chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; had a little throwing up of clear phlegm this morning; Fatigue/ feels tired; redness at injection site; This is a spontaneous report from a Pfizer sponsored program reported from a contactable consumer (patient). An 80-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in left arm on 19Feb2021 (at the age of 80-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing non-drinking cirrhosis of liver from Apr2020, Crohn's disease, anaemia and blood pressure from an unknown date and unknown if ongoing. Concomitant medications included ongoing Entyvio taken for Crohn's disease from 28Jan2021, ongoing iron taken for anaemia from an unspecified start date, ongoing Metoprolol taken for blood pressure from an unspecified start date and ongoing Amlodipine taken for blood pressure from 07Dec2020. No vaccine was administered on same date of Pfizer suspect. On 19Feb2021, patient had redness at the injection site, he experienced fatigue/ feels tired on 22Feb2021 and on 23Feb2021 patient experienced chills and had a little throwing up of clear phlegm. He did drink a lot of water. Maybe he had not drank enough. He walks 2-2.5 miles a day. He thinks little throwing up of clear phlegm was related to Crohn's Disease. His last dose of Entyvio was on 11Feb2021. His doctor said that was ok to take. No prior vaccination within 4 weeks. Outcome of the event redness at injection site recovered on 19Feb2021, Chills recovered on 23Feb2021, fatigue/ feels tired was not recovered and had a little throwing up of clear phlegm was unknown at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
dizziness and felt woozy almost all days; When I lay down I do get the spins and stuff; Nauseous; This is a spontaneous report from a contactable consumer (patient). This 21-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunization. The patient denied having any medical condition and confirmed not taking any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 21-year-old) as single dose for COVID-19 immunization. On 14Apr2021, the patient experienced dizziness and felt woozy almost all days, "when I lay down I do get the spins and stuff" and nauseous. The clinical course of the events was as follows: The patient reported, "I have been having dizziness and mild nausea since my second vaccine and I have got my vaccine on the 13Apr2021 and I have started on 14Apr2021 the day after the vaccine and it's been like a whole month already that I have been feeling like that dizzy and nauseous when I wake up in the morning and when I lay down I do get the spins and stuff, and then during the day as I work and stuff, I have to look up the stuff I get woozy. I have been taking Dramamine 25 mg tablet." The patient also mentioned that she cannot set an appointment at her doctor's office since they don't have appointments for 2 months. She is just calling to get a recommendation on which medication she can take and what she can do. The clinical outcome of the events, dizziness and felt woozy almost all days, "when I lay down I do get the spins and stuff" and nauseous was not resolved.  Follow-up attempts are completed. No further information is expected.
1st in the series  Nausea and sleepiness  2nd Headache on the day of the injection  Large red and warm wheal at injection site lasting at least one week after shot
Less than 24 hours after vaccine, started to notice blood in urine. This blood increased and I went to urgent care and was prescribed an antibiotic for a presumed UTI. This same thing happened with my Covid vaccine booster I later received in November. After having the same blood in my urine recently with a cold, I was diagnosed with IgA nephropathy.
1st dose of vax given 23OCT91 & 3 wks later devel hives; 2nd dose of vax given 3DEC91 & 12 hrs later devel stomach cramps w/vomiting; 24 hrs later devel hives under arms, waist area, back of knees & in scalp lasted until 5DEC91;
Only sore arm the day of the shot, 13 Apr.  The following day, 14 Apr, I had headaches; dizziness; achy sore in almost all muscles (not just the injection site); injection site was more painful as the day wore on; all my joints hurt; and the night of the 14th I had a fever, chills, and ringing in my ears (both).
Reaction began with redness on chest and itching.  Claritin was administered and then Benadryl about 5 minutes later.  After 15 minutes, whelps began to appear and itching worsened.  A single Epi-pen was administered.  EMS was contacted and person was transported to the hospital.
Induration of about 20 mm. Pain and redness at injection site one day post vax. Treated with Motrin for pain and fever.
Leg swelling; Dizzy; Headache; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced leg swelling, headache and was dizzy after two weeks prolong. The clinical outcome of the events leg swelling, headache and dizzy were unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported injury sustained as a result of a fall. She fell on her knees because she having difficulty controlling her leg muscles. She attributed the neurological component to the Moderna bivalent she had received from us. In addition, she also experienced high fever for a couple days post vaccination.
I had no symptoms after receiving vaccination 1. About 2 days post vaccine 2, I started having migraine type headaches. I am a healthcare provider and also started checking my blood pressure. I have a history of low to normal blood pressures, and after the second vaccination I have had almost daily headaches and issues with high blood pressure. My systolic pressure ranges from 140-180 and my diastolic ranges from 90-120. Initially I thought the migraines would be a short term effect but have continued which is why I am reporting now. I have no resolution and am facing daily long-term medications related to this vaccine.
