chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored M-M-R II (lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored M-M-R II, lot #J003785 and expiration date: 28-MAR-2015. She stated that the dates of administration of the M-M-R II for the 61 unspecified patients were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 27-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports received from the same source. Additional information has been requested.
unspecified patientes were administered improperly stored doses of PROQUAD and VARIVAX; no patient experienced symptoms; This non-valid spontaneous report was received from a health care worker referring to an unspecified patients of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On an unspecified dates after 19-JUN-2020, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T003017 and expiration date 25-JUL-2021; lot # S027465 and expiration date 02-MAR-2021 have been verified to be valid lot numbers) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #  S031494 and expiration date 07-OCT-2021 has been verified to be a valid lot number) for prophylaxis (concentration, dose, dose description, frequency of vaccination scheme and route and anatomical location of vaccination were not reported). The diluent used for administration of the doses was properly stored. No patients experienced symptoms.  There was no previous temperature excursion  This is a non-valid case due to a lack of patients' identifiers.
only a swollen lymph node under my left arm; some of the vaccine leaked from the injection site; some of the vaccine leaked from the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 17:15 (Lot number: EP6955) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Penicillins, reaction(s): "penicillins allergy", notes: Allergies to medications, food, or other products: penicillins. Vaccination history included: Bnt162b2 (Dose 1, single, Start Date/Time: [Pfizer] 08Mar2021 at 17:30), administration date: 08Mar2021, when the patient was 40 years old, for COVID-19 Immunisation, reaction(s): "arm pain", "swollen lymph node", "fever". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 30Mar2021, outcome "recovering", described as "only a swollen lymph node under my left arm"; UNDERDOSE (non-serious), INJECTION SITE EXTRAVASATION (non-serious) all with onset 30Mar2021, outcome "unknown" and all described as "some of the vaccine leaked from the injection site". Therapeutic measures were not taken as a result of lymphadenopathy, underdose, injection site extravasation.  Additional information: Facility where the most recent COVID-19 vaccine was administered reported as Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Patient has been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Reported that patient received second dose of the Pfizer Covid-19 vaccine this week (at the time of report). Unfortunately, she have reason to believe that some of the vaccine leaked from the injection site. The nurse tried to cover this up and did not tell her or re-administer more of the vaccine. Patient also barely have any symptoms from 2nd vaccine (only a swollen lymph node under left arm), even though she felt significant side effects from first (arm pain, swollen lymph node, fever). Patient was asking about how to proceed, questions was she still protected, need to get re-vaccinated and in which time frame.   No follow-up attempts are possible. No further information is expected.
20 hours post 4 year vaccine a 4.0 x 7.5cm area upper left thigh was noticed.  There is a hive or pustule about 2mm in center.
Low grade temperature of 100.6 Friday at 1:30am; This is a spontaneous report from a contactable nurse reporting for herself. This 28-year-old female patient received on 16Dec2020 08:00 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Dec2020 01:30 am, the patient had low grade temperature of 100.6 F. The patient recovered in Dec2020 without treatment. Information on the lot/batch number has been requested.
Right side Lips, face became numb. Right eye drooped, along with corner of mouth right side   Right side of tongue became numb, swelling of right jaw lymph node, ear ache, dry mouth.
