chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid19 breakthrough.  1st Vaccine given 2/21/2021.  Pt presents with URI, onset of 5 days ago and Covid exposure in the home.   Has c/o cough, SOB, Left sided chest pain radiating to back.
About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night, had mild sweats and chills and moderately severe body pain, especially in legs and back. The next morning had no sense of taste or smell. Body pain and loss of taste improved over the day. ,
Patient c/o foggy brain, headache diaphoresis, seizures, spasmodic abasia, spasmodic dystonia and fever x 4 days. E.R.: Patient went to E.R. on 11/13/18. Patient stated she was told it was a virus and discharged home from E.R. Second E.R.: Patient also stated she went to E.R. but did not remember date or tests performed. Third E.R.: Patient went to another E.R. and sat for 8 hours without being seen by Physician so she left the facility. Hospital: Patient admitted at hospital x 2 days. Date and tests performed unknown.
Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023; No Adverse Event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023).    No concomitant medicine were reported. It was reported that 6 patients administered bivalent doses after the BUD.  Vaccine  administered on 23-Feb-2023 after initially being stored in the refrigerator on 23-Jan-2023 from the bivalent Moderna covid-19 vaccine. No treatment medicine were reported. This case pertains to 4th out of 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-713876 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Live Significant follow up-(Batch/lot number received, Case narrative updated received); Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713876:(Master Case pt 1 of 6)
Initially some fatigue, 24 hours after c/o dif breathing seen in ER -c/o concurrent increased HR, muscle, back aches today 4/23/15 c/o twitching. Currently on ZYRTEC; generic SPRINTEC (BCP); FLONASE ibuprofen.
had them three times.; excruciating pain; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (has had three times).   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 shingles and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by patient's wife. The patient received a dose of Shingrix on 17th July and experienced shingles 3 times and excruciating pain and could not get his 2nd shot. Follow-up would not be possible as no contact details available.
Pfizer Dose 1 1/14/21 (lot NA); Pfizer Dose 2 2/4/21 (lot NA); Pfizer Dose 3 10/16/21 (FF2593); COVID Positive 2/20/22. 2/20/22: 73-year-old female with rheumatoid arthritis/Sjogren's syndrome on Imuran and hydroxychloroquine, chronic IVIG infusion for '' antibody deficiency'', bronchiectasis, fibromyalgia/chronic pain syndrome, hypothyroidism and mild cognitive impairment presented with abdominal pain, nausea and headache. Patient reports cough, shortness of breath and chest congestion is with the intermittent chills and fever. Fully vaccinated for COVID-19.  Patient was a febrile and hemodynamically stable.  COVID-19 antigen positive, CT abdomen and pelvis showed no acute intra-abdominal abnormalities however noted bilateral multilobar pneumonia superimposed on interstitial lung disease.  Patient admitted for COVID-19 pneumonia. 2/26/22: 73-year-old female with mild cognitive impairment, fibromyalgia/chronic pain, insulin seizure lung disease rheumatoid arthritis, chronic abdominal pain and anemia presented with generalized weakness found to be hypoxic with the COVID-19.  Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia, she has acute on chronic anemia with a drop in hemoglobin. Patient received standard treatment for COVID-19 with dexamethasone, Remdesivir, antibiotics and the oxygen. Subsequently she was weaned off oxygen to room air completed course of antibiotic Remdesivir and steroids 5. GI was consulted patient underwent EGD and colonoscopy which was unremarkable for acute evidence of bleeding, noted gastritis, diverticulosis and internal hemorrhoids. Patient to stop using indomethacin.  hemoglobin remained stable and GI recommendation is for capsule Enteroscopy if there is any further evidence of hemoglobin drop which did not happen during the hospitalization.  Therapy evaluated patient and recommended home with VNA.  Home O2 walk determined patient does not need oxygen at rest or with activity.  She was discharged home in a stable medical condition.
pt felt fine after both immunizations. she walked out the door and her legs were rubbery and she felt dizzy. next thing she knew she was laying down. She ended up passing out. Pt was taken to ER and had a bump on her head from her fall. she also broke a bone in her left wrist from her fall.
First Covid-19 vaccine was Pfizer given 8/14/2021. Inadvertent administration of other mRNA vaccine. Pt made aware, remained in clinic for approx 20 min post administration. no adverse reactions reported
Erythema, induration, warmth on area of vaccine site. BENADRYL ointment on area. Did not take antibiotics orally.
p/vax pt devel rash; small pink papules scattered over trunk & few on extremities; coalesced in 2 areas on chest & pink patch rt axilla; possible viral exanthem? sl cough & T101 9/11 & 9/12 subjective palpable fever per mom
On 6/19/2022 patient was referred to the hospital for evaluation and treatment for complains of unable to breath. He was admitted to hospital with diagnosis of: Bilateral pulmonary embolism and hypoxia.
