chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy intern refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-OCT-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # M013156, expiration date: 15-OCT-2017, intramuscularly (dose, site of administration were not provided) for prophylaxis. On the same day, reported as immediately after first vaccination, the patient received an additional dose of PNEUMOVAX 23 intramuscularly (dose, site of administration, lot#, expiration date were not reported) for prophylaxis, which was not expired. No adverse effect was reported. No product quality complaint (PQC) was involved.
Information has been received from the mother of a 30 month old male with no other pertinent medical history and no known allergies or adverse drug reactions reported who "at two months of age" was vaccinated SC with hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (date unknown). Concomitant therapy included unspecified antibiotics. At 30 months of age, the patient was reported to have experienced some "developmental delays"(date unknown). The patient sought unspecified medical attention. The patient underwent an Individualized Education Plan (IEP) Evaluation (results not reported). At the time of this report, the patient had not recovered from the event.  In follow up it was reported from an office worker that the patient had not been seen by the physician since 2004. In follow up information received on 26 Jul 2006 it was reported from an office  worker that the patient was no longer a patient of the physician's office and that the patient had transferred to another physician taking his records with him. The office had no details pertaining to this patient any longer and could not provide any information regarding the adverse event reported. No further information is available.
Patient started not feeling well the night after receiving vaccine.  Next day patient had flu like symptoms, headache, anxiety, increased heart rate and trouble breathing.  Patient also presented  with rash located back of neck and back - red, painful, burning and itching rash - painful to sleep on back the night after receiving the vaccine
had redness, heat and itching at the injection site.  will be trying antihistamine medications.
R arm upper arm swelling around injection site. Area of induration, erythema, slightly tender.
SORE ARM; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.
scarlet rash itchy rash all over; scarlet rash itchy rash all over; I couldn't swallow; breathing was difficult; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 13:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0183, Anatomical location: Arm Right, Vaccine Administration Date: 15May2021, Vaccine Administration Time: 12:30 PM), administration date: 15May2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FC3182, Anatomical location: Arm Left, Vaccine Administration Date: 21Aug2021, Vaccine Administration Time: 12:30 PM), administration date: 21Aug2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: DYSPHAGIA (life threatening) with onset 01Apr2022 at 15:45, outcome "not recovered", described as "I couldn't swallow"; DYSPNOEA (life threatening) with onset 01Apr2022 at 15:45, outcome "not recovered", described as "breathing was difficult"; RASH ERYTHEMATOUS (life threatening), RASH PRURITIC (life threatening) all with onset 01Apr2022 at 15:45, outcome "not recovered" and all described as "scarlet rash itchy rash all over". The events "scarlet rash itchy rash all over", "i couldn't swallow" and "breathing was difficult" required emergency room visit. Therapeutic measures were taken as a result of rash erythematous, rash pruritic, dysphagia, dyspnoea. Clinical course: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. Within an hour, patient developed a scarlet rash, itchy rash all over, then patient couldn't swallow and breathing was difficult.PatientI went to ER and was treated with IV Adrenaline (epinephrine), Steroids, Pepcid, O2 (oxygen), fluids.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine received at 0940 on 1/7 and at 0300 on 1/8 I woke up with low grade fever, chills and body aches. Extra strength Tylenol was taken mid afternoon on 1/8 and felt much better and no symptoms when I woke up on 1/9.
shingles; pt also exp aching leg & arm bones; poor appetites; unable to sleep all night; some form of shingles; infected hemorroid following flu vax;
+crying episodes for 3-4hr p/vax;mom gave APAP & bath to baby but still w/crying;pt cried self to sleep;mom did not tell MD until 2mo later on next vax;
Received Pfizer vaccines on 12/28/20, 1/18/21; tested positive for COVID-19 by PCR on 7/10/21. Unknown if patient was symptomatic.
Pt began inc temp 102 to 103 in PM p/receiving immun; Mom gave APAP but pt vomited 4x in PM; c/o redness & swelling @ inject site on lt deltoid;
Did not know we were pregnant, received vaccine. Got positive pregnancy test a few days later and miscarried the next month at 8 weeks with baby measuring 6 weeks. Have no history of miscarriage and two full term healthy babies prior to this. Unknown if related for sure, but this is the only change and timing seems important to report as possibly correlated.
