chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delayed her 2nd dose due to fear of COVID 19; Chills; mild arm soreness; body aches; Tiredness; did not go to work; This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills, pain in arm, general body pain and tiredness. On an unknown date, the patient experienced activities of daily living impaired and social problem. On an unknown date, the outcome of the chills, pain in arm, general body pain, tiredness and social problem were unknown and the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the chills, pain in arm, general body pain, tiredness and activities of daily living impaired to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. The vaccine lot and expiration date unknown. Patient reported body aches, chills, mild arm soreness, tiredness. The patient reported these symptoms started 18 to 24 hours after. Patient reported that the 3rd day after the vaccine she did not go to worked, but on the 4th day she was ok. The patient described it as a mild reaction. The patient was delayed her 2nd dose due to fear of COVID 19. The reporter did not consent to follow up.
Dose administered greater than 12  hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12  hours post puncture) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 37F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021 at 2:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021 at 2:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12  hours post puncture). On 28-Dec-2021 at 2:45 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12  hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date and time vial was first punctured: 27-Dec-2021 at 3 PM. The vial was stored in the refrigerator post puncture for 23 hours and 45 minutes. Date of administration of vaccine-28DEC2021 last shot at 2:45PM.Patients have not reported side effects No concomitant medication  were reported. No Treatment information was provided.
COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "migraine" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "known allergies: Phenergan". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, lot number unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, lot number unknown), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Paxlovid used as treatment of COVID-19 from 03Oct2023 to 07Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300355997 Same reporter/patient, different drug, different AE.;
Fever, body aches, was not able to move arm - advised cold compress and TYLENOL or ADVIL.
Insane migraine headaches that last for days, slight paralysis on Left side- arms and leg. Chest pains. Sx continue since receiving vaccines
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 06-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection (lot # K001500, expiry date: 06-NOV-2016; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to a temperature excursion for 24 hours, with the highest recorded temperature of 47 degrees Fahrenheit (8.33 degrees Celsius). the vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient broke out in a rash just on legs/thighs, not on immunization site. She is not sure if from shot. She never has had a reaction before. She has broken out into hives before due to cold weather. Patient taking ZYRTEC and BENADRYL.
within 10 minutes of vaccine patient started to have itching on body. I gave 50mg Benadryl and called 911. pt was assessed by ems and all vitals were stable at that time. pt refused transport to ER.
This is a spontaneous case, initially received from other health professional via pharmaceutical manufacturer (Merck) on 07-May-2018, concerning an 11-year-old, female child. On 05-Oct-2011, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient experienced severe reaction (unspecified). At the time of this report, the outcome of the event was not reported.
Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F; This non-serious spontaneous safety report was received with reference numbers 02202409 / 02202359 on 11-JUL-2022 and forwarded on 12-JUL-2022 from another health care professional.   The causal relationship between Vaxelis and the reported event of "Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F" was assessed as not applicable due to the nature of the event.  Further information is expected.
Adacel June 9th 2022, boostrix July 15th 2022; intermittent and sharp pain; pin and needles all over body; This case was reported by a physician via call center representative and described the occurrence of pain in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (ADACEL) for prophylaxis.   The patient's past medical history included tetanus.   On 15th July 2022, the patient received the 1st dose of Boostrix. On 9th June 2022, the patient received ADACEL. In July 2022, 3 days after receiving Boostrix, the patient experienced pain and pins and needles. On 15th July 2022, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the pain, pins and needles and interchange of vaccine products were unknown.   It was unknown if the reporter considered the pain and pins and needles to be related to Boostrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comments: The physician reported that she received Boostrix five weeks after receiving the initial dose as patient developed tetanus and it was advised as she needed to complete the primary series. Three days after receiving Boostrix patient developed pin and needles all over body (feet or hands or front or back except face). It was intermittent and sharp pain. The physician also reported that the patient received Adacel.   The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Boostrix and Adacel, which led to interchange of vaccine products.
