chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), COUGH, SPUTUM DISCOLOURED (yellow phlegm), ANOSMIA (perceives no smell) and AGEUSIA (no perceives no taste) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (body aches), COUGH, SPUTUM DISCOLOURED (yellow phlegm), PYREXIA (a slight fever) and CHILLS. On 05-Apr-2021, the patient experienced ANOSMIA (perceives no smell) and AGEUSIA (perceives no taste). On 04-Apr-2021, PAIN (body aches), COUGH, SPUTUM DISCOLOURED (yellow phlegm), PYREXIA (a slight fever) and CHILLS had resolved. At the time of the report, ANOSMIA (perceives no smell) and AGEUSIA (perceives no taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication nor provided. Treatment medication not provided.
SkinRash, Rash, pain at injection site Approximately 4 hours after injection of Moderna COVID-19 vaccine to left arm employee started to experience pain to injection site that progressively got worse, to the point employee was not able to sleep on left side. Employee reports pain to injection as "10" on 0-10 scale at 0830 12/29/2020. In morning of 12/29/2020 employee noticed raised macular below injection site that is not itchy or painful. Size of rash 6 inches x 3 inches. Employee instructed to take picture of rash. Employee now concerned about getting second dose of COVID-19 vaccine. No medications used to treat pain or rash.
Knot in left upper arm and pain. LUA pain prior to inj 7/10 post inj 9/10 Narrative:
Head started evening of second injection(June 18, 2021)  Head has continued daily including today, July 22, 2021.  Shingles (Zoster) symptoms started on June 30, 2021, 12 days after second injection. Zoster was diagnosed on July 4, 2021.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient did not experience adverse event at the pharmacy but called back ~ 1 hour or so later to report tongue swelling and throat itching. Instructed to take liquid benadryl and if it worsened or her breathing became labored to report to an ER
Left arm was swollen and sore. Often felt like a tight PB cuff. Strength and range of motion were weak. The previous December (2020) I had PT for right arm so there were records for strength and range of motion from a few months before. Both decreased considerably.  Two steroid injections and PT cured the problem. Also, had typical reaction, chills, aches, etc. night of the vaccination. Nothing sever. Lasted about 10 hrs.
Information has been received on 21-NOV-2016 from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-NOV-2016 the patient was vaccinated with an expired RECOMBIVAX HB lot # L010595, expiration date 12-NOV-2016 unknown route. No adverse effects were reported. No further information was reported. Additional information has been requested.
Information has been received from a nurse concerning an "18 to 19 year old" female consumer who on an unspecified date in April 2008, was vaccinated with a "second dose" of GARDASIL (lot # not reported). There was no concomitant medication. The nurse reported that the patient "fainted ten minutes after vaccination". The nurse note that "the patients who read the GARDASIL fact sheet prior to vaccination seemed more prone to fainting". It was reported that "most of the patients did not have breakfast and this may play a role because the vaccinations were given early in the day". The patient sought unspecified medical attention during an office visit. The patient recovered from fainting "on the same day". This is one of several reports from the same source. Additional information has been requested.
Large bruise left on patient's arm from spot of immunization still on 10/1/10 and patient concerned about it.
The day I got the vaccine I was fine. As the month progressed, I started felling uncoordinated. I started getting more cluster migraines up to the day I had my stroke on April 12, 2021. I was taken by ambulance on April 12,2021 because my right side had gone numb. When I arrived they gave me blood clotting medicine. I had all the symptoms of a stroke when they did the first CT scan, but it didn't show anything.  The next day they did a 2nd CT scan and it showed that I did have a blood clot, so it was confirmed that I did have a stroke. I was in the hospital for 4 days. I am now permanently taking aspirin and a cholesterol medication. I had seen a cancer doctor too but the tests that was ran didn't show anything. The doctors still don't know what caused the blood clot. When I left the hospital form being hospitalized, I had to go through physical therapy for 8 weeks. I did 2 weeks of at home physical therapy and then 6 weeks of outpatient physical therapy. Now sometimes when speaking I would have to slow down because I will start to slur my words. Every now and then I get very tired.
