chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Runny nose; coughing; Low grade tmeperature; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (coughing) and PYREXIA (Low grade tmeperature) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Arteriovenous malformations. Concurrent medical conditions included Hypothyroidism. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 12-May-2022 for COVID-19 treatment, LEVOTHYROXINE from 07-May-2022 to 21-May-2022 for an unknown indication.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced RHINORRHOEA (Runny nose), COUGH (coughing) and PYREXIA (Low grade tmeperature). At the time of the report, RHINORRHOEA (Runny nose), COUGH (coughing) and PYREXIA (Low grade tmeperature) was resolving.            The patient had past drug reaction allergy. The patient took other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously receives a COVID-19 Vaccine. The patient did not receive any treatment for reported events. Device date was reported as 21-May-2022.
I got my vaccine on Friday, April 9th at 1:30 p.m.  By 5:30 p.m., I felt extreme muscle pain throughout my body, arm soreness at the vaccine site, fatigue, nausea, and neurological impacts that reminded me of when I suffered a concussion several years ago.  My soreness and nausea subsided after five days, but my headache, lack of focus, light and sound sensitivity, and overall irritability have remained.  I find this deeply concerning.
w/i 24 hrs aft dtp/opv vax, infant ex severe diarrhea which lasted 4 weeks.  Mother advised to stop breast feeding and infant placed on formula.  Infant referred to MD.  dx pending further follow-up.
Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 22-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Menactra + varicella given wed.  7-22-09, + over course of the day patient presented to clinic on 7-24-09 with itching, swelling, + redness on both deltoids with palpable edges.
Dizziness; Headaches/little headache; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 12:15 (Lot number: EW0153) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; HEADACHE (non-serious), outcome "unknown", described as "Headaches/little headache"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness". The event "headaches/little headache" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took a medication for depression. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After her first vaccine dose on 07Apr2021, the patient experienced headaches with episodes of dizziness and weakness. The patient wanted to know what she could do for her side effects following vaccination and needed recommendations for what she could do about these symptoms, she needed medical advice. With the first COVID-19 vaccine, the patient experienced a little headache, dizziness and weakness. She didn't think her side effects were from the vaccine. When she got the second COVID-19 vaccine, she had a headache and she knew it was definitely the vaccine. She received her second COVID-19 vaccine on Thursday, 29Apr2021. When she received her second COVID-19 vaccine she was still experiencing side effects from the first COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
administration of FLUBLOK to patients under 18 years of age (with no advers event); Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional via Agency (Reference number- 00413960).  This case involves a 2 year old female patient for whom it was reported that administration of flublok to patients under 18 years of age (with no adverse event) (Product administered to patient of inappropriate age), while she received influenza quadrivalent recombinant vaccine (Flublok QIV).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  It is also an actual medication error case due to inappropriate age at vaccine administration.   On 29-Dec-2020, the patient received a dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 mL once via intramuscular route (lot number: UJ509AA, expiry date: 10-MAY-2021) as prophylactic vaccination in the left deltoid.  On 04-Jan-2021 (i.e., 6 days) after taking the suspect, it was reported that administration of flublok to patients under 18 years of age (with no adverse event) (Product administered to patient of inappropriate age) (intensity: not applicable). The event was reported as adverse event of special interest (AESI) as per the AESI list.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.    No further information was reported.
swollen and painful possible lymph node on left clavicle left arm sore for 3 days numbness and tingling in left arm following injection for a few hours
Noticed symptoms of weight loss 5/1/22 and then randomly o f thirst and excessive urination around 5/12/2022. Went to doctor on 5/20/22 and was diagnosed with diabetes. They are unsure if type 1 or 2 but suspect type 1 but multiple doctors have stated my situation is very odd, being I have no family history or other health concerns. My blood sugar was 584  5/20/22 and I was admitted to ER to receive fluids and get started on insulin injections immediately. Otherwise fit, healthy 27 year old with no previous health concerns before.
A report has been received from a Pharmacist concerning a 6 year old, female subject who had been receiving FLUMIST. FLUMIST started on 15-Feb-2016. It was reported that expired FLUMIST was administered to the patient. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between administration of expired FLUMIST and FLUMIST Quadrivalent. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of administration of expired FLUMIST to be unrelated to FLUMIST Quadrivalent.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Severe chills, muscle aches. Lasted about 24 hours this disappeared completely. No further reactions.
On 8/28 woke up with 2 papules on right ankle and started running a fever of 102. On 8/29 woke up with a large reddened indurated area on left thigh in the injection area from Hib and Varicella shots. The papules on the (R) ankle were cultured. The results were positive for MRSA. Bactrim started 8/29/07. Admitted to hosp 8/30/07.  9/14/07 Reviewed hospital medical records which reveal patient experienced fever, papules on right ankle, large red indurated area at left thigh injection site.  Saw PCP on 8/29/07, papules were cultured & started on oral antibiotics for cellulitis.  Returned to PCP on 8/30 w/o improvement & actually increased WBC.  Admitted 8/30-9/3/07.  Ped surgery consult obtained.  Erythema & significant induration from left hip to knee.  Started on IV antibiotics.  To OR for I&D of left thigh on 8/30 for deep abscess extending to subfascia.  Wound packed & continued IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics & wound packing w/follow up w/pcp & surgery. FINAL DX: MRSA abscess & cellulitis of left thigh, s/p I&D.
A nurse was inadvertently splashed with varicella virus vaccine live in the eye. Additional information has been requested.
