chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right after receiving the first dose of the Pfizer vaccine, patient fainted and fell to the ground from a sitting position. He was unconscious for a second and woke up not remembering anything. 911 was called and EMS came to evaluate but didn't not transport him to ER.
Client c/o "chest hurting and hard to breathe" approx. 15 mins. after 2nd Pfizer dose. EMS was called for transport to local hospital. V/S @ 12:35: AOx3, BP 118/90, HR 72. At 12:42pm, client reported increased difficulty breathing and rated chest pain 7/10. V/S @ 12:42 BP 122/82, AOx3, HR 66, RR 22. At 12:50 medics arrived on scene and assumed care of client.
C/O weakness, started about 3-4 days ago. Brought on by respiratory infection, has had cough and congestion. Pt having chills, fever, fatigue, congestion, sore throat, cough, sob, wheezing and nausea. Chest Xray shows pneumonia.
Vaccine administered 1/3/2014, within 96 hours patient experienced extreme vomiting, nausea and vomiting that lasted 7 days.
Initial report received from a health professional on 27 October 2008. A 46-year-old female patient had received a dose of FLUZONE SV 2008-2009 (lot number unknown; route and site of administration not reported) on 20 October 2008 and within 24 hours, she complained of sudden hearing loss in her right ear. The patient was seen by a physician on 22 October 2008. No additional details were provided. Documents held by sender: None
1 inch by 1 inch size red shaped circle rash at the injection site.  From what I can tell it is what is being referred to as Moderna Arm or Covid Arm. I feel an occasion itch every few hours out of the blue, but  other than that , I do not even know it is there.
Varicella given on Tuesday, 4/23/02. Temperature on Thursday, 4/25/02, was 105F and also on Friday, Saturday, Sunday, Monday and Tuesday. ER visit on 4/26/02 with a febrile seizure. Admitted to the hospital on 4/30/02. No medication would break the fever and had a seizure. Medical Records received on 9/09/2002 states nasal congestion and throat inflamed.
That afternoon developed HA, Vomiting, Fatigue & dizzy, Skin becomes "yellowish" and next day red pimple like rash on back.
After receiving the vaccine at about 5 pm, later in the evening she first noticed a rash on the arm lower than the site of the shot - the following symptoms were all over the arm radiating towards the elbow and inner left arm - it was very hot, red and inflamed, felt hard and looked like a tennis ball like hard lump, she also noticed a red streak like a red line towards the elbow. Today 12/02/17 - two days after receiving the shot - it is still sore and tender to touch, still hot, some rash, red horizontal line right above crease of the elbow, 2.5 inches long. Not as hard as it was before.
pt presented to clinic for 2nd moderna covid vaccine today and informed the covid  nurse about the complication from the 1st covid moderna vaccine given by another  nurse volunteer on 3/11/2021.  I was informed about this complication and spoke  to pt about history and symptoms.  pt stated that she had soreness for 2 days after the first injection but then  became more concerned when the pain lasts or more than 1 week and it's too  painful to perform ROM.  saw her PCP and there's concern that the deltoid  injection was given too high on ther deltoid region and thought it may have hit  the nerve and/or tenden sheath.  pt was eventually referred to allergist and  orthopedics. Given oral prednisone with no significnat relief.  Allergist didn't  think it's an allergy from the moderna vaccine.  pt was evlauated by ortho and  had an in-office ultrasound with unremarkable finding so she's referred to an  outside ultrasound study to be read by a radiologist.  pt has been icing the area, no warm compression.  being told to perforom ROM  exercise at home by ortho.  Thought of providing intraarticualr steroid injection  but ortho would like to wait until after pt obtain the 2nd covid vaccine.  Pt  stated that her pain is not as acute as it's initially presented.  pt's PCP has  mentioned about filing a VAER report but isn't sure if such report is done.  Plan:  discussed with pt that there's a possible IM technique issue by the nurse  volunteer giving the vacicne and plan to discuss further with the nurse when  she's in office next time (tomorrow?).  Also discuss with pt about possible COVID  vaccine complication, will have the contractor RN to file a VAER report just in  case PCP did not file one.  Pt cannot take NSAID due to kidney isssue. Encourage  heat compression and may alternate with cold compression.  Continue ROM exercise  including walking on the walll with fingers from anterior and lateral approach.  Encourage pt to continue following up with ortho and let us know in 1-2 weeks  whether pt is feeling better or worse.  pt verbalized understanding to plan.
Pt recvd 3 doses of Engerix-B vax 7MAY91, 4JUN91, & 11NOV91 & 11NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick). At the time of the report, MALAISE (felt sick) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-100824 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100824:dose 1
Bilateral eye swelling, left-sided facial flushing, left lip swelling, scratchy throat; helped with Zyrtec.
