chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWELLING OF LEGS, LEGS HAD DOUBLED IN SIZE, SWELLING IN THE CALVES; CALVES AND FEET FELT LIKE THEY WERE ON FIRE; SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY; SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY; SKIN ITCHED REAL BAD; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWELLING OF LEGS, LEGS HAD DOUBLED IN SIZE, SWELLING IN THE CALVES), BURNING SENSATION (CALVES AND FEET FELT LIKE THEY WERE ON FIRE), ERYTHEMA (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY), SKIN EXFOLIATION (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY) and PRURITUS (SKIN ITCHED REAL BAD) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 26-Oct-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (SWELLING OF LEGS, LEGS HAD DOUBLED IN SIZE, SWELLING IN THE CALVES), BURNING SENSATION (CALVES AND FEET FELT LIKE THEY WERE ON FIRE), ERYTHEMA (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY), SKIN EXFOLIATION (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY) and PRURITUS (SKIN ITCHED REAL BAD). At the time of the report, PERIPHERAL SWELLING (SWELLING OF LEGS, LEGS HAD DOUBLED IN SIZE, SWELLING IN THE CALVES), BURNING SENSATION (CALVES AND FEET FELT LIKE THEY WERE ON FIRE), ERYTHEMA (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY), SKIN EXFOLIATION (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY) and PRURITUS (SKIN ITCHED REAL BAD) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Extremebackanchestpain,severeanemia,pleuralandpericardialeffusions,cough,lowgradefevershighwhitebloodcellcount,veryhighsedrate,highc-reactiveprotein,aswellasmanyotheroutofrangebloodreadings.oncolchicineforinflammation.sickfortwomonths-prettymuchrecovered
T102.6 temp x 4 days, diarrhea x 2 days, measles like rash 6 days post vax;
generalized body rash, mainly located on lower stomach and groin, also a little at injection site and around sternum.
Swelling redness reported, advanced quickly.  Patient reported to doctor and is currently being treated with doxycycline.
Patient was unintentionally given an expired Moderna booster vaccination (0.25ml). Expiration date was 11/3/21 per the 30 day limit once Moderna is placed the fridge, which was 10/4/2021. The error was caught on 11/7/2021. No known adverse event occured at the time of reporting.
Patient was seen at hospital on 5/13/03 following immunizations earlier that day. Was in respiratory failure and transported to another hospital.
Severe redness on the left arm (where FLUAD and PNEUMOCOCCAL 23 injected), on chest and back. Pain, warm to touch and swollen arm since Monday 8/21/17 PM but didn't fully notice till 8/22/17 PM. The patient was requested to be seen by Dr on 8/23/17.
After receiving the 2nd dosage of vaccine, 2 days later I began having problems with my vision, which was on Sunday 4/4/21, I went to bed thinking it would correct itself. I woke up on Monday 4/5/21 and had double vision so I immediately went to the ER at hospital where my BP was 190/95.  At the hospital they did a CT Scan and an MRI which both came back normal, I was eventually diagnosed with 6th Nerve Palsy and referred to see a neurologist, I am currently under Dr's care at facility who is a neurologist in the specialty eye clinic. I am currently wearing a patch over my right eye to prevent the double vision which is still present.
Patient stated her blood pressure increased and she had to go to the hospital the following day. Now her blood pressure is lowered by a lot and she has pain in her side.
On Sept 18 I had the Shringrix vaccine. I started taking ibuprofen 400mg TID x 4 days immediately at the injection to mitigate skin reaction and pain. However, day 1 post vaccine (Sept 19) I got 3 inch reatcogenic site at injection site - red, hardening, and pain.  Also got malaise and feeling weak and tired. The latter symptoms lasted one day, but the skin reaction continued and then abated by Day 6 (Sept. 24).    However on day 11 (Sept 29), I developed pain (my typical shingle pain of muscle ache/bruising sensation) R  posterior pain at C6 (between scapula and spine).  On Day 12, Sept 30, the pain started to radiate from C6 right spinal area down the arm to top of R upper forearm.   At this sign I started Valtrex Sept 30, which worked 2 times prior when initiated to mitigate pain and later lesion development.  However, after 7 days on Valtex the pain got worse and persisted.  There were only 2 skin papules - one near elbow at top of R forearm started around 10/1   and one at top of R wrist started around 10/6.   At this date of reportin 10/8 I'm still experience mild-moderate my typical post-herpectic neuralgia (pain/ache.that feels like a deep brusing, from C6 spine down to wrist; at times worse and other times mild). I'm taking Neurontin 300mg capsules prn as they are very sedating to me. No relief from ibuprofen.    This pain distribution is the same as in May 2019 and December 2016 around C6 I'm concerned that the vaccine, Shingrix, triggered some neural - virus reaction. I'm reporting in case others also experience  their typical shingles pain in response to the vaccine. Thank you for considering and evaluation and assessing if labeling should be amended.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 30-OCT-2012 at 13:23, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022; Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.) and PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027l21a) for COVID-19 prophylaxis. No Medical History information was reported.    On 07-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired on 02-Jul-2022 and it was administered on 07-Jul-2022.) and PRODUCT STORAGE ERROR (Vaccine had expired on 02-Jul-2022 and it was refrigerated on 07-Jul-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. On 07-Jul-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The patient received 2nd dose, which had expired on 02-Jul-2022. Treatment information was not provided.   This case was linked to MOD-2022-606376 (Patient Link).
