chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When staff were entering todays 2nd dose of Moderna COVID 19 vaccine into the EMR, an alert  popped up that the series had already been completed. On review, it was noted that the patient had a dose of Pfizer in January, then booked a 2 dose series. First dose Moderna administered on 3/09/21 and then today 4/6/21 dose.
07/10/2021 I woke with nausea, headache, fatigue, body aches, hot with chills feeling flush, lightheaded. I have not had a fever even though I exhibit all the symptoms of having a fever, when I took my temp, it was normal. I had to report to work on 07/12/2021 though all my symptoms continue to persist to this day. The headache is my worst symptom that continues to be the same level of pain since this began. I am unable to relieve the headache, and it is worse upon wakening. I suffer waves of symptoms. The nausea has decreased in intensity, though it is lasting longer when it does come on.
Patient came to pharmacy to get meningitis shot for college. Upon getting the vaccine, patient became unconscious while sitting on the chair. About 10 seconds later, patient woke up and felt nausea. Patient didn't vomit. Patient sat and relax for the next 10 minutes and felt completely before leaving the pharmacy
After the second dose I got a rash within a week, but that particular rash was not too bad, but a couple of months later I got another rash, and it was awful. For the first one I did not need to go to the doctor since it was not too bad. I went to the doctor around on July 13, 2021, for the second rash, they prescribed me a topical cream and did not do any medical tests.
About 10 hours after getting the second vaccine, reactions included exact symptoms of my covid experience: severe muscle / joint pain throughout body (including pins and needles on bottom of my feet), extreme fatigue / lethargy lasting over 24 hours. Feeling better on the 30th hour after shot but still weak and tired. Left arm at place of injection has become very swollen, red, and in a lot of pain (not until about 20 hours after shot and has thus far remained this way.   That's all!  Thanks!
19MAR93 mom called pt had t103, irritable, not feeding; mom instructed to take pt to ER; 21APR93 told had ear infect; mom reports lt leg had small lump;
Pain in (L) deltoid where PNEUMOVAX was administered. Pain travels up to the neck and down to lower arm. Primary Dr contacted and told patient to wait and see if pain alleviates.
Gave 0.5 ml instead of 0.3 ml, pt stated she was fine, she was a nurse & thought the imz was 0.5 ml. Said it was a little sore but it hurt less than her 1st dose bc whoever gave 1st dose hit her bone.  She wasnt too concerned, explained info from pfizer & cdc that it shouldnt cause harm & higher doses were given in trials with mainly injection site soreness as symptom.
little of discomfort in her left arm during 1 day after the vaccine was given; bivalent booster administered instead of 1st dose of primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of LIMB DISCOMFORT (little of discomfort in her left arm during 1 day after the vaccine was given) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (bivalent booster administered instead of 1st dose of primary series) in a 52-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     The patient had never been diagnosed with/ tested positive for COVID-19. Patient had no acute and chronic illness at the time of vaccination. No AE cause patient to seek medical care.  Concurrent medical conditions included Penicillin allergy. Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (AFLURIA) for an unknown indication.    On 06-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 06-Sep-2022, the patient experienced LIMB DISCOMFORT (little of discomfort in her left arm during 1 day after the vaccine was given) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (bivalent booster administered instead of 1st dose of primary series). On 06-Sep-2022, LIMB DISCOMFORT (little of discomfort in her left arm during 1 day after the vaccine was given) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (bivalent booster administered instead of 1st dose of primary series) outcome was unknown.        The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.
rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2019, the patient received the 1st dose of Shingrix. In July 2019, 1 day after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. About 24 hours after the vaccine the patient had a red rash across patients torso.  The patient reported to the pharmacy the patient received it from they informed me that it was not a side effect. For tolerance after 2nd dose refer case US2019AMR166978.
Pt received pneumonia vaccine on 6/6/08 on 6/9/08 was seen by MD for progressive redness, tenderness, warmth, and discomfort that was spreading. Pt on LEVAQUIN, cool compress and antihistamine
Triggered an asthmatic response, restricting breathing. Occurred 9 hours after vaccine administration. Solved with prescribed Albuterol inhaler, two puffs of 90mcg spaced 1 minute apart.
High temp 101.7 crying non-stop for 6 hrs. Tyl-not reducing temp-advised to go to Er. (Rc'd Trige slip from ED).
Information has been received from a healthcare worker concerning a 38 year old female with no medical history or drug reactions/allergies who on 16-FEB-2009 was vaccinated with PNEUMOVAX 23 (lot number 659922/1667U) IM with no concomitant therapy. On 16-FEB-2009 the patient experienced arm pain, swelling and redness at the injection site. The adverse events were considered to be disabling. The patient had made a phone call for medical attention. No lab diagnostics were performed. The outcome of the patient's adverse events was not reported. This is one of the several patients from the same source. Additional information has been requested.
