chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; felt puffy in the back of her throat; felt like pressure down on that Thyroid area; felt a little swollen; pinched my throat and went down to my thyroid, and lasted for 4 hours; tight around neck; harder to swallow; This spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program Support. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0158, Expiration date: 31Jul2021) on 06May2021 at 08:00, via an unspecified route of administration, in right arm as DOSE 1, single for covid-19 immunization (age at the time of vaccination: 60-year-old). Patient medical history included: Thyroid issue that gets checked every 2 year and a Fib ongoing for which she takes medication. Patient does not have any problems. She had a nodule, and it was checked every few years to make sure everything was good. Patient did not receive any vaccine on the same day when BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06May2021, after taking the first shot, at 11:00 the patient felt puffy in the back of her throat. She added by 11:00, she felt like pressure down on that Thyroid area. It felt a little swollen and pinched her throat, went down to her thyroid and lasted for 4 hours. She felt this kind like it was tight around neck, harder to swallow, a little full kind of pressure there, it moved from top of throat, moving down and was right there when her Thyroid was tested, and they injected something. Patient stated it felt like the same type of thing after she received the first dose Pfizer Covid Vaccine. It was not like she could not swallow. She has no problem breathing and she could eat. By 12:00 this was all gone. She also had sore arm for which she took Tylenol at 11:30. The outcome of the events (felt puffy in the back of her throat, felt like pressure down on that Thyroid area, felt a little swollen, pinched my throat and went down to my thyroid, and lasted for 4 hours, tight around neck, and harder to swallow was resolved on 06May2021 at 12:00. The outcome of the event sore arm was unknown.  The patient wanted to know if the side effect will be worse after second vaccine. She has not received second dose of Pfizer Covid-19 Vaccine and feels like she is not protected. She would like to know if she can safely complete the series, as she doesn't feel protected.  Follow-up attempts are completed. No further information is expected.
No adverse effects reported. No additional Adverse events or PQC reported; HCP called to report a TE with GARDASIL 9.  Stored out of range and administered.; This spontaneous report has been received from a consumer regarding a patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On 24-MAR-2023, the patient was vaccinated with an improper storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), injection, at a dose of 0.5 milliliter for propylaxis, (strength, route of administration, and anatomical location were not provided; lot number W009829 had been verified as a valid number, expiration date had been reported and established as 19-OCT-2024) (product storage error).  There was no adverse event reported and no product quality complain (no adverse event).
no adverse event; received the first dose ofGARDASIL 9 on an unspecified date in November, 2019, and received the second dose ofGARDASIL 9 on 4/16/2020; The patient received the first dose ofGARDASIL 9 on an unspecified date in November, 2019; This spontaneous report was received from a 44 year old female patient. Information regarding the patient´s medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date in November, 2019, the patient received the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, lot # and expiration date were not provided) and received the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, route, frequency, lot # and expiration date were not provided)  on 04-APR-2020. No additional adverse event.
administered undiluted dose.  as of 24 hours-sore arm, fatigue.
Was administered as a booster to this patient on 9/2/2022; FDA stopped authorization on 9/1/2022 for ages 12> as a booster.   No adverse reactions or events occurred.
pt recv vax 6JAN98 & pt became pregnant (LMP 23DEC97);the pregnancy was confirmed by a home pregnancy test;expected date of delivery is 30SEP98;9JAN98 pt devel a lesion on lt breast that looked like varicella;poss r/t vax per reporter;
Swollen lymph nodes and swollen armpit on left side where the shot was. 2 days later and swollen armpit persists.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 02/12/2021 and 03/12/2021. They tested positive for COVID-19 on 05/12/2022. They were admitted to hospital 05/09/2022 and transferred to a different hospital on 05/12/2022. They experienced complications of acute respiratory failure, septic shock, and cardiac arrest. They remained hospitalized until their death on 05/20/2022.
On 1/20/00, Thursday morning, hives & swelling of eyelids, temp 100 & still present as of 1/21/00. Was treated by Dr on 1/21/00.
Breakthrough case admission after 3 vaccines Pfizer 2/26/21  Lot# EN6200;  Pfizer 3/19/21 Lot# ER8727;  Pfizer 11/4/21 Lot# FH8028
Began coughing on 12/7/22 and tested positive for Covid 12/8/22.  Vaccine administered
Received TDAP on 6/9/09 noticed hives to injection site and just below injection site to anterior upper arm. Had swelling blotchiness to areas and muscle aches. 6/15 Has slight red area to anterior upper arm today. To report if any further redness that does not go away.
This spontaneous non-valid report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with VARIVAX and M-M-R II intramuscularly for prophylaxis (dose, lot# and expiration date were not reported). No adverse symptoms were reported.
