chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were recovered/resolved. It was unknown if the reporter considered the fever and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient experienced feverishness and fatigue for a couple of days after receiving SHINGRIX. The patient got a 2nd dose of SHINGRIX in an afternoon of 22nd January 2019 at a pharmacy. The patient stated that the pharmacist said the patient would therefore likely experience those side effects with the 2nd dose of SHINGRIX. The patient said might be the 2nd dose of SHINGRIX would not affect them. The patient had been advised to contact their physician if the patient experienced any of these symptoms after 2nd dose.
BRUISED INJECTION SITE  / BRUISED RIGHT ARM; LEG PAIN; This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart failure, type 2 diabetes, abstain from alcohol, non-smoker, and unspecified allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 05-APR-2021, the subject experienced bruised injection site / bruised right arm. On 05-APR-2021, the subject experienced leg pain. Treatment medications (dates unspecified) included: menthol, and emu oil/trolamine salicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and bruised injection site / bruised right arm. This report was non-serious.
headache; Felt tired; Very bad chills; Muscle aches; Joint aches; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (Felt tired), CHILLS (Very bad chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (Felt tired), CHILLS (Very bad chills), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches) and NAUSEA (Nauseated). On 18-Feb-2021, CHILLS (Very bad chills), MYALGIA (Muscle aches) and NAUSEA (Nauseated) had resolved. On 19-Feb-2021, HEADACHE (headache), FATIGUE (Felt tired) and ARTHRALGIA (Joint aches) had resolved.            No concomitant medications were reported.  Patient did not take any treatment for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received contains no new information.
Anaphylaxis 2 minutes after administration; gagging and heaving; throat swelling until she couldn't breathe; 0.3 mg EPIPEN administered into left thigh; EPIPEN relieved acute throat swelling so that patient was able to breathe; blood pressure 182/127 and pounding headache; transported to hospital by EMS.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-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 29-Apr-2021 at 3:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 62.80.  Concomitant products were not provided.  On 29-Apr-2021, Excursion time was 10 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021. On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45 and 4 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I received the T Tap (plain tetanus) at 7:10 AM. At 8 AM at home I felt a sharp pain from my pelvis and nearly wet my pants. That night I was running fever of appx. 101* and had shooting leg pain. By 1/18/2013, I had shooting pain in my jaw. By 1/20/13 my lymph nodes in my neck were swelling and I felt choked, along with a fever and blurred vision in my right eye. My neck also shook when I tried to look down, in a palsied state. On 1/23/2013 my doctor took me off doxycycline I was also taking, but this only abated a little nausea in the following days. On January 27 my neck, face, and ear started burning; I could and cannot stand for a shirt collar to touch it at all.That night the abject sharp pain across my lymph nodes and larynx began, along with difficulty swallowing, and speaking in a low tone to my 4 year old daughter. February 7 Dr. prescribed prednisone, which I took 10mg of on Feb. 8, 2013, and that tiny bit had me in the cardiac ward of the ER by 8 AM the next morn. All tests came back normal, but the symptoms from the tetanus toxoid remained. I was there all day. At this point, chest pain began. I saw Dr. again on 02/13/2013, and he ran more tests; also kidney tests due to my frequent urination, but all tests were normal. On February 28 I was back in the ER with all symptoms and severe pain, also very elevated blood pressure, but tests came back normal. At this time I still have severe neck (laryngeal and lymph) pain, jaw pain, arm pain at injection sight, slightly bllurred vision on right side (the shot was on my left), chest muscular wall pain, ear pain, burning sensation, and horrible, continual pressure. I am widowed with 4 children, and this has RUINED my life!!! How dare the doctors not give us all the facts on booster shots!! I am seeing a specialist tomorrow, can't afford it, and may lose my home now.
No adverse event; Patient thinks that she received the pediatric 5M-11Y Monovalent vaccine instead of the Bivalent/Patient observed vaccine being drawn from the same vial as patient kids and administered to patient arm; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient thinks that she received the pediatric 5M-11Y Monovalent vaccine instead of the Bivalent/Patient observed vaccine being drawn from the same vial as patient kids and administered to patient arm) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient thinks that she received the pediatric 5M-11Y Monovalent vaccine instead of the Bivalent/Patient observed vaccine being drawn from the same vial as patient kids and administered to patient arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient thinks that she received the pediatric 5M-11Y Monovalent vaccine instead of the Bivalent/Patient observed vaccine being drawn from the same vial as patient kids and administered to patient arm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  Patient observed the HCP drawing the liquid out of the same vial (1 vial, Moderna COVID-19 vaccine meant for 5M-11-year-old) and administering to patient.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MODERNATX, INC. (E2B Linked Report). Sender's Comments:  MODERNATX, INC:Boy Child case MODERNATX, INC.-MOD: Girl Child case
Nose bleed 3-4 times a day until today; Dizziness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleed 3-4 times a day until today), DIZZINESS (Dizziness) and FATIGUE (tiredness) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced EPISTAXIS (Nose bleed 3-4 times a day until today), DIZZINESS (Dizziness) and FATIGUE (tiredness). At the time of the report, EPISTAXIS (Nose bleed 3-4 times a day until today), DIZZINESS (Dizziness) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. No Treatment information provided.
Red and swollen area at injection site spreading to under the arm.  Treated with Keflex by PCP, cellulitis, cleared in 2 to 3 days.
This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) unspec) was received from a consumer regarding an unidentified male pt who developed cerebellar ataxia. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date, the pt experienced cerebellar ataxia. The outcome is unk. No additional information was available at the time of this report.
