chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna/vaccine dose number=4; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 at 16:00 as dose 1, single (Lot number: EL0142), in right arm, on 04Feb2021 at 14:30 as dose 2, single (Lot number: EM9810), in left arm and on 02Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FD0809) at the age of 64 years, in left arm for COVID-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 14Jul2022 at 14:30 as dose 4 (booster), single (Lot number: 016B22A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Other medical history: Osteoarthritis. The patient's concomitant medications were not reported. Past drug history included: Nystatin, reaction(s): "Known allergies: Nystatin", notes: Known allergies: Nystatin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Jul2022 at 14:30, outcome "unknown", described as "vaccine brand other=Moderna/vaccine dose number=4"; DRUG INEFFECTIVE (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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
The spot on my arm where I received the GARDASIL 9 vaccine became painful months after vaccination and is swollen up and there is a bump there now. It was painful for a few days after vaccination but now months later the area has swollen up.
With both doses, in addition to the not unexpected swelling and soreness in the arm, I started feeling chills and body aches the evening of the day I received it (second dose was 8/21/2018). The following day, body aches were worse, and with the first injection I also had a fever of up to 100.1F on the second day. With the second injection in the series (8/21/2018) symptoms were not as severe but followed the same pattern. Fever was only around 99.1. By the second day after injection, I felt normal with only slight residual soreness in the arm.
got the flu; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient (age not reported) who experienced got the flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine for prophylactic vaccination with reaction of Flu.  The patient's medical history, past medical treatment, 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 and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got the flu (influenza) (14 days) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
After receiving vaccinations, within a few hours, son started running a high fever of appr. 103.8.  Contacted physician was advised to give tylenol, motrin.  Within a day or two, son started to wheeze and stopped eating and would eventually stop taking bottle.  Several trips to ER at Hospital.  Several of the trips, son was kept 2-4 days and released with no diagnosis.  In February/March after spending appr. 30 days, son wound up in ICU his pulse ox was 85.  After locating 5th new doctor, a bronchoscope with lung wash was performed and son was diagnosed with Moraxella catarrhalis, streptococcus pneumonia, Respiratory syncytial virus and two other unidentified bacteria/germs. Treatment included steriods, antibiotics, preventative medications, etc. His long term disability is scaring of the lungs and long term medications.
Received Gardasil #2, developed swelling around injection site after 2-5 minutes. That evening she developed hives on body and extemities-Mom gave Benadryl. Rash subsided but left side of face swollen but improved later in the day. 2 months ago 1st Gardasil given; she developed hives. Mom thought it was due to other allergies. Has been getting all over rash and swollen face since then.
Seizure. Vaxs rcv'd 10/25/99. 1/2/00, devel cough, fever. 1/3 exp generalized tonic-clonic seizure. At ER, temp of 101.4. Seizure persisted for approx 35 min. Pt exp resp failure. Child intubated & hospitalized.
VOMITED 2 TIMES, SWELLING OF FACE AND TONGUE, DIFFICULTY SWALLOWING.
Adminstered vaccine at 6:34. Approximately 6:55 pm patient stated her tongue felt funny and it felt like she had a lump in her throat. She stated it was similar feeling to how she reacts to shellfish which required a steroid to stop the reaction.  Patient's voice became more hoarse so I gave the patient 25mg of diphenhydramine around 7 pm (pt refused 50mg). Within 15 minutes the patient started sounding and feeling better.
Immediately after receiving three (3) vaccines, child c/o dizziness. Vital signs were monitored & stable. Child was observed for 15 minutes, reported no further complaints and left office with father.
Shingles after Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after Shingrix). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date 31 Jul 2023 HCP was questioning the efficacy of Shingrix. He stated he had patient who return to him with shingles shortly after they got their Shingrix vaccination. He recognized the vaccine was not 100% effective however 2 patients returning with shingles was giving him hesitation. He wanted to know the data and also wanted to know more data.  This case has been linked with case  US2023106935 reported by same reporter.; Sender's Comments:  US-GSK-US2023106935:Same reporter, same product, different patients.