Patient noticed some changes to his eye two days after receiving the Pfizer booster vaccine. He also received his flu shot at the same time. Symptoms included swollen red eye, and swollen lymph node on right arm. He was seen by an ophthalmologist and placed on a steroid. MD believes it was an inflammatory response to the vaccine as he has seen similar responses.
pt recvd Hep B vax & exp chest pain; no further details were provided;
small, red palpable lesion which blanch on rt anterior thigh, rt shoulder & a few on perineum;no purpura, or petechiae;these lesions started on rt thigh by inj area according to mom;red raised areas;rxn to immun-hives;
Noticed periodic tinnitus a few days after receiving the 2nd shot, has not gone away and has intensified over the last 4 days
Three to five minutes following vaccine administration patient was collapsed to the ground then  immediately got up and sat on the floor. When I got to him he was sweating and his arms were twitching. Even though he was alert, he was struggling  to straighten his arms. I made a 911 call and then administered one dose of epipen then within  a minute he thanked me for the epipen and he said he is feeling much better. Finally the paramedics came in and asked him if he still wants to go for further checkups. He agreed and left the store with the paramedics.
Got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got COVID) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced COVID-19 (Got COVID). At the time of the report, COVID-19 (Got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Patient got COVID19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment medication details reported.  Company Comment:  This spontaneous case concerns a 31-year-old male patient with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency between vaccine and event cannot be established.  SARS-CoV-2 test was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-589941 (Patient Link).; Sender's Comments: This spontaneous case concerns a 31-year-old male patient with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency between vaccine and event cannot be established.  SARS-CoV-2 test was positive.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient reported that 7 days AFTER receiving her vaccine her shoulder felt hard to the touch and felt hot. This lasted for 2 days. She self treated with ibuprofen and did not seek any medical care.
pain on side of head between temple and ear throbbing; hurts to touch as if was hit or banged with something; laying on a pillow hurts; This non-serious case was reported by a consumer via patient support programs and described the occurrence of temporal arteritis in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included gout. Previously administered products included Allopurinol.   On 28-OCT-2023 12:45, the patient received Arexvy. On 28-OCT-2023, several hours after receiving Arexvy, the patient experienced temporal arteritis (Verbatim: pain on side of head between temple and ear throbbing), tenderness (Verbatim: hurts to touch as if was hit or banged with something) and pain (Verbatim: laying on a pillow hurts). The outcome of the temporal arteritis, tenderness and pain were not resolved.   It was unknown if the reporter considered the temporal arteritis, tenderness and pain to be related to Arexvy.     It was unknown if the company considered the temporal arteritis, tenderness and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The patient reported that pain started a few hours after shot received and had continued since. The patient stated that he knew headache was a mentioned side effect but the sore to touch area that felt as if he was struck by something was very strange. The patient stated that it hurted to touch area and laying on a pillow hurted. Unlike any headache he ever had pain on side of head between temple and ear throbbing ache but strangely hurts to touch as if was hit or banged with something. The reporter consented to follow up.
A rash across her stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash across her stomach) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (A rash across her stomach). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (A rash across her stomach) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified high blood pressure medicine and diabetes medication.
Headache; Eyes hurting; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache and eyes hurting in Apr2021. The patient still has a headache on the third day of this and her eyes are still hurting. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial report was received on 14 September 2011 from a health care professional. A female patient (reported to be approximately 29 years of age), had received FLUZONE SV 2011-2012, lot number UH467AB on 13 September 2011 at 10:00 AM and two hours later at 12:00 PM, she had hives, itching and welts. By 1:30 - 2:00PM she was short of breath. The office physician "administered epi and another steroid injection when seemed necessary, (unknown)". The patient went to the emergency room to be evaluated and was later released. The patient had received many flu vaccinations over the years and never experienced a reaction. Outcome was not reported. Documents held by sender: None.
This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the fatigue to be related to Shingrix. Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The reporter wanted to know how long does fatigue last after Shingrix shot. The follow-up would not be possible as no contact details were available.
No other issues or concerns noted; a patient who received an expired dose of MMRII; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's concomitant medication, pertinent medical history and drug reactions/allergies was not reported.   On 21-MAR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) lot #T007235, expiration date 27-FEB-2022 (dose and route of administration were not provided) for prophylaxis (expired product administered). No other issues or concerns noted.
