chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not reported. Concomitant therapies were not provided. On 04-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot no. K007631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursion: 24 and 48 hours respectively. The lowest recorded temperature was 34. The highest recorded temperature was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
lymphedema; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema). At the time of the report, LYMPHOEDEMA (lymphedema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
This is a spontaneous report from a contactable consumer. A 15-month-old female patient of an unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration, in 2017, as single dose for immunization and influenza vaccine (MANUFACTURER UNKNOWN), via an unspecified route of administration, in 2017, as single dose for immunization. The patient's medical history and concomitant medications were not reported.  On the same day as the immunization, later that night the patient experienced febrile seizure in 2017.  The mother of the patient stated that her daughter was fine after her temperature came down. The clinical outcome of febrile seizure was unknown.
Patient received the wrong Covid-19 vaccine. Patient should have received the Pfizer bivalent but instead received the Pfizer monovalent vaccine.
Can't use his hands; fever; Tiredness; felt very bad; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got his first dose on 02Apr2021 and experienced Fever, Tiredness, Can't use his hands and felt very bad in Apr2021. His doctor gave him a medicine which is prednisone tablet. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
her son got a fever after the 1st dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "her son got a fever after the 1st dose".  Additional information: The reporter stated that her son got a fever after the 1st dose. However, upon probing and gathering some information the caller disagrees and doesn't want to continue anymore due to the process.   No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Vaccine given after sitting in room temperature for 6 hours and 25 minutes; A spontaneous report was received from a 57 year-old, male patient, age who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given after sitting in room temperature for 6 hours and 25 minutes.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007m20A) for prophylaxis of COVID-19 infection.  On 14 Feb 2021, a dose of Moderna's vaccine was administered to the patient after sitting in room temperature for 6 hours and 25 minutes. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, expired vaccine used,  was considered resolved on 14 Feb 2021.; Reporter's Comments: This report refers to a case of Expired product used for mRNA-1273(Batch number: 007m20A), with no associated AEs.
Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injection site big red area showed up about 2 weeks after 1st dose
stomach hurts; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurts) and NAUSEA (nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurts) and NAUSEA (nauseated). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurts) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD21-13068, MOD-2021-020915.; Sender's Comments: consistent with the safety profile. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is  consistent with the safety profile.
Two situations surfaced: 1) 12 hours after getting the shot, the area around the shot swelled up significantly.  This red swelling over 4 days went down in size but spread further. 2) Once swelling went down, I got a chronic sore throat. Still have it three weeks later.  I am not sick, but stuck with a sore throat.
Post shingles neuropathy; Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 78-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 08-JUN-2018, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles and post shingles neuropathy resulting from his use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles and post shingles neuropathy was unknown.   Upon internal review, post shingles neuropathy was considered to be medically significant.  The reporter considered shingles and post shingles neuropathy to be related to Zoster Vaccine Live(ZOSTAVAX).
5/22/2021 I had the second dose and in 5/24/2021 I started to notice I was losing strength in my arm and I could not do normal things that I do, I could not even brush my teeth, anything above me I could not pull down, the pain in my wrist and hand it was pretty bad, and it just kept escalating daily and I was doing exercises and massaging it to help relieve the pain. After 2 weeks I finally took Ibuprofen, then I went to urgent care and they gave me a shot of a muscle relaxer and a steroid because I woke up crying that day because my whole body was in pain by that time. They did a blood panel, and the result was that I have rheumatoid arthritis. They recommended to do an x-ray because my hand was very swollen. 3 weeks prior to feeling that way my doctor did a blood panel and said keep doing what you are doing because I was very healthy.
I was pregnant at the time of getting my COVID vaccines. I was due on 08/18/2021 to have my baby. On 08/17/2021 I went into the hospital thinking my water may have broken. My water had not broken, but I was admitted/induced due to high blood pressure/pre-eclampsia. I continued to have high blood pressure after delivery, and had to take high blood pressure meds for around 4 weeks after giving birth until it stabilized. I took my blood pressure every day for 6 weeks total after birth to continue monitoring for that initial post-partum period. I don't think the vaccine caused my pre-eclampsia, but I wanted to report it just in case.
