chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot # L032749, expiry date 04-NOV-2016; lot # L013324, expiry date 24-APR-2017 and lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Pt complained of itchy hands and neck after receiving a flu shot. She said it started in the evening and still had itchiness the next day. Recommended BENADRYL.
Patient received flu shot on 10/16/14, developed hives on 10/17, treated with antihistamines on 10/17. Went to ER on 10/18 due to "spreading rash and itchiness" kept overnight for observation, given prednisone, antihistamine and an IV. 10/23: pt. re-evaluated by provider, no rash, feeling well.
Large raised, swollen area of redness (also hot) on thigh at vaccine site.  Also large raised, area of redness in groin area.
chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard and could feel below the esophagus area, March 12 at 6:30 am T 99.9, BP 151/85 achy , took tylenol  and at 8:40 am BP 128/ 74   P 93, my back ached all day, 3:45 pm BP 141/74   P 90, Took tylenol for achy body, 6:00pm  BP 158/82  P 84,  8:08pm   BP 138/73  P82 . Felt very tired and slept in my chair 3:30- 6:00 pm, felt really exhausted and went to bed early : slept 9:00pm-7:00 am .  Saturday 3/13 /21  felt better T 97.3   BP124/69   P 64  felt fairly good all day but tired
Patient reports that he noticed chest pain after getting his COVID19 shot on 3/7/2021.  While patient admits that his arm felt sore, he reports that he was surprised to find mid chest pressure developing and persisting long after the shoulder pain resolved.  Patient describes the pain as a pressure-like sensation mid chest with some radiation to the shoulder, overall fairly mild in intensity (3/10).  Patient states that the pain seems to be brought on by "every day activities"  Patient reports that he walks but does not engage in strenuous activity typically.  Patient denies experiencing acid reflux.  Patient reports that the pain was resolved by nitroglycerin.
Redness and itching at site then redness spread to both arms, chest  & neck.  Approximately 45 Min to 1 hour later lips and tough were numb and became hoarse.
Woke 1 AM night of shots with high fever, vomiting, right leg swelling (at injection site), cough, diarrhea, fussy. Gave Tylenol (vomited some), cool baths. Seen about 11 AM in clinic - afebrile after Tylenol, hydrated, exam normal except for still very tender right leg. Left leg non-tender (TM's normal). Next night temp 102.9 rectal - checked, no sources untested. Observe, fluids, Tylenol, to ER if sicker.
Had a rash reaction like almost I was having them; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included disability.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 3-Jun-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient had dual insurances and was disabled, and the patient's shots were always covered. The patient got the shingles shot but had a rash reaction to it like almost like he or she was having them. Additional Supportive Information: The follow-up would not possible as no contact details were available.
gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave a 0.25mL dose of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL).    Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Approximately 3 weeks ago developed rash on face, no itching - stopped using acne medication cream from dermatologist. Has been applying baby powder to face. No fever and no rash, exception face and chin. Took to Dr to see rash, told to apply hydrocortisone 1% ointment and call dermatologist. 4/3/2014 Td to client, states she used ointment for few days and rash disappeared.
This spontaneous report was received from an office manager refers to an unknown number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On an unknown dates, the unknown number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M021407 and expiry date 30-APR-2018) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature excursion of 31.3 Fahrenheit for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Caught COVID; Caught COVID; Sore arm; With son-in-law's COVID symptoms, he had a fever with his head cold; With son-in-law's COVID symptoms, he had a fever with his head cold; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), COVID-19 (medically significant), outcome "unknown" and all described as "Caught COVID"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), NASOPHARYNGITIS (non-serious), outcome "unknown" and all described as "With son-in-law's COVID symptoms, he had a fever with his head cold". Clinical course: Patient had two doses of Pfizer Comirnaty, had a sore arm. Then two months later, patient caught COVID. Had to stay in isolation for ten days. This was around the time of the Delta variant. With patient's COVID symptoms, he had a fever with his head cold.   The lot number for bnt162b2 was not provided and will be requested during follow up.
It hurts when I lift my arm up and out. I received the FLUVIRIN shot on my upper left arm. I was told there would be soreness but I am still sore, achy, my left arm hurts and is constant, I am always achy and the discomfort I feel all the time, and it won't go away.
