chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he's had a swollen gland on his left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st shot of covid vaccine, No reaction), for Covid-19 immunization, reaction(s): "No reaction". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "unknown", described as "he's had a swollen gland on his left side".  Additional information: Caller got his 2nd dose on 01Apr2021 and for about a week now he's had a swollen gland on his left side. He wants to know if that is normal or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Fever, NauseaVomiting, chills Narrative:  Reports chills, fever, myalgia, vomitting within 48 hrs of vaccine, self resolved 12/31,2020.
Patient developed chills overnight after getting the vaccine.  Site of injection was swollen and red.  On March 29th, the swelling and redness extended to the elbow and was warm to the touch.  Benadryl was given, both orally and topically.  The oral benadryl given on a prn basis, was given 6 times over the course of 4 days, and seemed to work well for the patient.  6/17/09 Hospital records and DC summary received DOS 3/25/09 to 3/30/09. FINAL DIAGNOSIS: Severe aortic stenosis. Single vessel cornary artery diseases. Allergic reaction to a Pneumovax vaccination. Type-2 diabetes. Hypertension. Hyperlipidemia with a very high triglyceride level. Patient presented with induration and erthyma of R arm.
Please note: COVID19 booster shot was received.  Onset date of adverse event unknown.   On day 4 (11/09/21), a red spot noted at the injection site. It has since subsided.
Approximately 2 weeks after my 4th dose vaccination I contracted COVID-19 and had the following symptoms: Sore Throat, Body Aches, Fever, Headache, Cough, Fatigue and Lost of Taste. I took Tylenol every 6 hours and Robitussin every 8 hours and some cold compress. The medications helped ease my symptoms and as of today (05/17/2022) I am on the road to recovery and have been feeling better with minimal symptoms.
Itching started on  Tuesday Feb 2 and Rash showed up on  Thursday Feb 4th just below the shot area the size of a nickel over my old scar of a Polio shot giving to me as a child. Became sick on Thurs. with Diarrhea and vomiting. That is better today Fri. The Rash area is larger today and hot and itching.  Have used cortizone 10 for the itching
Found a clot in his lungs; Coughing up blood; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Found a clot in his lungs) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FINASTERIDE, FLUOXETINE, SIMVASTATIN, MELOXICAM, LEVOTHYROXINE, FOLIC ACID, ATORVASTATIN, VITAMIN D3 and TESTOSTERONE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY THROMBOSIS (Found a clot in his lungs) (seriousness criterion medically significant) and HAEMOPTYSIS (Coughing up blood). At the time of the report, PULMONARY THROMBOSIS (Found a clot in his lungs) and HAEMOPTYSIS (Coughing up blood) outcome was unknown.            It was reported that after taking the second vaccine,  the patient was coughing up blood and went to the emergency room, and they found a clot in his lungs.  Treatment information was not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Extreme headache) and MYALGIA (muscle pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Extreme headache) and MYALGIA (muscle pain). At the time of the report, MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Extreme headache) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Tinnutis. I never previously experienced this.  It has now been over 2 months. It has subsided a little bit.   I have gone to a Chiropractor who adjusts the jaw I am taking natural supplements. I am doing acupuncture. I am doing ear exercises.  I had a CT scan done and bloodwork-thankfully everything was normal. I got a full hearing test done at an Audiologist and my hearing is excellent. I am also doing meditation and praying often.
This is a spontaneous report obtained from a contactable nurse. A 13-year-old male patient received TRUMENBA (NDC # 0005010005, Lot. M95612, Expiry Date 30Jul2017), intramuscular, in left arm, on 06-Jun2016 at 15:10, 0.5 ml, single dose. Medical history included ongoing Complement C2 Deficiency, diagnosed at around age 7 and ongoing cyclic vomiting syndrome. Concomitant medications included oral omeprazole, 20 mg, once daily, from 01Oct2015 (ongoing); PERIACTIN ongoing and oral ZOFRAN 4 mg, as needed (1 tab every 8 hrs) ongoing. The patient experienced headache, muscle pain, leg weakness and fatigue on 07Jun2016. The events did not require emergency room or doctor visit. No hospitalization was required. The patient recovered on 08Jun2016. The reporter assessed the events as related to TRUMEMBA. Follow up (06Jun2016): New information received from a contactable physician includes: expiration date and route of administration of the vaccine provided, medical history, and concomitant medications. Follow-up attempts completed. No further information expected. Follow-up (05Aug2016): This is a follow-up report combining information from duplicate reports 2016297625 and 2016297767. The current and all subsequent information will be reported under manufacturer report number 2016297625. This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 13-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient experienced fatigue and muscle pain lasted 24 hours period, both on an unspecified date with outcome of recovered. Follow-up (05Aug2016): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported in response to the HCP letter sent in cross referenced case which included: Patient's full name received. Follow-up attempts completed. No further information expected.
