chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started decreasing my periods; High anxiety; Lack of sleep; Lack of focus; Depression; Low estrogen / got tested for "my" low estrogen; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 12May2021, the patient started decreasing her periods, high anxiety, lack of sleep, lack of focus, low estrogen and depression. It was also reported that that the patient did not know what was going on with her for a couple of months. The patient started taking anxiety medicine and got tested for low estrogen. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event anxiety and low estrogen and included treatment with unspecified anxiety medicine and unspecified pill respectively. On an unknown date in 2021, the patient underwent lab test and procedure which included oestrogen test and the result was low estrogen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started 'decreasing my periods', high anxiety, lack of sleep, lack of focus, depression and 'low estrogen / got tested for "my" low estrogen' was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Hardness at injection site the night of injection per patient. Redness started the next morning. Redness on 6/12/17 measured approx. 15cm.
still got shingles/suspected vaccination failure); got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (3 other times when patient was much younger) and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: still got shingles/suspected vaccination failure)) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The had received shingles shot and still got shingles thus year. The patient did not think they were as bad as could had been without shot.  The patient had shingles 3 other times when patient was much younger and was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
VOMITING/PUKING; LOOKED PALE; BODY ACHES; DEHYDRATION; COULD NOT MOVE PROPERLY; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting/puking, looked pale, body aches, dehydration, could not move properly, weakness, chills, and fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, vomiting/puking, looked pale, weakness, body aches, dehydration and could not move properly was not reported. This report was non-serious.
This non-serious medically confirmed health authority report (initial receipt 31-Aug-2014) concerns a 60 year old female patient. On the 22-Aug-2014, the patient received AFLURIA (batch number T 58806) via the intramuscular route for the protection against seasonal influenza viral infection. On the 22-Aug-2014, a short time after receiving the vaccine on the same day, the patient developed muscle soreness at the injection site, which had persisted to date. No redness or swelling was noted. The patient was referred to her primary healthcare provider to determine whether or not the patient had some type of muscular ailment versus and injection site reaction. Outcome was not yet recovered.
Rash on Right Elbow that spread to legs . Continue to have out breaks of spots that look like chicken pox's on approximately 50% of body with rash or scaly like skin that resemble shingles. Development of elbow looks like "Covid Arm" . I was treated it with Neosporin Visits to PCP 2/16/2021 for unrelated issue was given clindamycin, had severe reaction. Completed antibiotic as prescribed was then given oral steroid for reaction. Returned to PCP 3/2/2021 was given topical steroid, spots continue to spread, revisited 3/9/2021, prescribed topical steroid and oral steroid and advised to report as possible adverse events. Elbow rash stated after 1st dose give 1/14/2021. Spread of spots and rash continued and progressed throughout my body after the 2nd shot given 2/11/2021 along with stiffness of arm and shoulder where shots were given.
3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. Achy and feeling cold about 2 hrs after that. Then headache, shaking, muscles quivering, fever, weakness, some itchy spots, increased urination throughout next several hours.  Fitbit showed elevated heart rate for several hours. 3/23/21: Nausea and vomiting. Could not keep water down. Very weak/shaky. That night, went to ED. Treated for dehydration and allergic reaction. 3/24/21: Able to tolerate clear liquids. Still weak. 3/26/21: Woke up with rash on both legs (small bumps, not itchy). Added bread to diet. Still weak. 3/29/21: Low grade fever, strong pain in right side of lower back.
A physician reported that a 7 month old male received his 3rd dose of Prevnar and subsequently, developed an injection site reaction characterized by erythema and "a lot of" swelling. No further information was available at the date of this report. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar. See HQ1366125MAY2001.
Developed red, hot, raised, itchy blotch  under the left arm (shot injected into left arm) and also left upper chest above nipple area. Patient took Benadryl capsules (dose not known) and anti-itch cream (name of med unknown). Syptoms developed during the evening of July 9 (one day after vaccine administration) and persist until today with significant improvement.
Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03171. A 50-year-old female patient received an injection of INFLUENZA (manufacturer and lot number unknown, route, site and date not reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1." Ten days after vaccination, the patient developed "numbness of both upper and lower extremities, and lower lip, generalized ophthalmoplegia, bilateral ptosis, bilateral vertical and horizontal ophthalmoplegia, remarkably hypoactive vestibulo-ocular reflex, generalized areflexia, motor weakness in both upper and lower extremities with left side worse as compared to the right" and decreased perception of sharp sensation, touch, and vibration." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 86 mg/dl, electrodiagnostic testing on week 4 was "highly suggestive of Acute Inflammatory Polyradiculopathy (AIDP) (sural sparing, median ulnar responses)." Electromyography (EMG) showed "reduced motor response, absent motor units." At week eight, Electrodiagnostic testing showed mild improvement. The patient had been diagnosed with Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN) and ophthalmoplegia." The patient was hospitalized and treatment included intravenous immunoglobulin" (IVIG) (0.4g/kg/day x 5days). " The patient showed "slow improvement in eye movements, motor and sensory response," but had persistent areflexia. She "did not show any signs of improvement by two months." At four months, the patient still had "bilateral facial and distal lowe extremity weakness and sensory loss." The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, this patient met level 1 diagnostic certainty criteria outline by Collaboration Working Group because of quadriparesis. Documents held by sender: None.
Got the shot still got shingles / Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Not sure when adverse reaction started, she reported the reaction on 11/10/2011. S&S: red, itchy, sore and experiencing muscle weakness.
patient very light headed and slightly unresponsive. B/P 106/68. lowered to floor with feet elevated and cold packs applied to forehead and back of neck.
Case number PHEH2014US023654 is an initial spontaneous report from a health care professional receive don 24 Nov 2014, with a follow up received from health care professional on 05 Jan 2015. This report refers to a 67 years old male patient. His medical history and concomitant medications were not reported. The patient had tolerated the vaccines well in the past. He was vaccinated with FLUVIRIN, (batch number: 14584P) intramuscularly at a dose of 0.5 ml into the right deltoid on 24 Nov 2014 at 08:00 AM. It was reported that the vaccine administered was at 0.9 degree Celsius over the weekend. The reporter confirmed that the vaccine was not frozen. No adverse events were reported following the inadvertent administration. Follow up received from health care professional on 05 Jan 2015: updated patient demographics, dose and site of FLUVIRIN vaccine.
On the 8th day after the first Moderna COVID19 vaccine I experienced a very deep throbbing migraine headache that affected my vision. I could not read as there were bright lights that blinded my ability to read. This did not go away for 2 days. Today is the 24th day after the first shot and I still have a very slight headache. I've never had headaches in the past.
Patient was supposed to receive Moderna BIVALENT vaccine and was accidentally given the Moderna MONVALENT vaccine
Gave patient wrong vaccine instead of Menactra I gave her Bexsero (which are almost similar) per RN. Bexsero is recommended at age 16 like a booster vaccine and she shouldn't have any reactions to the vaccine, N.P and I
I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; And then for the next 9-days I had a very high fever; chills, body aches and So tired; chills, body aches and So tired; chills, body aches and So tired; my arm was sore; but was too sick to go to the doctors; I still do not feel back to my normal self; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old non-pregnant female patient received BNT162B29 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration in left arm on 05Mar2021 02:00 PM (at the age of 64-years-old) as dose 1, single for covid-19 immunization. The patients medical history include High Blood Pressure, Sinuses constantly, Chronic Pain. The patient concomitant medications (medications in two weeks) include buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), methylphenidate hydrochloride (RITALIN), Lisinopril, Hydrochloride, drospirenone, ethinylestradiol (DIVA). Patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and was tested to COVID post vaccination. On 12Mar2021 patient had undergone with Nasal Swab test which resulted as negative. Patient had the 1st shot on Friday 05Mar2021, she was fine, Saturday 06Mar2021, her arm was sore, then Sunday 07Mar2021 09:30 AM when she woke up she could barely talk and she was so congested she thought she was getting a very bad cold or Flu. And then for the next 9-days she had a very high fever, chills, body aches and so tired she would have to sit down on the stairs in her house, and it just kept going on with no relief. she made a doctor appointment for 18Mar2021 but was too sick to go to the doctors. Patient still do not feel back to her normal self. She was afraid to get the 2nd shot on 26Mar2021, she called the health department in which where she received her 1st shot and was told to go to the appointment and let them know. And made a decision then, but she already know that she can't go through the side effects. Patient had not received any treatment for the events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore. Outcome of events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore recovering and for the events I still do not feel back to my normal self was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Chills (2 days); fever (2 days); headache (continuing); runny nose (2 days); fatigue (continuing); cough (continuing)..  Called primary care doctor who prescribed Paxlovid.
