chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and concomitant medications were not reported. On unknown dates since 11-MAY-2015, the patients were vaccinated with unspecified number of improperly stored doses of PEDVAXHIB (dose and route of administration not reported, lot # K015464, expiry date 09-JUL-2017 and lot # K026532, expiry date 07-AUG-2017). It was unspecified which lots were administered to which unspecified patients. No adverse effects were reported. Additional information has been requested. This is one of several reports from the same reporter.
Severe pain (nerve type) that began at 10 pm following injection. First injection felt like it was ?grabbing? my arm, different feeling than typical vaccine soreness. First vaccine, kept working on moving arm and was able to overcome. Did have Covid arm beginning on day 8, a nuisance only. I?m known to my physicians as strong, stoic, and have high tolerance to pain. Pain radiated from shoulder through the end of my fingers. Felt like battery acid, and shocking feeling, pure nerve pain. On scale of 1 to 10, pain was 10 most of the night, 8 at best. I avoided  NSAIDS as recommended. Finally took 1/2 tramadol at 7 am, totally immobilized arm with blankets and towels, used medical grade ice packs to control the pain. Pain was significant days 2 and 3 (probably 8), little better third morning. Suddenly at 4:30 this afternoon, most of pain left suddenly. As being a tough woman, this pain was horrid. It was similar to having shoulder surgery when the nerve block ?runs out?, without narcotics to get through the pain. It may have been a high IM injection, but yes 3 fingers down from acromion. Felt high
Admited 10/12/2021.   Arrived via POV from PCP office after c/o SOB x1 week. Test positive today. c/o generalized weakness. History of Present Illness  89yo man with multiple medical issues who presents with cough and congestion. He is vaccinated for COVID since March, 2021. His symptoms started roughly 1 week ago. He denies fevers and chills. No n/v. Reports significant weakness. He went to his PCP today and his pulse ox was 82% on RA and he tested positive for COVID. He was sent to the ED for further care. Here he underwent CTA PE protocol which showed no PE but he does have b/l airspace disease. He was hypoxic on his ABG and admission was requested.     Review of Systems    A complete point 10
This infant had a high fever of 103, vomiting, no appetite, pale, diarrhea, and keep dozing off. Diagnosis was severe reaction to Prevnar per family physician. Treatment at the hospital was IV Suprax.
Went into seizure minutes after having this vaccine! Complained of not feeling good, then immediately fell sideways onto desk ,eyes rolled back in head, body was stiff and shaking, lost color to skin. Patient couldnt talk, hear or had any awareness.
ITCHINESS AND SWOLLEN BIG RED MARK ON THE INJECTION ARM BELOW THE INJECTION SITE
This spontaneous report as received from a physician refers to a 72 year old female patient with asthma and no known drug reactions or allergies. In 2009, the patient was vaccinated with a dose of PNEUMOVAX23, lot # reported as 01124 (Lot number 01124 is an invalid lot number for PNEUMOVAX23 for because the patient has asthma so she was a candidate for PNEUMOVAX23 (dose, route and expiration date were not provided). In 2011, the patient was diagnosed with rheumatoid arthritis and pulmonary fibrosis. At that time, the patient was prescribed ENBREL, methotrexate and isoniazid. On 21-MAY-2013, the patient developed pneumonia and was hospitalized and given oxygen. The patient's current medications are prednisone and ACTEMRA. The patient could possibly be taking other medications but the physician was not sure. At the time of the report, the patient's status was unknown. The physician thought the pneumonia was possibly life-threatening and also it was considered to be medically significant as the patient received oxygen in the hospital. Additional information has been requested.
Pt Lt thigh red and lumpy 2 days after shots. Week of Oct. 12th area had more redness with raised pus areas. Tender to touch. Brought child to clinic 10/20/08 - Instructed to take to PMD. Mom agreed. 10/26/08 - TC to mom. Took to PMD. Told to put ice off and on and MOTRIN 1-3 times/day. Will give abx if doesn't get better. Mom feels area has improved. Doctor said area was infected "probably from the area not being cleaned well enough before shots.
