chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaginal bleeding/spotting in menopause; Vaginal bleeding/spotting in menopause; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in left arm on 03Mar2021 14:45 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior to vaccination. The patient previously took lavender creams and experienced allergy. On 06Mar2021 at 03:30 PM, the patient experienced vaginal bleeding/spotting in menopause. There was no treatment received for the events. The patient underwent lab tests and procedures which included COVID test (nasal swab) which was negative on 05Mar2021. On an unspecified date, the patient recovered from the event.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: TINGLE DOWN ARM VACCINATED WIITHIN 15 MINUTE WAIT PERIOD WENT AWAY AFTER 25 MINUTES
I was having trouble breathing. My asthma got very severe. My heart rate and blood pressure went up. I ended up in the ER to have breathing treatments to help me breath. I had inconclusive EKG from my watch. I have an enlarged right ventricle. I also have double heart beat sometimes. They got horrible in December and have persisted since. I had to start taking Metoprolol to even out my arrhythmia.
Patient has substantial bilateral lung PE 12 days post vaccination; This is a spontaneous report from a contactable other health professional. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (at the age of 65 years) as single dose for covid-19 immunisation.  Medical history included allergies: penicillin and testim. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on an unspecified date for covid-19 immunization. The patient had substantial bilateral lung PE (pulmonary embolism) 12 days post vaccination on 14Mar2021 (as reported, pending clarification). The event resulted in emergency room/department or urgent care and hospitalization in Mar2021. Treatment of heparin infusion with rivaroxaban (XARELTO) initiation planned was received for the event. The patient had no covid prior vaccination and had not tested post vaccination. Outcome of event was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event pulmonary embolism 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 RAs, Ethics Committees, and Investigators, as appropriate.
After returning home from the Doctor, patient's arm where the vaccination was administered started to swell.  For the next few days, it swelled to a very large size, becoming impossible to even wear a shirt.  The pain was intense and the swelling did not allow patient to do any normal activities.  I reported the reaction to the Doctor, and was told to use ice and a pain reducer, since there was not much they could do in office.  I did so, but it did not seem to provide much relief.  The swelling had to run it's course for nearly a week until his arm was back to normal.
I received my COVID Booster shot at Pharmacy on Sunday morning, 11/14/21. The next day, less than 24 hours after receiving the shot I had a fever that night and had fever blisters in my mouth, 2 at the time. I was not able to go to work on Monday. The next night I had a fever again and woke up with 2 more mouth sores/blisters. I had a total of about 6 mouth sores and was unable to eat for about 10 days. I did not have this reaction with the 2 doses of Moderna. The blisters were gone for about a week and reappeared and this is when I called my doctor to get an appointment to get seen.  I thought this was normal until I started to read about the Pfizer shot and herpes simplex if dormant it will appear. I have a history of HSV 1 and 2. I have not had an outbreak of HSV 2 for about 10 years and my last outbreak of HSV 1 was in September 2018. I usually have a backup prescription of Acyclovir in case of an outbreak. Since I have not had one it never occurred that the COVID shot would have depressed my immune system and caused me to have an outbreak. I had to make an appointment to see my primary care provider and was seen on 12/9/21 and was prescribed Acyclovir 400mg 1 tab 2 times a day for 7 days. After being on the medication for 3 days I have improved and my sores are better.
Chills, high temperature 101+, lethargic, skin is hyper sensitive.
Tired; headache; lip tingling with second vaccine; lip tingling with first vaccine; left sided postnasal drip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lip tingling with first vaccine), UPPER-AIRWAY COUGH SYNDROME (left sided postnasal drip), PARAESTHESIA ORAL (lip tingling with second vaccine), FATIGUE (Tired) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and ROSUVASTATIN for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PARAESTHESIA ORAL (lip tingling with first vaccine) and UPPER-AIRWAY COUGH SYNDROME (left sided postnasal drip). On 09-Mar-2021, the patient experienced PARAESTHESIA ORAL (lip tingling with second vaccine). On an unknown date, the patient experienced FATIGUE (Tired) and HEADACHE (headache). On 06-Feb-2021, PARAESTHESIA ORAL (lip tingling with first vaccine) and UPPER-AIRWAY COUGH SYNDROME (left sided postnasal drip) had resolved. On 09-Mar-2021, PARAESTHESIA ORAL (lip tingling with second vaccine) had resolved. At the time of the report, FATIGUE (Tired) and HEADACHE (headache) had resolved.            Events include term tingling in the left arm and hand,itching in the face and neck had resolved    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Consumer reported additional events
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received FLULAVAL Tetra (2018-2019 season) for prophylaxis. On an unknown date, the patient received FLULAVAL Tetra 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL Tetra 2018-2019 season, the patient experienced influenza-like symptoms and injection site stinging. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site stinging was unknown. It was unknown if the reporter considered the influenza-like symptoms and injection site stinging to be related to FLULAVAL Tetra 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient experienced stinging at the time of injection and had flu like symptoms which lasted for 2 to 3 days. The reporter agreed to be contacted for follow up.
