chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNtech COVID-19 Vaccine EUA. Immediately after administration of her second dose, patient reported feeling hot, dizzy, and light-headed. She has a positive history of fainting after vaccines. She did not faint after her dose but did feel faint. She moved herself to the floor after feeling light-headed and laid there for a couple minutes with a cold pack provided. She got up and went to observation and felt comfortable to leave the clinic.
21 y/o female with past medical history of ADHD and Depression that presents with dizziness and nausea, weakness onset post vaccination. Patient states that this is her second dose in the two-dose series. Patient denies previous reaction to 1st dose or previous vaccination in the past. Patient states that she also did not eat or take her medications this am. Patient received her vaccination to the Left arm. NP noted patient pale and diaphoretic.  Patient placed into wheelchair and taken to the partitioned area with the Paramedics. Patient noted to be hypotensive (84/47 BP) patient immediately placed in Trendelenburg and placed on 2L O2 NC. Patient vitals improved, 91/54 BP, 72 HR, 98% RA, Resp 14. Patient denies difficulty swallowing, sore throat, difficulty breathing or chest pain. Patient provided with a bottle of water, a mint and a fruit bar since she did not eat today. Patient, within 15 mins, states that she is feeling better and no longer dizzy. Patient no longer diaphoretic and color has returned to her face/lips. Patient vitals rechecked, 97/65 BP and all other vitals stable. Patient instructed to sit up for 5 mins, then sitting position for 5 mins and then placed in standing position for 5 mins. Patient states that she feels better and that she is no longer symptomatic. Patient monitored for 30 mins total. Patient discharged home in stable condition with mother and sister at side.
Lymph node swelling in both breasts; Lymph node tenderness and mild pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 12:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID) and progesterone (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced lymph node swelling in both breasts, tenderness and mild pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.Therapeutic measures were not taken as a result of events. The clinical outcome of the events lymph node swelling in both breasts, lymph node tenderness and mild pain were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Lips went numb, partial tongue numbness, spread to the face, elevated blood pressure 180/130, elevated heart rate 131 at its highest.
PATIENT WAS GETTING HER FIRST DOSE OF THE COVID VACCINATION AND WAS TOLD TO HAVE A SEAT FOR AT LEAST 15 MINUTES FOR POST-VACCINE SURVEILLANCE. PATIENT'S FRIEND ALERTED ME, SAYING THAT THE PATIENT WAS HAVING A REACTION. SHE REMAINED SITTING IN THE LOBBY, VISION WAS DARKENING, HANDS WERE TINGLY, AND PATIENT WAS SWEATING PROFUSELY. PATIENT NEVER FULLY LOST CONSCIOUSNESS. 911, EMS, MANAGEMENT, AND HER MOTHER  WERE CALLED IMMEDIATELY. PATIENT'S EVALUATION WITH EMS WERE ALL WITHIN NORMAL LIMITS BUT HER HANDS AND FINGERS REMAINED COLD AND TINGLY. SHE REFUSED TO LEAVE WITH EMS AND HER MOTHER DROVE HER TO THE NEAREST EMERGENCY DEPT.
A physician reported that a male in his 70's received an injection of Pnu-Imune 23 in 01/01. Subsequently, he developed an injection site reaction characterized by "pronounced swelling and hardness of entire upper arm". The patient also developed a fever. He recovered. MANUFACTURER'S COMMENT: The reporter indicated that 2 patient's experienced this event; however, only 1 is presently identifiable. An additional report will be generated when identifying information is provided.
chills; Swelling the size of a tennis ball under his arm (the vaccine was received) at the lymph node; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and LYMPHADENOPATHY (Swelling the size of a tennis ball under his arm (the vaccine was received) at the lymph node) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced CHILLS (chills) and LYMPHADENOPATHY (Swelling the size of a tennis ball under his arm (the vaccine was received) at the lymph node). The patient was treated with PARACETAMOL (TYLENOL) on 22-Apr-2021 at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and LYMPHADENOPATHY (Swelling the size of a tennis ball under his arm (the vaccine was received) at the lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MODERNATX, INC.-MOD-2021-090572 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-090572:cross linked; husband case
Pt was given immunization and told to sit in front of the pharmacy for 15 minutes. He was given a card with the time stating when he could leave. He did not wait. He and his mother walked to the produce section of the store. About 5 minutes after he received the vaccination I was notified by management that our pt had passed out in the produce department. When I got there the patient was sitting in a chair and drinking a bottle of water. He acknowledged that he did not sit as I had asked and as he was walking he began to feel dizzy and started to sweat. His mom said he got pale and then passed out. I waited with him for a few minutes until his color had returned and he said he was feeling much better.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JAN-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 30-JAN-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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.
