chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sight of injection started swelling, getting red, and getting hot about a day later. Redness has progressively grown in size over the past two days and it has continued to be swollen and hot to the touch. It?s now about 2 x 3 inch blotch and has started itching in the past 24 hours. I did not have any reaction to the first vaccine except a very sore arm.
This spontaneous report was received from a licensed vocational nurse via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 30-MAY-2017 (reported as "today"), the patient was vaccinated with an expired dose of VAQTA 50 U/1.0 ml, injection (lot # M040421, expiration date: 26-MAY-2017; exact dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA003473:
numbness in both legs and right arm; pain in back; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 67-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; El898Z), via an unspecified route of administration in arm left on 26Jan2021 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. Medical history included the patient was diagnosed with COVID-19 prior to vaccination and had no known allergies to medications, food, or other products. The concomitant medication included levothyroxine sodium (SYNTHROID) 50 mg for an unknown indication. On 18Jan2021, the patient underwent throat swab, and the result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After one week of the vaccination, on 02Feb2021 at 15:45, patient experienced numbness in both legs and right arm and pain in back. The patient did not receive any treatment for the adverse event. The clinical outcome of the event numbness in both legs and right arm and pain in back were not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.   Amendment: This follow-up report is being submitted to amend previously reported information: adverse event (AE) onset latency was recalculated. For lab test "Throat swab" was re-coded as "SARS-CoV-2 test". For con-med, "50 mg" was added as dose/units". Lead sentence update as "...a contactable consumer". Final sentence updated as "No follow-up attempts are possible. No further information is expected."
Second dose was not administered because of the reaction to first dose; Rash all over body; Hives on arms, hands and legs; Was very allergic to it; Itchy; Bottom of the feet are sore; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives on arms, hands and legs), ALLERGY TO VACCINE (Was very allergic to it), PRURITUS (Itchy), PAIN IN EXTREMITY (Bottom of the feet are sore) and INTENTIONAL PRODUCT USE ISSUE (Second dose was not administered because of the reaction to first dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included SIMVASTATIN and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced URTICARIA (Hives on arms, hands and legs), ALLERGY TO VACCINE (Was very allergic to it), PRURITUS (Itchy), PAIN IN EXTREMITY (Bottom of the feet are sore) and RASH (Rash all over body). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose was not administered because of the reaction to first dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on arms, hands and legs) had not resolved, ALLERGY TO VACCINE (Was very allergic to it), PRURITUS (Itchy), PAIN IN EXTREMITY (Bottom of the feet are sore) and RASH (Rash all over body) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Second dose was not administered because of the reaction to first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included blood pressure medication. On 15-Apr-2021, the patient experienced PRURITUS (hands itch), the outcome unknown. The patient had applied a cream with steroids to treat the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Additional  information included reporter details(consumer),  new concomitant medications (simvastatin and Prilosec), new events (was very allergic to it, rash all over body, itchy hands itch and bottom of the feet are sore) were added.
Patient received vaccination. That night he woke up with nausea, shaking, and felt faint and weak. His arm was sore and stiff into the next day.
Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.
Muscle pain injection site, both arms at junction of deltoid and biscep, high hamstrings bilateral, right knee/calf neck, low back; Muscle pain injection site, both arms at junction of deltoid and biscep, high hamstrings bilateral, right knee/calf neck, low back; Muscle pain injection site, both arms at junction of deltoid and biscep, high hamstrings bilateral, right knee/calf neck, low back; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP). It was unknown if the patient had any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and benazepril (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021, the patient experienced muscle pain injection site, both arms at junction of deltoid and biceps, high hamstrings bilateral, right knee, calf, neck and low back. The events did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain injection site, both arms at junction of deltoid and biceps, high hamstrings bilateral, right knee, calf, neck and low back were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Initial misuse report received from a healthcare professional on 13 May 2013. PENTACEL, ActHIB and IPOL vaccines were administered to a patient on the same day. No adverse event was reported. List of documents held by sender: none.
passing blood clots/having a total of 4 of them she has passed/noticing one when she went to the bathroom to urinate; she went into the bathroom and wiped, without actually going to the bathroom, she noticed the blood clot(s); felt like she needed to go to the bathroom/felt weird like something needed to come out; headache; dizziness; hot and cold sweats; This is a spontaneous report from a contactable consumer (who is also the patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 16Apr2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Apr2021, after the first vaccination, the patient experienced "some of the usual side effects" described further as headache, dizziness, and hot and cold sweats. On 18Apr2021, 2 days after the first vaccination, the patient experienced passing blood clots having a total of 4 of them she has passed. She reported noticing one when she went to the bathroom to urinate. For the other blood clots, she reported it felt like she needed to go to the bathroom further described as "felt weird like something needed to come out." When she went into the bathroom and wiped, without actually going to the bathroom, she noticed the blood clot(s). The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient reported the following symptoms that were occurring after vaccination and continued 5 days post vaccination:  body aches, clammy skin, chills, nausea, and a  decrease in appetite.
