chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling post vaccination; This is a spontaneous report from a contactable pharmacist received via a sales representative. A patient of unspecified age and gender  received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling post vaccination on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number was requested.
This case was reported by a consumer and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with live attenuated human ROTARIX, (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea. At the time of reporting the outcome of the event was unspecified.  Please see case A0798921A for an additional case of diarrhea with ROTARIX reported by the consumer.
Stared on Oct 19 in the left forearm I got the shot in and in the morning, I noticed it was all over the truck of my body may abdomen and my chest they looked like a bunch of round dots. I started taking Clairton and Benadryl hydrocodone and other anti-itch medication.
Patient was given Pfizer Bivalent 5-11yrs old instead of the Pfizer peds primary series. Patient was due the 2nd dose in the primary series. Patient didn't have any reaction while being monitored in clinic.
We gave patient Janssen on 10/1/21 because patient said she had not receive any Covid vaccine before. Insurance rejection showed that patient received Pfizer vaccine on 09/27/2021.
Have a rash that itches behind both knees and behind my elbows; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. On 29th March or 30th March 2021, the patient noticed a rash that itched behind both knees and behind elbows.  The patient asked if this was normal.
patient had some facial drooping and some paralysis; Initial information regarding an unsolicited valid serious case was received from an other health professional via Global Medical Information (GMI) (Reference number- 00334033) and transmitted to Sanofi on 27-Oct-2020.  This case involves a seven-year-old male patient who experienced some facial drooping and some paralysis (facial paralysis), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccines at the same time.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073MA and expiration date: 30-Jun-2021, pre-filled syringes) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a serious facial drooping and some paralysis (facial paralysis), two hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  Patient's father said that his face was not moving the way it was supposed to and so the patient was referred to the emergency room.. Father wanted to know if that was a known side effect.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.; Sender's Comments: This case concerns a seven years old female patient who experienced some facial drooping and some paralysis, two days after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Dizziness, headaches, muscle spasm (seizure like), blurred vision. Two doctor visits, two ER visits. EEG done (4/18/12) but negative results.
joint pain in both knees and right should, now also beginning in left shoulder, there is also muscle pain in both legs and what seems to be nerve or tendon issues in both legs and right arm
Injection site became red and swollen close to FLUVIRIN site approx 8 hours after injection. Swelling and rash became better after day 3 and continued to improve. No treatment required except cold packs used by patient.
pain in her arm; mild arthritis into the shoulder; This is a spontaneous report from a contactable consumer and other healthcare professional (Physician Assistant, primary care provider family medicine). A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/lot number: AA7118, Expiry Date: May2021), via an unspecified route of administration administered to the left deltoid on 13Aug2019 at 0.5 ml, single for immunization/prevention in physician office.  Medical history included osteoarthritis from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient experienced pain in her arm on 13Aug2019 and this term was highlighted by the reporter. The reporter considered the event pain in her arm was medically significant. The patient had pain in her arm she didn't want it to be 3 months later whenever or if her arm gets worse and it was not reported. The reporter did not know if indeed the pain in the patient's arm was caused by the vaccine because the patient also had osteoarthritis.  The pain in the patient's arm started immediately that day after being given the vaccine and so they were attributing it to the vaccine. They did see the patient back in the office on 28Aug2019 and did an X-ray and noted mild arthritis into the shoulder. They have referred her to physical therapy.  The patient ended up calling the office a few days after the injection and they recommended her to use paracetamol (TYLENOL) and heat pads to make her more comfortable. The event 'arm pain after the injection was given' required a visit to physician office. The outcome of the event pain in her arm was not resolved, the outcome of mild arthritis into the shoulder was unknown. The results of tests and procedures for investigation of the patient included:  X-ray on 28Aug2019 with result mild arthritis. The reporter assessed the event pain in her arm is adverse event to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: The event pain in arm is considered related to PREVNAR 13 based on temporal association and currently known drug profile of the suspected vaccine.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
You can take water and put it in the arm and, and it's going to be sore; This is a spontaneous report received from non-contactable reporter(s) (Other HCP and Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "You can take water and put it in the arm and, and it's going to be sore". Additional information: Action taken: Unknown; Causality: Not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
03/27/2023 I started having a cough, fatigue and fever of 102.0. I went to my Physician s  and had a Multiplex PCR test I tested negative for Influenza, Strep and COVID-19. I continue to have a congested cough, I had an Xray today and it was normal. I will be following with my PCP today.
running a fever of 101.1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Sep2022, outcome "unknown", described as "running a fever of 101.1". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was calling on behalf of the husband (Name withheld). Caller just want to know, the Bivalent shot (Name for Bivalent shot was not clarified hence captured as Bivalent vaccine) was given yesterday to the husband (Name withheld) and he was running a fever of 101.1. Caller was querying how high the fever can go and how long it will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lower extremity weakness and syncope started 11-19-13 evening resolved on 11-22-13. No treatment.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a 0.5mL dose of GARDASIL. Subsequently, four weeks after being vaccinated the patient developed "mrsa around the mouth." The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Ringing in her ear; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and TINNITUS (Ringing in her ear) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (Dizzy). On 18-Apr-2021, the patient experienced TINNITUS (Ringing in her ear). At the time of the report, DIZZINESS (Dizzy) and TINNITUS (Ringing in her ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-155644 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155644:friend of a friend
injection site Soreness/ left arm continues to be sore; initially had a lump at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 48-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5P499, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2020, the patient received Fluarix Tetra 2020-2021 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In November 2020, less than 2 weeks after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site lump to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. 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 patient received Fluarix Quadrivalent 2020-2021 season vaccine approximately two weeks before the time of reporting in left arm. The patient reported injection site soreness and she stated that she initially had a lump at the injection site, but it had dissipated. The patient's left arm continued to be sore. The patient was referred to her physician. The reporter consented to follow up.
