chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 minute wait post covid 19 vaccine. Patient complied. After initial 30 minute wait, patient complained her mouth was dry and asked for water. Water provided, patient denied other symptoms. Based on history patient advised to wait another 20 minutes, and notify staff prior to leaving. 5-10 minutes later husband alerted nurse that she was feeling worse. Upon assessment, patient complained of swollen tongue, and difficulty swallowing. Adverse reaction protocol initiated. Client laid on cot, vitals taken, EMS called. Tourniquet applied above vaccination site, distal pulse check every 5 minutes. Nasal cannula, 4L applied. Blood pressure high, patient became flushed, complained of worsening in swallowing. Epi pen given in right thigh, Benadryl given IM in right deltoid. EMS arrived and took over care. Patient transported to hospital.
Mild rash on chest; This case was reported by a nurse via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experience a mild rash on her chest after receiving Shingrix. The reporter did not consent to follow up.
Pt recvd 3rd dose of vax & 4 hrs p/vax exp pain in rt leg & weakness in dorsiflexion of foot; probably unrelated discogenic sciatic nerve irritation indicates responsible MD;
Redness, itching sensation and swelling down lt arm to elbow. Minimal redness and swelling.
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The vial was initially stored in the refrigerator on 20-Apr-2021. HCP said that none of the patients experienced side effects so was not sure if should send the form anyways. Also mentioned that there were 14 patients instead of 18 because of some duplicates   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: HCP confirmed that there were 14 patients instead of 18 because of some duplicates.
On the evening of 1/21/2021 I got hives. I took Benadryl and it lasted for about 2 days.
Long COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-729253 (Moderna).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6203), on 26Mar2021 as dose 2, single (Lot number: ER2613) and on 15Oct2021 as dose 3 (booster), single (Lot number: FF8814) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing), notes: Treatment: Symbicort; "allergies" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "BP/Blood pressure" (unspecified if ongoing), notes: fairly under control; "depression" (ongoing), notes: treated for depression which is working very well. The patient's concomitant medications were not reported. Past drug history included: Symbicort for asthma, notes: She has asthma and is on Symbicort, which keeps her lungs under good condition;. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "not recovered", described as "Long COVID". Therapeutic measures were taken as a result of post-acute covid-19 syndrome.  Additional Information: The 1st 3 doses were Pfizer and she claimed that she did not get relief of her long Covid symptoms. Patient had also received Moderna on 22Apr2022 as dose 4, single (Lot number: 001M21A) and on 19Oct2022 as dose 5, single (Lot number: AS7164B) for covid-19 immunisation and claimed that she was symptom free for at least 6 weeks after getting the doses. Patient had also received other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient stated that she contracted Covid-19 in Mar2020 before she received the 1st dose of the Covid-19 vaccine which led to her having long Covid. The symptoms she mentioned were fever and fatigue. She had been pretty much sick for 13 months. She stated that she would be pretty lucky if she had 4 days symptom free but symptoms mentioned come back. The symptoms would also appear when she was under a lot of stress like at the time of the call where she had now been taking Dayquil for 3-4 days. She was losing a lot of time at work.
Injection site really sore and swollen; sore to the touch. Patient felt horrible; no energy and headache. Started feeling somewhat better later in the afternoon, but it took a while. On 7-19-2018, patient woke up with 3 red splotches around the injection site and injection site was still really sore. I recommended that patient seek medical attention. Doctor diagnosed patient with Shingles.
Arm has pretty large bump; Arm is warm; Arm is pink; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm has pretty large bump), FEELING HOT (Arm is warm) and ERYTHEMA (Arm is pink) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm has pretty large bump), FEELING HOT (Arm is warm) and ERYTHEMA (Arm is pink). At the time of the report, PERIPHERAL SWELLING (Arm has pretty large bump), FEELING HOT (Arm is warm) and ERYTHEMA (Arm is pink) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.
