chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Feb2021 (Lot number: EL3247) at the age of 26 years as dose 2, single and intramuscular, administered in arm right, administration date 20Jan2021 (Lot number: El3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 28Dec2021, outcome "recovered" (Jan2022) and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab; (Jan2022) positive. Therapeutic measures were not taken as a result of covid-19. Clinical course: The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Unable to breathe through nose; Loss of voice; Throat hurt; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Father) reported for a 19-year-old female consumer patient (daughter) that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. Agent stated that the Caller reported that his daughter had side effects, this morning which include, unable to breathe through nose, lost her voice, and throat hurt. Agent also stated the Caller contacted an emergency advice line, and he was advised to call Pfizer, but if his daughter had breathing problems to go to the hospital. The outcome of the event was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's information on medical history, concurrent conditions and concomitant therapies was not reported. On 30-NOV-2017, the patient was vaccinated with RECOMBIVAX HB lot # N009802, expiration date 19-DEC-2019, intramuscular (dose number was not provided) for prophylaxis. The pharmacist reported that, previous to administration, a temperature excursion happened: 11.3°C for 4 hours were data logged. The reporter stated that no previous temperature excursions happened before. The pharmacist did not report any adverse events. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1712USA009299.
woke up w/swollen lip, gen malaise;went to ER told had a delayed allergic rxn, recv steroid inj & antihistamine, feeling somewhat better;
Pt recvd 2 Hep B vax & recvd 3rd vax Engerix-B 24OCT91; p/3rd dose exp fever, shoulder (at inject site) & neck pain, vague radiating pain; recovered w/o treatment;
Approximately 25 minutes post vaccination client reports "throat closing, unable to swallow and heart racing." States "throat closing lasted one hour and heart racing lasted about 2 minutes."  No trouble breathing.  She drove herself to the ER. She did not check in at ER. She waited in waiting room for approximately 7 minutes and then felt better so she left. Was not seen by any medical professionals.
The roof of my mouth and my gums became very inflamed/swollen; The roof of my mouth and my gums became very inflamed/swollen; The roof of my mouth and my gums became very inflamed/swollen; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 12:00 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, penicillin allergy. The patient had received the first dose of the same vaccine from Lot number=ER8732 on 30Mar2021 01:00 PM at the age of 61 years old, at the left arm. The patient experienced the roof of my mouth and my gums became very inflamed/swollen on 19Apr2021 with outcome of recovering. The patient received treatment for the events, IV Steroid, and a prescription for Oral steroids. The patient was not pregnant. No covid prior vaccination, the patient was not tested post vaccination. The events were assessed as serious.
A 11-year-old patient was inadvertently immunized with Pfizer-BioNTech COVID-19 vaccine which is approved for 12 years-old and older.  Patient was observed for the recommended 15 minutes post-vaccination with no adverse events noted.
Patient got 1st dose of COVID-19 vaccine on 4/6/21 and started developing rash/hives at night on her inner thigh with severe itching and puffiness around her eyes. She took two Benadryl capsules and rashes were gone after 6-12 hours. She did not have any shortness of breath or swelling on her face, neck or tongue. Patient called to inform this at pharmacy on 5/5/21 to ask if she should still take her 2nd dose
intermittent right arm/elbow pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): NVSC2021US144922_NS.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "intermittent right arm/elbow pain". Additional information: Relationship to patient: self. Event : The patient stated that he received Covid-19 Vaccine and Covid Booster and since then had experienced intermittent right arm/elbow pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Oblong circle type area measuring 12.75cm X 9.5 cm red and somewhat swollen, warm. located at base of deltoid.  resident denies pain. treated with ice to site TID until resolved.  Onset 1-21-21  - will continue to monitor until resolved.
Swelling and heat; Swelling and heat; chills, all that stuff; Shot hurt the moment it was given to her; Headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her), HEADACHE (Headache) and FATIGUE (tired). At the time of the report, SWELLING (Swelling and heat), FEELING HOT (Swelling and heat), CHILLS (chills, all that stuff), VACCINATION SITE PAIN (Shot hurt the moment it was given to her), HEADACHE (Headache) and FATIGUE (tired) outcome was unknown.            Patient is on concomitant medication, but does not mention which ones. No treatment was reported by the reporter.   This case was linked to MOD-2021-405931 (Patient Link).
