chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on chest and right side of neck; Headache; Fever; Chills.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 16:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included cancer, radiation thyroiditis, crohn's disease and arthritis. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), hydrocodone bitartrate, paracetamol (NORCO), lisinopril dihydrate (LISINOPRIL), levothyroxine (MANUFACTURER UNKNOWN) and meloxicam (MELOXIC); all from unknown date for unknown indication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 17:00 (at the age of 58-year-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 07Apr2021 at 20:00, the patient experienced rash on chest and right side of neck, headache, fever and chills. it was reported that he was prior cancer patient, right side squamous cell carcinoma resection lymph nodes removed on this side as well as radiation effects. All treatment from 2017-2018, nothing recently. 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 reported event. The clinical outcome of the events rash, headache, fever and chills was recovering.   No follow-up attempts are needed. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 11:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 11:13 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 21.53.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 22-Jun-2021, Excursion time was 08AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
The patient's doctor called the pharmacy to report the adverse events the patient was experiencing. Per physician, patient showed up to the office with hives and rashes all over the body.  Physician reported that the hives were raised, red, and itchy.
Reaction to the first dose was mild. Within 12 hours of receiving the second dose, I experienced headache, fever (highest reading was 102.6) and violent chills that lasted for several hours. Chills stopped and fever broke at around 36 hours. Extremely fatigued and slept or rested most of 48 hours.  Also developed a lingering cough but no shortness of breath. Constant bad taste in mouth, and food tastes bitter so no appetite. Pain at injection site went away quickly, but still have pain further down left arm and in lymph nodes. Feeling better at 72 hour mark, but tired and still have bad taste in mouth so everything tastes bitter. The main reason I'm reporting this is that I would like to pose a question -- Since women tend to have more negative reactions to the vaccine than men, and women tend to have more autoimmune issues than men, could there be a connection? Could that be why I had such a bad reaction to the second dose? My autoimmune issues are mild, but I have several. I need to take a corticosteroid for Crohn's disease but have deliberately delayed beginning treatment until two weeks after my second dose (May 8, 2021). I wasn't able to find much information about this. Thank you.
fever / 100.7; This case was reported by a consumer and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 20th January 2021, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced fever of about 100.7 degree F. The reporter consented to follow up.
Soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on her arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Hypertension.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on her arm). At the time of the report, PAIN IN EXTREMITY (Soreness on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant product use was not provided by the reporter.
Swelling on left thigh, pain, warmth, tenderness, left thigh firm to touch throughout.
Pt feels dizzy, hot, headache.  VS BP 122/80, HR 75, RR 18, Osat 98% Left arm numb from elbow down.
Pain in my arm where I received the vaccine; Cannot raise my arm ; like my shoulder; Fatigue; I thought maybe I dislocated the shoulder; Starting to feel like pretty bad joint pain like I sub-located the joint; Feels like strain; Muscle pain; This is a spontaneous report from a contactable nurse, the patient.  A 50-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/lot number: EK9231; Expiry Date: 30Apr2021), via an unspecified route of administration in an unspecified site on 26Dec2020 around 12:40 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The patient has no relevant medical history. The patient's concomitant medications were not reported. I received the Covid vaccine today and I am a Nurse and I am having pretty significant pain in my arm where I received the vaccine. Consumer (Nurse) stated, "I had the vaccine at around 12:40. I came back to my unit and around 3:00PM, I moved a patient. I was holding a patient and so I thought maybe some of that was just fatigue from holding a patient in the procedure but and then I started to move it and I thought maybe I dislocated the shoulder. I was starting to feel like pretty bad joint pain like I sub-located the joint and then it started to be in you know, then I was like really trying to concern like what the sensation was that I was feeling .Knowing all while I got the vaccine and I am feeling the muscle sort of feels like strain. I was told that I cannot say for sure if it just the vaccine. It could also be the handling the patient. But it is both types of pain like looking at the side effects it says joint pain, muscle pain. Injection site pain I do not have. Tiredness and headache no. So it is Muscle pain and joint pain I have. I took a Tylenol (not further clarified) as the pain really started to bother me at around 4. I took Tylenol at about 5 and I started putting an ice pack at around 5:30. It is still pretty significant I would say with those interventions this calmed down to about at 6 and I cannot raise my arm like to my shoulder. I am scheduled to get the second shot on the 17th." It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  The patient took Tylenol for pain. The clinical outcome of vaccination site pain, vaccination site movement impairment, fatigue, joint pain, myalgia, was unknown.