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Pyrexia: 101f (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatments were reported.   This case was linked to MOD-2021-041249 (Patient Link).
Lightheadedness Fever, despite Tylenol (101.3) Muscle pain - primarily in lower back and quads Joint pain - ankles, knees, hips
I started having intense chills; developed a fever of 102.5; I had a big headache as well; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received second dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3248), via an unspecified route of administration right arm on 04Feb2021 06:45 at single dose for covid-19 immunization. Age at vaccination was 25 Years. Patient was not pregnant at the time of vaccination. Allergies to medications, food, or other products included Penicillin allergy. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included Ovasitol. Historical vaccine included first dose of bnt162b2(COVID19, Pfizer, Lot number: EL3248) via an unspecified route of administration on right arm on 13Jan2021 06:45 at single dose for covid-19 immunization. On 04Feb2021 at 18:00, the night after she received the vaccine (12 hours afterward) she started having intense chills and developed a fever of 102.5. She had a big headache as well. Tylenol was received as treatment for the events. Outcome was recovering.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient did not experience temperature excursion previously. On 28-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
A couple of minutes after receiving the vaccine, my cheeks and ears got really hot and red.  The EMTs talked to me, asked if I felt okay and if I wanted to them to take my vitals and then they said we could go.  I took two benedryl that I had brought with me and that helped after about 20 minutes or so.  I took another benedryl at bedtime because my cheeks were still feeling hot but not as badly as when it first happened.
Patient's parent reported a large raised reddened area approximately 4 inches in diameter. Area was warm and hard to the touch. Steroid and antibiotic injection given to reduce inflammation and treat possible cellulitis at injection site on 11/10/17. Instructed to return to clinic if not improved or worsens within next day or two.
Patient became profoundly anxious. She could not leave her home without having a panic attack. To this day, she continues to struggle to be able to go to the grocery store.
Pt noted itching immediately after vaccine, the next day large indurated area 4 x 5 cm. Hives experienced the next day. Resolved with OTC CLARITIN.
loss of appetite; itching; dizziness; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), PRURITUS (itching), DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), PRURITUS (itching), DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, DECREASED APPETITE (loss of appetite), PRURITUS (itching), DIZZINESS (dizziness), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            No concomitant was provided. Patient treatment information was not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
This case was reported by a physician and described the occurrence of atopic dermatitis in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject's medical history included seasonal allergy. Concurrent medications included ZYRTEC. On 23 July 2010 the subject received 1st dose of CERVARIX (.5 ml, unknown route, right arm). On 25 July 2010, 2 days after vaccination with CERVARIX, the subject experienced atopic dermatitis and itching near injection site. The atopic dermatitis and itching occurred on the area above the deltoid on the same arm as she received the vaccination. At the time of reporting the events were improved. The vaccination course with CERVARIX was discontinued. The physician considered the events were possibly related to vaccination with CERVARIX. Follow-up information was received on 17 August 2010. It was reported that the events began on 25 July 2010 and resolved by 01 August 2010. Medical history of seasonal allergies began on 17 December 2002 and continues. It was reported that CERVARIX was given intramuscularly in the right deltoid. Concurrent ZYRTEC was taken orally at 10 mg daily beginning on 17 December 2002 for allergic rhinitis and allergies.
This spontaneous report was received from a male patient of unknown age, who referred to himself. The patient concurrent condition included blood pressure abnormal. The patient pertinent medical history included a pacemaker for his heart. The patient did not have any known drug reactions or allergies. On an unknown date (reported this Monday), the patient was vaccinated with ZOSTAVAX, 1 time vaccine, in the right arm to prevent shingles (route of administration, lot # and expiration date were not reported). Concomitant medication included: blood pressure medication (unspecified). On 11-OCT-2017 (reported as for 3 days now), the patient experienced rash at the injection site. There were no lab diagnostic studies performed. The patient did not seek medical attention. At the time of the report, the outcome of the event was not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported.
Developed a small patchy red rash near injection site.  It did not itch or cause pain.  It may have been there before I noticed it.  It was gone within 24 hours after I first noticed it.
BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On an unspecified date, the patient experienced blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210553711-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Extreme high blood pressure 201/100 , goes from extreme to normal in an hour continuously.