Chills; A spontaneous  report (United States) was received from a  consumer concerning an   female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced chills.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications was  not reported.  on unknown date prior to the onset of the symptoms, the patient received their first  of two planned doses of mRNA-1273 (Batch number Unknown)  for prophylaxis of COVID-19 infection   On 11 Feb  2021, patient reported  the event chills for  about 36 hours.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.   The outcome of the event chills is unknown
not yet gotten the second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose, 0.5 ml intramuscularly in left arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was not recovered/not resolved.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient asked about financial assistance with her second shingrix vaccine. She got the first shot 2 to 3 yrs ago, but had not yet gotten the second shot, which led to incomplete course of vaccination.  She was instructed to get 2nd dose as soon as possible and that she did not need to restart the series. The reporter consented to follow up.
Fever, muscle aches, sore throat, nausea and vomiting, headache, diarrhea, no taste and smell, persistent pain and pressure in chest
Mother reported that daughter woke up from a nap at approximately 3:00pm on 1/23/2023 and was itching  her neck.    Her neck was red and had hives and her face was swollen.  Mother took her daughter to Urgent Care.   Child was administered Benadryl and symptoms resolved.  Swelling of face the rash completely gone within 36 hours.
This spontaneous report was received from a healthcare worker and refers to an adult patient of unknown age and gender. There was no information about the patient's pertinent medical history and drug reactions or allergies. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (lot # L048848, expiration date 09-AUG-2018; exact dose, site and route of administration were not provided). No adverse effect was reported. Additional information is not expected, because there is no consent to follow up.
I had a cough, running nose, headache, scratchy throat, sinus irritation, chills, upset stomach, diarrhea, body aches, fatigue, and weakness for a couple days. I went to the doctor, and they tested me for the flu and COVID-19. I was positive for COVID-19, and they prescribed me benzonatate.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 07-AUG-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On or about 26-SEP-2013, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and VICODIN for management of his painful symptoms and chronic pain. On or about 03-OCT-2013 and 22-OCT-2013 the patient sought subsequent treatment from the physician for continuance of a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed TORADOL and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
pain to left leg above left ankle the day of vaccination 2 hours after vaccination; felt it during her walk, relieved  at rest. denies swelling, redness or warmth. had headache next day and has been getting everyday since. headaches relieved with medications per hcw, headaches are same as usual headaches but has been more frequent. stomach cramps on day of vaccination and next day only with meals and when eating. stomach cramps went away after 2nd day.
This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a adult female patient who received 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician assistant stated that, after receiving SHINGRIX, the patient felt ill for 24 to 49 hours. SHINGRIX was administered in a local pharmacy, not in this office. No details were available or reported for this case.
approximately one hour after the injection, I was experiencing some motion sickness (driving home).  Several hours after the injection, I became very emotional to the point of having a significant emotional argument with my partner. My partner (same vaccination, same day) experienced the same thing. We both woke up the next morning free of these adverse events and reflected on the unusual feelings we both experienced after the shot.
Starting the next day after the vaccine 1st dose, I notice a throbbing pain right below my stomach.  I did not take any medications.  I went to the doctor after 2 weeks of having this pain.  They did blood test and urine sample and was referred to the ER for a CT scan.  Everything came back normal.   I was still having abdominal pain and was referred to a GI specialist. The GI performed sigmoidscopy (normal) and nothing was prescribed and to follow up in a few months.  I am still having abdominal pain, but it is very mild and has not effected my quality of life.
Pt. states that after receiving the 2nd dose of Moderna 04/06/2021, started experiencing symptoms within the same month of short term memory loss and eye crossing. Primary visit with recommendations for referrals Blood Test and Neurologist visit. Neuro visit 02/2022 with no recommendations. No known update or prognosis.
Client felt light headed and hot while waiting in  the observation area. Transported her via wheelchair to the EMS room. COt was provided for patient as well as an icepack for her neck. Patient felt better at 12:41 PM and was escorted out to car. Snack and water provided.
Left deltoid with 14cm x 11cm of erythema, petechiae, and ecchymoses
DIZZINESS WITHIN 10 MINUTES OF INJECTION AND PERSISITING FOR UP TO A DAY AFTER. PATIENT REPORTED FEVER AND CHILLS THE DAY AFTER VACCINATION. PATIENT HAS EXPERIENCED REDUCED/POOR SLEEP SINCE DATE OF VACCINATION. PATIENT HAS SEEN RETURN OF PREMATURE VENTRICULAR CONTRACTIONS (PVCs) SINCE VACCINATION AND REPORTS BENIGH BEATS AT 20-22%.