ER visit on 11/21 - concerns of a blackened right fifth toe. Biotic ointment and Call your podiatrist or surgeon early next week and consider early amputation before spreading infection does occur. 12/3 - hospital admission gangrene. Procedure - Acute osteomyelitis of right foot. ED visit and hospital admission were within 6 weeks of receiving the COVID vaccine.
bumps on the deltoid and they were experiencing side effects, such as chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (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: CHILLS (non-serious), outcome "unknown", described as "bumps on the deltoid and they were experiencing side effects, such as chills".  Additional Information: He states he has no bump on his arm and has no side effects. He feels it was given below the deltoid muscle. He wants to know if he should get another dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was brought to observation after receiving the first dose of the Pfizer vaccine. 15 minutes after receiving the vaccine patient stated in a clear and complete sentence, "I can't breathe, something is in my throat." Vital signs were initiated immediately at 2:25PM. Patient denied chest pain, rash, or hives. Deep breathing techniques were initiated. Patient burped and stated she feels better. Patient noted to have palpitations, and crying spells. Continuous monitoring and deep breathing exercises were done. Patient stated she is anxious. No signs of allergic reaction were noted.  EMS was called for further monitoring as per patient's request. Patient was calm and felt better. Patient states, "I feel better, my throat is better." Patient noted to have crying spells again when EMS arrived to the site. Patient left with EMS. Steady gait noted, equal and bilateral chest rises noted throughout incident.
Started getting sick after my second dose of Pfizer EN6198 on 02/26/2021.  Head started swelling and felt sick all over my body.  My left sinus area and throat was producing excess mucus. Muscle pain and joint pain with fever.  Lymph nodes in neck and under arms were swollen.  Rash on chest too.   Caused 6th nerve palsy and double vision.  I had gone to the ER at Hospital on 04/21/2021 and tests were run and I didn't test postive for Covid19.  They released me and I continued to feel sick for months.  I have also had numbness and tingling in hands and feet.  Lots of burning in the feet that continue to present day.  My double vision is still present.  I continue to have repeating symptoms. Numbness on nose.
got confused; short term memory loss/ multiple episodes of memory loss; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (got confused) and AMNESIA (short term memory loss/ multiple episodes of memory loss) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (got confused) and AMNESIA (short term memory loss/ multiple episodes of memory loss). At the time of the report, CONFUSIONAL STATE (got confused) and AMNESIA (short term memory loss/ multiple episodes of memory loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
headache; tired; cold; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 09:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included dermatographia. The patient had no allergies to medications, food, or other products. Concomitant medications included testosterone (MANUFACTURER UNKNOWN), quetiapine (MANUFACTURER UNKNOWN), dextroamphetamine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received influenza vaccine (FLUZONE; Lot number: UT7115KA) in the right arm and meningococcal vaccine b (SANOFI PASTEUR; Lot number: U6586AA) in the left arm, both taken on 24Mar2021 for 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. On 07Apr2021 at 11:00, the patient experienced headache, cold and tiredness. The events did not result in doctor or other health care 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 headache, cold and tiredness was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Shingles on left side of the body after 4 to 5 days after vaccination.
Pain, arm swollen 2 inches larger than normal for 3 days raised red welt 6 inches by 4 inches around site, fever at site, intense itching at site w/moderate itching all over. Started acetaminophen alternated w/ibuprofen closing and cont. x 4 days on 10/9. Also iced and gave BENADRYL x for 2 weeks after due to systemic itching.
on 9-19-22, pt noticed one bump on R. arm ,  now has 5 total bump close to injection site.  the injection site has a lump under skin/ pt.  The bumps are drying up now . Injection site is sore and itchy.
Around 1pm patient received the vaccine and went to bed around 9pm. Normal temperature is 97.5 but had fever since temperature was at 99.7. Patient felt nauseous but did not take any medication. Next day, called doctor on, the next day. Patient felt like had flu, headache, fever, could not eat very much, and nauseous. Eventually took all regular meds, took Tylenol and Aspirin to help for fever. Still had fever on 2nd day in the morning but by 10am did not have fever. Went to the doctor and patient was told to take it easy; no meds were given. Headache lasted through the 3rd day. Today feeling much better, not energetic but ok. Patient had redness, soreness at site of vaccination; there was no swelling like after the first dose. Patient feels she is on her way to recovery.