Now, she has the exact symptoms as when she had Covid; She can barely walk up the stairs; loss of appetite; This is a spontaneous report from a contactable consumer (on behalf of her sister) via Medical information team. A female patient of unspecified age (Age: 60, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 20Mar2021, as 1st single dose for COVID-19 immunization. Medical history included COVID-19 on Dec2020. The patient's concomitant medications were not reported. The reporter stated that the patient had COVID in early December and had severe muscle aches and pain, loss of appetite, headache but not a fever. After vaccination, she had the exact symptoms as when she had COVID. Patient feels like she has COVID again. It was reported that she could barely move in December. She stated that it was from the shot because she was fine up until she went for her shot. She started feeling it later on that night and the next morning (which she states was today). Patient could barely walk up the stairs. She stated they understand that they will be worse after the second dose. The reporter enquired if these symptoms are normal and how long they would last and if she can expect for it to be worse after the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: Unable to reach patient, patient reported event to the pharmacist who notified the provider.-Mild, Additional Details: Attempted to call patient x 3 with no success. Event reported by Pharmacist to the provider that patient needed to go to the ER for evaluation due to vaccine side effects.
Four days after vaccination I noticed my Lymph node was protruding from my neck.  It is my left clavicular Lymph node. It was very painful. I saw a doctor multiple times and I was told that it may have been related to the vaccine. A week later it had gone down a little and the pain was a little better.  It is still enlarged but not painful. I got the second dose 013M20A (02/12/2021)of the vaccine and had chills, body aches and flu symptoms but my Lymph node did not swell up. I got second dose in the other arm. My left arm is still hurting since that first dose. It feels like a bruise.
Patient was nauseous and sweating a couple minutes after his covid vaccine.  Patient was examined by Dr. Patient laid flat for approx. 20 minutes.   Gave patient a cool compress. Patient was feeling better once he left about 25-30 minutes later.
about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & acetaminophen), severe muscle aches, could barely move or sleep About 24 Hours after vaccine - same symptoms continued but developed very painful golf ball size lump under left armpit (lymphnode) same side as injection; around noon - the fever started to break but remained elevated (101.7-101F); remaine din the low 100's all day with being on ibuprofen/acetaminophen and still achy/headaches but not unbearable About 48 Hours later - woke up at 3 AM with another 101 F - went to work but left around 9 AM not feeling well (may just have been from exhaustion from not sleeping well the previous 2 nights); lymphnodes still swollen and painful; 101 F around 7-8 PM About 72 hours later - no fevers, feeling better; developed rash on left arm below injection site (red, slightly raised, warm to touch, painful to touch but not itchy), lymph node still painful but not as big About 96 hours later - rash same size, slightly swollen, painful to touch; lymph node smaller in size but still painful to touch
Patient started feeling dizzy, having headaches. After that patient started complaining of tirness. Patient had these same reation from previous dignious of HPV it made her start having seizure again. After a couple of day getting injection the patient would start feeling bad and then would start having seizures.
Nausea, vomiting, left arm pain/swelling, transient dyspnea
Information has been received from a nurse referring to a 39 year old patient of unknown gender. The patient's pertinent medical history and drug allergies were not reported. On 02-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L041629 with expiration date of 22-APR-2017, dose, strength and route unknown) (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
She got her vaccine, her arm was swollen last night.  When she woke up this morning the area of the vaccine was bubbling.  It looks like fluid.  It started out as a little bit but it's gotten worse and the area is getting worse and the skin is bubbling and swelling.  It is warm to touch and itching, and does not want to touch it.  She went to the pharmacy where she got the vaccine and they told her to give us a call.
Vaccine administered at 8:43am; t 8:58, Associate complained that her lips felt tingly. Associate was provided Benedryl 25mg po at 9:05 am; associate verbalized relief of tingling symptoms at 9:30; Assoc was released to home; Vital signs were taken; BP 137/80, 97% Spo2, Heart rate 80; vital signs were obtained after Benedryl administered.
TINGLING IN CHEEK (ONE SIDE); This spontaneous report received from a pharmacist concerned a 33 year old male. 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: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced tingling in cheek (one side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in cheek (one side). This report was non-serious.
The patient was given the Prevnar vaccine on 10/29/19 in his right arm and had significant bruising from the injection site down to his elbow. He presented to us on 11/8/19 and asked if this was normal. He had taken a picture of his arm to show us. He stated that it was getting better and he just wanted to let us know. He did not ask for treatments. etc.
Patient was acting nervous prior to the shot and bending over kneeling down in anticipation. Once the shot was given, she reported feeling a stomach ache after the shot.
Pt developed a pulmonary embolism, symptoms developed late in the evening of 1/30/2022. She went to Urgent care on the morning of 2/1/2022 for acute shortness of breath. Oxygen saturation was 82-84%. She was taken by ambulance to the ER and admitted for 7 days. She was diagnosed with acute pulmonary embolism.