Syncopal episode, patient lowered to the floor, patient became coherent after approximately 20 seconds. Patient alert and oriented, BP and HR stable. EMS was called and arrived on scene to check VS and blood glucose, which were stable. Mother declined going to hospital as child was stable.
The patient was given the Janssen vaccine, and the syringe was removed too soon while depressed the plunger. The vaccine ran down the arm. The vaccine was then readministered. This report is being done right after administration. Any adverse effects are unknown.
Immediately post vax, the pt experienced a 3 X 3 rash, redness, itching and swelling at the injection site. the pt reported that he was seen by a physician in Guatemala who provided antibiotics (NOS) for 4 days and topical ointment without results. The outcome of the event is ongoing.
Approximately August 30, 2003 she developed absence seizures.  In October, 2003 she developed occasional tonic-clonic seizures.  She has been assessed by a pediatric neurologist, and the current diagnosis is atypical absence seizures.  She is taking Depakote. The medical records received on 2/11/04 state seizurre diagnosis was confirmed. Within 1-2 weeks after onset of AE (seizures) the child developed UTI, HA, fever, vomiting and vulvitis.
Patient received 0.2mL of undiluted Pfizer Bivalent 10mcg/0.2mL for children under 12 years of age. Patient does not have any adverse reaction as of 11/1/22 at 5:30pm. Patient was advised to follow-up with pharmacist tomorrow.
sensitive to the touch; red, rectangular area about two inches away; makes her think it wasn't given in the muscle; had the first dose in November; This case was reported by a consumer via call center representative and described the occurrence of touch sensitivity increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced touch sensitivity increased, erythema, vaccine administered at inappropriate site and incomplete course of vaccination. On an unknown date, the outcome of the touch sensitivity increased, erythema, vaccine administered at inappropriate site and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the touch sensitivity increased and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed a red, rectangular area about two inches away from where she was given the injection and there was no soreness when she moved her arm which makes her think it was not given in the muscle, which led to vaccine administered at inappropriate site. However, it was sensitive to the touch. The patient received 1st dose in November and did not received 2nd dose yet, which led to incomplete course of vaccination. The reporter did not consent to follow up.
The same day of vaccination, the pt experienced a local reaction that consisted of a "quarter sized raised wheel and raised rash wit erythema halfway down the left arm. The local reaction lasted all day and into the evening." The following day, the pt recovered.
Information has been received from a physician concerning a female who on 06-SEP-2007 was vaccinated with the first dose of Gardasil. Subsequently the patient called the physician on 29-OCT-2007 and stated that she experienced tremors on the same arm she received the Gardasil. The patient's tremors on the same arm she received the Gardasil persisted. The sought unspecified medical attention. Follow-up AE information 13-NOV-2007: Per the reporter, one month after receiving the first dose of Gardasil, the patient developed a movement disorder and tremors in the arm in which she was vaccinated. The symptoms have lasted three weeks and are ongoing. Concomitant therapy included montelukast sodium (MSD). The montelukast sodium (MSD) was discontinued and symptoms persisted. The patient has seen a neurologist who states that he has never seen a case like hers before. The neurologist also states that the condition resembles a "rubal tremor". Unspecified diagnostic studies were performed by the neurologist. Patient placed on prednisone treatment and is doing "a little better". Memo 30-NOV-2007: Per the physician, the patient developed tremors and movement disorders in the arm in which she was vaccinated with the first dose of Gardasil. The symptoms persisted for the past 4 weeks. The patient was treated with low dose prednisone and has recovered. Additional information has been requested.
Vaccine given 121118 Tuesday. Increased redness and swelling noted Thursday Patient is on antibiotic for URI. 5x9 Erythema increased tenderness notes Friday.
