chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 4 vaccines Moderna 3/17/21 lot# 007B21A;  Moderna 4/14/21 lot# 043B21A;  Moderna 12/16/21 Lot# 067H21A;  Moderna 10/30/22 lot# 014H22A
Patient had pneumonia shot 2/7/06 - Right arm is red, swollen and firm from shoulder to elbow. Also area is itching. No pain, patient started feeling itchiness in right upper arm last evening. Zyrtec 10mg to take one daily for 7 days given 2/8/06. B/P 108/64-60-20-98
Headache, Arthralgia, Fever, chills, thirst, diaphoresis Narrative:
sore throat; Pressure on the right side of neck; Right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included TERBINAFINE and METOCLOPRAMIDE for an unknown indication.    On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). In August 2021, NECK PAIN (Pressure on the right side of neck) and MYALGIA (Right arm soreness) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved.            Concomitant medication included Birth control.  No treatment medication was reported.  Patient had confirmed she has not visited her primary care yet.
Client was unable to fully wake up in am, feeling "terrible", nausea with vomiting throughout day, unable to eat or drink or stay awake. Client was described as "incoherent and out of it" by spouse. Family took client to ER Friday evening and he was admitted overnite. Received IV fluids (deh)ydration, low KCL. Very weak overall. Client was discharged on Saturday, went home and continued to sleep all day until Monday, when he felt "good". Client is refusing to consider getting the 2nd shot.
Woke up on the 8th day after vaccination with intense itching and a small at the injection site. As the day progressed the itching has remained intense, the lump has grown significantly, the area is quite warm to the touch, and is red. I have called my doctor and am scheduled for an appointment to confirm suspicion of ?COVID arm? on Thursday. Treatment consists of Motrin and ice packs.
patient tested positive for shingles and is being treated with antivirals; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (patient tested positive for shingles and is being treated with antivirals). At the time of the report, HERPES ZOSTER outcome was unknown. Not Provided.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Herpes zoster: positive Positive.     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.   Reporter did not allow further contact
Cough      "I feel like I need to cough something up but it won't come up" denies fevers, tested negative for C19 4 days ago     HPI    Patient is a 45-year-old male who presents for persistent productive cough for the past couple days, not aware of sick contacts. She denies fever, chills, nausea, vomiting, chest pain or shortness of breath. Does report generalized myalgias today, vital signs are within normal limits. He is accompanied by his girlfriend who he lives with. No recent trauma, travel. Does not take any medications at home. Denies past medical history.
Information has been received from a health department nurse concerning a patient who on 04-MAR-2009 was vaccinated with a dose of GARDASIL (lot number, site and route not reported) which was stored at 35F for 24 hours on 23-FEB-2009. No details about the patient were known. Also reported as out of range for one day on 04-MAR-2009. The reporter answered and reported that they only had one patient who received a first dose of GARDASIL (lot number 660389/1968U, site and route not reported) on 04-MAR-2009. There was no adverse event was reported. No further information was expected.
Mother states the child has been sick, personality changes, napping frequently and has watery eyes and a runny nose. She was vaccinated on 4/11, developed a low grade fever and lethargy on 4/16. By 4/20 mother reports she had a fever of 103 degrees taken orally with a bad cough and a large amount of mucus from chest and nose. On 4/22 and 4/23 she was kept out of school for continued fever of 103 degrees. On 4/28 she got a rash on her cheeks, by 4/29 rash has spread to chest, back, arms and thighs. Parent describes rash as pink and raised, but not filled with fluid. She reports child has been very sensitive to things in her environment and has a high pitched scream when she is upset, which is abnormal for her.
Mild Itching on the face; hives on the face; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Mild Itching on the face) and URTICARIA (hives on the face) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 RASH PRURITIC (Mild Itching on the face) and URTICARIA (hives on the face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in February 2021 for Rash and Hives, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Mild Itching on the face) and URTICARIA (hives on the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact
received second vaccine on 2/2/21, started having arm swelling, heat, itching, and redness to the arm on she received the shot in. Went to urgent care on 2/5/21.
Flu-like symptoms - headache, body ache & discomfort, chills, fatigue began 06/27/2022 (tested positive COVID) - began Paxlovid regimen for 5 days & isolated began feeling better on/about day 6. Felt ill again on 07/05/2022 (about 3 days after Paxlovid duration ended)  and tested positive for COVID - isolated again for 5 days & began felling better around day 5.
5 months after vaccination, I started noticing numbness, burning and pain to left foot. It became progressively worse in severity and involved more toes. I did not go to see a doctor. It is always there but worse at night.
