chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received varicella vaccine on 12-05-14. Mom states she noticed swelling of face on 12-7-14 a.m. and took him to ER at medical center. Dx with ear infection and rx cefdinir. Mom reported he had fever but did not take it. Noticed swelling of feet and hands this a.m. Brought to our health unit. Client received 2nd Varicella Vaccine at the Health Unit on 12/05/14 at approx. 1:00 p.m. Mom noticed child had a fever and his face was puffy on 12/07/14 at 10:00 a.m. She took him to the ER at Medical Center. The doctor diagnosed him with an ear and sinus infection. The MD states the facial swelling was due to the ear infection. He was rx cefdinir. Mom brought client to our health unit today, because she noticed his feet were swollen and hands. Client did have swelling/puffiness of hands and feet bilaterally. Denies fever since Sunday. Temp today 97.2 degree F. Consult CDNS. She states to complete a VAERS. Informed mom that it could be a reaction to the antibiotic. Discussed warning signs-increased swelling, hives, wheezing or trouble breathing. Instructed mom to seek ER care if his s/s worsen or do not appear. Instructed mom to call pharmacist and discuss s/s to ensure this is not a reaction to the antibiotic. Verbalized understanding. Client does not have insurance or a PCP.
Joint pain in both shoulders (pain scale of about 4-6). It still hurts and the pain is not related to any unusual activities. Aleve
Admitted on 3/21/2021 with severe encephalopathy; still currently hospitalized.
Patient came to clinic to receive the jynneos vaccine. Nurse took what she thought was the correct vaccine out of refrigerator and administered it to client, realized after that she had actually given COVID-19 10mcg/0.2 mL vaccine. Administered 1 cc of this vaccine subcutaneous to this client.
This is a spontaneous report from a contactable consumer (Patient wife) or other non hcp. A 44-years-old male patient received BNT162B2 (BNT162B2, Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, expiration date was not reported), dose 1 via an unspecified route of administration on 26May2021 (at the age of 44-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from 2020 to an unknown date. concomitant medications were not reported. on 27 May 2021 the patient experienced severe chills, muscle weakness, fever/he is having a temperature, nothing crazy. it was 99.9. the patient underwent lab tests and procedures which included body temperature: 99.9 on 27May2021. The outcome of event severe chills was not recovered, while outcome of other events was unknown. Follow-up (27May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (wife) reported for a 44-year-old male patient new information included event detail was updated. Follow-up (27May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (wife) reported for a 44-year-old male patient Limited information available over the call. Information on the lot/batch number has been requested.
Back pain; Sore throat; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Back pain) and OROPHARYNGEAL PAIN (Sore throat) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced BACK PAIN (Back pain) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, BACK PAIN (Back pain) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            No concomitant medication was reported.    No treatment information was reported.   Reporter did not allow further contact
Outer hip pain, woke up with it on Friday March 19th (2.5 days after shot) lasted until Thursday March 25th  Would be more painful at night and would go away with Tylenol.  Started my menstrual period during this time and thought the pain could be from that until I heard of others having lower back and hip pain after the shot.
Mother states that infant fell asleep around 10 PM on 06/17/14, woke up at 12 midnight screaming and didn't fall back asleep till 2 AM. Woke up around 5 AM on 06/18/14 with a rash on abdomen and had a fever around 100.2; mother states fever has not got any higher than 100.5, that infant hasn't had an appetite all day and has been sleeping a lot through out the day. Injection site was red and swollen.
Experienced coughing, clammy, itching.  Treated with IV fluids, claritin.  Patient went back to work in the hospital and was fine in the AM of 10/2/08.
Several days experienced fatigue. Not feeling well. Tuesday night - sensation of flutter in throat and chest. Got better. Wed. night - flutter sensation and felt heart beat. Diagnosed w/ atrial fibrillation. IV Heparin. Converted on the 30th, started on COUMADIN.  12/15/2008 ER records received for DOS 10/29-30/2008 with DX: Atrial Fibrillation with rapid ventricular rate.  Hypokalemia. Pt presented with c/o irregular heartbeats and chest discomfort. PE (+) for irregularly irregular heartbeat. Admitted for medication mgmt.
