chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe numbness and tingling  of both lower limbs extending from the buttocks to the toes on 02/02/2021 to 02/3/2021 associated with lower limbs weakness. resolved  with some residual right thigh muscle tenderness and sensitivity.  chills low grade fever headache and severe nausea resolved by 02/03/2021
Feeling lightheaded; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and light headedness. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the light headedness was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and light headedness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The consumer reports having a moderate reaction following Shingrix vaccine that included flu-like symptoms for approximately 36 hours and feeling lightheaded on an ongoing basis, and that this lightheaded feeling only occurred after receiving Shingrix. No history of this before. Limited information provided. Call abruptly disconnected while consumer speaking. Caller did not provide any demographic information during briefness of the call.
After my first vaccine, I noticed I was feeling very loopy, almost as if I was drunk. Dizziness and GI upset. I have since been having GI issues and have been extremely lethargic.
He came back 3 weeks after receiving Moderna and said it was Pfizer. With 3 wekks time differnce he received Pfizer. He also checked the box on the consent form.
Fever x2D. Tmx 103R. vomiting, lethargy. Tx: Fever measures PO fluids - Pedialyte
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number 084J21A. Data revealed that the vaccine administered on Feb16-March 31st, 2022, from lot number 084J21A maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. No ill effect post administration was reported.
The cases were received on 21 March 2014. Initial misuse report received from health care professional on 25 Oct 2013. A 10 year old patient had received a 0.25 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
This spontaneous report as received from a registered nurse refers to a 11 years old female patient who on 28-AUG-2012 was vaccinated with the first dose of GARDASIL (lot # and dose was not reported). No other co-suspects were reported. Concomitant medications included: diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) te). On 28-AUG-2012, the patient fainted. It was given liquid (gingerale) to the treatment of the adverse event. No lab test was performed. The patient sought unspecified medical attention. At the time of the report, the outcome of fainted was reported as recovered/resolved on 28-AUG-2011. Additional information is not expected.
Report 2001030201-1 describes an allergic reaction in a 6 year old female who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. In September 1996, the vaccinee received her first injection of Engerix B. Subsequently, the vacinee had an allergic reaction. As of 12/20/01, the outcomes of the event was unknown.
Fever, headache. For 2 days, then onset of progressively severe proximal myalgias.  Started prednisone 2/20/21.
mild sore throats; This is a spontaneous report from a contactable consumer (patient) via medical information team. This consumer reported similar event for two patients (himself and partner). This is the first of two reports.  A male patient of unspecified age received first dose of PFIZER-BIONTECH COVID-19 VACCINE (BNT162B2; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was due to receive the second dose and reported that he experienced mild sore throat, no fever on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324389 same drug/reporter/event and different patient
numbness, tingling, muscle weakness and pain in hands and feet for about 14 hours.  Couldn't grip anything and constantly stabbed with needle like sensations in hands and toes. Recipient still struggles with muscle weakness in hands and feet four months after vaccination.
Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No acute adverse reactions have been reported by the patient or guardian.
cough Narrative:  Developed a dry cough the day after vaccination (2/4), which persisted for about 3x weeks. No associated SOB, wheezing or other adverse effects. No other cold/flu like symptoms or known sick contacts. The cough was not alleviated by OTC cough syrup. He went to UC on 2/7, where a rapid non-nasopharyngeal COVID test was negative. He went back on 2/14, where he states they did a non-rapid nasopharyngeal swab - which was also negative. At that visit, they prescribed a zpack, which he completed. He notes that he was told each time his lung exam was WML and that they did not perform a CXR either time.
fever; "stopped up" difficult to breathe with mask; "stopped up" difficult to breathe with mask; This is a spontaneous report from a contactable Other HCP reporting for self. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a fever and is "stopped up" difficult to breathe with mask. Outcome of events was unknown. Information on the lot/batch number has been requested.
received only the diluent of Shingrix; received only the diluent of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows:  The reporter was patient's daughter. The age at vaccination was not reported. The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, on the same day, patient received complete dose of Shingrix. The reporter declined to provide any information or a FU and mentioned that if the patient wants to provide any information they will call us back. The reporter did not consent to follow up.