Approximately 7 hours after the shot, Patient started shaking, mild shakes at first but then the shaking became more violent, I helped him lay down in bed as he was not able to control the shaking and his legs became stiff. I was monitoring his temperature and he did not have a fever. I was massaging his hands and legs, this went on for 45 minutes to 1 hour. When the shaking subsided, the fever started, at this point I gave him Tylenol and continued to monitor his temperature.  He is better this morning.
It was reported that a pt (5 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
got a mild case of COVID/got tested positive; got a mild case of COVID/got tested positive; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (batch/lot number: unknown) for covid-19 immunization; BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (batch/lot number: unknown) and as dose 2, single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got a mild case of COVID/got tested positive". The patient underwent the following laboratory tests and procedures: COVID-19 test: positive.  Additional information: The reporter informed that she got the four doses of Pfizer COVID-19 vaccine. She was interested of getting the fifth shot. The reporter was asking about the time frame of when she will be going to get the fifth shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt experienced a sore neck for 10 days; chills/fever and congestion for 3 days; both wrists and knees were sore a swollen for 3 days; soreness at the bottom of rib cage for 21 days; constipation and loss of appetite for 14 days; and ears were plugged up for 21 days.
Since the weekend of July 22,03 Post vaccination w tetanus experiencing severe hives, must be controlled w antihistamine (after W 2nd generation)
PATIENT RECIEVED MODERNA DOSE 1 ON 03/11/2021.  ON 03/14/2021 SHE NOTICED A KNOT ON THE SIDE OF HER NECK ON THE SAME SIDE OF HER BODY THAT SHE RECIEVED THE VACCINE.  SHE SCHEDULED AND APPOINTMENT WITH HER DOCTOR AND WAS FOUND TO HAVE SOME SWELLING UNDER HER ARM PIT AS WELL ON THAT SAME SIDE.  HER DOCTOR DID BLOOD WORK (CAME BACK NORMAL PER PATIENT) AND PROVIDER HER WITH AN ANTIBIOTIC (KEFLEX),
syncope; POTS; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 13-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2010, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, headache, and fatigue. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Patient required hospitalization due to breakthrough infection. She received J&J vaccine on 03/19/21. Hospitalized from 08/13/21 - 08/19/21. Below is copied from discharge summary:   Says diarrhea with 3 loose BMs today; I see a small formed stool in bedside commode but resting tachycardia 100s PT advise home with intermittent supervision sats 95% with exertion on her home 3 l NC, pt v relucatnt to go home saying son is out of town, also a big component of her base line anxiety too Maintain COVID isolation for 20 days 8/13-9/2   8/16- 99% on home 3 lmp NC; refuses to let go of unneeded O2 " i've been on it for 2 yrs"   8/15- 100% on home 3lmp NC- dips to 97% on RA   8/14- 94% on RA with good wave - however says 3 lpm NC home O2 dependant x 2 yrs and gets v tearful when I remove O2   Now says was told at  hospital a day before this ER visit for couple of days of gen wkness, poor appetite, vomiting and not feeling well and was told to have COVID   dispo - clinical improvement in diarrhea, then  STR who accepts COVID
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case is linked to 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281635, 2018SA281636, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692 (same reporter). This case involves a four months-old (also reported as five months-old) female patient who was vaccinated with PENTACEL (batch number: C5507AA, expiration date: 05-Sep-2019, dose, left thigh was the site of administration the route was not reported for both vaccines) on 12-Sep-2018 which was stored at 30 F temperature for four hours. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt received Pfizer vaccine on 04/09/2021, Lot number ER8735. Received Moderna Vaccine Lot 022C21A on  05/07/2021.  No complaints. Vitals stable. Monitored 30 mins after vaccine.
Child started running a fever of 101.2 degrees Farenheit around 7PM, she was given Tylenol for fever at this time. Mom noticed hives/rash on her abdomen, back, and both thighs. Childs eyes were swollen and started oozing yellow drainage. Child also had respiratory distress where she would gasp for air and couldn't get her breath. Child wouldn't make any facial expressions or body movements and would just stare. Mom also stated child did not want to eat or drink anything after shots.
muscle pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL3247 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 at 14:30 (age at vaccination 44 years) as dose 1, single for COVID-19 immunization. Medical history included Known allergies: sulfa drugs from an unknown date and unknown if ongoing known allergies was sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. On 24Feb2021 at 16:00 the patient experienced muscle pain at injection site. Since vaccination the patient was not tested for COVID-19. The patient took ibuprofen as therapeutic measures for muscle pain at injection site. The patient was recovered from the event on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
possible loss of hearing; fall; the broken part is behind the left knee; incomplete course of vaccination; Ringing in the Ear/tinnitus since two days after the first shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (possible loss of hearing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Overweight and Hypertension. Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced TINNITUS (Ringing in the Ear/tinnitus since two days after the first shot). On 16-Jun-2021, the patient experienced LOWER LIMB FRACTURE (the broken part is behind the left knee) and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On an unknown date, the patient experienced DEAFNESS (possible loss of hearing) (seriousness criterion medically significant) and FALL (fall). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain relief, at a dose of 1 dosage form. At the time of the report, DEAFNESS (possible loss of hearing), FALL (fall), LOWER LIMB FRACTURE (the broken part is behind the left knee) and TINNITUS (Ringing in the Ear/tinnitus since two days after the first shot) had not resolved and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, X-ray: abnormal (abnormal) the broken part is behind the left knee, per x-ray examinations..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated that the patient has planned a left leg surgery on 21Jun2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Significant follow up. Lab data, treatment medication and new events are added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe headache lasted 1 week, took Tylenol.  Body aches, night sweats, upset stomach  lasted 1 week, then, enlarged  lymph node in groin, lasted 2 weeks,  soreness still in that leg.
