chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; stuffy nose; felt like chewing on glass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 26Mar2021, outcome "unknown", described as "stuffy nose"; FEELING ABNORMAL (non-serious) with onset 26Mar2021, outcome "unknown", described as "felt like chewing on glass". Therapeutic measures were taken as a result of oropharyngeal pain, nasal congestion, feeling abnormal.    Additional information: Patient was prescribed Azithromyacin and is seeking medical advice whether to proceed with second dose on 10Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist reporting on a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The pharmacist reported that the patient called and reported having a rash that appeared two weeks after the administration of ZOSTAVAX, it was reported that the rash was "over a lot of the body" and it was "not itchy" (rash generalized). The outcome of the rash generalized and the causal relationship between the event and therapy with ZOSTAVAX were not reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In September 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In February 2017, the patient was treated by a physician for heart failure. The patient was diagnosed with heart failure and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, heart failure and/or other zoster-related injuries was determined to be medically significant. Additional information has been requested.
numbness, tingling in left hands on 9/26/09. numbness in left leg/arm/foot/hand 9/28/09. numbness in left side of face 9/28/09.
Diarrhea developed 8 days after receiving RotoTeq vaccine.  Appearance: watery, green with mucous, no blood. Continues yet today (12/16/20)  Stool sample sent to lab for C/S.  Sars/Covid swab negative.   Diaper area excoriation.
I developed a series of cysts near the injection site 48 hours after the injection. They look like burns.
Within 2 hours post vax, the pt experience a partial loss of vision in the right eye. Later was diagnosed with optic neuritis.
get her period two weeks early; urine was dark; blood in urine; Pain in arm; weak; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (get her period two weeks early), CHROMATURIA (urine was dark), BLOOD URINE PRESENT (blood in urine), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (weak) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (get her period two weeks early), CHROMATURIA (urine was dark), BLOOD URINE PRESENT (blood in urine), PAIN IN EXTREMITY (Pain in arm), FATIGUE (weak), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, MENSTRUATION IRREGULAR (get her period two weeks early), CHROMATURIA (urine was dark), BLOOD URINE PRESENT (blood in urine), PAIN IN EXTREMITY (Pain in arm), FATIGUE (weak), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided          No treatment information was provided.   This case was linked to MOD-2021-095606 (Patient Link).
Zoster eruption; dysesthesia localized to the trunk area; This case was reported by a physician via call center representative and described the occurrence of herpes zoster in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 72 hrs after receiving Shingrix, the patient experienced dysesthesia. On 25th August 2020, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster and dysesthesia were unknown.   The reporter considered the herpes zoster and dysesthesia to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and presented dysesthesia localized to the trunk area.  One week after the vaccination, patient had a zoster eruption.  The vaccine was administered at an unknown reported by physician so information about site of administration, lot and expiration was not available to physician.  It was reported as time to onset and the lack of immunocompromising conditions in the patient was suggestive of a causal relation between Shingrix and the onset of the zoster episode. The reporter consented to follow up.
Per documentation of other RNs invloved, at 1009, patient began reporting sensation of numbness in right arm and "feeling funny", she also presented with visible flushing and reported itching and feeling anxious.  We monitored the patient's vital signs q5min and administered 25mg Benadryl IM.  Over the course of aproximately 1.5 hours, the patient's flushing had visibly diminished, she reported significant improvement in her anxiety and stated that the itching was "nearly resolved."  Her vital signs also improved and were WNL, including pulse, O2 saturation, temperature and blood pressure.  The patient stated that she felt well enough to return to work and verbalized understanding that if any symptoms develped or worsened she was to report immediatley to the ED.
Rash to face, legs, back, and stomach. c/o itching. No fever. Daycare was wanting to see if child was contagious. Mother has called to report s/s and ask the health department if related to vaccines. Discussed possible SE from MMR vaccine and it should go away, but if not any better in the next 24 hours to see MD.
patient received first pfizer covid 19 vaccine and shortly following felt tingling from shoulders to finger tips that persisted along with arms, shoulder feeling heavy   no resp distress or nausea / vomiting;  staff checked vital signs, oximetry and blood sugar all of which were normal  in serial fashion  sugary beverage provided and gradual resolution of sx, not necessarily related to any or our intevention  husband came and escorted to their vehicle  if sx resolve as i suspect they will, she would remain a candidate for a second dose of vaccine
Dose received in parts 0.05ml and then 0.45 ml; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .05 ml. On 30-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .45 ml. On 29-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml). On 30-Apr-2021, INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.  Patient received 0.05ml of first dose of vaccine on 29-apr-2021 and after 24 hours on 30-apr-2021 received 0.45ml dose
Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Oct-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
ALMOST IMMEDIATELY AFTER INJECTION OF ADACEL, THERE WAS SWELLING AT INJECTION SITE (KNOT FORMED UNDER SKIN).  A COLD COMPRESS WAS USED FOR APPROXIMATELY 15 MINUTES AT THE STORE AND A DOSE OF 50 MG BENADRYL (LIQ) WAS GIVEN.  PATIENT WAS GOING TO CONTINUE USING THE COMPRESS ON THE WAY HOME. THE SWELLING HAD GONE DONE SOME BEFORE SHE LEFT, AND THE PATIENT'S FRIEND WAS GOING TO STAY AND OBSERVE HER THIS EVENING.
