chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea and vomiting; nausea and vomiting; couldn't stand up; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0105), dose 1 via an unspecified route of administration, administered in right arm on 12May2021 as single dose to prevent the Covid 19 virus. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0217), dose 2 via an unspecified route of administration, administered in left arm on 02Jun2021 as single dose to prevent the Covid 19 virus. Patients medical history was not reported. Concomitant medication included vitamins from an unspecific date to an unspecified date. No additional vaccines administered on same date of the Pfizer Suspect. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations was not available. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not have any illness at the time of vaccination. No AEs following prior vaccinations. Additional Vaccines administered on same date of the Pfizer suspect was reported as none. After receiving the first dose of the COVID-19 vaccine two weeks passed and then patient started having nausea and could not stand up because patient threw up everything patient had eaten on an unknown date in 2021. She received the first dose of the Covid 19 vaccine last month and two weeks passed and she started having nausea and vomiting, she could not stand up because she threw up everything she had eaten on an unspecified date. She stated she has had nausea for the past 2 or 3 days and yesterday it was very strong. Patient stated she wanted to know if she could take Pepto Bismol for nausea after the vaccine as she already took it. She asked if after two weeks it was possible to still have side effects, and asked if she could start taking her vitamins and drinking alcohol again. Investigation Assessment was reported as no. Right now, about two weeks had passed since she received the second Covid 19 vaccine. Exactly two weeks and she was feeling a lot of nausea and she felt like she wanted to throw up. She had not thrown up but she had taken Pepto Bismol. She was asking if it was ok to take Pepto Bismol. She was asking if this is related to the Covid 19 vaccine. She also had itchiness around her whole body especially her back. She had avoided all tests and medications except for the Pepto Bismol that she took yesterday, 15Jun2021. Adverse events (AEs) did not require a visit to: Emergency Room, Physician Office. Relevant Tests was reported as none. Therapeutic measures were taken as a result of nausea and vomiting. The outcome of the events was unknown.
Shortness of breath.  Heart palpitations.  Swelling in feet.  Exercise intolerance.  Resolved in a couple of weeks.
This spontaneous report as received from a physician, as part of a marketing research program, refers to 30 patients of unknown gender, aged between 11 to 22 years old, who were enrolled the program. The patients had no pertinent medical history. On unknown dates the patients were vaccinated with GARDASIL 9 (dose, route and lot # not reported). There was no concomitant medication. The patients complained of burning at injection site (onset dates unspecified). No tests were carried out for diagnosis. The event did not prevent the administration of the second and third dose. The outcome of the event was reported as recovering. The physician considered the event to be related to GARDASIL 9. Additional information is not expected because the physician was not willing to be contacted.
This spontaneous report as received from a physician refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. On 09-DEC-2013, the patient was vaccinated with a first dose of GARDASIL lot # J013777, expiry date 11-AUG-2016 (dose and route were not reported). On 15-MAY-2014, the patient was vaccinated with a second dose of GARDASIL lot # J013777, expiry date 11-AUG-2016 (dose and route were not reported). The reporter stated that the patient developed postural orthostatic tachycardia syndrome after receiving GARDASIL (exact date not provided). The outcome of the patient developed postural orthostatic tachycardia syndrome was reported as not recovered. Relatedness between the therapy with GARDASIL and the event: postural orthostatic tachycardia syndrome was not reported. Additional information has been requested.
Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches
High fever up to 103, severe headache, antibiotics iv, antibiotics for 7 days.  Tired for 5 additional days. After 48 hours fever had gone, headache was gone.
