chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cough; Dry throat; This is a spontaneous report from a contactable consumer, the patient. A 47-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 in the left arm on 06Oct2021 at 16:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Oct2021 at 16:30, 30 minutes after shot, the patient experienced cough and dry throat and still coughing on 11Oct2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cough/coughing and dry throat was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This case was reported by a representative of the Division of Vaccine Injury Compensation and described the death of a child (age and gender not specified who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed that may have been Infanrix. Concurrent medications and medical history were not reported. On an unspecified date in 2001, the child received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine. In the immunization record, the manufacturer was recorded; however, the handwritten lot number looks like Q or the number 2 then 989AZ or 989A2. A lot number DTPA989A2 would correspond to Infanrix. At an unspecified time post-immunization, the child died. A claim was filed that asserts that the death was caused by thimerosal. Thimerosal was not used as a preservative in Infanrix lot DTPA989A2.
Flu like systems, started with soreness in the morning, than escalated to chills, fever, hypertension..  A couple of coughs and sneezes and overall fatigue and eventual exhaustion all signs were present on the Friday throughout the day, by Saturday morning, all but the soreness cleared up.
11:10, got pale, laid him down on table. Eyes staring, "jerking motions". No resp. distress. Smelling salts used immediately w/instant response. Given lollypop, walked out of office OK. F/up call. No symptoms, doing fine.
Pt was scheduled for office visit for a follow up regarding shoulder pain. Pt stated they received their first COVID vaccine in clinic prior. 1st dose was not documented in patient's chart. Coworker and reporter searched for lot number and vaccine administered in the clinic as patient stated to update correct 1st dose. Pt was given 12yr+ Pfizer booster at 5:00pm on 9/29/2022. Pt received only 1 dose of Pfizer and was due for their 2nd COVID vaccine.
Pt recvd MMR vax & currently exhibited a lack of response to measles; No further details were provided;
Note: I took the Johnson and Johnson vaccination. That isn?t listed in the choices on this form.  About four or five hours after the vaccination, my lips, tongue and airway felt warm and swollen. Several hours later it felt like bronchitis and it lasted until the next day. My abdomen and diaphragm area also felt tight. I had a slight fever and my right arm was very mildly sore. No other symptoms. I took Benadryl at three in the morning on April 9, and again later that afternoon.
1 1/2-2 hrs after getting the FLUZONE influenza IM injection he had lip swelling lower> upper. Taken to the ER. Etiology of the reaction to influenza vaccine vs angiodedema from lisinopril. No previous ADRs to either agent. Treatment: Diphenhydramine 50 mg once, Ranitidine 150 mg once.
Pt received Janssen vaccine on 05/11/2021 but then also came to Pharmacy #15982 on 06/29/2021 and Pharmacy #2769 on 07/23/2021 to also receive these shots from Pfizer.  We were not able to contact the patient directly but when we contacted the Original Pharmacy store they believe he also did receive this shot.  We check each and every shot in the system for COVID shot history and this did not show up that he had previously received any COVID shots.
This spontaneous report was received from a registered pharmacist concerning a female patient of unknown age. On 05-JUL-2013, the patients husband was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date reported as J000435 and 10_APR-2014 respectively), subcutaneously. Concomitant medications of the patients husband included several medications (unspecified) and he had no drug reactions or allergies. On 08-JUL-2013 (also reported as on an unknown date), the patient (wife) was diagnosed with shingles by an unspecified physician. No further information was provided regarding the patient (wife). Outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Mother brought patient into clinic to receive second dose of Pfizer. The only one we had in our EHR was from January 26 making todays dose a second monovalent. After administering The vaccine Mother presented me with another Covid immunization card that had 2 dates listed from 2021 of which those vaccines were given at pharmacy. I informed Dr. she said to submit a VARES and inform Mother that another possible vaccines was to be given in a couple Months as a Bivalent Dose. No adverse reactions or problems were noted.
This spontaneous report was received from a other health professional refers to a patient of unspecified number of patients of unknown ages and genders. On an unknown dates,the patients were vaccinated with an unspecified amount of improperly stored doses of PNEUMOVAX 23 lot # N004564, expiration date:22 AUG-2018 for prophylaxis. The sterile diluent (unknown lot, unknown expiration date) used for reconstitution did not undergo a temperature excursion. No adverse effects reported. The vaccines were exposed to temperature ofemperature: 9°C to 25°C (8.6C),time frame: 48 Hours.No previous excursions were reported.The reason of the call was  not temperature alarm received via Digital Data Logger.
