chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hypersensitivity; swelling; This is a spontaneous report from a contactable consumer (patient) via Sales Rep originating from a Nursebased on information received by Pfizer(Mfr. Control number: 21121474US).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunization. Patient also received botulinum toxin type a (BOTOX COSMETIC, Powder for injection), 10 UNITS to forehead and 10 UNITS to glabella on 12Mar2021 (Lot Number: C6736, Expiration Date: 30Nov2023), at 10 iU, single for skin wrinkling. The patient medical history and concomitant medications were not reported. On 16Mar2021 the patient experienced swelling and allergic reaction/hypersensitivity. The patient was going on vacation and was treated with Medrol Dose Pack to relieve the swelling on 16Mar2021. At the time of the report, the outcomes of hypersensitivity and swelling were reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pain and soreness in right arm, limited range of motion, could not lift any weight, need to left arm to position right arm for most movements, X-ray showed no bone damage. I was given 600 mg Ibuprofen to take around the clock. After 9 weeks I was able to move arm on its own and started adding weight-bearing slowly, until now.
Large red welt with pruritis at the site of varicella vaccine injection (upper left arm), duration of 7 days post-administration.
2:45 pm-Patient came into Covid Observation area after reporting tight feeling in lymph nodes around back and sides of neck. Patient alert and oriented, able to speak in complete sentences. No face, lip or tongue swelling noted. Patient able to swallow saliva and sips of water. States she experienced similar symptoms after 2nd dose of Moderna, was given Benadryl 50 mg and observed for 1 hour after 2nd dose. Patient states she took Benadryl 25 mg today at 2 pm shortly before arriving for her booster dose of Moderna as a preventative measure.  2:50 pm- VS: Temp 96.7, BP 151/77, HR 91, RR 18. 02 SATs 99% RA, no pain Call placed to ED physician on call, the doctor, informed of patient symptoms above. Verbal order given for Cetirizine 10 mg po x 1 now,  continue to observe patient and call MD back with an update in 15 minutes. Verbal order read back and confirmed.  2:55 pm- Cetirizine 10 mg po x 1 given as ordered.  3:06 pm- VS: BP 147/70, HR 71, RR 18,  02 SATs 99% RA.  3:14 pm- Call placed to the doctor, provided update. Patient states she feels much better, tight swollen lymph nodes in neck is mostly resolved. Per the doctor, continue to monitor patient for another 15 minutes and call her back with an update.   3:29 pm- VS BP: 141/63, HR 67, RR 18, 02 SATs 99% RA. Patient reports symptoms have resolved. Denies feeling drowsy and states she is able to drive home.  3:34 pm- Update call to the doctor, informed that patient symptoms resolved and patient denies feeling drowsy. Per the doctor, ok for patient to take additional dose of Zyrtec or Benadryl when she gets home and to seek emergent care if she develops any difficulty swallowing or swelling of face, lips or tongue.  3:38 pm- Patient discharged home in stable condition with above discharge instructions. Patient verbalized understanding of all.
Developed thrush on left side of tongue, down left side of throat. Caused lymph nodes to swell in left neck  below left mandible joint  and pain in Eustachian tube  and inside ear.
Alteration in the menstrual period, a lot of pain in the arm, itching in the arm, redness, brain fog, tiredness, sleepy.
Pt recvd vax JUN92 & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; heaviness in the arm;
HAND AND ARM WENT A LITTLE NUMB; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hand and arm went a little numb, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand and arm went a little numb, and the outcome of headache was not reported. This report was non-serious.
This spontaneous report as received from a female consumer of an unknown age who reporting on herself. In June 2013 reported as mid-June, the patient was vaccinated with ZOSTAVAX, injection in the right arm (route, dose, lot number and exp. date not provided). The patient reported that she had been having several severe side effects after having received ZOSTAVAX. She was being so weak and tired that could barely walk - she went to the hospital on 02-JUL-2013 (it was not reported if the patient was hospitalized). She began to experience neuropathy in her right foot during one of her two hospital visits (also reported as on 02-JUL-2013). Her neuropathy was only in her right foot, and the right side of her body was the injection side (in her right arm). She also had breathing problems from 02-JUL-2013. She could not breathe when laying on her right side. If she accidentally rolled over onto her right side while sleeping, she woke up unable to breathe. Before the onset of these adverse experiences, she reported being very healthy. She reported currently being homebound and on oxygen because of her adverse experiences, for about a month. She had sought treatment from many unspecified physicians, including cardiologists and other specialists and she had been arranged an appointment with a pulmonologist next week. She also spoken with unspecified pharmacists. She made two trips to the hospital (hospital information unspecified), but she did not specify whether or not she was hospitalized on either occasion. The patient had unspecified esophagus tests and other unspecified tests (results not provided). The outcome of events was reported as not recovered/not resolved. Upon internal review, being so weak and tired that could barely walk, neuropathy in right foot and breathing problems were considered as disabling. Additional information has been requested.
