chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ON 11/05/03, PATIENT DESCRIBED SEVERE RIGHT ARM PAIN WITH LARGE AMOUNT OF REDNESS AND SWELLING - SEEN AT LEXINGTON MEDICAL CENTER ER (PRIOR TO ER VISIT,VOMITED-ARM POUNDING AND TURNING RED ON 11/04/03, 2 HOURS POST IMMUNIZATION ADMINISTRATION). GIVEN DILAUDID AND BENADRYL. INSTRUCTED TO USE ICE ON ARM X 2 HOURS, THEN HEAT.
Administered  the above vaccine past 75days of storage in the frig to 25 days past BUD. I'm calling all 55 patients to let them know their options.
1 dose of Shingrix only should be given to patients fully vaccinated with Zostavax; Dr said that accdg to Agency, 1 dose of Shingrix only should be given to patients fully vaccinated with Zostavax; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Zostavax (received on an uknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination and off label use. On an unknown date, the outcome of the incomplete course of vaccination and off label use were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician stated that, acording to Advisory Committee 1 dose of Shingrix only should be given to patients fully vaccinated with Zostavax. Till the time of reporting, the patients did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The physician planned to recall patients after conversation with Medical Science Liaison. The reporter did not consent to follow up.
severe leg pain; low grade fever; screaming and crying; screaming and crying; pain and stiffness; This spontaneous report as received from a pharmacist refers to a 12-year-old female patient. No information was provided regarding the patient's medical history, , concomitant therapies and previous drug reactions.     The patient's concurrent conditions included juvenile idiopathic arthritis which she outgrew at around 6 years of age.  On an unknown date in October 2018, (at 8-9AM) during a yearly checkup the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiry date, strength, dosage information, route of administration and anatomical locations were unknown for prophylaxis. On the same day at around 8PM that night, the patient experienced severe leg pain, a low grade fever (pyrexia) and was screaming and crying.   The reporter stated that the next day, the patient experienced a little bit of pain and stiffness (musculoskeletal stiffness) but was fine the following day. No additional adverse experience information provided. The patient had sought medical attention and was treated with motrin (IBUPROFEN) and acetaminophen (TYLENOL).   No additional adverse experience information provided.      On an unknown date in 2018 (reported as two days after vaccination), the patient was recovered from pain in extremity, musculoskeletal stiffness, crying, screaming and pyrexia was reported as recovered/resolved. Causality was not reported.
mild SOB, facial tingling/numbness, flush, light headed all while eating lunch. Pt sats 100%. No resp distress noted. LS CTA. VSS. Denies chest pain or other symptoms
Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Per the reporter, "the patient who already received the first dose of GARDASIL came in to the office with anticipatory anxiety about receiving the rest of the series of GARDASIL. The patient did not mention any side effects after receiving the first dose of GARDASIL, but for some reason she is having anxiety about receiving the rest of the series." The patient sought unspecified medical attention. No further AE information is available. Additional information has been requested.
Extreme swelling at vaccine site, red spot - after 10 days, still some swelling Nausea, headache, general discomfort (felt like I was hit by a truck) - about 5 days, lessening each day  Treatment with acetaminophen
Missed period for 3 months- when it finally came back, it was very painful and severe PMS was experienced (which was unusual).
low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (low grade fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included  an unspecified high blood pressure medication.
Mom said pt devel 102.6 temp about 18 hrs post vax & swelling, redness & pain in lt upper arm, w/red streaks into armpit (lt); Taken to pvt MD who treated w/Augmentin & APAP 10AUG91; Dx cellulitis;
Woke up with uncontrollable urge to move my arms along with tingling and numbness in the arm. Red streaks on the arm at the objection site that lasted several days. The Red streaks have subsided but the tingling and numbness and urge to move my arm has not. Overall feeling of malaise fatigue and buddy aches
Patient received only the liquid component of the vaccine; Patient received only the liquid component of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA688A, expiry date 30th April 2023) for prophylaxis.   On 15th April 2022, the patient received Menveo. On 15th April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: The patient received only the liquid component of the Menveo vaccine. The consent to follow up was given. Additional Supportive Information: The patient received only the liquid component of the Menveo, which led to inappropriate preparation of medication and incorrect dose administered.