Within 5 minutes of vaccine administration patient was signaling for attention. She was hyperventilating and moaning but was able to speak and describe her symptoms. She complained of cramps in her stomach that spread to her back in the kidney area. We tried to get management but they didn't respond. I referred to the clinical binder which dictated an ambulance was appropriate for this reaction. We asked patient if she would like an ambulance and she responded in the affirmative. Ambulance arrived in minutes and they took patient away. Her husband by her side was already calling for help. In about an hour and a half later the patient's husband returned with an insurance question and reported to us that the patient was doing fine and the hospital found nothing wrong with her. He said they plan on keeping her for an hour for observation but she just had an initial bad reaction to vaccine but was fine by the time she arrived at the hospital.
passed away suddenly a day after getting his first Moderna covid vaccine. He got the vaccine said he felt fine other that having a sore arm he has in good spirits and joking around according to his  coworkers. He died suddenly a day later circumstances are unknown ,He had passed before he was discovered.  No autopsy was done. Aneurysm is suspected.
severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (severe fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was provided.  Concomitant products included METOPROLOL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (severe fatigue). At the time of the report, FATIGUE (severe fatigue) had not resolved.            Concomitant medications included allergy medications, cholestrol medications and GERD medications.  No Treatment information was provided by the reporter.  Patient stated that he was very active person and it was very unusual for him to have this fatigue.
Between Aug90 + Nov90 pt vax w/ 3rd hepta B  expired lot. No adverse reaction.
Shortly after injection given the patient experienced localized redness and irritation. Within 30 minutes had localized swelling greater than 50 mm at the injection site. Patient denies itchy, SOB, eye irritation or throat swelling. ZYRTEC 10 mg tablet given in the office per o/o Doctor. Continue ice or heat tx and ZYRTEC for next 2 days.
She received the 2nd vaccine 2 weeks after the 1st vaccine. when did she test positive for covid? VSafe
This spontaneous report was received from a nurse referring to 29 unspecified patients of unknown age and gender. The patients' pertinent medical history or concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N014368, expiration date: 09-MAY-2017 (dose, frequency and route of administration were unspecified) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperature excursion was as follows: Temperature: 17.9 Fahrenheit degrees Time frame: 1 Hour and 33 Minutes Previous temperature excursion? No Was call because of a "data logger"? No.
patient's wife came into my store and told me her husband came in to get the shingrix vaccine and it was given too high up on his arm.  He had to go to the emergency room due to extreme shoulder pain.
Severe chills 8 hours after vaccination and I vomited 14 hours after vaccination
This spontaneous report was received from a female patient of unknown age who was reporting on herself. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, after receiving ZOSTAVAX, the patient developed a "silver dollar sized, rised" pinkish lump at the injection site. The outcome of the event and relatedness between the event and ZOSTAVAX were not reported. Additional information is not expected as no contact details were provided.
Nerve pain down left arm, where Tdap administered. No prev adverse event of w/any immunizations.
Patient received 1st Pfizer vaccine on 10.1.21. Patient diagnosed with eccentric mural thrombus by PCP on 10.19.21. Patient does have history of super mesenteric thrombosis in 2014 (thought to be from oral contraceptive). Patient instructed not to get 2nd dose of vaccine by provider.
very lethargic; high fever of 103; rash on arm at injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (very lethargic), PYREXIA (high fever of 103), VACCINATION SITE RASH (rash on arm at injection site) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced LETHARGY (very lethargic), PYREXIA (high fever of 103), VACCINATION SITE RASH (rash on arm at injection site) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, LETHARGY (very lethargic), VACCINATION SITE RASH (rash on arm at injection site) and CHILLS (chills) had not resolved and PYREXIA (high fever of 103) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (abnormal) fever has gone down slightly, 101. On 18-Apr-2021, Body temperature: 103 (High) High fever.         No concomitant medication were reported.
Arm became sore late evening, 3 am was wakened with severe headache, migraine level and fever. Body aches increased throughout the day. Tylenol to reduce fever as much as possible. Low grade fever persists throughout- Saturday morning still have headache and muscle soreness
Pt. received vaccines 8/6/03. TC to FHD 8/11/03 c/o redness, swelling and lump on right arm in midline section of right upper arm. Advised pt. to return to clinic to be evaluated.  Lump on right upper arm, with redness. Denies fever at any time. Painful when lifting arm. No hotness felt at site. Pt. had put benadryl cream on site and had applied ice. Appears to be more of a defined local reaction.
Patient states she has a rash all over and is itchy. On exam there is no rash visible
She fainted, ghostly white. Then she went into seizure. BP 100/60.
