chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32).; 8 patients who received a dose from a vial that was stored refrigerated for more than 30 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32).) and PRODUCT STORAGE ERROR (8 patients who received a dose from a vial that was stored refrigerated for more than 30 days.) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32).) and PRODUCT STORAGE ERROR (8 patients who received a dose from a vial that was stored refrigerated for more than 30 days.). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)/Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32).) and PRODUCT STORAGE ERROR (8 patients who received a dose from a vial that was stored refrigerated for more than 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: F/U received on 04-OCT-2021 include dose administration information.
approx 4hr p/vax began screaming off & on & when asleep jumping as if something hurts;T99.7 ax & several loose bm w/dec appetite throughout day;pt seen in office 30OCT smiling again took 4oz of formula well & more active;
SHOULDER PAIN; MALAISE; HEADACHE; OUT OF BREATH; RED CHEEKS; FEELING COLD; CHILLS/SHIVERING; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, leaky valves, pacemaker, and latex allergy. The patient experienced drug allergy when treated with ibuprofen, levofloxacin, prednisone, tramadol, and tramadol hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180029,  expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma, alprazolam, amlodipine, apixaban, and flecainide. On 15-MAR-2021, the subject experienced feeling cold. On 15-MAR-2021, the subject experienced red cheeks. On 15-MAR-2021, the subject experienced chills/shivering. On 16-MAR-2021, the subject experienced out of breath. On 16-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced malaise, and shoulder pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Urine analysis (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, out of breath, shoulder pain, malaise, and red cheeks, and the outcome of chills/shivering and feeling cold was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Information has been received from a 66 year old female with a history of herpes zoster prior to 2005 and with no allergies who on 18-APR-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included vitamins (unspecified), omega-3 fish oil and 81 mg aspirin. On 29-APR-2007, 10 days after vaccination the patient had hair loss and most of her hair were lost over the next 2 months. At present her hair is "mostly gone with a few spots of fuzz". It was reported that the patient had her hair permed on 28-APR-2007 and the hair loss started on 29-APR-2007. The patient had picked up the vaccine and transported to the physician's office for administration. On 09-AUG-2007 the patient underwent thyroid stimulating hormone (TSH) test-normal, testosterone level test-elevated, mammogram-normal, CAT scan of the abdomen-normal and chest x-ray-normal. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Nausea, chills, coughing, sore throat, postnasal drip, aches and pain at injection site.
In item 4 I only listed my last difficulty, but I have had adverse eye issues after all 3 Moderna vaccines. Vaccine #1 was on 3/17/21. On 3/22/21 I developed severe iritis in my right eye. It went away with prescription drops. Vaccine #2 was on 4/14/21. On 4/25/21 I woke up and my left eye was crossed inward and I had double vision. MRI revealed no neurological problem and was inconclusive regarding my eye. Situation went away in one month. Booster shot #3 was on 11/19/21. On 12/2/21 I woke up with my right eye crossed inward and double vision. Then on 12/10/21 my near site in my left eye started to fail. MRI and CT scan show no physical problem and optic nerve looked normal. They have put me on steroids, but as of today neither eye is working properly.
Fever, 48 hours Frontal headache w/ severe pressure, 48 hours Nausea, 24 hours Hot flashes, 24 hours  Pain at injection site, 12 hours Body stiffness, 48 hours
I woke up around 2:00am with pain when I inhale.  It feels like pleurisy.  I can feel the pain in my lungs, upper back/shoulders and neck.  I have asbestosis so shortness of breath is always an issue.  The pain is not.  I am assuming it will pass in the next 24 hours or so.
got the COVID arm with a very big welt on her left arm; got the COVID arm with a very big welt on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (got the COVID arm with a very big welt on her left arm) and URTICARIA (got the COVID arm with a very big welt on her left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (got the COVID arm with a very big welt on her left arm) and URTICARIA (got the COVID arm with a very big welt on her left arm). At the time of the report, VACCINATION SITE REACTION (got the COVID arm with a very big welt on her left arm) and URTICARIA (got the COVID arm with a very big welt on her left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient did not use any treatment medication. It was reported that it started a week or 10 days after vaccination. The patient was due for her second shot on 16-Feb-2021.
