chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On first dose patient developed swelling at site of injection as well as fever and chills lasting around 36 hours - second vaccination injection site also swelled uip and was "wprse" than first time
Developed chicken pox on 04/01/2005,  like younger brother. Pt has at least 30 lesions.
On 04/05/2022 Health Department (HD) went to facility and they provided a COVID immunization card that stated he had received the pfizer vaccine on 01/12/2021 and the lot number was  EL32A6. The second pfizer vaccine on the card was on 02/02/2021 and the lot number was EL3247. Upon that HD asked the patient if this was his first booster and he said yes. So, having the signature and proof of vaccine HD administered what HD understood was the first pfizer booster shot. When going to enter into system HD saw the record that he was administered a booster on 02/15/2022.
RUA --> GARDASIL - Site IM given area of swelling and redness and mild itching 2cm x 2cm.
This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL or GARDASIL 9 (it was unknown which one of both vaccines the patient received) intramuscularly (lot#, anatomical location and frequency were unspecified). Concomitant therapies were not reported. Then, three weeks post vaccination (on an unknown date); the patient experienced a gradual onset of severe muscle pain all throughout her body. It was stated that the patient sought for medical attention visiting the physician's office, that no intervention to prevent serious criteria was necessary, that myalgia was not congenital abnormality or significant disability or incapacity or life threatening, that the patient was not hospitalized and that no PQC was involved. At the time of the report, the outcome of myalgia was unknown. The relatedness of GARDASIL or GARDASIL 9 with myalgia was not reported. This is one of several reports from the same source. Additional information is not expected since the physician did not wish further contact.
Patient received booster shot earlier than the recommended 5 months. Second dose was 09/03/2021 and received a booster on 01/10/2022.
Extensive left arm swelling, redness, tenderness. She was later diagnosed with cellulitis in the arm and treated for it.
first dose 1.5 months ago, has developed Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 15th June 2022, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: Reporter was the health care professional (HCP) who stated that a patient received her first dose of Shingrix 1.5 months ago from the date of reporting. On the day of reporting, the patient had developed Shingles. The reporter consented to follow up.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 04-MAR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K023624, expiration date 19-FEB-2016, exact dose and route of administration were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Information received from a pharmacist pt in hospital in labor tested positive for hepatitis B surface antigen.
Swelling, redness greater than 2" diameter. Hot to touch, itchy, pain at inj site. TX: ice, BENADRYL.
Moderna on 4/12/21 and 5/10/21. Positive on 1/3/22
Stroke-like symptoms approximately 2-3 hours after receiving shot (aphasia), BP bottomed out, was transported by EMS and is currently on a ventilator in hospital. CT scan clear; MRI pending.
I tested positive for COVID-19 after being swabbed day after my vaccine. I also had symptoms of fever, chills, body aches, stomach cramps, headache.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was traumatic hemorrhage of left cerebrum with loss of consciousness.
Going to pass out; Immediately got dizzy; Sweating; Vision was grey and unclear; Vision was grey and unclear; All face and arm colors turned white; Could barely hear; This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient had allergies to Clindamycin and penicillin, green beans, raspberries, coffee, and tea. Patient was not pregnant. Patient received the first dose of bnt162b2 on 08Aug2021 (as reported), at the age of 17 years old. Concomitant medication included unspecified birth control rod in arm 3 months ago. Patient immediately got dizzy, started sweating, vision was grey and unclear, all face and arm colors turned white, could barely hear, and felt Like going to pass out on 08Aug2021. Pharmacist gave glucose tablets (4) not diabetic. Outcome of events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
looked weird; slightly itched; It's rather pink.; "my left leg started to bother me"; inflammation of the muscle in left leg; inflammation of the nerves in left leg; "it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/; tired/ been calling people to help me/ it is making life difficult; it was hurting pretty good; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me") and MYOSITIS (inflammation of the muscle in left leg) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DENOSUMAB (PROLIA) for Bone disorder (NOS), LEVOTHYROXINE for Thyroid disorder.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PAIN (it was hurting pretty good). On an unknown date, the patient experienced SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me"), MYOSITIS (inflammation of the muscle in left leg), INFLAMMATION (inflammation of the nerves in left leg), MYALGIA ("it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/) and FATIGUE (tired/ been calling people to help me/ it is making life difficult). The patient was treated with ARNICA MONTANA (ARNICARE) for Pain and Inflammation, at an unspecified dose and frequency and MELOXICAM for Pain and Inflammation, at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me"), MYOSITIS (inflammation of the muscle in left leg), INFLAMMATION (inflammation of the nerves in left leg), MYALGIA ("it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/), FATIGUE (tired/ been calling people to help me/ it is making life difficult) and PAIN (it was hurting pretty good) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other events include Moderna COVID arm. concomitant product usage were  putting ice on her arm when she got it after both doses,  Arnicare.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Significant follow up appended - new events added, concomitant medications were added.
