chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 9 pm on the day of the injection, I started to alternate between chills and being hot. This continued over night with profuse sweating during the night. My wife says I was running a fever. My sleep was not restful and I had strange dreams during the night. The next morning my body ached all over and I had a very red spot about 2 inches in diameter where I had the injection the day before. The spot was very sensitive and slightly swollen. I had no energy the following day and still had the body aches. The following night I felt overheated during the night with profuse seating again. I was not able to lay on the arm with the injection as it was very sore and sensitive. I started to feel better on the second day and the swelling was slowly going down with the injection site and the redness was disappearing. I did not have any reaction when I had the first shot in April in the series of 2. As of today's date I am back to normal and my arm is not longer feeling any signs of the shot.
Hospitalization: 3/15/2023 - 3/21/2023 (6 days) Presentation to the ED: was found down on the ground  COVID + date: 3/15/23 Treatment: supportive care. no specific treatment.  Discharge to: SNF 029L20A 1/22/2021 010M20A 2/23/2021 035C21A 10/20/2021
Patient had a slight fever from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration
join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints; Within first hour of injection slight nausea that lasted a few hours; pain in hands; This is a spontaneous report from a contactable healthcare professional.  A 41-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 28Dec2020 10:15 at a single dose for covid-19 immunisation. Medical history included food allergies to dairy and nuts. Concomitant medication was not reported. On 28Dec2020 11:00, the patient experienced slight nausea that lasted for few hours, along with join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints. By end of day the patient could not type on phone due to pain in hands. Ongoing joint pain for almost three weeks now. The patient did not receive treatment for the events. The outcome of event nausea was recovered in Dec2020; all other events was not recovered.
Information has been received from a physician concerning a 14 year old female patient who was vaccinated with 3 doses of GARDASIL. Physician stated client went to his office in October 2009 presenting muscle weakness and a patch on her cornea, unspecified cornea. The physician reported that at that time, the patient's mother told her child was healthy until then. The physician stated that the client may have developed Multiple Sclerosis. Client was referred to neurologist. The patient outcome is unknown. Patient sought medical attention. Upon internal review, Multiple Sclerosis was considered to be an other important medical event. Additional information has been requested.
Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 16 month old male patient who was vaccinated with (0.5 ml x 2) third dose of ACTHIB (frequency once, batch number U6110AA, expiry date 21-JAN-2020) intramuscularly in left thigh on 13-AUG-2018. It was a case of actual medication error as product preparation error as mixed 2 ACTHIB (0.5 ml x 2) diluents together and administered as a vaccine. It was unknown if any adverse event occurred. 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 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 sender: none.
upset stomach; aching; soreness at injection site; headache; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced upset stomach, pain, injection site pain and headache. On an unknown date, the outcome of the upset stomach, pain, injection site pain and headache were unknown.   It was unknown if the reporter considered the upset stomach, pain, injection site pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After receiving the Shringrix the patient experienced upset stomach, aching, soreness at injection site and headache. The patient asked how long do side effects from shingle vaccine usually last.
t102 24 hrs p/vax (APAP) vomiting follwoed by flaccid limp episode @ 30 hrs lasted approx 6 hrs;
My son had both Meningococcal vaccines on his left arm without problems. The GARDASIL vaccine was administered in his right arm and Band Aid applied. Immediately after this injection, (he was seating on the exam table, legs dangling) his head dropped to his chest and was not responding. He then started to fall over to his left side. I grabbed his legs which became rigid-sticking straight out and nurse grabbed his upper body which was also rigid. He was unresponsive and started to groan. He became terrifyingly white and his lips turned blue. He had a few minor twitches in upper body. He then jerked his head up and screamed "What". We calmed him and he laid on the table a bit dazed for the next 10 minutes. He stayed in the doctor's office for another 20-30 minutes and completely recovered. The MD performed a neurological evaluation before he left.
pt recvd vax; mom stated child began high pitched crying that lasted 4 hrs on 16nov95;
lt leg swollen & red, crying all afternoon, high pitched 4PM & 3AM; not eating well;
At first the vaccination site was a little sore and I had a small pea sized bump. It went away within a few days, however I woke up this morning with a burning sensation in my upper arm. The area is warm to the touch, itchy and there is a large egg sized lump.