Patient presented with eye blinking, vision loss, and tremors of arms/legs initially concerning for seizures, on 6/27/21. Had a normal EEG on 7/15/21 and an MRI on 8/10/21 which showed "BRAIN PARENCHYMA: No acute infarct or mass.   Small focus of T2 hyperintense signal within subcortical white matter of left superior frontal gyrus anteriorly, with indistinct gray-white differentiation." Proceeded to have ongoing episodes with eye blinking, extremity shaking, but preserved consciousness, sometimes with vision loss in July, August and early Sept 2021. Presented to the ED on 9/4/21 for increased frequency of eye fluttering and hand twitching, started on Keppra.  Returned to ED on 9/6/21 for new episodes of breath holding, eyes closing, but no loss of consciousness. Admitted for monitoring at that time and had another EEG on 9/7/21 which was also normal. During admission had addition of loss of tone with episodes. Seen by Neurology, and Psychology services. Felt that based on description and videos of episodes, they were unlikely to be seizures and Keppra was stopped on 9/8/21 without increase in episodes..Has  ongoing evaluation for periodic paralysis syndromes, cataplexy, and functional neurologic disorder.
High fever (102-103) for approximately a day and a half, severe headache, neck ache, injection site painful, red, warm to touch and swollen.
Left arm began severly itching.  No relief with OTC Benadryl, cortisone cream.  Rash going down arm.  No fever or numbness of arm.
Patient presented for second dose without an appointment during a 30 minute period that our computer tracking system was down.  Due to system being down, patient received 2nd dose today only 12 days after receiving the first dose.  The patient and her husband thought they were instructed to return 10 days after the 1st dose, but this was misunderstood by them.  They were only able to get through as we had no way to look up their previous appointment during that brief time period.  Their appointment for second dose in the system was appropriately scheduled dosing interval.  I spoke with patient's wife, and he was feeling fine as of several hours after the 2nd dose.
Information has been received from a registered nurse concerning a male adult patient who on 20-NOV-2007 was vaccinated subcutaneously with a 0.5ml dose of MMR II and on 26-FEB-2008 received subcutaneously a second 0.5ml dose of MMR II. The physician stated that the patient had titers drawn on 24-Feb-2008 and 04-APR-2008, both titers for measles were negative. The patient sought unspecific medical attention. At the time of the report the patient status was unknown. Additional information has been requested.
Mom brought child back to clinic on 10/5/09 for evaluation of LD with warmth below and around area with redness. Vaccine given 10/2/09. Mom reports rash, itching, edema, bled a lot. Mom applied cool, then warm cloth to area. Did not take to see MD. No problem with breathing.
arm was sore; slept the entire day; Off-label use; Booster; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient), forwarded as an Adverse Event by the Escalation team  A 65-years-old patient of an unspecified gender received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. The patient medical history included immuno-compromised, rheumatoid arthritis (RA). Concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single and dose 2 single for COVID-19 immunization. It was reported that patient was mildly immuno-compromised (RA) the day after patient slept the entire day and patient arm was sore. The outcome of the events slept the entire day, arm was sore was unknown.  Follow-up attempts are completed. No further information is expected.
My right neck from my ear to the bottom of my chin swelled up like I had the mumps. I was fevered and weak and I had trouble swallowing. I would regurgitate food I'd try to swallow. It lasted for two weeks. I am still  ( 6/21/21) having pressure on my jaw and ears and throat on that side.
Headache, Myalgia & NauseaVomiting Narrative: Experienced some symptoms the day following the second dose, but then 6 days later experienced headache and nausea/vomiting she attributed to the vaccine
Muscle aches, headache, nausea beginning 6 hours after shot. 16 hours after the shot I experienced extreme sudden onset nausea and dizziness which subsequently led to me passing out and throwing up. I then experienced profuse sweating and chills.
She got her vaccine, had no problems.  She was at a friends house and got down playing bridge, got up to go home and she fell down.  She was taken to the ER and they diagnosed her with having a stroke.  She was admitted to the hospital.  She was there for about 5 days and then went to rehab for 5 weeks, Rehab.  She had PT while she was there, OT as her whole right side made her have difficulty walking and her arm was affected which it is better but still not normal.  She is under the care of her PCP, Dr.  She was put on a heart medicine, aspirin and a cholesterol pill.  81 mg, Atorvastatin 40 mg, and Losartan 100 mg.  She was started on 50 and then was doubled.    She did not have any problems with anything, no medical problems until she had the stroke.
pt recv vax 5DEC96 & pt exp pain & dec ROM in rt arm 30min p/vax;rt deltoid was tender around the inj site & warm to touch;the following morning pt devel a non-raised erythematous rash in the medial aspect of rt arm;tx w/tapering dose pred;
size of base ball and run down to arm/size of 2 to 3 base balls; little dizzy; very itchy to injection site; muscle pain; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (size of base ball and run down to arm/size of 2 to 3 base balls), DIZZINESS (little dizzy), VACCINATION SITE PRURITUS (very itchy to injection site), MYALGIA (muscle pain) and FATIGUE (tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE MASS (size of base ball and run down to arm/size of 2 to 3 base balls), DIZZINESS (little dizzy), VACCINATION SITE PRURITUS (very itchy to injection site), MYALGIA (muscle pain) and FATIGUE (tired). At the time of the report, VACCINATION SITE MASS (size of base ball and run down to arm/size of 2 to 3 base balls), DIZZINESS (little dizzy), VACCINATION SITE PRURITUS (very itchy to injection site), MYALGIA (muscle pain) and FATIGUE (tired) outcome was unknown.            The itching was 3 to 4 inches above elbow. Treatment includes Patient rubbed the alcohol on the injection site and then applied moisturize.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up included Non-significant data: Reporter's information, Patient age added On 10-May-2021: TCR added on 10-May-2021: Patient has mail address but does not have access to it.