Only pulled out to give the doses and then put back in the fridge; No adverse event; Dose administered over12 hours post puncture; 0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered over12 hours post puncture), PRODUCT STORAGE ERROR (Only pulled out to give the doses and then put back in the fridge), WRONG PRODUCT ADMINISTERED (0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Oct-2022 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered over12 hours post puncture) and WRONG PRODUCT ADMINISTERED (0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Only pulled out to give the doses and then put back in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered over12 hours post puncture), PRODUCT STORAGE ERROR (Only pulled out to give the doses and then put back in the fridge), WRONG PRODUCT ADMINISTERED (0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered over12 hours post puncture), PRODUCT STORAGE ERROR (Only pulled out to give the doses and then put back in the fridge) and WRONG PRODUCT ADMINISTERED (0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster).    No concomitant medications were reported.  It was reported as one vial, 5.5 mL was first punctured on 10-OCT-2022 at 9:00 AM and the same vial was administered on 11-OCT-2022 at 12:30 PM and the vial was stored in fridge post puncture and vial doesn't undergo any temperature excursions. It was also reported that Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius equals to 46 to 77 degree Fahrenheit) was less than 24 hours. Vial was only pulled out to give the doses and then put back in the fridge.  No treatment medications were reported.
Immunization on 12/16/02. Fever the following am went to ED-fever ntoed 11pm 12/17 then well since. Viral illness possible-monitor of likely reaction to immunization.
Vomited; Lost 10 pounds of weight; Could not sleep for 3 days; nausea; fatigue; Arm around the injection site was red; Arm around the injection site was swollen; chills; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 10 pounds of weight), INSOMNIA (Could not sleep for 3 days), VOMITING (Vomited), VACCINATION SITE ERYTHEMA (Arm around the injection site was red) and VACCINATION SITE SWELLING (Arm around the injection site was swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm around the injection site was red), VACCINATION SITE SWELLING (Arm around the injection site was swollen), CHILLS (chills) and HEADACHE (Terrible headache). On 25-Feb-2021, the patient experienced INSOMNIA (Could not sleep for 3 days), NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 10 pounds of weight) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (Lost 10 pounds of weight), INSOMNIA (Could not sleep for 3 days), VOMITING (Vomited), VACCINATION SITE ERYTHEMA (Arm around the injection site was red), VACCINATION SITE SWELLING (Arm around the injection site was swollen), CHILLS (chills), HEADACHE (Terrible headache), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non significant FU
Patient reported to clinic for Influenza vaccination.  After vaccine was administered, it was discovered that patiet had already had athe same vaccine on 11/04/2022.
Pneumonia vaccine approx. 9:30AM. Arm became painful 5-6  hours later. 9 or 10 hours later was suddenly soaked in sweat and experienced "waves of dizziness". (Wife experienced similar symptoms one hour earlier)Gradually felt better.
On 12/29/2000 the patient developed chicken pox that included 50-100 vesicular lesions distributed across his chest, back and extremities. Unspecified medical attention was sought. Additional information has been requested.
During administration, while needle was inserted in the left deltoid and plunger was being depressed, the needle disconnected from the syringe and an unknown amount of vaccine was wasted/administered. Called Agency, there is no current guidance on how to proceed in these situations. No contraindications to giving the dose per Agency. Made judgement call which included education with the patient about no safety data on situations like this, recommended revaccinating. Patient was in agreement, even knowing that there is unknown guidance/safety data regarding these situations. Patient was revaccinated, no further incidents took place. No adverse events occurred after vaccinating, including 15 minute waiting period.
Pt. presented to E.R. on 7/27/09 after falling at home - was admitted - EEG was positive for seizure, neurologist believes Tdap could have caused seizure.  10/1/09 Consultant records received DOS 8/28/09. Assessment: Partial Seizures. Patient presented with c/o of bifrontal headaches associated with photophobia and having passed out twice in one night. Nauseated and dizzy. Continued fatigue, leg stiffness, and leg cramps. 11/2/2009 MR from 7/27-7/29/2009, patient presented with c/o's rt thigh pain, weakness, dizziness, tinnitus, heart palpitations, nausea, disorientation, patient stated fell down twice without her awareness, also c/o's headaches. Tx: Telemetry, IVF,  Neuro consult was normal. Dc Dx Syncope  ICD-9 codes: 780.2, 784.0, 959.01
PT DEVELOPED SWELLING, REDNESS, TENDERNESS, AND FEVER ON/AROUND SITE OF INJECTION ON RIGHT ARM. AREA MEASURED AROUND 50 MM IN LENGTH. REACTION WAS ON SQ AREA OF RIGHT ARM.