Side effects after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Side effects after vaccine) 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 VACCINATION SITE REACTION (Side effects after vaccine). At the time of the report, VACCINATION SITE REACTION (Side effects after vaccine) outcome was unknown. Not Provided          No concomitant medications were provided. No treatment details were provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-054743 (Patient Link).
4.5 mo pt became ill 13 days p/2nd immun; 3 days later pt was dx as having H. Influenza meningitis; @ time of report pt is doing fine;
developed Acute demyelinating polyneuropathy or Guillian Barre syndrome on 12/14/19 requiring hospitalization and treatment with Intravenous immunoglobulin. Hospitalized 12/15-12/21/19
PENTACEL was administered to a 15-year old patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician via Agency (Reference number- 00882537) and transmitted to Sanofi on 02-Dec-2021.  This case involves a 15-year-old male patient was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product administered to patient of inappropriate age)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE CONJ (MENINGOCOCCAL VACCINE CONJ) for prophylactic vaccination.  On 02-Dec-2021, 15-year-old male patient received first 0.5ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ473AAA and expiry date: 09-Jul-2022) (Frequency = once) (Strength = standard) (Form: solution) via intramuscular route in the right deltoid for prophylactic vaccination (product administered to patient of inappropriate age).  It was reported "Nurse asks what adverse events they should look out for; asks if the vaccine would be considered valid? Nurse states that the patient was receiving PENTACEL because he has no immunization record, so he was supposed to be getting a catch-up series. Nurse states they thought they could administer PENTACEL so that the patient did not have to receive as many shots. Nurse states after they realized that PENTACEL is not approved for patients his age, they called the patient and his mother at home; states when they called the patient and his mother, no adverse events were reported to them. Nurse states that the patient did not experience any adverse events that required treatment while he was at their office; states the patient also reported no adverse events that required treatment when they contacted the patient at home. No further information provided by the reporter".  This case was an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient under 65 received Fluad QIV; Body aches; Fever; Injection site soreness; This spontaneous case from the  was received on 05-Nov-2020 from other health professional (nurse) via The Agency (reference number: SEQW20-04824) and concerned a 50-year-old, female patient.   The patient's relevant medical history included heart disease and hypertension (HTN). The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced fever, body aches and injection site soreness. The patient was treated with ibuprofen.    The outcome of the events was not reported.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095 and 202006097 (the same reporter).  Company comment: The patient experienced pain (reported as 'body ache'), pyrexia and vaccination site pain on an unspecified date after administration of Fluad Quadrivalent. Causality is assessed as possibly related for vaccination site pain (due to anatomical plausibility) and unassessable for pyrexia and pain (temporal association is unclarified, and the patient also suffers from unspecified heart disease). Patient under 65 received Fluad QIV- product administration error is assessed as unrelated per company conventions.; Sender's Comments: Company comment: The patient experienced pain (reported as 'body ache'), pyrexia and vaccination site pain on an unspecified date after administration of Fluad Quadrivalent. Causality is assessed as possibly related for vaccination site pain (due to anatomical plausibility) and unassessable for pyrexia and pain (temporal association is unclarified, and the patient also suffers from unspecified heart disease). Patient under 65 received Fluad QIV- product administration error is assessed as unrelated per company conventions.
Immediate back pain, sore throat, and headache. Approx.4 days later, patient awoke with hives/rash across chest, legs, and arms. She went to the ER where she was given a medrol dose pack and Benadryl cream which temporarily subsided the rash. It did return 48 hours later.
Developed water retention, ringing in (L) ear elevated BP with blurred vision. Sx occurred gradually over 1 wk after receiving Hep A/B (TWINRIX). 3-23-10, 4-23-10, 9-23-10.
Very itchy rash on legs and back within 3 days of vaccine. This rash has return twice more since second dose of vaccine. Never had this happen to me before. I can't say that it's related to the vaccine. Seems likely to me.
