chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt safety incident post 1st Moderna vaccine At 1258 shortly after administration of Moderna vaccine #1  while in the post vaccine observation area Pt stated she was dizzy and hot (room was very warm) BP was taken 163/95 p68 (AT HOME RUNS 110s/60s, p 70-80) Oxygen 98% RA Pt feeling like she was going to faint and stated throat feels tight.  Remarked in normal sentences she has a vocal cord d/o and gets easily  winded and SOB, not on any inhalers. Pt uses CPAP with oxygen at night at home. Pt placed in a manual WC and taken to private exam room  placed on exam table in Trendelenberg position Ice packs provided to neck and axilla Placed under fan to help cool pt off. Pt stated still able to speak in full sentences without WOB, she had not eaten  much this morning prior to vaccine, had a coffee and a sweet cake nothing substantial. Losartan 25mg  x1 taken this morning for her HTN. At 1312 BP 138/102 auto cuff p68 Since pt felt her throat was getting tight, hands and mouth felt tingly and numb, "like she gets at home frequently." Vocal cord d/f listed as one of her medical issues. Provider asked pt if we can give her a benadryl shot, and she agreed. She was given benadryl 50mg IM  ( LOT# 019312, exp 1/21) in her left arm deltoid opposite of her Moderna shot arm.  Manual BP 138/102 p66 pursed lip mouth breathing. Guided pt to breath in through her nose slowly and slowly exhale through her mouth. 1317 Pt stated she was nauseated, provided zofran 4mg SL same as she takes at home. Pt started to feel better within 5m of the zofran. Afterward stated she felt better. At 1338 BP 130/96 p62 Oxygen 98% RA no WOB She was provided a small coca-cola and drank most of the can afterward began to feel better. Able to sit up. Speaking full sentences has baseline raspy voice per daughter due to the vocal cord d/f she has as her chronic medical issue. No WOB. Per daughter pt has these same "spells" often at home.   She was able to sit up, color came back to pts face, able to finish her soda and pt asked to eat something, provided a donut and able eat a donut while chatting. Pt stated she was feeling better. Since the temperature in the room was warm at the time,  the AC was turned down to make room cooler A cool pak was applied during the episode to the back of pts neck Pt felt her sxs resolved.   1345 Repeat BP 132/96 O2 sats 98% on RA   She verbalized she was feeling better and was grateful  for our care. Reminded pt to eat and drink prior to her next vaccine in 4 wks and we can prepare to observe her in an exam room  independently with a provider  or RN and have the benadryl and zofran on hand. Pt was able to walk with her daughter  to her car  in stable condition. Safety report filed.  A task sent to pts provider to help plan for pts second Moderna covid vaccine in 4 wks
Too much dilutant given-  Used 2 ml instead of 1.8 ml
Diarrhea; GI upset; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 31Aug2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "celiac disease" (unspecified if ongoing); "fibromuscular dysplasia" (unspecified if ongoing); "possible ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN. Past drug history included: Gluten (celiac disease), reaction(s): "Known allergies: Gluten (celiac disease)". The following information was reported: DIARRHOEA (non-serious) with onset 26Sep2023 at 04:00, outcome "not recovered", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Sep2023 at 04:00, outcome "not recovered", described as "GI upset". Therapeutic measures were not taken as a result of diarrhoea, abdominal discomfort.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient's heart went out of rhythm and began to beat very rapidly; This is a spontaneous report from a contactable consumer (patient).   A 78-year-old female patient (weight: 71.21 kg, height: 168 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) on the left arm, at single dose, on 17Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder and acid reflux (oesophageal), both from an unspecified date. Concomitant medication included levothyroxine, from an unspecified date, at an unknown dose, for thyroid disorder. On an unspecified date, in Feb2021, the patient's heart went out of rhythm and began to beat very rapidly. No treatment received. Blood test was performed on an unspecified date, in Feb2021 to check vitamin D level, B12 level and thyroid (unknown result). Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse event was unknown at time of this report.
