chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Officially I fainted, but I describe in detailed events of occurrence below.  I was using my laptop doing some busy work while I waited the 15 minutes after taking the first shot of the Pfizer/BT Vaccine. I had the feeling that I could feel the vaccine coursing through my chest but I thought that was irrational and my mind and nerves playing tricks.   I continued to work and let my mind wander for a moment. Next thing I know I was dreaming for a time and then I slowly awakened by the staff calling my name asking "are you OK, do you know where you are?"   I was able to answer correctly, but my mind felt fuzzy/foggy where I felt as if I was running on automatic but my conscious mind was not in full control. At the time, It was hard to describe at the time how I was feeling as I was trying to note it down for future reference. All I could put down were simple words and I could not form full statements. Though I was very present in the moment. I can remember the name of the Nurses who I was talking to, and what we were talking about.  They took me to be observed for about an hour longer. While I waited, I felt warm, especially in the areas of the back of my head and chest. I was not in any pain, but I was very thirsty. I was also getting pretty hot sitting there, but that may be because of the fact the ER Triage room has full glass wall in full sun. At the end of the hour the sun dropped lower in the sky I felt the normal cold refrigerated Hospital I am used to. I felt weak initially but by an hour I had regained most of my strength by the time the triage nurse took my vitals. After the physician looked over me and my report, they did not give me a reason of concern that would warrant keeping me and let me go home to rest.
Warm to touch, red, area bruised approx 20 CM in diameter.  Sore to touch, skin intact no lesions or open area.  Appreared 2 days post vaccination.
Information has been received from a licensed practical nurse concerning a female who was vaccinated with GARDASIL vaccine (yeast) 0.5 mL, intramuscular. The nurse reported that she heard that the patient developed some injection site swelling after vaccination with GARDASIL vaccine (yeast). It is unknown if the patient sought medical attention. Additional information has been requested.
Full body itching and a rash spreading from the injection site up and down my arm within 10 minutes of the vaccine, difficulty breathing, large lump at injection site forming immediately. For 2 weeks following the injection, I was incredibly ill with fever, chills, upset stomach, headache, loss of taste and smell, body aches, and chest congestion. During that time, I was tested for Covid 4 times and each test was negative.
pt stated after the vax that she had a sore arm around the injection site.  On 2/11/2021 pt states she got dizzy, light headed and her face feels flushed.
Vasculitis rash. A physician reported an infant received her 2nd injection of Prevnar in the R thigh and 3rd injection of Tripedia in the L thigh on 4/18/01. Three days later on 4/21/01 the child developed a vasculitis like rash on the right lower leg and ankle.
I had COVID-19 in July of 2020 and the symptoms I experienced the day following my injection felt exactly like my onset of COVID-19:  body aches and low-grade fever which subsided two days after my injection.  I also had muscle soreness that lasted for 5 full days following the injection and lymph node pain in my left armpit for 7-10 days following my injection.  I had no adverse event from my second dose on 5/4/21.
3/19/2021   Patient  was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  . Complained of a heart racing and feeling flushed   Assessment : Time of assessment. 0920a   Actions taken:  Vitals sign taken BP- 121/78. HR- 94, O2 - 100%. Recheck at 0921- 78  Waited in observation 30 mins         Medications administered: No medication administered.   Disposition:The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.       Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/19/2021  9:11 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8727   NDC: 59267-1000-1          Electronically signed by , RN at 3/19/2021 11:52 AM  Immunization on 3/19/2021
Hematuria started the morning after the 2nd dose of the Pfizer COVID vaccine. The same thing happened after my first dose. Prior to this, I have no history of hematuria.   Just like after my first dose of the Pfizer vaccine, the hematuria started the following day and lasted for about 3-4 days.
Swelling- Rash  on left arm only at vaccine site and red rash blotchy down upper arm  Took antihistamine and  hydrocortisone cream Day later fading and arm is sore
mild sore throat; she had appearance of bull neck, but without fever. Swelling extends to midline over trachea--more tender over trachea than parotids; bilateral parotid swelling; mumps; This spontaneous report was received from a physician and refers to her daughter - female patient in her late 20s .The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), administered for prophylaxis (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided).  In August 2022, the patient experienced mumps. The patient returned from a trip. She then traveled. She returned home to visit parents on 15-AUG-2022. On 18-AUG-2022, the patient told the reporter by the phone she had swollen glands. On 19-AUG-2022, the reporter saw the patient and she had very painful bilateral parotid swelling-not swollen glands. On the same date in the evening, she had appearance of bull neck, but without fever. Swelling extended to midline over trachea-more tender over trachea than parotids at that time. On 20-AUG-2022, the patient experienced mild sore throat (reported as minimal systemic sx today - mild sore throat). The reporter got permission from department of health to send the buccal swab sample for mumps polymerase chain reaction (PCR). At the time of reporting, the outcome of the events was not provided.   The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  This is one of 2 linked reports.; Sender's Comments:  US-009507513-2208USA009009:
Patient felt dizzy a couple minutes after the shot. She got in the car about 10 minutes after the shot and started getting hard pains across her shoulder and down her back. She ended up calling 911 in her car because of the pain. The ER doctor said her blood pressure was elevated, but ruled out heart attack or stroke after completing some tests. She was discharged later that date. She said the bruise from the IV went away after a couple days, but the bruise from the shot is still clearing away after 11 days.
