chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received first dose of Pfizer Covid 19 Vaccine in left deltoid. At the end of the 15 minute waiting period after the vaccine, the client complained of tingling in left arm. Client verbally referred to follow up with primary care provider.
Swollen lymph nodes, severe lymphadenopathy; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female 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 05Apr2021 at 10:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder and shellfish allergy. 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 amfetamine (AMPHETAMINE) for attention deficit disorder (ADD) from an unknown date and unknown if ongoing. Concomitant medications also included sertraline hydrochloride (ZOLOFT) and lamotrigine (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date and unknown if ongoing. On 05Apr2021 at 12:00, the patient experienced swollen lymph nodes, severe lymphadenopathy. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of the adverse event and included treatment with steroids and MOTRIN started from an unknown date. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab test for SARS-CoV-2 and the result was negative. The clinical outcome of the event swollen lymph nodes, severe lymphadenopathy was recovering 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.
Limited mobility and pain with movement of shoulder. Pain occurs with lifting arm up or forward, and less so with moving arm behind back. Mobility is limited with active movement only, not with passive. Weakness also but may be directly due to pain.
Patient received a 3rd Moderna Monovalent vaccine in error.  He had received the first two doses already on 10/4//2022 & 11/1/2022.
Sunlight sensitivity.  Was like having my eyes dilated.   Was extreme when I walked outside after receiving the shot, hut has lessened somewhat.  To date I still have the light sensitivity.  A different color to sunlight is noticeable.   Also I'm feeling heighten tension to surroundings like noise, making me somewhat anxious.  More so at times,  than other times.  I think this is related to weather (humidity, barometeric pressure, temperature) .  I've noticed on humid days when it's sunny, I just as soon lay low.  Was never like this before the shot.  -- I would also add that I have walked out of those building for the last 20 years and have never had a reaction to sunlight like what I experiences.  My two sons were with me at time and I noticed them squinting and covering their eyes.
Hives and rash about 2 hours after vaccination, patient prescribed BENADRYL by family physician. Hives and rash resolving by evening.
rash on upper thigh; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on upper thigh) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced RASH (rash on upper thigh). At the time of the report, RASH (rash on upper thigh) outcome was unknown.            Treatment Benadryl pills and cortisone cream.  Upon internal review on 24-May-2021, age was corrected to unknown.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non-significant information received on 24-MAY-2021. Reporter's contact details obtained
Day after shots patient started with flushed bright red cheeks. She does not have a fever. They come and go, sometimes just one cheek sometimes both. When red, they are hot to the touch. This has been going on for a week now.
Information has been received from a currently 62 year old female patient with allergy to penicillin referring to herself. The patient got hives and rashes easily. On an unknown date in 2012 (reported as "about 3 years ago"), the patient was vaccinated with ZOSTAVAX vial, 0.65 ml one shot (route was not provided). The patient had no concomitant medication. On an unknown date in 2015 (reported as "a few months ago"), the patient developed a mild itchy rash with no blisters on her body and she thought she maybe had a mild case of shingles because three were "bands" of the rash that appeared on her stomach. The patient saw the physician to seek medical attention. No lab diagnostic studies were performed. The patient was received steroid cream for the treatment of the event. At the time of the report, the patient did not recover from the event. Additional information has been requested.
RECEIVED FIRST DOSE OF PFIZER COVID VACCINE ON 02/21/21. WENT TO ICC ON 02/28/21 WITH COMPLAINT OF FEELING LIGHT HEADED AND HAD AN ELEVATED BLOOD PRESSURE.  INSTRUCTED TO GO TO ER.  WENT TO THE ER ON 02/28/21 AND BE EVALUATED CURRENTLY.
The pt experienced a hard mass at the site of injection, redness, blister-like, inflammation from shoulder to below elbow of affected arm. The pt complained of significant pain.
sz w/fever w/in 12hr of vax;sz grand mal approx 30 sec duration;past history febrile sz;
Continued Headache, dizziness, swollen lymph nodes, fatigue, chills, body aches
Follow up information has been received from a licensed practical nurse concerning a 74 year old male patient, with hypertension, hyperlipidemia, erectile dysfunction ("ED"), and unknown drug reactions/allergies who on 08-NOV-2005 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  It was also reported that the patient received a second dose of influenza virus vaccine (AVENTIS) intramuscularly in the right deltoid on the same day.  The patient stated "about 1 hour after she got home", on 08-NOV-2005, 'the area became red swollen, hot to touch".  There was no illness at the time of vaccination.  It was reported that the patient either presented to the office or called the office to report the adverse events.  The treatment was a warm compress and follow up call to the physician if needed.  Outcome was reported as unknown.  No product quality complaint was involved.  Additional information is not expected.