After having his 2nd Covid shot, my father was complaining of headaches and a stiff neck.  Exactly 2 weeks after having the 2nd Covid shot, my father had a stroke while driving which caused an accident.  He was rushed to a Trauma Center for *Cerebrovascular accident (CVA) due to embolism of left middle cerebral artery, *Atrial Fibrillation Paroxysmal, and  *Acute Respiratory failure with hypoxia,
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose number unknown, single (Lot number: EW0217) at the age of 44 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". It was reported that patient's sore throat and body ache came back after those were gone. The test results became positive after being negative.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; and SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Caller states he has now tested positive for COVID-19 and he has had symptoms for a couple days; Caller states he has now tested positive for COVID-19 and he has had symptoms for a couple days; Caller states he has a progressively increasing temperature everyday he had a temperature of 104 yesterday; This is a spontaneous report from a contactable consumer (patient). A male patient of 67-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 66-year-old) as 2ND DOSE, SINGLE; and then dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, that he participated in a clinical trial for Pfizer COVID vaccine. He originally received two placebos and then received two doses of the actual vaccine. States he has now tested positive for COVID-19 and he has had symptoms for a couple days. He would like to know if there is a specific test, he could take to see if he received the actual Pfizer COVID vaccine? He states he has a progressively increasing temperature everyday he had a temperature of 104 yesterday and his doctor advised him to take Tylenol, Ibuprofen and to stay hydrated. He had no side effects after receiving the vaccine and he had more side effects after receiving the placebos. Outcome of event for Covid-19 was recovered and for the other events it was unknown.  Information about lot or batch number has been requested.
On January 16, 2022 I experienced what turned out to be a transient ischemic attack (TIA) of 4-5 minutes duration, went to the ER at a local Hospital.  CT scan and exam performed, referred to Dr. for follow up care & testing.  Symptoms presented with vision anomalies, left side tingling, and dizziness while speech remained normal.   On February 11, 2022 I experienced another TIA of 20-25 minutes duration that resulted in the left foot pronation and left leg sciatic pain along with jaw misalignment, all of which resolved to normal over several months.  It originally presented with left side tingling and dizziness.  On November 30, 2022 I experienced a very minor TIA of approximately 30 seconds duration with lip tingles and dizziness.
Pt c/o chest tightness, palpitations and dizziness 10 mins after receiving the second dose of the vaccine. She reported that she has no past medical hx. She was assessed and monitored by NP, EMT, and paramedic. She had mild anxiety, BP - 130/98, repeated BP- 128/82, HR-102, went down to 88, resp -18, O2 sat 98% on RA, SR w/o ectopy on monitor. She was kept at site until she reported that she felt better and had no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911 and go to the ED, follow up with her PCP, register with mobile reporting app. She verbalized understanding and willingness to comply. She left site in no acute distress, calm, awake, alert, oriented to person, place, time, and situation.
Chills; slight headache; tired; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 13:15 as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. The concomitant medications included omeprazole (MANUFACTURER UNKNOWN) of 40 mg and multivitamins for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206) via an unspecified route of administration in the right arm on 08Mar2021 at 13:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 30Mar2021 at 06:00, the patient experienced chills, slight headache and tiredness. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, headache and tiredness was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
pt recv vax OCT97 & exp serum sickness like synd w/arthritis, adenopathy & fever;
1 month after my second dose, I was experiencing chest pain. Went to the ER and my systolic blood pressure was in the high 180's and diasystolic was 110's. They did a liver ultrasound and lab work. Found that i have elevated liver enzymes and a fatty liver.
06/01/2021 @ 07:00PM - Full body rash, made worse with any type of friction (severe burning and itching)- still ongoing Using Benadryl(2 tabs QID), NSAID (800mg TID), colloidal oatmeal baths(QD)- no relief of symptoms
PATIENT REPORTS DEVELOPING "WIDE SPREAD HIVES ALL OVER BODY" WITHIN 24-48 HOURS FOLLOWING INJECTION. SOUGHT CARE FROM MD AND WAS ADVISED NOT TO RECEIVE SECOND DOSE.
This spontaneous report as received from a consumer (the patient's mother) refers to a 19 year old non-pregnant female patient with depression. Concomitant therapies included LEXAPRO. The patient did not have drug reactions or allergies. On an unknown date the patient was vaccinated with GARDASIL or GARDASIL 9 (lot# and expiration date not reported, 0.5ml, intramuscularly, dose number not reported). The reporter could not confirm which vaccine was used. On an unknown date, the patient experienced hair loss, fatigue and unspecified stomach issues after receiving the vaccine. The patient used an unspecified prescription and over the counter (OTC) antacids to treat her stomach problems and an unspecified steroid lotion and steroid injections for her scalp. The patient discontinued series of the suspect vaccine. The patient sought medical attention by calling an office. The outcome of the adverse events was not reported. The relatedness between the adverse events and the suspect vaccines was not provided. Additional information has been requested.