Erythema 11.2cm X 18.5cm; central blanching 1.4cm X 1.8cm. Right thigh 73.5cm; Left thigh 35cm.
Fatigue 6 days Fever about 12 hours after 2nd dose, then again 6 days later (chills, sweating, shaking) Racing heart, 6 days after 2nd dose. Shortness of breath, 6 days after 2nd dose. Acetaminophen and ibuprofen.
felt needle prickling; burning on scalp; on left temple and eyebrow area, noticed a rash pink and round that kept spreading, now on eyes and head and went to eyelids and had pain; shingles; pain was going towards her left ear; soreness on her scalp/pain on scalp; felt like a pimple that kept progressing and starting to grow, felt like she bumped her head; body aches; chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles), PAIN OF SKIN (soreness on her scalp/pain on scalp), ACNE (felt like a pimple that kept progressing and starting to grow, felt like she bumped her head), EAR PAIN (pain was going towards her left ear) and PARAESTHESIA (felt needle prickling) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 15-Dec-2020. Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE and LISINOPRIL for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (body aches) and CHILLS (chills). On 16-Feb-2021, the patient experienced PAIN OF SKIN (soreness on her scalp/pain on scalp) and ACNE (felt like a pimple that kept progressing and starting to grow, felt like she bumped her head). On 18-Feb-2021, the patient experienced EAR PAIN (pain was going towards her left ear). On 19-Feb-2021, the patient experienced HERPES ZOSTER (shingles), PARAESTHESIA (felt needle prickling), SKIN BURNING SENSATION (burning on scalp) and RASH (on left temple and eyebrow area, noticed a rash pink and round that kept spreading, now on eyes and head and went to eyelids and had pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency; GABAPENTIN (NEURONTIN) at an unspecified dose and frequency and ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles), PAIN OF SKIN (soreness on her scalp/pain on scalp), ACNE (felt like a pimple that kept progressing and starting to grow, felt like she bumped her head), EAR PAIN (pain was going towards her left ear), PARAESTHESIA (felt needle prickling), SKIN BURNING SENSATION (burning on scalp), RASH (on left temple and eyebrow area, noticed a rash pink and round that kept spreading, now on eyes and head and went to eyelids and had pain), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications levothyroxine, hydrochlorothiazide, lisinopril Treatment details were not provided.
Tinnitus.   I have only rarely experienced the high pitched ringing in my ears.  In Early 2021 I changed jobs, and began working from home.  With this I began frequently wearing BOSE Quiet Comfort II noise cancelling headphones for meetings a few times a day, though they were typically passively on, but I wasn?t listening to anything.   Mid 2021 I noted my ears were ringing a lot.  Not to a painful level, but enough to make me question if the noise cancellation of the headphones might have something to do with it.  I hadn?t even considered that it might be vaccine related until seeing a news article this morning indicating a plausible link.    It is difficult to estimate the level of impact this has had on me.  It  has been somewhat depressing as I notice it most times when alone without something requiring concentration.  I have wondered if I can even hear complete silence anymore as it doesn?t ever seem to go fully away. At other times it is strong enough to interfere with my attention in normal conversations and can be rather depressing, as it reminds me we are mortals, and our bodies do eventually fall apart.  I second guess myself if maybe at some point I ran a table saw or something without hearing protection, thinking nothing of it, and destroyed my hearing.  I wanted to get this submitted to aide in gathering statistical data to drive research, as It seems plausible to me that this condition may be causal.  It is at least correlated time-wise.
Patient started oral typhoid June 7, 2007. He took his 2nd pill June 9, 2007. That evening he c/o chest pain, severe headache - he rated it a "7" out of 10 and a possible upper chest rash. He felt nauseated. His mom gave him 50mg Benadryl and 2 Tylenol and he went to bed. Said he felt better the next day. He had no fever with incident.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PLAXOVID) from 07Aug2022 to 11Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blood coming out of right ear; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, in Arm Left on 13Apr2021 20:00(age at vaccination: 60 Years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history included renal disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no allergies, patient didn't had covid prior to vaccination, patient was not tested with covid-19 to post vaccination. The patient experienced blood coming out of right ear on 16Apr2021 03:00. No therapeutic measures were taken for the event. The outcome of the event ear haemorrhage was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Context: The pt is a 68 yr/o female presenting to the ED c/o dizziness.  Patient states that her symptoms started earlier this week.  She states that they started about the day after she received her second Covid vaccine and her daughter has similar symptoms.  She states that when she is standing she feels "dizzy" and states that she has to hold onto furniture she feels that she will fall.  She denies feeling like she is in a pass out.  She denies any unilateral numbness or weakness.  She denies any fevers, cough, vomiting, or diarrhea.  Recently treated for urinary tract infection.  Had been on chemo and radiation until September for lung cancer.  She was sent from immediate care for further evaluation. There are no further complaints at this time.
