chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received 1st dose of Pfizer (5-11) Covid-19 vaccine on Friday 11/12.  Mother called 1 week later to report the patient was suffering from side effects of the vaccine.  Symptoms started on Wed 11/17.  Her face was swollen, a little of redness but not hot; her eyes was smaller due to the puffiness/swollen face; rash on face, legs, and body; itchy skin; pain on both palms and soles of feet, this pain was on and off and was described as a shocking pain; throat pain.  Parents gave her 1 dose of Benadryl Wednesday night.  Father denied any medications at time of vaccination.  Father denied any adverse events following previous vaccines.  I advised father to seek advice from patient's doctor.
Lightheaded, faint feeling approx 2 hours after receiving tetanus. No treatment was seeked.
Initial literature report was published on 10 October 2007. The article was received on 15 October 2007. A 2 month-old female patient with a normal birth history, that was breast-fed and thriving, received her routine 2-month immunizations, including Prevnar, Rotateq, Daptacel (lot#not reported), ActHib, Recombivax HB, and inactivated polio vaccine (manufacturer unknown). She cried immediately after vaccination, quieted down in a few minutes, and then left the office. The mother reported that the baby fell asleep in the car and looked fine. When she got home, the mother put her into her bed, where she slept about 3 hours. She then cried, and when the mom picked her up, she was cool and clammy, with a pale skin color. Her temperature rectally was 96.5 F. The mom called the physician and took her to the nearest emergency room. By the time she was seen about an hour later, her color was good and the temperature was said to be normal. A sepsis evaluation was performed (except for lumbar puncture); all tests were normal. At the end of the examination, the baby was acting entirely normally, and she has been free of symptoms ever since the single episode. According to the reporter the illness in this 2 month-old female infant fitted the definition of a DTaP vaccine-related hypotonic hyporesponsive episode (HHE). The cause of HHE was not known. An extensive follow-up assessment in 1998 did not reveal permanent sequelae after HHE. The reporter believed that the patient should continue her regular immunization schedule without change after a single HHE event.
ACUTE PULMONARY EMBOLISM 4/9/2023 PANCYTOPENIA ACUTE PULMONARY EMBOLISM 4/9/2023 RECTAL BLEEDING
Pt in ER c/o body aches, chills, and loss of appetite onset 3 days ago.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age of other race and hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised, and flu-like symptoms. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, on MAY-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. The patient was on steroids.  On an unspecified date, the patient experienced suspected immunological vaccine failure, and flu-like symptoms with shortness of breath sometimes, body aches, and febrile but not fever. Laboratory data included: COVID-19 antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189781.; Sender's Comments: V0: 20210826672-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
soreness at injection site; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a adult female patient who received HAB (Twinrix) for prophylaxis.   On 10-MAR-2023, the patient received the 1st dose of Twinrix (left arm). On 10-MAR-2023, less than a day after receiving Twinrix, the patient experienced injection site pain (Verbatim: soreness at injection site). The outcome of the injection site pain was not recovered/not resolved.   The reporter considered the injection site pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     The company considered the injection site pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   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: 10-Mar-2023 This report was submitted via the online direct entry reporting system. The case was reported by the patient for herself. The reporter denied to consent to follow up.
Client states he had seizure like symptoms.  He states he felt weak and layed down on the floor in his office at home.  He states he had some involuntary twitching.  He states that he woke up after falling asleep and went to bed.  He states that he slept well through the night and felt fine in the morning.  Employee did not seek medical care.  He was informed that he should be seen by his Provider.
High fever and rash appeared 4.5 days after vaccination, fever is still consistent with rash 3 weeks later. Varicella injection site is just now having a reaction on 2/25/2019 that is continuing to grow accompanied with a knot and warm to touch sensation.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: vaccine received was reported as yes. No other medication in 2weeks. Product COVID 19 Treatment, Treatment start date 02Jan2023, Treatment stop date 06Jan2023, device timestamp 22Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Next morning fever and chills.  Took tylenol and went to see the doctor.  Tested negative for the flu.  Fever went away that day.  Arm became very sore and feeling very tired.  Today is day 5 and site of injection is still red,  swollen,  and very sore.  Still very tired.
Blood blister; scarred areas; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (Blood blister) and SCAR (scarred areas) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2DA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD BLISTER (Blood blister) and SCAR (scarred areas). At the time of the report, BLOOD BLISTER (Blood blister) and SCAR (scarred areas) outcome was unknown. Not Provided          other concomitant medication include blood pressure pills treatment include Epsom salt.   This case was linked to MOD-2021-097962 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: follow-up received on 31-may-2021 and contain no new information
Subjective fever, stomach pain, headache on the night of 4.12 after getting the shot; the next day, she had similar symptoms. The following morning, however, she felt fine, but then she sat down and started having stomach pain again.  When she stood up, she felt dizzy and then passed out, per mom; mom thinks she was shaking a bit, but mom had caught her and then thought her eyes were slightly opened and looking up; that lasted about 30 secs, no head injury. She came to right away; mom doesn't think she was completely back to her normal self, but she doesn't describe a post-ictal state of sleepiness. Mom took her right away to the hospital on 4.14 after the episode of syncope; her tests and imagining all came back neg. also had shoulder pain and continued to have abdominal pain.