Right shoulder and neck became red, swollen, and painful; had a black out spell and dizzy spells. Discharge Summary received on 12/22/2004 states pt experienced fever and immunization reaction.
pt died in the home with hospice after being brought to ED via EMS for SOB, AMS; when EMS got to the home, pt unresponsive with BS of 27; treated for low BS; found to be positive for COVID; DNR; wife decided to take him home with hospice
15 minutes after receiving vaccine, client began c/o headache, flushing, diaphoresis, and dizziness. Vital signs were obtained. BP was elevated. Client given oral Benadryl after c/o itching. No rash noted. Obtained VS every 15 minutes while monitoring for 45 minutes post Benadryl administration. VS stabilized. Client stated he was feeling better and was released home with spouse driving.
Initial misuse report received from a healthcare professional on 04 April 2014. A 03-months-old patient of unknown gender had received FLUZONE QIV 0.25 ml (batch number not reported) on an unknown date. The patient did not experience any adverse event. The patient received FLUZONE QIV at an incorrect age. The list of documents held by sender: none.
One week after receiving the vaccine, developed a rash on my arm around the injection site.  It was roughly 4-5 inches in diameter.  Very Itchy.  Applied Hydrocortisone 1% ointment for a few days to help with the itching.  Then switched to applying lotion.  Rash went away after about 1 week.
I felt fatigued all week. On the fifth day I felt like I had been kicked below the belly button. I had the same type of pain as Diverticulitis below the belly button on the left side.  My doctor suggested warm compresses and Tylenol for the pain and that helped a little.  Starting around day nine I have had some Diarrhea for two days so far.
Acute respiratory distress, wheezing, facial swelling (primarily left side of face) within 20 minutes. Responded to Solumedrol 20mg IM, Albuterol/Atrovent nebulization, and Benadryl. Hospitalized for observation.  Nurse follow up on 06/30/04 states: "Per review of hospital discharge summary, final diagnosis was anaphylaxis (ANAPHYL).."
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 3:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 3:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 28.85 for dose administered on 12-Feb-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 10:00 AM and 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
mom states pt cried 1 1/2-2hrs-sounded strained w/o being able to be consoled later same day following administration of vax; mom did not contract MD; no rx;
16:53 Pt states head, legs itchy 17:00 Given Zyrtec, 10mg PO 17:18 Benadryl 50mg, IM  BP 125/63 HR 75 02 99% RA,  17:27 pt staes tongue starting to swell, 17:32 epi 1:1000 .5ml IM left thigh 17:39: tongue improving 02 sat 99% RA  17:58 pt stable for discharge home, provided transport to car pt
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On 08-SEP-2014 unspecified number of patients were vaccinated with ROTATEQ, oral (dose, lot # not reported) that had been improperly stored. No adverse event symptoms were reported.  This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not give a consent for contact.
After first shot - felt severe flu-like symptoms. Very lethargic, no energy, boy ached ALL over. Lasted two days.  After second shot, at 1 am, I woke up with EXTREME convulsions. Entire body was shaking all over, looked like I was being electrocuted. Conditioned worsened over next 30 minutes. I then asked my husband to hold me as tight as possible to stop the shaking. He did so and it took over 30 min. for the extreme convulsions to cease.I was not "hot nor cold", meaning no fever. The next two days I had the same symptoms as after the first vaccine -  felt severe flu-like symptoms. Very lethargic, no energy, boy ached ALL over
Increase agitation, aggressiveness, nocturnal tremors (cries in sleep), unable to have restful night sleep since 2nd day after shots.
