chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 13-OCT-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 328, 200, 24 and 132 hours and the lowest recorded temperature reported were 29, 32, 33 and 34 Fahrenheit (F) (-1.666666667, 0, 0.555555556 and, 1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
The left arm where the vaccine was injected exhibited a patch of red skin below where the vaccine was administered.  The red patch of skin is warmer than surrounding area.  Noticed the red patch of skin 58  hours after injection.
arm is in a lot of pain; Swollen arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: arm is in a lot of pain) and swelling arm (Verbatim: Swollen arm). The outcome of the pain in arm and swelling arm were not reported.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Arexvy.     It was unknown if the company considered the pain in arm and swelling arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-NOV-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The reporter stated his/her arm was in lot of pain and was swollen. The follow-up could not be possible as no contact details were available.
Mom called stated "my child is having an allergic reaction to shots.  His lips are turning blue and swelling.  He is itching like crazy." LPN instructed parent to take child to emergency room on 1-16-2007 at 17:40
feels sick; feels very terrible; Neck hurts; breathing faster; 10 year old child received a booster dose of the Moderna Covid 19 vaccine; accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts), RESPIRATION ABNORMAL (breathing faster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR45048) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (2nd Dose Lot: FK5217) on 30-Nov-2021, Pfizer (1st dose and Lot: FK127). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Asthma and Milk allergy.    On 14-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 milliliter. On 14-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) and ACCIDENTAL OVERDOSE (accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine). On an unknown date, the patient experienced ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts) and RESPIRATION ABNORMAL (breathing faster). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts), RESPIRATION ABNORMAL (breathing faster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) and ACCIDENTAL OVERDOSE (accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine) outcome was unknown.            Concomitant medication were not reported. It was reported that patient received 1st Booster dose.
Patient requested newest Pfizer vaccine, received Novavax. Well tolerated, onlyreports headache
Post-vaccine complications. J&J 9/21. Since 16 days following the shot, has had muscle and joint pain, back and abdomen pain, headaches, disequilibrium, sleep problems and anxiety. Has seen 2 neurologist, workup has been negative. Has only received meds for anxiety and to help him sleep.
balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 years old  female patient (pt). No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-DEC-2014, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at pharmacy as recommended for long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequently, the pt, was treated by a health care for balance problems(date unspecified date). The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
12 HOURS AFTE R SHOT I STARTED RUNNING A FEVER AND ACHE ALL OVER.  MY EARS STARTED RINGING SOMETHING DURING THE 17TH, BUT WAS NOT FEELING WELL SO I DIDN'T THINK A WHOLE LOT ABOUT IT.  THE RINGING HAS CONTINUED SINCE THAT DAY.  IF I OPEN MY MOUTH AND PUSH MY BOTTOM JAW OUT, IT IS REALLY LOUD.  This continues to wake me up at night and does not stop.  Will it ever go away?
12 days after receiving the Moderna booster shot. Rashes started appearing through the top part of body. The rashes would come and go and would not stay on area. Two days after, rashes started to appear on lower parts as well. Rashes have seem to become bigger but they come and go.
possible renal complications after Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of renal disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 18th July 2022, unknown after receiving Shingrix, the patient experienced renal disorder. On an unknown date, the outcome of the renal disorder was unknown.   It was unknown if the reporter considered the renal disorder to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-Jul-2022 Reporter's Comments: The reporter stated that there were possible renal complications after Shingrix vaccination. The other healthcare professional ended chat before agent able to confirm if a patient was involved or if this was a general enquiry. No consent for follow up obtained as other healthcare professional ended chat before agent could obtain.
When I woke up in the morning on February 8, I felt dizzy the moment I rolled right and face down.  I felt I could not walk. After a while, dizziness calmed down a little and I was able to walk. Then I went to the urgent care.  I was diagnosed with "Benign paroxysmaI positional vertigo, unspecified laterality". The instructions from the doctor were to watch social media and try it several times until my issue resolves. And I got a prescription for meclizine 25mg Tab. I didn't know if the exercise was effective. I felt meclizine was a little effective. It almost healed in a few days.  And I felt it completely recovered in about 2 weeks. But I felt dizzy on 04/30/2023 again. I woke up at 5:30am and went to the bathroom.  At that time, I suddenly had a ringing in my ears, and I felt dizzy.  When I got back to bed, my dizziness soon subsided. I took meclizine 25mg 1 Tab just in case.  I didn't have any dizziness after the morning event.  But I was tired that day, maybe because of the medicine.  I recovered next day.
Woke up on 2/5/21 feeling extremely fatigued with not much strength, with chills and body aches and no appetite. Started feeling better towards the end of the day and by the next morning, 2/6/21 I was 90% better.
