chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Internal tremors), DIZZINESS (Lightheaded) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental care (had a dental work during the same period of time).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-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 TREMOR (Internal tremors), DIZZINESS (Lightheaded) and HEADACHE (Headaches). At the time of the report, TREMOR (Internal tremors), DIZZINESS (Lightheaded) and HEADACHE (Headaches) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.  Patient reported of still having some of the symptoms sometimes.
Moderna vaccine given 4 days after the BUD. Manufacture expiration 7/13/22, stored in Freezer until 5/10/22, then transferred to refrigeration with new BUD of 6/9/2022. Vial stored in refrigerator until first puncture on 6/13/22 then discarded. No additional doses given out of this vial. No report of poor signs/symptoms.
Woke up the morning after vaccine with a pounding headache. This headache has continued through today (2nd day after vaccine). Tylenol does not lessen my symptoms.
20 min after vaccine shot I had very dry mouth; difficult to swallow saliva; Back of tongue seemed swollen; feeling of swelling in the back of my throat 6 hours after vaccine; This is a spontaneous report from a contactable other health care professional (patient). A 48-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8736), via an unspecified route of administration, administered in right arm on 26Apr2021 14:45 (at the age of 48 years) as dose 2, single for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7533), via an unspecified route of administration, administered in left arm on 05Apr2021 14:30 (at the age of 47 years) as dose 1, single for COVID-19 immunization and experienced normal soreness around injection site, tenderness, soreness in the entire arm developed, 5-6 days post injection a small rash. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not get COVID tested post vaccination. On 26Apr2021 15:05 (20 min after vaccine shot) the patient had very dry mouth and she had trouble swallowing. Back of tongue seemed swollen and it was difficult to swallow saliva. A few hours after shot swallowing got better. She still had a slight problem with a feeling of swelling in the back of her throat 6 hours after vaccine. This is very concerning and scary to feel like she cannot swallow easily and constantly having to swallow saliva. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No Follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning an 8 year old male who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live when he was younger. There was no concomitant medication. On 8/16/04, the patient presented to the office with herpes zoster. The patient was given Acyclovir as treatment and sent home. No product quality complaint was involved. The nurse practitioner also reported another patient (WAES0408USA02244) who experienced herpes zoster after vaccination with varicella virus vaccine live. Additional information has been requested.
Diagnosed with Shingles; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 24Jan2021 10:45 (Lot was not reported) as 1 st dose, single then on 17Feb2021 10:45 (Lot was not reported) as 2 nd dose, single; both via an unspecified route of administration in left arm (at the age of 83-years-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a hospital. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, was unknown if patient been tested for COVID-19. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient was diagnosed with Shingles on 05Mar2021. An unspecified treatment was received for the adverse event. The consumer considered the event as non-serious as did not results in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Immediately following receiving vaccines, patient had syncopal episode while on exam table. Primary nurse immediately called for medical assistance at 11:22am and laid patient back onto exam table. When medical staff arrive patient was sitting up on table alert but stated to feel dizzy and stated that he was seeing stars. Initial set of vital signs: BP: 107/62 HR: 68 RR: 18/min Pulse Ox: 99% room air. Patient given apple juice and gummy snacks.  Upon further assessment, patient reported to not having anything to eat all day prior to visit. 11:37AM patient sitting up and reported to feeling better. Vitals rechecked with the following results: BP: 115/73 HR: 69 RR: 16/min Pulse Ox: 100% room air. Patient escorted out with his cousin at 11:44 alert and oriented.
Woke up broken out in hives on my upper torso, back, arms, and face/head with extreme itching. This is the first time I have ever had hives. I got my first flu shot ever 4 days earlier. Went to urgent care and was given a steroid shot, prescribed Hydroxyzine. Treatment is ongoing and hives have not gone away.
weeping rash in the butt crease. Just reporting it now, but it started in May, I would wake up in the middle of the night with a terrible wet itching sensation in my buttocks. Treated it with athlete's foot Tinactin, other medications. Silver paste. Nothing stops it. Burning sensation when using Tinactin and then would apply other stuff, twice a day after washing area with soap.   Nothing changes. Rash on the skin, scaly.
Expiry date of vaccine per Pfizer EUA was 1/17/2022.
excessive fatigue, brain fog, hair shedding more than usual, constant muscle aches/fatigue, shortness of breath and high heart rate during low/moderate activity. I am an avid cyclist and do not drink or smoke and all of these are unusual for me to be having and started after my doses of the vaccine.