Redness at injection site began Sat (3/5/11) afternoon. Sunday increased redness, hard in center, warm to touch increasing in size. Temp 99.5 degrees. Seen in clinic 3/7/11 treated with Clindamycin 300mg TID x 7 days.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L038018, 13-SEP-2017) (route and dose unspecified). The vaccine was stored at 34 F for 24 hours (data logger: yes). There were no previous temperature excursions. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. In the 1980s and in the 1990s the patient was vaccinated with 2 doses of hepatitis b vaccine (recombinant) (names of vaccines were unknown) (lot# and route not reported), respectively. Nurse reported that a patient did not respond to the 2 series of hepatitis B vaccinations (names of vaccines are unknown). Additional information is not expected.
redness and itching at the injection site; redness and itching at the injection site; The vaccine administrator missed the main deltoid muscle. maybe it was a SQ injection; This is a spontaneous report from a contactable Nurse reporting for herself. A 72-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , subcutaneous in the right arm on 11Jan2021 09:00 at single dose for covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient stated that the vaccine administrator missed the main deltoid muscle. maybe it was a sq injection on 11Jan2021 09:00. The patient reported she experienced  redness and itching at the vaccination site  on 13Jan2021 with outcome of not recovered.  Further information has been requested.
-UNIT REPORTED LIPS SWOLLEN & EYES SWOLLEN  TO MDG -SM DROVE TO URGENT CARE- GIVEN STERIOD SHOTS TOLD TO  RETURN IN 1 HR IF SYMPTOMS CONTINUE  CALLED SERVICE MEMBER AT 1214 TO CONFIRM IF HE WAS HAVING ADDITIONAL SYMPTOMS. URGENT CARE GAVE HIM FAST ACTING STERIOD AND INSTRUCTED HIM TO TAKE ZYRTEC THEN BENEDRYL EVERY 6 HRS
Extreme gas for 3 days; days one and two were extremely bad, day 3 was less but not normal. Pain at the site of injection for 3 days Heat at the site of injection for 3 days Extreme fatigue for 3 days
Raised, red vaccine site - 2 inches noted on Feb 5. Felt faint, short time - for approximately 10 minutes on Feb 4.
shortness of breath; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills). At the time of the report, DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 90/50 (Inconclusive) inconclusive. On 03-Apr-2021, Body temperature: 104 (High) high. On 03-Apr-2021, Oxygen saturation: 85 percent (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. No treatment was reported.
My son in law tested positive for Covid on 05/07/2022. I tested negative on 05/07. I started feeling a bit tired on 5/08 but still tested negative. By 5/9 I was testing positive. I have had a runny nose, congestion, a cough, fatigue, and dizziness. I also had a fever during the night which is abnormal for me. I contacted my PCPs office. The nurse called on Monday who recommended an antiviral. After confirming that my insurance would cover the medication, I spoke with the nurse again who informed me that I needed to have a telehealth appointment. I had the telehealth appointment Tuesday at 3pm after which she prescribed me the antiviral medication. I finished my last dose of that on 5/15 and am testing negative for Covid as of yesterday, 5/16.
Patient didn't receive full 1st dose (some of the vaccine ran down her right arm); A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient didn't receive full 1st dose (some of the vaccine ran down her right arm) with the use of mRNA-1273.    There was no medical history provided. There were no concomitant medications provided.   On 25 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Batch # unknown), in her right arm, for prophylaxis of COVID-19 infection.   On 25 Dec 2020, the patient didn't receive full 1st dose (some of the vaccine ran down her right arm). It was noted the patient has been scheduled for an antibody test in the future to see how she is doing. There was no treatment information provided.  Action taken with mRNA-1273 to the event of patient didn't receive full 1st dose (some of the vaccine ran down her right arm) was not provided.  The outcome for the event of patient didn't receive full 1st dose (some of the vaccine ran down her right arm) was resolved.; Reporter's Comments: This case concerns a 69 year old female patient who received the first of two planned doses of mRNA-1273 (Batch # unknown), in her right arm, for prophylaxis of COVID-19 infection and the patient didn't receive full 1st dose. There were no reported adverse events associated with this case of incomplete dose administered.