Severe intestinal cramping, diarrhea, nausea 5 days after shot. ~90% recovery next day (6 days after shot).  After my second Moderna shot I had severe intestinal cramping and nausea 5 days after the shot, abut did not have diarrhea.  90-100% recovery next day (6 days after shot).
Immediately after injection was administered on 9/16/2010, site began to swell. Swelling continued for around 10 minutes until it became about the size of a quarter. Patient was watched and given a BENADRYL 25mg capsule. Swelling began to recede after about 15 minutes. Patient felt fine and was called 2 hours later at which time was told patient was fine.
blood pressure around 198/95; heart beat is on 95bpm; Sweating; Felt horrible; throat started to closed; difficulty of breathing; heart beat was on 100-120 bpm; blood press was high over 130-150.; warm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), FEELING HOT (warm), THROAT TIGHTNESS (throat started to closed) and DYSPNOEA (difficulty of breathing) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included xendrofine iGg, GABBA penting, miopity, AMITRIPTYLINE, Simbo cords, ProAir                                                         emergency lungs, TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), MONTELUKAST SODIUM (SINGULAIR) and pills to sleep sometimes for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Feb-2021, the patient experienced FEELING HOT (warm).   On 24-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), THROAT TIGHTNESS (throat started to closed), DYSPNOEA (difficulty of breathing), HEART RATE INCREASED (heart beat was on 100-120 bpm) and BLOOD PRESSURE INCREASED (blood press was high over 130-150.).   On 02-Apr-2021, the patient experienced BLOOD PRESSURE ABNORMAL (blood pressure around 198/95) and HEART RATE INCREASED (heart beat is on 95bpm). At the time of the report, HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), FEELING HOT (warm), THROAT TIGHTNESS (throat started to closed), DYSPNOEA (difficulty of breathing), HEART RATE INCREASED (heart beat was on 100-120 bpm), BLOOD PRESSURE INCREASED (blood press was high over 130-150.), BLOOD PRESSURE ABNORMAL (blood pressure around 198/95) and HEART RATE INCREASED (heart beat is on 95bpm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant products included xendrofine iGg, GABBA penting, miopity, AMITRIPTYLINE, Simbo cords, ProAir                                                         emergency lungs, TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), MONTELUKAST SODIUM (SINGULAIR) and pills to sleep sometimes for an unknown indication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: NNI
Received the vaccination afternoon of April 2 and began experiencing intense pain in shoulder and hasn't subsided since. I am still experiencing severe pain and limited range of motion. The injection was administered high on the shoulder near the joint instead of the usual place in arm. I was not ever experiencing any shoulder pain before the injection.
Patient received vaccination and approximately two minutes later started to experiance dizziness and nausea. Patient began to actively vomit. Patient did not produce high quantity of emesis. After lying down and receiving cold compress symptoms began to resolve.
Information has been received from a mother concerning her daughter who was about 7 years old, who on an unknown date, was vaccinated with a dose of ATTENUVAX. There was no concomitant medication. The mother reported that right after her daughter got the ATTENUVAX, she developed fever and a few spots. She almost "looked like she had measles". The patient recovered "about a week after it started". It was unknown if the patient sought medical attention. No further information is available.
Coughing; Nose running; Hurts head when I cough; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), RHINORRHOEA (Nose running), PRIMARY COUGH HEADACHE (Hurts head when I cough) and FATIGUE (Tired) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing), RHINORRHOEA (Nose running), PRIMARY COUGH HEADACHE (Hurts head when I cough) and FATIGUE (Tired). At the time of the report, COUGH (Coughing), RHINORRHOEA (Nose running), PRIMARY COUGH HEADACHE (Hurts head when I cough) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Rec'd LAIV on 10/15/15, developed stuffy nose. 10/18/15 developed sore throat, headache, fever 104. Fever approximately 101 with MOTRIN. Is taking fluids okay.
Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter called to get information on Kinrix, that was administered to an inappropriate age patient which led to inappropriate age at vaccine administration. After collecting demographic information, the reporter realized she was calling the wrong company and abandoned the call. Very limited information known before call was abandoned. No other information was provided by reporter. NO PQC reported.