Fever; fatigue; body aches; This is a spontaneous report from a contactable other hcp (Husband) via Pfizer sales representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, fatigue, body aches on an unspecified date. Patient experienced side effects after receiving shot. Symptoms included fever, fatigue, and body aches. Symptoms appeared after 1/2 of getting the shot and lasted a day. Clinical outcome of events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021338631 same reporter/product/event, different patient
About 20 hrs after vaccination, patient began to experience facial swelling about lips and eyes. Difficulty with swallowing and generalize body aches. Patient placed on prednisone taper and prescribed epi-pen for future allergic reactions. Symptoms still present 6/27.
on 9/2/99 mom reported that child had a rash on arm,shoulder, chest area that devel the day p/vax given 7/20/99;did not seek medical treatment-resolved;
Sore arm, chills, Very sore throat, run down,  listless, coughing, lost my voice
Woken up by a sharp pain in my chest; Myocarditis; This is a spontaneous report reported by a contactable consumer. A  23 years old male consumer (patient) reported for himself that he received the second dose of (Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number ER8727) at single dose for COVID-19 immunisation on 19Apr2021 at 01:00 PM. Relevant history included Anxiety, Depression and Other mental health related illnesses. The medications that patient received within 2 weeks of vaccination included: fluoxetine hydrochloride (PROZAC), bupropion, nortriptyline. The patient previously received the first dose of Batch/lot number: ER8727, for COVID-19 immunisation on 29Mar2021 at 01:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Several days after receiving the second dose, the patient was woken up by a sharp pain in chest on 28Apr2021. After two days in the hospital he was told he had Myocarditis and was prescribed Colcrys and a large dose of Ibuprofen. The patient was still being seen for follow ups in regards to this. Outcome of event was unknown.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Nasal Swab (COVID-19) test on 28Apr2021 and 12May2021, both negative result.
Patient was seated ready to have her 2nd dose Pfizer vaccine administered in her right arm at 10am on 2April2021.  On the first attempt the needle punctured her skin but did not fully insert.  Same syringe/needle was used on the right arm again,  different site to give the full dose of vaccine. No other effects were observed
COVID 19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00am.
Pt reported hx of vasovagal. At 1747, one minute after vaccination, patient lost consciousness for 20 seconds. Pt did not fall. Pt was transferred over to the cot by multiple RN?s. V/S initiated x5 WNL aside from slight bradycardia in set one. Ice packs applied to nape of neck and extremities. Water provided. Pt reported feeling better & was moved to a seated position at 1800. Pt didn?t tolerate well so pt was placed back in laying position. At approximately 1815, pt was brought to a seated position, tolerated well with only slight lightheadedness and tingling sensation in extremities. Pt stood up and walked around a bit, tolerated well. Pt then escorted over to observation at 1830 for an additional 15 minutes. During observation, symptoms fully resolved. Pt A&O x4.    Pt left observation at 1846 in a lyft after reporting complete resolution of symptoms. Pt left ambulatory with a steady gait.
Woke up in the middle of the night with horrible joint pain. Couldn?t lay comfortably in any position. Every single joint in my body was aching, even the small joints in my fingers. It was especially horrible in my upper back and shoulders.
vial was placed in fridge on 8/19/21, and therefore expired on 9/18/21. Box was only marked with 9/18, which was the date it was received in the store. pt received dose outside of the known effective storage window of 30 days. Pt was contacted and stated she had full immune response to the vaccination, including fever, malaise, headache, and slept all day. Pt declined re-vaccination recommendation.
Hives on forehead, wheezing, the area where PCV13 was given had some hives. Pt was given 0.01 of epinephrine on (L) thigh immediately and responded. Pt was kept under observation for another hour. Vial signs normal, Pt stable. No signs of distress. Pt sent home.
Extreme chills starting at 11:30 pm. Chattering teeth.  Felt chilled to the core. Thus lasted for 4 hours followed by fever and sweating for several hours. Headache and extreme fatigue. Got up and took ibuprofen then slept entire day.
back started getting very stiff.; tired after booster dose; nausea; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (back started getting very stiff.), FATIGUE (tired after booster dose), NAUSEA (nausea) and HEADACHE (bad headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 008C21A and 021B21A-1) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (back started getting very stiff.), FATIGUE (tired after booster dose), NAUSEA (nausea) and HEADACHE (bad headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (back started getting very stiff.), FATIGUE (tired after booster dose), NAUSEA (nausea) and HEADACHE (bad headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-455718, MOD-2022-455736 (Patient Link).
At bedtime on 10/25, the day I received the vaccine, I started to feel a spasm in my back and neck. The spasm would jump around my back and my stomach. I was unable to control my bowel movements. I was getting up screaming and anything I tried to do to control my bladder and bm made the spasms worse. I went through the night and fell asleep at 4 o'clock. The next morning I had a PT appointment and went to it in pain. The PT examined me and told me to see my doctor right away. I had knots in my neck and back and they cramped up. I went into an urgent care, they put me on muscle relaxers and extra strength ibuprofen. I started to get relief. On 10/27/21 it was finally lessening. I woke up today 10/28/2021 feeling better and spasms gone.
- Got chills- body felt drain, swollen in left arm - Redness under arm, headaches, sweating - TYLENOL, diarrhea, vomiting, numbness in face.
Vaccine was received on 1/25/19, patient reported event to pharmacy on 1/28/19. Reported 3 inch circle in diameter, that is red, raised an hot to the touch. Patient did not have a reaction to the first dose of SHINGRIX or to any other past vaccines.