Pain; Joint pain; Fatigue; Fever for 1 day/Fever; Nausea; Vomiting; Chills; Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.), PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PYREXIA (Fever for 1 day/Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.). On an unknown date, the patient experienced PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), PYREXIA (Fever for 1 day/Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right pointer index finger is still hurting/her finger is still like this and stated that it has been over a week.) had not resolved and PAIN (Pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), PYREXIA (Fever for 1 day/Fever), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            Patient received 1st and 2nd dose of Pfizer COVID-19  vaccine. No relevant concomitant medications were reported..
booster shot of moderna COVID 19 shot- had Headache, vomiting, worsening restless legs syndrome lasted 10/29/21 night- into 10/31/21 has resolved now
Brain fog" after 1st dose; Lethargy after 1st dose; When the plunger was injected into me felt an intense burning "like a match was in my arm"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Brain fog" after 1st dose), LETHARGY (Lethargy after 1st dose) and VACCINATION SITE PAIN (When the plunger was injected into me felt an intense burning "like a match was in my arm") in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID and ATENOLOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog" after 1st dose), LETHARGY (Lethargy after 1st dose) and VACCINATION SITE PAIN (When the plunger was injected into me felt an intense burning "like a match was in my arm"). On 15-Feb-2021, FEELING ABNORMAL (Brain fog" after 1st dose), LETHARGY (Lethargy after 1st dose) and VACCINATION SITE PAIN (When the plunger was injected into me felt an intense burning "like a match was in my arm") had resolved. Not Provided      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.   This case was linked to MOD-2021-090267 (Patient Link).
5 hours after immunization felt"like getting Flu"headache sore throat general malaise Tired no fever lasted through next day
This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in October in 2015, the patients were vaccinated with improperly stored dose of PROQUAD (Merck) (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
Varicella vaccine administered with 5/8" needle to left upper arm @ approx 11:10 AM. Pt left exam room @ approx 11:20 AM and used bathroom. Pt reported feeling lightheaded and her father caught her as she began to fall after exiting bathroom. Pt was yelling and kicking her feet as her father held her. Pt was put in supine position by HD staff with feet elevated. BP 101/55 P69 @ 11:10 AM. Pt c/o stomach ache and frontal HA. Cool cloth applied to forehead. Color pale. At 11:30AM pt left walking after reporting feeling better. Stomach ache gone color returned to normal BP 100/60. Cont to c/o Frontal HA. Suggested hearty lunch, increase fluids, no caffeine. Indoor quiet activity for 24 hours. TYLENOL for HA. Report to ER if condition worsens or does not improve.
Right frontal headache and pain progressively.  OTC medications dulled the pain, but it continued despite conservative management with OTC medications, rest, and increase in fluids.
right eye herpes dendritic keratitis; herpes dermatitis of the eyelid; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 13-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, reported as shortly after receiving Zoster Vaccine Live (ZOSTAVAX) the patient suffered from right eye herpes dendritic keratitis and herpes dermatitis of the eyelid. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, right eye herpes dendritic keratitis was determined to be medically significant. The events right eye herpes dendritic keratitis and herpes dermatitis of the eyelid were considered to be disabling.
Approx 5 hrs after receiving vaccine, pt started with severe pain in arm that was injected. Pt unable to lift arm. Still in severe pain 3 days later. Some edema at inj. site. Extremely tender to touch.
Pt had a local reaction to DTAP characterized by a firm area that was warm with erythema, measuring 6cm X 8cm. No fever. Treated with Motrin  2 1/2 tsp QID prn pain, cool compress and recheck in 1 week.
immediate 4x3 cm wheal & flair w/improvement over 10 mins;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a expired dose of PNEUMOVAX 23 (route, lot number# and expiration date unspecified). No adverse effects reported. Additional information has been requested.
Vaccine administered 10/18/04. Patient presents 10/19/04 with right knee swollen/red streaks from knee. Started on oral antibiotic therapy. Presents 10/20/04 with more swelling. Referred to hospital.
I had chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (I had chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030L20A and 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported. No allergies were reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (I had chills). At the time of the report, CHILLS (I had chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient experienced chills after administer of first dose, second dose and third dose of Moderna.  The outcome was reported as recovered on an unknown date, and the symptoms were improved.  No treatment medication was provided.   This case was linked to MOD-2022-614384 (Patient Link).
August 27th. Woke up with tingling and itching Right mid back wrapping around slightly to side. Next evening feeling continued but now hurt. My husband checked bright red spots with tenderness when touched actually hurt. Itches and burns. This goes on the areas developed small blisters. After a few days maybe 2-3 I thought I think I agave shingles and took Shingrix over a year ago. I take Valacyclovir in the house so I took 2 doses. It felt much better so I stopped honestly thinking Maybe I was wrong. With 36-48 hours the burning hurting resumed so I went ahead and took Valcyclovir again and the area has now scabbed over still itches and hurts slightly. I do have a Hx Disseminated Zoster as a teenager requiring hospitalization it primarily was on face and involved my eye as well  and frequent oral Herpes but never shingles on any area of back.