Body aches all over, fever 100.4, significant raised red rash all over chest, back and neck; Vaccine was Moderna Booster 100 SUSP #0.25   NDC#80777-0273-99 by Pharmacist
Eczema worsened significantly after vaccinations, starting in May, usually on legs and spread to arms. Has not been this bad for decades. Went to a telemedicine visit through insurance company because of sinus issues (family doctor was concerned about in-person visit). Given a topical cream (do not recall the name), which has not resolved the eczema.
Vaccine was administer by medical assistant. Vaccine not recommended for less than three years old, even though the manufacture describes on the box that it is for 6 months and up. Vaccine contains mercury.
This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a child unk patient who received HAVRIX pediatric (batch number M7L59, expiry date 16th December 20160. On an unknown date, the patient received HAVRIX pediatric. On an unknown date, an unknown time after receiving HAVRIX pediatric, 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: Medical assistant reports a pediatric patient received their booster dose of HAVRIX 2 weeks early.
tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) in a 58-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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Redness, swelling, itching - left pharmacy and on way home felt headache, chokey feeling throat - took Benadryl med, took nap & all was better when I woke up. To date I still have swelling, redness & itching and need Benadryl to relieve the itching in particular - site is bigger than originally noticed.  I originally felt that these were mild symptoms but because it has been  4 days and they haven't gone away, I felt I should report them.  The area on my arm that has been effected is about the size of a teacup saucer.
Information has been received from a physician concerning a 4 year old male who was vaccinated subcutaneously in the arm with a 0.5 ml dose of Proquad. Concomitant unspecified vaccinations were given in the other arm. Subsequently, the patient's arm swelled up like there was a band around it, the arm size increased by 4-5 inches across. Unspecifed medical attention was sought. No product quality complaint was involved. Additional information has been requested.  Follow-up information not provided.
miscommunication on previous vaccines received. Patient was unsure of which vaccines she needed at her appointment . she presented her last visits immunization form but did not communicate that she had previously received any vaccines prior to her visit in August. Chart was checked for confirmation but failed to see that the patient had her first dose in July. The patient was informed of vaccines that she needed at the visit based on the catch up list. provider stated "2 doses of hepB are needed, 2 doses of varicella are needed, TOTAL" but patient did not voice that she had already had 2 dose of hepB. Once the provider went to chart the immunizations given it was then discovered that the patient did in fact already have 2 doses of hepb even the provider previously checked her immunization record..
Guillain Barre syndrome; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex with unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. As per the reporter, "Cousin had JnJ vaccine four months later and had been diagnosed with Guillan Barre." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210949880.; Sender's Comments: V0- 20210949856- covid-19 vaccine ad26.cov2.s Guillain barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
One week post vaccination patient developed Covid-like symptoms including fever, fatigue and headache along with redness, swelling and pain at injection site. No side effects in the 2 days immediately post-vaccination except for a slightly sore arm. Patient did go in for a Covid test 1 week post vaccination and was confirmed negative.
No adverse event; Patient was administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster).    Concomitant product use was not provided by the reporter. This case was for patient 15 of 16. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2022-692175:master case(same reporter)
Vaxelis was given to a 11 year old patient; This non-serious spontaneous safety report with reference number 2022SA085058 (and inquiry # 01012639), was received by a partner on 09-MAR-2022 and forwarded to Agency on 11-MAR-2022, from a Non-Health Care Professional .  The causal relationship between Vaxelis and the reported event "Vaxelis was given to a 11 year old patient" was assessed as not applicable due to the nature of this event (off-label use since Vaxelis was administered in unapproved population).  No further information is expected given that the reporter did not give consent to be contacted.
Patient was given a Pfizer 2nd dose 0.3 ml (not diluted) vaccine. Patient should have been given  Pedi Pfizer 6mo-4yrs dosage of 0.2 ml diluted with 2.2 ml normal saline. Patient was observed for 15 minutes then discharged.
Pt states that he began having weakness, body aches, nausea & vomiting approx. 3 hrs p receiving the 1st Hep B vaccine.  Temp<100. Lasting 2-3 days.
Patient stated that she had inflammation in her chest that was burning. Patient also had some intense chest pain, and she went to the ER and was told to take ibuprofen and tylenol for pain. Patient said this reaction went on for 22 days and then she went to ER again bc pain had gotten to bad, and she was prescribed vicodin for pain.
Day 1: Sore arm Day 2: low grade fever of 99.7, Day 3: low grade fever 99.5 and woke up with extreme vertigo which lasted 2 days. Could not get out of bed. Also felt like my head was congested and ears clogged, but did not have a cold. I have allergies, but clogged ears is not something I've ever experienced with them. I did take Benadryl to try and help that. Day 5: continued to experience dizziness which has gotten better each day. I'm still experiencing dizziness when I move my head too quickly or stand up. It's livable, but wish it would go away. Haven't seen a doctor, just living with it. I had vertigo and nausea on day 6 of my first vaccine so the side effect was consistent. Just don't understand why it happened.
received last week a dose of Shingrix but the intended vaccine was Varivax; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: received last week a dose of Shingrix but the intended vaccine was Varivax). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt date: 18-AUG-2023 A pharmacist reported that a patient who received last week a dose of Shingrix but the intended vaccine was Varivax which led to wrong vaccine administered.  The HCP wanted to know what was the recommended interval to administer Varivax after Shingirx.
Information has been received from a physician concerning a 79 year old overweight female with hypertension who on 06-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck), injection (lot # not provided). For the most part, the patient appeared to be healthy with no evidence of any immunodeficiency. In the beginning of October 2008, the patient experienced shingles. The patient sought medical attention and got treated in early October 2008. The outcome of the patient was unknown. Additional information has been requested.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 01-OCT-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 888 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.