This is a serious spontaneous case, initially received from a nurse on 30-Nov-2017, concerning a 58-year-old, adult, male patient. The patient's current conditions included allergy to tree nuts, dust, codeine, sweet potatoes, tuna, cat, dust mite and unknown fish. The patient's medical history was not reported. The patient had not taken any regular medications. The patient had recommended to take EPIPEN, BENADRYL and CLARITIN as needed or in case of emergency situations. It was reported that the patient had no reactions from prior vaccines. The patient had allergic reactions often, hence he carried BENADRYL with him. On 14-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 01544621A, expiry date: 30-Jun-2018). On the same day, about 5 minutes after vaccine administration, the patient experienced dizziness, itchy chest tightness and  flushing in neck and face. The patient took BENADRYL 50 mg oral. About 5 min later, patient's breathing became easier but continued flushing, reported modelling of arms and face and continued to complain of tightness in the chest but had no signs of respiratory distress. The patient took another dose of BENADRYL and hives were noticed on shoulder and upper back. It was reported that, modelling continued, the breathing was regular, but he reported as feeling tight. The patient was taken to the hospital in ambulance and admitted. He stayed 2-3 hours and was discharged from the hospital on the same day with Famotidine 40 mg for allergic type of symptoms, which was recommended to take as needed. The patient also recommended to consult a dermatologist to perform a new allergy skin test. On 21-Nov-2017, it was reported that, the patient had similar reaction again and treated himself with Benadryl. The patient once again went to hospital and prescribed with Famotidine and then discharged from hospital after a quick observation. At the time of the report, the patient was recovered from the event. Follow-up received from other health professional (nurse) on 30-Jan-2018: The nurse confirmed that patient had not taken any medications and was using EPIPEN, BENADRYL and CLARITIN as needed or in case of emergency situations. The hospitalization details,  allergic conditions (tree nuts, sweet potatoes, cat, tuna, dust mite and another unknown fish), treatment medication (Famotidine) and outcome of the event were updated. The nurse also confirmed that the patient had similar reaction again and treated himself with BENADRYL. The patient once again went to hospital and prescribed Famotidine and then discharged from hospital after a quick observation. Narrative amended accordingly.
Headache, Fever, fatigue Narrative: missed work following second dose due to flu-like symptoms
Information has been received from a medical assistant concerning a patient who on 11-APR-2007 was vaccinated with the first oral dose of Rotateq. On 09-AUG-2007 the patient was vaccinated with the second oral dose of Rotateq, 17 weeks after the first dose. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, a year later, the patient received a second dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for an unknown reason. No adverse effects were reported.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date since 13-JUL-2015, the patient was administered with RECOMBIVAX HB lot # J013394 with expiration date of 25-AUG-2016 (strength, dose and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
4/13/04 - 4/27/04: Swelling of arm from shoulder to elbow. 5/10/04: Developed double vision and inability to move right eye in socket. 5/30/04: Movement returned, but unable to focus. 6/12/04: Vision measured at 20/200. 10/04: Vision improved to max 20/40; uncorrectable. Medical Records received on 2/16/2005 states strabismus and amblyopia. 60 Day Follow up: Permanent 4th nerve palsy that may require surgery in adult years as it becomes more bothersome.
Pt with juvenile rheumatoid arthritis vaccinated with MMR developed body aches, fever, sore throat, back pain, and arthritic symptoms which were thought to be a recurrence of juvenile rhematoid arthritis.
5/30/03 6:30 PM 103 fever until 10:30 PM. 6/2/03 to PMD Dx ear infection on Augmentin.
Pt reports arm hurt more than any other vaccine (this was HPV #3) and today 5/3/17 has progressively worsening general body aches and nausea.
Later in the day, after receiving his second dose of Shingrix, he noticed a fast heart rate on his Apple Watch. Normal HR is 40s to 50s and HR was greater than 90, sometimes in the 110s. No lightheadedness or other CV symptoms. Seen in clinic the next day, on ECG he had atrial flutter with 2:1 AV conduction. His only other new symptoms that he attributed to the Shingrix was headache. He is going to follow up remotely with his Cardiologist (electrophysiology specialist) within 1-2 days.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 09-APR-2018, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, lot # N003697 and expiration date on 13-MAR-2018, for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (MERCK). There was no adverse effect reported. No product quality complaint was involved.
accidentally injected with a Daptacel vaccine 0.5mL on 17May2019 that expired on 16May2019/no AE; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 months old male patient who received an expired dose (0.5 mL) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 17-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-May-2019, the patient received 4th dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA and expiry date: 16-May-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to expired vaccine used.  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 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.  List of documents held by sender: none.
Severe aches, weakness, faintness, vomiting, loss of bladder control, burning feet, sweating, shivering.
First dose: sore arm; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 (at the age of 53-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. No medical history. On Mar2021, the patient experienced first dose: sore arm. Outcome of the event was unknown.    Additional Context: The caller is calling about the Pfizer covid vaccine. The caller finally got this number to report her side effects. The caller had the shot from withheld on 27Apr2021 at 4:00pm. Wednesday the caller was perfectly fine, this was great. The caller is perfectly healthy. Thursday morning at 5:00 am the caller got up to go to work and had straight blood when peeing. At this point the caller didn't have any pain, she was just peeing blood. The caller went to work and her pee got brighter red as the day went on. By the end of the day the caller had pain in the lower part of her stomach and back on one side. It got to the point to where the caller went to the emergency care and did a peed test for a UTI, it came back negative. They sent the caller to the hospital where they did a scan on her stomach and couldn't find anything. At that point they treated the caller for kidney stones. It turned out the caller has a kidney stone and keeps getting them since the shot. The caller is hoping that she can stop the kidney stones from forming. The caller got this shot to keep her safe but now this happened from the shot.