Narrative: Headache, Tachypnea, Palpitations, Hypertension, Tachycardia, SVT, light sensitivity, right lymph node pain/swelling. Employee referred to cardiologist, echo normal, referred to electrophysiology. On Metoprolol for 1 week. Returned to work 5/18/21. 6/1/21 reports only remaining symptoms is fatigue. No other follow-ups required at this time.
arm became bruised; arm became painful and swollen with a rash; arm became painful and swollen with a rash; arm became painful and swollen with a rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (arm became bruised), PAIN IN EXTREMITY (arm became painful and swollen with a rash), PERIPHERAL SWELLING (arm became painful and swollen with a rash) and RASH (arm became painful and swollen with a rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (arm became bruised), PAIN IN EXTREMITY (arm became painful and swollen with a rash), PERIPHERAL SWELLING (arm became painful and swollen with a rash) and RASH (arm became painful and swollen with a rash). At the time of the report, CONTUSION (arm became bruised), PAIN IN EXTREMITY (arm became painful and swollen with a rash), PERIPHERAL SWELLING (arm became painful and swollen with a rash) and RASH (arm became painful and swollen with a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
12/25/02 at 12 noon; tongue noted to be edematous and unable to swallow food. Given Benadryl and transported to ER c/o throat swelling and erythema to upper arms bilaterally. Dehydrated with hyponatremia. Rx: hydration, antibiotic-steroid IV. Diagnosed Stevens Johnson syndrome to drug reaction.
chest pain; tunnel hearing/partial hearing loss; This is a spontaneous report from a contactable consumer.  A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 05Aug2021 13:00 (Batch/Lot Number: FA7484) (at the age of 36-years-old ) as single dose for covid-19 immunisation.  Medical history included cough from 30May2021 to 06Sep2021.  There were no concomitant medications.  The patient had received the first dose of bnt162b2 (lot EW0181) on 13Jul2021 Intramuscular Left arm and experienced prolonged period as well as late period.  On 05Aug2021 at 22:00 the patient experienced tunnel hearing, partial hearing loss happens about 1-2 days out of the week since the second Pfizer vaccine was given. On 11Aug2021 at 03:00 chest pain started a week after second Pfizer vaccine given . Chest pain got so severe that the patient had to go to the ER. Medication at ER helped with further severe pain (so far). The event tunnel hearing, partial hearing loss were considered serious as Persistent/Significant disability and Important medical event. The outcome of the event was not recovered, the outcome of the chest pain was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021892717 Same reporter/ patient, different dose/ AEs.
up to 8 months to receive both doses; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 age at vaccination was not reported. The reporter stated that, they were given guidance that, the patients had up until 8 months to receive both doses of Rotarix, but she read in the prescribing information that, both doses must be administered by the time the patients were 24 weeks.  The reporter stated that, since they were initially given guidance on patients receiving both doses by 8 months of age, some patients had been received Rotarix outside of the timeframe recommended in the prescribing information, which led to lengthening of vaccination schedule. The reporter consented to follow up. No patient demographics were available at the time of reporting The reporter consented to follow up via postal.
Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization.  BP: 146/111, P 144; o2 99%, RR 16.  She was given albuterol inhaler x 3, Epi-pen x 1, benadryl 25 mg with some iprovement. She was sent to ED.  PMHx: tree nut allergy, Hashimoto's thyroiditis, hereditary hemochromatosis, PCOS;  Taken to ED
Upon attempting to get out of bed about 9:15 AM on Saturday, February 27, pain in my right knee was so severe I collapsed back onto the bed. Pain in my left knee was strong but less severe than the right. I did not seek treatment, but limited walking, aided by two canes, to necessary movement. By evening the pain seemed to be lessening and through Sunday and Monday continued to diminish.  By Tuesday I was able to walk without noticeable pain.