chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has not received the second shot; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He has not received the second shot) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He has not received the second shot) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He has not received the second shot) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported patient received last received moderna on 12-May-2022. Patient had not received second shot. It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medications were not reported.   Reporter did not allow further contact
Nausea and vomiting that developed 1 day after vaccination and has persisted for 9 days.  Chills but no discrete fever previously had Covid 90 days ago.
First vaccine was 3/1/21. 3/2/21 had muscle & joint aches, weakness, low grade temp, swollen lymphoid under arm  until 3/3/21.  Second vaccine was 3/22/21. Had same symptoms only more severe & higher temp.   This time I was sick 4 days & unable to work.  I was not better until 3/26/21
Between 24-30 hours after receiving the vaccine, I began having body aches and chills. Body aches were severe for 3 1/2 days. Began having sore throat, head congestion congestion, mild cough after day 3 from the day I received vaccine. On day 6 after vaccine, still with head congestion, occasional cough, left ear pain and mild body aches
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had four temperature excursions as follows: one for 64 hours with the lowest recorded temperature of 31 F (-0.555555556 Celsius), one of 8 hours with a lowest recorded temperature of 29 F (-1.666666667 Celsius) one for 72 hours with a lowest recorded temperature of 33 F (0.555555556 Celsius) and the other one for 64 hours with the lowest recorded temperature of 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Client was in the observation area with his spouse post vaccination. Wife reported client dropped his paperwork and became pale, diaphoretic and unresponsive. EMS responded immediately at which time the client was responsive, awake, alert and oriented. Client assessed and found to have vital signs within normal limits. 12 lead EKG performed and normal. Residual leg weakness improved quickly and patient was counseled regarding transfer to Emergency Department which was declined.
Enlarged lymph nodes to occipital/base of skull area and behind right ear. This lasted four days. Then a few days later developed a itchy rash isolated to anterior and posterior torso. This is still prominent today (12/8/09). Also, I have developed a blister on my mouth. I have no hx of cold sores. I want to add that I did have my hair colored on 11/23/09. This was two days before my injection. Although my scalp was itchy I have never had a reaction to hair dye in the past.
This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a 60-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 26th March 2018 11:18, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, 1 day after receiving SHINGRIX, the patient experienced erythromacular rash. On an unknown date, the outcome of the erythromacular rash was not recovered/not resolved. It was unknown if the reporter considered the erythromacular rash to be related to SHINGRIX. Additional information was received as follows: The reporter stated that the patient developed red spots on her chest the day after receiving the SHINGRIX. The spots appeared to be enlarging but the number of spots had not increased. At the time of reporting, they were fingertip size red spots that did not itch or cause pain.
blood sugar has been severly erratic, going sky high then dropping really low; my blood pressure goes high and low.; First dose on 01Nov2021 and second dose on 15Feb2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1; Lot number: Unknown; Vaccine location: Left arm), administration date: 01Nov2021, when the patient was 44-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Feb2022, outcome "unknown", described as "First dose on 01Nov2021 and second dose on 15Feb2022"; BLOOD GLUCOSE FLUCTUATION (medically significant) with onset 01Mar2022, outcome "not recovered", described as "blood sugar has been severly erratic, going sky high then dropping really low"; BLOOD PRESSURE FLUCTUATION (medically significant) with onset 01Mar2022, outcome "not recovered", described as "my blood pressure goes high and low.". The events "blood sugar has been severly erratic, going sky high then dropping really low" and "my blood pressure goes high and low." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose: (01Mar2022) my blood sugar has been severly erratic, going sky, notes: my blood sugar has been severly erratic, going sky high then dropping really low, I never had blood sugar problems before; (01Mar2022) really low, notes: my blood sugar has been severly erratic, going sky high then dropping really low, I never had blood sugar problems before; Blood pressure measurement: (01Mar2022) my blood pressure goes high and low, notes: also my blood pressure goes high and low. Therapeutic measures were taken as a result of blood glucose fluctuation, blood pressure fluctuation. Clinical Course: The patient was not tested for COVID post vaccination. Patient tested COVID prior vaccination. Patient did not have known allergies. The patient did not receive other vaccine in four weeks. Facility were COVID-19 vaccine was administered as pharmacy or drug store. The patient reported that, after receiving second dose her blood sugar has been severely erratic, going sky high then dropping really low, she never had blood sugar problems before, also her blood pressure goes high and low. The patient received treatment was Metformin for blood sugar, Losartan for blood pressure.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site became red, swollen, hard, and quite painful. Swelling Lasted  more than 2 days. Became itchy on second day. Took ibuprofen for pain.
