chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A staff member reported there was a client "on the floor" in the observation area. This PHN asked NP to assist with possible emergency. Both providers to patient side, this PHN went to grab cot as patient reported feeling "lightheaded." Patient initially refused treatment, but was then willing to move to cot from floor. After about a minute on the cot, Patient became more pale and lost consciousness. Patient's pupils dilated fully, RR was  6 with wheezes, gasps, and grunts, and his body went rigid with tonic clonic, seizure-like movements. His wife, was present and this PHN asked her to call 911, Patient came to several seconds later and was able to respond to his name. VS: 110/60, HR: 68. RR even and increased, skin: color returning but pale, diaphoretic. EMTs arrived shortly after Patient regained consciousness and we transferred care to them. They eventually cleared Patient, as he declined transportation to the ED, and he left the site.
Patient came in with 2 other family members. Questions were all answered "no" on COVID vaccine consent form, and reviewed by writer.  Writer asked if patients had any questions. There were no questions. Vaccine was administered, and then the patient asked "Does this interact with the Johnson & Johnson Vaccine? We all got it about a month ago." They did not make this known until the vaccines were already administered. Writer contacted nurse for guidance. Told to report this as an incident, as the patients received two brands of vaccine. No adverse affects have been noted.
R arm, 5x3 cm zone of erythema, induration this was measured 2 days after the injection.
Patient complained of tingling up arms and legs and also muscle spasms in legs. Also reported headache and fever. Lasted for 4 days.
This case is linked to case number 2013-07841 and 2013-07842 (same reporter after MENACTRA). Initial misuse report received from a healthcare professional on 01 July 2013. An adult patient had received MENACTRA vaccine in 2009 for traveling. On an unspecified date after 4 years, the patient again received another MENACTRA dose. (No information was provided regarding the patient). The patient did not report adverse event. List of documents held by sender: none.
PREVNAR 13 - reaction on right thigh - local 50 cent piece size red, swollen, blotchy, no systemic reaction noted. Mother noticed hard lump next day but recommended ice/heat, ADVIL age appropriate.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 16-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
12cm x 9cm erythematous plaque right lateral thigh warm to touch. Non tender. Diagnosed cellulitis; Omincef 250mg/5ml 5ml po gd x 10 days
CLINICAL IMPRESSION: Acute on chronic respiratory failure, unspecified whether with hypoxia or hypercapnia. Healthcare-associated pneumonia. Pneumonia due to COVID-19 virus, Hyperkalemia, Elevated troponin, COPD exacerbation.
DIXXINESS WITHIN 5 MIN AFTER IMMUN FOLLOWED BY SEIZURES, TAKEN TO ER
Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5 ml first dose of Gardasil. Subsequently the patient developed "swollen cherry sized lymph nodes on her right side of the body" where Gardasil was given. A complete blood count was performed, results not reported. Unspecified medical attention was sought. After six weeks the lymph nodes started to go down. At the time of the report the patient was recovering. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5 ml first dose of GARDASIL. Subsequently the patient developed "swollen cherry sized lymph nodes on her right side of the body" where GARDASIL was given. A complete blood count was performed, results not reported. Unspecified medical attention was sought. After six weeks the lymph nodes started to go down. At the time of the report the patient was recovering. Additional information has been requested.
Fever starting 24 hours after vaccine which peaked at 104 degrees at 48 hours post vaccine.