Red, tender, warm, and swollen Left arm hurts to touch. Started today (5/15/16) when she woke up, sent her to dr. care.
Information regarding Prevnar injection was received from a mother of a 15-month-old male patient who received a fifth injection of Prevnar by accident on 17-Jul-2006 along with a dose of Poliomyelitis vaccine Inactivated (manufacturer unknown). On the same day, the child developed labored breathing, wheezing and deep, dry barking cough. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 17-July-2006. Dose regimen was 1 dose 1 time per day. Additional suspect vaccine included Poliomyelitis Vaccine Inactivated. Concomitant medications were not reported. On 17-Jul-2006, the patient received a fifth injection of Prevnar by accident (accidental overdose) (incorrect dose administered), along with another childhood vaccine. On the same day, the child developed labored breathing (dyspnoea), wheezing (wheezing) and deep, dry barking cough (cough). On 18-Jyl-2006, the child had no wheezing or dyspnea. As of 18-Jul-2006, the child had not recovered from the cough. No additional information was available at the time of this report.
Pt. came in to the pharmacy to show the reaction she had to the vaccine.  On 4/13/2022 patient received shingrix and prevnar 20 in the right arm.  On Wed had aches and pains; on friday awoke drenched in sweat; on sat pulse racing greater than 100. The patient presented to the pharmacy with a big welt on righ arm that seemed from shoulder to elbow.  Advised patient to use Ice and benedryl and she will be following up with dr on 4/18/22.
Inflamed and swollen left arm 4 days. Take BENADRYL 50mg q 4 H x 2 days.
Red whelp 5 " in diameter occurred the evening of the vax. The area was hot to the touch; lasting for 7 days. Administered Motrin every 8 hours along with ice packs. Pt still has bruise on leg where shot was given.
My TSH thyroid number has always been below 2.0. After my first vaccine had symptoms of low thyroid worse after the 2nd. Got blood test and the value was 3.2 this is significant. Nothing in my life; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8734), via an unspecified route of administration, administered in Arm Left on 20Apr2021 15:15 as 1st dose, single dose and second dose received via an unspecified route of administration, administered in Arm Left on 11May2021 15:15 (Batch/Lot Number: WE0170) as 2nd dose, single dose for covid-19 immunisation. Medical history included hashimoto thyroidist (had for over 20 years) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium, sertraline hcl taken for an unspecified indication, start and stop date were not reported. The patient previously took Sulfa and experienced allergies. No other medical history was reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient reported that her TSH thyroid number had always been below 2.0. After her first vaccine had symptoms of low thyroid worse after the 2nd. Patient got blood test and the value was 3.2, this was significant. Nothing in her life had changed to account for this. Last time thyroid checked was Nov2020 and was normal. Treatment was received for adverse event (AE), thyroid medicines was increased. Patient visited doctor or other healthcare professional office/clinic visit due to AE. The outcome of the event was recovering.
Information has been received from a medical assistant concerning a 16 weeks old male patient who on 17-DEC-2010 was administered the first dose of ROTATEQ (Lot # and expire date not reported), per oral. No adverse symptoms were reported. It was unknown if the patient sought medical attention. No further information is available.
Patient received the booster shot on 30OCT2021; The expiration date for booster is Oct 11, 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the booster shot on 30OCT2021; The expiration date for booster is Oct 11, 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the booster shot on 30OCT2021; The expiration date for booster is Oct 11, 2021). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the booster shot on 30OCT2021; The expiration date for booster is Oct 11, 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Red, raised, indurated x 3 days. Tx'd with cellulitis. Treated with Keflex 4-25-08
Pt developed hives on his face about an hour after receiving vaccine, treated with 25mg Benadryl with relief.
The patient s niece stated her uncle is coughing up phlegm; he is really tired; his arm hurting; This is a spontaneous report from a contactable consumer. This consumer (Patient's niece) reported for a patient (Reporter's uncle)   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Patient also received SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) via unspecified route of administration for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient's niece stated her uncle is coughing up phlegm, his arm hurting, and he is really tired. The patient just got the Covid shot when these symptoms took place while being on Entresto. The outcome of all the events were not recovered.   Information about lot/batch number is Requested