"covid arm" red swollen at the injection site, 1.5 weeks after 2 dose of vaccine. red and bumpy, quarter sized.
I started getting really achy and chilled around 9PM and over the next several hours progressed severely: my fever was 103, I threw up multiple times, I had terrible terrible body aches - on a cellular level, my body was burning up but also so cold I was shaking uncontrollably, my nose was runny, my ears hurt, my eyeballs hurt, my head hurt, I couldn't sleep.
The vaccine was leaking out of the hole the needle made to pierce the septum/ no AE; only able to get 0.7 ml out of the single dose vial initially and She was unable to give the patient her dose/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (Reference number- 00733317) and transmitted to Sanofi on 20-Aug-2021.  It was reported that a 30-year-old female patient while receiving RABIES (HDC) VACCINE [IMOVAX RABIES] (powder and solvent for suspension for injection) third 1 mL dose [lot T1B813M, expiry date 27-Dec-2021] via unknown route at an unknown administration site prophylactic vaccination then the vaccine was leaking out of the hole the needle made to pierce the septum (product leakage) and nurse only able to get 0.7 ml out of the single dose vial initially and was unable to give the patient her dose (product dose omission issue).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of potential medication error due to missed dose (latency was on same day).  It was reported "Caller state that she has a patient there to receive their 3rd rabies vaccine and she only able to draw up .7 ml of the vaccine instead of 1 ml of the vaccine. Caller stated that she did use sterile diluent."  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 holder's compliance with the requirements set out in the 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.
History provided by: Nurse Patient is a 59 year old female with history of HTN presents to the emergency department with complaints of htn urgency with associated severe dizziness, headache, and vomiting. Per EMS, patient was at home sitting in her driveway when neighbors found her complaining of dizziness and headache. x1 emesis noted prior to arrival. When EMS arrived to the scene patient's BP 200s systolic. Upon arrival patient's BP is 260/180. Per nurse, patient received 2nd dose of the covid-19 vaccines yesterday 3/4/21.   CT the head demonstrated cerebellar hemorrhage/hematoma in the patient was intubated for airway protection. She was placed on a nicardipine drip.   During my exam the patient she had he had to be intubated and was complain of dizziness nausea and vomiting.  She had been feeling this way the majority of the morning and they had never experienced these symptoms before.
Developed painful, red bump on skin that is warm to touch. Three days later it is still here, along with low-grade fever of 100.3 - 100.6, achy, throat pain, headache, chills, swollen lymph glands.
Pt received 2 doses of Pfizer, 6/12/21 and 7/3/21. Pt told us they had never received the vaccination and marked as such on their vaccine immunization form and confirmed when discussing side effects. Upon review in web application she had received Pfizer previously.
Headache  - developed within first 30 minutes and lasted for 3 hours   Redness, swelling, & pain at injection site - started 16 hours after injection
Moderna COVID-19 Vaccine   I received the vaccine yesterday 1/11/21 at 1135.  About 2 hours later I started feeling symptoms :   Headache dull still.  I've been having this pain/ache in my ribs and upper torso of it is crushing inward. My ribs feel like they are being squeezed too hard like a person hugging so tight that you are having difficultly breathing. And the upper torso under my ribs feels like when you have not ate anything in days of hunger pain (but I am not at all hungry) and it start to hurt soo bad that you can only hunch over and hope it goes away.   These issues have been on and off yesterday and today with the dull feel that has not gone away of a 3 or 4 to in a moments notice 8. Currently it is a 3 with a dull squeeze to ribs and barrable hunger pain (I am not hungry).
Muscle aches and severe headache reported by parent 2 days post vaccination.  MD advised Motrin-to see MD if headache not resolved in 24 hours
I had a mild sore throat, nasal congestion, sneezing, and fatigue. I tested positive for COVID-19 at home. I talked to my doctor, and they prescribed me PAXLOVID. I rebounded with the same symptoms. It took me 15 days to test negative. After I was negative, I was really fatigue for a few days when normally I wouldn't be. This was around December 8-10th.
Woke up Monday (3/29) with clogged ears that would not pop. I felt like I was in a a tunnel, couldn?t hear myself talk and couldn?t really hear others. I was also dizzy, my head was spinning. It was usually tolerable but it got progressively worse to the point where I had to call off work a few days later. When I would look down I would get dizzier.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 16-MAR-2015, the patient was vaccinated with improperly stored VARIVAX lot # K007982 dose number 2. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.