Swollen lymph node, neck and underarm, in varying sizes; Painful lymph nodes, under arm and neck, lymphadenopathy; Ridiculously tired, exhausted; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: ER8737, expiration date: unknown), dose 1 via an unspecified route of administration in Arm Left on 31Mar2021 at 13:30 as 1ST DOSE, SINGLE; dose 2 via an unspecified route of administration in Arm Right on 28Apr2021 at 13:30 (Lot Number: EW0171) as 2ND DOSE, SINGLE (at the age of 37-years-old) for COVID-19 immunization. Medical history included ongoing smoker (patient stated probably started smoking 10 years ago and describes himself as a mild smoker, clarified as less than a half of pack or so, a day). The patient's concomitant medications were not reported. Patient had no prior vaccination and had no AE following prior vaccinations. Patient had no family history. On 23Apr2021 at 17:00, 2.5 to 3 weeks later, after first dose the patient experienced swollen lymph node, neck and underarm, in varying sizes; painful lymph nodes, under arm and neck, lymphadenopathy and patient was Ridiculously tired, exhausted. Patient reported that he had a lymph node on his neck that was the size of an egg and a cluster, more prominent and was getting larger; lymph node in his armpit was about an inch by an inch, he had a node off to the side of a larger node, that was the size of a nickel, and appeared similar to a marble under his skin. Patient stated that in first week he slept a lot, but then the tiredness may be lessened and still exhausted and takes a random nap. Painful nodes have worsened until 26Apr2021. Caller stated that he had seen multiple doctors, including an Urgent Care, and his sister is a doctor. He went to an ear, nose and throat doctor last week and the doctor was scheduling him for a biopsy of the lymph node, and it was assumed that this was a side effect of the vaccine. Patient went to the emergency room on 28Apr2021 for swollen and painful lymph nodes. Events continued after his second vaccine, on 28Apr2021. The patient underwent lab tests and procedures which included computerised tomogram on 29Apr2021: The largest lymph node, measuring 2.3cm by 3.1 cm. Patient also had blood work. Therapeutic measures were taken as a result of painful lymph nodes, under arm and neck, lymphadenopathy with Advil and Tylenol have been effective, but he can tell when the medication is wearing off, and it was time for the next dose. The outcome of Fatigue was unknown and other events were not recovered.  Follow up needed, further information has been requested.
Pain in arm since 30 minutes after shot At 11:30 AM- (15 hours post shot), feverish, on/off aches  At 9:30 PM- 25 hours later- chills shakes, migraine
Narrative: Mr is a 76yo male with a PMH significant for HTN, GERD,  PTSD who called PCP with complaints of hand tremor and "pounding" of heart which he states began 2-3 days after receiving his second dose of COVID-19 vaccine on 4/9 and has persisted. PCP recommends neuro follow up along with Holter monitor and Echo. The issue is likely not secondary to COVID-19 vaccine, per PCP.
Case number PHEH2015US000666 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 79-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 22 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen instead thought it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
On 06/30/2001 the patient was seen in the ER. The patient had fallen from the couch to the floor, was irritable, and would not bare weight on the left leg. On 06/30/2001 the patient developed erythema in an area 7.2 x 4.5.
(L) Thigh swelled within hrs of receiving MMR (SQ) and DTaP (IM) on 09Feb09. No erythema. Swelling approx 1 in greater than R leg. Non-painful but tense. Slightly warmer than (R) leg. BENADRYL 6.25 mg PO given for itching @ site of inj. MOTRIN 9.25 mg POQ 6-8 hrs prm. Warm baths BID.
pt recv vax in 1992 & devel vomiting, rash & t102.8; no further details were provided;
Feb 27, 2021 - Noticeable tenderness in arm began in the evening before bed. The soreness from initial injection days after had subsided and strangely seemed to return. Noticed when tried to lay on arm while in bed.  Feb 28, 2021- Work up early and began to palpate some soreness at injection site. Within a few hours, the arm began to feel hot and "burning sensation" from deltoid radiating down to wrist. Rash began to accompany the sensation along with "itchyness'" as hours progressed. I took a Benadryl that evening. By 4:00am March 1, was awoken by itchy sensation all over my body with extreme burning sensation in the left arm. I inspected my body and had hives and a rash on all limbs (bilateral legs, bilateral arms with worse being the left arm and hand". I immediately went to see my Primary care physician who prescribed both antibiotics and prednisone. I was also told to continue with antihistamines (Zyrtec, Benadryl). I also went to see an allergist who added a topical ointment for itch relief. Did not recommend antibiotics.
8 days following vax pt devel fever; 11 days following vax pt devel rash consistent w/measles rash; pt had febrile seizure on 15SEP95 was hospitalized for that, discharged on 16SEP95;
That next morning not feeling well, no appetite, nauseous. Chills and fever by 5 PM, vomiting, diarrhea, sore joints. 6 day duration.
