chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty with arm; Arm was itchy; Arm was swollen; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Difficulty with arm), PRURITUS (Arm was itchy), PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Arm was red) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PRURITUS (Arm was itchy), PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Arm was red). On an unknown date, the patient experienced LIMB DISCOMFORT (Difficulty with arm). At the time of the report, LIMB DISCOMFORT (Difficulty with arm), PRURITUS (Arm was itchy), PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Arm was red) had resolved.        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.   No concomitant medications reported. Treatment included Benadryl and Ice
10 minutes after vaccine--throat became tight, some scattered itching, O2 sat to 93%, lungs mild-moderate decreased air movement. Took Proair inhaler, 10 mg Prednisone, 25 mg Benadryl. 1 hour after injection symptoms resolved and sat up to 98+% and lung clear moving better air per the RN monitoring for reactions. 1 day post injection-- exhausted, spordaic and severe muscle cramps, chills 2 day post injection, chills better, muscle cramps stronger, abdominal muscles and intestines cramping
Information has been received from a registered nurse concerning unspecified number patients who on unspecified dates were vaccinated with a series of HepB (thimerosal free) (manufacturer unknown) in her office. It was reported that "the patient might have been given RECOMBIVAX HB". The patients "still" had negative titers. It was unspecified if the patients sought medical attention. At the time of reporting, the patients' outcomes were unknown. Follow up information received from the nurse who denied that she made the report stated that she did not know where this report came from. All telephone attempts to obtain follow-up information has been unsuccessful. No further information is available.
Information has been received from a physician's office, concerning an 8 month old male patient who on 08-MAR-2012 was vaccinated with a dose of ROTATEQ (lot number 671576/01240AA) (route, site and dose not provided). Secondary suspect vaccine given on the same day included a dose of RECOMBIVAX HB (lot number, route, site and dose not provided). Concomitant vaccines given on the same day included a dose of PENTACEL and a dose of PREVNAR. It was reported that on an unspecified date the patient was hospitalized for rotavirus. The patient was treated with ZOFRAN and IV fluids. The patient was discharged on 04-MAY-2012. The patient had not been to the physician's office for a follow up visit. At the time of the report, the patient had recovered. Additional information has been requested.
Onset of severe axillary pain (injection site left deltoid) the night following administration. Over the next 3 days, there was ecchymosis, swelling, and tenderness of the left axilla extending to the left breast. These symptoms subsequently resolved.
A report has been received from a Health Professional concerning a 13 years 24 weeks 1 day old, male patient who had been received Nasal FLUMIST Quadrivalent (Intranasal) 0.2 Mililitres, started on an unknown date. It was reported that a dose of FLUMIST that expired on 04-JAN-2016 was administered to a patient on 25-JAN-2016. The outcome of the event of Expired Dose was unknown. The report was considered to be non-serious.
A non-serious spontaneous report of hives has been received from a registered nurse concerning a 7.5-year old male patient subsequent to FLUMIST.  No medical or drug history were reported for this patient. The patient received FLUMIST into both nostrils on 06-Oct-2008.  The patient developed hives ten minutes following the administration of FLUMIST.  The hives were distributed on the patient's bilateral thighs and on the forearms.  The patient was treated with DIPHENTYDRAMINE 25 milligrams.  There were no breathing problems noted.  The patient was reportedly "calm" in approximately one hour.  The adverse event was less prominent as well.
This spontaneous report has been received from a consumer who was a 70 years old male patient with no drug allergy or pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX on 20-JUL-2012. Concomitant medications included: FLOMAX. On 22-JUL-2012 (reported as 2 days after vaccination) the patient developed what looked like a mosquito bite on his stomach and back. They itched. The patient went to the doctor who advised him he had shingles. They were just bumps now. The patient sought medical attention by visiting doctor and unspecified ointment and unspecified pain pill and valacyclovir were given for the treatment. And blood work yearly was performed. At the time of report, the patient was recovering. Additional information has been requested.
Caller received 1st dose of Covid vaccine 09Feb2021 and then tested positive for Covid on 14Feb2021; This is a spontaneous report. A contactable female consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that received 1st dose of Covid vaccine 09Feb2021 and then tested positive for Covid on 14Feb2021. Her next dose is 02Mar2021 and she is wondering if she can take the 2nd dose on time. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Feb2021. The outcome of the event was reported as reported as unknown.   Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & exp severe pain-abdominal upper rt quadrant; 2 hrs later chills, fever; seen by MD 24NOV & t102 orally; cough began 23NOV, mucus in throat & MD then was pus in back of throat;
Headache, dizziness, difficulty breathing. Difficulty breathing started about 7:10 pm and and EPI-PEN was administered at 7:26 pm.
Tingling fingers of arm vaccine applied to followed by (almost exactly 12hrs post vaccine) strong chills, fever, very achy body (even eyes!), several bouts of diarrhea, nausea, and weakness. Took 600 mg ibuprofen before bed.