After a week my injection site became red and itchy. A few days later the site was swollen and looked like a giant hive. The redness keeps getting larger and is painful. The injection site is now warm to touch and also feels hard.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2009, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) in a hospital for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2009, the patient was treated in the emergency room of the hospital for a blistering 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 would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-OCT-2013, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On an unknown date (reported as on or about 22-JUL-2013), the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
NO ADVERSE.  Reporting only administration error.  Patient was given expired Pfizer 5-11YO original formula for booster.  Vial had LOT# FK5618 which lists as expired on 08/31/2022 on Pfizer website.  Patient vaccinated on 09/09/2022.  Pfizer had no guidance.  Patient re-scheduled for re-vaccination.
Almost immediately following injection pt. developed severe itching on the back of his neck. His face, ears, feet, and legs below the knee became flushed and warm. Mother put a cool compress on his neck, gave him a bath, and put topical BENADRYL on affected areas. Symptoms disappeared within an hour of onset. (No redness/swelling at injection site).
Cellulitis - symptoms redness of skin since 10/14/11, local temp, elevated. No fever. No difficulty walking since 10/16. Signs - indurated and erythematous involvement of large portion of left thigh. Rx BACTRIM.
pt recv vax 31JUL;2AUG felt very tired c/o bones et muscle aches;11AUG reported fever 102-myalgia cont;stated devel sneezing, coryza;no cough;12AUG97 broke out on face, arms, trunk, small pinpoint raised red rash;
Employee's left arm is red, warm to touch and tender about 1 hour after vaccine and still red, tender 10/5/2017.
No adverse event.  Vaccine was administered ~1 hour after expiration time.  (Vaccine diluted at 0850 and expired at 1450 and was drawn up at the time of the appointment) Vaccine was administered at 1600.  Our Medical director reached out to Pfizer about the stability of vaccine - they said treatment recommendations is the discretion of the provider.
Information has been received from a registered nurse referring to an unspecified patient of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 09-AUG-2017, the patient was vaccinated with improperly stored doses of VARIVAX (Lot # N001530, expiration date 13-JAN-2019, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported. The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA008578: US-009507513-1709USA007601: US-009507513-1709USA007602: US-009507513-1709USA007604: US-009507513-1709USA007605: US-009507513-1708USA007019.
Fever 102; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 102). At the time of the report, PYREXIA (Fever 102) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102F.         No relevant concomitant medications were reported.  No treatment information was provided.
Light headed Heart rate increased Throat tightening Shoulders/back achy Headache Stuffy Slight chest pain Injection site pain
This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 19-APR-2016, the patient was vaccinated inadvertently with pediatric dose of VAQTA, K012457, expiry date 04-JUN-2017, 0.5 ml instead of an adult dose. No adverse effects were reported. Additional information has been requested.
Felt very loopy, tingling in legs, acting like under influence, hard time focusing, very silly.
Swelling, pain, redness at injection site.  Joint pain worse in limb (left) where vaccine was given.
Arm hard as a rock and swollen. Turned black and blue about a day later. Arm still black and blue as of 10/11/2016 and feels slightly swollen but getting better.
The patient states that since completing his 2-shot series of  the MODERNA COVID-19 vaccine, he has experienced decreased libido and erectile dysfunction.
pt recv vax 1996 & pt failed to seroconvert;5JAN98 pregnancy test revealed that pt was pregnant;
Heart racing; shortness of breath; tightness of chest; seeing black spots in my line of vision.