The day after vaccine was given pt developed redness, color, induration, tenderness and itching.
Hib was given at 10:55 a.m 3/10/21 in right thigh mom states later that night on 3/10/21 he started limping and turning his right foot outwards when walking.  She states no redness or bruising, just slight swelling of that thigh.  Mom brought him in to office to have that leg looked at 3/12/21
Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a female 0 day old infant who on 01-SEP-2009 was vaccinated with a first dose of GARDASIL via transplacental administration. Concomitant therapy included vitamins (unspecified). On 03-MAY-2010 the infant experienced jaundice at birth and slow weight gain. On unspecified date, the infant was sent to NICU for r/o sepsis. At the time of the report, the infant recovered from jaundice at birth and slow weight gain. The outcome of sent to NICU for r/o sepsis was unknown. Additional information has been requested. The mother's experience has been captured in WAES0910USA02157.
8x4 cm reddened lump with bumps around area, painful to touch.  Cellulitis vs. vaccine reaction per MD. Treated with PCN 250mg/5cc - 2tsp Q6hrs
Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022; No Adverse event; patient received their 2nd primary dose 4 days after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received their 2nd primary dose 4 days after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022) and NO ADVERSE EVENT (No Adverse event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received their 2nd primary dose 4 days after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received their 2nd primary dose 4 days after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received their 2nd primary dose 4 days after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022).    No concomitant medication was reported.  It was reported as patient received vaccine from individual vial and vial size was 5.5 ml. On 06-SEP-2022 vial was initially stored in refrigerator and vaccine was administered on 10-oct-2022 and vial didn't undergo any temperature excursions.  Patient dose information was also reported as Dose number 2, Moderna, Lot number 083B22A, 0.5ml on 09-Feb-2021.  No treatment details reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history was not provided. On 02-MAR-2014 the patient was vaccinated with an expired dose of MMR II (lot # 1579AA; expiration date 12-OCT-2013). Strength and dose were not reported. No adverse effects were reported. No further information was provided. Additional information is not expected.
BUD 04/07/2022 administered 04/12/2022. Consulted Pfizer who could  not provide stability data beyond 04/09/2022 and recommended revaccination which was provided on 05/13/2022
Experienced a little soreness in his arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Diabetes. Concomitant products included EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) for Diabetes, ROSUVASTATIN for High cholesterol, ASPIRIN [ACETYLSALICYLIC ACID].    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection). At the time of the report, INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Moderate pain in left calf muscle, 300mg ibuprofen every 8 hrs, pain reduced but still there.
Patient received that MCV4-MenQuadfi in Left arm(deltoid). Patient at first tolerated the vaccine. He went to stand and then sat down in the chair. I noticed that his color in his face had changed. He looked pale/pasty. I kept talking with him & told mom to keep talking with him as well. The other two nurses got him a cold compress for his neck & a cold rag for forehead. He was profusely sweating the whole time. He also vomited once in the trash can. We had him sit there until his color got better and he felt better. We had also gave him a bottled water which helped him. He finally said after about 20 minutes that he was feeling better. We advised mom to keep an eye on him that evening & if any changes take him to the ER. Mom voiced understanding. I did call mom that next day to check on him. Mom said that last evening he was tired but did okay. He was doing okay the next day.
Developed numerous symptoms after the after receiving Anthrax #1 and TDaP in 2010. These included fatigue, nausea, dizziness. She never felt well again and went on to develop numerous other symptoms and began medical evaluations within 2 months. These symptoms include myalgias, short term memory loss, alopecia, lung infections, allergies, diarrhea, headache, orthostasis, unrefreshing sleep.