Information has been received from a 71 year old male consumer who in December 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported). The consumer stated that in December 2010 was diagnosed with a case of shingles. The consumer did not remember ever having chicken-pox. The patient has been given steroid injections for the pain and discomfort. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information was received from the consumer who stated that in February 2009 (previously reported as December 2010) with a dose of ZOSTAVAX (Merck) at the age of 71. The patient stated that he cannot remember ever having chicken pox, but it was possible. Whether from fatigue, mental anxiety or a weakening of the immune system, in December 2010, the patient was diagnosed with shingles with its symptoms, especially the pain. He stated that only after a series of steroids injections, he was relieved of almost all the pain and "discomfort". The patient stated that if ZOSTAVAX (Merck) only lessens the symptoms and/or duration for the shingles, he was as thankful to have had the vaccination as he was for the steroid treatment. Additional information has been requested.
NauseaVomiting reports fever: 99.2 Narrative:   Other Relevant History:
1/30/2021 Admit Note:  Patient presents to the ED complaining of chest discomfort.  Patient has a history of hypertension, congestive heart failure, COPD, afib, and multiple other medical problems. Presented to the ED with some left-sided chest pain. She had an episode of chest pain when she received her first Covid vaccine a month ago and was thought to be related to a GI symptoms she had negative EKG at that time.  She received her second dose of Covid vaccine couple days ago and was woken up at 4:00 this morning with a feeling of chest discomfort that she describes as a pressure sensation with no associated shortness of breath or cough or nausea or vomiting.  (cont below)She states she was given aspirin and EMS was called but the chest discomfort is resolved by arrival to the ER after the aspirin. 2/2/21 Discharge Note: Chest pain did not appear to be cardiac in nature.  Old CT scans that showed some chronic lung changes and also old rib fractures.  The pain that she has seems to be consistent with either GERD or hiatal hernia.
Pt presented with local site redness and small cluster of blisters. Recommend pt get checked out w/primary MD. Pt was seen on 12/7/15 determined was a allergic reaction and given BENADRYL.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: pt statement...left corner of mouth and side of tongue numb from thursday to sunday at 7pm spread to face, neck, arm, and down leg. patient went to  ER  dr rule out stroke and sent pt home with moderna covid vaccine reaction as possible cause
Approximately 3 hours after injection the patients arm turned red, started swelling, and itching occured approximately 2 days. It was very red from the site of injection to her wrists.
12/30/2020 1st Covid Pfizer Vaccine EK9231 Left Arm 0730p 1/20/2021 2nd Covid Pfizer Vaccine EL3247 Left Arm 0730p 4/18/21 ill 4/20/2021 Antigen test + Covid, PCR test pending Employee is currently off work
received dose two of Engerix-B five and a half months after dose one; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 39-year-old male patient who received HBV (Engerix B adult) (batch number 4345R, expiry date 11th August 2023) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose five and a half months ago).   On 19th December 2021, the patient received the 2nd dose of Engerix B adult. On 19th December 2021, unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient Pharmacist reports the patient received dose two of Engerix-B five and a half months after dose one, instead of one month after dose one, which led to lengthening of vaccination schedule.
Soreness at injection site: 2/24,  beginning approx. 9:00 PM Soreness at injection site and when lifting left arm: 2/25 - 3/3 Extreme fatigue: Unable to keep eyes open/stay awake - 2/25 Feeling sluggish: Body felt heavy/tired, but able to stay awake - 2/26
fever; achy; extremely tired; I think the person had covid at the time; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included toxoplasmosis, infectious mononucleosis. The patient's concomitant medications were not reported. On an unknown date, the patient experienced fever, achy, extremely tired, think the person had covid at the time. The patient was going to get open heart surgery. The outcome of the events was unknown. There was no product quality complaint present.  The lot number for the vaccine was not provided and will be requested during follow-up.