Pt. was light-headed right after she was injected with the Janssen vaccine which she explains happens when she gets shots. She started to seize after 2 minutes, which lasted for about 5 seconds. 911 was called and ambulance took her to the hospital.
Case number PHEH2015US026830 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) intramuscularly in to left deltoid on 13 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked he temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided.
Immediately after I got the shot,  my throat and tongue got extremely dry and scratchy,  felt different
RARE STROKE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medication included birth control. On an unspecified date, the patient experienced rare stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20221005785 -covid-19 vaccine ad26.cov2.s - Rare stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pt recvd 3 doses of Hep B vax 17APR90, 17MAY90, & 5NOV90 & 21JAN91 it was determined that titer was neg; Booster dose given 14FEB91 & 11JUL91 titer was neg; 2nd booster given 21AUG91 & 23OCT91 titer neg; booster #3 pending as of 3JAN92;
Swollen Hand and Wrist; Swollen wrist and hand; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen Hand and Wrist), JOINT SWELLING (Swollen wrist and hand) and PYREXIA (fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout. Concomitant products included APIXABAN (ELIQUIS), LOSARTAN, PROPRANOLOL and LEVOTHYROXINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen Hand and Wrist), JOINT SWELLING (Swollen wrist and hand) and PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (Swollen Hand and Wrist), JOINT SWELLING (Swollen wrist and hand) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events were not provided. The patient went to urgent care for an assessment. Patient gave consent to safety for Follow-up.
Patients first dose of covid vaccine was moderna, inadvertently was given pfizer for second dose. patient waited 20 minutes after administration, spoke with Dr., he stated that the patient should not have any adverse reactions, and he is considered fully immunized, does not need to repeat any doses,
He got his vaccines, initially he had no reaction  Slight soreness in both arms, but he played golf 2 days later and he played golf again 3 days later.  On Monday 10/31/22 he had loose stools, which he thought it was something he ate the day before and felt that it would go away.  This is now day #3 and he is still having the same symptoms, and feels that it is related to his vaccines.  He may have a low grade fever.  The first day he did have some fatigue and a little nausea, but that went away within the next day.
THE PATIENT HAS A BIG SWELLING AT THE INJECTION SITE RIGHT AFTER I TAKE OUT THE NEEDLE.
Patient stated she is doing fine, this information submitted is just to notified PCP. No further needs by the Patient.
Pt received a Moderna vaccine for her first injection and a Pfizer vaccine for her second injection 1 month later. Patient received both moderna and pfizer vaccine. At this time she does not have any concerning symptoms. We discussed not knowing the efficacy because it has yet to be studied. Also, discussed there is no need for antibody testing at this time. If she does develop any covid symptoms she should get tested. She is to continue to follow CDC guidelines pertaining to social distancing and wearing a mask. Did submit her information to our Event reporting system .
Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Visible hives, shortness of breath, and rapid heart beat- 25 minutes post vaccination Decreased BP, followed by increased BP - 30 minutes post vaccination Given 50 mg chewable children's Benadryl at facility: 35 minutes post vaccination EMS called: approximately 40 minutes post vaccination  EMS placed IV, pushed epinephrine and solumedrol, and transported me to Hospital. Emergency Department: pushed another dose of epinephrine, Benadryl, and Pepcid. I also received an EKG.  Discharged from ED at 4pm Relapse in symptoms (Shortness of breath, nausea, rapid heart rate, and hives): 7p.m. Return to ED at 9pm and discharged at 1 a.m. 1/16/2021
She got the vaccine, everything was fine, and woke up the next morning with a rash went all the way from about 2" below her shoulder to almost her elbow, wrapping around the whole arm except for about 1" on the underside.  She took Hydrocortisone,Triamcinalone, and an antihistamine.  The Dr. had recommended Allegra.  The rash lasted several weeks into March.  She went to an allergist for the 2nd reaction.