This case was reported by a consumer via call center representative and described the occurrence of malaise in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose in 2018, refer case US2018GSK221320). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced malaise, lightheadedness, injection site erythema and injection site rash. On an unknown date, the outcome of the malaise, lightheadedness, injection site erythema and injection site rash were recovered/resolved. It was unknown if the reporter considered the malaise, lightheadedness, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient received SHINGRIX and experienced redness and a rash at the injections site that lasted 3 to 4 days. The patient also felt malaise and lightheaded for a few days. The patient did not consent to follow up as she never saw her doctor.
Infanrix (DTaP) dose given instead of TDaP; Infanrix (DTaP) given to 11 year old; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Infanrix .5 ml and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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 reported as follows: The age at vaccination was not reported. Infanrix (DTaP), one .5ml dose given to this 11 year old patient instead of TDaP; which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Information has been received from a health professional concerning a 39-year-old female pt who on 03/15/2001 was vaccinated SC with a 0.5 ml dose of Varicella virus vaccine live. Comcomitant therapy included cold medication (unspecified). On 03/29/2001, the pt developed less than 15 lesions and injection site sensitivity to touch. Unspecified medial attention was sought. No further information is available.
Menstrual Cycle started over a week early and was unusually heavy. Feeling very weak and fatigued.
Redness, pain, and swelling around the injection site lasting longer than 72 hours later
Info has been received from a physician concerning his son who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt developed a mild breakthrough case. Unspecified medical attention was sought. No other info was provided. Additional info has been requested.
It started off as  generalized rash with itching and burning on one shoulder then moved to other parts of the body.
Heart Palpitations; 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 PALPITATIONS (Heart Palpitations) 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 PALPITATIONS (Heart Palpitations). At the time of the report, PALPITATIONS (Heart Palpitations) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I have developed severe vertigo with leg muscle weakness. I feel as though I am on a boat. Within an hour of these episodes starting, I develop a severe migraine.
Client was seated on mother's lap & moved when syringe was inserted in left thigh.   Needle came out and was bent yet no vaccine was administered.  New dose was obtained and successfully administered in right thigh.
First COVID vaccine given 2/11/2021, second dose covid vaccine given 3/10/2021. Person was exposed to a COVID person. On 7/25/2021 experienced headache, fatigue, SOB and cough.  Tested positive for COVID on 7/26/2021. Received Monoclonal antibody treatment on 7/26/2021. Pt was tested at our health system, but never cared her prior to that. No previous health records available.
Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. After receiving the vaccine, the patient passed out and fell and broke two of her front teeth. Dose information was unspecified. At the time of the report, the patient had recovered. Additional information has been requested.
After receiving the vaccine a few days later around the 7th of February I had to go to the ER for calf pain and leg swelling, They did an ultrasound and discovered that I had a blood clot that had formed. On the 9th I followed up with my PCP and they scheduled another ultrasound for the 12th of February, and there was no change in the blood clot size. After that I had another ultrasound in March 12th and that was the last scan that I had received. The swelling and pain did go away around the beginning of March and they prescribed me to take Aspirin for a year to deal with the formation of the blood clot. And I stopped taking my birth control to get better results.
Patient came to pharmacy Sunday 9/28 approxiamtely 3pm with chief complaint of warmth, swelling and redness in left bicep area. There was bruising in left deltiod where high dose flu shot was given Friday 9/26, but no redness or swelling in that region. Advised pt to contact dr Monday morning and seek medical help if rash spread, fever, or dizziness occured. I will follow up with PCP and oversight physicain.
Pyoderma Gangrenosum of right breast. Treated with topical Mupiricin 2%, Clobetasol Proionate Cream .05% ( discontinued during treatment due to allergic skin reaction to steroid), Tacrolimus Ointment .1%, Ketoconazole 2%.
Swelling of right arm, indurated, no erythema, mildly tender to palpation.
noticing changes on her skin slowly/psoriasis went away/psoriasis almost entirely gone following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (noticing changes on her skin slowly/psoriasis went away/psoriasis almost entirely gone following vaccination) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002G21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Psoriasis.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (noticing changes on her skin slowly/psoriasis went away/psoriasis almost entirely gone following vaccination). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (noticing changes on her skin slowly/psoriasis went away/psoriasis almost entirely gone following vaccination) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received  contains updated patient demographics, event outcome was updated to recovered. On 16-Sep-2021: Follow up include Non significant information
Moderna bivalent booster was given 1 day earlier than 4 day grace period allows from previous booster. Bivalent booster given 9/29/22 Previous booster given 8/4/22 No adverse event
Patient reported that she experienced hives going up her left arm, in between her fingers, on her neck, and around her nose.