Acute encephalomyelitis; This is a literature report for the following literature source(s): "Acute encephalomyelitis in a 52-year-old male post messenger ribonucleic acid severe acute respiratory syndrome coronavirus 2 vaccination: a case report".  A 52-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, 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: ENCEPHALOMYELITIS (medically significant), outcome "unknown", described as "Acute encephalomyelitis".; Sender's Comments: The Company cannot completely exclude the possibel causality between the reported Acute encephalomyelitis and the administration of the suspect, BNT162b2, considering the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
fever, headache. chills. shivers. body ache. dizziness.tiredness
Chills throughout the night, headache, red rash in area of shot, bodily aches
36 hrs post injection developed 10-12 nodules on the outer edge of tongue. Lymph nodes on left neck became sore and swollen at 72 hrs post injection. Headache right side at 96 hrs. Physician prescribed Azithromycin and magic mouth wash.
Shortly after my second shot I developed clotting and swelling in my legs'. My feet started to feel like they were Burning, and my toes turned dark!!!! and painful.  I started to forget many simple things, like how to make my reports in Excel, something I have been doing for years. I almost quit my job due to poor memory. My Memory is some what better. but my legs still swell, and my toed are still dark, and my feet are very uncomfortable. My doctor In another country said he has had (MANY) cases like my case, and told me I was a super dumb, for getting the vaccine after I had already had and recovered from COVID 19. which by the way was a nothing sickness for me and my family. we just took out Protocol vitamins.  I won't be taking any more Vaccines of any kind EVER!!!!!
Pfizer-BioNTech COVID-19 Vaccine  Soreness at injection site, generalized body aches and malaise, headache/neck ache, low grade fever (99.3), mild chills.
aches; couldn't move her neck; chills; fever; A spontaneous report was received from a healthcare facility staff member concerning, a 73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, aches/pain, fever/pyrexia and couldn't move their neck/musculoskeletal stiffness.  The patient's medical history provided included rheumatoid arthritis. Products known to have been used by the patient, within two weeks prior to the event, included prednisone, hydroxychloroquine, paracetamol for rheumatoid arthritis.  On 02 Feb 2021, approximately 8 to 10 hours prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On the same day, 02 Feb 2021, the patient experienced chills, aches, fever and couldn't move their neck.   The patient was scheduled for their second dose on 03 Mar 2021 and wanted to know if it was dangerous for the patient to get it as they heard the second one was going to be worse.  Treatment for the event included Paracetamol which the patient took just more than the usual (4 daily to 6 daily) to treat their symptoms.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the events chills, aches, fever and couldn't move their neck were considered resolving at the time of this report.
Pt had a choking episode, 2 days post vax administration, and fever with partial complex seizure (as described by mom). Neurologist believed isolated seizure. Subsequently discovered aunt with partial complex seizures.
I developed chilblains on my hands and feet, which Dr. of Dermatology determined to be related to my immune response to the Covid-19 vaccine. The chilblains were treated with a topical steroid and resolved after one month.
had a little leg swelling; baby had been non-stop crying/screaming ever since receiving the vaccines; This is a spontaneous report received from a contactable reporter(s) (Physician). Other Case identifier(s): 2022SA145228 (Sanofi case number).  A 2-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 20Apr2022 as single dose (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), (Batch/Lot number: unknown); cinacalcet hydrochloride (ROTOCALCET), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CRYING (non-serious) with onset Apr2022, outcome "recovered", described as "baby had been non-stop crying/screaming ever since receiving the vaccines"; VACCINATION SITE SWELLING (non-serious) with onset Apr2022, outcome "recovered", described as "had a little leg swelling". The action taken for diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid and cinacalcet hydrochloride was unknown.  Additional information: It was reported Patient: 2 month Old male patient Product: Pentacel Event(s): Wednesday. 20Apr2022, patient was vaccinated with Pentaccl, Prevnar and Roto liquid around noon, left leg, Parent called afterhours number around 9pm and reported that the baby had been non-slop crying/screaming eve: since receiving the vaccines. The baby also had a little leg swelling. parent did stale that the baby slept an hour or two but When awake began to cry/scream again. Physician shared she was in touch With the parent multiple times throughout the evening and night, She also saw the baby first thing this morning and the baby seemed fine. The baby was no longer crying and didn't seem to have any swelling or redness of the left leg. Physician is ok to receive follow up, Action taken with Diphtheria, Tetanus, Ac Pertussis. IPV And Bib Vaccine (Pentacel), Pneumococcal V Accine Conj 7V (CRM197) (Prevnar) and rolo liquid was not applicable. It was not reported if the patient received a corrective treatment for the events 'had a little leg swelling, baby had been non-stop crying/screaming ever since receiving the vaccines). At time of reporting, the outcome was Recovered Resolved in April 2022 for the event had a little leg swelling and was Recovered / Resolved in April 2022 for the event baby had been non-stop crying/screaming ever since receiving the vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: To correct Suspect Product Coding.