She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one; Half her face swollen from all of these vaccines; her lip and face were a little swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EM9809), in right arm for covid-19 immunisation. The patient's relevant medical history included: "tumor Giant cell" (unspecified if ongoing), notes: She has a tumor Giant cell in her back . She had her injection Friday afternoon and does not think it caused it.; "Stated she is fat" (ongoing), notes: Illness/AE: Stated she is fat, Onset Date: 20-25 years. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL1283; expiration date: unknown; Anatomical location: right arm), administration date: Jan2022, for COVID-19 Immunization, reaction(s): "flushing/ just right cheek would flush real red", "her lip and face were a little swollen", "Half her face swollen from all of these vaccines/ It was her left side". The following information was reported: SWELLING FACE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Half her face swollen from all of these vaccines"; FLUSHING (non-serious) with onset 2021, outcome "unknown", described as "She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one"; LIP SWELLING (non-serious) with onset 2021, outcome "unknown", described as "her lip and face were a little swollen".  Additional information: It was reported that half her face was swollen from all of the vaccines. It was her left side. Recovered completely. It took a long time for the face to be normal. It was not swollen real big, but her lip and face were a little swollen. She told she already takes allergy pills. She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one. She took her normal medications. She had a tumor Giant cell in her back. She had her injection Friday afternoon and did not think it caused it.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173786 same patient/drug/events, different dose;
Per niece 30 minutes approximately post shot pt. developed a blister, has rash around area - no rash or blister near injection sits. Blister is size of maybe pinky nail. Pt. took BENADRYL and went to immediate care. Pt. reported some itching near blister areas.
Patient was given the Pfizer vaccine instead of the Moderna (should have received the Moderna vaccine as a second dose)
Large subcutaneous nodule over the right upper bicep muscle that has persisted for almost a year since the vaccine; nonindurated, nonerythematous, nonpainful, nonpruritic; It is clearly visible just looking at her arm. It was not present prior to receiving the "high dose flu shot" last year.
on or about 11:00 pm I felt pain on my upper lip and then that morning I had a cold sore on my lip. Never had any fever blisters, or cold sores in my life. I tried otc med but it didn't help. Got another on my lip the next day and have been getting them since my shot. Don't know what could have caused them, except the flu shot.
p/vax pt exp varicella like ash w/greater than 50 lesions on entire body, scalp, face, trunk, arms & legs;
Arm is hurting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm was hurting.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date the patient's partner reported their arm was hurting after getting the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter's Comments: This case concerns a female patient, who experienced an event of arm was hurting. The event occurred after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Patient noted worsening redness, swelling & itching around the injection site (Lt deltoid) the evening of 7/14/11. The patient was given PNEUMOVAX 1150 am on 7/14/11. The patient was seen in clinic 7/15/11. Patient advised to take OTC antihistamines. A f/u phone call a few hours later showed improvement of symptoms. It was noted to be a reaction to PNEUMOVAX 23 and not cellulitis due to presentation of symptoms.
fingers were swollen and red; At the site of injection is a white mark with 2 red dots; Headache; She was nervous; a metallic taste; fingers were swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (She was nervous), DYSGEUSIA (a metallic taste), PERIPHERAL SWELLING (fingers were swollen and red), ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced NERVOUSNESS (She was nervous), DYSGEUSIA (a metallic taste), PERIPHERAL SWELLING (fingers were swollen and red) and HEADACHE (Headache). On 26-Mar-2021, the patient experienced ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots). On 25-Mar-2021, NERVOUSNESS (She was nervous) and DYSGEUSIA (a metallic taste) had resolved. On 26-Mar-2021, PERIPHERAL SWELLING (fingers were swollen and red) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) outcome was unknown.            no treatment medication provided.  no concomitant medication provided.
At 5:30 am the day following vaccination woke up with severe new unset right flank pain.  Went to ED and was found to have a kidney stone on CT scan.  Was treated with hydration and Toradol.  However, spiked a fever (possibly due to vaccine) and was pan-cultured (blood x2 and urine) and given IV antibiotics for possible UTI/pyelo.  Blood and urine cultures were negative and was discharged after overnight observation.  Did not have a history of kidney stones before this event.
Patient reports globus sensation ("golf ball in throat") and hoarseness starting about 5 minutes after injection.  She was observed for 30 minutes and was leaving the vaccination site but was noted to have vocal change.  She was given a dose of diphenhydramine 50 mg IM after about 1 hour and transported to ED.  She reports she was given prednisone, observed for about 2 hours, then discharged home.  Other than a headache, she denies any other symptoms (rash, itching, dyspnea, dizziness, nausea).
Nausea, stomach cramping, pain and swelling at injection site. Lasted two days after vaccine.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EJ1686), in left arm, on 07Feb2021 as dose 2, single (Lot number: EL9261), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 69 years, in left arm 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), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Jul2022) Positive, notes: Rebound after 4 days after paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies. Patient did not receive any medications within two weeks
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
VACCINE ADMINISTERED WAS  STORED  IN THE FRIDGE FOR MORE THAN 30 DAYS  AS RECOMMENDED BY THE  MANUFACTURER