Patient received vaccine around 10 am. She waited 30 minutes in the clinic with staff due to history of numerous allergies (zantac, demerol, amoxicillin, paxil, gluten). After patient left the site, she returned around 11:18am reporting she was feeling poorly (specifically with nausea, headache, and itchy/sore throat).  No lip swelling , shortness of breath, hives noted. Vital signs were monitored and were stable. Diphenhydramine 50mg given orally and EMS notified as per our company protocol. Patient left via ambulance at 11:32 in stable condition to Hospital .
Severe headaches,  nausea, unsteady, restricted diet (crackers, potatoes, farina, oatmeal, bananas), fatigue
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after receiving the moderna covid vaccine (less than 5 minutes), the patient fainted but remained breathing with a normal pulse. The patient experienced sweating and flushing. Patient flucuated between responsive and unresponsive. EMS arrived within 5 minutes of the incident to take the patient to the hospital.
Patient noticed Monday morning after 3rd dose she experienced pain and tenderness on her left side of her shoulder, chest, neck, arm and in the general area.  She also experienced swelling and redness on the left side.  She noticed she had swelling in her lymph nodes in the left side of her upper body.  When she came to the pharmacy she was still experiencing these symptoms.
Information has been received from a 59 year old female with a sulfonamide allergy and fibromyalgia who on 06-MAR-2006 was vaccinated IM with a dose of Recombivax HB. Concomitant therapy included PREMARIN. On 06-MAR-2006 the patient experienced lethargy, flu symptoms, fatty tumors in left side and under the right arm, pain with urination, "triggered" fibromyalgia, elevated blood pressure, and depression after vaccination. She had cultures done for her bladder. At the time of the report the patient was recovering. It was noted that she also had an adverse reaction while taking EFFEXOR. Other unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
5 days after immunization - diarrhea   8 days after immunization - seizure  also had pneumonia when in hospital.  10/21/08 Reviewed hospital medical records of 9/24-9/25/2008. FINAL DX: new onset seizures, aspiration pneumonia & rotavirus diarrhea Records reveal patient experienced irritability & loose stools x 2 days.  On day of admit, shaking upper extremities/body, grunting, head deviated to right, foaming at mouth x 1-2 min followed by blank starring.   Transferred from outlying ER after receiving Valium for 2 additional witnessed seizures.  Neuro consult done.  Tx w/antiseizure meds & antibiotics.  D/C to home on continued meds w/Neuro outpatient clinic f/u.
Recipient  put that he was 18 on form when he was only 17 (DOB 8/30/03) so J&J vaccine was given one week too early.
Patient said he did not feel good around 4pm the day of vaccination. Around 9pm patient said he was hot. His face, ears, neck and shoulders were very red and hot to the touch. He was then saying he was having hot/cold flashes. He said his arms around the injections sites were hot and itching.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patients were administered an unspecified number of improperly stored doses of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017 (dose and route of administration were not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Patient is 16 yo male who came to the pharmacy with his mother and his sister. Per patient's mother, patient does not have any issue with vaccine before. Patient got Pfizer at 2:10 pm and at 2:24 pm, he told his mother he is not feeling good. At 2:29 pm, he started to turn pale and 5 minutes later, he vomited. 10 minutes later, he back to normal. Asked patient to stay for another 15 minutes before leaving the pharmacy. At 3pm , patient left and feeling okay.
Swollen, purple color appeared on right hand, soreness in hand, rash appeared under armpit.
Pt recvd DTP @ 930AM @ clinic; slept approx 10 p/then cried from 12-3P inconsolable;
Information has been received from a mother concerning her 11 day old son with no past medical history and no drug allergies who on 05-MAY-2005 was "accidentally" vaccinated with hepatitis A virus vaccine inactivated. There was no concomitant medication. Subsequently the patient developed redness of the skin. There were no relevant diagnostic laboratory tests. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Suspected vaccination failure; herpes outbreaks; eyes herpes; herpes on throat; herpes on ear; patches over skin; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 10th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, herpes ophthalmic (serious criteria GSK medically significant), herpes esophagitis (serious criteria GSK medically significant), herpes zoster oticus (serious criteria GSK medically significant) and patchy rash. On an unknown date, the outcome of the vaccination failure, herpes zoster, herpes ophthalmic, herpes esophagitis, herpes zoster oticus and patchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster, herpes ophthalmic, herpes esophagitis, herpes zoster oticus and patchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported for the 1st dose. The patient had experienced constant and recurring herpes outbreaks since the second dose, occurring in the eyes, throat, ears and patches over skin.   The reporter reported that this event has necessitated patient be seen by his primary care doctor and they have been running blood tests to investigate. The reporter consented to follow up. This case was considered as suspected vaccination failure as time to onset for the event and laboratory confirmation were unknown.      Lab Comments: Lab test performed on unknown date
Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2016, strength, dose, lot#, expiration date and route were unknown. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 9 months old patient who in April 2012, was vaccinated with a 0.5 ml dose of VAQTA intramuscularly (lot number not reported). No adverse effects were reported. Additional information has been requested.
