chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEHYDRATION; HAVE NOT HAD ANY TASTE; VOMITING/COULD NOT KEEP ANYTHING DOWN; HEADACHE; EXTREME EXHAUSTION; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included dehydrated.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dehydration. On 09-APR-2021, the subject experienced have not had any taste. On 09-APR-2021, the subject experienced vomiting/could not keep anything down. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced extreme exhaustion. On 10-APR-2021, Laboratory data included: CAT scan (NR: not provided) Normal, and Spinal tap (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting/could not keep anything down on 10-APR-2021, was recovering from have not had any taste, and dehydration, and had not recovered from headache, and extreme exhaustion. This report was non-serious.
Area of erythema on L inner thigh approx. 3-4 cm of area, no edema or hardness to leg.
I woke up at 04:00 am with loud tinnitus in my left ear. It lasted about 1 hour until the volume decreased enough to go back to sleep. Today, 12/04/2021, I have lingering tinnitus that remains. It's not as loud as it was during the night. This tinnitus was the loudest I have ever experienced.
This child had impaired speech, severe mental retardation, and autism. The first six months, she could not sit up alone, and hypotonia. At age eleven we started mercury detox, her symptoms are from mercury poisoning.
I took the shot at 10:50, first early side effects where mild burning sensation in the legs couple of hours after the vaccine, later pain in the legs in the afternoon. At night I had a mild fever, chills, body aches (everywhere) unbearable headache (still going on 24 hours after the shot), pain at the vaccination site (left shoulder, still strong after 24 hours), pain in the lungs (I sneezed a couple of times).  I took Tylenol every 4 hours, but did not improve, only brought the fever down a bit.  Today after 24 hours, I still have headache, muscular aches, and fatigue.
On December 19th around 12:00pm, I received the shot. I felt tenderness at the injection site, that evening, I went to bed and woke up at 3am in the morning with intense arm pain. I took 2 Tylenols and a ice pack. I was able to go back to sleep, I woke up at 9:00am and I noticed I was having continuous palpitations. At 12 went to get lunch and I was standing in line and notice the palpitations getting worse. They were constant and a minute apart. I went to urgent care, they took my vitals, blood pressure, and EKG. Upon the doctor reviewing the EKG the doctor referred me to emergency room for further testing. I arrived at the emergency room at 4:00pm, I waited in the lobby for 4 hours and performed another EKG, chest CT scan and took several vials of blood to exam. CAT scan and X-ray came back clear, blood level markers for blood clot came back elevated. I was discharged the same day at 11:45pm with diagnosis of heart palpation of unknown origins.
Information regarding PREVNAR was received from a healthcare professional regarding a 13-month-old male patient who experienced hives,  extensive, located on chest back and extremities.  The patient received fourth dose on 06-Aug-2008.  The patient also received the first dose of MMRII (Merck), the first dose of HAVRIX (Smith Kline Beecham) and the first dose of VARIVAX (Merck) on 06-Aug-2008.  The patient experienced hives, extensive, located on chest back and extremities on 09-Aug-2008.  Treatment included BENADRYL and PRELONE and patient was instructed to avoid heat.  On an unspecified date in 2008, the patient recovered.  No additional information was available at the time of this report.
Right arm stiffness; pain, warmth, redness, swelling, 3"x2" firm knot, itching. ice pack 20 minutes several times per day & Benadryl.
Bruise at left elbow; Itchy Rash; Redness; Tiered; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy Rash), ERYTHEMA (Redness), FATIGUE (Tiered), INJECTION SITE PAIN (Pain at injection site) and CONTUSION (Bruise at left elbow) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced FATIGUE (Tiered) and INJECTION SITE PAIN (Pain at injection site). On 26-Jan-2021, the patient experienced RASH PRURITIC (Itchy Rash) and ERYTHEMA (Redness). On an unknown date, the patient experienced CONTUSION (Bruise at left elbow). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Injection site reaction, at a dose of 1 dosage form and CORTISONE ACETATE for Injection site reaction, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy Rash), ERYTHEMA (Redness), FATIGUE (Tiered), INJECTION SITE PAIN (Pain at injection site) and CONTUSION (Bruise at left elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.
bleeding at injection site; large bruise; sensation of chill/cold at vaccination site at time of injection; soreness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:00 (at the age of 71-years-old) at a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within 2 weeks of vaccination, included tamsulosin (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN). The patient experienced bleeding at injection site, large bruise, sensation of chill/cold at vaccination site at time of injection, and soreness on 15Jan2021 13:00. The events were reported as non-serious. The clinical course was reported as: The bleeding at injection site saturated the Band-Aid, but subsided quickly; the large bruise, which was now diminished, but still exists some 17 days later (as reported); sensation of chill/cold at vaccination site at time of injection; and soreness, although not significant, it still persists to this date of reporting. The patient underwent lab tests and procedures which included nasal swab: negative on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of bleeding at injection site was recovered on an unspecified date, sensation of chill/cold at vaccination site at time of injection was recovered on 15Jan2021, and large bruise and soreness was recovering.