Numbness down right arm and right leg, light headed, headache after 15-30 mins. Left side of face went numb and weak 45min after. Was sent to ER via Ambulance. Head CT was negative for stroke. As of 3/24/2021 have numbness that bounces from left and right leg and arm and left side of face is still numb and weak and a headache and right arm and hand swollen
p/ pt recv vax subsequently pt exp stinging at inject & 1day later rpt large area around inject that was swollen, hot, hot, hardened & red.
Achey on 6-3-09. Severe pain in arm,shoulders,knees,back and fever of 103.7 6-4-09. ER on 6-5-09 was given Levaquin, Vicoden,Ultram. 6-6-09 pain meds are helping except for shoulder. Saw a ortho Dr. x-rays done all normal. Now still has pain in L arm remains on Vicoden and Ulram. Has MRI scheduled for 6-29-09.
Pt states FluMist taken approx 1330 on Jan 8, 2005.  Mid morning Sunday stomach/bloating/bad gas, queasy feeling began.  Headache then started took 2 Advils and about 1330 on her head hurt so bad that by 3pm she started vomiting. Then around 5 pm chills began 101 temp reported by pt. Diarrhea began. Headache still present. Taking Tylenol/Advil every 4-6 hours. Woke up today called in sick. I referred her to her doctor. Stated she understood.
dizzy; weak; SODIUM IS LOW; This is a spontaneous report from a contactable consumer based on information received by Pfizer. This case was split from master case 2021711724. This non-serious solicited report was reported on 07Jun2021 by a consumer from a commercial program.  A 72-year-old female patient received BNT162B2 (solution for injection) via unknown route of administration on an unspecified date as unknown dose, single for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included etanercept (ENBREL, Solution for injection in pre-filled pen) for rheumatoid arthritis (had been using sure click autoinjectors for about 10 years). No co-suspect medications were reported. The patient took vaccine on an unknown date. On an unknown date (reported as the next day after vaccine), the patient was very dizzy and weak. The patient underwent lab tests included blood sodium: low on an unspecified date, blood draw came back and showed that her sodium was low. The patient had always been a water drinker and at some point, her healthcare professional advised her to drink less water. It was reported that the patient HCP stated to stop etanercept injection one week before and one week after COVID-19 (Coronavirus disease 2019) vaccine. The clinical outcome of the events was unknown.  Follow up is not required. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
covid-arm redness and swallow, hot and itching (not too much and not for a long period) after the 8th day of the vaccine.
Patient experienced hand and leg paresthesias and urinary incontinence after receiving the flu vaccine. According mom patient was also abnormally hyper.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 23-SEP-2014, the patient was vaccinated with an improperly stored dose of GARDASIL, lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the reported temperature excursion lasted 48 hours, where the lowest recorded temperature was 1 F (also reported as 1 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
Vaccine was initially stored in the refrigerator on 04-MAY-2022 and then administered.; Patients received expired Moderna Covid-19 vaccine for their booster doses; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna Covid-19 vaccine for their booster doses) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 04-MAY-2022 and then administered.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, o32F21A, 017C212A and 026B21A) 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) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna Covid-19 vaccine for their booster doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 04-MAY-2022 and then administered.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna Covid-19 vaccine for their booster doses) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 04-MAY-2022 and then administered.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No side effects or adverse events were known for 1st and 2nd (primarydose) and 1st booster dose. Vial did not undergo any temperature excursions. It was reported that 4 doses were given on 04-May-2022 and 1 dose was given on 05-May-2022 No treatment information was provided.   This case was linked to MOD-2022-560262, MOD-2022-561458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up received updated No New Information
PREVNAR 13 given 4/24/15. Shortly thereafter patient developed urticaria with significant arm pain 10/10. Urticaria resolved after 24 hrs, continues to have arm pain 4/10 no other symptoms.
it got worse; pain was from hamstrings to down below ankles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it got worse) and MYALGIA (pain was from hamstrings to down below ankles) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (it got worse) and MYALGIA (pain was from hamstrings to down below ankles). In October 2021, PAIN (it got worse) and MYALGIA (pain was from hamstrings to down below ankles) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Magnetic resonance imaging: normal normal.         Concomitant medications included high blood pressure medication and cholesterol medications.  The patient had been to many specialists and they ruled out all other conditions.  He saw neurologist, RA doctor, cardiologist, orthopedist.  The patient was recommended to get physical therapy.   This case was linked to MOD-2022-505486, MOD-2022-505568 (Patient Link).