29 y/o White male approach staff member and c/o dizziness ten minutes after receiving  2nd dose of Pfizer vaccine. Staff member notified EMS and NP of the incident   PT was evaluated by on-site by  EMS and NP.  Patient stated he had not eaten since yesterday afternoon prior to coming in for vaccine. VS were taken and EKG initiated. Patient stated he was feeling better after eating a snack and asked to leave. Patient has a medical Hx of Anxiety D/O and PTSD. NP advised patient that since his vitals were still elevated and dizziness still present she recommended he be transported via rescue for further evaluation. Patient declined and was asked to sign an AMA form. Patient agreed and picked up from the facility by family member.
This spontaneous report as received from a pharmacist refers to a currently 75 year-old female patient. In 2012, the patient was vaccinated with a second dose of ZOSTAVAX (dose, lot/batch number, expiration date and route were not reported). It was reported that the patient was vaccinated with the first dose of ZOSTAVAX (dose, lot/batch number, expiration date and route were not reported). On an unknown date, the patient developed shingles after receiving the second dose of ZOSTAVAX. No product quality complaint (PQC) involved. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
right hemiparesthesia of the face, seen at ED, given bolus LR, CT scan with contrast head and neck, routine labs
2 hours after injection, patient experienced reduced sensation in lower arm with reduced ?. Injection area was edematous with redness and heat.
Broke out in a rash, more bumps, than a rash, all over for 5 to 7 days and 3 to 4 days, she ran a fever ranging from 100F to 101F.
SWOLLEN LINGUAL FRENULUM  - PER DR GOOGLE THIS CAN BE A REACTION TO A VACCINE - SEE LINK BELOW  https://www.jaci-inpractice.org/article/S2213-2198(18)30586-5/abstract
Moderna covid-19 vaccine given by right deltoid IM infection. Swelling at the injection site within 1 minute of injection. Ice pack applied. 5 minutes later, patient felt lightheaded, elevate her legs on a chair. She had waves of on and off nausea throughout the 30 minute monitoring period. Her and her husband felt confident enough to go home.
Tested positive for Covid-19 on 18Jul2022; Tested positive for Covid-19 on 18Jul2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP) via COVID-19 Adverse Event Reporting. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), on 01Apr2021 as dose 2, single (Lot number: ER8730) and on 05Dec2021 as dose 3 (booster), single (Lot number: 33130BO) at the age of 48 years for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, and all described as "Tested positive for Covid-19 on 18Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive. Therapeutic measures were not taken as a result of vaccination failure and covid-19. The clinical outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162b2 vaccine,  cannot be excluded for the suspected vaccination failure and COVID-19. There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Joint Swelling right elbow  3/31/21, Big Headache 4/3/2, am to 10 pm, Going to get physical therapy for right elbow, using cold pack.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In or around September of 2016, the patient was inoculated with ZOSTAVAX (lot# and route not provided) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles. In or around March 2017, the patient was diagnosed with shingles by a physician. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Shingles was reported by the lawyer to be disabling. Additional information has been requested.
"covid arm"  large red rash on the upper left arm, it was itchy for a couple of days.
Swollen lymph node on left side of neck and collar bone, throbbing discomfort / sensation down left arm , scapula, cheats and heart. Lymph node showing discoloration of black and blue, red splotches on neck and chest, severe headache lasting days  at a time,  burning in stomach, fever like chills warm and cold, brain fog, anxiety
FELT NAUSEOUS; This spontaneous report received from a consumer concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the subject experienced felt nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt nauseous on 07-APR-2021. This report was non-serious.
I requested a blood test to determine how effective my vaccine still is after six months. The results of the blood test was non-reactive. According to the doctor, I am not protected at all anymore, just six months after my vaccination and I don?t know what to do now.
Parent called on Tuesday 9/9/08 and stated that her child might have had an allergic reaction to the varicella vaccine. He received the vaccine 9/4/08. Child complained of wrist pain and leg pain on Friday and she noticed that his top lip was swollen. He was given Benadryl and the swelling was reduced. Child went to school yesterday because the leg and wrist pain were resolved.
Pt COVID+ 10/13, pt to the ED 10/13 for hypoxia, pt with fever at 101.8 and HR at 140-160 and RR of 35. 10/14 pt has strong cough, tachycardic. 10/18 fever resolved, pt non verbal, on oxygen via trach. 10/21 pt with no s/s of pain or discomfort noted. 10/22 pt with no S/S of acute distress or discomfort noted, VSS. 10/24 pt has had no episodes of resp distress. 10/26  pt experienced no diff beathing and O2 st was 91%. Pt discharged 10/25.
Pt was in for 2 year check-up on 2/28/01 and received 4th DTAP in left thigh. On 3/1/01, returned to clinic with reddened raised area and was warm to touch.
