chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient approached the pharmacist on 7/18/18 and informed pharmacist of side effects she has been experiencing since receiving the second SHINGRIX dose on 7/5/18. Side effects reported were soreness and swelling at injection site as well as hot to touch. Patient declined any fever and injection site did not appear red to pharmacist. Site felt slightly warm to touch. Pharmacist advised patient that these were normal expected side effects and to contact her primary care provider if they did not show improvement after 3 days or do not respond to ice or analgesics. Patient reported that there was improvement since the vaccination in these symptoms. Patient also reported blurry vision occasionally and eye irritation that started coincidentally after the vaccination. Patient declined any other factors that may be contributing to these eye issues such as allergies. Patients eyes did appear red and irritated to pharmacist. Pharmacist informed patient there is no listed side effect involving the eyes from SHINGRIX and referred patient to have her assessed by a provider to determine cause of blurred vision/eye irritation. Patient visited a walk-in clinic 7/8/18 and the provider there advised patient to wait a few more days to see if any improvement and to follow up with primary care provider.
Started having vertigo early morning of 3/23. Got up to walk to the bathroom and needed to hold onto the walls as my balance was   way off. This has continued since then off and on. Seems to be better in the PM and almost gone but when I sleep it comes back every morning. It occurs mostly when walking but if I move my head too quickly when sitting I will also get dizzy. I did go to the UCC on 3/25 and was dx with benign [paroxysmal vertigo and mild right ear infection. I do have nystagmus when I tilt my head to the right at times. I have been taking Meclizine 25mg q8hrs and Doxycycline q12hrs but with only minimla change in the dizziness. I did see online other report also having dizziness after the vaccine so wanted to send in this report.
Fluid-filled blister at the site, Hot to the touch. The reaction wasn't noticed until the next afternoon when my daughter removed her bandaid from the shot location. I gave her Benadryl for the reaction 27 hours after the shot was given, as instructed by our local Pharmacist..
first dose caused flareup from my autoimmune disease; A spontaneous report was received from a consumer concerning a female patient, who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced first dose caused flareup from my autoimmune disease  As provided by the reporter ,The patient does not have medical history.  On 23 FEB 2021,the patient received her first  planned dose of mRNA-1273 intramuscularly in arm for prophylaxis of COVID-19 infection.   On 23 FEB 2021, after receiving mRNA-1273, the patient experienced first dose caused flareup from my autoimmune disease  23Mar2021. This patient reports having an autoimmune disease. She is calling because she believes the first dose of the vaccine caused an autoimmune disease flare up. Concerned because she believes she might still be having a flare up by the time its due for her second dose next week. Wants to know if she should postpone her appointment until the flareup is gone and is there a limit for how long it is able to be from the first dose.  Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient was treated with Benadryl 50mg liquid at 2:50 pm for dizziness and throat sensation described as trouble swallowing or feeling the need to swallow twice.  BP, HR, O2sats, and temp all wnl.  She did start to complain of more throat pain and described a history of anaphylaxis in the past with the same feeling in her throat; therefore I administered 0.3 mg epinephrine per auto-injector at 3pm and called 911.  Vital signs remained stable including O2 levels, EMS arrived at 3:20 pm, she was starting to feel ill again, they took her to the ER.
Day of the event: lower back started aching within a couple hours, worsened by the hour so I had to take my laptop to bed by afternoon and stayed there all night.  Next morning, bent down to pick something up and threw my back out entirely, dropped me to the floor and it's never been the same since.   3 weeks after the injection, I started waking up to swollen lips periodically for 2 weeks.
body aches; running a fever; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration on 03Jan2021 at 12:30 at a single dose as a Covid vaccine. Medical history included bariatric surgery three months ago. He used to have high blood pressure, but after the surgery his blood pressure went away. Concomitant medications included multivitamins and calcium to keep himself healthy. On 04Jan2021, the patient was running a fever which started at 10:30 AM and he was concerned about going to work with the fever. He also had body aches on an unspecified date, but that could be because he went hiking for three days in a row. He told his boss, but said it could be because he went hiking. The patient clarified that he works from home and at the clinic. He didn't know if he should go. He was asking if it's ok to go to work. He was taking his temperature with two different things. It was reported that his temperature was 99.7 degrees Fahrenheit. Outcome of the events was unknown.
Moderna vaccine was administered to a 16 year old in error.  This was missed in our screening process.  There were no adverse events.  Reporting because this administration did not meet the EUA requirements.  We will also follow-up with the agency for guidance on administration of 2nd vaccine.
Client began to lean forward in the chair after receiving the HPV Vaccine. He had previously had 5 other injection and a TB test. Serial vitals taken, Oxygen applied per mask, ammonia per nares when no immediate response to O2. Given crackers & water. Had not eaten any breakfast. After return to conscious state assisted to lie down & rest in exam room. Nurse & family remained at his side. He reported he was feeling better. Some numbness in fingers remained. Assisted to a chair as he progressively aroused. MMR Vaccine held. Info sent to school nurse to expalin why it was not given as requested.