Son reported fever, headache, painful swallow, neck pain, feeling of being out of his mind, intense fatigue.
the vaccines experienced multiple excursions/ no adverse event; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a Nurse by phone.  This case was cross-referenced with cases 2019SA125033, 2019SA125041, 2019SA125047, 2019SA125054, 2019SA125066, 2019SA125072, 2019SA125087 and 2019SA125094 (same reporter).  This case involves a four-years-old female patient who was vaccinated with a 0.5 ml dose of IPV (VERO) [IPOL] (Batch number: N1K931M and expiry date: 19-Nov-2018) via intramuscular route and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (details not reported) on 16-Feb-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to incorrect product storage. The vaccines experienced multiple excursions.  Case details: there was temperature excursion of multiple vaccines.  1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad.  Caller stated their Ipol MDV was opened and administered to patient. The patient also received Daptacel injection at the same visit.  No adverse event was reported following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
cheeks being numb; lips numb; Headache; both times when she received Covid vaccine She had the same mild allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "polyethylene glycol allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "cheeks being numb"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "lips numb"; HEADACHE (non-serious), outcome "unknown"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "both times when she received Covid vaccine She had the same mild allergic reaction". Therapeutic measures were taken as a result of allergy to vaccine.  Additional information: she took Paxlovid pills and completed the 5 days, she mentioned that she experienced numbness in the face, she need to wear a mask after, she wants to confirm that no excess virus is replicated. She also wants to confirms that she cannot infect anyone after 10 days. She is still having some sneezing and coughing but does not know if it is because she is allergic, Caller states that she has had enough Benadryl.she has 2 allergies, specifically ethylene glycol that is from polyethylene glycol, which caller referred to as PEG during the call. Initially because of her allergy, it was not clear if she should get vaccinated. The Pfizer covid vaccine was great, she initially did not believe she could be vaccinated because she was focused on PEG, there has to be an alternative. They will always fail to reach herd immunity with this PEG issue, unless people take Johnson and Johnson but that's terrible, out there in medical community Johnson and Johnson burned down their lab because they can't get rid of the contamination. At the moment it is un clear if she having an allergic response, she had covid now, she is unsure if she will have the booster. Description of Product Complaint: Description of complaint:  PC1: Paxlovid, She completed the 5 days, she mentioned that it was difficult for her to understand the information in fact sheet. Caller states that she has looked at the Paxlovid data sheet, caller complains that maybe she would be able to better read it, if the data sheet was in blank ink instead of grey ink, caller states that she has new prescription glasses, and she also had to use a magnifying glass  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Graves' disease; Autoimmune Inflammatory Syndrome Induced by Unknown; This is a literature report for the following literature source(s): "Case Series Of New Onset Graves' Hyperthyroidism After Administration Of Sars-Cov. A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), 1 month after the suspect product(s) administration, outcome "recovering", described as "Graves' disease"; ASIA SYNDROME (medically significant), outcome "recovering", described as "Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA)". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: below 0.003, notes: 4 months later; Thyroid stimulating immunoglobulin: 3.99, notes: 4 months later; Thyroxine free: 4.1 ng/dL, notes: 4 months later; Autoantibody test: positive. Therapeutic measures were taken as a result of basedow's disease, asia syndrome. Additional information: The patient developed hyperthyroid symptoms one month following the first dose of the Pfizer vaccination. She responded well to methimazole 10 mg daily.  The patient didn't had a personal or family history of thyroid disease. Our case series adds to the growing evidence for SARS-CoV-2 vaccine-induced Graves' disease (GD), suggesting the incidence may be higher than initially thought and may occur after the 1st, 2nd or booster doses. One potential mechanism is the Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA), which is likely triggered by the mRNA lipid nanoparticles present in the SARS-CoV-2 vaccine. Our patients all met criteria for ASIA with exposure to adjuvants, manifestations of autoimmune endocrine disorders, and positive autoantibodies. In our case series, patients had symptoms for weeks to months before their diagnosis of GD highlighting the importance of patient education regarding possible thyroid complications following vaccination to ensure prompt diagnosis and treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case a possible causal association between the reported event Graves' disease, Autoimmune/inflammatory syndrome induced by adjuvants and the suspect drug   BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200099853 Same article and different patient /drug.;
Generalized malaise with fever (102.1 - 102.2 with Ibuprophen) Severe joint and nerve pain with muscle soreness.