client reported itchiness after receiving 1st dose Pfizer Covid Vaccine. Client had been sitting in waiting room 15 mins and was leaving when he approached both EMTs. First vitals at 1844: blood pressure 131/88, pulse 85, oxygen 99%. PHN  arrived, client sitting on chair, alert and oriented. Client stated itchiness on upper left back, began when he sat down 15 mins ago. Per client not worsening, noticed palms of hands slight pink. Per client no shortness of breath, itchiness not spreading. PHN asked to see clients face, no redness or swelling noted, no rash on back or injection site. PHN asked client to remain in observation longer to complete 30 mins, client agreed. Per client had sat down at 1826. No current medical history, medications or allergies. Vitals at 1851: blood pressure 129/90, pulse 83, oxygen 97%. Per client itchiness minimal, had not radiated anywhere else. Palms returned back to normal color. Client stated 30 mins had passed since he first sat down and was ready to leave. Client not driving, here with family member. ER precautions given of symptoms return or worsen
Arm pain on day one subsided approximately 24 hours later. Today my arm is swollen with a large painful red lump.
Dizziness, constant ringing in both ears, chest pains, weakness in shoulder muscles, and uncontrollable shaking of both arms and hands.
3OCT97 pt devel erythema, macular papular rash, swelling & itchiness @ the inj site;pt also exp coughing & an itchy throat;pt recovered;
nausea; tired/every day since receiving the product, she has had extreme fatigue; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 78-year-old) as 2nd dose, single, in left arm for COVID-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included unspecified high blood pressure medicine. Patient had no other vaccines on the same day as the COVID vaccine. On 03Feb2021, the next day after receiving Pfizer COVID vaccine, the patient was very tired. On the third day, the patient became even more tired. Patient also had nausea, but that comes and goes. Fatigue does not go away and every day since receiving the product, she had extreme fatigue. Patient had been on high blood pressure medications for a long time, so she thought that could have done it. The clinical outcome of the event was tired/every day since receiving the product, she has had extreme fatigue was not resolved and the clinical outcome of the event nausea was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Woke up at 3:00 a.m. feeling extremely cold despite warm PJs and plenty of blankets. Got up to turn the heat on and saw that the temperature in the room was 65 degrees, so it was not an especially cold night. Went to get a drink of water but was shaking so violently that I had a hard time filling the glass--water was just splashing  or spilling out. Body temperature later that morning and throughout the day was around 100 degrees. My normal body temperature is on the low side, around 97 degrees. Slept and/or dozed most of the day and slept nearly 12 hours that night. Four days later, am getting over it but am still feeling fatigued and not eating much. Arm is still slightly tender.
Confirmed Breakthrough Case  COVID-19 (Pfizer) 1 66 Years 11 Months 02/12/2021 local County Health Department Pfizer EL9265   COVID-19 (Pfizer) 2 67 Years 03/05/2021 local County Health Department Pfizer EM9810   COVID-19 (Pfizer) 3 67 Years 8 Months 10/25/2021 local County Health Department Pfizer EW0162
sore arm; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ASTHENIA (felt weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus systemic and Drug allergy. Concomitant products included HYDROCHLOROTHIAZIDE, OMEPRAZOLE, HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) and AZATHIOPRINE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ASTHENIA (felt weak). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and ASTHENIA (felt weak) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-101606 (Patient Link).
fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (201792). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "flu". The following information was reported: HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever". Additional information: Patient believed in the vaccine just a little worried about side effects cause she had side effects with both of vaccines she got the flu with the first and had a headache for 7 days and a fever with the second one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Covid monitoring documentation. PT admitted 12/16/22 documented to have positive covid. PT received Pfizer 3/15/21 Lot EN6199 for dose 1. Dose 2 was Pfizer given on 4/01/21 Lot ER2613.
Redness, warmth, and swelling on left upper arm at DTAP/IPV injection site. Cellulitis at injection sites on left arm.
This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of GARDASIL (lot # K009482, expiration date 06-MAR-2017) which were exposed to temperatures outside of the recommended range, were administered orally to the patients. No adverse experience had been reported. Temperature and time frame were: 1.2 degrees Celsius (C) for 22 minutes; 1.3C for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 331min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009624: US-009507513-1611USA009625: US-009507513-1611USA009626: US-009507513-1611USA008904.
