chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she used to be 6'2 but she thinks she has shrunk a little; nauseous/she is still just a little queasy; tried to get out of bed, and the whole world tilted on her/everything turned upside down; sore arm; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 17Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation.  Medical history included Breast cancer in 2003 or 2004, for which the patient was in three clinical trials following that time. The patient reported that she requested to have the vaccine administered into her right arm because she is a breast cancer survivor. The patient has no concomitant medications.  The patient confirmed that she did not have any other vaccines on the same day as the COVID vaccine. The patient previously received Letrozole for breast cancer and provided that she has not taken letrozole or any or medications, not even vitamins, for the last three years.   On 18Jan2021 the patient experienced sore arm, which was not severe per the patient. On 21Jan2021 at around 03:00, the patient was nauseous and when the patient tried to get out of bed, the patient felt like the  "whole world tilted on her". The patient reported the same thing continued a few times when she tried to get up, she just couldn't because everything turned upside down. So the patient went back to sleep, and she got up at 11:00AM, and she feels much better now, and now she is just having a little bit of remaining queasiness, like she can't go on a run right now, she is not 100%.  The patient inquired if these are known side effects of the product. The patient also reported that she that she used to be 6'2 but she thinks she has shrunk a little from an unknown date. The patient stated that her PCP was not aware that she received the vaccine. The clinical outcome of the sore arm was recovered on 19Jan2021.  The clinical outcome of the nauseous/she is still just a little queasy, tried to get out of bed, and the whole world tilted on her, and thinks she has shrunk a little was unknown.
Pt woke up day after vaccine with dizziness, nausea/vomiting, fatigue and had syncope x 3
Dizzy; Weird sensation; Cold feet; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (Weird sensation) and PERIPHERAL COLDNESS (Cold feet) in a 51-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (Weird sensation) and PERIPHERAL COLDNESS (Cold feet). At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (Weird sensation) and PERIPHERAL COLDNESS (Cold feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications  reported were Vitamin C and estroben. No treatment medications were reported.
Mother and baby stop by in the clinic the following day after baby had vaccinations reported baby had temperature of 38.5 C (101.3 F) and was fussy.  Mom stated gave son Tylenol and gave sponge bath.  Mom stated after 6 hours of taking Tylenol baby was fine.
Patient vaccinated on 07/28/2003.  Received TD/IM/LA.  Patient returned on 07/31/2003 with a reaction on the left arm.  Area of reaction measured 5 cm x 3.5 cm, was warm to touch, pruritic, and noted erythema.  Three papular urticaria areas where noted on the boarder of swelling to left upper arm.  Patient instructed to take Pediatric Benadryl - 1 teaspoon every 6 hours for 3 days or until resolved.  Tylenol protocol "after shots"-given.  Apply ice pack to area.  Returned on 08/04/2003 if condition not resolved.  Patient verbalized understanding.  No apparent distress noted.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 0.65 ml, subcutaneously, lot# M033910, expiration date17-OCT-2017 (anatomical location was not reported) for prophylaxis. The sterile diluent (manufacturer unknown) used for vaccination was not expired.
81 year old male patient with PMH of CHF, COPD, CAD, DM, HLD, HTN presented to ED with complaints of increasingly becoming short of breath over the past two weeks. He reported a dry cough for the past several days. He denies any associated CP, N/V/D, fevers/chills. Covid-19 + test on 11/2/2021.  Admission Dx: hypokalemia, SOB, CHF exacervation and pneumoia due to COVID-19 virus. Acute hypoxic respiratory failure.  D-dimer 596-861.  Treatments oxygen, remdisivir, gentle diuresis, Bumes, decadron, antibiotics, NSTEMI, CAD.  lovenox, eliquis, asa and lipitor. Pt discharged.
Had the above shots. Later that night was limp for 30 minutes. Developed a fever the next day.
reaction in eyes; This case was reported by a consumer via interactive digital media and described the occurrence of eye disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced eye disorder. On an unknown date, the outcome of the eye disorder was unknown.   The reporter considered the eye disorder to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient had a reaction from the first shot in his/her eyes. The patient did not get the second one. The followup could not be possible as no contact details were available.
Patient filled out consents for vaccines listed above, and marked she was not pregnant, the vaccines were given. She came back about 10 min later asking what would happen if she was pregnant; after speaking with her and questioning her she finally disclosed she was in fact pregnant and was due 9/13/18. Her OB doctor was notified and she was educated on potential risks.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955), on 04Apr2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "lupus" (unspecified if ongoing); "hypogammaglobulinemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Hashimoto's hypothyroidism" (unspecified if ongoing); "chronic bronchitis" (unspecified if ongoing); "spina bifida" (unspecified if ongoing); "Club foot" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LORATADINE; SERTRALINE; VALACYCLOVIR HCL. Past drug history included: Cefaclor, reaction(s): "Allergies: Cefaclor"; Fioricet, reaction(s): "Allergies: fioricet"; Ceclor, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 19Jun2022, lot number: GC2132, indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Blisters on my lips and a rash below my lower lip. It also happened a few days after my first dose (3/2/21 Lot # 027a21a) but I didn't connect it to the vaccine until it happened again after the second dose.  After the first dose, it started with an itch below my lip and then I noticed that the skin had sloughed off below my lip and started to scab over. I applied topical antibiotic ointment and lanolin but nothing seemed to help but keeping it moisturized until it faded after about a week. This time, my lips have blistered in addition to the skin breakdown. I have not seen the doctor for it because it seemed relatively minor and has resolved on its own in the past. It's mildly painful and uncomfortable.
pt reported she began to have s/e the evening of 3/26 after receiving injection, reported fatigue, body aches, chills, unable to get out of bed, ongoing x 5 days with no improvement.