I got my vaccine on Thursday. Around 8pm I had the fever, chills, body aches. Higher heart rate ? typical vaccine response. Friday the next day, my heart rate had gone higher than it did in the past. Running at 150-160. Then around that evening, I started to have some chest pain and pressure, but it was pretty mild and not too bad. Drank some water and took some aspirin. Overnight it got worse and water and pain meds did not help. I started to having some squeezing in addition to the chest pain and pressure. Heart rate remained high at 150-160s and it woke me up in the morning at 4am. So I went to the ER at 8am and they ran tests, did an EKG, did some labs. And they monitored me until about 10:30AM. They did a heart monitor as well. They told me to go home and monitor it. It has pretty much gone back to normal and my heart rate is normal. Vaccine is just weird with that heart rate thing.
red, splotchy rash devel 2 days p/vax; rash most noticable on rt thigh but covered all areas from waist down;
Lesion (approx. size 1/8"x1/2") on arm about 2 1/2" from site of injection.  No other obvious trauma to area.
heart was throbbing a lot; waves of lightheadedness; This is a spontaneous report from a contactable consumer based on information received by Pfizer   This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was throbbing a lot) and DIZZINESS (waves of lightheadedness) in 84-year-old female patient who received apixaban (Eliquis) tablet for Cerebrovascular accident prophylaxis.  CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunisation.  Concurrent medical conditions included Thyroid disorder, Blood pressure high and Cholesterol.  On 14-Mar-2021, the patient started Eliquis (oral), 5 milligrams twice a day. On an unknown date, the patient started Covid-19 Vaccine (unknown route). On 19-Mar-2021, 5 days after starting Eliquis, the patient experienced PALPITATIONS (heart was throbbing a lot) and DIZZINESS (waves of lightheadedness). The action taken with Eliquis (oral) was unknown. At the time of the report, PALPITATIONS resolved and DIZZINESS outcome was unknown.  For Eliquis (oral), the reporter did not provide any causality assessments.  Concomitant Drugs for thyroid, high blood pressure and cholesterol.  Most recent information was received on 29-MAR-2021 from a consumer incorporated the above: Patient attributes, concomitant drug added, and event attributes updated.  Further company follow-up with the consumer is not possible.
Pain in elbows, neck. 9 months later (2000-2001) tingling, back pain and stiffness, lack of mobility neck, shoulders, hip, knees, back, etc. Numbness (9-12 months), heart palpitations, dizziness, depression on anxiety, nausea, headaches, sleep problems (9-12 months), finally being treated 2006. 02/22/07-records received for DOS 09/08/99-07/06/2005 Patient requested lyme disease vaccine on 09/08/99.  02/16/00-complained left knee pain, problem with eyes. 01/25/02-hurt neck on 12/15/01. twisted while showering. treated with naprosyn. 10/02/02-bitten by a tick on LLE today. Treated with Doxy 100mg. 12/13/02-anxiety times 2 years. feels depressed. Paxil prescribed. 12/3/03  2/21/05-complained of neck and upper back pain. lived heavy boxes on 2/19/05mild headache. 2/21/05-without vertebral tenderness. musculoskeletal neck shoulder pain. 03/22/07-records received from neurologist one year after receiving Lyme vaccine started having arthritic pain and muscular symptoms. Significant fatigue, cognitive difficulties mood problems headaches and insomnia. Myofascial syndrome of neck and shoulders. Per 60 day follow up: Some recovery, but not 100%.
This spontaneous report as received from a registered nurse refers to a 2 year old female patient. Medical history was not provided. On 12-AUG-2010 the patient was vaccinated with VARIVAX (Merck) lot number 666702/0026Z with expiration date 22-DEC-2011) dose 1. Concomitant medication was not provided. 3 months after the first dose of VARIVAX (Merck) (estimated as November 2010) the patient experienced chickenpox. The outcome of chickenpox was unknown. Additional information has been requested.
Left thigh red from top of thigh to knee, hot, left leg swollen to just below knee, twice the size of the right leg and skin taut. TX for left cellulitis with Keflex 200mg tid.
Reddened area, size of half-dollar, left arm.Swelling arm/neck/shoulder. MD diagnosed cellulitis.
patient received the high dose flu on 9/28/2022 and then requested again and received the same medication on 10/7/2022. Patient has reported no adverse effects following the second dose