Initial report was received from a health care professional on 16 August 2010 with additional information received on 18 August 2010. An 11 year old female patient with a past medical history of asthma, acne, eczema of the shins and a positive PPD in 2006 which was treated with INH, had received on 03 May 2010 injections of MENACTRA, lot number U3362AA and ADACEL, lot number C3446AA (routes and sites of administration not reported). The patient developed bumps on her hands, itchy, swollen and inflamed ears, swollen eyes, a bad flare up of eczema and a rash on her face, neck and shins on 07 May 2010. The patient was seen by her physician and treated with prednisone on 10 May 2010. She reported the rash was still present on 13 May 2010. The patient was seen again on 15 May 2010 at which time she was diagnosed with secondary impetigo and treated with AUGMENTIN. The patient was seen by an allergist on 19 May 2010 and was diagnosed with an "allergy to the vaccine". The patient was reported to have recovered. No further information was available at the time of this report. Documents held by sender: none.
The patient received her vaccine a 10:30 AM. At 11:30 AM the patient presented to nurse with a mild itchy rash to neck and chest.  Progressed rapidly to shortness of breath. The nurse conducted an assessment and treatment was offered and excepted by the patient for an allergic reaction. The patient was injected with Epinephrine and all was called.  When the paramedics arrived the patient was still having breathing trouble.  They transported the patient to the ER a 11:45. Discharge from the hospital at 3:30.  In the evening followed-up with the patient and the patient responded that she was tired but otherwise okay.
G.I. symptoms, achy and "bronchitis-like" for 3 weeks.
4 day, post vax, right tonsil swollen out past uvula. Had earache and neck was swollen a huge size. Also had fever. Called HD with no response. Called 1-800 number on back of VIS and instructed to call private MD for meds. Called MD and was rx'd Bactrim TID. On 12/30/02, signs and symptoms improved.
vaccines excursion for 31.1F for 30 minutes on March 15th which was received by 35 pediatric patients; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 35 patients (age and gender unknown) who received dose of IPV (VERO) [IPOL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and TUBERCULIN TEST [TUBERSOL]. (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date.  Information on the batch number was requested.  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 incorrect product storage. Vaccines excursion for 31.1F for 30 minutes on March 15th which was received by 35 pediatric patients  Adverse event not 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.
Dizziness, inability to breathe on humid days (shortness of breath)  Breathing is easier on days with humidity of less than 55%
Bexsero was administered instead of the Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old patient who received Men B NVS (Bexsero) (batch number ABXA57AA, expiry date 30th September 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 16th September 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the a patient came in to the office for Menveo but it was not in stock at the time of the appointment. The clinician determined the patient was at high risk for MenB, so Bexsero was administered at the appointment instead of the Menveo, which led to wrong vaccine administered.  The parent did not want the Bexsero to be given so the office was completing an incident report and investigating further. The reporter consented to follow up.
pt recvd vax 16JUN95 & 7 days later 23JUN95 pt devel fever of 100.0, malaise & few lesions on trunk;24JUN95 pt devel toothache;25JUN95 9 days following vax pt devel approx 20 lesions on back & chest;MD felt pt had typical chicken pox rash
Patient was given HEPATITIS B vaccine on 2/25 @ 17:30.  The second dose was given on 2/26 @ 02:00.
This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information is not expected.
he completed the series of the Shingrix / last injection was in 12/2019; shingles on his left flank, back, and stomach; still has nerve pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, mepolizumab (Nucala) solution for injection in pre-filled syringe for prophylaxis and mepolizumab autoinjector device administration system for asthma.   Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix. On 1st December 2019, the patient received the 2nd dose of Shingrix. On 1st June 2019, the patient started Nucala (subcutaneous) 100 mg at variable dosing and mepolizumab autoinjector device. On 15th June 2020, less than 2 years after receiving Shingrix, 197 days after receiving Shingrix, not applicable after starting Nucala and 380 days after starting Nucala and mepolizumab autoinjector device, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and gabapentin. Nucala was discontinued on 1st June 2020. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and mepolizumab autoinjector device. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix, Nucala and mepolizumab autoinjector device. It was unknown if the reporter considered the shingles to be related to Nucala and mepolizumab autoinjector device.  Additional details were provided as follows: After receiving Shingrix, the patient experienced shingles on his left flank, back and stomach. Till the time of reporting, the patient still had nerve pain at the site where he experienced the shingles. The patient reported that, he was in discussion with his physician if he was going to restart the Nucala. The reporter consented to follow up.