This spontaneous report as received from a health care professional refers to a patient of unknown age and gender who on 11-AUG-2014, was vaccinated with ROTATEQ, 2 ml, orally. The healthcare worker, reported that ROTATEQ that underwent a temperature excursion has been administered. No adverse effect reported. No further information was provided. The outcome of ROTATEQ that underwent a temperature excursion has been administered was unknown. The reporter considered incorrect product storage to be not related to ROTATEQ. This is one of several reports from the same source. Additional information has been requested.
11 days after injection, noticed red rash like area on arm at injection site, it feels hard knot as large as the rash underneath holding heat. I had not noticed before day 11.
PATIENT STATED SHE HAD SWELLING OF THE EYES, SOME CONGESTION, AND CHEST TIGHTNESS WITH WHEEZING
Pt developed hives and rash on forehead.   1 dose of oral Benadryl was given.
Within 24 hours of injection in the left arm, the left axillary lymph node began swelling and causing high pain. At 24 hours, the swelling was the size of a golf ball, with pain high enough to almost cause vomiting. At 48 hours, the swelling was about the size of a lemon, with pain so intense it cause incoherence.  Diagnosis: unilateral axillary lymphadenopathy  Treatment: 60mg of ketorolac by intramuscular injection, 500mg of naproxen twice a day orally with meals
Headache; Body ache; Left leg ache; Shingles on left leg, foot and ankle; This is a spontaneous report from a contactable consumer (the patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in left arm on 09Feb2021 as single dose for COVID-19 immunization. Medical history included bananas allergy, allergies to bug spray, and known allergies to "Gamoglobin" and "Flagti Soln" (as reported), from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication. The patient previously took cefalexin (CEPHALEXIN), ciprofloxacin, levothyroxine, and neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and experienced drug allergy. The patient previously received the first dose of BNT162B2 (Lot number: EL3302), on 22Jan2021 08:30, on left arm, for COVID-19 immunization. On 12Feb2021, the patient experienced headache, body ache, left leg ache and shingles on left leg, foot and ankle. The events resulted to a doctor or healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment for the events was Valacyclovir Hcl 1g tablet. Outcome of the events was not recovered.
Noted that MMRV and Varicella vaccine were given together so the patient received two doses of the Varicella vaccine. Mother of patient spoke with pediatrician after the event. No adverse reactions noted at this time.
This is in follow-up to report(s) previously submitted on 5/29/2009. Information has been received from a physician and a nurse concerning a 13 month old female who on 23-FEB-2009 was vaccinated with MMR II. The same day, the patient was vaccinated with VARIVAX vaccine and PREVNAR vaccine. The patient received the three vaccines and two days ago on 04-MAR-2009, the patient developed a red macular and papular rash. At the time of this report the patient's red macular and papular rash persisted. The patient sought medical attention by phone and visit. Follow up has been received from a physician reported the biracial patient who was vaccinated with a first dose of MMR II, in her right thigh, lot number: 661444/0529X. That same day, the patient was vaccinated with her first dose of VARIVAX in her right thigh, lot number: 66020/1119X and 4th dose of PREVENAR, in her right thigh, lot number: C69205B. The pateint developed a red macular and papular rash in her extremities. On exam, the patient had red macules of the palate and red maculopapular rash on the trunk and extremiteis. Additional information is not expected.
Expiration date provided by Moderna is 13-Oct-2021,vaccine placed in refrigerator on 26-Oct-2021 and administered on 01-Nov-2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Expiration date provided by Moderna is 13-Oct-2021,vaccine placed in refrigerator on 26-Oct-2021 and administered on 01-Nov-2021) and EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date provided by Moderna is 13-Oct-2021,vaccine placed in refrigerator on 26-Oct-2021 and administered on 01-Nov-2021). At the time of the report, PRODUCT STORAGE ERROR (Expiration date provided by Moderna is 13-Oct-2021,vaccine placed in refrigerator on 26-Oct-2021 and administered on 01-Nov-2021) and EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No temperature excursion and no adverse event was reported. Treatment information was not provided. The vial was stored in refrigerator on 26 October 2021.