pt recv vax 15DEC95 & 25DEC95 pt devel raised, red bumps on the body;the pt had not devel a fever;@ the time of the report, it was unk if the pt had recovered;No further details were provided;
Pt states that left arm is still  extremely sore and hurts to lift and sleep on (almost 6 months after receiving shot)
Pt was reported to be found dead the morning after vaccination. There is no clear association between vaccination and death, considering patient age and comorbidities. Medical examiner office informed clinic the next day
Itchy hives that come and go all over the entire body, some tightness in chest.  This started Monday 11/22 into Tuesday 11/23 overnight.
Intense nausea without vomiting, Intense chills for approximately 13 hours, with muscle aches in arm, neck and legs. Migraine (not headache) post injection starting 16 hours post inj. lasting 13 hours easing to minor headache until 2nd day. Low grade fever for 24 hours.  Extreme Fatigue for 32 hours post injection. Left eye blurriness intermittently starting on 2nd day and still ongoing. Injection arm pain, and lack of concentration. Fatigue intermittent on 2nd and 3rd day still ongoing.
Information has been received from a nurse concerning a "teenage" female who on 22-JAN-2008 was vaccinated with her first dose of Gardasil.  Subsequently the patient experienced dizziness, nausea and vomiting.  No other information was available.  The patient sought unspecified medical attention.
Approximately 10-15 minutes after vaccination I felt nauseous and hot, my body was shaking. My throat was tight and I had trouble breathing through my mouth. This lasted approximately an hour and the throat tightness persisted a few hours. Approximately 15 hours later I felt fatigued and had a headache and my arm was extremely painful. For the next 3 days after the shot my arm felt increasingly painful, and at the site of injection there was a swollen red lump that grew progressively larger and more painful.  On the 4th day after the shot I started taking over the counter benadryl and using an anti-itch cream. Following this, the swollen part of my arm stopped getting larger and I felt less fatigued. I got progressively less symptomatic the 3 days following that. Today is 7 days  post vaccination and my arm is still painful at the injection site and there is a quarter sized area that looks like a faint bruise. No other symptoms at this time.
Booster; I started to get chills and shake; this is uncontrollable for 2 hours uncontrol I mean I could not hold glass of water I was shaking so bad; I started to get chills and shake; this is uncontrollable for 2 hours uncontrol I mean I could not hold glass of water I was shaking so bad; My arm is too sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: LOSARTAN taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot# for second shot: Consumer stated, "EW0172", Date of second shot: 26Apr2021, AE=I got really nauseous), administration date: 26Apr2021, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "I got really nauseous", "low blood pressure"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION; Flu vaccine (I had a flu vaccine (Unspecified Vaccine). I think I have that 2 weeks prior to this vaccine.). The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "Booster"; CHILLS (non-serious), TREMOR (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I started to get chills and shake; this is uncontrollable for 2 hours uncontrol I mean I could not hold glass of water I was shaking so bad"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "My arm is too sore". The patient underwent the following laboratory tests and procedures: blood pressure measurement: low, notes: drop in blood pressure probably like 74 over 54. Therapeutic measures were taken as a result of tremor.  Additional information: Treatment for Adverse Event: Consumer stated, took like rice pack and warm them up in the microware so they could be like heat pack  put around  to help stop shaking. Consumer stated, had a flu vaccine (Unspecified Vaccine). think had at 2 week prior to this vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Minor!  After 9 days I developed a itchy, slight, red rash on arm approximately  2cm below injection site.  Size 5cm X 8cm.  I am only reporting this because the clinic gave us a card to use with a smart phone to report any different occurrence.  I do not have a smart phone so I am using this approach, in case you want this information.