This is a spontaneous report from a contactable physician communicated to a Pfizer company representative. This physician reported similar events for three patients. This is the first of three reports. Three children, all being administered routine kindergarten immunizations, received PREVNAR13, on an unknown date. Relevant medical history, concomitant medications and past product history were not reported. On an unknown date, following administration of PREVNAR13. It was reported that "the site was swollen the size of a softball, hard, and warm to the touch". Two of the children also had hives at the site At the time of this report, the outcome of the events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.
A report has been received from a Medical Rep concerning a 16 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started during Oct-2014. 16 year old pregnant patient on October 6 or 7, 2014 inadvertently administered by FLUMIST QUADRIVALENT. The outcome of the event of pregnant 16 year old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: No other medication in 2 weeks. Paxlovid Treatment start date on 29Oct2022 and stop date on 02Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1PM woke up from nap w/high pitched screams, unconsolable crying, fever 103 ax; used APAP but fever cont & crying; seen by MD @ 230PM poss ear infect started ATB & told to cont APAP; pt lethargic; adm to hosp had some vomiting & diarrhea;
doses administered after excursion; doses administered after excursion; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), PRODUCT STORAGE ERROR (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), PRODUCT STORAGE ERROR (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), PRODUCT STORAGE ERROR (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and PRODUCT STORAGE ERROR (doses administered after excursion).    No concomitant information was reported. Reporter called to discuss a temperature excursion that occurred several days ago in the Freezer. Patient received vaccine from vaccine that underwent a temperature excursion in the Freezer. It was found out about the excursion in an audit. No adverse event reported. No treatment information was reported.
SWELLING AND REDNESS AT INJECTION SITE, FEVER, VOMITING, BODY ACHES
This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (shingrix) (batch number 333TE, expiry date 15th April 2023) for prophylaxis. Previously administered products included shingrix (1st dose received on 12th November 2018, from batch G45LN, expiry date 13th March 2019). On 30th December 2021, the patient received the 2nd dose of shingrix. On 30th December 2021, unknown after receiving shingrix, 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 age at vaccination was not reported. The case was reported by the pharmacy Intern. Till the time of reporting, the patient did not receive the 2nd dose, which led to lengthening of vaccination schedule. The reporter consented to follow up. The health care professional gave permission for follow-up.
A patient received an expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Treatment information was not reported
After dose 1  - this is what happened : I was fine during my 15 min wait but as I was driving back home  I started to feel a bit nauseous and then  there was a warm feeling in the back of my throat. That  turned into a burning feeling within minutes.  By an hour later   I started to feel tightening/ constriction in the back of throat  and like something is stuck there.  My voice felt  very hoarse.  I called the nurse she suggested Benadryl but I had a 4 pm kiddo to work with and Benadryl knocks me out so didn?t take it. I think my body was fighting having an allergic reaction.  My breathing  was a little labored but nothing too bad. I was not terribly surprised  because I?m typically allergic to everything.  On Tuesday - Everything hurt like a bad flu. Fever, Nausea, headache, fatigue, cough etc. That persisted for several days last wk.  By the weekend I felt better just fatigue, phlegm, cough .....  PS - I was fine on Monday prior to vac.  Dose 2 - had a slight warming in back of throat but nothing too bad.  7 hours later and +for the next 24 hour - fever 101.5,(even after 800mg ibuprofen) non stop vomiting, inability to eat or drink, terrible headache - like a bad flu.  Somewhat better today( in that I can actually sit up in bed and type)  but very dehydrated and trying to rehydrate without having to go to ER for fluids.