Vaccine Administered at Inappropriate Site; Swelling; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose, refer case US2019AMR235181).   On 18th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced swelling arm and pain. On 18th December 2019, the patient experienced vaccine administered at inappropriate site. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm, pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the swelling arm and pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and the vaccine was administered at a site not the deltoid, which led to vaccine administered at inappropriate site. She believes it was somewhere between the recommended site and the bicep.  Swelling developed in the arm and she believed that the vaccine leaked into the soft tissue.  The reporter consented to follow up. No additional data given.
The Act Hib was reconstituted with sterile water instead of the specified saline diluent (0.4% sodium chloride). Pt developed upper respiratory infection symptoms over the next 24 hrs. Nasal congestion and discharge. As of 3-3-17 symptoms resolving.
Red, hot, swollen, itchy splotch from injection site down arm irregular size.  Moving down my towards fingers
she was sick; status migrainosus; extremely debilitating; Had fever which comes and goes; she also experienced lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was sick), STATUS MIGRAINOSUS (status migrainosus), ASTHENIA (extremely debilitating), PYREXIA (Had fever which comes and goes) and LYMPHADENOPATHY (she also experienced lymphadenopathy) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she was sick), STATUS MIGRAINOSUS (status migrainosus), ASTHENIA (extremely debilitating), PYREXIA (Had fever which comes and goes) and LYMPHADENOPATHY (she also experienced lymphadenopathy). At the time of the report, ILLNESS (she was sick), STATUS MIGRAINOSUS (status migrainosus), ASTHENIA (extremely debilitating), PYREXIA (Had fever which comes and goes) and LYMPHADENOPATHY (she also experienced lymphadenopathy) outcome was unknown. No concomitant medication were reported. Patient was sick since she had 2nd booster of Moderna vaccine with fever which comes and goes. No treatment medication were reported.  This case was linked to MOD-2021-012616, MOD-2022-646519 (Patient Link).   Reporter did not allow further contact.
Jaw bone popping and sometimes out of place, lower back pain . Reporting for your side effect information only. No need for medical attention ar this time
Swelling and erythema at injection site on right arm and urticaria, swelling and redness on lower right arm and right face cheek and lips.  Patient was treated with DIPHENHYDRAMINE.
Client presented his vaccination card the showed the second dose of a Pfizer primary series being administered on 9/19/2021. Client presented for booster a month early but received a booster of Janssen due to a clerical error of only counting 4 rather than 5 months out from the second dose of the primary series.
very depressed; can not walk properly; Blood pressure increased; Sinus tachycardia; Vertigo; Arthritis; Left foot swells; Hypertension; Heart racing; Vision problem; Ringing bells in his ears; Cant drive by himself; Physical therapy for bowel moments; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing) and VISUAL IMPAIRMENT (Vision problem) in a 59-year-old male 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing), VISUAL IMPAIRMENT (Vision problem), TINNITUS (Ringing bells in his ears), IMPAIRED DRIVING ABILITY (Cant drive by himself) and BOWEL MOVEMENT IRREGULARITY (Physical therapy for bowel moments). On 20-Jan-2021, the patient experienced SINUS TACHYCARDIA (Sinus tachycardia) and VERTIGO (Vertigo). On 21-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased). On an unknown date, the patient experienced DEPRESSION (very depressed) and GAIT DISTURBANCE (can not walk properly). The patient was treated with LISINOPRIL on 21-Jan-2021 for Hypertension, at a dose of 20 milligram; METOPROLOL on 12-Feb-2021 for Palpitation, at a dose of 25 milligram and Physical therapy for Bowel movement irregularity. At the time of the report, ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing), VISUAL IMPAIRMENT (Vision problem), TINNITUS (Ringing bells in his ears), IMPAIRED DRIVING ABILITY (Cant drive by himself), BOWEL MOVEMENT IRREGULARITY (Physical therapy for bowel moments), DEPRESSION (very depressed), GAIT DISTURBANCE (can not walk properly), SINUS TACHYCARDIA (Sinus tachycardia), VERTIGO (Vertigo) and BLOOD PRESSURE INCREASED (Blood pressure increased) outcome was unknown.        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.   On 20 Jan 2021 CT scan of brain was done with unknown results and patient was sent home. On 12 Feb 2021 Blood pressure was 157/78 , Heart rate 99 , respiration rate 18 was found. No concomitant medications were reported. The patient had seen multiple doctors for his symptoms   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: significant follow up received and new events ( Vertigo, sinus tachycardia and blood pressure increased) were added.