Patient has red, swelling, and painful area at elbow area, not at the injection site. Patient was advised to take BENADRYL on 11/17/2016. Injection date is 11/15/2016.
"Patient received Janssen Vaccine. While in Post Vaccine Observation area patient reported her heart was beating fast. Patient escorted to EMS Observation Room. BP 122/85, HR98, RR18, SpO2100%. Patient rested and felt better. Patient refused transport to hospital for evaluation and left clinic ambulatory with no complaints." Site Supervisor Report
Patient received Gardasil vaccine 4/5/07 and 2 days later developed fever to 103 body aches, sore throat, nausea, headache.
2/9/06 reports red, swollen arm from shoulder to elbow (left) noticed on 2/4/06. Child cried, verbalized that it hurt. Denies fever. Reports normal activity/use of extremity. Improved today.
Extremely bad headache, very dry mouth, body aches all over, intestinal tract problems (diahrrea) - *temperature unknown, but face/cheeks very warm Took 2 Tylenol at 9am Still feeling symptoms, but  a little better at 2pm
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 06-JUL-2015, the patient was vaccinated with unspecified improperly stored doses of MMR II (lot: K014833 and Expiry: 14-SEP-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient became pale, and felt he may pass out. Then appeared to have a mild seizure with syncope. Patient was lied down by this provider and quickly recovered and became very lucid. Also more diaphoretic after episode. Did not remember losing consciousness. Heart rate during syncope/seizure decreased to approx 45/minute. Ambulance was called and Patient taken to local ER for evaluation.  Evaluation was negative for any illness or medical condition. Patient taken to ER for thorought evaluation, not because he was compromised by syncope/seizure. Patient called 102d MDG after several hours to report he was fine and all ER tests/evaluation was negative.
I had my vaccination on 09/23/2022. On 02/03/2023 I started to experience UTI symptoms and I took a 5 day antibiotic. I started to experience throat issues with a white spot on the back of my throat on one side on 03/17/2023. I am seeing an Ear Nose and Throat specialist on 03/29/2023 because I am still having symptoms on my throat on 03/28/2023 and would like further checkups. I have recovered from the UTI on 03/28/2023.
clinical deterioration; Arm swelling; extreme pain; This spontaneous report was received from a pharmacist via company (ref# 2019SAO00167) and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route of administration, anatomical location, lot# and expiration date were not reported).    On unspecified dates, she experienced swelling of the arm and extreme pain that led to clinical deterioration, and she was hospitalized in an intensive care unit (ICU).   The outcome of the events was unknown.  The causality assessment was not provided.
first and second dose in 2019, outbreak of shingles / suspect Vaccination failure; shingles in eye; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix. In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The patient called on day of reporting to inquire if it was recommended to get a booster for Shingrix. The patient stated she had the first dose of Shingrix in April and second dose in June of 2019. The patient stated she had an outbreak of shingles in her eye last year. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation for herpes zoster was unknown at the time of reporting. The reporter consented to follow up.
I got very weak. I could not walk well. I was dizzy and I had a terrible headache.  The headache went away after one day. After 2 days of staying in bed, I felt a bit better and went for a walk, that was Saturday. On Sunday I was even better and thought I was on my way to doing well. I went swimming and felt fine. The next day, Monday,  I was sick again but with a runny nose as well. I felt very weak and tired. It was as if I relapsed but added another symptom. Now today is Tuesday and I am the same if not worse with a runny nose. I'm not sure if this is a continuation of the vaccine, or if I simply caught a cold.
Vaccine breakthrough in an immunsuppressed host.   COVID + 9/7/21.   Admit to acute care 10/4/21
Week 29 pregnancy , given COVID moderna vaccine Experienced chills, fever, severe muscle ache, diarrhea, nausea from 4/10/21 to 4/12/21
On left anterior thigh, area of erythema and swelling at vaccine site about 4 cm by 4.5 cm (+) hot to touch (+) induration.
Mom states child was tired and irritable with T. 99 degree F evening of immun. This persisted until 10/5/13 when temp went to 102 degree F, then on 10/6/13 temp went to 103.2 degree F. Child had poor appetite and fluid intake throughout. Evening of 10.7/13 started eating and drinking. Had fever med at 9PM. 10/8/13. No fever. Appetite good. Some coughing now.