Chief Complaint  poss. ck pox  Problems  07999: viral and chlamydial infection in conditions classified elsewhere and of unspecified site viral infection Onset: 03/24/2005 46611: acute bronchiolitis due to respiratory syncytial virus (rsv) Onset: 03/17/2005 46619: acute bronchiolitis due to other infectious organisms Onset: 04/15/2005 481: pneumococcal pneumonia [streptococcus pneumoniae pneumonia] Onset: 10/07/2005  Medications  None recorded.  Allergies  NO KNOWN DRUG ALLERGIES  List all non family members in the household: 4. Daycare: Y. Do you have any pets / what kind: NO. Exposure to smokers: NO. Smoke alarm in home: Y.  Family History  None recorded.  Surgical History  None recorded.  Document Review  N/A  Clinical Guidelines  Name History Status    Vitals  T: 97.7 °F (temporal artery)   Wt: 27 lbs. (12.3 kg, 29th %)   Notes: LC    Vaccines  Vaccine  Type  Date Given  Route  Site  Lot #  Manufacturer  Date on VIS  Date VIS Given  Vaccinator   Diphtheria, Tetanus, Pertussis  DTaP  03/07/2007  IM  LT  C2552AA  SANOFI-PASTEUR  07/30/2001  03/07/2007  lcampos  DTaP  05/26/2005          DTaP  03/29/2005          Haemophilus Influenzae Type B  Hib-HepB  05/26/2005          Hib-HepB  03/29/2005          Hepatitis A  HepA  03/07/2007  IM  LT  1213F  MERCK & CO.  03/21/2006  03/07/2007  lcampos  Hepatitis B  Hib-HepB  05/26/2005          Hib-HepB  03/29/2005          Measles, Mumps, Rubella  MMR  03/07/2007  SQ  RT  0986F  MERCK & CO.  01/15/2003  03/07/2007  lcampos  Pneumococcal  PCV7  05/26/2005          PCV7  03/29/2005          Polio  IPV  05/26/2005          IPV  03/29/2005           HPI  Friday noted mult lesions , 4 dAYS with fever, very itchy, mild URI. VZV vac 3/06  HPI  None recorded.  Birth History  None recorded.  Prenatal History  None recorded.  ROS  None recorded.  Physical Exam  Patient is a 2-year-old male. General Appearance: General Appearance: active and alert, smiles, playful. Level of Distress: NAD. Attentiveness: good eye contact.  Head: Head: normocephalic, atraumatic.  Eyes: Eyes: conjunctiva non-injected, no conjunctival exudate, normal lids, PERRL.  Ears, Nose, Throat: Ears: normal except where noted. Nose: normal except where noted. Pharynx: normal except where noted.  Neck: Neck: supple, no masses, normal thyroid.  CVS: Rate and Rhythm: RRR, normal S1, normal S2, arterial pulses normal.  Lungs: Respiration, Rhythm and Depth: no respiratory distress, normal breath sounds.  Abdomen: Auscultation: normal bowel sounds. Palpation: non-tender. Liver: no hepatomegaly. Spleen: no splenomegaly.  Skin: General: no cyanosis, generalized warmth. Moisture: dry. Lesions: no rash, no petechiae, mult eryth pap some with scabs in gen distribution.   Well Child ROS  Patient is a 2-year-old male.  Diagnoses / Orders  0529 - VARICELLA WITHOUT MENTION OF COMPLICATION - Aveeno bath Keep isolated at least 1 week, call OB since Mom pregn and not sure if had Dz HYDROXYZINE 10 MG/5 ML SYRUP - Submit Date: 04/17/2007    Take 11/2 teaspoon by mouth every 8 hours for itch     Qty: 1 120 ml bottle     Refills: 0      Return To Office  Appointment to see ssanchez for Sick Visit or Follow-up at  Office on 04/17/2007 - - rash. add note
Initial report was from a health care professional on 26 September 2011. A 72 year-old male patient with no reported past medical history had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of later, experienced a high fever of 103 and chills. The patient was hospitalized over night and was told it was a "reaction from the flu vaccine". No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
I got Covid even after vaccination; I got Covid even after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 16:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single and administered in arm left, administration date 01Mar2021 16:00 (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 patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the has been patient tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Nov2021, outcome " recovering ", COVID-19 (medically significant) with onset 12Nov2021, outcome "recovering" and all described as "I got Covid even after vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Nov2021) positive. Therapeutic measures were not taken as a result of covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Five minutes after receiving vaccine, she c/o being SOB.  Vitals were stable.  O2 sat 98% BP 164/94.  She was given 25mg benadryl.  5 minutes later she c/o swollen glands and feeling light headed. She was taken to the ED where she received 125mg methylprednisolone, famotidine and NSS.  Symptoms resolved within 2 hours and she was discharged to home with a prescription for an Epi pen.
Approximately 15 minutes after receiving the vaccination, my throat became dry and my eyes began watering. It was hard to tell but my throat felt slightly swollen also. I drank some water and a few minutes later things seemed to clear up. Randomly throughout the afternoon I had similar dry/itchy/tingling in my throat but not as strong as the time right after the vaccination. I didn't suspect this was directly related to the virus since I have allergies to grasses, trees, pollen, etc. and take over the counter allergy medicine as needed.  At 3:30am today (4/10/21) I woke up having to use the restroom and when standing up out of bed I was extremely dizzy. After laying down in bed the dizziness disappeared. When waking up later in the morning the dizziness/light headed feeling was still present when standing. I also have noticed random strange pinching pain in my legs that only last for 1-2 seconds and sends a quick short pain sensation throughout my body.    I have no clue if any of this is related to the vaccination received, but after noticing news articles with issues in a few folks receiving the Janssen vaccine, I decided I would pass this info along just in case.
