chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
No known adverse effects; the physician received a dose of M-M-R II via the intramuscular route in error; This spontaneous report was received from a male patient of unknown age, who also was a physician. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 06-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), 0.5 ml, lot # R036580, expiration date 17-DEC-2020, via the intramuscular route in error (instead of subcutaneous route) for prophylaxis.       No known adverse effects reported.
allergic reaction; one small itchy hive on left forearm; one small itchy hive on left forearm; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 04Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 05Feb2021 (at the age of 72-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient was scheduled for CT Scan on the same date as COVID vaccine and scheduled to take the Prednisone 55 mg(x3) on the same day to counter allergic reaction due to contrast dye used in CT scan. Upon consultation with radiologist, CT scan was postponed for 5 days, to avoid taking Prednisone on the same day as covid-19 vaccine. The patient took CT scan on 10Feb2021 and took three 55 mg prednisone to counter allergic reaction due to contrast dye used in CT scan. It was reported that the patient had no side effects during CT scan except for one small itchy hive on left forearm on 10Feb2021. The outcome for the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching skin and severe eye itching that lasted 7 days. Headache, chills, fatigue - duration 3 days. Very swollen, hot and red at injection site - 7 days.
Head was hurting a lot; Heart rate escalated dramatically/ his heart like while lying down, his rate like increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (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: HEART RATE ABNORMAL (non-serious) with onset 26Nov2021, outcome "unknown", described as "Heart rate escalated dramatically/ his heart like while lying down, his rate like increased"; HEADACHE (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Head was hurting a lot". Relevant laboratory tests and procedures are available in the appropriate section.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. Since December 2014 the patients were vaccinated with M-M-R II (lot # J010993, expiration date 06-SEP-2015, dose, dose#, frequency and route not reported) which had been improperly stored. No information regarding concomitant therapy was provided. No adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
feeling not well; headaches; pain at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (feeling not well), HEADACHE (headaches) and INJECTION SITE PAIN (pain at the injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Feb-2021, the patient experienced MALAISE (feeling not well), HEADACHE (headaches) and INJECTION SITE PAIN (pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (feeling not well) and HEADACHE (headaches) was resolving and INJECTION SITE PAIN (pain at the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
the following day, my left arm turned red about the size of a tennis ball.  the area itched a lot, didn't scratch but it was tender.  then a few days later the itching stopped and the area only looked bruised.  there was never any pain, only itching and it is just about gone as of this date, almost 2 weeks later.  did seek medical assistance from family doctor, as it wasn't an emergency and I knew it would go away.
Patient has a history of pseudoseizures and had a seizure like episode within 48 hours of administration of a Hib vaccine
The patient began to feel a headache 10 minutes after the administration of the vaccine. The patient emesis. After observation for 30 minutes, the patient went back to feeling normal.
experienced severe side effects afterwards, pain,  vomiting/ weakness.  He ended up in the emergency room and based on the Band-Aid placement and further evaluation, the doctor determined that the vaccine was administered in the shoulder joint.  Her dad is now receiving cortisone shots and is unable to move that arm.
Approximately 1 week after vaccine administration in her L deltoid patient noticed two enlarged lymph nodes in her L axilla. When examined today (05/12/2021) nodes are mobile, nontender and approximately 1cm in diameter.
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: F-EP7533) and on 20Apr2021 as dose 2, single (Lot number: FCEW0151) at the age of 51 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No known allergies and other medical history. No follow-up attempts are possible. No further information is expected.
within 24 hours of administration patient complained of redness and swelling of left arm.  patient used ice and ibuprofen and reaction resolved within 7 days
1 day after immunization developed erythema, induration and pain of left anterior thigh.  Started on Keflex for a presumed staph infection.  This worsened over 24 hours and she was admitted with complaint of difficulty walking due to pain, temp to 101, and development of vesicles - rupturing honey colored fluid.  Was placed on IV Ancef, zyrtec, and ibuprofen with a working diagnosis of Vaccine reaction vs. infection.  A lesion was unroofed and fluid cultured on 4/29 (today).  Unable to obtain a gram stain.  Has had improvement in intensity of erythema and induration as well as improvement in the pain. Follow up 6/30/05: I was the hospitalist for this patient and have not seen the patient since the day I reported the event.