low oxygen; upset stomach; high fever, 102; nausea; fatigue; headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (low oxygen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   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) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HYPOXIA (low oxygen) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (high fever, 102), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and RASH (rash). At the time of the report, HYPOXIA (low oxygen), ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (high fever, 102), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and RASH (rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree Celsius Fever.         Tylenol was taken as treatment medication. Concomitant medications were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Fever of 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.5) in a patient of an unknown age and gender 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 17-Jun-2021, the patient experienced PYREXIA (Fever of 101.5). At the time of the report, PYREXIA (Fever of 101.5) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2021, Body temperature: 101.5 (High) 101.5.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Information has been received from a physician concerning a female patient who two months ago "approximately on 21-MAR-2012" was vaccinated IM in the right upper arm with the first 0.5 ml dose of GARDASIL (lot # 672233/1561AA).The physician reported that the patient, went to the office for the second dose of GARDASIL and, at that time, reported that she had developed significant redness and swelling at the site of injection the day after receiving her first dose of GARDASIL "approximately on 22-MAR-2012". The patient self-treated with BENADRYL and the injection site reaction resolved without requiring medical treatment. The physician did not administer the second dose of GARDASIL. It had not been determined if the GARDASIL series would be discontinued. At the time of the report, the patient recovered. The patient sought medical attention by visit to the office. Follow up information has been received from a physician refers to a 11 years old female patient with none known pre-existing allergies, birth defects and medical conditions. The patient was vaccinated intramuscularly in right arm with a first 0.5 ml dose of GARDASIL lot # (672233/1561AA) on 15-MAR-2012. No other co-suspects were reported. Concomitant medications included MENACTRA, HAVRIX and BOOSTRIX. It was reported that on 16-MAY-2012, when a second dose of GARDASIL (dose, route and Lot # not reported) was scheduled, mother reported that the patient had redness and swelling on the arm where GARDASIL first dose  was given (onset date was 15-MAR-2012, reported also as a few hours after administration). The mother reported that the patient received BENADRYL for the reaction. On ER mother was instructed to see allergy department in the hospital to further evaluation. At the time of the report the patient's status was recovered (recovery date was not provided). Additional information is not expected.
The next day I had fever, body aches, and headache. Not too long after that I was getting swelling in my arms and legs. I contacted my PCP. She didn't think it was related and there was no outcome or diagnosis. I was put on a diuretic. I am mostly recovered and have swelling in both arms and legs occasionally.
7 days p/vax pt devel a rash which started on the back of neck & cont over the next 2 days to envelope entire body;it was a flat, red rash;pt also had fever 3-4 days w/highest reading 104.4 despite APAP & ASA;
rash itches, uncomfortable; got a rash on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Function kidney decreased and Blood pressure abnormal.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 24-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (rash itches, uncomfortable) and VACCINATION SITE RASH (got a rash on his arm) outcome was unknown.            Reporter reported that patient had low kidney function and she was concerned taking Benadryl. Furthermore she mentioned that patient was on lot of medication and they were blood pressure related, but she did not specify which ones.  Reporter states that doctor did not think the rash was from the vaccine.   This case was linked to MOD-2021-397536 (Patient Link).
On 07-15-21 we had a nurse vaccinating for Pfizer at one table and a nurse vaccinating for Janssen at another table. Each table keeps their vaccines in color coordinated boxes that is assigned for each vaccine being administered. At approximately 12:20PM the nurse who was vaccinating Janssen closed her pink box labeled J&J and stepped away 6 feet from her table to speak to the service representative that was checking in our patients. Unbeknownst to us, the nurse vaccinating Pfizer walked to the other table and grabbed vaccines from the pink box labeled J&J and took them back to her station and put them into her clear box. There were a total of 2 vaccines taken from the Janssen box. At approximately 12:45PM the nurse vaccinating Janssen returned to her table and noticed that two vaccines were missing from her box. The other nurse then proceed to give her one back. The nurse vaccinating Janssen immediately brought the syringes to a supervisor for disposal. Based on the timeline we have compiled a list of patients that were vaccinated by the nurse who took the Janssen vaccines. Patient was to receive his second dose of Pfizer but now based on the above instance we are unsure if he was given Janssen. Administration has been made aware of the instance and an MD has been in contact with the patient.
Information was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. It was reported that improperly stored PROQUAD (dose, frequency, route, lot# and expiry were not reported) doses had been administered to unspecified patients on unspecified dates. Number of doses administered were unspecified. This is one of 2 reports received from the same reporter. Additional information has been requested.
Retinal hemorrhage inside left eye; Impaired vision; Occular migraine; Swelling inside left eye; Severe headache; A spontaneous report was received from a reporter like consumer concerning a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like retinal haemorrhage, eye inflammation, headache, visual impairment, retinal migraine.  The patient's medication history was not provided. Concomitant medications were not provided.  On 17 Feb 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 030M20A) intramuscularly in the anatomical location for prophylaxis  of COVID-19 infection.  On 18 Feb 2021, 28 hours following the vaccine administration, the patient experienced events like very small hemorrhage inside left eye, swelling inside the left eye, headache, impaired vision, ocular migraine with swelling inside the eye being medically significant. Laboratory details were not provided.  No treatment information was provided.  The outcome of the event was unknown.  Action taken with mRNA-1273 in response to the events were not reported.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
Patient reported to have developed a fever, swelling of upper arm around injection site, skin on torso turned red and later peeled.