Headache, Fever, BACK PAIN, BODY ACHES 7 CHILLS, JOINT PAIN Narrative:
Information has been received from a healthcare worker concerning a female patient who was vaccinated with the first and second doses of GARDASIL vaccine (yeast). The patient experienced feeling faint, with vomiting, dizziness, and an injection site reaction with swelling and redness after each dose. The patient recovered from feeling faint, with vomiting, dizziness, and an injection site reaction with swelling and redness. Injection were administered at another location. Additional information has been requested.
Left Ear Pain radiating to Left Shoulder; Swelling of Lymph Node Left Arm; Left Ear Pain radiating to Left Shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of the first episode of EAR PAIN (Left Ear Pain radiating to Left Shoulder), the second episode of EAR PAIN (Left Ear Pain radiating to Left Shoulder) and VACCINATION SITE LYMPHADENOPATHY (Swelling of Lymph Node Left Arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced the first episode of EAR PAIN (Left Ear Pain radiating to Left Shoulder) and VACCINATION SITE LYMPHADENOPATHY (Swelling of Lymph Node Left Arm). On 22-Apr-2021, the patient experienced the second episode of EAR PAIN (Left Ear Pain radiating to Left Shoulder). On 22-Apr-2021, last episode of EAR PAIN (Left Ear Pain radiating to Left Shoulder) outcome was unknown. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling of Lymph Node Left Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Fever; This is a spontaneous report from a contactable consumer (patient's mother-in-law). This consumer reported similar event for herself and 3 patients. This is the third of four reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not reported), via an unspecified route of administration on an unspecified date, as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had a fever on an unspecified date after the vaccine. The outcome was unknown for the reported event.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021565268 Same reporter/drug/event, different patient;US-PFIZER INC-2021564473 Same reporter/drug/event, different patient;US-PFIZER INC-2021566846 Same reporter/drug/event, different patient
This spontaneous case, initially received from other non-health professional via pharmaceutical manufacturer (Novartis) on 03-Aug-2018, concerning a 76-year-old, elderly, female patient of weight 126 kgs (280 pounds) and height 175.3 cm (69 inches). On an unspecified date, the patient was administered influenza vaccine, [dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported]. On an unspecified date, after vaccination, the patient developed allergy to flu shot. At the time of the report, the outcome of the event was not reported. The reporter assessed the case as non-serious. Update 26-Aug-2018: Significant case correction was performed with IRD 03-Aug-2018: The co-suspect (COSENTYX) and the event (pink eye) was removed. The narrative and case comment amended accordingly.
This spontaneous report as received from a pharmacist refers to a unspecified patients of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, lot # N021170, expiration date: 27-OCT-2018) reconstituted with improperly stored diluent. Data logger was involved, conditions of previous excursion were unknown by reporter. Was call because of. No adverse effects were reported. Additional information has been requested.
flu symptoms:  pain in arm worst the second day, general tiredness, body aches, drowsiness,
friend got VERY sick within two weeks of getting their so called "safe & effective" profit shots/the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP..  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: ILLNESS (non-serious), outcome "unknown", described as "friend got VERY sick within two weeks of getting their so called "safe & effective" profit shots/the Pfizer shot".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have not had a menstrual cycle in 1.5 years and three weeks after my second Pfizer COVD shot, I started spotting and the next day had and still have a full mentrual cycle going.
Patient was given a BHCG test on 25 Oct 2017. On 26 Oct 2017 patient BHCG was not screened for results. Patient given Anthrax with BHCG result of greater than 15000, positive result.
Info has been received from a physician concerning a 9 year old male with no allergies or medical history who on 9/3/96 was vaccinated in the left thigh with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. In approximately, 4/05, "now", the pt has experienced a mild case of chickenpox. At the time of the report, the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info from a physician indicated that on 4/5/05, the pt developed a mild breakthrough varicella infection. No lab tests were done and the pt recovered on an unknown date. Additional info is not expected.
Diagnosed with blood clots in both lungs.  Caused damage to heart 3/18/2022.  Took blood thinner for 3 months.  Medical facility refused to scan in order to ensure all clots were gone.  Hosptized August 22, 2022. Large umbrella blood cot covering both lungs along with smaller clots in each lung.   Heart damaged even more.  According to Medical professionals I almost died.  Nothing but cover ups ever since.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved by State of for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.