approx 9 hrs p/vax pt noted t101 R, poor body tone, pale, sleepy, swollen lips & face & distorted cry;
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA279966, 2018SA279967, 2018SA281637, 2018SA279973, 2018SA279979, 2018SA281635, 2018SA281634 and 2018SA281687. This case involves a 17 years old patient who received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5984AB. It was a case of actual medication error due to product storage error. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
This nurse removed opened vial of Moderna from storage, 2-8 C. Placed in cooler with ice packs along with two other unopened vials of Moderna. This nurse then transported and gave the three vials to the agency nurse. Agency nurse administered open vial of Moderna to persons who had signed up for the Booster vaccination of the Moderna Vaccination 0.25ml. Once completed updated Manager that the bottle given to her was open and was going to open another vial. This nurse confirmed with the manager that the bottle had been opened previously, 1/19/2022. This nurse had mis read the storage information regarding Moderna to be stored unopened and unused for 30 days. This nurse made telephone call to each person affected by this opened vial. Per Medical Director Dr, offered everyone a dose of 0.25ml out of the new unopened vial. RN
Patient presented to receive the Pfizer, Bi-valent COVID Booster, gray cap for 12+ Patient was administered Pfizer, Bi-valent, COVID booster, orange cap, age 5-11 years, at the dose of 0.3ml in error
Information has been received from a physician concerning an 87 year old female who on an unspecified date was vaccinated SC with a dose of Zostavax. Subsequently, three weeks after vaccination the patient developed "something like chickenpox." Unspecified medical attention was sought. It was not reported how many lesions the patient developed. The physician was unsure if it could be related to Zostavax. There was no product quality complaint involved. No further was provided. Additional information has been requested.
At 3:30pm, the child received MMR, Td, IPV, and Hep A vaccines. The pt became pale and fell face down. Vital signs-blood pressure 100/5D, P. 88. Ice packs applied due to lacerations on lips and lost a tooth.
Within 5 min after this vaccine, pt felt lightheaded and dizziness, rated 5/10. Also weakness to left foot and shin area, slight numbness- initially rated 8 or 9/10. Laid pt flat, applied cool damp cloth to forehead and neck, and gave orange juice. Full ROM, very slight weakness noted with left foot plantar flexion against resistance, but later strength appeared equal. Pt reported feeling better after 30 min, dizziness gone, very slight lightheadedness. Left LE weakness about 3/10 at 30 min, then 1/10 at 60 min upon leaving clinic. Pt able to walk without difficult, but said foot/lower leg still felt a little strange. As precaution, brother picked up patient to go home. Pt will be with brother for the next few hours.
NOT FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
On June 25, 2022, it started with sore throat, headache and minor body aches. I was very tired. I tested at home for COVID-19 and it was positive. I never got fever. We waited until Monday June 27, 2022, to call the doctor and got PAXLOVID. Then my symptoms were feeling better actually before PAXLOVID. My worst day was Saturday through Sunday. My worse symptom was the sore throat, just painful to swallow like razor blades. I also had a dry cough at night. The fatigue and lack of stamina lasted the longest. I believe I didn't regain my strength July 13, 2022.
Significant edema and warmth to elbow circumferentially by 24 hours.  Extended to wrist by 48 hours, receeded and almost resolved by clinic visit on 12/16/03.  No systemic symptoms.  Treatment with PO antihistamines.
No adverse effects were reported; The nurse reported a dialysis patient was accidentally administered a dose of PNEUMOVAX 23 by intravenous route into their dialysis fistula; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 05-JUL-2019, the dialysis patient was accidentally administered  a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot number R022879 and expiration date on 02-AUG-2020, by intravenous route in the dialysis fistula, for prophylaxis (dose and dose number were not reported) (incorrect route of product administration). No adverse effect were reported.
rash around the injection site and very sore muscle. Next day (6 a.m.)  a 100.0 temperature with general stiffness and dizziness and headache. At 10:30 and  at 100.1
Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm.  She has been having fever, muscle aches, arm pain and chills.
boil is coming up under her arm; can not raise my arm up and down/hard to move it around; throbbing pain; severe pain; She has swollen under her armpit; sore arm/whole shoulder is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/whole shoulder is sore), SWELLING (boil is coming up under her arm), MOVEMENT DISORDER (can not raise my arm up and down/hard to move it around), PAIN (throbbing pain) and INJECTION SITE PAIN (severe pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fibromyalgia and Rheumatoid arthritis. Concomitant products included METOPROLOL for Blood pressure, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Pain, ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/whole shoulder is sore). On 18-Mar-2021, the patient experienced SWELLING (boil is coming up under her arm), MOVEMENT DISORDER (can not raise my arm up and down/hard to move it around), PAIN (throbbing pain), INJECTION SITE PAIN (severe pain) and ARTHRALGIA (She has swollen under her armpit). At the time of the report, PAIN IN EXTREMITY (sore arm/whole shoulder is sore), SWELLING (boil is coming up under her arm), MOVEMENT DISORDER (can not raise my arm up and down/hard to move it around), PAIN (throbbing pain), INJECTION SITE PAIN (severe pain) and ARTHRALGIA (She has swollen under her armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Vicodin used for treatment.
Severe chest pain. Swollen breast on opposite side of vaccine injection. Urgent care diagnosed with Costochondritis. Severe breast swelling still needs to be diagnosed.
Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a non-health professional. This case involves a 63 years old female patient who experienced neck pain, facial pressure, sluggish movement, she feels like something is in her throat, headache and fatigue, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Oct-2017, patient received a 0.5 mL dose of suspect FLUZONE QUADRIVALENT lot 00844621A via unknown route in the left deltoid (Frequency- once). On an unknown date, the patient developed a non-serious neck pain, facial pressure (facial pain), sluggish movement (hypokinesia), she feels like something is in her throat (throat irritation), headache and fatigue, following the administration of FLUZONE QUADRIVALENT. The patient had visited the office on 31-Oct-2017, 24-Jan-2018 and 08-Aug-2018. Relevant tests were not reported. Final diagnosis was fatigue, headache, she feels like something is in her throat, sluggish movement, facial pressure and neck pain. It was not reported if the patient received a corrective treatment. The patient was not recovered from the events. Documents held by sender: none.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 06-NOV-2015 the patient was vaccinated with M-M-R II (lot # L012479, expiration date 10-APR-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Approximately 10 hours after shots given, child had a seizure. Then 2 more seizures within the next 6 hours. Child admitted to hospital next day. No other seizures noted. Put on Phenobarbital.
a 90-year-old male patient inadvertently received two doses of Flublok Quadrivalent/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 90 years old male patient who was inadvertently received two 0.5 ml doses of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1930, expiry date: 30-Jun-2020 via intramuscular route in the right deltoid and left deltoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to extra dose administered.  At the time of report no adverse event was reported.  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.  List of documents held by sender: none.
Itchy rash with welts at injection site. Site is also feverish. "Moderna arm." Developed one week after injection. Hydrocortisone cream did not help with itching or swelling.
Headaches started a few hours after the vaccine and then fever/chills/sweats also started around that time. It?s been two days since the vaccine and I do not feel headaches anymore but I am still sweating and I have a mild fever.
Diagnosed Alopecia Areata, Reoccurring rash on face and hands contact dermatitis (NOS). Prednisone for inflammation from rash Kenalog injection for Auto immune Disease Alopecia Areata.
Patient apparently received the Pfizer vaccine dose # 1 on 5/8/21 while he was out in the community.  On 09/21/2021, patient signed up for the Moderna  vaccine and he denied receiving any vaccine. Writer administered the Moderna Covid-19 vaccine. On 09/23/2021, writer was notified that patient had received the Pfizer vaccine on 05/8/2021. No apparent adverse reaction noted at this time. Will cont to monitor
Patient received a 3rd booster dose, but she is under 18 years of age and wasn't eligible for a 3rd dose.  Patient had no adverse reaction.
Pain and redness immediately after injection. Pain ranging from 6/10 to 10/10 in entire upper arm remains 5 months after vaccine.
Inconsolable crying X > 6 hours, decreased feeding. No fever, no vomiting. (+) Acetaminophen given - baby seemed more comfortable, sleeping, decreased fussiness.
Patient had the first dose of the Moderna COVID-19 vaccine last 01MAR2021. Caller mentioned he had a hospital situation; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient had the first dose of the Moderna COVID-19 vaccine last 01MAR2021. Caller mentioned he had a hospital situation) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had the first dose of the Moderna COVID-19 vaccine last 01MAR2021. Caller mentioned he had a hospital situation). At the time of the report, IMMUNISATION REACTION (Patient had the first dose of the Moderna COVID-19 vaccine last 01MAR2021. Caller mentioned he had a hospital situation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  It was reported that patient had the first dose of the Moderna COVID-19 vaccine on 01-MAR-2021 and experienced a hospital situation.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Left arm redness and swelling with small blisters at shoulder (administration site). Patient indicates headache, pain and warm to touch at site. Cannot lift arm over head. Recommended BENADRYL, IBU and APAP. Also contact PCP.
I got my Moderna COVID-19 booster on 12/17/21.  On 12/31/21, I started feeling itchy throughout my body and where ever I would scratch, welts/hives would form. The welts are very itchy and would go away about a half hour later. I went to my PCP on 1/5/21 and he told me I have dermatographia. I received an IM Decadron 6mg injection in office and prescriptions for prednisone 20 mg taper and hydroxyzine 25 mg prn. Upon completion of the prednisone taper, my dermatographia was still present and persisted to the time of this report, about a month later. I have been since taking Allegra and cetirizine prn for the urticaria.
Wide spread muscle pain, back pain, episodic joint pain, chronic fatigue. Pt with history of back, neck, joint, pain received covid vaccine on 5/11/21 and complains of increase in all symptoms. Previously negative inflammatory markers are now positive for autoimmune condition.
Patient was in her usual state of good health prior to following her immunizations on 11/19/2003.  Patient was reportedly sleepier in the afternoon and developed a high fever at bedtime and had a febrile seizure at 02:00 and brought to the hospital.
Soreness at injection site for 1 week after injection. Which patient claims to have gotten better with no other residual affects. After few weeks (aprox. 12/27/17) arm soreness reappears and starts to increasingly get worse. Received called on 1/2/18 from patient claiming adverse event and has appointment with MD in upcoming week.