4 days post injection developed redness and rash and swelling  on toes of right foot. 8 days post injection developed circular rash , on left arm ,  at injection cite and below cite .
taking a "sick day."/could be making him sick/causing him to be ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "taking a "sick day."/could be making him sick/causing him to be ill". It was unknown if therapeutic measures were taken as a result of malaise. Additional information: Patient was taking a "sick day." Then sent several text messages to the reporter asking if the vaccine could be making him sick. Then sent messages inferring that he felt the vaccines were "shady" and causing him to be ill.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sore arm, felt like bumped into door frame; slightly restless sleep; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and sleep restless. On an unknown date, the outcome of the pain in arm and sleep restless were unknown.   It was unknown if the reporter considered the pain in arm and sleep restless to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-SEP-2022 Reporter's Comment: This case was received from consumer via interactive digital media. The patient stated that he/she would rather have an option intensely painful rash for a few weeks than a sore arm for a few days.  The reporter stated that, After the vaccine that first night was a slightly restless sleep and his/her arm felt like  bumped into a door frame.  The reporter mentioned gotta be worse than the shingles the patient would never had. The follow-up would not possible as no contact details were available.
Erythema + induration of left arm covering approximately 60% of surface area of left arm. Single puncture would still visible near top of erythematous + indurated area. Cephalexin prescribed empirically  for suspect cellulitis.
Hardening of lip filler after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Hardening of lip filler after 2nd dose) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL DISCOMFORT (Hardening of lip filler after 2nd dose). At the time of the report, ORAL DISCOMFORT (Hardening of lip filler after 2nd dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.
Patient experienced paralysis from the lower chest to toes 12 hours after vaccination.  She was taken by ambulance to the Hospital, then transferred to another Hospital.  She will now be transferred to the a Clinic.
received an expired  pediatric ENGERIX-B vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the certified medical assistant called from a doctors office. The age at vaccination was not reported. The reporter stated that, the patient received an expired pediatric Engerix B vaccine, which led to expired vaccine used. The reporter did not have the chart in front of her therefore did not have the patient's date of birth and failed to ask for the patient's initials.
Tingling in the back of throat; Tingling in the face; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13Apr2021 at 17:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfa (sulfonamide) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021 at 17:45, the patient experienced tingling in the face and back of throat. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling in the face and back of throat was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Had the vaccine. Still got shingles/Suspected vaccination failure; shingles in my eye!; Miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and feeling miserable. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and still got shingles in her eye. The patient stated that miserable. The patient was treated with drops two times a day and antivirus pill every single day forever. The patient stated that oh the joy. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Fatigue, headaches, migraine starting 3 days after the shot. Sore arm for 8 days. 7 days after the shot, a lot of redness/rash like around injection site. Lump in neck appeared on the same side of the neck as the  injection.
Itching throughout whole body, rash on chest.  Used most OTC anti-itching remedies.  None has stopped the itching or cleared the rash.
Headache, Myalgia, Diarrhea, Chills Narrative:
3 weeks after received PEDIARIX developed a firm nodule at surface of skin. Now 4 1/2 months later it is still firm & hard. Feels more granulomatous/collagenous than lipomatous. We will follow this clinically. But may need surgical intervention in future.
suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was 1 of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
I had a mild reaction of rash after my first vaccine 1/14/21 but it went way after taking 25mgs of Benadryl. The second shot I was instructed to pre medicate with Benadryl before hand. After my second shot 2/11/21, within about 5-10 minutes I started with a red hot spot on my left ear, and a rash at injection site. Then it spread down my arm and to my chest. I took another 25 mgs of Benadryl and was given Pepcid as well. My chest started getting a tightness feeling in it and then I was instructed to go to the Emergency Room. I was gocen solu-medrol in IV and it seemed to help.  The next morning 2/12/21 I took 25 mgs of Benadryl prophylactically. At 1142, I started feeling like the rash was coming back. It started under my chin and spread all over my face to my neck and chest and to my arms. My chest started feeling tight again. My blood pressure was 154/94, pulse 108. I got in touch with the nurse who was with me the night before with my first reaction and she instructed me to go to the ER again. There they gave me another round of solu-medrol IV. And sent me home with steroids to take.  Today, 2/13/21 I woke up and my face still is rashy and hot to the touch, my eyes are puffy and tongue is more swollen than usual and my chest still feels tight. I have taken the steroid dose for this morning and Benadryl 25mgs.
5 minutes p/vax, pt c/o dizziness, lethargy, h/a; pt had one emesis & suddenly became very cold, sweating & pale; pt appeared very lethargic; pt given Epi, DPH & Decadron;
13OCT call from pt reports entire rt arm is swollen extending down to elbow w/pain down to hand
Next day left deltoid to elbow redness and swelling-fever,headache,and aches all over especially legs-relief with tylenol-denies rash,hives,shortness of breath or chest pain-went to PMD and is improving-encouraged to return to PMD if symptoms worsen or other problems occur.