"Tennis ball sized inflammed and red area at the site of the vaccination; temp 100.3; evaluated in office today 08/29/2011 and redness is 5x6cm and hot and indurated, nontender at site of injection.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/06/21 2nd dose01/27/21 Diagnosed covid positive:08/31/21 Symptom onset:08/31/21 Exposure:Home Symptoms:cough, fatigue,muscleaches,sorethroat,HA
A serious spontaneous report of Steven Johnson's syndrome and erythema multiforme manifested by little red dots on hands, feet, legs, face and trunk and itching, has been received from a pharmacist concerning a five-year-old male, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 08-Oct-2010. Three hours after FLUMIST administration, the patient had little red dots on hands, feet, legs, face and trunk. The patient had itching but no respiratory symptoms or vomiting. The physician thought that the patient had Steven Johnson's syndrome and erythema multiforme. The patient had FLUMIST for the past three years with no adverse effects the first two years. The events of Steven Johnson's syndrome and erythema multiforme resolved on 11-Oct-2010.
patient presented for 2nd dose. stated that following 1st dose there was a noticeable bump. this started to decrease up until about a week ago when it began to enlarge then exude a pus like substance. patient does not have a PCP but referred to Urgent care for f/u for potential infection.
A few hours post vaccine, developed splotches and a scratchy throat.  Took a Benadryl which resolved those symptoms. Wed, woke up with terrible headache, nausea and kidney pain, no other urinary symptoms or fever. Took Tylenol and Advil alternating between the two. Thursday, had kidney pain and diffuse joint pain. Friday, joint pain improved, still had kidney pain and do as of today, 4 Jan 2021.
This spontaneous report as received from a nurse refers to a patient of unknown age. In approximately January 2012, about a year ago, the patient was vaccinated with the first dose of GARDASIL. On 08-JAN-2013 the patient received the second dose of GARDASIL in the office. No other co-suspects were reported. No concomitant medications were reported. At the time of the report, no adverse effects were reported. Additional information has been requested.
A nurse reported the occurrence of an injection site reaction in a 15 month old female who received Infanrix for prophylaxis. The vaccine provider submitted this report directly to VAERS. The vaccinee's medical history, concurrent conditions, and concurrent medications were not provided. On 7/31/02, the vaccinee received her fourth injection of Infanrix (566B2) into her right leg. At an unspecified time post-immunization, she developed an injection site reaction characterized by large areas of erythema and an area of warmth and swelling measuring two inches by three inches. Two days later, the injection site reaction resolved. The reporter considered the injection site reaction to be probably related to Infanrix administration.
Patient is 70 Years Old Female LUE erythematous rash, swelling, pain and warmth after PCV13 administration 8/28/2017 to Left upper arm. Pain worse the night of getting shot, unable to move arm, had fever as well that night. On 9/1/2017 visit, pain improved but rash spread downward toward elbow, rash very pink and warm, no skin peeling, and patient no longer febrile. Skin Comment: erythematous flat rash L upper arm following humeral distribution down to L elbow, very warm to touch, nontender, negative Nikolsky's sign. Assessed Skin rash, allergic as comment only - PCV vaccine, PO and topical Benadryl.
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219731, 20211219686, 20211220537, 20211220233, 20211219807, 20211219953 and 20211221158.
After getting vaccine patient fainted, feel dizzy, shaking, feel like have fever, cannot walk. Called 911. Ambulance came and bring patient to hospital.
vertigo; IBSD; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea ), VERTIGO (vertigo) and IRRITABLE BOWEL SYNDROME (IBSD) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced DIARRHOEA (diarrhea ) and IRRITABLE BOWEL SYNDROME (IBSD). On 08-Feb-2021, the patient experienced VERTIGO (vertigo). At the time of the report, DIARRHOEA (diarrhea ), VERTIGO (vertigo) and IRRITABLE BOWEL SYNDROME (IBSD) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in early 2000). Concomitant products included Aspirin. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On 3rd April 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced, injection site rash, numbness of upper extremities, and injection site erythema. On 3rd April 2018, the outcome of the numbness of upper extremities was recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site rash and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site rash, numbness of upper extremities, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Immediately after receiving SHINGRIX, the patient experienced swelling and soreness at the injection site. Less than a day, after receiving SHINGRIX, the patient also broke out with red splotches about two inches in circumference around the injection site. Less than a day, after receiving SHINGRIX when the patient left the pharmacy, the patient experienced numbness in her entire left arm, starting as she was driving home from the pharmacy and lasting for approximately two hours. The swelling and soreness lasted for approximately two weeks. The red splotches were resolving but are still visible on the day of reporting. The reporter gave permission to contact her physician.