11OCT95 fever, lymph node pain, bone/joint pain, no appetite, very, very ill;pt different since this day;pt also exp sore throat, diff concentrating; dx chronic fatigue synd;
fingers numb; heaviness in chest for 30 minutes; Tingling sensation in fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (fingers numb), CHEST DISCOMFORT (heaviness in chest for 30 minutes) and PARAESTHESIA (Tingling sensation in fingers) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPOAESTHESIA (fingers numb), CHEST DISCOMFORT (heaviness in chest for 30 minutes) and PARAESTHESIA (Tingling sensation in fingers). On 04-Mar-2021, CHEST DISCOMFORT (heaviness in chest for 30 minutes) had resolved. At the time of the report, HYPOAESTHESIA (fingers numb) and PARAESTHESIA (Tingling sensation in fingers) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160/101 mmHg (High) 160/101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Starting 05/09/2022, I developed cold like symptoms: Sore throat, congestion, headache, fever, diarrhea and coughing. I tested myself that day and was positive. I scheduled a COVID-19 test at the pharmacy and when they did it it came back as unable to be ran (error with test). I went to the urgent care on 05/11/2022 and, due to having positive at home tests, they didn't feel the need to run another one. So, they told me to go home and rest. The fever I had was pretty high, around 104. It gradually got lower but it lingered for about 5 days. I had stuffiness, congestion and coughing for about 5 days. The fatigue lingered for about a month before it went away.
A legal complaint was received from an attorney alleging that a male child received series of Hib-Titer, Tri-Immunol, and Engerix B vaccines from July 1995 through October 1996. According to the complaint, as a result of the mercury in the thimerosal-tainted vaccination received during these developmental years, the plaintiff now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. This event was considered medically important. No further information was available at the date of this report.
Shingles; Redness; Pain; Blister; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles vaccine (received 10 to 15 years ago from reporting).   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced shingles, erythema, pain and blister. On an unknown date, the outcome of the shingles, erythema and pain were not recovered/not resolved and the outcome of the blister was unknown.   It was unknown if the reporter considered the shingles, erythema, pain and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine about 1 week ago from reporting. The patient reports that she now had shingles.  She had redness, pain, and she was starting to get blisters. The patient stated that this current case of shingles was in the same area as before. Patient gave consent to follow up with healthcare professional (pharmacy). The reporter consented to follow up.
H1N1 vaccine given 12/4/09. Began with diarrhea 12/7 and has had x 1 week. Rec. seeing PMD, maintain fluids.
Febrile seizure-45 secs of blank stare and bilateral upper extremity shaking-no treatment.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 06-MAY-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot # 0801AA, expired date 28-APR-2013) orally. This was patient's first dose. No adverse effect report. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
pt recvd vax 30SEP93 & seen in ER 1OCT93 acute fever 102-103, limp (hypotonia & diarrhea; discharged on 1OCT93; orders rx Pediolyte that noc; then APAP PRN for fever; seen 2OCT93 in office; t100 R;
Pt received the vaccine at 2:45 pm on 11/9. Approximately 1 hour later, she felt her throat become constricted. Hey eyes became swollen. She took cold medicine and was able to breath throughout night. 11/10 she received BENADRYL and felt much better.
post vaccine (left) arm soreness with hardness and redness around the injection site; redness is still there it is warm to the touch; post vaccine (left) arm soreness with hardness and redness around the injection site; post vaccine (left) arm soreness with hardness and redness around the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE INDURATION (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE ERYTHEMA (post vaccine (left) arm soreness with hardness and redness around the injection site) and VACCINATION SITE WARMTH (redness is still there it is warm to the touch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 VACCINATION SITE PAIN (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE INDURATION (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE ERYTHEMA (post vaccine (left) arm soreness with hardness and redness around the injection site) and VACCINATION SITE WARMTH (redness is still there it is warm to the touch). At the time of the report, VACCINATION SITE PAIN (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE INDURATION (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE ERYTHEMA (post vaccine (left) arm soreness with hardness and redness around the injection site) and VACCINATION SITE WARMTH (redness is still there it is warm to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-093874 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Follow up was attached and it contains AE related information; 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.