Information has been received from a consumer on a news station reporting that her teenage daughter (age not reported) was vaccinated with GARDASIL in December 2007. Subsequently in February 2008, 2 months after receiving GARDASIL the patient developed an "autoimmune disease". The patient developed a rash on her face  and arms, leaving scars. She had swelling all over, pain in her joints and poor circulation in her fingertips. Her doctor says "she now suffers from an autoimmune disease and says it is possible the GARDASIL triggered her illness". The mother stated that her daughter had no prior illness or hospitalization. At the time of reporting the patient had not recovered. Upon internal review autoimmune disease was an other medical event. The reporter felt that the autoimmune disease was disabling. Additional information is not expected.  11/21/08 Reviewed PCP medical records o 12/12/07-10/01/2008. FINAL DX: SLE, mixed connective tissue disorder, anemia of chronic disease Records reveal patient in good general health 12/2007, sexually active but urine protein 300+ (H).  Started on Bactrim.  RTC 1/3/08 w/fatigue.  RTC 2/08 w/symetric nodular rash on arms & face x 1 wk w/mild itching & aches/pains x 6 mo.  Dermatology, Rheumatology, Nephro & GYN consult done & dx w/SLE (ANA+, rash & proteinuria). Tx w/steroids & plaquenil.  10/24/08 Reviewed rheumatology clinic records of 4/1/08 & hospital medical records of 7/23-7/25/2008.  No other records available. FINAL DX: mixed connective tissue disorder w/SLE  Records reveal patient had initially been seen in rheumatology clinic on 3/18/08 & dx w/SLE.  Tx w/steroids, plaquemil & ASA for rash & (+)ANA.  Improved by 4/1 visit w/only minimal pain in distal fingertips.  Had been seen by ophthalmology 3/22/08 & exam WNL.  Exam on 4/1 revealed slightly enlarged but nontender inguinal lymph nodes, hyperpigmented plaques on face, upper arms, axillae, vasculitic rash on palms, plinter hemorrhages in distal fingermails. Dx at that time: SLE w/discoid rash, elevated muscle enzymes & (+)ANA; splinter hemorrhages in fingernails.  Tx w/additional steroid cream to rash.    7/23-7/25/2008 Hospital admission. FINAL DX: mixed connective tissue disorder w/SLE w/acute flare up for high dose methylprednisolone therapy. Records reveal patient experienced facial swelling, difficulty walking, fatigue, bluish discoloration of index fingers.  Seen in rheumatology clinic 7/22 & admitted for high dose steroids. Improved & d/c to home on additional meds to f/u w/rheumatology clinic.   12/5/08 REviewed hospital medical records of 11/5-11/9/2008. FINAL DX: Exacerbation of lupus Records reveal patient experienced increased joint & muscle pain x 2 wks, difficulty standing, difficulty raising arms above shoulders.  Tx w/high dose IV steroids before returned to oral maintenance dose.  Also reviewed additional Rheum clinic medical records of 3/18-10/16/2008.  No new info identified.  12/12/08 Reviewed ER medical records of 7/27/2008. FINAL DX: knee pain; thrombocytopenia Records reveal patient experienced bilateral leg pain & progressive weakness x 1 day.  Tx w/steroids & IV antibiotics.  D/C to home w/rheum clinic f/u.
Her feet feels like they are swollen; Dizziness; Nausesation; weird feeling from her knees down. It is like a coldness, it feels like she has wet socks on. She feels it down to her ankles; weird feeling from her knees down. It is like a coldness, it feels like she has wet socks on. She feels it down to her ankles; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0173; Expiration Date: Aug2021), dose 1 via an unspecified route of administration, administered in Deltoid Right on 05May2021 around 2'clock or 3'clock  (57 years age at the time of vaccination) as dose 1, 0.3 mL single for COVID-19 immunisation at Other- Stadium. Medical history included ongoing Pseudo Tumor (Has a VP shut for this), Kewari-1 (Commented this is a congenital birth defect), ongoing Renal dysplasia (Commented she has a stent in her kidney for this), ongoing all her valves are leaking, Tethered spinal cord (Had surgery for this years ago). Concomitant medications included blood pressure pills and a water pill, but no additional details provided. Patient reported that after first dose patient has had a weird feeling from her knees down. It is like a coldness, it feels like patient has wet socks on. Patient felt it down to her ankles. Patient was wondering if patient should get the second dose on 26May2021. Weird Feeling from knees down: It started that night on 05May2021. Patient was having issues with her shoes. Patient feet felt like they are swollen. Patient mentioned she does takes a water pill and has a VP Shunt. Her shoes feel tight on her. It is like Patient was retaining water. Patient was having swollen ankles and her feet were swollen. When probed for outcome and if event was still ongoing patient stated it was coming and going. Patient also later added Patient was having dizziness. It was periodically. Clarified it started the next day, 06May2021 . When probed for outcome patient sated it was like patient gets period of it. It was like a little vertigo. It comes and goes. Patient later clarified and confirmed outcome as it was getting better. Nauseation started the following day, on 06May2021. Patient initially stated it was pretty much going away. Later clarified and confirmed it has gone away. Patient had a little bit yesterday, but now Patient has recovered completely. The outcome of event Dizziness was recovering, for Nausesation was recovered on 16May2021 and for all rest events was unknown.