Horrible headache, back ache and foggy head  Took Motrin, excedrin and more Motrin over a 12 hrs period that did not take the pain away. 2 days post vaccine (2nd shot) headache and other issues began to resolve with additional Motrin
57 y/o female with hx of RA and breast CA on MTX and Anastrol was seen in vehicle for mild dizziness apx 5 minutes after vax, Pulse Ox 99%, HR 65, pt's symptoms improved with putting car seat back, lungs clear no CP or SOB opted to wait in car x 30 minutes total, felt better prior to discharge
Vaccination card says use the vaccine by 2/18/2021; A spontaneous report was received from a consumer concerning a 33-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccination card says use the vaccine by 18 Feb 2021.  No relevant concomitant medications were reported.   On 19 Feb 2021, approximately 1 day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (007M20A) intramuscularly for prophylaxis of COVID-19 infection.  Vaccination card says use the vaccine by 18 Feb 2021 (expired vaccine used).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event vaccination card says use the vaccine by 18 Feb 2021 was considered resolved.; Reporter's Comments: This report refers to a case of Expired product administered for mRNA-1273 (lot # 007M20A), with no associated AEs.
Tenderness; Extremely swollen and painful Lymph node in armpit of arm that received the injection.; Extremely swollen and painful Lymph node in armpit of arm that received the injection.; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 44-years-old female patient (Non Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 07:30 as single dose for covid-19 immunisation. Medical history included drug hypersensitivity (Penicillin). Patient was allergies to Penicillin and Ceftin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) and zinc (ZINC). On 27Jan2021 the patient experienced extremely swollen and painful Lymph node in armpit of arm that received the injection. Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection, I'm still experiencing tenderness and the lymph node is still swollen. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
PATIENT REPORTS TINGLING IN HANDS, NAUSEA, AND SWEATING WITH THE FIRST DOSE
Symptoms began with intense burning in the feet, gradually spreading to the calves and minimally into the hands.  There was also a very annoying continuous buzzing/tingling sensation in foot/toes that progress up my leg into my arms and fingers.  The tingling was like electrical shocks that occurred several times a night, waking me up from a sound sleep.  No problems before the second Moderna dose.  No prior Covid-19 exposure. The symptoms eventually faded after several months.  On 10/28/2021 I received my Moderna booster.  The side effects included chills, aches, muscle pain.  Two days later, the symptoms described above reappeared.  Feels like neuropathy and electrical shocks but not as intense as the second dose.
5 minutes after DTaP was given, child's right deltoid became red and swollen.  Entire deltoid was covered in urticaria.  Sent client & mother to ER.  Spoke to child's father later - says client was given "a couple of shots" in the ER & and was told to give her Benadryl at home and treat with warm & cool compresses.
Neck stiffness; Headaches; Swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck stiffness), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swelling on the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA XT) and ALPRAZOLAM (XANAX) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck stiffness), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swelling on the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In March 2021, MUSCULOSKELETAL STIFFNESS (Neck stiffness), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swelling on the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-075003 (Patient Link).
Swollen lymph nodes; Injection site pain; Tiredness; This is a spontaneous report from a contactable Nurse(patient). A 31-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 22Dec2020 20:45 at single dose at left arm for COVID-19 immunization. The patient was not pregnant. There were no known allergies or other medical history. There were no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included ascorbic acid (VITAMIIN C), ergocalciferol (VIT D), vitamin b complex (SUPER B COMPL); reported as prenatal. The patient experienced swollen lymph nodes, injection site pain, tiredness; all on 23Dec2020 14:00 with outcome of not recovered. The events were non-serious. No treatment received for the events.
Vaccinator gave the IMZ (Pfizer). Immediately after, she sat down to write the IMZ on his personal IMZ record card. Vaccinator observed his head going forward, then leaning forward. His mom stepped out of the way and he fell out of the chair onto his head. He appeared to be having a seizure when he initially hit the ground and then when waking up. He was incoherent for about 10 seconds. We kept him on the floor and supported him while applying ice packs to the back of his neck. He was coherent and breathing normally within seconds. He could communicate his needs and told us he felt fine. We called EMS to have EMS evaluate him - because we thought he had a mild seizure and a possible concussion. EMS took over and took him to the hospital for further evaluation. His family will be contacted tomorrow to check on his condition
Pt. states that after receiving the 3rd Booster of Phizer 09/29/2021, started experiencing symptoms 10/07/2021 (Pulmonary Embolism  located in the "Saddle Back" *Massive in the Lung ), *Previous Knee Surgery 10/01/2021. ICU 2 24hrs, transported to Cardiac for Follow-Up *home care with recommendations Blood Thinner. Emergency Room visit 10/12/2021, Blood Clot located in the *Right Leg, moved into the Lung Lobe.
2-3 days p/ 1st dose, reporter informed that pt had a red, 50 cent size mark on lt arm, paled in about a wk. 3 days p/2nd dose reporter informed lt arm swollen, red & warm to hot fr shoulder to elbow. Subsided in few days.