Patient was administered a flu shot by wellness nurse at 1134 on 9/8/2020.  At 1143, patient complained of nausea, became sweaty, and unresponsive.  EMS was called and then cancelled at 1144 when patient came back to.  Patient's vital signs were obtained.  Patient was oriented and tolerated fluids.  Patient moved from siting position to ambulating with no problems by 12:05.   Patient returned call to health department on 9/9/2020 at 12:00 noon.  Patient denies any problems or concerns related to flu vaccination
On Friday (02/12) my upper arm, just below the injection site became red and itchy.  With pressure I could feel some lumps nearby.  The next morning (2/13) the area of redness and itchiness had expanded in all directions and and was also swollen and felt hot to the touch. By afternoon it had expanded to about an inch or more above the injection site, and was also expanding downward and around the sides of my arm. By bedtime, it was about the size of my hand.  Still red, swollen, hot to the touch, itching, and still had some deep lumps that were only noticable when rubbing deep.  Over time, I realized that where I could feel the lumps was the direction of the spread.   On 02/14 it was still spreading and the itching was worse.  (Don't gasp, or laugh, but spit did more to relief the itching more than water)   Feb. 15 it started getting better, and by 02/17  it was almost gone, except for the blotchy redness.
One shot injected into each thigh. Injection site of left thigh had no reaction. Injection site of right thigh had large, asymmetrical red inflammation. Hives on face, chest. Tylenol given regularly since injection, have not been able to confirm a fever.
Fever, body aches, ear pain, shakes, lethargic, weak, high heart rate
diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and HEADACHE (headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache). On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Seconds after getting vaccine. I experienced rapid heart rate. And feeling like I was going to faint. Also both of my hands went extremely cold..
tested positive via Rapid PCR; tested positive via Rapid PCR; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 46-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 at 09:00 as dose 1, single (Lot number: EN6198), in left arm, on 16Mar2021 at 09:30 as dose 2, single (Lot number: EN6206), in left arm, on 25Sep2021 as dose 3 (booster) , single (Lot number: BA30135), in left arm and on 28Apr2022 as dose 4 (booster) , single (Lot number: FM7553) at the age of 46 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "not recovered" and all described as "tested positive via Rapid PCR". The event "tested positive via rapid pcr" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical Course: Age group reported was Adult (18-64 Years). Patient received more than 3 doses. No other vaccine in four weeks. No other medications in two weeks. Course of the event: onset headache in the evening of 15Jul2022. Sinus pressure pushing on his teeth started in the morning on 16Jul2022 and post-nasal drip along with nasal congestion started on17Jul2022, tested positive via Rapid PCR on 18Jul2022. Not Known Drug Allergy. No covid prior vaccination. Covid tested post vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment were given for symptoms headache, sinus disorder, upper-airway cough syndrome, nasal congestion. Patient was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
pt recvd MMR vax on 2OCT91 & immed following vax devel redness, warmth & 4+ edema @ inject site on arm; several hrs later, devel a t102; swelling was noted next day; pt recovered;
Glands swelling 4-5 hrs post imm. 10/27 neck glands swollen, pain in joints. ER-told allergic reaction to MMR. Temp of 100 & chills.
Fever, feeling of spiders crawling on me, loss of appetite, general feeling of unwell, very tired but not sleeping well, severe cold sores on lips and in nose
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 93-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The box of vials were received from the state of Colorado on 14-Oct-2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm. It was reported that 4 vials had been used/administered, 1 open/punctured & about half used. 5 vials remain unpunctured.  No concomitant medications were reported.  No treatment information was reported.