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.  Reporter stated that they had a carton of vials in the fridge which was kept in there from the freezer on 01 Sep 2021. Vials were used on 05 Oct 2021, 07 Oct 2021, 08 Oct 2021, 11Oct2021 and 12 Oct 2021. In total, 16 patients were vaccinated in these dates using five vials. The vial was received in the refrigerator on 01 Sep 2021 and has been used to vaccinate past its expiration date of 01 Oct 2021.   This case was linked to MOD-2021-352746, MOD-2021-352860, MOD-2021-353006, MOD-2021-353022, MOD-2021-352843, MOD-2021-352625, MOD-2021-352822, MOD-2021-352833, MOD-2021-352837, MOD-2021-352948, MOD-2021-352955, MOD-2021-353005, MOD-2021-353227 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up information included no new information
Patient called 8/24/21 stating that she had a rash develop on her wrist (of the same arm as vaccination site) within 24 hours of receiving her second COVID vaccine.  It has since become a widespread rash with significant pruritus.  Patient was advised to treat with cetirizine (since she states she cannot take diphenhydramine), topical hydrocortisone or benadryl (if tolerated), and to seek medical attention if symptoms persist or worsen.
Face edema, lymphedema.  It was reported that a female pt received vax in 10/1999. Reportedly 4 days post vax, the pt experienced facial swelling and swollen lymph nodes. The pt was seen by an infectious disease doctor and had a biopsy done on one of the lymph nodes, the report was lymphoma. The pt was seen by an oncologist and went through chemotherapy. From additional information received on 10/04/99, it was reported that the pt recovered from the experience. As of 04/10/00, reported, 'Reviewed, no additional information at this time...' per physician.
I got the shot on Thursday the 16th and Saturday morning, the 18th, I woke up with my left thumb was extremely painful (same side as the shot). I?ve never had anything like that happen before. I?ve never experienced anything like that in regards to getting the COVID shots. I already had an appointment to see my doctor on Tuesday for a regular checkup. While I was there, I told her about it and asked if it could be perhaps a side effect. I saw that joint pain could be a side effect of the vaccine. She examined the thumb and thought it was tendonitis. She prescribed 3-day course of prednisone. She said if that didn?t fix that in 5-6 days, she gave me a referral to a hand specialist. Previous experience with other COVID vaccines have been mild so this instance surprised me. Unsure if it has anything to do with the vaccine at this time.
Patient developed acute pain, itching and warmth at site of vaccine administration. She developed a rash extending to the top of the LEFT shoulder into the LEFT earlobe
A 17 year old patient was given the vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was given the vaccine.) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was given the vaccine.). On 01-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was given the vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment medicines were reported
Pt recv vax on 1/9/98; on 1/10/98 pt exp fever(103F) & injection site rx of redness, pain &blistering;redness streaked into the axilla.  Pt to M.D.;tx=antibiotic.
Client received first dose of Pfizer vaccine @ approximately 2 pm, started to feel itchiness in throat and ear areas @ 2:15pm, made RN aware at 2:30pm.  No rashes or hives noted in said areas by RN, client denies trouble breathing.  RN offered Benadryl, client declines stating she does not like drowsiness from Benadryl, prefers to take her own medicine loratadine in car.  Client left home with husband, aware to follow up with primary physician.
under his armpit it is like very swollen lymph node; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) 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 (dose number unknown , Manufacturer- Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "under his armpit it is like very swollen lymph node".  The lot number for bnt162b2 was not provided and will be requested during follow up.
fatigue, headache, muscle pain, joint pain, chills, nausea, fever, cough. at this time still having them.
Initial unsolicited report received from a physician on 07 April 2015. A 13-year-old male patient had received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number, dose number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient felt claustrophobic in class. Corrective treatment and laboratory details were not reported. The event had cleared when he got outside and the patient had recovered on an unspecified date. Documents held by sender: none.
He got the vaccine, had no reaction other than slight soreness.  Then 2 weeks later he fell to the ground, was rushed to the hospital and had CT scan that told that he had a blood clot on the left side of his brain.  Had slow drip for 2 hours and then started getting feeling back in right side of his body and speech started coming back.  Was admitted to the ICU at Medical Center.  The next day did another CAT scan and there was no sign of the blood clot.  He is now on Plavix, heart pills, as well as Lasix.  His blood counts have been low since this and still being monitored to that.   Blood count 129 3 months ago, and 104 the other day.  Hemoglobin is low as well.   Went to the ICU to a regular room and then released.  Due for the 2nd vaccine while in the hospital and then had it subsequently on 3/9/21.  He did not have any reactions from that vaccine other than some soreness.   Lot #EL3302.    Before moving 22 years ago he did have a stroke and was hospitalized for 9 days, and has not had any problems until after the vaccine.  He believes that it is more than coincidence that for over 23 years  he has been fine, and that he had it 2 weeks after the vaccine.