Initially on vaccine evening  3/19/21 mild sore arm, mild brain fog,  following day03/20/2021  headache, tired, second day post vaccine 03/21/2021 no noticeable symptoms .  03/17/2021 first notation of headache,, 03/18/2021 headache continued all day ,03/19,2021 notation of headache setting in early evening , 03/20/2021 notation of tiredness all day accompanied by headache and achy everywhere-joints-muscles. Days following had notation of mild headache/body aches.  04/01/2021-8:30am  Extremely Dizzy upon getting out of bed, Strong Panic attack-symptoms subsided with am medications, and reappeared about 11:00am.  Strong Panic attack, very dizzy, neck stiff,muscle tightness in shoulders, sysmptoms continued off and on
7 patients devel large welt (approx 1 1/2inches), redness, swelling & pain @ inj site;all pt had negative allergy hx to eggs;
About 12 hours after I received the first shot, I began to experience chills and a fever that ranged from 101-103.2. This fever came and went for about 24 hours. I also experienced chills, have a lot of swelling at the injection site and a body ache.  I took Tylenol every 4 hours and eventually the fever went away. Its been 3 days since my vaccine and I still have swelling and body aches. I just wanted to let you know in the event that this information is helpful. It may just be my immune system's reaction.
lost feeling in legs; nausea; Dehydration; insomnia; This is a spontaneous report received from COVAES from a contactable consumer (patient).  A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:30 at the age of 41-years-old (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE for covid-19 immunisation.  The patient's medical history was not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no any other medications the patient received within 2 weeks of vaccination. The patient experienced lost feeling in legs 10 days after 2nd vaccine (as reported), extreme nausea, dehydration and extreme insomnia on 15May2021 04:00 with outcome of recovering. Since the vaccination, the patient had not been tested for COVID-19.
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. From an unspecified date in June 2015, the patients were administered an unspecified number of improperly stored doses ROTATEQ orally (lot # K016263, expiration date 26-JUN-2016; lot # L008574, expiration date 22-NOV-2016; strength and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient got their scheduled 0.25 milliliters Moderna booster (3rd dose) administered on November 23, 2021 around 03:35 PM. Approximately five minutes after the shot the patient started to feel lightheaded, hot, and feel like fainting. My pharmacist colleague helped me dial emergency services as agreed from the patient when asked. The paramedics arrives approximately at 03:53 PM. After some initial assessment by the paramedics, patient states she feel nausea and the paramedics suggest she go get and check it out at the hospital. Patient agrees and left with the paramedics.
I had my vaccination on 04/01/2022. In 08/2022 I had an abnormal EKG. This indicated I had a Left Posterior Vesicular Block. I was asymptomatic. I have a follow up with my cardiologist in 11/2022.
1-2 days after MMR #2 and Hep A #1 given in left thigh child developed 10 cm x 15 cm red, itchy, slightly warm lesion on left thigh.
13Feb91 sudden swelling developed @ inject site, developing into a knot, rash localized on rt arm also developed. No SOB, diaphoresis, shock. Development of rash & swelling was sudden & frighten mom. Pt taken to ER & given Benadryl.