Several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes."; Stiff Neck noted in correlation with discoloration; This is a spontaneous report from a contactable Nurse reported for herself. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at right arm on 28Dec2020 15:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Factor V, Behcet's disease, Hypertension, and allergy to PCN. Prior to vaccination, the patient was not diagnosed with COVID-19  The patient's concomitant medication was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's past drug history included steriod Injection to left shoulder 23Dec2020. On 09Jan2021 11:30, Approximately 12 days after receiving vaccine, several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes." I was seen in the ED, unsure of what is causing this, will be seen by MD next week. Lighter purple on second day, seems to be resolving. Stiff Neck noted in correlation with discoloration. Adverse event resulted in: Emergency room/department or urgent care. No treatment received for the events. The patient underwent lab tests and procedures which included Nasal Swab 2019 Novel Coronavirus SARSCOV-2 by PCR was negative on 09Jan2021. The outcome of the events was recovering.
Day two of shot I had a mixture of migraine and headache daily for 6-8 weeks. Chest hurt for a week and left arm (opposite arm of the shot) ached few a few weeks post first shot. Brain fog, fatigue, and confusion occurred for 10 weeks post shot. I was PCR, rapid, and antibody tested on many occasions and came back COVID negative. I also gained 15 lbs in 4 weeks even though I was eating less. Doctor ran hormones and estrogen was substantially higher than ever recorded in the previous 5 years. I have hormones tested yearly and they are always on the very low end. It is not week ten and the severe OCD, anxiety, and brain fog have just started to reduce.
nausea, diarrhea, vomiting, chills, body aches and severe pains to hips and knees, sweats
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: pt passed out after about 10 minutes while in observation area. dad was next to her and she did not fall. emt were called to check her out and after 1/2 hr pt seemed to be ok
PATIENT EXPERIENCED AN ITCHY WELT AT THE INJECTION SITE. THIS GRADUALLY SPREAD ACROSS HER SHOULDER AND NECK AND FACE. SHE SHOUGHT TREATMENT AT HER LOCAL CLINIC AFTER TOPICAL BENADRYL WAS NOT RELIEVING HER SYMPTOMS
Pt started experiencing severe temperature night of 1/08/2021 with chills very fatigue. Severe all over the body.
No ADR Patient was supposed to be received their first dose of their primary series and inadvertently received the bivalent Pfizer which is only indicated as a booster dose.
I received the vaccine at 1630 on 09/22/2021. During the morning of 09/23/2021 I began developing numbness and tingling in the middle of my right eyebrow. On 09/24/2021 the numbness and tingling had spread throughout my eyebrow, underneath my right eye, down my right cheek, into the front of my right ear, down into the right corner of my lips and down into the right side of my throat and neck. I developed a burning sensation that felt and continues to feel like my face is being burned. I was evaluated at the local Walk In Clinic and started on high dose steroids. On Saturday 09/25/2021, I developed excruciating bilateral distal femur pain and felt as if I couldn't express my words. The numbness, tingling in my face continued this day. On Tuesday 09/28/2021 I developed chest fullness, chest discomfort and chest pain in different areas. I did present to the local Emergency department. My BNP was slightly elevated.
Patient's hip started having pain around 2 hours after vaccine. Stiffness in the joint started progressing to the point of patient having trouble taking off her socks and walking. Patient was walking with a painful limp. At 12:30 AM on 2-1-21 patient awoke with pain radiating down left leg and could not bend leg or move in bed. The pain lessened a Medrol pack relieved pain for two days. On 2-4-21, patient awoke with such pain that she went to the emergency room. Sciatica was the diagnosis which patient has never had. Patient awoke with severe pain again on 2-7-21 and had another trip to the emergency room. Sciatica was determined the problem again and a CT was ordered that showed no back or disc issues. Pain and difficulty walking has continued to persist even with medication and physical therapy. Patient is using a walker with continued decreased strength and pain in the left leg and hip.
About 12 hours after the injection the following started...fever, severe body aches, severe body weakness, unsteadiness/shakiness, legs felt as though they were going to give out, fatigue, nausea. VERY sore, swollen and somewhat itchy left armpit (I am assuming this is the lymph node -also same arm shot was given). The injection site is sore, hot, swollen and itchy (can?t tell if it?s red because I have a very large tattoo that covers this area).   It?s been a little over 48 hours and everything has subsided except the nausea and the armpit/lymph node is extremely sore, swollen and itchy. Slightly still shaky but its getting better.
injection site reactions; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site reaction (Verbatim: injection site reactions). The outcome of the injection site reaction was not reported.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.     It was unknown if the company considered the injection site reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV- 2022 The pharmacist stated that some patient experienced injection site reaction and might decide not to receive the second dose. The reporter did not agree to follow up from GlaxoSmithKline.   Upon internal review the case was updated on 20-NOV-2023. This case was initially processed as invalid, however upon significant follow-up received on 10-NOV-2023, case became valid and it was missed to add appropriate significant follow-up tracking, due to which regulatory reports had not been scheduled. The case was amended for error correction. Summary of Changes: Significant amendment tracking added with description as error correction, Shingrix dose number added and narrative updated.
19AUG91 onset w/fever, dec appetite & fussiness; to ER on 20AUG91 for outpatient treatments w/ROcephin IV & adm p/blood tests came back w/HIB influenza in blood was adm 21AUG91;