Shortly after taking the Jassen COVID-19 vaccine (4 days), I started noticing sporadic bumps appearing on my skin starting on my hands and slowly spreading down my arms, followed by my chest, and finally spreading to my private area.  These bumps slowly started developing into a rash with my chest being the main area that's affected. As this progressed I went to the doctor's office on April 5th to see what could be done. The doctor prescribed me 25mg of Banophen (Diphenhydramine) with instructions to take one pill every six hours to ease the pain. Unfortunately, the bumps have continued to spread sporadically throughout my body, the rash gets worse every night, and the itching is constant.
This is a spontaneous report from a contactable consumer or other non HCP via clinic. A 81-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: ER8727, Expiration date: unknown), via an unspecified route of administration on 19Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received his first vaccine dose on March 19th (Lot ER8727, no expiration date). asking when he was able to get his second vaccine dose or if he needs to repeat the entire series because he had covid. Caller reports that first vaccine dose her husband was diagnosed with Covid through a rapid Covid test at rite aid, stating, suspect he may have already had Covid because he contracted Covid a few days after he got the vaccine. Caller reports that a few days after her husband received the vaccine started feeling sick he wasn't able to notice if or when he had any symptoms. Caller reports that her husband got Monoclonal antibodies and Remdesivir while in the hospital. She reports that the Monoclonal antibody people said wait 90 days to get the vaccine, then our Family doctor wanted him to wait 120 days. Now he (my husband) is nervous and jerky because of the delta strain. Caller states, there was so much conflicting information just want to clarify when he should get the second dose or if he needs to repeat the series. The patient underwent lab tests and procedures which included rapid Covid test unknown result on an unspecified date. The outcome of events was unknown.
Fever; Chills; Body aches; A spontaneous report was received from a 22-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills and fever, body ache.   The patient's medical history, as provided by the reporter, included COVID-19 infection during mid-November and recovered by the end of November.  No concomitant medications were reported.   On 31 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the evening of 31 Jan 2021, after receiving mRNA-1273, the patient felt "worse".  The patient experienced chills, fever, and body aches which lasted for 2 days.   Action taken with mRNA-1273 in response to the events was not reported.
THE CUSTOMERS MOM CALLED AND STATED HE STARTED HAVING TIGHTNESS IN CHEST. I RECOMMENDED CALLING HIS CARDIOLOGIST AND IF NO RESPONSE TAKE HIM TO THE ER. I CALLED ABOUT AN HOUR LATER AND THE MOM STATED THEY WERE AT THE ER WAITING TO BE SEEN. HAVE NOT HEARD BACK. WE WILL FOLLOW UP TOMORROW
5 days after the first shot began to feel pain when moving my left arm - pain is n the armpit area.  Also armpit area is very sore to the touch.
BP 100/100 mmHg, HR 72 History of Orofacial granulomatosis, neurofibromatosis type 2 and Sjogren's and trigeminal neuralgia Around 10 minutes after receiving the vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened.
03/24/2021 I went to my ortho doctor I have developed bursitis and treated it with an injection and steroid pack.
Rash on upper left arm, blue/swollen toes- first pregnancy due date 7/4/21
Immediate feeling unwell and dizzy, vision change Unwell x two weeks w/ chills first day only, headache, muscle & joint aching, fatigue At 13 days post ?COVID Arm? red, tender, no itching Now feeling well
101.7 fever, chills, headache, muscle aches, joint aches, pain at injection site with hardness and swelling at site. Started with injection site pain and muscle aches at about 12 hours  (12am), chills by 2am, and progressed  to full detailed symptoms by the time I woke up at 615am (fever,
Pt developed a rash 2 days after vaccines were given on 8/8/11. Pt also had a fever.
This spontaneous case reported by a consumer, describes the occurrence of illness (sick/"vaccine made me very sick") and feeling abnormal ("thought I was getting ready to die") in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (sick/"vaccine made me very sick") and feeling abnormal ("thought I was getting ready to die"). At the time of the report, illness (sick/"vaccine made me very sick") resolved and feeling abnormal ("thought I was getting ready to die") outcome: unknown.  No concomitant or treatment medication reported.
Constant dull ache in deltoid area of left arm. Occasional throbbing pain that radiates down to hand. Now at 6 wks. post-vaccine. No treatment sought.
aching in major joins; Went to bed last night very cold; woke up around 2am; fever over 101; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (1st dose received on an unknown date, reference case US2020AMR254730).   On 21st December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced joint pain, feeling cold, poor sleep and fever. On an unknown date, the outcome of the joint pain, feeling cold, poor sleep and fever were unknown.   It was unknown if the reporter considered the joint pain, feeling cold, poor sleep and fever to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient mentioned that he/she went to bed last night from the reporting date and felt very cold, he/she woke up around 2:00 am and had ache in major joins and fever was over 101. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254730:Same reporter
skin is sensitive to touch, they feel sore all over, but more like a nerve endings kind of thing.; armpit had a painful lump, like a swollen lymph node.; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (armpit had a painful lump, like a swollen lymph node.) and VACCINATION SITE PAIN (skin is sensitive to touch, they feel sore all over, but more like a nerve endings kind of thing.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN B COMPLEX, FISH OIL and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021 at 1:59 PM, the patient experienced LYMPHADENOPATHY (armpit had a painful lump, like a swollen lymph node.). On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (skin is sensitive to touch, they feel sore all over, but more like a nerve endings kind of thing.). The patient was treated with PARACETAMOL (TYLENOL) for Skin discomfort, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (armpit had a painful lump, like a swollen lymph node.) and VACCINATION SITE PAIN (skin is sensitive to touch, they feel sore all over, but more like a nerve endings kind of thing.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Dtap was given on 3/7/17 - vaccine was expired on 3/5/17 (2 days prior to administration) - no AE reported by parent.