I have never in my life experienced so much pain from cramping from my period in my entire life. I typically have very light, manageable cramping during my period. This period I felt like I was going through labor, I got so dizzy I had to lay on the floor so I wouldn't faint, I threw up, medicine didn't even touch the symptoms in any way, the pain lasted for hours, and I couldn't sleep.
This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Nausea the morning after. Not a sore throat but it feels like my throat is slightly swollen. I can still drink and swallow just fine.
Throw up reflex/nausea, sore arm, mental fog. Swelling at site of injection lasted 2-3 days.
Patient has a long history of seizures.  He has seizures on a daily basis.  He lives with his family,  who are his primary caregivers, they family provides all of his activities of daily living.  Patient received vaccine on Friday morning, feeling well throughout the day according to the father.  Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing.  called 911 who came to the house and the patient died in the house.  I do not believe he went to the hospital.
pt recv vax 27FEB98 @ 4PM lt arm & @ 6PM devel t99.8;28FEB98 induration around inj site;sore throat;h/a (frontal);seen in ER;1MAR cellulitis;pt hosp;
Difficulty breathing; Nausea; Vomiting; Lightheadedness; Patient feel nausea, lightheadneness. EMS was at patient side for 10 min .Water given. After the 30 minute patient stated " I feel ok now". Patient left to go home.
Tingling, lip edema, facial flushing lasting ~15min. DC home in stable condition
pt had APAP 1 hrs prior to shot; 2 hrs p/shot pt had temp which went to 101; pt cont to run temp 19SEP92; t101-102; pt was on APAP entire time; pt had sx & was seen in ER; pt exp fussiness & would cry 30-45mins; also had loss of appetite;
Soreness and anxiousness with 1st vaccine. More severe reaction to 2nd vaccine. Experienced headache, nausea,  burning sensation through entire body, body aches and cramps,  fever of 101.5, chills, painful mobility, raised and red injection site, foggy headed
This spontaneous report was received from a physician refers to a 19 year old male patient. On an unknown date, the patient was vaccinated with first dose of GARDASIL (strength and frequency was not reported). Concomitant therapies included SEROQUEL. On an unknown date, the following day after administration of GARDASIL, the patient experienced blurred vision, headache and muscle aches. The patient sought medical attention and visited the neuro ophthalmologist who noted that the patient had extreme papilledema and an extremely high opening pressure. On an unknown date, a lumbar puncture was done and the result was reported as negative. The outcome of the event blurred vision, headache, muscle aches and extreme papilledema and an extremely high opening pressure was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Headache; Itchy; red rashes all in my chest and around my neck; All of my breast is red around my neck; sometimes it feel like I get like short of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: moderna (first dose; lot: 034F21A), administration date: 22Oct2021, when the patient was 77-year-old, for COVID-19 immunization; moderna (second dose; 067F21A), administration date: 20Dec2021, when the patient was 77-year-old, for COVID-19 immunization; moderna (third dose; M8022-2A), administration date: 28Jun2022, when the patient was 78-year-old, for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itchy"; RASH (non-serious), outcome "unknown", described as "red rashes all in my chest and around my neck; All of my breast is red around my neck"; DYSPNOEA (non-serious), outcome "unknown", described as "sometimes it feel like I get like short of breath". The events "red rashes all in my chest and around my neck; all of my breast is red around my neck" required physician office visit. Therapeutic measures were taken as a result of rash.  At first patient just had a headache, like she had flu thing and like that and a little upset. Patient was wondering while she was itchy, but she did not know why she was itchy so and on Friday night she did not know but she did not pay no test finally, patient look around neck and looked all in her chest. Patient got red rashes all in chest and around neck. So, that was some of the side effect and sometimes it feels like she gets like short of breath.
pneumonia; pneumonia; This is a spontaneous report from a contactable consumer (patient's son)  An 84-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown.   Information on the lot/ batch number has been requested.