EXTREME FATIGUE; LOW PLATELET COUNT; BRUISING IN ARM; 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 past medical history included: tumour from neck, and concurrent conditions included: tumour removed (In Sep-2021, the patient had a tumor removed from her neck). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced bruising in arm. On SEP-2021, the patient experienced low platelet count. Laboratory data included: Blood test (NR: not provided) platelet count of 22, and Platelet count (NR: not provided) 22. On 24-JAN-2022, Laboratory data included: Platelet count (NR: not provided) 35. On 06-MAY-2022, Laboratory data included: Platelet count (NR: not provided) 51. On an unspecified date, the patient experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low platelet count, extreme fatigue and bruising in arm was not reported. This report was non-serious.
second vaccine was at 10:30AM on 3/29/21. I experienced increased frequency of ocular migraines (Kaleidoscopic irregular frame in field of vision that starts small and increases in size till it disappears over 15-30 minutes. That is followed by a mild headache and mild disorientation. This has been the usual symptom of an ocular migraine for me. Difference was a big increase in frequency.)  Ocular migraines occurred in PM of 3/2/21, AM on 3/3/21, AM and PM on 3/5/21, PM 3/6/21, PM 3/7/21, AM  3/11/21, PM 3/15/21, PM 3/19/21, and AM 3/20/21. I had one instance on an ocular migraine after the second Moderna dose on 4/1/21. I contacted both my PCP and Opthamologist on 3/8/21. Doctor followed up with me to find out whether the migraines were always occurring in the same field of my vision from instance to instance later in the week as well. I told him they seemed to be occurring in different spots including a perceived difference in which eye. Only treatment was to watch and see if it stayed as frequent or subsided in frequency. It seems to have resolved itself by today 4/9/21.
Pain in the mouth; Pain on the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Pain in the mouth) and VACCINATION SITE PAIN (Pain on the arm of injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Oral lichen planus in 2016. Concurrent medical conditions included Pre-diabetic, Thyroid disorder, Panic attacks, Glaucoma and Dyslipidemia. Concomitant products included PREDNISONA, LEVOTHYROXINE, LISINOPRIL, PROPRANOLOL, METFORMIN, METHENAMINE, RETINOL (VITAMINE A), OMEPRAZOLE, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), MULTIVITAMINS;MINERALS, CYANOCOBALAMIN (VITAMINA B 12), CALCIUM, PROBIOTICS NOS, ZINC, ASCORBIC ACID (VITAMIN C ACID), IBUPROFEN, TRAMADOL and CURCUMA DOMESTICA for an unknown indication, GENTIAN VIOLET.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced ORAL PAIN (Pain in the mouth) and VACCINATION SITE PAIN (Pain on the arm of injection). At the time of the report, ORAL PAIN (Pain in the mouth) and VACCINATION SITE PAIN (Pain on the arm of injection) outcome was unknown.            Action taken with mRNA-1273 is not applicable.  No treatment information was provided.  Concomitant medication also include ginfisona.
Left arm very sore everyday for 10 days, on the 9th day, injection site swelled up and was inflamed , with a rash, hive like.  I called my Dr and I sent a picture of my arm via email.  She determined it might be cellulitis and prescribed Keflex.  My Brother in law who is an ER Dr gets daily briefings, and on 1/18/21, a physician reported this 7 day itch being reported by the Moderna vaccine.  The speaker himself who is a Dr experienced the same symptoms as I did.  So I stopped Keflex after 1 day, the swelling and rash were completely gone the next day 1/23/21.  So I had to learn this from researching info and calling my brother in law.  My arm still slightly aches and throbs ... but no swelling or rash.  Hope this will go away.
Headache, Sedation, Myalgia, Arthralgia, Swollen lymph nodes, Hot Flashes, Redness/Swelling @ injection site Narrative:  Other Relevant History:
Patient had red, itchy rash on left arm around injection site. At least 6 inches in length. Reported on 9/22/2021.
Entire left leg swollen from hip to mid-calf for 24 hrs. Mom did cool compress and TYLENOL and swelling resolved by next day.
Complain of itching of the mouth, throat, and  tongue. Congested chest and ?fuzzy? Blurry in the head.  Itching from the  chest area to the head.
Admitted for severe pre-eclampsia in third trimester, Cholestasis during pregnancy in third trimester (31w1d). Patient  underwent primary low transverse C-section delivery with bilateral salpingectomy, without complications, at 34w0d.  Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient self-reported to this office pain in his left testicle which began within 30 minutes of receiving vaccine. He walked home from school/vaccination site and by the time he got home he had so much pain he could barely walk. He denies swelling or discoloration of scrotum/testes. Called my office at 342pm and pain was lessening. Mom reports that he went to bed at 730 pm and pain was completely resolved when he awoke this AM.    Discussed care with patients PCP and was given triage advice for testicular pain and vaccine reaction.
The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022; Administered with the vaccine that had been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that had been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. The patient received second booster. Treatment information was not provided.