREMITY (Patient started having pain in his arm about a day after the shot, and it lasted about a week). In November 2023, the patient experienced CHEST PAIN (Patient had pain around his heart). In November 2023, PAIN IN EXTREMITY (Patient started having pain in his arm about a day after the shot, and it lasted about a week) had resolved. At the time of the report, CHEST PAIN (Patient had pain around his heart), FLATULENCE (Gas) and ERUCTATION (Burping) outcome was unknown.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   The patient had pain around his heart, and it was worse some days than others.  Treatment medication was not reported.
ROTATEQ was administered at 3 weeks of age; This spontaneous report was received from a medical assistant regarding a 3 week old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2019, at 3 weeks of age, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot number and expiration date unknown) via route defaulted to oral for prophylaxis (inappropriate schedule of product administration).
Information has been received from a Registered Nurse concerning her 12 year old daughter with no pertinent medical history and no known drug allergies/drug reactions, who on an unspecified date, when she was 1 year old, was vaccinated with a dose of VARIVAX (Merck). There was no concomitant therapy reported. It was reported that soon after administration of VARIVAX (Merck) the patient developed a mild case of varicella. She mostly had lesions on her face and some scattered on her abdomen. It was reported that the patient also had fever. The patient sought unspecified medical attention. There were no laboratory diagnostic tests performed. It was reported that on an unspecified date the patient had recovered. It was reported that on an unspecified date when she was 5 years of age, the patient also developed Henoch Schonlein syndrome after administration of unspecified vaccines. The patient developed edema and pain in both her ankles. The patient also had blood in her urine and later she developed blister like lesions on both her legs. The patient was hospitalized overnight (unspecified hospital). No further information is available.
Initially I felt fine. I went home from the shot and took a nap. Upon getting up I had severe anxiety and mild dizziness. As both faded away when I went out to do grocery shopping that night, I began to feel a heaviness in my heart with a constant pain best described as an ache. A week later I still have this ache and shortness of breath to the point where I have been unable to sleep and very much considered going to the ER but hesitated as I don't know how much they would just brush off my condition. The pain in my heart isn't followed by palpitations but I generally feel slower, fatigued and when I feel the pain it is enough of a distraction to make me feel like I am cognitively absent and or "Out of It."  I work out every day, do not drink and or do drugs. I am what I would consider to be in excellent to superior health.
Pt recvd vax 20JUL92 & 1 1/2 hrs following vax exp aching from head to toe, h/a, t101, chills; over next 5 days appetite dec & devel dry feeling in throat area; red warm to touch area @ inject site size of baseball; draggy as if run over;