Systemic: Chills-Mild, Systemic: patient reported some dizziness and tingling and anxiety. Patient had a pulse of 125 and temp 98.4 Called emergency services and continued observing patient till they arrived; symptoms lasted 0 days
11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for further assessment. Client also reports tingling in the fingers. Client was offered water which was taken and a seat by an open door for air. Client removed mask. Vitals taken: BP 185/100, Pulse 136. 11:59 Vitals taken: O Sat 99% Pulse 162. Client experiencing faintness and dizziness. EMT assessed Client further. 12:01 Client reports a slight tightness in her throat but reports the dizziness is lessening. Client reports no difficulty breathing. Vitals taken: O Sat 99% Pulse 142. 12:04 Vitals taken: BP 163/108, Pulse 128. 12:06 Vitals taken: O Sat 99%, Pulse 118. Client reports dizziness and tightness in the throat is lessening and feeling better. 12:08 Vitals taken: Pule 100, O Sat 98%. 12:11 Client reports no dizziness and the tightness in her throat is getting better. BP 157/99 Pulse 98. 12:15 Client reports that she feels well enough to leave. Client did decide to take a Benadryl due to a little tightness remaining. Client denied feeling any other previous issues or dizziness. Client given a 25mg (one tablet) of Benadryl. Education given regarding Benadryl taken. Client is here with her husband and daughter. Husband was present and Client felt well enough to leave. Client was able to ambulate to the car unassisted and her husband was able to drive her home
Chief Complaint   pt brought to ED via EMS for diarrhea, SOB, weakness, and lethargy. tested positiver for covid last thursday  History of Present Illness     Patient is a 79-year-old male with past medical history significant for diabetes type 2, hypertension, gout presenting to the emergency department today with profound shortness of breath and increased fatigue and weakness after recently being infected with COVID-19.  Patient was diagnosed on Thursday with COVID-19.  Patient had 2 days of symptoms prior to this.  Patient had positive sick contact of his daughter who also had Covid.  Patient notes that he was vaccinated against COVID-19.  Patient was obtunded on scene for EMS and perked up after 700 mL of normal saline.  Patient admits nausea associated with symptoms.  Patient has had persistent diarrhea associated with the symptoms.
Injection site redness and pain within 12 hours, lasted about 36 hours and cleared. 8 days later, injection site became red, painful, and itchy, with an overall feeling of being jittery and feeling ?off?.
I haven't had regular periods since being vaccinated. I spotted for a few days in October of 2021; had a few days of a more 'normal' period in March of 2022, but haven't bled since. My period has been coming like clockwork every 6 weeks, after getting the shot, it hasn't been the same. It hasn't gotten better. I don't know what to do.
Pharmacist forgot to reconstitute (PEDS) pediatric Pfizer vaccine prior to administration. Patient received a double dose.
Pain  at the injection site; Swollen lymph node left armpit; swelling at the injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8932) via an unspecified route of administration in the left arm on 28Mar2021 at 15:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. Concomitant medications were not reported. 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 left arm on 07Mar2021 at 16:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 28Mar2021 the patient experienced pain and swelling at the injection site, swollen lymph node left armpit. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the events pain at the injection site, swelling at the injection site and swollen lymph node left armpit was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Pt recv vax on 11/19/98; on 11/20/98 pt exp itching (hands, feet, neck), hot skin w/ goose bumps
Redness, soreness, inflammed area 2-3 inches in diameter at site of injection, warm to the touch.
Patient reports chills, fever, aches, and weakness starting 8 hours after vaccination and continuing into the following day.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There was no information on patient's concurrent conditions, medical history or concomitant therapies reported. On an unknown date, the patient was administered two doses of MMR II (albumin status unknown) (lot #, expiration date, route of administration and indication were not provided). No adverse effect was reported. Additional information is not expected.