Pain during shot and after.  Bad night.  Chills. Muscle pain.  General feeling of discomfort, head to foot.
do know 3 other women who developed breast cysts after a Pfizer vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CYST (non-serious), outcome "unknown", described as "do know 3 other women who developed breast cysts after a Pfizer vaccine.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101193628 same reporter/product/event, different patient.;US-PFIZER INC-202101193630 same reporter/product/event, different patient.
Initial report involving a cluster of four cases received from a registered nurse on 10/31/05. This case involves Twin B. A five year old twin developed red, warmth and induration of 13/08 at the injection site after receiving the IM injection of Tripedia, lot number U1348AA in the right thigh on 10/18/05. The pt received in concomitant the IM injection of IPOL, lot number W1582-2 in the left thigh. The pt was diagnosed with cellulitis and treatment with Augmentin. Recovery status was reported as unk. Follow up information received on 6/12/06. It was reported that the female pt had no significant past medical history. The pts symptoms developed one day post immunization. She was seen by a physician the following day and was diagnosed with cellulitis. No lab testing or cultures from the site were done. The pt fully recovered after treatment with Augmentin. Further information is not expected. Same reporter in cases 2005-02249, 2005-02250, 2005-0225, 200502252. Case 2005-02252 involves Twin A.
Patiet received Menactra, Gardisil, Adacel, and, and Havrix. She became pale and nauseated. Her skin was cool and clammy. Her head went down appearing as if she was faint, but she was able to hear and answer questions.  Spirits of ammonia applied. BP was 70/40. She was then placed in a supine position with legs elevated. Her symptoms then subsided and BP returned to 110/70. She stayed at the state health center for one hour accompanied by her mother who drove her home.
Fatigue; Slight headache; Arm sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 12Apr2021 at 11:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 22Mar2021 at 11:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 14:45, the patient experienced fatigue which was going on day 4, slight headache and arm sore at injection site which resolved on day 02. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm sore at injection site was resolved on 14Apr2021. The clinical outcome of the events fatigue and slight headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Given an Adult dose of Hepatitis B rather than the pediatric formulation.  No adverse effects have been noted.  CDC was notified and this nurse was told to fill this out per their request since an adolescent received an adult dose instead a pediatric one.
patient describes feeling dizzy assessed by RN and paramedics, blood pressure 142/100, 105, 99% RA, patient given water and discussed her anxiety. Vitals reassessed 132/90, Patient refused hospital.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 09-NOV-2018, the patient was vaccinated with an expired dose of M-M-R II albumin status RHA, lot # M039914, expiration date 26-SEP-2018 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
FEVER; This spontaneous report was received from a consumer and 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, intramuscular) dose was not reported, administered on 03-MAR-2021 to left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-MAR-2021, the patient's wife reported that her husband had received the Janssen COVID-19 vaccine and developed a fever of 103.7 degrees Fahrenheit.  The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient had not recovered from fever.  The patient assessed the event of fever as not related to COVID-19 vaccine Ad26.COV2.S. This report was non-serious.
52 m active alcoholic with lab abnormalities c/w heavy etoh including pancytopenia (anemia to 7s, throbocytopenia to 70s, mild leukopenia-since 12/20); 2 recent admissions (feb march 2021) with likely etoh-induced pre-renal AKI; DM; who received 2nd dose of moderna 4/8/21.  After not being in contact with his family for several days, family sought him at his residence where he was found pulsless and apneic on the floor with some scant blood near his face.  CPR-- >transported to hospital where upon attempting to intubate profuse bleeding into larynx/pharynx noted.  Despite ongoing cpr and mechanical ventilation team in ER was unable to re-establish pulse.  He was pronounced dead at about 8 PM 4/9/21.
he missed the dose; he got sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported for a male patient that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiry date: Unknown), dose 1 via intramuscular route on 27Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date the patient got sick and missed the 2nd dose originally scheduled on 24FEB2021. He was given another schedule to get the 2nd dose which was last 28MAR2021and he missed again and asking will still need to get the 2nd dose of covid 19 vaccine. The outcome of the events were unknown.   No follow-up attempts are needed. Information about batch/lot number cannot be obtained.  Amendment (02MAY2021): This follow-up report is being submitted to amend previously reported information: Amended the event "Missed dose" recoded to Inappropriate schedule of vaccine administered.
Arm started itching at injection site on Day 9.  Red Bloch about 2-3 inches wide at injection site and smaller spot below injection site.  Itchy and irritating.    Still present after almost 12 hours.   Put anti-itch cream on to help with itching.  Had sore arm for about 36 hours after initial injection.  Arm was very painful to lift.