Approximately, 10 minutes after completing her 15 minute observation, the patient returned to report swelling of the throat, face, and lips. She was given 10ml of liquid Benadryl. BP: 118/78, P: 70, R: 16, T: 99.2F. Ten minutes after administering Benadryl, the patient reported returned sensation of lips and reduced swelling observed in face. Patient denied return or increasing symptoms post Benadryl. She was monitored for 1 hr post initial complaint and released after symptoms improved.
On July 14, 2022 I was exposed at work to a coworker who had been with someone who tested positive for COVID. On July 16, 2022 I tested positive for COVID. My symptoms were sore throat, runny nose, "swimmy" head, diarrhea, cough, and exhaustion. On July 18, 2022 my primary care physician prescribed Paxlovid, Ipratropium spray, and Benzonatate Capsules.
I started hearing a high pitched ringing in my ears every so often.  Then I noticed it was ringing all the time.  I never had this before.
Patient is a 16yr old previously healthy female who presents with thrombocytopenia and anemia with 7days of vaginal bleeding. Patient presented to Hospital ER with a heavy menstrual period with multiple clots and a nose bleed. Patient reports that she started her menstrual period at the age of 12 and have always been irregular. The longest length of time she has gone between having periods is 3 months while the shortest time length between periods is 1 week. Her menstrual period usually lasts approximately 7days with an average of 4 heavy days. On average she will change her pad 4 times per day. Pads will be soaked through with blood and on heavy days she will double pad. During this current period her flow continues to be heavy and she has needed to change her pad approximately 6times per day. During this current period patient has also noted multiple clots with wiping during this period. On the morning of admission while blowing her nose a dime size blood clot was noted to be on the tissue. At Hospital CBC was drawn and she was noted to have a cbc significant for low platelets of 10 and hemoglobin of 9.4. Petechia and lower extremity bruises were noted. She was transferred to another ER.
got the flu three time; Initial information regarding an unsolicited valid non-serious case received on 12-Nov-2020 from a consumer (Patient) via social media.  This case involves a patient of unknown demographics who got the flu three time, while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date (reported as last year), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu three time (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE. Patient also reported that no shot this year didn't get the flu at all.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
I had a severe rash all over my body. I had to go to the emergency department twice and was prescribed Benadryl (25 mg every 6 hours for 6 days) and Prednisone (50 mg daily for 4 days) the first time. The doctors both said I had hives. The second time I went to the emergency department was because my rash has gotten worse and was now in my face  (eyes, mouth). This doctor prescribed  Famotidine (40 mg daily for 15 days), Loratadine (10 mg  daily), and two epinephrine injectors just in case of anaphylaxis.  After a week of having the rash and taking all medications plus adding calamine plus itch relief spray my rash went away.
Very red around site about1x3 inches very itchy for about 8 days. No pain just pink and red next to that small black and blue mark
Severe Right sided chest pain, right sided muscle spasms and difficulty breathing two weeks after vaccine was administered Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or deep veins or any risk factors in patient.  Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively improved over days. Was discharged after 6 days on admission. Was discharged on oral anticoagulant (Rivaroxaban aka xarelto)
Slept well the night of my vaccination, and woke up feeling okay.  About an hour and a half later, I experienced severe chills, to the point of shaking.  Half way through breakfast, I stopped eating as I no longer was hungry.  I had to go back to bed.  The chills subsided, but I ached all over, similar to having the flu.  It is now day two, and I am still tiring easy.  I did not report this to my physician, as I am doing much better.
fever up to 101.3F; Chills; Pounding headache; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date unknown) for prophylaxis.   On 20th June 2020, the patient received the 2nd dose of Shingrix. On 20th June 2020, immediately after receiving Shingrix, the patient experienced fever, chills and pounding in head. On 23rd June 2020, the outcome of the fever, chills and pounding in head were recovered/resolved.   It was unknown if the reporter considered the fever, chills and pounding in head to be related to Shingrix.  Additional details were reported as follows: The patient received the dose of Shingrix and shortly after that experienced fever up to 101.3 degrees fahrenheit, chills and pounding headache that continued up to 23rd June 2020. The pharmacist also reported that this patient has recovered from this symptoms. The reporter consented to follow up. The batch number was reported as AJ9N5 however it was captured as KJ9N5 as per sales data sheet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020127743:same reporter
within 15-20 seconds after administering the vaccine, patient was feeling lightheadness and pain going down his back. Brief shortness of breath but resolved quickly thereafter. Had patient lay down on his back and checked for breathing for vitals, called 911 but refused any treatment. No need for an epipen either. Patient's pain resolved after 5-7 minutes and was able to stand up. Recommended he sit for a little bit longer, which he did and was able to go home. Patient was conscious and able to communicate with me throughout the timeframe.