Generalized weakness, weakness along radial nerve pathway, parathesia; no soreness vax given in lt arm; pt did not have a bit only worked w/animals in the barn;
Allergic reaction; rash on stomach; throat swelling; This case was reported by a nurse via sales rep and described the occurrence of hypersensitivity in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 14th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced hypersensitivity, rash and throat swelling. The patient was treated with epinephrine (Epi Pen). On an unknown date, the outcome of the hypersensitivity, rash and throat swelling were unknown.   It was unknown if the reporter considered the hypersensitivity, rash and throat swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported.   The patient reported rash on stomach and throat swelling. Emergency room (ER) visit was required and epi pen was given to the patient.  ER physician did not think this allergic reaction was shingles.  The patient released same day from ER
Moderna 3/19/21, 4/15/21, 12/14/21. Positive on 11/12/22
Subsequent to receiving one dose of varicella virus vaccine live the pt learned she was pregnant. The pt delivered a male infant, with a small birthmark on the head. It didn't look like a scab and she noted I think it was probably nothing. Follow up information states the patient was vaccinated with the second dose of varicella virus vaccine live on approximately 12/14/2000.
Dose 2 received March 10 at 11 am. At approximately 2 am March 11, I awoke to severe headache, chills, significant joint and injection site pain and flashes of light in both eyes.
Sat 23Jul. The left arm started to hurt again more; Then got 2nd shot 24May Never stopped or improved Then on 12Jul I woke up with worst pain on right forearms; I couldn't lift coffe mug or put my hair in bun; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24May2021 (Lot number: Ew0186) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number:Ew0173,, lot unknown:False,, administration date:03May2021,, administration time:06:30 PM,, dose number:1,, vaccine location:Left arm), administration date: 03May2021, when the patient was 46 years old, for covid-19 immunisation, reaction(s): "Pain Started on my forearm day after first COVID 19 shot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Jul2021, outcome "not recovered", described as "Then got 2nd shot 24May Never stopped or improved Then on 12Jul I woke up with worst pain on right forearms"; MOVEMENT DISORDER (non-serious) with onset 12Jul2021, outcome "not recovered", described as "I couldn't lift coffe mug or put my hair in bun"; PAIN (non-serious) with onset 23Jul2021, outcome "not recovered", described as "Sat 23Jul. The left arm started to hurt again more". Therapeutic measures were not taken as a result of pain in extremity, movement disorder, pain.  Additional information: The patient has not received any other vaccine in four weeks. Then got 2nd shot 24May Never stopped or improved Then on 12Jul I woke up with worst pain on right forearms to the point I couldn't lift coffee mug or put my hair in bun. Or work on laptop. Was also awoken. Rested it for a day then improved The pain was internal the top of forearm. The length of it ans on botttom. Like something heavy fell and crushed it. It improved as I tried not to use it too much Sat 23Jul. The left arm started to hurt again more Functional but hurts to twist ans turn and lift and stretch. Hard to open jars. The patient has not had covid prior vaccination. The patient not tested covid post vaccination.    No follow-up attempts are possible. No further information is expected.
tested positive on 23Dec2021 but did not have symptoms; tested positive on 23Dec2021 but did not have symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5.5 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 23Dec2021, outcome "unknown" and all described as "tested positive on 23Dec2021 but did not have symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 20Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: Yes Other medication in 2weeks: Yes, Known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got shot-got shingles-very very mild\ suspected Vaccination failure; Got shot-got shingles-very very mild; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingles and it was very mild. The patient stated there was no problem. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Pharmacy technician, thought she was injecting patient with COVID19 Moderna, but she ended up injecting the patient with a blank syringe of 0.5ml of air. When she realized there wasn't any vaccine in the syringe, she informed the patient and he was OK with her injecting his arm again with a syringe filled with 0.5ml  COVID19 Moderna. Patient did not show/mention any adverse events.
I had an adverse reaction approximately 35 minutes after my injection when I was  driving home. I had numbness on the left side of my mouth and lips which came on very quickly. This numbness was identical to the feeling of Novocain injected for dental work, except it came on much faster. My cheek and left side of the throat were swollen. I was also chilled.  The intense numbness lasted about 20 minutes. The swelling did not worsen.     12 hours later I had some numbness and swelling in the bottom left lip.  The cheek and throat swelling were gone.  24 hours following the injection I had swelling in the left side of the bottom lip and numbness in the corner of the left lip only.  36 hours later all symptoms were gone.