80 year old female presents today with allergic reaction to Pneumovax 23.  She was given the vaccine on Friday at appt. She got her Pneumovax 23 in right deltoid and Flu vaccine in left deltoid.  She stated," Saturday she noticed her right arm starting with redness and swelling." She could hardly lift her arm. Examined right arm upper arm around injection site. No redness or swelling noted. There is Redness, swelling and warm to forearm down to her wrist. She also presents with a fine, red rash on her arms, neck, and trunk area. No rash on abdomen or legs. She denies any itching.  Dr examined arm and rash . He agrees it an allergic reaction to Pneumovax 23. Talked about starting her on a steroid pack but afraid it would cause more harm than just using OTC anti-histamines, cool wrap to arm and elevation. Patient and daughter agrees with Dr orders.  Instructed daughter to call if no signs of improvement. She and patient verbalized understanding.  Called director at Health Department and reported reaction. Also called Infection Disease. Completed reaction on care zone  and completed Vaccine Adverse Event Reporting System (VAERS) online .
This is a 38 yo M, admitted on 8/9 with sepsis (febrile to 39.5, leukoctosis, LA >2 and hypotensive), initially testing neg for covid, but then did test positive 8/11.  The patient reported he completed a course of COVID-19 vaccinations in 06/2021.  During hospitalization in our ICU, the patient completed remdesivir and  dexamethasone which resolved his acute hypoxemic respiratory failure over time.  Furthermore, the patient was suspected to suffer from superimposed bacterial pneumonia and completed antibiotic therapy.  He had AKI with metabolic acidosis (likely due to renal failure and lactic acidosis), and required bicarbonate IV in addition to aggressive IV fluid resuscitation.  Furthermore, was noted to suffer from elevated d dimer and elevated BNP, but fortunately CTA showed no PE.  Echocardiogram showed preserved LVEF 50%, but did show signs of RV systolic dysfunction. His hospital course was further complicated by elevation in LFTs, which normalized, and hyponatremia as low as 129, which also resolved.
R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is a spontaneous report from a contactable Physician (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL6142), via an unspecified route of administration on 07Jan2021 14:45 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included hypothyroidism, hx of Hodgkins from 1994, breast cancer from 2005. Concomitant drug included levothyroxine sodium (SYNTHROID). The known allergies included Bactrim, bacitracin, non-ionic contrast. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Right arm pain - at site of injection, significant nausea, headache, body aches and chills. fatigue on 07Jan2021 20:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
then two positive tests 21Feb with slight dry throat; then two positive tests 21Feb with slight dry throat; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FF2589) at the age of 58 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Feb2022, outcome "unknown" and all described as "then two positive tests 21Feb with slight dry throat".The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) positive; (21Feb2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with covid prior to vaccination. The patient had been tested for Covid-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported LOE events and the suspect drug BNT162B2 cannot be excluded.
The patient received improperly stored dose; No additional adverse effect reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 19-JUN-2020, the patient was vaccinated an improperly stored dose of with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S023646, expiration date 31-MAR-2022, unspecified route (strength, dose, anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature above 47 degrees fahrenheit/9 degrees celsius (9.15 C) during 15 minutes. There was a previous temperature excursion above 47 degrees fahrenheit/9 degrees celsius (8.62 C) during 11 minutes. It was reported that digital data logger was involved. No adverse effects were reported.
Narrative: COVID infection following COVID vaccine series 01/19, Pfizer, dose #1 02/11, Pfizer, dose #2 02/11 CXR impression: Retrocardiac pneumonia has resolved. 08/22 pt cc: cough, diarrhea, rhinorrhea, sore throat exposure; unknown 08/23 COVID swab, result: detected
02/23/2023:   At 1:55am resident was found unresponsive, no respirations noted, unable to revive.