5-10 minutes post 3rd dose of vax, the pt's mother stated that while driving home her son had a seizure with the following symptoms: face beet red, shaking, eyes wide open but not responsive, hands clenched, lost control of bladder, and head sweating profusely. Mother headed back to the clinic but by the time they got there, the episode had resolved. At the clinic they reportedly found the pt's blood pressure and pulse to be low. Pt felt out of sorts for a few days. It took a few days for pt to return to normal.
01/13/22 presents to ED for "altered mental status". PMHx of "liver cancer and liver cirrhosis"
WEAK; TIRED; Headache; Loss of smell; Muscle pain; Chills; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle pain. On 01-APR-2021, the subject experienced loss of smell. On 01-APR-2021, the subject experienced tired. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced weak. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of smell, chills, tired, headache, and muscle pain on 02-APR-2021, and had not recovered from weak. This report was non-serious.
weakness, positive covid test in fully vaccinated pt, received booster (Pfizer) 12/20/2021
batch of hives that showed up about two weeks after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (batch of hives that showed up about two weeks after the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (batch of hives that showed up about two weeks after the first shot). At the time of the report, URTICARIA (batch of hives that showed up about two weeks after the first shot) 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 linked to MOD-2021-230169 (Patient Link).
Rapid heart beat (over 120 while resting according to smart watch), shortness of breath, dizziness from 19Dec-20Dec. Heart rate still up but breath/dizziness is no longer a concern.
Pt states that she got her second Moderna vaccina on Friday, July 9. Said she got some soreness and sniffles right after and then got better. Last night, Monday night at around 0415 Tuesday morning, she woke up from sleep with "excruciating pain" in her upper left arm (injection site). Said it was very localized to the deltoid muscle. Took some ibuprofen and went back to sleep. Said pain is better now - 2/10 at rest and goes up to 6/10 with movement. Upon exam, left deltoid area is very tender to palpation.
Hives:  "Maculopapular wheals covering entire body".  Treated with prednisone 1 tablet PO daily for 5 days.  Referred to Allergist.
I did not have an adverse reaction to the vaccine. I did test positive for COVID-19 on 06/14/2022. My symptoms started on 06/13/2022 with a sore throat that was in the far back/nose area; sneezing multiply times in a row and coughing. Never had a fever. I had a telehealth visit with my doctor who prescribed me a z-pac antibiotic, steroids and zinc.
General malaise began around 9:15 PM. Fever and chills began around 10:30 and lasted through the night into Friday, 3/26/21 AM.
@ time of vax pt devel knot @ site;bruise noted a few days later;
Alopecia Areata - first noticed nickel sized new onset bald spot on 2/5, later realized there was another spot in the back of head as well
Booster; She woke up and could not move at all like she was dead; She took her blood pressure and first she had no pressure; She felt like she would pass out; She felt dizzy like she would pass out; Her left arm felt numb; Her lymph node under her arm was inflamed; This is a spontaneous report from a contactable registered nurse (patient).  A female patient of an unspecified age received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Oct2021 at 09:00, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient previously received the first and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, for COVID-19 immunisation. Nurse stated that she wanted report serious side effects after she received the booster shot from the hospital. On an unspecified date, in Oct2021, the patient felt dizzy, she felt like she would pass out, her left arm felt numb, her lymph node under her arm was inflamed, she woke up and could not move at all like she was dead. She took her blood pressure and first she had no pressure.   The adverse events were described as "patient woke up and could not move at all like she was dead. She went to the bathroom and felt like she would pass out. Stated that she wanted to call 911 and she put salt under tongue and drank a lot of water. Stated that she put her feet up on the sofa. Stated that she took her blood pressure and first she had no pressure. Stated that she drank more water. Stated that she felt dizzy like she would pass out. Stated that checked her pressure and it came up 77/33. No further details provided. Stated that her pressure today (22Oct2021) is in the 120s and yesterday it was in the 110s (21Oct2021). Stated that her lymph node under her arm was inflamed. Stated was in the left arm where she had the vaccine". Clinical outcome of the adverse events was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.