she thought she just caught the flu; cough; flu like symptoms; cold; sore arm; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 12Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient said that after she received the first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 12Mar2021, she had a sore arm. The day of the present report (09Apr2021), she woke up with flu-like symptoms. She said she had the sniffles, cold, and sore throat. She said she had no temperature, her vital signs were normal, and everything was normal. She also said that this was not a reaction to the first dose, but she thought she just caught the flu. Patient wanted to know if she should still receive the second dose as scheduled. She said she was due to receive the second dose on 14Apr2021. It was also reported that she got a cold, sore throat and cough before her second dose of vaccine. Her second dose scheduled on 14Apr2021. She got her first dose last 12Mar2021 and it was more than 21 days timeframe. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of inadvertent FLUMIST administration to a 20 month old was received from a physician concerning a 20-month-old female. Neither relevant medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 04-Oct-2011. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
340 mom called pt screaming high pitched x 10 mins; unable to console; site red where immun given; 415 shivering;
24 hours after receiving covid vaccine,  patient complains of generalized weakness and confusion, body aches, temp = 103 F,  hypertension (196/116).  Patient is provided with supportive treatment of symptoms with acetaminophen and IV fluids.
still got the flu; Initial information received on 23-Dec-2022 regarding an unsolicited valid social media non-serious case received from  a consumer/non-health care professional   This case involves an unknown age and unknown gender patient who still got the flu  after receiving  Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a INFLUENZA VACCINE produced by unknown manufacturer (strength , dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for flu.   On an unknown date the patient developed a non-serious event still got the flu  (influenza) (unknown latency) following the administration of Influenza vaccine.  It is unknown if there were lab data/results available.   Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu ).  At time of reporting, the outcome was Unknown for the event still got the flu .
UNDERDOSE; This spontaneous report received from a pharmacist 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: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included testosterone. On 07-APR-2021, the subject experienced underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of underdose was not reported. This report was non-serious.
1 dose years ago, never got the 2nd; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1 dose years ago, never got the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-MAR-2023 The nurse reported that patient never got the 2nd dose. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a Bell's Palsy symptoms on 1/16/2021. Patient received vaccine dose #1 on December 18, 2020 and dose #2 on January 8, 2021.
Conusion,mental fog,trouble thinking clearly,insomnia,waking up every few hours,heart palpitations,heart beating fast and abnormal,confusion happened about 5 minutes after the shot and has been on and off the last 3 days since the shot.I visited with my doctor and she said she can't do anything about my symptoms and that my heart is beating normal at that time of the visit.
First dose of moderna covid-19 vaccine was given on 4/26/21 and second dose was given early on 5/13/21. Pt waited 15 minutes after administration in the immunizations lobby to monitor for reactions.
This case was considered medically important for the event of bronchitis. Information regarding PREVNAR 13 was received from a consumer regarding a 4-year-old male patient who experienced arm swelling, bronchitis and dehydrated. At 4 years of age, the patient received a dose on 05-Oct-2010. On 05-Oct-2010, after being administered the PREVENAR 13 vaccine, the patient experienced arm swelling. The following day, he complained of chest pain and threw up for about 12 hours. On 07-Oct-2010, the patient was lethargic and was taken to the Emergency Room. He was diagnosed with bronchitis. he was also noted to be dehydrated. Outcome was unknown. No additional information was available at the time of this report. Follow-up 02DED2010: Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or Med Watch report may indicate in the appropriate field that it is an initial report. Follow-up received from a contactable physician. The patient recovered from the events on an unknown date. No other new information provided.
Patient report pain in upper right chest pointing with index finger 5 minutes after vaccination. Vitals taken all normal. She requested sips of water. She reported delayed fever/chills then night of first dose with resolution.  Experienced feeling cold/chills . moved to recovery bed and put on coat. temperature 96.3 F via infared thermometer.  pain intensified radiating to back on same side. Pulse elevated 98. bp 130/78. diffculty swallowing due to pain with dry mouth. temp 97.8 F. pt request call 911 for transort to ER at 13:42. Continued pain with coughing. No longer cold now warm. Heart rate 100 temp 98.1 F. Onset of headache at 14:07 with dizzyness. Heart rate 113 Oxygen saturation 100%. EMS arrived 14:15 transported to Medical Center.
He got his vaccine, drive thru, left and did some errands, went home, had some fever, tenderness in the arm, then about 3 days later he started having itching on his back, it got worse and then ignored it, took OTC treatments, and then went to his Dermatologist who he continues to see and says the itching is nerve racking and tries not to scratch it, but it continues.   Was on Triamcinolone, and put on Clobetasol Propionate cream which he is starting today.  He has also tried other treatments and hoping this one helps him.    He got his vaccine, drive thru, left and did some errands, went home, had some fever, tenderness in the arm, then about 3 days later he started having itching on his back, it got worse and then ignored it, took OTC treatments, and then went to his Dermatologist who he continues to see and says the itching is nerve racking and tries not to scratch it, but it continues.   Was on Triamcinolone, and put on Clobetasol Propionate cream which he is starting today.  He has also tried other treatments and hoping this one helps him.
redness & swelling w/tenderness @ inj site right p/vax tx, ice application & observation;