1 minute after vaccine injection I experienced a tightening of my throat.  It was very uncomfortable and made it difficult to swallow  and felt like a "lump in my throat".  I asked an onsite nurse if this was a common reaction, and she offered medical attention.  I denied it because it was not getting worse.  She gave me a bottle of water and it seemed to help it a bit while drinking.  But, quickly returned after water was swallowed.  I was monitored for 30 minutes as recommended.  The tightness remained for 1 hour post vaccine injection and disappeared as quickly as it started.  I fear the second dose may be worse.
Dry mouth; Fatigue; Sore arm; This is a spontaneous report from a contactable consumer. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Prior to the 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 glipizide, metformin (GLIPIZIDE; METFORMIN) 5mg/500mg taken for an unknown indication from an unknown date and unknown if ongoing. On 08Mar2021, the patient experienced dry mouth, fatigue and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 dry mouth, fatigue and sore arm was resolved on an unknown date in Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Headache( back of head, base of neck and eyes) Nausea (resolved) lack of appetite (resolved)
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown date, the patient was vaccinated with the improperly stored dose of PROQUAD lot #: L024125, expiration date on 30-DEC-2016 (route, dose, and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 22.1 degrees Celsius for 16 hours. Data logger was involved. There was no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Several weeks after receiving the second injection all the skin on my hands started cracking (bleeding in some locations) and then the skin started peeling off. I could literally grab sections of skin and peel it off in sections. That lasted for several weeks to a month and then the hands started to heal and it started on my feet, again with bleeding and sore cuts and then the cracked skin started peeling off. I didn't take photos of my hands but I have photos of what was happening to my feet. My wife was afraid it was some contagious disease. I'm in good health, 73 years old at the time, and have never had that condition happen before. It was quite concerning. Item 20 below asks if I've fully recovered. The hands have completely "healed" and the feet for the most part with a lot dryness and the split skin cuts still healing.
Stomach pains; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Jun2021 at 13:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to citrus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jun2021, the patient experienced stomach pains and vomiting and the patient could not keep anything down. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or 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 stomach pains and vomiting was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Raised 7cm x 4cm welt over injection site. Localized, tender to touch.
2"area of induration & erythema 2 days after receiving varicella vaccine. August 11, 2008 date given.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 17-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Information has been received from a consumer concerning her daughter who on 09-JUN-2010 was vaccinated with a first dose of GARDASIL (lot number not provided). On 09-JUN-2010 the patient went unconscious and had a seizure. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Upon internal review seizure was considered to be an other important medical event. No further information is available.
On 10/21/2020 @ 3:00pm, patient presented to clinic to have TB test read and informed me that she was having with redness and swollen and  warm to the touch areas at injection sites on both arms. TB test was red but not raised and was negative for TB after  I went and asked Dr. to view patient's arms and  her judgement was to  have Dr. verify reaction sites.  Dr. examined patient and documented  "Patient with large allergic wheal at injection site bilaterally No purulence Some warmth Patient reports metal allergy -- has to use gold or silver only, otherwise skin breakdown Suspect allergic reaction to needle from injection, as patient received multiple injections (Flu R Deltoid, MMR/V in L SQ) and reaction the same bilaterally Patient cannot tolerate benadryl due to over sedation. Topical Triamcinolone 0.1% applied to wheals. Patient reported improvement Rx Topical Triamcinolone 0.1% sent to pharmacy of choice. Patient instructed to contact office if wheal expands or no improvement of symptoms by Friday."
Information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history and no drug reactions/allergies who on 16-FEB-2008 was vaccinated with the first dose of GARDASIL, on 14-APR-2008 was vaccinated with the second dose of GARDASIL, and on 23-SEP-2008, the patient was vaccinated with the third dose of GARDASIL into her left deltoid (Lot# 659968/0847X). There was not concomitant medication. On 24-SEP-2008, the patient developed severe pain radiating from the injection site (left deltoid) up into her neck. The patient's severe pain radiating from the injection site (left deltoid) up into neck persisted. It was reported that the patient sought medical attention: phone call. Additional information has been requested.
The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 14Feb2019 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician received via a sales representative. The physician reported similar event for 2 patients. This is the 2nd of 2 reports. A 17-year-old female patient received TRUMENBA, lot number and expiration date was not provided, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu like symptoms on an unspecified date. The outcome of the event was unknown. Information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2019080948 Same reporter/product, similar event, different patient.
Vaccine may have been stored under conditions that departed from the manufacturer's recommended specifications. Rite Aid consulted with the vaccine manufacturer regarding this issue.  In such a circumstance, the manufacturer deems the vaccine not to be viable.  Additionally, the CDC recommends that patient repeat 1 dose of the same COVID-19 vaccine immediately (no minimum interval). Patient may not have received the full benefits of the vaccine. The additional dose is provided at no cost. Patient will think about it and will call back when she can return to get additional dose.