Patient complained of itching on left cheek.  Given 25 mg Benadryl and juice itching resolved after 10 minutes
4.21.2021- I spoke with (patient's husband) related to spouse. Husband stated the patient has a history of 2nd Degree Type 2 heart block, pacemaker placed at the age of 14, and she currently has issues with an eating disorder dx with anorexia. Patient is reported to be approximately 68-70 pounds at the time of vaccination. March 8.2021-  Husband states he and his wife came to receive the vaccine around 1630. After, receiving the vaccine the patient stated to her Husband "my arm really hurts." She begin experiencing s/s at approximately 1900 including: fever, chills, runny nose, fatigued and tired - reportedly temperature was 100.0 and the patient began to drink Gatorade and take Tylenol. Monday, 3.15.2021 patient continued to have symptoms therefore, (husband) contacted Moderna Representatives from the safety team, to determine if it would be safe for the patient to get the 2nd vaccine dose - advised everyone that does not have contraindications should be vaccinated-advised to reach out to PCP. Husband stated that the patient did not want to go to her PCP because of her eating disorder. The patient worked from bed during the week per the husband and spent 90-95% of her time in the bed after receiving the vaccine. Husband states on Saturday 3.20.2021 the patients fever had subsided however, she continued to feel poorly and remained bedbound most of the time. Husband is an Pilot 3.23.2021 stated once, he had landed he began trying to contact wife but she was not answering the phone, after several attempts to contact wife - Husband called a neighbor to check on wife. Upon, entering the residence the neighbor found wife lying on the floor unconscious and not breathing. The neighbor notified Husband and called 911. EMS arrived at the scene and pronounced the patient as a DOA. Husband states that the death certification list cardiac arrest, electrolyte imbalance, and heart block, as causes for death. Husband is concerned that the vaccine may have contributed in some way demise of his wife as he stated "she was never the same after the vaccination."
Pt recvd vax JAN89 & on 30JAN89 pt was ill; 01FEB89 had fever taken to ER; signs of ear infect & resp problems was sx w/pneumonia; Pt was treated on 116FEB89 infect resolved; later pt not responding to voice;lost equilibrium & speech abilit
Myalgia, Fever, fatigue Narrative:  Per nursing report: " took 2nd dose of Moderna yesterday about 8:15 am yesterday. C/o aches,chills,left arm soreness, diarrhea and  temp of 103.3 this morning. "
PASSED  CAPSULE IN STOOL; This spontaneous case report was received from an other healthcare professional (PVX2019-374) on 08-Feb-2018. The report describes a 34-year-old adult male consumer who "passed capsule in stool". The consumer was receiving Vivotif capsule (lot number: 3003215 and expiry date: 29-Apr-2019) for an unknown indication.  It was reported that the consumer was taking Vivotif. He passed a whole capsule when he went to the restroom.  The action taken with Vivotif with respect to the event "passed capsule in stool" was not applicable.  The clinical outcome of the event "passed capsule in stool" was unknown.  Company's Comment: In this case a 34-year-old adult male consumer "passed capsule in stool" following intake of Vivotif. The causality of the event "passed capsule in stool" was considered as not applicable.; Sender's Comments: Company's Comment: In this case a 34-year-old adult male consumer "passed capsule in stool" following intake of Vivotif. The causality of the event "passed capsule in stool" was considered as not applicable.
Information has been received from a physician concerning a 17 year old female who on 10-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 657006/0188U) injection. On 12-MAR-2007 after vaccination with a second dose of Gardasil (lot # unknown). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). Subsequently the patient experienced flat rashes on both her arms and chest after going out into the sun. Medical attention was sought. On an unspecified date the patient had recovered. The mother of the patient mentioned that she took the patient to a travel clinic for an unrelated cause and was told by a nurse there that patient's receiving the Gardasil vaccination should not have sun exposure for 24 hours. The patient did not have such a reaction after her first dose 10-JAN-2007. On 25-JUL-2007 the patient received her third dose of Gardasil. No additional information was provided. Additional information has been requested.
After 7 days, redness at injection site, possible cellulitis (not confirmed), warm to touch, itchy, rash on body and pimples on face, sleepy, fatigue.
This case meets vaccine breakthrough criteria .  SXS INCLUDE COUGH, GENERALIZED WEAKNESS, BODY ACHES, FEVER
Hives all over my entire body appeared, the allergic reaction went away after taking anti histamine pills but serious allergic reaction returned next day, took more medication but reaction returned causing me to black out, I  completely lost control of my bodily fluids, was taken to the emergency room on Dec. 20th 2021 1am.