We were driving and patient was in her car seat. She appeared to be falling asleep when suddenly her eyes opened up wide, they rolled up and she appeared frozen. She lost her skin color, was not blinking eye lids, her hands were shaking a bit. She then had clear bubbly liquid coming out of her mouth. She was unresponsive for about 3 minutes as she had the seizure. After that she made slight sounds as if she wanted to speak but could not. The paramedics arrived. We were on the freeway and they took us to the nearest ED. Patient had a fever out of nowhere and they gave her ibuprofen. They did urine test and she had no infections. She slept for an hour and cooled down and they determined she had a febrile seizure. Prior to the seizure patient was not sick nor had a fever.
I contracted COVID-19 on 04/17/2022 with symptoms of fatigue, congestion, chest pain, painful sensation in lungs. COVID-19 rapid nasal swab was positive 04/18/2022 I was prescribed Paxlovid, and I began experiencing fever of 103.8, pain in my lungs moved to my kidneys, I was having frequent urination, abdominal pain, diarrhea, pain in my facial bones around eyes and ears, blood pressure was 70 over 40, coughing, and I had an elevated heartrate. The highest intensity of my symptoms lasted for 3 days. By day 5 my voice became more hoarse, I began coughing more, elevated fatigue. I felt very fatigued for 2 and a half weeks from onset of illness, and still have a lingering cough.
For 3 days he didn't feel well, aching, hands hurt, cold, no fever that he could tell, HR 115, but then HR went back to normal and still cold.
vaccinated & boosted with Moderna & then 2 Pfizer; picked up COVID in Aug; picked up COVID in Aug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "picked up COVID in Aug"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "vaccinated & boosted with Moderna & then 2 Pfizer". Clinical course: Patient was 74 fully vaccinated & boosted with Moderna & then 2 Pfizer vaccinations. Patient was picked up with COVID in Aug & still had it. patient was having concern if there were any research into the treatment.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Above vaccine given @ 11A on 9/1/21 and vaccine expired on 8/31/21. Reported to Moderna awaiting further instructions.
Janssen COVID-19 Vaccine EUA. Vaccine burned while being injected and for about 4 hours afterwards. Arm hurt for a good week after as well. Had a small red raised bump at injection site for about 6 days. Have not had a period for 4 years due to my birth control, got my vaccine on 03/30/2021 and then started a brown and clotty period on 04/01/2021. Period last about 9 days and seems to be gone now besides an odor. Had undescribable cramping in abdomen. Had some type of stomach bug (fever, vomiting, diarrhea) on 03/27/2021 that lasted about 72 hours. Then had another episode of diarrhea on 04/04/2021. Currently having bad headaches and right thigh cramps. Blood pressure and temperature seems to be running higher than my normal still.
Joint pain; fever; sweats; muscle pain bad enough to wake me from sleep; muscle pain bad enough to wake me from sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 08:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Latex" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 01; UNKNOWN MANUFACTURER, Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 02; UNKNOWN MANUFACTURER, Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 03; UNKNOWN MANUFACTURER, Lot number: unknown), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 04Oct2022 at 22:00, outcome "recovering", described as "Joint pain"; PYREXIA (non-serious) with onset 04Oct2022 at 22:00, outcome "recovering", described as "fever"; MYALGIA (non-serious), SLEEP DISORDER (non-serious) all with onset 04Oct2022 at 22:00, outcome "recovering" and all described as "muscle pain bad enough to wake me from sleep"; HYPERHIDROSIS (non-serious) with onset 04Oct2022 at 22:00, outcome "recovering", described as "sweats". Therapeutic measures were not taken as a result of arthralgia, pyrexia, hyperhidrosis, myalgia, sleep disorder. Additional information: The patient did not have covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
On day 8 (12/31/20) woke up and noted a 4cm x 4cm red indurated area at injection site and edema of left deltoid.  Mild burning noted at site. Incidental finding noted, also woke up with pain in left groin.