Tiredness; Headache; 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 FATIGUE (Tiredness) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were provided. No treatment information was provided.
I vaccinated the 1st dose on 12/4/2021. The next day (4/13/21) a rash started on his right arm and itchy. The next day (4/14/21) the rash began on the left arm also very itchy. I started taking Benadryl. But the effect goes away very quickly and the itch starts again. Then the rash spread down both arms all the way to the hands. On 4/17/21 the same rash began to appear on both legs and a lot of itching. As of today (4/19/21) the rash is increasing. Does not get better.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. From on an unknown date in February 2018 to 25-JUN-2018, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, PEDVAXHIB, GARDASIL, ROTATEQ orally, M-M-R II, VARIVAX and PROQUAD (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. The vaccines were reconstituted with properly stored STERILE DILUENT. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. Clarification has been received on 26-SEP-2018 stating that the case concerned temperature excursion and no adverse event. There was no event of seizure.
Adverse reaction to the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction to the moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction to the moderna vaccine). At the time of the report, ADVERSE REACTION (Adverse reaction to the moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Substantial pain at injection site; Headache; Neck pain; Lower back pain; Chills; Fever; Dizzy; 24 hours of grief; This is a spontaneous report from a non- contactable consumer (patient) or non-healthcare professional. A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 30Mar2021 at 00:00 (at the age of 66-years-old) as dose 2, single and also the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Oct2021 at 00:00 (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left leg on 09Mar2021 at 00:00 (at the age of 66-years-old), as dose 1, single for COVID-19 immunisation. On an unknown date in 2021, after the second dose, Patient experienced substantial pain at injection site, headache, neck and lower back pain, chills, fever, dizzy and 24 hours of grief. On 06Oct2021 at 19:15, after the third dose the patient experienced the same events as that of second dose. This was significant enough to make it wonder if contacting COVID would be less impactful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events substantial pain at injection site, headache, neck and lower back pain, chills, fever, dizzy, 24 hours of grief were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She stated she was very sore at injection site day of the injection then pain while abducting the arm. Patient states she is still having pain abducting her arm one week later.
So painful; they reared their ugly head; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the pain and shingles were not recovered/not resolved.   It was unknown if the reporter considered the pain and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-SEP-2022 Reporter's comment: This case was reported via interactive digital media. The patient reported that he/she had one shot and the day before his/her second one they reared their ugly head. It was so painful and had to take Valtrex for a week. Still not gone completely. Additional supportive information: Since it was a case, they reared their ugly head was conservatively captured as Shingles. Follow-up would not possible, as no contact, details were available.
5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuana use, who presents for slurred speech. Accompanied by wife. Patient was in his normal state of health until Friday when he got his Pfizer Covid vaccine.  About 5 hours later he was noted to have a headache and some slurred speech but patient and wife did not think anything of it.  They went to some graduation parties this weekend and his speech continued to get worse which is what prompted them to present to the ED today.  He denies that this is happened before.  Feels like it is difficult for him to find words but not to actually say words.  He does surf but denies being in murky water or swimming in fresh water. He denies IVDU. No underlying coagulopathy or cardiac history.
rt arm inject site swollen, red, febrile, tender to touch; tx DPH;
3 cc administered (drug error), 6 dose inj. Arm painful and red @ injection site.
No additional AE reported. No PQC reported; 14 year old male patient was suppose to receive GARDASIL 9, however he received VAXNEUVANCE; Medical assistant reported that 14 year old male patient was suppose to receive GARDASIL 9, however he received VAXNEUVANCE instead. VAXNEUVANCE was accidently administered to patient because HCP thought GARDASIL 9 and VAXNEUVANCE boxes looked simila; HCP thought GARDASIL 9 and VAXNEUVANCE boxes looked similar; This spontaneous report was received from a medical assistant and refers to a 14-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 14-SEP-2023, the patient was suppose to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), however he received pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE lot number X019110 with expiration date 30-AUG-2025 instead, (dose, route and anatomical location were not reported) for prophylaxis.  Pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) was accidently administered to patient because healthcare professional thought rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) boxes looked similar and accidently grabbed the wrong product (product label confusion, wrong product administered and product design confusion). No additional adverse events were reported.