FIRST DOSE WAS PFIZER PEDIATRIC BECAUSE THE PATIENT HAD 11 AT THE TIME, 2ND DOSE ADMINISTERED WAS 0.2ML PEDIATRIC INSTEAD OF ADULT DOSE BECAUSE THE PATIENT TURNED 12 AFTER THE FIRST DOSE
Initial report was received from a patient on 20 September 2011. A 66-year-old male patient had received FLUZONE HIGH-DOSE in left deltoid (lot number and route of administration not reported) on 06 September 2011. On the same day, six hours after the injection the consumer developed chills lasting 30 minutes. He then experienced disruptive sleep, sweating, felt feverish, fever like dreams lasting ten hours. For the next eight hours he felt weak along with a headache. The patient had a prior flu vaccine thirty years ago. No further information was available at the time of the report. The patient outcome was recovered/resolved. Follow-up information was received from a healthcare professional on 28 November 2011. The patient reported that he does not know the lot number and no further additional information to provide. Documents held by sender: none.
Moderate to severe vertigo; intense dizziness; nausea; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up information on 14Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer or other non hcp (patient) reported about herself. A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EM9810), via an unspecified route of administration, administered in left arm as dose number unknown, single on 09Feb2021 10:45 (at the age of 64-year-old) for covid-19 immunisation. Medical history included hashimotos disease, high cholesterol and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications levothyroxine and wellbutrin within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medication included levothyroxine, omeprazole and bupropion hydrochloride (WELLBUTRIN) all taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 23:30, the patient experienced moderate to severe vertigo, intense dizziness and nausea. As per reporter, patient was not getting no help from anyone and called local numbers but did not get help locally. She called regarding second dose 25Jan2021. Hard time to start all over again to schedule an appointment. How can she get an appointment for her second dose. No treatment was received for the events. At the time of this report, outcome of events was recovered on unspecified date in 2021.  Follow-up attempts completed. No further information expected.
severe neck / pain for a month; severe / arm / pain for a month; severe / back pain for a month; had my first Shingrix shot Jan. 14th and was due for second one in July / How long past my time can I wait for second shot?; This case was reported by a consumer via media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced neck pain, pain in arm, back pain and incomplete course of vaccination. On an unknown date, the outcome of the neck pain, pain in arm and back pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the neck pain, pain in arm and back pain to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported for 1st dose and was not applicable for 2nd dose. The patient had received 1st dose of Shingrix and experienced severe neck, arm and back pain for a month. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient enquired how long past time he/she could wait for second shot.
Pt presented to ED on 2/3/22 with progressive increase in shortness of breath and cough.  The patient is coronavirus positive.  The patient has a white count of 4.1.  She has a saturation of 91% on 10 L.  The patient had a 1-view chest x-ray, which revealed extensive bilateral airspace opacity consistent with multifocal pneumonia, likely COVID-19.  Pt discharged 2/9/22 Pt previously vaccinated Janssen 5/8/21
Left deltiod-red, swollen and painful thru the night. Treatment-labs drawn, wound aspiration and Rocephin inj. given. Patient admitted to hospital. Grandson removed dressing and manipulated site. Don't know if allergic reaction or cellulitis, or what this "manipulation" contributed to this situation.
1/12/21 received the vaccine and had mild symptoms of injection site pain and LGF.  By morning of 1/13/21, c/o fever up to 103.4, joint pain, especially in spine, dry heaves/nausea, dizziness and metallic tastes.  Symptoms resolved within 2 days.
Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration; Expired dose was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (first dose) on 07-May-2021 and Pfizer (second dose) on 28-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  The vial was initially stored in the refrigerator on 06-Apr-2022.  The patient received first booster dose of Moderna vaccine on 07-Apr-2022.  The healthcare provider had a lot number of the vial which they thought expired at a different time. However, when the healthcare provider entered the lot number on Moderna's online expiration tool look up, it was found that the lot had expired on 02-Apr-2022.  The healthcare provider reported that each patient was administered with a dose from a different vial and each of the vial was stored in the refrigerator on the day before administration.  The vial did not undergo any temperature excursion. It was reported that the patient had not reported of experiencing any adverse reactions to this expired dose.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Significant follow up contains : Added reporter, updated suspect product dose details, and updated narrative. On 05-May-2022: Follow-up received and reporter's email address updated.