dizziness; muscle aches; chills; fatigue; subjective fever; sore throat; headache; congestion; This is a spontaneous report from a non-contactable consumer, the patient. This 52-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration from 30Dec2020 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included depression from an unknown date and unknown if ongoing and dyslipidaemia from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. 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. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram (CITALOPRAM) and atorvastatin (ATORVASTATIN). On 30Dec2020, the patient experienced dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat. The adverse events resulted in a doctor or clinic visit. Therapeutic measures included Tylenol and Nyquil. The clinical outcome of dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat was not resolved. It was also reported that since the vaccination, the patient was tested for COVID-19 on 04Jan2021 via nasal swab, results pending.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1. Chills - onset earlier than with each of the previous shots; duration approximately 36 hours as opposed to 12 hours with previous shots 2. Fever - onset earlier than with each of the previous shots; duration approximately 36 hours as opposed to 12 hours with previous shots; temp of 100.6 was slightly higher than with previous shots 3. Deep fatigue - new with the bivalent booster; felt extremely tired no matter how much I rested; duration was approximately one week 4. Dizziness - new with bivalent booster; off and on for several days 5. New with bivalent: About 5 hours after receiving the shot, had a sudden intense feeling of faintness, accompanied by graying vision and a strong feeling of pressure in my head
low grade fever of 99.1 degrees F; nausea; diarrhea; joints hurt; Bladder infection; Covid-19 positive test result; sore arm; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection), SARS-COV-2 TEST POSITIVE (Covid-19 positive test result), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and PYREXIA (low grade fever of 99.1 degrees F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches). On 05-Mar-2021, the patient experienced CYSTITIS (Bladder infection) and SARS-COV-2 TEST POSITIVE (Covid-19 positive test result). On an unknown date, the patient experienced PYREXIA (low grade fever of 99.1 degrees F), NAUSEA (nausea), DIARRHOEA (diarrhea) and ARTHRALGIA (joints hurt). At the time of the report, CYSTITIS (Bladder infection), SARS-COV-2 TEST POSITIVE (Covid-19 positive test result), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), PYREXIA (low grade fever of 99.1 degrees F), NAUSEA (nausea), DIARRHOEA (diarrhea) and ARTHRALGIA (joints hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
I was awakened the next morning (22 hours after vaccine) from the discomfort of pressure in my chest which lasted for 2 and half days. The only way I can explain it is that it felt like I had a 15 to 20 pound cat lying on me. I was able to breathe ok and my vitals were normal. The day after the pressure stopped I started getting shooting pains in the armpit of the arm where I got the shot and that pain lasted for 2 weeks.
around 15 mins. post injection c/o "tongue felt numb".  Was medicated immediately with 50mg of Benadryl and within 5 minutes client reported that his tongue sensation was normal again. Was observed for an additional 30 minutes-vital signs stable and released to f/u with PCP.  Called client later in the day and reported he felt "fine".
fever 101-102 chills headache  sore neck sore left arm fogginess
I left facility directly after vaccine. I was not instructed to stay. My husband and I nearly got down the road when I immediately started to feel as if my entire body were on fire from the inside. My limbs became heavy. It was the same feeling I get when stung by a wasp. I immediately took a few Benadryl. I also threw myself into a panic at that point and took an anti-anxiety pill that I carry on-hand incase of unanticipated events. It was very scary. I was alright in the end, however, I felt it necessary to bring attention to. And it seems as if I may have developed a blood clot in the palm of my hand. I am going to the doctors first thing next week.
Approximately two weeks after receiving the COVID vaccine my legs became very weak. I was previously working  and I noticed my legs were weaker and giving out on me. I went to my primary doctor on 2/28/21, but he did not detect any abnormality other than weak legs. The first week in March, I resigned from my job due to the fact that my legs were getting worse and became weaker each day and I was falling very frequently. With the onset of acute leg weakness with severe pain; I requested my doctor to order further exams. Due to the sudden evolution and thrombosis affecting; there is a strong possibility that the COVID vaccine given could well have affected and contributed to the  partial paralysis suffered by this senior.
Swelling, erythema, non painful at the injection site measuring 5-6" in diameter.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-SEP-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 3 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 200, 32, 0 and R; 24, 33, 0.555555556 and R; 132, 34, 1.111111111 and R. This is one of several reports received from the same source. Additional information has been requested.
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
Child felt nauseated, vomited x3, became limp,very pale, B/P 94/55 apical rate 118, respiratory rate 28. Responsive, good air entry bilaterally. 911 called. Child stated she felt like she was choaking.EMS responded right away. Taken to ER vis ambulance.Pt diagnosed in  ER with vasovagal reaction. No epinephrine or benadryl given. Discharged home.
Original admit for vascular sugery of LLE. Developed resp failure and tested positive for COVID 12/29/21; dx w/ COVID pna. Received HFO2, remdesevir, steroids, IV abx. Improved and DC to SNF.
Headache began 4 hours after injection, body aches began 5 hours after injection, both became progressively worse over the next 5 hours. Took Tylenol and Advil in order to fall asleep. Symptoms gone next morning
(L) shoulder 1 1/2 " diameter swelling and redness. Not painful (decreasing from day 1) Ice pack, monitor x sx of infections.
a serious hive condition has developed after shot #2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "a serious hive condition has developed after shot #2". The event "a serious hive condition has developed after shot #2" was evaluated at the physician office visit.  Additional information: My wife believed in the Covid Vax. She has had 3. However, a serious hive condition has developed after shot #2. Doctors cannot figure it out. We need help from Pfizer to turn this condition around.  The lot number for bnt162b2 was not provided and will be requested during follow up.