Bexsero administered instead of Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a male patient who received Men B NVS (Bexsero) (batch number 9R42C, expiry date unknown) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 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 Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The nurse practitioner reported that Menveo was ordered for the patient but Bexsero was administered in error. The health care professional did not have expiration date at time of the reporting, forgot to ask about follow up but telephone number and email were present in the HCP details. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received a dose Bexsero instead of Menveo, which led to wrong vaccine administered.
At the end of the first dose my Dr. ordered a CT scan for swollen Lymph nodes. The report from radiology are showing enlarged lymph nodes located in the left side of my neck measuring at up 1.1 sonometers. They only found them on the left side where the vaccine was given. I was told to do self examinations and notify them if they get larger. I had a mild headache and soar arm after the vaccine.
2 scabs; Discoloration too; I had fatigue; I felt very weak; Had a little bit of fever; forehead hurt / when the sun hit my forehead; did not eat much either; I lost weight.; I stayed inside / husband and my son / help me out / I could not do this alone; I had the Shingles last year but / I got the shingles shot 2 years ago/Suspected vaccination failure; I had the Shingles / they were just there / on the right side of my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, scab, skin discoloration, fatigue, weakness, fever, forehead headache, appetite absent, weight loss and activities of daily living impaired to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine 2 years before day of reporting. In 2020 (last year), the patient had the shingles for 5 weeks, but they did not hurt or itch, they were just there, and she had them on the right side of my forehead with 2 scabs and discoloration too. The patient had fatigue in which she felt very weak and had a little bit of fever. The patient stated that the only time her forehead hurt was when the sun hit her forehead, so she stayed inside, and she did not eat much either and she lost weight. She was glad that she had her husband and her son with her to help her out because she could not do this alone. The patient stated that before this she never had shingles and she did not want them again and she had heard if you get them the second time it was worse than the first time, so she just pray that she did not get a second time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR081738, for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR081738:Same reporter. Hearsay case.
p/vax pt mild fever & one pock mark then one & half weeks later has no fever but has 10-12 fresh pock marks
Horrible burning and redness on her feet/Caller states her feet turned red like a fire engine; a COVID arm with a rash on her arm; Horrible burning and redness on her feet/Caller states her feet turned red like a fire engine, and they were burning; Her arm hurt very little; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Horrible burning and redness on her feet/Caller states her feet turned red like a fire engine"; RASH (non-serious), outcome "unknown", described as "a COVID arm with a rash on her arm"; BURNING SENSATION (non-serious), outcome "unknown", described as "Horrible burning and redness on her feet/Caller states her feet turned red like a fire engine, and they were burning"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Her arm hurt very little". Additional information: After her 1st vaccine she developed a COVID arm with a rash on her arm. She then stated she had horrible burning and redness on her feet before taking her second vaccine. She is trying to decide if she will take the booster dose or not. Declined to complete a full safety report. Other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials. LAB-1450-15.0 Revised: 20 October 2021. Caller would like to know in the clinical trials, when people had such reactions like the hypersensitivities, did they continue to take the second shot. Caller states that she is scared to take the booster due to her reaction and her HCP feels as though she should switch to Moderna. The caller feels "that the devil you know is better than the devil you dont know." She doesn't want to have a "horrendous reaction" and she doesn't want her reaction to "morph into anaphylaxis. Serious Adverse Events Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients. Caller states after the first vaccine, her arm hurt very little. Caller states, before the second vaccine, she got a rash on her arm, Covid arm. Caller states her feet turned red like a fire engine, and they were burning. Caller states she had to put them in cold water and ice cubes. Caller states that effect with her feet, lasted through the second vaccine. Caller states she had it for 3 weeks and then it went away. Caller confirms that she is in (Privacy). Caller states she is not sure if she wants to get the booster vaccine. Caller states she has discussed it with her doctor, and he recommended that she get the Moderna booster.   No follow-up attempts are possible. No further information is expected.
Evening of 7/25 felt tired and went to bed. Next morning, 7/26 woke up with"pins and needles" sensation throughout body.  Slept all day and in the evening woke up with same. The sensation felt like glass on skin, head to toe, except for left side of face but all of the head.  Next day continued very fatigued, but all day sensations. Took Tylenol to find relief.  Taking it now around the clock every 5hrs.