swollen red spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen red spot on arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen red spot on arm). At the time of the report, VACCINATION SITE SWELLING (swollen red spot on arm) 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.
My father went to thr hospital for knee pain and was admitted to the ER same day saying he had COVID. He spent 4 days in ER and was then transferred to local ICU.  After a couple days he was released from ICU into a room in the hospital. At somepoint here, he was sedated by hospital staff because they said he was taking tubes out of his body and stuff. He never came too after be sedated, and was moved back to the ICU. Another few days passed with no one havimg a clue what was going on and finally MRI was conducted  MRIs by the doctor revealed 'numerous strokes in his brain.' He died on August 26, 2021
She had numbness in her temple for six months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "She had numbness in her temple for six months". Additional information: The receptionist at my dentist office knows that reporter work for Pfizer and told me after her vaccine. The Pfizer COVID vaccine on. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5 days ago received TDAP (L) upper arm. Now pt c/o pain, swelling, below site of injection. Tender superficial swelling not involving injection site.
This is a spontaneous report from a contactable physician communicated through a Pfizer sales representative. This physician reported for an adult patient (more than 50-year-old), race and sex unknown, who received PREVNAR 13 at 0.5 ml single dose on an unspecified date. Relevant medical history and relevant concomitant medications of the patient were unknown. It was reported that on an unknown date the patient had a local site reaction. Relevant laboratory tests were unknown. Therapeutic measures were unknown. Clinical outcome of the reported event was unknown at the time of the report.
The pt has a swollen, erythematous, right upper arm, urticaria, tenderness to the touch, warm with sloughing off of dermis and a superficial rash. No other symptoms. Seen by a physician and symptoms were treated accordingly.
Flushing, rapid hear rate,  high blood pressure, confusion, feeling of passing out, hot flashes from head to toe that would repeat in waves, rapid eye movement, excessive sweating, not able to carry conversation, waxy feeling on tongue when asked to eat something. Observed by ER nurse for 20-30 min prior to being taken to the ER. Heat waves continued for several hours after vaccine.
COVID-19; FATIGUE INCREASED; NAUSEA INCREASED; HEADACHE INCREASED; MUSCLE ACHE INCREASED; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, and anxiety, and other pre-existing medical conditions included: The patient was not pregnant and was not allergic to any drug at the time of this report. The patient is an other health professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 37 years old. Concomitant medications included bupropion, and escitalopram. On 13-JUL-2022 at 15:00, the patient experienced fatigue increased, nausea increased, headache increased, and muscle ache increased after treatment. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue increased, nausea increased, headache increased, and muscle ache increased and the outcome of covid-19 was not reported. This report was non-serious.
Patient was admitted 01/31/22 due to acute hypoxemic respiratory failure due to COVID-19. This is considered a breakthrough case
Client noted soreness the morning of 5/26/10 and by lunch the area was real swollen and sore. Had temp. 100.4 5/26/10 p.m. Reported diarrhea on Thursday and c/o headache. Had been putting ice on site but had not taken any fever or pain relievers. Client to take BENADRYL 50 mg every 6 hours and Ibuprofen every 6 hours or TYLENOL every 4 hours and will continue to use ice compresses. Talked with client 5/29/10 - states swelling and redness have decreased.