Information has been received from a physician concerning a 11 year old female patient with chronic seasonal allergies, allergic rhinitis, obesity and possible attention deficit disorder who on 14-MAR-2007, at 5:00 PM  was vaccinated IM with a dose of Gardasil. lot # 655849/0263U. Later that day she developed a headache between her eyes and malaise. In folllow up it was reported that on 14-MAR-2007 patient developed headaches, eye pain and mild malaise at 6:00 PM. On 15-MAR-2007 patient had a physical examination which was normal. Her symptoms completely resolved within a few days. On 16-MAR-2007 patient recoverd. Addititional information is not expected.
Pt held breath as imjection was given, Held breath until passed out, Gasped for a breath then went still again, Eyes rolled back, Went pallor, Lips blue, Whimpered + started with breath again.
8:51 am onset of 104 degree fever. Parents administered TYLENOL alternating with MOTRIN. At 1:33pm parents called. Child with 106 degree fever. Bought into the office at 2:00 pm.
c/o soreness in rt deltoid 3 days p/3rd inj given; 6in by 6in reddened area, hard, warm to touch, did notice burning when inj given
Metallic taste in mouth x 5-10 minutes after receiving vaccine, treated with oral benadryl, tingling in lips and tongue, Solumedrol IM given and transported via ambulance to ED.  Lung sounds and vital signs within normal throughout, no rashes.
I took Tylenol prior to vaccination. About 5 or 6 hrs later, I had heaviness in my arm and mild headache. I took Tylenol again and I was fine. I started having headaches, so I checked my BP. It started spiking to like  168/100 and 180/110. I went to cardiologist and he did an ECHO, checked the carotid in my neck and a doppler to check for blood clots. Everything was normal. He prescribed a new BP med (Losartan - 50mg once a day) and diuretics (HCTV - 12.5 mg once a day in the morning). My BP was stabilized, but then it started to increased again, so he increased my Losartan to twice a day. Now it's stabilized.
Moderately severe reaction. DTaP site red, swollen, warm. 7cm across.
Soreness at the injection site; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 18Mar2021 17:00 (Lot number: EP6955) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not have any allergies to food, medications or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The event did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J014131 and expiry date: 07-NOV-2015 reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that product were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
white blood count "shot up to 18"; severely swollen lymph nodes; sick; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot Number: UNKNOWN) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a reaction after having her first vaccine dose. The patient was sick for 2 weeks and was seen at the Urgent care, ER and the doctors office for severely swollen lymph nodes in her neck. The patient was placed on steroids and her white blood count "shot up to 18". The outcome of the events was unknown.  Information about lot/batch number has been requested.
Signs and Symptoms: lightheaded, hives, tachycardia, decreased BP Treatment: diphenhydramine 25mg oral, famotidine 20mg oral, and oral fluids (Verbal order by Dr.) Patient symptoms improved and feeling stable to leave with her husband after 30 mins. Patient was recommended to take Zyrtec 10mg x1 within the next hour by Dr.  Patient was also told not to receive another Moderna or the Pfizer vaccine by Dr.
Itching and burning along right chest wall on 2/8/21, worsened with shingles rash 2/9, started valtrex to treat it. Right rib (T5 dermatome) rash, burning and rib pain worsening 2/20/21, classic shingles symptoms.
Mother states son complained of pain following the vax in the right arm. The pt also experienced swell of the sight. The pt did not sleep well and did not attend school the following day. The pts arm was red from the injection site to the wrist. The pt was seen in the ER with a fever of 102. Was given antibiotics and released.
Completely achy all over from fingertips to toes- all joints; This is a spontaneous report from a non-contactable consumer. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 at 14:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. It was unknown whether the patient had taken any concomitant medications within two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.  On 03Apr2021 at 07:30, the patient experienced completely achy all over from fingertips to toes- all joints. Therapeutic measure was taken as a result of the event completely achy all over from fingertips to toes- all joints and included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19.The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events- completely achy all over from fingertips to toes- all joints was recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected
No adverse effect reported.; Physician reported that 6 month old received first dose of ROTATEQ yesterday.; This spontaneous report was received from a physician referring to a 6 month old patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 29-OCT-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (strength, dose, frequency, and indication were unknown) with  lot # S004399 and expiration date 06-NOV-2020 for prophylaxis. No adverse events were reported. Sibling 6 month old twin also received dose yesterday.  This is one of two reports received from the same reporter.
Swollen tender lymph node  by left collar bone starting the day after booster, low fever for the day after booster, nausea night of booster that was gone the next morning
On 30Mar91 awoke /w swollen hands & fingers,painful, mottled.Hands felt feverish.Seen by MD on 1Apr91.Intermittent pain & swelling fingers, ankles, & feet cont.
Woke up the next morning after the shot with a terrible headache and heart palpitations. Went to the ER  at the hospital . They said I had PVCs which I never had before until after the shot. Went for other tests in two weeks