Started having pain in back that radiated around to adbomen. This then progressed to a red raised rash on lower mid back.  She went to her physician on 6/1/12 and was diagnosed with shingles.  Physician started her on oral medication.
On day 7 a small rash appeared on injection sight.   It has continued to grow.  It is about 2.5 inches around now.  It is hot, red, and itchy.  Cold compress removes itch but that?s it.  I also have a swollen lymphnode in armpit on that arm as well.
Severe bleeding and menstrual blood clots during menstrual cycle. Doctor treated with tranexamic acid.   Next period April 2021 was normal.
Information has been received from a physician via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot number and expiration date were unknown). On an unknown date, the patient got the shingles after she received ZOSTAVAX. The outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Pt experienced dry cough, occasional fever, episodic Diarrhea starting 8/13/2021, and is now admitted to hospital for treatment since 8/17/2021
At 1:30pm Varivax 0.5ml SC given; 2:00pm pt develops redness and hives on face, arms, trunk. 2:10PM Epinephrine 1.1000 (1mg/ml) 0.5cc SQ given. 2:15pm Prednisolone 15mg/5ml 5ml given per stomach tube. 2:30PM Pt clearing some, hives still noted, nail beds blue, O2 sat. 81%. Pt transferred to hospital for further care.
Rebound COVID with symptoms and positive antigen test; Rebound COVID with symptoms and positive antigen test; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 011L20A), in left arm, on 08Feb2021 as dose 2, single (Lot number: 030L20A), in left arm and on 13Sep2021 as dose 3 (booster), single (Lot number: 939902), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound COVID with symptoms and positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID with symptoms and positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as no. Anti viral details: COVID 19 Treatment, Paxlovid treatment started on 10Aug2022 and stop on 15Aug2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Rash occurred. Vaccine given on 6/18/10. Pt became itchy within 2-3 days and on 6/21-6/22, few papules developed.
Patient was given the flu vaccine around 830am and then went home. Close to 12pm mom returned to clinic stating patient's face was swollen. Patient was checked in and examined by a doctor, given Benadryl, monitored, and then released home.
Patient presents to the emergency department for generalized weakness and productive cough. He was recently hospitalized with COVID pneumonia and discharged. He was admitted for management of his recovering COVID illness and hypoxia. He was discharge 4 days later in stable condition to a skilled nursing facility.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 12/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient stated that about a week after taking the vaccine on 4/7/21, he experienced dizziness the only symptoms (no ear pain). No fever, body aches, chills, headaches, sob and no chest pain. He states the dizziness is getting slightly better but not much. Patient  Made an appt for PCP for the 4/22/21 15:20 Advised patient to get Benadryl or get a Transderm patch to place behind ears to help with the vertigo he's feeling. Will follow back up on Monday 4/19/21.
Symptoms began 1 day after 2nd dose was given. Lymph nodes swollen in axillary area (not painful), supraclavicular area (none painful), and cervical area (very tender) also shoulder joint pain all symptoms on the side the shot was given after the second dose. Currently 6 days post vaccination and all tenderness is gone lymph nodes smaller however still swollen.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
This spontaneous report was received from female consumer under her 65-years-old referring to herself via company representative. The patient's concurrent conditions, drug reactions, allergies and concomitant therapies were unknown by the reporter. Her medical history included an unspecified cancer that was diagnosed ten years ago. In 2018 (reported as "on an unspecified date last year" ; the patient was vaccinated with the PNEUMOVAX 23 injection, for prophylaxis for an unknown indication (doses number where not reported; routes and anatomical locations of vaccination, lot numbers and expiration dates were unknown by the reporter; a she was vaccinated with the influenza vaccine for an unknown indication (doses number where not reported; routes and anatomical locations of vaccination, lot numbers and expiration dates were unknown by the reporter). On unknown date (reported as "approximately three months after receiving the vaccines"), the consumer was admitted to the hospital , where she was performed a chest X-Ray and a full diagnostic work-up, and was diagnosed with the flu (Influenza) and a pneumococcal disease (pneumococcal infection). The patient received treatment for the events according to the reporter. The outcome of the events was reported as resolved. The causal relationship between PNEUMOVAX 23 and influenza vaccine administration and the occurrence of the events not provided by the reporter. Upon internal review, the event pneumoccocal infection was determined to be medically significant.