"COVID Arm" - Raised red circle rash (itchy) on injection site - started about a week after appointment and lasted for about 2 days
I developed vulvar ulcers 3 days after receiving the moderna booster shot. They presented as two mirrored red ulcers on the inner labia of the vulva area. My primary symptom was pain and discomfort in the vaginal area. I went to the gynecologist the following day, where I was prescribed steroids (predisone) and a topical analgesic. They took swabs and drew my blood to run tests to rule out Epstein Barr and any STDs. After the results came back, the doctor diagnosed me with general vulvar ulcers, most likely caused by my immune system being suppressed during my reaction to the covid booster shot. The ulcers slowly went away after about a week of being on steroids.
Shoulder became sore about an hour later.  Hands and feet started gradually becoming cold approximately after about 2 hours?.went to bed under covers to warm hands and feet?.put sock on but extremities became freezing cold.  Got up out of bed to drink some water and notice a green hue in the lighting. In my kitchen, we have ceiling bluish white lights but my vision color acuities saw the kitchen in a mint greenish color light. The green numbers and setting on my refrigerator panel were enhanced green. It is as though the other color perceptions in my eyes were not working. Everywhere I looked, the flat screen TV, laps etc. had mint green hue. After resting the night and highway into the next day my hands and feet got back to normal temperatures. The greenish hue or tint in my vision came back to normal  about a day and a half. My color perception didn?t instantly return to normal but a noticeable gradual return until the spectrum was normal.
Information regarding PREVNAR 13 was received from a nurse regarding a 12-month-old female patient who experienced fussiness. The patient received a dose on an unspecified date in 2010. The patient experienced fussiness in 2010. Outcome was unknown. No additional information was available at the time of this report. See related case(s): US-WYE-H16741310 (adverse event, non-expedited).
Patient received AFLURIA at PCP office on 11-09-15 at 1402. At 2020 patient presented to ER with tightness/pain in throat. At 2045 pain was gone, lungs clear, EKG normal sinus rhythm, no block no ST changes. No angioedema. Can swallow without difficulty. No rash noted. Prescribed hydroxyzine 25mg q 4h x2 days.
This case was reported by a other health professional via sale rep and described the occurrence of fainting in a 16-year-old male patient who received BEXSERO (batch number 149001, expiry date 1st September 2016). Concomitant products included MENACTRA, On 4th April 2016, the patient received BEXSERO .5 ml. On 4th April 2016, immediately after receiving BEXSERO, the patient experienced fainting. On 4th April 2016, the outcome of the fainting was recovered/resolved. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details provided as follows. The healthcare professional reported that, the patient fainted instantly after receiving a dose of BEXSERO vaccine in the left arm once the needle was pulled out. The patient also received the MENACTRA vaccine right before the BEXSERO administration in the right arm. The patient recovered after a few moments.
Puffy around area of injection, very squishy. Muscle is pink, red in color. Not itchy, slightly warmer than other deltoid (R) arm. Headache at 20-3 am - took 2 TYLENOL. First year getting HIGH DOSE flu vaccine.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of "other" ethnicity and unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 32-35 degrees Fahrenheit for 12 hours) doses of ROTATEQ (orally, lot # M039067, expiration date 18-APR-2018; dose was not reported) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005222:
Patient started with a warm arm well below the injection site with redness some time on 9/14/17. She went to the walk in clinic on 9/15/17 and the Provider there diagnosed her with cellulitis "probably" from the vaccination. She was prescribed prednisone and BACTRIM DS and the red area was "circled" by the provider.
3 days after vaccine fever 102.5. 4 days after vaccine headache and cranky. 10 days after vaccine diarrhea. 13 days after vaccine fever 101.4, diarrhea, night terror. 14 days after vaccine diarrhea, fever 102.2. 16 days after vaccine "eyes playing tricks", flashing lights, looks like things getting closer x 1 month. Resolved then recurred again Aug 07.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient became pale after injection was given. She did not faint, and stayed responsive throughout event.-Mild, Systemic: Weakness-Mild, Additional Details: Patient became pale after injection was given. She did not faint, and did not become unresponsive. She was given water and orange juice and regained color and felt better afterwards. We sat with patient for about a half hour until she felt fully fine to go home. Patient says she has a history of fainting, especially when giving blood.
With 48 hrs of vaccine, developed a frequent "shuddering movement" (? tic). Lasted few days with decreasing frequency.
Herpes Zoster (Shingles) rash appeared approximately 2weeks after first vaccination, it became more pronounced approx  1 week after the 2nd vaccine on 02/23/2021