Information has been received from a physician concerning an approximately 23 year old female patient who was vaccinated with Gardasil.  The physician stated that a patient of hers came into the office telling her that her neighbor's daughter received Gardasil and suffered from a stroke or a clot.  No further Information was provided.  The physician that the representative calls on, did not have any details about the patient.  Upon internal review, stroke was considered to be an other important medical event.  Additional information is not expected.
This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding concurrent conditions, medical history or concomitant medication was not provided. On 22-DEC-2017, the patient was vaccinated with ZOSTAVAX intramuscularly instead of subcutaneously, as prevention of shingles(dosage information, lot number and expiration date were not informed). The patient stated any adverse events as a result of the injection. It was also reported that no treatment was given for adverse event, The patient did not seek medical attention.
Diffuse urticurial rash on abdomen, chest, back, arms, thighs.
had only a sore arm; muscles were sore.; This is a spontaneous report from a contactable physician (patient, psychologist, work as a healthcare provider in a prison system). A 69-year-old male patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number reported as: E316, either 05 or 85) via an unspecified route of administration on 21Dec2020 (between 13:15 and 13:30) in the right arm for COVID-19 immunization. Medical history included flu, not recently, several weeks ago. Concomitant medications were reported as none. The patient had only a sore arm on 21Dec2020 as a side effect.  The patient also reported muscles were sore on 21Dec2020. The outcome of the events was unknown.  Caller stated he wanted to check and make sure he wasn't supposed to have side effects. He had seen on TV people complaining of chills, fever and headache. As he was looking at the document he was given, he may have called the wrong number for the question to ask: he was lucky enough as a healthcare professional to be administered his first shot of Pfizer's COVID vaccine, and with the exception of where the site where it was injected, his right arm being a little sore, like with any shot, he had not experienced side effects, like headaches or nothing, and today he noticed he didn't get a check in, he got texts. But his question was: if he didn't feel side effects, did it mean the vaccine was not necessarily taking, if no side effects, did it mean it will not be effective? Stated it was just minor, like any other shot. He did not mind participating in this study, for information, since Pfizer may be counting soreness in the arm, but he did not perceive this as a problem. He got the vaccine on Monday 21Dec2020, between 13:15 and 13:30, and then it was just like, he had a flu shot, not recently, several weeks ago, and to the same point. No further details provided. Like within a couple, three hours, it started, and it was difficult to sleep on it, just sore, no redness/inflammation, he could not tell where the skin was punctured, just his muscles were sore. He called the number on the sheet, he was just real curious, he did not feel bad, like he hears on TV, and he knew personally people who got symptoms and he no symptoms, that he can ascertain. No further details provided. His appointment was 1:15, it may have been in his arm at 13:25, or 13:30 or something, he went and sat for his 15 minute wait time, at 1:30, so it was between 13:15 and 13:30. Outcome reported as it was OK during the daytime, but to sleep on that side, it can feel sore, and he turned to the other side, it did not keep him from typing, lifting, writing, working, emptying the dishwasher. He had a registration code, was given a card. Read from his vaccination card: provided date of vaccination 21Dec2020, vaccine name Pfizer COVID 19, stated lot was written in ink, looked like it was E316, stated he can't read, it was smeared, but then said next dose is 11Jan2021. States it was E316, either 05 or 85. He didn't have the sore arm before he got it, and it is going away now, or it would go away.   Information on the lot/batch number has been requested.
headache; fever; upper respiratory symptom like running nose; body ache; tremendously itching all over her body; A spontaneous report was received from a Healthcare Professional concerning a 35 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myalgia, allergy to vaccine and vaccination adverse reactions.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, fever, upper respiratory symptom like running nose. Body aches and itching all over the body.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events (headache, fever, upper respiratory symptom like running nose, Body aches and itching all over the body), was unknown.  The reporter assessed the events, [headache, fever, upper respiratory symptom like running nose, Body aches and itching all over the body] as related to the suspect drug.