Chronic stuffed nose, muscle aches, flu like symptoms. This has been going on for about 2 months. Also feels at times that glands are swollen. And some breathing difficulty at time along with chest congestion.
Received 2nd Anthrax vaccine on 22 Jan 2000. Approximately 18 months later, noted a nodule to the AVA site which has persisted varying in size over an 8 months period of time. As of May 2005, this nodule persists and she is requesting it's removal and questioning any studies on this issue?  Requests entry into database for nodular formations AVA site. Also c/o non-specific "illness and fatigue" when nodule large.
Unviable vaccine given. Temperature data logger info not recorded for 4 days. No patient side effects or adverse events.
[As narrated by wife] patient started to not feel good and felt tired 2 weeks after 1st does. Felt even weaker after the second dose. Had chest x-ray and EKG was told that there was inflammation around the heart and that he had pneumonia. COVID test was negative at hospital. Patient continued to worsen and died on 2/19/2021. Death certificate states cardiogenic shock, respiratory failure, pneumonia
Information has been received from a 66 year old female with high blood pressure, mitral valve prolapse, sulfonamide allergy and drug hypersensitivity to erythromycin and saccharin would make her chest palpitate.  Illness at the time of vaccination included a sinus infection.  The patient was seen by a dentist on 16-MAR-2007 who said her "sinus looked cloudy."  On 16-MAR-2007 the patient was vaccinated, into the left arm, with a dose of Pneumovax 23.  Concomitant therapy included NORVASC, AVELOX and hydrochlorothiazide (manufacturer unknown).  On approximately 17-MAR-2007 the patient experienced headache that comes and goes.  On 17-MAR-2007, at 01:30 her "chest was pounding."  The patient noticed a butterfly rash across nose, underneath eye and under the cheek on 17-MAR-2007.  The patient discontinued therapy with AVELOX due to the advice of her pharmacist.  At 8:00 pm, her left arm started to burn intensely.  Her left arm swelled up and looked like a bullseye, and was red and about 3 inches long and 2 inches wide.  The area was very tender.  The consumer iced the area all night and took ADVIL for the pain.  On 18-MAR-2007, the butterfly rash spread to the forehead.  On the afternoon of 18-MAR-2007, the patient started to shake and had chills which later subsided.  The patient also developed heart palpitations and cold hands.  The patient discontinued taking ADVIL and was taking aspirin.  At the time of the report, the patient rash on her forehead was better but the butterfly rash was still on her face.  Her arm continued to hurt and she still had palpitations.  The consumer felt that headache might have been due to her sinus infection.  Additional information has been requested.
Nauseous afterwards believed to be due to  anxiety, stomach pain.  That evening, the nausea continued.  Arm very sore.  Woke up overnight with low-grade temperature and big knot in arm.  The following day , the temperature remained.  I slept until 1p that day (normally up at 6a) and went to bed at 8p (normally in bed about 10p).  Zero energy, migraine, nausea and zero appetite.  The fever broke at about the 24hour mark.  On the following day, still very tired, stomach upset but arm pain much better. Today, all symptoms gone except stomach upset.
Approximately 12 hours after shot I experienced high fever, chills, body aches and headache. Symptoms lessened with Tylenol and have since returned. Fever now low grade, body aches and headache are mild.
10/06/15 2:00 AM Arm is swollen, hard and hot. 10/06/15 11:00 PM severe headache. 10/07/15 6:00 AM Rash on face. Headache pain is less and rash is starting to subside 11/05/15.