Sharp pains in left arm and upper left neck.  Upper neck pain is on going still. Chest pains have been on going since my second dose(almost a month)
vaccine given was expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix) (batch number 0628ae, expiry date 26th January 2015) for prophylaxis.   On 11th February 2013, the patient received Havrix. On 11th February 2013, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The supervisor reported that she has a Hepatitis A vaccine, that may or may not be Havrix (GlaxoSmithKline).  The health care professional reported that the vaccine was given with two possible expiration dates of either 26th January 2013 or 26th January 2015.  The reporter was unable to confirm expiration date or manufacturer. The reporter stated that her paperwork for administration indicates the expiration date of 26th January 2015 with manufacturer of Merck, but the reporter believes it may be a GlaxoSmithKline product.  Search of lot number returned no results.  The reporter gave consent to follow up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used. As it was not clear that patient that received Havrix or other brand of Hepatitis A vaccine, therefore in worst approach Havrix was coded as suspect and follow-up clarification request was raised. Expiry date was captured as 26th January 2015 as per reported verbatim (HCP states her paperwork for administration indicates the expiration date of 01/26/2015 with manufacturer of Merck, but HCP believes it may be a GlaxoSmithKline product).
super sick; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (super sick) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (super sick) and HEADACHE (headache). At the time of the report, ILLNESS (super sick) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported
I developed an upper respiratory infection that began with a cough. The cough was horrible. I saw the doctor on December 02, 2022. My voice was really raspy. I was prescribed amoxicillin and I was already taking BENADRYL. Initially my coughing kept me from sleeping at night but now I am able to sleep through. My voice is still scratchy, but the phlegm is gone, and the cough is not as severe. I was not given  any medical test and I have not completely recovered.
My cleaning lady said she is having pain in her lower leg, that she is going through the exact same thing; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that, her cleaning lady said she was having pain in her lower leg, that she was going through the exact same thing on an unspecified date. The patient underwent lab tests and procedures which included ultrasound scan and x-ray on unknown date. Now they want a neve conduction test and MRI. The event was considered as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
flu; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that patient only get the flu when patient have been around people that had the flu vaccine It can slough for up to 2 weeks after injection. But hey, your body, your choice.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case
herpetiform rash on right side back and leg the night of vaccination. no treatment. resolved in 10 days. no rash at injection site.
After the third dose of my vaccine, I had a Lymph node swell up. After Biopsy it has been confirmed that I have Non-Hodgkin?s Follicular Lymphoma, Grade 1-2. I have had that in the past and it went into remission. I had swelling in the Lymph node in my neck on the right. I had had a check up five days before the third dose if the vaccine. It was a yearly check up with my Oncologist and she did not notice a problem with my Lymph node. Nine days after getting the shot I went to my Primary care Physician and she noticed that my Lymph node was enlarged. I had an Ultrasound and then a Biopsy.
Meningococcal MCV4 LOT# U3433AA- Exp. 08/02/11 vaccine administered 08/10/11, 8 days after expiration date. Dose not re-administered.
Fever 102.7 for three days, chills, lethargy for a week, bad muscle aches, dry mouth and eyes, very bad headache, stuffy nose, cough, nausea, skin very sensitive like a sunburn, sharp pains at spine, , chest tightness, some symptoms continue today... a month later. I was way sicker from the vaccine than from actually having COVID.
Information was received from a physician via a field employee. The physician reported that on a social media physician's group, there is an article that associated GARDASIL with ovarian failure. Additional information is not expected.
PATIENT WAS ADMINISTERED THE 12YR<  COVID 19 VACCINE  INSTEAD OF 5-11 YR OLD VACCINE. PATIENT WAS OBSERVED FOR 30 PLUS MINS.