Fever; body chills; swelling at injection site; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Jun2021 at 18:00 (age at the time of vaccination was 13-year-old), as dose number unknown, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. 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 concomitant medications within two weeks of COVID vaccine. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 03Jun2021 at 12:00, the patient experienced fever, body chills and swelling at injection site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body chills and swelling at injection site were not recovered at the time of this report.  Follow-up attempts completed. lot/batch number has been requested.
After my first covid vaccine dose, I had a heavy period lasting 3 weeks. After my second dose, I spotted lightly and then lost my period completely for 3 months. Since receiving this vaccine, I've had only 2 periods in the 7 months since vaccination.
The patient developed a painful brachial neuritis (Parsonage Turner syndrome) in the left arm three days after administration of Tdap in the left deltoid.  Slight improvement to date on prednisone therapy; ultimate recovery unknown.
Pfizer vaccine was administered without being diluted. Tried to notify mother on 9/30/2022, no answer, Left message to call me back. Tried to call again 10/3/2022 0800, Left message to call back. 11:30 am Mom called back, states that child was fine all weekend, no side effects at all. Did very well with vaccinations.
Diarrhea; Arm looks like it has cellulitis; Moderna arm ( swollen , itchy and warm to the touch); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), INJECTION SITE CELLULITIS (Arm looks like it has cellulitis) and INJECTION SITE HYPERSENSITIVITY (Moderna arm ( swollen , itchy and warm to the touch)) in an 82-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), INJECTION SITE CELLULITIS (Arm looks like it has cellulitis) and INJECTION SITE HYPERSENSITIVITY (Moderna arm ( swollen , itchy and warm to the touch)). At the time of the report, DIARRHOEA (Diarrhea), INJECTION SITE CELLULITIS (Arm looks like it has cellulitis) and INJECTION SITE HYPERSENSITIVITY (Moderna arm ( swollen , itchy and warm to the touch)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Awakened at 9AM 4/15/05 with swollen cheeks (face) and eyelids. T:99.3. Cheeks flushed and warm. No erythema, itchiness or rash. No swelling of mucous membranes. Given 50mg PO Benadryl with improvement. Placed on Medrol dose pak with resolution of symptoms. Injection site of Td also swollen.
Felt immediate headache, followed by extreme exhaustion, fatigue, body aches (the same day as the 2nd dose) within about 10 minutes after it; and for the next two days. Felt better by 02/14/2021. Began feeling ill again on 02/17/2021, body aches, extreme fatigue, feeling very hot but not having a fever, nausea. It seemed to get better on about 02/21/2021, but then on 02/22/2021, all of the same feelings and symptoms came back and are still present today. I have reached out to my primary doctor to let him know and he suggested that I submit this information here as well.
bilateral PEs with extensive right LE DVTs. Pt's brother had the same and died from his clots 10 days after receiving his Pfizer vaccine.
A few days after the 1st shot i noticed my lymph nodes were swollen under my left arm pit as well as a few swollen lymph nodes along and around my collar bone on the left side.  As of today, the day i got my second shot the lymph nodes are still swollen. They are smaller than 3 weeks ago but still large.  I had extreme exhaustion as well as brain fog for about 3 weeks
plantar fasciitis on the left foot [after second dose]; bad heel pain; This spontaneous case was reported by a consumer and describes the occurrence of PLANTAR FASCIITIS (plantar fasciitis on the left foot [after second dose]) and PAIN IN EXTREMITY (bad heel pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PLANTAR FASCIITIS (plantar fasciitis on the left foot [after second dose]) and PAIN IN EXTREMITY (bad heel pain). At the time of the report, PLANTAR FASCIITIS (plantar fasciitis on the left foot [after second dose]) and PAIN IN EXTREMITY (bad heel pain) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to  (Patient Link).
Case number PHEH2014US001741, is an initial spontaneous report received from the medical assistant on 22 Jan 2014 with a follow up information received on 07 Feb 2014. This report refers to a 10-year-old male patient. His medical history and concomitant medications were not reported. His general health condition was good with normal social life. He was vaccinated with MENVEO (batch number: M13051) intramuscularly on 20 Jan 2014 at 11:33 AM. Two minutes after the vaccination, he experienced stomach pain. Shortly after that, he fainted in the arms of the nurse and remained unresponsive for 10 minutes. His vital signs appeared slightly lower than normal. Blood pressure was 80/50 mmHg and pulse was 58 at 11:55 am. On the same day, at 12:42 pm his blood pressure was normal with a value of 104/68, pulse rate was normal with a value of 88 beats per minute, body temperature was normal with a value of 36.9 degree Celsius and BMI was 15.1 (normal). His constitutional status and other examinations of eyes, ears, neck, respiratory, cardiovascular, gastrointestinal, genitourinary, musculoskeletal and skin were normal. He was given oxygen and he regained consciousness. The patient recovered and was discharged in a stable condition. The seriousness and causality of the events were not reported. Follow up information received from medical assistant on 07 Feb 2014: updated few examinations (pressure, pulse rate, body temperature, BMI) and general health condition (healthy).