Patient fully vaccinated for COVID-19 with Janssen on 3/26/21. Patient arrived to ER  8/31/21 with cough, shortness of breath and generalized malaise. Symptoms started 1 week prior. Patient endorses loss of taste and smell. Patient admitted to reporting hospital on 8/31 for acute hypoxic respiratory failure 2/2 COVID-19 pneumonia. Patient was discharged on 9/8/21 to home.
Fever; inflamed sinuses; lethargy; lack of appetite; mental confusion; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: en6201), via an unspecified route of administration, administered in Left arm on 18Feb2021 03:30 pm (52-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The concomitant medications were reported as none. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: el8982), via an unspecified route of administration, administered in Left arm on 28Jan2021 03:30 pm (52-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient does not have COVID prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 19Feb2021 12:30 pm, 21 hrs after vaccination, the patient experienced Fever, inflamed sinuses, lethargy, lack of appetite, mental confusion. No treatment was received for the events. The outcome of the events were recovered with Sequel.  No follow-up attempts are possible. No further information is expected.
Left eye swollen 24 hours later, took Benadryl in ED and resolved right away
Vertigo started a few days after. I felt very woozy and I needed to lay down and sometimes it would come with a migraine and sometimes it would not. Tingling  and pain started in my fingers and moved up my wrists and arms. After a week and a half, my left foot went numb and a loss of sensation. On January 7, 2022, my entire body started twitching uncontrollably and I was shaking for an hour. I woke up an hour later, and it came back. I have had twitching and a buzzing sensation and went to urgent care and started a course of Prednisone on January 15, 2022.  The Prednisone has helped.
Pins and needles feeling along with tingling in all 4 limbs, weakness in arms and legs. (Neuropathy)
11 patients received IPOL from the punctured multi-dose vial of IPOL after the first excursion with no adverse event; Initial information received on 28-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old female patient who 11 patients received ipol from the punctured multi-dose vial of ipol after the first excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (with an unknown batch number) for Immunization.  On 10-Dec-2021, the patient received a  dose of suspect IPV (VERO) with the dose of 0.5 ml (lot U1A45M) via intramuscular route in (unknown administration site, frequency, strength, and expiry date).  On 10-DEC-2021 the patient received ipol from the punctured multi-dose vial of ipol after the first excursion with no adverse event (product temperature excursion issue) (unknown latency) following the first dose intake and (unknown latency following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (11 patients received IPOL from the punctured multi-dose vial of IPOL after the first excursion with no adverse event).  At time of reporting, the outcome was Unknown for the event 11 patients received ipol from the punctured multi-dose vial of ipol after the first excursion with no adverse event.  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.
Spoke with mom 10/28/04 9:00 AM. Stated daughter received shots on 10/26/04. Was fine on 10/26/04 and 10/27/04 AM. However, on 10/27/04 7:30 PM, mother noticed right upper arm swollen to tennis ball size and redness to golf ball size. Hot to touch, no streaks, no fever, no decreased range of motion. Giving Tylenol and cool compresses to arm. Told mom to call 10/29 with progress report. Mom called 10/29. Redness and swelling are subsiding. Call placed to mom on 11/2/04...arm back to normal on 10/31/04. No residual problems.
*FIRST* I am not sure of the  brand of the vaccines. When I looked online in her chart to double check the ones given (HepA, meningococcal conjugate and Tdap) it just said the type but no other info. Patient has received countless numbers of shots, IVs, blood draws, etc and never had an issue. The MA administered the Tdap in the right arm then the other two in the left. She said "OK all done" and I handed my daughter her shirt to get dressed when she just fell over and fainted on the exam table. She was totally pale, having no color in her face/lips and it took a good 30 seconds plus to get her to come to. When she came around and regained consciousness, she seemed almost startled. She had no recollection of the immunizations (saying "what what are the shots done??!!). After sitting for a while and having something to drink, she was feeling better so we were able to go home. She had eaten breakfast and had a snack of peanut butter and crackers in the car on the way to the appointment so she wasn't hungry at the time. I don't know if this would be considered a "reaction" or not but wanted to report it just in case.
CoughWheeze wheezing the next morning after getting vaccine  Narrative: no wheezing noted on exam; pulse ox  wnl. no resp distress noted
In the afternoon on 4/22/2021, I began to experience mild itchiness around the injection site on my left arm.  That evening, I began to also have some warmth in the area and noticed some swelling as well.  Upon looking at the site in the mirror, I could see a large, round area on my upper left arm that was raised, red.  No tenderness/pain.  Symptoms today continue to be mild swelling and minor itchiness.  I also have been dealing with 3, small spots in my right armpit, that appear to be ringworm.   I noticed these appear shortly after the shot on 4/22, but i didnt attribute it to the shot at the time.  I've had ringworm in the past, but it's only ever been one spot at a time, not 3.  And it's an unusual place on my body & I cannot think how I would have contracted it.  So I am not sure if it's truly.ringworm or some type of ezcema. I'm planning to also report all of this to my primary MD.