The patient did not express any abnormal signs of symptoms immediately after receiving the vaccine; inramuscular route instead of the indicated subcutaneous route; This spontaneous report was received from a pharmacist and refers to an adult male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 20-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) 0.5 ml, intramuscularly in the left arm, lot number S001338 was verified to be valid, expiration date reported and established as 14-JAN-2021 for prophylaxis.  The patient did not express any abnormal signs of symptoms immediately after receiving the vaccine. As the vaccine was administered intramuscularly instead of subcutaneously, the pharmacist wanted to know if the patient needed to visit the hospital.
pt recv vax OCT96 & 24DEC96 & pt exp laryngitis, fever 101 & bad cough;dx w/flu & was treated w/ATB; pt has not yet recovered;
Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number has been requested.
left leg swelling; This case was reported by a pharmacist via call center representative and described the occurrence of swelling of legs in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number X54CN, expiry date 27th May 2023) for prophylaxis.   On 27th July 2022, the patient received the 1st dose of Shingrix. On 28th July 2022, 1 days after receiving Shingrix, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was not recovered/not resolved.   It was unknown if the reporter considered the swelling of legs to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: The pharmacist reported a patient received her dose of Shingrix late morning/early afternoon in left arm. The patient reported when she woke up she had left leg swelling. The Vaccine Administration Facility was the same as Primary Reporter. The follow consented to follow up via HCP email.
Clinic for covid vaccinations on 3/31/21 Patient came to clinic and spoke no english. Patient dob was missed and she was only 17yrs for vaccination for 18yrs and older. Patient needed no treatment and has no side effects form vaccination
Information has been received from a physician concerning an approx 69 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently the pt c/o injection site pain, redness and swelling toward the elbow. Medical attention was sought and the pt was treated with warm compresses and ibuprofen (Advil). The AE's resolved after 5 days. No product quality complaint was involved. It was also reported that within the same week two other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649732/0513P) and developed AE's (WAES0410USA02673 and 0411USA00720). Additional information has been requested.
COVID; COVID; Moderna dose 4 and 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6201), on 24Mar2021 as dose 2, single (Lot number: ER8727) and on 06Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 50 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 016J212A) and on 17Oct2022 as dose 5 (booster), single (Lot number: AS7148B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Known allergies: sulfa medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022, outcome "unknown", described as "Moderna dose 4 and 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Feb2023, outcome "unknown" and all described as "Diagnosed with COVID 23Feb2023". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 24Feb2023.
Patient turned pale, then fainted. Patient then layed on table/monitored for 30 minutes after injection. B/P taking after, then before she left.
bilateral hives; pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (bilateral hives) and VACCINATION SITE PAIN (pain at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (bilateral hives) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, URTICARIA (bilateral hives) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        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.   Concomitant medication was not reported. Treatment medication was not reported.
Incorrect mRNA COVID-19 product inadvertently administered for 2nd dose No adverse events noted or reported
flu like symptoms; sick; feels pretty bad today; red blotches on face; extreme fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick), MOOD ALTERED (feels pretty bad today) and RASH MACULAR (red blotches on face) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .  Concomitant products included LEVOTHYROXINE, CALCIUM, MAGNESIUM, VITAMIN D3, FAMOTIDINE, MONTELUKAST and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick), MOOD ALTERED (feels pretty bad today), RASH MACULAR (red blotches on face) and FATIGUE (extreme fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick), MOOD ALTERED (feels pretty bad today), RASH MACULAR (red blotches on face) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included b12 complex, ginko boiloba,  . No treatment information was provided.
Mother called Health Department October 12th, 2018 at 9:30 AM explaining that her daughter woke up at 6:30 AM that morning not feeling well. Had a fever of 103.7 and vomited 4 times that morning. Mother stated that her daughter was saying that her stomach hurt and just ached all over. Mother stated that they had been given patient TYLENOL which brought the temperature down to 100.2. Daughter not showing any other signs and symptoms. Alert and oriented and responding appropriately, no difficulty breathing. Nurse stated to mother if symptoms continue and fever does not come down with TYLENOL to call their healthcare provider. Nurse made a follow up phone call on 10/15/18 at 9:00 AM, mother of patient stated that her daughter is feeling better and is back to her baseline. Mother stated that symptoms lasted until 10/13/18 around noon time. Patient's fever continued until Saturday at noon but that TYLENOL helped keep the fever down.
Patient received dose 1 of Pfizer cov-19 vaccine.  Approximately 10 minutes after administration, team member began to report that he did not feel well.  He was hot, then cold, felt nauseous and very dizzy.  He vomited 3 times.  We called 911 immediately.  I monitored patient's breathing until emergency personnel arrived.  EMT determined that situation was not life threatening.  Patient left with his wife and stated he was heading to urgent care clinic.