37 y/o male rec'd Janssen vaccine @ 2:24pm, while in the recovery area, uprising to exit, c/o feeling a little lightheaded and dizziness.  Assisted back to sitting position, vitals stable, stated had not eaten since 0700 this am, provided w/snacks and hydration, monitored for an additional 20 minutes, symptoms resolved completed, denied having any further dizziness or lightheadedness, able to stand w/o c/o any kind and ambulate freely.  DC stable from recovery area to self care.
FRUSTRATED; NERVOUS; HEADACHE; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. . The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced frustrated, and nervous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of frustrated and nervous was not reported. This report was non-serious.
feel a sharp tingling (tangy) pain for a moment; muscle of her injected arm "is still giving me trouble; pain of the injected arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax and flu vaccine with an associated reaction of no adverse event.   On 11-FEB-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling sensation (Verbatim: feel a sharp tingling (tangy) pain for a moment), muscle disorder (Verbatim: muscle of her injected arm "is still giving me trouble) and pain in arm (Verbatim: pain of the injected arm).  The outcome of the tingling sensation, muscle disorder and pain in arm were not resolved.   It was unknown if the reporter considered the tingling sensation and muscle disorder to be related to Shingrix. The reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the tingling sensation and muscle disorder to be related to Shingrix. The company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 12-OCT-2023 The patient self-reported.  She got her first shot of Shingrix on February 11, 2023 in the left arm.  She was unable to find the lot number of the vaccine given but did provide the contact information for the pharmacy where the shot was administered.  She reports that even though she got the Shingrix shot 8 months ago the muscle of her injected arm was still giving me trouble.  She said that there was no pain during the injection but about 2-3 days later she felt that something went awry and she indicated that she had no problem moving the injected arm but sometimes when she had her arm in certain positions, for example, if she lifts her arm or turns it she will feel a sharp tingling (tangy) pain for a moment. Due to this she had not taken Shingrix shot 2.  The patient did not consent to follow-up.
Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO3249; Expiration date was not reported) on 20Jan2021 (12:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included watermelon allergy. Concomitant medications included celecoxib (CELEBREX), metoprolol tartrate, simvastatin and lisinopril. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Expiration date was not reported) on the right arm on 30Dec2020 (when the patient was 56 years old) for COVID-19 immunization. On 21Jan2021 (03:45), in the morning, the patient's blood pressure was sky high; had severe vertigo; nausea; vomiting; and cold sweats. The patient had resulted in the emergency room/department or urgent case for the reported events. The patient had received unspecified medications as treatment for the nausea and vertigo. The outcome of the events, 'blood pressure was sky high', 'severe vertigo', 'nausea', 'vomiting' and 'cold sweats', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 (nasal swab) post-vaccination which was negative on 21Jan2021.
Mother states her daughter was admitted to the hospital 10/19/00, related to increased bruising and nosebleeds. Mother states daughter plays soccer so she did not pay too much attention to the bruising which had been occurring for 1-2 months. Dx'd with ITP. Referred by PCP to hospital with platelets of 3000. On admission platelets 6000. Admission Dx :Thrombocytopenia
This spontaneous report was received from a pharmacist and refers to a 56 years old patient of unknown gender. On 03-JUN-2015, the patient was vaccinated with improperly stored PNEUMOVAX 23 (route of administration, dose, lot number: K012424, expiry date: 05-JUN-2016). The vaccine was exposed to -10.4 C for 2 hours on 26-MAY-2015. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, historical condition and concomitant medications were not reported. On 22-JUN-2018, the patient was vaccinated with a dose each of both VARIVAX and PROQUAD subcutaneously for prophylaxis (overdose). No known adverse effects. This is a non-valid case due to lack of patient identifier. Upon receipt of follow-up information, it was determined that this case is now valid because patient identifier was received. Follow-up information was received from a registered nurse on 13-AUG-2018. The 12 month old male patient received both the vaccines VARIVAX (lot # N019600) and PROQUAD (lot # N028444) intramuscularly using public funds at a public health clinic/hospital during the same visit. The patient was concomitantly administered HAVRIX, PREVNAR 13 and a Hib conj vaccine (unspecified carrier). No prescription drug treatment was required for the experience. The patient had no illnesses at the time of vaccination and had a birth weight of 5lb. 14oz. The patient's guardian was contacted. No medical event occurred.
Patient started having numbness and joint pain in her left arm within one hour of administration. By that evening, she had pain in all her joints. Joint pain lasted 3-4 days. She had vertigo when standing. Experienced confusion and forgetfulness for 24-36 hours.