Right Eye - Diplopia 6th Nerve Palsy; Double vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jun2021 11:15 (Lot number: EW0181) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient had none relevant medical history. There were none concomitant medications. Vaccination history included: Bnt162b2 (Prev dose Lot number: EW0202, Prev dose Administration time: 11:00 AM, Prev dose Vaccine location: Left arm, Prev dose Dose number: 1), administration date: 25May2021, when the patient was 56 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received any other medications within 2 weeks of vaccination was none reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient known allergies was none reported. The following information was reported: VITH NERVE PARALYSIS (medically significant) with onset 14Aug2021 08:00, outcome "recovered" (Dec2021), described as "Right Eye - Diplopia 6th Nerve Palsy"; DIPLOPIA (non-serious) with onset 14Aug2021 08:00, outcome "recovered" (Dec2021), described as "Double vision". The events "right eye - diplopia 6th nerve palsy" and "double vision" were evaluated at the physician office visit. Reported that right eye - diplopia 6th nerve palsy. The right eye was not moving from left to right. Double vision. Started Ayurvedic and Homeopathic medicines from the first week of the eye problem. After the 6th week, the right eye moved a little bit and then took another 6 weeks to move completely towards the right side. But both eyes' speeds were not in sync and had double vision towards the right side. After another 4 weeks, both eyes were in sync and vision was normal. From Dec2021 first week onwards, eye vision was normal. He used both Ayurvedic and Homeopathic medicines until vision was normal. Patient visited doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of vith nerve paralysis, diplopia.
9/14/2021 at 09:25AM, Patient began to feel dizzy and felt like she was going to pass out.  VS at this time BP 173/113 P 113 O2 99% and labored breathing.  At 09:28, patient reports that she feel like her throat is swelling.  Epi  given at this time. VS. 195/120 P 105 02 100%.  Emergency response was initiated and patient was evaluated in ED.
Swollen right eye lid; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 02Sep2021 at 15:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate (FLONASE) and unspecified iron pills; all from unknown dates for unknown indications and unknown if ongoing. On 02Sep2021 at 17:00, the patient experienced swollen right eye lid. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event swollen eyelid was resolving at the time of this report.
Pt said "heart feels like it is racing more than usual and I feel like I am going to pass-out".  Instructed pt to take mask off. Gave her water and had her open her windows for fresh air and to cool her down. She started feeling better after doing those thing. She did call her cardiologist and he instructed her to go to the ER. She did not want to be transported by EMS, so she called a friend to come get.   Called PT on 4/8/2021 to see how she was doing and she reported that she was feeling much better, but that her cardiologist wants her to be cardioverted before her next dose.
Pfizer-BioNTech COVID-19 Vaccine EUA Woke with very swollen and numb upper lip.  Took Benadryl and Acetaminophen.  Symptoms have greatly reduced over the course of the day.
Ipsilateral supraclavicular lymph node swelling with associated pain; Ipsilateral supraclavicular lymph node swelling with associated pain; dose_number=3; This is a spontaneous report received from a contactable reporter(Physician). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech COVID-19), intramuscular, administered in arm left, administration date 10Dec2021 09:00 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; IBUPROFEN. Past drug history included: Zantac, reaction(s): "known allergies: Zantac". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 09:00, outcome "unknown", described as "dose_number=3"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 11Dec2021, outcome "unknown" and all described as "Ipsilateral supraclavicular lymph node swelling with associated pain". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain. Additional Information: the patient did not received any other vaccine within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient had not been diagnosed with COVID-19,and Since the vaccination,patient had not been tested for  COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Two days after my initial shot, I noticed I had a sore spot on my right collar bone. I felt it and it was a swollen lymph node. Over the next few days it got smaller and was eventually gone within that next week. During this time I also felt soreness under both my armpits as if I had swollen lymph nodes there as we. All was gone about a week after these all appeared.
* I am having a fluttering heart problem.  * This symptom has begun 10th day after the first dosage of Pfizer-BioNTech  vaccination.
Light headed; vision changes; Neck pain; Ear pain; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient 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 15May2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included chronic pain, depression and anxiety. The patient received other medications in two weeks, and was unspecified. The patient previously took Neosporin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Apr2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 12:45, the patient experienced light headed and vision changes, neck pain and ear pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events light headed, vision changes, neck pain and ear pain were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient, 61 y.o. male who presented to ED on 11/18/20 with bilateral upper and lower extremity weakness s/p influenza vaccination on 11/9/20.   ? Patient received IIV4 ? Fluzone (Sanofi Pasteur) Lot #UT7102KA.   ? Neurology consulted on 11/18/20, started IVIG 0.4mg/kg/day x5 days for Guillain-Barre diagnosis.   ? Patient?s case was further complicated by respiratory failure requiring BIPAP, then intubation and eventual transfer to MC for concern of seizure and EEG monitoring
Pt became encephalopathic, developed afib, and urinary retention.  Admitted to the hospital for 2 week stay until encephalopathy resolved.  Afib broke spontaneously.  Required foley catheter placement.