08/21/21    - I started itching and hurting bad. I thought I was having a sciatic nerve attack.  It was across that nerve below my waste in your back, went down your legs and wrapped around from my thigh to my hip and back around the front and down the right leg.  The next day or two, I broke out in a rash. In another day or two, I had small blisters that hurt.  I saw my doctor on 8/23/21.  She prescribed pain pills.  I began taking the pain pills that day which helped with the pain. The rash lasted a couple of weeks.  The pain lasted a couple of months. Then the sensitivity, as in touching and pressing, was very sensitive until the end of the year or first of 2022.   I have recovered from the shingles.
After being given the Hep A vaccine, the client was seated for approximately 10 minutes. He got up and walked over to where the nurse was administering vaccines to his older brother and suddenly fainted into the nurse's lap. We layed him down and he immediately woke up. His BP 100/80 Pulse 80/regular and respirations 18 nonlabored. His color was normal, skin cool and dry. He remained in our clinic for 45 minutes. He said he was still a little dizzy so we advised the mother to keep him home from school for today.
Pt. was given VARICELLA vaccine 1 week prior to 12 mos. birthday.
Face is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: SWELLING FACE (non-serious) with onset 21Nov2021, outcome "unknown", described as "Face is swollen". Therapeutic measures were taken as a result of swelling face.  Additional information: Reporter stated that the patient (daughter) got a shot yesterday, she is 9-year-old and her face is swollen today. Reporter stated that patient received some Tylenol yesterday and Benadryl in case of allergic reaction before she went to bed. So, Benadryl, single tablet 25 mg and 500 mg Tylenol in case if she got like fever to it." (further clarification unknown if patient was experiencing allergic reaction and fever, hence allergic reaction and fever not captured as events).  Follow-up attempts completed. No further information is expected.
As patient was waiting in waiting area approximately 5 minutes after receiving her 1st COVID vaccine, pt's friend called pharmacist over as patient felt she was about to faint. She had her eyes closed and said she felt faint. Notified incident command to call for provider. We moved her to an exam room so she could lie down. She said she felt warm and dizzy. Pt breathing heavily. Denied chest pain. Had stomach pain and some nausea. Pt was given water. ER provider arrived about 4:30 and listened to lungs, carotids, talked to patient regarding vasovagal reaction. Pt slowly began to feel better and was talking and laughing. Waited with patient until 4:50, able to stand on own, not dizzy anymore, felt okay to leave.
Patient states they experienced an upset stomach, nausea, and dizziness about 30 minutes after receiving the first dose of the Moderna COVID-19 Vaccination. Patient does not have any history with reactions to vaccinations in the past. Patient was offered water and had blood pressure readings done twice, 5 minutes apart, with readings of 154/108 mmHg, heart rate 105 and 151/105 mmHg, heart rate 104. Patient needed additional transportation from parents to safely arrive home. Continued to observe patient for more than one hour.
Approx 10 min p/vax, 4cm red area noted to arm around inject site; approx 1/2 cm raised, white, firm area noted just under inject site; applied ice to site & gave 1/2 tsp of DPH; p/20 min redness to site dec; white raised area remained;
Developed an Acute nonoocclusive DVT in left leg 10 days after my first vaccine.  Decided to decline my second vaccine.  I do have a history of having blood clots, but last one was 32 years ago.
Information has been received from a pharmacist concerning an adult patient how on 12-JAN-2010 was vaccinated intramuscularly with 2 doses of adult formulation (1 mL) RECOMBIVAX HB (LOT# not reported). No adverse effect was reported. No further information is available at this time of the reporting. Follow-up information has been received which reported that the 44 year old male patient with an illness of hepatitis C at time of vaccination who on 12-JAN-2010 at 16:01 PM was vaccinated intramuscularly with 2 doses of adult formulation RECOMBIVAX HB (1 mL per dose, one on left deltoid (LOT# 660951/0398X) and another dose on right deltoid (LOT# 660951/0398X)). It was reported that in 12-JAN-2010 at 10:00 PM, the patient experienced flu-like symptoms. The patient's outcome was unknown at this time of reporting. Follow-up information has been received which reported that the patient got the RECOMBIVAX HB (unspecified) on each arm rather than a RECOMBIVAX HB (unspecified) and hepatitis A virus vaccine (unspecified). The patient possible experienced flu-like symptoms. The patient's outcome was unknown at this time of reporting. No further information is available.
Patient report red rash on extremities and trunk that comes and goes since administration on 6/5/13. Rash is blotchy and itchy. Immediately after injection (L) arm became swollen; treated w/antihistamine 6/24/13. Patient seen at health center treated w/prednisone.