The HPV vaccine was administered at 04:20, within 20 sec patient stated she felt sick to her stomach and a bit dizzy.  She then passed out on the exam table. She then seemed to have a seizure type activity which lasted about 20sec.  We raised her feet in the air and told her to open her eyes.  She woke up and was very confused as to what happened.  She was kept laying down for 30 minutes and then was helped to slowly sit up.  Patient stated she felt nauseous.  Dr. ordered oral Zofran.  She was then discharged from the clinic.  On her way out, she did vomit in the waiting room and stated she felt much better.  Parent was told to contact Dr. via cell phone if she had any concerns that night.   No call from parent occurred.
Pt recv vax 30MAY97 & 1JUN97 pt devel 2 spots under arm w/low grade fever;4JUN97 pt devel over 100 spots w/temp 101;spots were red, irregular w/oozy center par; only 2-3 had crusted over;
No adverse symptoms reported; inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant referring to a currently 59 years old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 11-DEC-2019, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA)(lot # R031045, expiration date was 18-NOV-2019)(strength, dose, frequency and route were not reported) for prophylaxis. No adverse symptoms reported.
patient began experiencing symptoms of Covid-19; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 22 year-old male patient who began experiencing symptoms of Covid-19 (suspected covid-19), while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.   On 06-Oct-2020, the patient received 1 mL first dose (once) of suspect RABIES (HDC) VACCINE (lot P1E521M and expiry date 30-Oct-2020) via unknown route in the left deltoid for pre-exposure.  On an unknown date in Oct-2020, the patient began experiencing mild symptoms of Covid-19 (suspected covid-19) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  Case Details: The patient was scheduled to receive a second pre-exposure prophylaxis dose next day (Day 7). He was tested that day for Covid-19 with the results expected in 5 to 7 days.  If he was Covid-negative, then Imovax Rabies pre-exposure prophylaxis would be proceeded. Patient needed the pre-exposure prophylaxis due to taking a job working with dead animals in studying white-tailed deer wasting disease.  Laboratory test results included: COVID-19 - On an unknown date in october 2020: [results expected in 5 to 7 days].  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
three days after vaccine I developed palpitations.  These have become more persistent in frequency and duration. I also developed fatigue, SOB, dyspnea.
An itchy rash on my left arm at the injection site. The rash manifested over 10 days after the injection. It lasted 2 days.
difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown.  Information on the lot/batch number has been requested.
On 9/17 at around 10:00 pm client states her arms and legs started shaking really bad. She was awake and talking but her ext were shaking uncontrollably.  She had mild nausea at the time but that is all.  She said the shaking would go on for about 15 then stop for about 5 minutes then start back up again. She said this shaking lasted about 45-60 minutes. She then went to bed and felt better the next day. She also experienced normal side effects from the vaccine like, pain in the arm, mild body aches, and feeling tired. She said she felt back to normal on Sunday 9/19/21
LUMP UNDER THE FOREARM; PAIN IN THE ARM ALL THE WAY TO THE TIP OF FINGERS; HEADACHE LIKE MIGRAINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced lump under the forearm, pain in the arm all the way to the tip of fingers, and headache like migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache like migraine, and had not recovered from pain in the arm all the way to the tip of fingers, and lump under the forearm. This report was non-serious.
Affected area was swollen and red; Affected area was swollen and red; Intense Itching on the Injection Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Intense Itching on the Injection Arm), VACCINATION SITE ERYTHEMA (Affected area was swollen and red) and VACCINATION SITE SWELLING (Affected area was swollen and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to dried mushroom).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Intense Itching on the Injection Arm). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Affected area was swollen and red) and VACCINATION SITE SWELLING (Affected area was swollen and red). On 28-Mar-2021, VACCINATION SITE PRURITUS (Intense Itching on the Injection Arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Affected area was swollen and red) and VACCINATION SITE SWELLING (Affected area was swollen and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by the reporter.  No concomitant medication provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13 May 2021 included:Patient demographic details updated, second dose details, relevant medical history details. Event information was updated.
Nodules in the neck area of the clavicle swollen. Front and back chest pain. Chikungunya-like muscle aches, headache, pain in joints fingers, wrist, hips, and feet. General pain in the body especially in the neck towards the head by the back of the neck. Pain in the left arm.
immediately after receiving vaccine pt experienced tingling in arm/numbness in face/neck/jaw.  she also had blotchiness on chest and neck. She was given benadryl and remained in the pharmacy waiting area. After leaving, she reported swelling of tongue, throat. She went to urgent care and was given additional benadryl and was given a prescription for an epi-pen and medrol dose pack.  Follow up with patient today, she reports she is doing much better and symptoms have resolved.
Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The patient self-reported this case. She received her first Shingrix dose about two weeks ago.  She experienced diarrhea soon after and it was lasted two weeks (diarrhea, not recovered).  She was an appointment with her physician to provide a stool sample and rule out other causes.  She was nothing else to report.  The reporter was consented to follow up with physician. Additional Supportive Information:  This case has been linked with the case US2022137996 reported by same reporter.; Sender's Comments:  US-GSK-US2022137996:Same reporter
The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 18 September 2013. A patient whose age was over 64-year had received FLUZONE ID. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Nausea, vomiting, chills, fever. Tylenol taken. Nausea, vomiting, and chills lasted from 2 am to 5 am.  Fever from 2 am to following day 6 pm
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician at an eye center for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Breakthrough case admission after three vaccines Moderna 3/15/21 Lot# 038A21A;  Moderna 4/12/21 Lot# 040B21A;  Moderna 11/9/21 Lot# 069f21A;
Moderna vaccine given instead of Pfizer for patient's second dose of covid vaccine. Dr notified with only instruction given was to notify patient and inform pt of  no need to repeat dose.