Mild COVID-19 disease with a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mild COVID-19 disease with a little fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (Mild COVID-19 disease with a little fatigue). At the time of the report, COVID-19 (Mild COVID-19 disease with a little fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient had mild COVID-19 Disease on  SEP2021 with a little Fatigue only. Patient received Monoclonal Antibody on 17-Sep-2021.  Company comment: This case concerns a 74-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of COVID-19. The event occurred 6 months after the second dose of mRNA 1273 COVID-19 vaccine. Patient had mild COVID-19, and felt a little fatigue only. She received monoclonal antibody as treatment. The patient's age may have increased her risk of getting infected with COVID-19.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 74-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of COVID-19. The event occurred 6 months after the second dose of mRNA 1273 COVID-19 vaccine. Patient had mild COVID-19, and felt a little fatigue only. She received monoclonal antibody as treatment. The patient's age may have increased her risk of getting infected with COVID-19.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Pain began at time of immunization and worsened. Arm soreness, only able to lift arm approx 4" then intense pain begins. Rate pain at 8/10. Hes taken Advil.
Received 2nd dose of Pfizer on 1/26/21 (Tuesday).  Felt fine on 1/27(Wednesday, scheduled day off).  Woke up 1/28 (Thursday)  around 3:00 am drenched.  Had fever/chills and headache all day.  Again on 1/29 (Friday) woke up drenched - had slight fever, but no headache.  Called PCP on Thursday - told to rest, hydrate and eat BRAT diet.  Called Thursday & Friday was told the same.  By Saturday, felt almost myself again.
Arm soreness starting around 7:00 pm day of shot. Headache, fatigue, muscle aches starting 3:00 am, lasting until 9:00 pm, the day after receiving the second COVID vaccine shot. Took Tylenol at 1:30 pm and 7:30 pm the day after shot.
In JUL2022 I had a minor exposure to rabies and had the Imovax vaccine. I then had a second exposure to rabies, and got a booster dose on 04SEP2022 and 07SEP2022; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 64 years old female patient who was first time administered vaccine IPV (VERO) [IMOVAX] in Jul 2022 and received the booster dose on 04 Sep 2022 and 07 Sep 2022 for her exposure to rabies with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rabies Vaccine (RABIES VACCINE); Tetanus Vaccine (TETANUS VACCINE) and Rabies Vaccine INACT (CHICK EMBRYO) (RABAVERT) for Immunisation.  In July 2022, the patient received a dose 1 of suspect IPV (VERO) (with batch lot number, strength, dose: not reported) via unknown route in unknown administration site for prophylaxis.   On 04-Sep-2022 she also received a dose 2 of the same vaccine with (batch lot number, strength, dose: not reported) via unknown route in unknown administration site for prophylaxis.   On 07-Sep-2022 she also received a dose 3 dose of the same vaccine  with (batch lot number, strength, dose: not reported) via unknown route in unknown administration site for prophylaxis.  In JUL-2022 the patient reported a non-serious event of in jul2022 i had a minor exposure to rabies and had the imovax vaccine. i then had a second exposure to rabies, and got a booster dose on 04sep2022 and 07sep2022 (inappropriate schedule of product administration).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IMOVAX) was not applicable.  At time of reporting, the outcome was Unknown for the event in jul2022 i had a minor exposure to rabies and had the imovax vaccine. i then had a second exposure to rabies, and got a booster dose on 04sep2022 and 07sep2022.     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.
Pt broke out on right arm from injection site to wrist with little blisters. Injection given 18Jul04, pt presented to medical 17Oct04 with open sores still visible from blisters. No treatment. Pt presents to medical stating every time I received the Anthrax shot, I break out in little blisters. Pt received #4 in the series 18Jul04, still has open sores from blisters. From injection site to wrist. Evidence of old scarring from past blisters. Pt states no difficulty breathing, H/A's, N/V and no respiratory problems when this occurs. Filled out Vaers form sent in 19Oct04. Left message for return call on continuation of this series.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with GARDASIL (dose, strength, route and lot# were not reported), which had been exposed to light. No adverse effects were reported. Additional information has been requested.
Tachycardia sometimes bradycardia  Severe headache  Loss of breath  Joint pain Loss of hear
Sunday afternoon the 27th, I started feeling like I was getting a cold. My eyes were watering a little bit. I thought I was getting a cold. I went home after a concert and I felt groggy. I got up the next morning a little bit after 6AM and I was just not feeling well and I felt warm. I took my temperature and it was 99.9. That was surprising, so I took out my COVID-19 home tests and took one, and it was positive. I instantly called the nurse line and immediately asked for the antiviral. I was prescribed the Paxlovid, and I got a lower dose. My records for my kidney function were just lower in function compared to normal range. But it was enough that I couldn't get the full dose, so I received the low dose for Paxlovid. I started it that same afternoon and took that for 5 days. The only noticeable effect of taking it was the slight metallic taste in my mouth when I woke up the next morning. The fever went away within a day and my symptoms were mostly upper respiratory. I had an  occasional cough. I took regular cough medicine for that. I had a slight productive cough for 4-5 days. I generally felt lousy but nothing pronounced. I had slightly stuffy sinuses and cleaned them out. I was mostly feeling unenergized. It took until the next weekend until I was feel better, but I was still fatigued for about 3 weeks after. It wasn't excessive, but I seemed to get tired easily. I seemed to be okay, but just sleeping a little bit more than usual. I seem to have recovered.