Tested positive for Covid-19 ten (10) weeks after 4th vaccination (second booster) for Covid-19
Joint pain in upper extremities; shoulders, wrists, elbows, hands. Differential dx R/O by Primary Care Physician, Rheumatologist, Infectious Disease Doc, Orthopedist. Onset two weeks after last vaccination, worsened/persisted until September 2021. Gradually resolving.  No apparent swelling or redness.  Responded to anti-inflammatories somewhat, better response to low-dose Naltrexone. Also responded (temporarily) to cold application
caller can't breathe; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: GH9693) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "caller can't breathe".  No follow-up attempts are possible. No further information is expected.
Icy hot, burning, sunburn feeling intermittently all over body. Mostly arms, legs and shoulders; This is a spontaneous report from a non-contactable consumer, the patient. A 42-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 on 02Apr2021 at 13:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. 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. On 03Apr2021 at 20:00, about 30 hours after first vaccine, the patient started to get an icy hot, burning - sunburn feeling intermittently all over her body. Mostly arms and legs and shoulders. It was day 10 and still continuing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and was asked to take antihistamines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event icy hot, burning, sunburn feeling intermittently all over body, mostly arms, legs and shoulders was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (16Aug2021): Amendment: This follow-up report is being submitted to amend previously reported information: Patient's initials field updated. Narrative was updated.
Fatigue, Body Aches, Sweating, Nausea, Chills
Fever 102.4  Diarrhea Chills Skin and joint pain  Headache
pt recv vax; noticed small bumps on cheeks, face;to Ped who was unable to give specific dx;some type of allergic rxn and area on arm could be scabies;no tx given;given meds;
nausea no vomiting Narrative: pt reported N/D after COVID vaccine and per employee health took OTC Pepto
Swelling around face, eyes, backs of legs that presented morning after vaccine administration; went to doctor and was given steroid shot which resolved.
Fever began 19MAR t105, poor appetite, ear pain (nl exam); lt adenopathy; 21MAR t105.9; 24FEB t105, 23FEB t104; 24FEB t102.2;
?Pins & needles?-type tingles, like very quick mini electric-y shocks as pins and needles. Mainly in fingers/hands, across chest, neck, ears. Some face and some inner thighs. Strong enough to wake me from sleep. Lasted ~4 hours and then decreased in intensity and faded off. Also had other typical side effects (fatigue, headache being the main ones), but wanted to report the tingles since they are not listed as side effects anywhere which really freaked me out.
Information has been received from a registered nurse concerning a female who was vaccinated with a dose of VAQTA. Subsequently the patient experienced an unspecified reaction. The patient contacted the office. Subsequently, the patient recovered from unspecified reaction to vaccine. No other information was available. No product quality complaint was involved. Additional information has been requested.
I got a bad rash all over my body. It first started as a patch on my leg that spread all over my leg. I took some benadryl and the rash went away. I went to the doctor who said it was probably just a small reaction to touching or eating something. However, approximately 4 hours later the rash started to come back and within a couple hours went all over my body. All over my legs, arms, back, neck, and face. I had to go to the ER to get an IV. The rash went away and I was able to go back home. However, the next day my rash came back. I was prescribed steroids and took benadryl every 4 hours to keep my rash at bay. Once the 4 hours were ending the rash always started to come back. This lasted for approximately a week until it went away.
The patient woke the morning after (Friday) her immunization with rash covering majority of her body.  took Benadryl and rash resolved by Sunday.