Afebrile, excessive irritability, refusing to feed, posturing-physical exam by MD, observation, released after fussiness stopped and feeding resumed.
Information has been received from a pharmacist concerning a 44 year old male with no pertinent medical history and no allergies who in 4/02 was vaccinated with a dose of MMR (second generation) (lot 639694/1212L). It was unknown if concomitant medication was given. Subsequently, the patient developed intestine intussusception and anorexia. Medical attention was sought and an extensive workup was performed but no specific information given. It was unknown if treatment was required. The patient recovered. The reporter stated that they have not established that MMR cause these symptoms. The reporter also stated that in doing some research on his own he knows that hepatitis B virus vaccine had contained Thimerosal and he knows that from his research that Thimerosal is Mercury and that it can cause some strange things in the nervous system in the body, he also reported that thimerosal was linked to intussusception. Upon internal review, intussusception was determined to be an other important medical event (OMIC). Additional information has been requested.
arm hurting, sore arm; vaccine was mixed with sterile water instead of saline; vaccine was mixed with sterile water instead of saline; felt unwell after her 2nd dose; tired and does not feel great; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 2nd dose, single dose, via an unspecified route of administration on 18May2021 11:45, for covid-19 immunization (at the age of 18-years-old). Medical history included covid-19. It has been a couple of years since patient had not received any other vaccine. There were no concomitant medications. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration on 27Apr2021, as single dose for covid-19 immunization at the age of 17-years-old and had really high fever, ears really hurting, Ears got so puffy and filled with fluid. It was stated, that her 18-year-old daughter already received both doses of the Pfizer-BioNTech Covid-19 Vaccine. She said her daughter was 17 years old when she received the 1st dose, but was 18 years old when she had her 2nd dose. She said her daughter had a really bad reaction to the 1st dose, and also felt unwell after her 2nd dose. The reporter stated that on 18May2021 11:45 the patient received second dose of vaccine and stated that someone from pharmacy told that patient's vaccine was mixed with sterile water instead of saline and after receiving the vaccine the patient felt unwell and she was tired and does not feel great on an unspecified date in May2021 and on 19May2021 patient's arm was hurting and had sore arm. Reporter wanted to know if her daughter gets revaccinated or whether she was still fully vaccinated. She was referred to her health care provider for that information. Pfizer has not tested the effects of using sterile water for injection as the diluent for the current formulation of the Pfizer-BioNTech COVID-19 Vaccine. The diluted vaccine using sterile water for injection as the diluent should be appropriately discarded and not used for vaccination. The Pfizer-BioNTech COVID-19 Vaccine has not been tested with sterile water for injection as the diluent. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
VARIVAX administered after a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 28-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck)(VARIVAX) (0.5 ml, once, strength and route were not reported, lot # T024281 has been verified as valid, expiration date 15-JUL-2022) for prophylaxis.  The vaccine administered experienced a temperature excursion of 7.1 degrees Fahrenheit, for a time frame of 59 hours 45 minutes. There were no previous temperature excursions. No digital data logger was involved.
This is a spontaneous report from a contactable female consumer reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced a burnt rubber smell. Patient reported that she received her second dose of vaccine in April. One week after her first dose caller began to start experiencing a burnt rubber smell. patient would like to know if that side effect has been reported. The outcome of event was unknown. Response: Reviewed package inset section (6.1 Clinical Trials Experience) Revised: 19May2021; Information on the lot/batch number has been requested.
Chronic hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ENO117) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 04Mar2021, for COVID-19 Immunization. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: URTICARIA (medically significant) with onset 08Apr2021, outcome "not recovered", described as "Chronic hives". The event "chronic hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria and include antihistamines and cream.
in the Neck (From Shoulder blade to neck and chin); Swelling opposite hand; A spontaneous report was received from a consumer concerning herself, who is a 80-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling in the neck (from shoulder blade to neck and chin), swelling opposite hand.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the events swelling in the neck (from shoulder blade to neck and chin) and opposite hand (not the injected arm/hand).  Treatment information was not provided.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable  The outcome of events swelling in the neck (from shoulder blade to neck and chin), swelling opposite hand was unknown.
Patient started feeling "pins and needles". She then had a seizure. Her blood pressure was low and she was extremely hot. The seizure was short. We had her lay on a mat and put ice packs on her and gave her water. She said she hadn't eaten today so we gave her orange juice to raise her blood glucose. Patient is not diabetic. Patient recovered quickly. She refused offer of ambulance. Her boyfriend arrived and said he was going to feed her then take her home.