Information has been received from a registered nurse concerning a 11 year old female who on 24-MAR-2009 was vaccinated with the first dose of GARDASIL subcutaneously instead of intramuscularly. No AE involved. The patient sought medical attention with physician. Follow up information was received from the registered nurse. It was reported the 10 year old (previously reported as 11 year old) patient with no known allergies or medical conditions who at approximately 12:45 pm on 23-MAR-2009 (previously reported as 24-MAR-2009) was vaccinated with the first dose of GARDASIL (lot # 661952/1129X) subcutaneously into the right arm instead of intramuscularly in error. At the same time, the patient complained of soreness at site. No labs or diagnostic tests were performed. At the time of reporting, the outcome was not reported. No further information was available.
This spontaneous report as received from a pharmacist refers to a 52 year old male patient with white blood cell count decreased and multiple sclerosis. On an unknown date in April 2013, the patient was vaccinated with VARIVAX for "prevention of chickenpox". Concomitant therapies included sterile diluent. On an unknown date in 2017, the patient experienced "varicella titer" negative. The outcome of antibody test negative was reported as not recovered/not resolved. The causality assessment was not provided.
This spontaneous report was received from a consumer who is the patient mother refers to a female patient of unknown age. The patient mother explained that her daughter received her first dose of GARDASIL (lot # not reported) in August of 2011, she stated that her daughter second dose of GARDASIL was given in October of 2011. The patient has not received the third dose at this time, and the family was debating on completing the series. Additional information is not expected.
pain in lt arm around inj site so painful could not sleep on lt side;reported to clinic 30OCT95;scheduled for carpal-tunnel procedure in lt hand 31OCT95;advised to call orthopedic surgeon a/31OCT;lump is still palpable in lt arm;
Two days following the shot, the are on my arm began to swell and itch.  Applied antibiotic ointment one a day and the swelling went down after several days, however a large red rash appeared.  I still have the large red rash and it is very itchy.  At this time I am not doing anything further.  I am waiting a few more days and then I will call my doctor.
Varicella - Information has been received from a registered nurse concerning a 7 year old male who at the age of 3 was vaccinated with one dose of varicella virus vaccine live (unknown site ).  on 27 apr 2000.  the reporter indicated that the patient has now developed varicella with < 100 lesions.  The patient sought unspecified medical attention.  Also reported was the patient's sister who was vaccinated and experienced a similar event (wases 00051832)
Sever pain at the injection site and arm, chills, sever fatigue, arthralgia.
Breakthrough case admission after 2 vaccines Pfizer 2/1/22 Lot# FG3527;  Pfizer 2/25/22 Lot# FG3527
Arm infected (warm and red to touch for several days) dr prescribed antibiotics to prepare for surgery.
Some of the vaccine leaked out during administration, so a lower-than-authorized dose was administered. Patient was asked to return the following day to the vaccine administration site and underwent repeat administration on opposite volar forearm without event. There are no apparent sequelae of this vaccine administration error.
Son got a fever which caused a seizure that lasted about 5 minutes. 911 was called an son was taken to hospital vis ambulance. He remained at hospital until about 1:3am when he was discharged with febrile seizure and pneumonia. On Sun 2/28, around 3:30pm son started getting a fever and was taken to urgent care and we were sent to hospital ER right away. We were discharged about an hour later and told to keep his temperature down. Fever went away around midnight.
He got his vaccine, he felt fine.  Then he felt like he had smoked too much like he could not take a deep breath while inhaling.  He was starting to worry as it was lasting too long for heartburn for about 2 weeks.  He went to the ER on 10/6/22 and they did testing and he had no blood clots, everything looked fine.  They put him on an inhaler (Symbicort), which is helping some.  He had x-rays and had a CT with contrast of his chest.  They wanted to keep him for observation but he refused.  He was given IV antibiotics in the hospital and put him on oral antibiotics.  He went to his PCP the next day told him to FU as needed.
Patient received vaccine 4/24 and called 5/1 stating she has had diarrhea, soreness at site, shivering, then 4/30 she started with a stiff neck and sore left leg, called her MD and MD suggested she take APAP.
Sx onset 7/24/21 with cough, runny nose, nasal congestion, chills, muscle aches, fatigue, & nausea.
Initial information received from a healthcare professional on 21 January 2013. A 34-year-old female patient, had received an intradermal dose 1 of FLUZONE ID (lot number: UT4465BA) in the left deltoid on 19 January 2013. The patient had past medical history of gestational diabetes with two previous pregnancies. The patient denied any illness at the time of vaccination and did not have any pre-existing physician diagnosed allergies, birth defects or medical conditions. The patient's concomitant medications were not reported. On 20 January 2013, the patient developed an area of redness size of a half dollar and warm to touch at the reaction site. The patient was 11 weeks pregnant. The last menstrual period date was unknown and estimated date of delivery was August 2013. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome of events and pregnancy was unknown. Documents held by sender: none.
Hive rash on arms, torso,thighs with itching Benedryl 50 mg
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 03-Jan-2012, the patient inadvertently received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 23-Apr-2012: There was no late occurring adverse events.