My mom is having a bit of anxiety after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "My mom is having a bit of anxiety after the vaccine".  Additional information: Reporter wanted to know if it was okay to take the anti-anxiety medication after having the vaccine for the patient. Reporter hung up the call abruptly, further probing could not be done. Hence, limited information available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
constantly having tons of mucus and phlegm; sinus infections; allergies; feels sick on a daily basis; constantly having tons of mucus and phlegm; throws up; it gradually got worse.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 43 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included alopecia areata from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced constantly having tons of mucus and phlegm causing productive cough on an unspecified date with outcome of not recovered, sinus infections causing sinusitis on an unspecified date with outcome of unknown, allergies causing hypersensitivity on an unspecified date with outcome of unknown, feels sick on a daily basis causing illness on an unspecified date with outcome of unknown , constantly having tons of mucus and phlegm causing secretion discharge on an unspecified date with outcome of not recovered, throws up vomiting on an unspecified date with outcome of not recovered and it gradually got worse.leading to condition aggravated on an unspecified date with outcome of not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt c/o nausea following vaccine administration. vitals: BP 100/62, O2 96%, RR 18, T 98.4, P 62. denies pain, stated nausea and anxiety are normal following an injection. pt's s/s resolved after 30 mins pt was d/c and wad educated on contacting medical services if s/s worsens or reoccur.
Patient described symptoms of Bell's Palsy, confirmed by doctor and suggested that it may be from the flu shot as they did not find anything from other tests. Signs of numbness in face occurred approximately 13 days later. Patient was given medication from hospital to help with the swelling and an antiviral.
Forty five minutes after the injection she had pruritis, urticaria, redness, and her eyes were burning with irritation. She had hives on her left arm, left outer thigh, back, right arm, and inside of right thigh.
09/24/2003 7:00AM: 20 mm injection site right arm inflammation and pain-no edema; 09/24/2003 14:00: 46mm inflammation and edema high pain.  Site was measured by MD. A follow up report received 10/9/2003 adds: Area 100 x 95mm wide.
Patient immediately had pain at injection sight.  Patient was instructed to take Extra Stength Tylenol.  Returned the following day and area of arm was swollen and still extremely painful.  Patient was given Rx for Hydrocodone 5/325mg.  Patient is still not able to extend arm out in front of her and still has swelling.
Leg weakness on 1/29. On 1/30 returned to ER with vomiting and progressive bilateral lower extremity weakness and inability to walk.
Shaky, dizzy, clammy, vomiting, diarrhea, and headache 30 min after administration duration of symptoms: 3-4 hrs.
IM 10/20/2003.  Noticed redness 10/21/2003 area warmth.  Approximately 8cm erythema on 10/22/2003.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) had not resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-020834, MOD-2021-020834 (Patient Link).
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided    This case was linked to (Patient Link).
Swelling & itching: hands feet & throat  Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would  hurting, especially if pressure was applied to move or walk Shallow breathing  Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm  Went to emergency room in  around 8:30 PM on  Thursday March 25th.  Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM.  Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.
Severe arm pain, severe headache, horrible muscle pain, nausea, fatigue,. Unable to get relief with ibuprofen or acetaminophen.
No known adverse effects.; patient received a dose of VARIVAX and a dose of PROQUAD.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.     On 02-APR-2020, the patient was vaccinated with a dose varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S020965 and expiration date 07-JUL-2021), and with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot number  S012470 and expiration date 20-OCT-2020) (overdose), for both vaccines were administered as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported). No additional adverse effects were reported.
A physician reported via a company representative that a male child received his second dose of Prevnar. On 07-JAN-2002, at 28 months of age, the child was diagnosed with meningitis due to Streptococcus pneumoniae. The reporter considered the event to be life-threatening. No further information was availble at the date of this report. Follow-up information received on 27-FEB-2002 from the physician indicated that the child was a 25 month old male who presented to an emergency room on 15-JAN-2002 with a four day history of vomiting, fever, irritability and bilateral ear drainage. That same day he was admitted for hospitalization where he was treated with IV fluids, Tobradex (tobramycin/dexamethasone), vancomycin and ceftriaxone. a head CT was negative for cranial abscess. A CSF culture grew penicillin, meropenem and ceftriaxone reisrtant Streptococcus pneumoniae. a blood culture was also positive for penicillin, meropenem and ceftriaxone resistant Streptococus pneumoniae. On 18-Jan-2002, repeat lumbar puncture results showed clear and colorless fluid with a protein level of 97 mg/dL, glucose of 54 M4 mg/DL and WBC level of 456/mm^3. The child recovered and was discharged on 21-Jan-2002. Additional follow-up information received on 28-FEB-2002 indicated tha t the pneumococcal isolate was identified as serotype 19A. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Prevnar.
LEFT SIDE FACE SWELLING , SINUS PRESSURE, TONGUE FELT FUNNY PATIENT TOOK BENADRYL FOLLOWING MORNING