NOT ADVERSE EVENT:  Patient was given the correct vaccine NDC 59267-1055-04 lot number FT1551 -- however box of previous lot number was scanned instead lot number FL2757 with expiration date of 9/30/22
This spontaneous report as received from a female consumer refers to herself. The patient was vaccinated with first dose of GARDASIL (lot# not reported) in 2006 and the last two doses in 2012. It was unknown if the patient sought medical attention. The consumer stated her physician stated she did not have to start the series of vaccines. Additional information is not expected.
some lingering muscular pain in my arm; two red 'blotches' near the injection site; a slight rash that was more pronounced after a shower; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (two red 'blotches' near the injection site), VACCINATION SITE RASH (a slight rash that was more pronounced after a shower) and MYALGIA (some lingering muscular pain in my arm) 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 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced RASH MACULAR (two red 'blotches' near the injection site) and VACCINATION SITE RASH (a slight rash that was more pronounced after a shower). On an unknown date, the patient experienced MYALGIA (some lingering muscular pain in my arm). At the time of the report, RASH MACULAR (two red 'blotches' near the injection site), VACCINATION SITE RASH (a slight rash that was more pronounced after a shower) and MYALGIA (some lingering muscular pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Unintentionally, an expired hib vaccine was administered to patient. No treatment nor symptoms, signs reported yet.
About 3 hours after vaccination administration, severe soreness to leg muscles and general joint pain, especially in ankles occurred.
Large blisters all on the back and back of legs. Extremely itchy. Resolved in 1 week. Pt reported same side effects from a bubonic plague vaccine received decades ago.
Deltoid muscle swollen and painful. Limited range of motion - cannot raise arm more than 90 degrees. No weakness in grip. No numbnes or tingling of lower extremity.
Hospitalized 4/7 for covid pneumonia.  Still hospitalized 4/9/2021
Central retinal artery occlusion (CRAO); Permanent vision loss right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 07Oct2022 as dose number unknown, single; SYNTHROID. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN7206, Location of injection: Left arm, Vaccine Administration Time: 08:00 AM), administration date: 05Mar2021, when the patient was 52-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 26Mar2021, when the patient was 53-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FE3592, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 04Dec2021, when the patient was 53-year-old, for Covid-19 Immunization. The following information was reported: RETINAL ARTERY OCCLUSION (hospitalization, disability, medically significant) with onset 20Nov2022, outcome "recovering", described as "Central retinal artery occlusion (CRAO)"; BLINDNESS UNILATERAL (hospitalization, disability, medically significant) with onset 20Nov2022, outcome "recovering", described as "Permanent vision loss right eye". The events "central retinal artery occlusion (crao)" and "permanent vision loss right eye" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of retinal artery occlusion, blindness unilateral.
Headache, Tiredness, Stomach Ache, Chills, Body Aches, Sore Joints, Fast Heart Beat
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. On an unknown date the patient experienced a mild case of shingles. It was reported that the patient sought medical attention (details unspecified). The patient was treated with unspecified antivirals.  The outcome of a mild case of shingles was reported as not recovered. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therpay with ZOSTAVAX was unknown. No product quality issue was reported. Additional information has been requested.
SWELLING AT SITE OF INJECTION THAT HAS INCREASED SINCE THE DAY THAT THE SECOND DOSE WAS GIVEN
Patient presented to clinic on 6/28/2017 with concerns for possible reaction. Patient states that she did not have any reaction after receiving the vaccine. Patient states that she has some redness , swelling and muscle soreness afterwards. Patient states that later that evening she notice that she had some swelling around the elbow area. Patient states that it seems to be getting worse and she has notice that he swelling has radiated up the arm. Patient states that she began to have itching and rough skin on 6/27/2017 along with lower right arm pain.(Vaccine given L deltoid PCV13). Patient states that she was ordered new medication on the day the vaccine was given but states that she did not start the medication until 6/26/2017. Patient denies having elevated temperatures. Patient was not in any distress and was informed by care coordination to go to PCM or ER for evaluation . Patient verbalized understanding.