Janssen-Covid19 vaccine eau  Full body aches Extremely lethargic hard to grasp things with hands Dizzy when standing Severe headache/migraine  Fever Cold Runny nose Congestion
This is one of several patients in the last couple months that have had local reaction (redness, hot to touch, swelling, pain) when these two vaccines are administered in the same location on same day.
Aching muscle in use of upper arm. This still persists after 5 months especially when raising my arm.
fever starting morning /p Hib shot, going up to 104 /win 48 hrs-Rhonci heard in both lungs, Dx: bronchiolitis, Ceclor-Tx
Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored ROTATEQ (lot # L013192 with expire date 19-JAN-2017, dosage was not provided) orally. The conditions storage was 32 F for 240 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client states ~ 9pm on 10/29/02 L arm sore, swollen, had a knot and redness at site of injections. Wed am noted redness and swelling of entire arm from shoulder to elbow. Wed evening developed abdominal cramping and diarrhea. Thursday am she states redness/swelling of arm decreasing. Few abdominal cramps. Advise to see physician if symptoms worsen.
Received the H1N1 vaccine on 11/4/09, 11/6/09 reports no appetite, intermittent nausea, 11/7/09 reports feeling hot, sweaty, and having chest pain. Denies rash, SOB, swelling. Went to ER, reports that doctor told him he had a reaction. ER doctor instructed him to take MOTRIN 11/8/09 reports no appetite 11/9/09 began to feel better. Symptoms were transient.
After 2nd injection, injection site was sore, hot and red with welps. Its been 7 days and and arm is still red, hot and itchy.
Information has been rec'd from a physician concerning a 13 yr old male with chronic bronchial asthma who on 11/23/01 was vaccinated with one dose of pneumococcal vaccine2 polyvalent (lot # 6372631448K) in the L deltoid. Concomitant therapy included montelukast sodium, (MSD) (duration, dose and indication not reported). Other concomitant therapy included fluticasone propionate (*) salmeterol xinafoate  (Advair), budesonide (rhinocort) and albuterol. On 11/25/01, 2 days post vaccination, the pt was seen in the ER for severe cellulitis 15cm diameter at site with pain and a fever on 104F. The pt rec'd treatment with an IV cephalosporin and was released with an oral cephalosporin, acetaminophen (tylenol) and warm compresses. The pt was seen again in the ER on 11/27/01 because the cellulitis had not improved. The pt rec'd treatment with IV cephalosporin and was released with oral cephalosporin, acetaminophen (tylenol) and warm compresses. The physician noted that this was the 1st injection to be used from the multi-dose (pneumococcal vaccine 23 polyvalent) vial. No one else had rec'd the vaccine from this vial and the physician was holding the  vial. The physician asked if there ere any recalls and if a culture should be done on the vial. The physician requested a response or follow-up on the vial and lot number check. Follow up information noted that after two courses of IV antibiotics plus an oral antibiotic course, the patient recovered on 11/30/01. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Upon internal review, the patient's severe cellulitis 15cm diameter at site was determined to be an other important medical event. Additional information has been requested.
Approximately 20-25 minutes after injection, very delayed vasovagal response. Awoke immediately after response. Approximately 15 minutes after response, very nauseated. Unable to ambulate - very weak.
lack of appetite; Temperature was 101.9 F; chills; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-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 23-Feb-2021, the patient experienced DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). On 24-Feb-2021, DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101.9 (Inconclusive) 101.9.
This spontaneous report was received from a 65 year old female patient regarding herself. On 10-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). Approximately on an unknown date in March 2013, the patient experienced itching. The patient sought no medical attention and no treatment was given for the event. The outcome of itching was reported as not recovered/not resolved. Additional information is not expected.
19 Y/O White male ADSM is referred for persisting lesion at initial SPV X6 months. Symptoms : Nodule, subcutaneous, Erythema, Pain, Lesion, Pustule, Lesions, Papule.  2/20/09 Received medical records  FINAL DX: none provided Records reveal patient's small pox innoculation site LA never scabbed over but remained a pustule which would not heal & became a nodule under the skin w/increased pain, swelling & drainage.  Referred to Derm on 2/6/09, no report included.
developed symptoms of Bell?s Palsy about 2 weeks after second dose of Moderna. Had numbness in mouth for 3 days. Right side of face was immobile by the fourth day of mouth symptoms. Was prescribed anti-viral medication. The palsy symptoms went away after about 5 weeks.
Patient experienced severe headache, muscle and nerve shooting pain throughout her entire body, inflamed joints and was not able to get out of bed.
Infected tooth; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced infected tooth on an unspecified date. Patient stated she was supposed to get her second dose of the Covid vaccine but she was on antibiotics and wants to know if that was ok. I did clarify and she started taking antibiotics after her first dose of the vaccine. The medicine was for an infected tooth. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
She had COVID-19 vaccine and had shoulder soreness and stiffness afterward which has not resolved but has in fact worsened. She has previously had frozen shoulder and this feels the same. She has tried exercises at home from previous PT but she is not improving and pain is worsening.