No other AE.; products were administered to patients after a temperature excursion; This spontaneous non-valid report as received from an Office Managerrefers to patients of an unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On an unknown date, the patient the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection, lot #T041337 was confirmed to be valid, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injectionunk, lot #U011995 was confirmed to be valid, expiration date: 15-APR-2023, lot #T034389 was confirmed to be valid, expiration date: 08-OCT-2022 administered for prophylaxis (strength, and route of administration were not provided). The administered doses underwent a temperature excursion of 55 degrees Fahrenheit for 14 hours and 4 minutes. There were previous temperature excursions. No additional adverse effect was reported.  This is non-valid report due to lack of the patients' identifiers.  Follow up information has been received from a vaccine provider on 23-FEB-2022, referring to a 42 years old female patient. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions. Fridge thermometer by "05B" point and recovered 14 hours. Temperature excursion. Fridge Door was not reputed to be good. The Temperature excursion occurred as a result of a reading from a digital Data Logger (reported as temp log "revised" for digital thermometer). The suspect vaccines were discarded after excursion developed (reported as discarded vaccines that were no longer usable). On 13-JAN-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (route/site: intramuscular/deltoid, single use vaccine) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) (route/site: subcutaneous/"triage", single use vaccine) at public health clinic hospital. The vaccines purchased with private funds. The patient had titers tested following immigration series. No adverse events. Manufacturer contacted. The vaccines were not available for return/evaluation. The vaccines used according to the instruction leaflet.  This is one of four reports from the same reporter.; Sender's Comments:  US-009507513-2202USA008508: US-009507513-2202USA008509: US-009507513-2201USA004692:
chills; sweats; fatigue; headache; dry heaves; fever; soreness; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 13:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 18:45 the patient experienced chills, sweats, fatigue, headache, dry heaves, fever, soreness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, sweats, fatigue, headache, dry heaves, fever, soreness was not recovered.  No follow-up attempts are needed. No further information is expected.
Fever, chills and body aches, ~13 hours after second shot in the series.; Fever, chills and body aches, ~13 hours after second shot in the series.; Fever, chills and body aches, ~13 hours after second shot in the series.; This is a spontaneous report from a non-contactable consumer. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 06Apr2021 at 08:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Apr2021 at 21:00, the patient experienced fever, chills and body aches approximately13 hours after second shot in the series. 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. The clinical outcome of the events fever, chills and body aches was recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient states she got the flu shot 2 days prior to presenting to ED and developed itchy rash on her face and mild abdominal cramps.  No SOB, trouble breathing.
Breakthrough case admission after 2 vaccines Pfizer 5/29/21 lot# Ew0191;  Pfizer 6/19/21 lot# Ew0181
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in May 2017 (reported as sometime between the dates of 27-MAY-2017 AND 30-MAY-2017), the patient was vaccinated with ZOSTAVAX vial 19400 PFU (plaque-forming units) (lot#, expiry date and dosing details were unknown; reported as injection) for prophylaxis. Other suspect therapy included sterile diluent (MERCK) (dosing details, indication, lot and expiration date were unknown) used to reconstitute ZOSTAVAX. The reconstituted vaccine was given subcutaneously in the patient's forearm. Approximately in May 2017 post vaccination; the patient experienced redness and itchiness at the injection site. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapies. There were no product quality complaints (PQC) involved. Additional information has been requested.
took a nap after getting home from 2nd shot. Awoke at 3:50pm with feeling of Flu like symptoms(chills, ache). Took (2) Tylenol as recommended by Vaccine administrating nurse at clinic.
"Hives" (raised, reddened areas) approx 1/2" beginning on trunk and going down legs slightly and somewhat on arms; none on face. Did not itch until 2 days later and then have itched ever since. It has been 3 weeks and 50% are still present but "drying up" per mother. No fever, no SOB
High  fever - 102.5, chills, aches, nausea for more than 48 hours.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2019GSK020885). On 2nd February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient who herself was the Nurse. The age at vaccination was not reported. A day before the vaccination, the patient received a 2nd dose of SHINGRIX. The reaction was as bad as 1st dose.
The medication that was injected stung me. My arm just kept stinging, I kept ice packs on it all day. After 3 hours I started feeling very tired which lasted for days. The next day my left gland in my neck was swollen, arm was hot. I felt like I was getting a sinus headache. The gland kept swelling on and off for about a week.  The tiredness lasted for about three weeks. Developed a rash on my chest and lower back area. The doctor gave me a cream to use on the rash.