patient tested positive for the COVID virus; This is a spontaneous report from a non-contactable consumer (patient). A 31 (unspecified unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 23Feb2021 at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose of vaccination on 23Feb2021, 7 or 8 days later she started developing symptoms, she was sick the following Wednesday (unspecified date in 2021) then she got tested and it came back positive yesterday evening, last night (04Mar2021). The patient tested positive for the COVID virus. The patient asked if she could get the vaccine as scheduled and if there is any time frame for the 2nd dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax for prophylaxis;24 hrs later exp rash on chest & itching;; was seen by MD;
he has a bad leg and can't walk; he has a bad leg; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (he has a bad leg and can't walk) and LIMB DISCOMFORT (he has a bad leg) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 GAIT INABILITY (he has a bad leg and can't walk) and LIMB DISCOMFORT (he has a bad leg). At the time of the report, GAIT INABILITY (he has a bad leg and can't walk) and LIMB DISCOMFORT (he has a bad leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
w/in 24 hrs high pitched prolonged crying, stiffening of body; throw head back called MD said given APAP call back; 12 day petite mal sz; MD ordered test; not sleeping well; stiffens up then 1st picked up; cries self to sleep;
Patient's husband called me to report the patient was experiencing redness swelling and itching at the injection site. They stated they did not have this reaction with the first vaccination. They were encouraged to put a cold compress on the site and continue to monitor. They were instructed to seek medical attention if the swelling continued to spread and become severe.
Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2021 15:30 (Lot number: EL8982) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Jan2021, outcome "recovered" (14Jan2021), described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Prior vaccinations: None. Concomitant drugs: None. Patients medical history: None. Specific Relevant Test for Thromboembolic events with Thrombocytopenia: None. Comments/Narrative: Patient had enclosed a brief narrative, in that knowingly, due to age his hand writing was quite poor. At this time he had not recived his booster vaccination. 1st dose- 13Jan2021: Merely a sore arm around 24 hours.  No follow-up attempts are possible. No further information is expected.
Got injection at 5:15 by 7:30 my arm, legs, and face had broken out in hives. By 8pm my body began to ache and my throat felt as if something was stuck in it on one side. I took two Benadryl and went to sleep. When I woke my body ached, I had a slight headache and a low grade fever. By Saturday night, my arm pits were swollen. I went to doctor Monday and he diagnosed an allergy to the Tdap.
pt recvd vax; questionable szs; mom states had at least 3 szs;pt hosp for observation and no abnormalities were discovered;mom not very cooperative;MD will contact social svcs to check on baby;
Patient experienced a skin rash on the biceps region of her left arm and also reported a headache that was relieved when she took TYLENOL.
Patient received the covid vaccine on 12/22/2020.  No problem with the vaccine. Today, 12/30/2020 she reported with a new onset of sore throat, mild headache, and mild rhinorrhea. No fever, chills, cough, or fatigue.  Had the covid self swab test on 12/29/2020 - awaiting for result.
ABNORMAL ERYTHEMATOUS SCALING RASH RIGHT LEG WHERE PREVNAR WAS GIVEN.  PRESCRIBED TRIAMCINOLONE ACETONIDE 0.1% CREAM 1 RIBBON APPLIED TO AFFECTED AREA TWICE A DAY.  PREDNISOLONE SODIUM PHOSPHATE 15 MG/5ML SOLN, 1 TEASPOON DAILY X 3 DAYS.
woke from sleep in middle of night with "seizure-like" activity, described as "convulsing", lasted 2.5 hours; once this ended left with sore arm and back; no skin rash or other visible signs of reaction(s)
Lips are swollen; Rash on the neck; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips are swollen) and RASH (Rash on the neck) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer BioNtech (lot no. EN6204) on 13-Mar-2021 and Pfizer BioNtech (Lot no. EW0151) on 03-Apr-2021.Past adverse reactions to the above products included No adverse event with Pfizer BioNtech and Pfizer BioNtech.Concurrent medical conditions included Allergy (Allegra). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Allergy, VITAMIN D [VITAMIN D NOS] for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced LIP SWELLING (Lips are swollen) and RASH (Rash on the neck). At the time of the report, LIP SWELLING (Lips are swollen) and RASH (Rash on the neck) outcome was unknown. Treatment information was not provided.
pt presented to ofc 8:30 on 11APR96 w/ c/o painful, sore lt arm nausea & gen achiness;lt arm had an area of erythema & induration approx 2 inches in diameter which was warm & painful to the touch