Patient reports about 3-4 days after the vaccine he started to have vivid dreams. He states the dreams lasted for about 1-2 weeks after they started.
BLOODY NOSE; BLOOD IN THROAT; STOMACH PAIN; DIARRHEA; BIT HIS TOGNUE; This spontaneous case (PVX2019-973) was received from a consumer on 23-Apr-2019. It describes an 18-year-old adult male consumer (height: 66 inches/ 167.64 cm and weight: 140 pounds/ 63.50 kg) who bit his tongue, had stomach pain, diarrhea, bloody nose, and blood in his throat following the intake of oral Vivotif (one capsule every other day) for typhoid prophylaxis.   Case report: The consumer took two doses of Vivotif on 19-Apr-2019 and 21-Apr-2019, respectively. On 20-Apr-2019, he bit his tongue. He applied ice on it regularly. On 21-Apr-2019, 12 hours after taking the second dose, he had stomach pain followed by diarrhea, which he believed was possibly related to the vaccine. On 23-Apr-2019, he had an episode of bloody nose and had some blood from his throat as well, and he drank water to treat it. His nose bled for 30 minutes whereas blood in his throat was still present at the time of the report. However, he did not attribute these to the vaccine.  The consumer's concurrent medical condition included a rug rash which he got from a fall on 16-Apr-2019 and he was recovering from that. He did not smoke or drink alcohol.   The consumer's medical history included asthma and he was also allergic to amoxicillin (rash) and penicillin (rash). He reported that he did not a have history of commonly getting a bloody nose.  Action taken with Vivotif with respect to the events was unknown.  The consumer had recovered from the events, diarrhea and stomach pain on 22-Apr-2019, while the events bloody nose and blood in his throat were not resolved. He had been recovering from the event bit his tongue.  Company's Comment: In this case, an 18-year-old adult male consumer bit his tongue, had stomach pain, diarrhea, bloody nose, and blood in his throat following the intake of oral Vivotif. The causality has been assessed as not related for the events "bit his tongue, bloody nose, and blood in his throat" as they related to trauma incurred by the consumer. The events "stomach pain and diarrhea" were reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the events with Vivotif has been assessed as possible.; Sender's Comments: Company's Comment: In this case, an 18-year-old adult male consumer bit his tongue, had stomach pain, diarrhea, bloody nose, and blood in his throat following the intake of oral Vivotif. The causality has been assessed as not related for the events "bit his tongue, bloody nose, and blood in his throat" as they related to trauma incurred by the consumer. The events "stomach pain and diarrhea" were reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the events with Vivotif has been assessed as possible.
Red, swollen area on arm. Hot and painful to touch. Still present on Day 3.
Injection site reaction; red, swollen, ring around injection site, hot to the touch, painful
Information has been received from a physician concerning a male (age not reported) who in November 2006, was vaccinated with his first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Four months later, the patient received his second dose. No problems were reported. Additional information has been requested. 08/31/07 This is in follow-up to report(s) previously submitted on 4/13/2007. No additional information is available.
Pain; Headache; Severe Myalgia to legs nest day after 2nd dose then to shoulders, arms; This is a spontaneous report from a contactable physician. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) via intramuscular on 27Feb2021 (at the age of 37-year-old) as single dose for COVID-19 immunisation. Medical history included right blepharospasm, history of angioedema, vulvodynia, and endometriosis. Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9810) intramuscularly on 06Feb2021 (at the age of 37-year-old) as single dose for COVID-19 immunisation. The patient experienced pain and headache on an unspecified date, experienced severe myalgia to legs nest day after 2nd dose then to shoulders, arms on 28Feb2021. None prior vaccinations within 4 weeks. Seriousness criteria for event pain was reported as disability. The outcome of the events was unknown. Reporter considered the suspect product had a causal effect to the adverse event.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) to reported events is possible based on temporal association and known profile of the product.
Received vaccine on 2/17/2021 at the healthcare facility. States about 6 days later on 2/23/21, her  L arm became extremely sore, itchy and swollen. Also, looked severely bruised from just above the site the vaccine was given down below the elbow. Saw MD on 2/24/21. Reports taking Plavix and doctor told her the Plavix could be a contributing factor to the severity of the bruising. MD advised pt. that the pain to the L arm and the bruising was likely related to the COVID-19 vaccine.
Severe left side back pain starting Friday morning.  This spread to generalized severe back pain.  Unable to stand or walk as of Sunday night.  I would describe it as 9/10 on the pain scale.