I do not know the name of the vaccine other than it was a high dose flu vaccine. I was extremely hyper (x 10), felt out of control with rapid breathing, sobbing, couldn't stop moving, then vomiting, started to calm down and  feel better by 10 pm.  Dr. (not directly) suggested I go to ER or could take Benadryl.  I am a caregiver so did not want to go to ER.  My Benadryl was old but took one tablet.  I had the same reaction last  year and made that known to the vaccine-giver so was told the decision was up to me  whether to take it or not.
Dizzy; wretched; blood pressure was got high; fast heart rate beating; I was very sick; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Left on 14Mar2021 as single dose for COVID-19 immunization. Medical history included blood cholesterol abnormal and blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included potassium (POTASSIUM) taken for an unspecified indication. It was reported that, she got one Pfizer shot and she was due for the next one in the morning at 11:25. The first shot that had gotten, she went to the emergency room; on 23Mar2021 she was wind up, dizzy, wretched and blood pressure was got high. It was one she thought like 184 over like a 160 or 170 and she had fast heart rate beating and it. She was in the emergency room with elevated blood pressure; she had fast heartbeat and pressure was very high. She was very sick and was afraid to take that second shot of vaccine. Therapeutic measures were taken as a result of blood pressure was got high as she was taking Metoprolol tartrate pills for it. The patient underwent lab tests and procedures which included blood pressure measurement which was elevated and heart rate which was fast on an unspecified date. The outcome of all events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient got dizzy and started shaking.  Face turned red.  Patient calmed down shortly.  Parent then admitted patient had anxiety over needles and required special attention at doctor's office for vaccinations
Woke with 65mm erythema & warmth to injection site. Followed by tender cervical lymph nodes on vaccination side, body aches, fatigue, temperature 99.4 oral
Dizziness and motion sickness that lasted for almost 3 weeks.  Significant fatigue that lasted for months
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022; No adverse event; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022). Concomitant drugs were not reported. Number of doses/vials: around 50 doses from 5 vials. The vials were initially refrigerated on 08-Jul-2022. The vial did not undergo any temperature excursions. Treatment details were not given.
I have SOB and weakness.  I have a fever.  I went to the ER. I am on oxygen.  They did a Covid-19 screen test, positive for Covid-19.  I am currently hospitalized.  They did chest X-ray, mild disturbing to lower bottom of the lungs.  I was pulmonary embolism which has now cleared up.
Pt woke up on 5-9-12 with golf ball size redness, swelling and itching on his right arm.   Spoke with mom on 5-11-12 and they applied a cool compress and she stated the redness is about half the size.  No meds given at this time for the treatment.  Mom will continue to observe and follow up with physician if redness increases.
really bad headaches; heart rate is a little higher than usual; numbness at the side of the shot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 45 [units unspecified]) received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 16Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She had her first dose of the vaccine on 16Jan2021 and had no side effects, just "numbness at the side of the shot". She mentioned however, since Sunday (24Jan2021), she's been having "really bad headaches" and has noticed that her "heart rate is a little higher than usual". The patient reported she had headaches more than 1 week after receiving the vaccine. She added that she didn't really have any symptoms, but she know like the main symptoms were within like the 3 day period. She has been experiencing the symptoms now and she doesn't know if it could be like a delayed reaction to the vaccine but she had the curiosity and wanted to report if and see if it is the delayed reaction or something else. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.
headaches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from an unspecified date at 11 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. During inbound call from the patient, the patient stated "I just got the COVID vaccine but I've been having headaches and fatigue". During inbound call from the patient, the patient has medical inquiry: If she should take the Xeljanz medication after getting the COVID-19 Vaccine. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
While taking a shower I noticed that my arms had a rash in various spots. Then I noticed I had other spots on my thighs and around my underwear line. The rash was worst on my arm that got the injection. After being out of the shower for about 30 minutes, the rash lightened in color but is still there now.