4:35 PM localized reaction right and left deltoid injection sites, redness and welt approx 5 minutes after varicella and MMR given. Dr made aware. 4:40 PM Applied cold compresses to bilateral deltoid areas. Checked per Dr. No other adverse reaction noted. Benadryl 4ml PO given at 5 PM. Checked every 5 minutes. Redness decreased and welt resolved. Checked per Dr. Pt home with parents, may give 4 ml Benadryl PO tonight every 6 hours PRN.
Onset of symptoms on 12/8/21, tested positive at home on 12/13. Received monoclonal antibodies as an outpatient on 12/15/2021, staff during infusion felt patient looked unwell and advised him to go to the emergency department after his infusion. Initially no hypoxemia in the emergency department, but dropped into the high 80's with ambulation and was thereafter requiring 4L supplemental O2.  Chest x-ray was read as no acute disease, although on personal review there appears to be slight bilateral scattered patchy opacities.  ? Dexamethasone 10 mg given in the emergency department on 12/14/21, continue with 12 mg x 9 additional days or until hospital discharge ? Remdesivir x 5 days or until hospital discharge, started on 12/14/21
flu symptoms; This case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 2nd dose of Shingrix. On 23rd September 2020, 1 days after receiving Shingrix, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was not recovered/not resolved.   It was unknown if the reporter considered the flu symptoms to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The patient was vaccinated with dose of Shingrix at afternoon. The patient experienced flu symptoms. Patient ended call abruptly before any additional information could be gathered. No additional information provided. The reporter did not consent to follow up.
Heart rate dropped to 30; A spontaneous report was received from consumer concerning a 56 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient's heart rate had dropped to 30.  The patient's medical history was organ transplant. Concomitant product use was not provided.  On 22-Jan-2021, the patient received the first of two planned doses of mRNA-1273, Batch number 011J20A, intramuscularly for prophylaxis of Covid-19 infection.  On an unknown date, the patient's "heart rate was dropped to 30". He was hospitalized for 6 days.   Treatment medication was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was unknown.; Reporter's Comments: This case concerns a 56 year old male patient with relevant medical history of organ transplant who received the first of two planned doses of mRNA-1273 (Batch number 011J20A) intramuscularly for prophylaxis of Covid-19 infection and experienced a serious unlisted event of decreased heart to 30 and was hospitalized for six days. Treatment details not provided. Very limited information regarding this event has been provided at this time which precludes a proper medical assessment and in addition, patient's history of organ transplant may provide an alternative explanation and the event is unlikely related to the vaccine. Further follow has been requested.
The patient call and reported right ear pain and numbness in the right foot. The symptoms occured at approximately 6 PM on 11/01/2001. The ear pain passed by the AM of 11/02/2001. The patient states she also has TMJ. The patient's MD was called and advised the patient if she is not better by 11/05/2001 to see him, and if it is worse over the weekend to go to the ER.
Information has been received from a physician and a healthcare worker concerning a 13 year old female who in June 2008, was vaccinated with a dose of GARDASIL vaccine (yeast) (route and administration site not reported). Two weeks past the vaccination, the patient fell down the stairs. The fall was serious enough that the patient required follow-up with the patient's pediatrician. Additional information has been requested.
Severe facial acne that I've not suffered with since my teens, no bleeding or irregular bleeding, PMS symptoms, pain, heavy bleeding if I do start, chronic fatigue
10mins post vacciantion pt had a syncopal event with associated nausea, flushing and sweating Vitals: 11:55 105/62, 86, 20, 100% -- > 12:15 105/69, 92, 100% Pt stable and released from the vaccination site @ 12:24
Patient had pain similar to a flare of pancreatitis, patient has a history of intermittent episodes of pancreatitis. She said pain was mild and took ibuprofen for the pain. Ibuprofen didn't seem to help and but  helped with the pain. Patient recovered without further treatment, pain lasted about 12-18 hours.
no adverse event; Dose1-17-Mar-2021 and Dose2-13-sep-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose1-17-Mar-2021 and Dose2-13-sep-2021) and NO ADVERSE EVENT (no adverse event) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had never been diagnosed with or tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included GERD, Vertigo and Schizophrenia. Concomitant products included LANSOPRAZOLE for GERD, CLOZAPINE for Schizophrenia, MECLIZINE [MECLOZINE] for Vertigo.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose1-17-Mar-2021 and Dose2-13-sep-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose1-17-Mar-2021 and Dose2-13-sep-2021) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose1-17-Mar-2021 and Dose2-13-sep-2021).    The patient received fourth dose on 12-Oct-2022 and the fifth dose of Moderna Bivalent lot no. 023H22A, route intramuscular on left arm. No treatment medication were reported.   This case was linked to MOD-2023-714206 (Patient Link).