Right arm swollen; no history of trauma; able to move arm freely. Cellulitis right arm.
Lots of fever, inflammation in the right immunization area, malaise in the body, patient had to go to the doctor for medical assistance, ANCEF was administered.
Headache, nausea, chills, fever, fatigue, arm soreness. All started at about 8 pm the day of my shot, about 9 hours after injection. Headache & arm soreness started earlier, about 6 hours after my shot. Symptoms worsened into night and peaked about 2 am. Fever broke about 9 am next morning. Headache continued into night
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for covid-19 on 24Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Headache all day the day following injection. Chills off / on all day the day following injection. Cough - mostly afternoon / evening the day following injection. Listlessness all day the day following injection.
11 year old patient inadvertently given adult dose of Pfizer for second dose in vaccination series.  Patient weighs 67kg.   NKDA.  Patient tolerated first dose well per observers from last event.  Patient observed for 30 minutes.  No adverse reactions noted.  Discharged to caregiver.
Woke up next day w/scratchy throat, by Friday (48hrs) sore throat, runny nose. By 8th & 9th coughing, congestion, chills, started taking ROBITUSSIN & TYELNOL.
itchy skin, generalized to entire body. Red raised patches to skin. Red raised area at injection site.
Per mother of Pt; Pt arms became tender + painful (@ injection site) approx 6-7 hrs after injections, the hands became swollen itching next day Pt reported to mother. A rash between her fingers - mother noticed swelling on her wrists Pt mother reported s/s resolved @ the time.
This case was reported by a healthcare professional via a sales representative and described the occurrence of red spotty (injection site) in a subject of unspecified age and gender who was vaccinated with combined KINRIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of KINRIX in an unknown thigh. At an unspecified time after vaccination with KINRIX, the subject experienced red spots at the injection site. The nurse reported that she instructed the subject to apply a cold compress to the injection site. At the time of reporting the outcome of the event was unspecified. It was reported that this event occurred in 4 additional subjects. Linked case numbers include A0803829A and A0803833A Through A0803835A. This case was reported by a healthcare professional via a sales representative and described the occurrence of red spotty (injection site) in a 4 year old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX in an unknown thigh. At an unspecified time after vaccination with KINRIX, the subject experienced red spots at the injection site. The nurse reported that she instructed the reporting the outcome of the event was unspecified. It was reported that this event occurred in 4 additional subjects. Linked cases numbers include A0883829A and A0803833A through A0803835A. Follow-up information received on 28 August 2009 indicated that follow-up information would be returned via a batch report versus specific subject information as doing this would require pulling "80" charts. It was reported that the subject was for years of age and received an concurrent vaccination hepatitis A vaccine, MMR vaccine and Varicella vaccine. It was noted that the hepatitis A vaccine and KINRIX were administered in one leg and MMR vaccine and Varicella were given in the other. No concurrent medications were received. It was additionallly reported that at the time of vaccination, parents are told about the side effects and if they occur, to use BENADRYL, cold compress and TYLENOL to treat.
after the vaccine, began to be nauseous,; rumblings in my stomach; diarrhea; severe tiredness; slight headache; slight pain or stiffness on left arm; slight pain or stiffness on  left arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 hours (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, metal allergy and the patient was allergic to sulfur and sulfate. The patient did not take any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 09:30 hours, after the vaccine, the patient began to be nauseous and had rumblings in the stomach, diarrhea, severe tiredness, slight headache and slight pain or stiffness on the left arm from the shot. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events nauseous, rumblings in the stomach, diarrhea, severe tiredness, slight headache and slight pain or stiffness on the left arm were resolving at the time of report.  No follow-up attempts are possible. No further information is expected.
I had red rash down my elbow left side and a rash on back of my neck and down to my waist. My doctor gave me a cortisone cream, it took about a month to go away.
I could not lay down because I was having such a hard time breathing sitting up. I had noticed that my ankles were swelling, it had been about five days since I had laid down, I thought I would try to lay down to get my swelling down. As soon as I laid down, I felt like I was drowning, as if I was being squeezed extremely tight. I managed to get myself to the edge of the bed and slowly sat up and caught my breath. I called my sister who came and rushed me to the emergency room. Once there I was given an emergency breathing treatments so my airways could be open. They started taking my blood for test, chest x-ray, CT scan, PCR Rapid COVID-19 test, Influenza A and B. Everything came back negative and normal; they said I had a respiratory infection. I was released after five or six hours with antibiotic medication to help combat the infection. I do still get very fatigued, I am happy that I was able to retire this year.
Onset of chills and fever of 100 within two hrs of shot,  24 hrs later fever rose to 101, 36 hrs later 99.5.  Muscle aches, general weakness and sick feeling, no swelling, red or tenderness noticed at injection sight. 48 hrs all symptoms completely gone.  High fever scary for someone in excellent health!