I had a big red bump in my arm within 24 hours of first shot and it went away within a couple of days and then came back again a few days later for another few days. It was hot to touch and a little itchy.
Developed a stroke; This is a spontaneous report received from a contactable consumer.  A 74-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (30 days after received first dose) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (maybe 6 months for the first dose) as dose 1, single for COVID-19 immunization. On an unspecified date the patient developed a stroke. The patient was fine. The patient did not function properly, was not right anymore, lots of stuff wrong with the patient that could have been avoided. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a 22 year old female Medical Assistant refers to herself with no pertinent medical history. The patient reported that when she took LORTAB (UCB, Inc) and metaxalone (manufacturer unspecified) she got hives. On 30-APR-2013 the patient was vaccinated IM in the right deltoid with the third dose of GARDASIL (dosage and lot # not reported). Concomitant therapies included metformin, amitriptyline hydrochloride, EFFEXOR, SEROQUEL and LOESTRIN. On 30-APR-2013, she had pain at the injection site. The pain started soon after the injection was administered and had been persistent ever since. There was no treatment given for the event. There were no lab diagnostics studies performed. The patient sought medical attention via seeing her unspecified primary care provider. The outcome of pain at the injection site was reported as not recovered/not resolved. Additional information has been requested.
About 7 hours after injection, I had a large flutter feeling in my chest that lasted about 3-5 seconds.  It happened again about 10 minutes later, nothing after that.
pt states that her arm was a little sore after getting vax but a week later she had two marks on her left arm below the injection site that became itchy and red, swollen, which then turned very bumpy.  The redness spread up the arm toward the shoulder.  On 3/24 her left arm is hurting, itchy that comes and goes and has a sore throat that feels different than usual.  Pt says she will go to Urgent Care if her symptoms get worse.
Patient received PNEUMOVAX immunization in right arm on 09/26/17. Patient came by store 09/28/17 in the evening with patch of redness extending from site of injection to under the arm. Patient said area was warm and she had a temp of 100 degrees earlier. Patient taking TYLENOL and will see her Dr. on Friday. Dr. said it was a normal immune response and no need for any treatments.
On 10/6/98 pt exp puffy/blurry/watery eyes, difficulty breathing; tx=Proventil inhaler
BODY ACHE; SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the patient experienced body ache, sore arm, chills and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and headache, and had not recovered from sore arm. This report was non-serious.
I had a blood clot in my left lung. went to ER , spent three days in the hospital was given medications (Xarelto ) required to taking medication now for a least a year.
02/26/2021 I got the vaccine and on the next day I had low grade fever, arm soreness, fatigue, leg weakness, neuropathy like symptoms, terrible headache, nausea. A couple weeks later I developed strong chest pain, I had never had chest pain before. It would go away and then it would come back. I have recovered from all of this.
This is a spontaneous report from a contactable nurse. A 4-month-old female patient of an unspecified ethnicity received PREVNAR 13 (lot number S31255 and expiration date 01Jul2018) intramuscular (left thigh), at 16:14, at 0.5 ml, single; PEDIARIX (manufacturer GSK; lot number 7275T and expiration date 16Sep2019)  via an unspecified route of administration; PEDVAXHIB (manufacturer Merck; lot number N007752 and expiration date 01Dec2019) via an unspecified route of administration; and ROTARIX (manufacturer GSK; lot number LL773 and expiration date 19Feb2019)  via an unspecified route of administration, all given on 17Aug2017 for routine immunization for a 4-month well visit. The patient had no medical history. Concomitant medications were not reported. On 18Aug2017, the patient developed hives. Therapeutic measures included administration of diphenhydramine (BENADRYL) for a couple of days and has not needed this. Outcome of the event was recovered on an unknown date. The physician thinks that it was unlikely that it was related to the vaccine.
PT DEV 50 CENT SIZED ERYTHEMA AT SOI 24 TO 36 HRS AFTER IMMUN. FOLLOWING DAY DEVELOPED LITTLE RED SPOTS OVER ENTIRE BODY, NO FEVER, NO COUGH, SPOTS RESOLVING - PT FINE
Patient received the second dose of Pfizer vaccine. Shortly after within 1 minute, patient stated that she was light headed. Pharmacy provided her with a bottle of water. Her hands were shaking as she was reaching for the water bottle. She turned notably pale and her vision started to fade/blurry. Pharmacy called EMS and they arrived shortly. After EMS examination, patient was fine and everything appeared to be normal. Per the family member, it was anxiety that caused it. She did not have any previous reactions to vaccines.
No adverse effect reported; On 27-AUG-2019, one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.     On 27-AUG-2019,  the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dosage schedule, route, anatomical location were not reported)(it can not be determined which lot number was vaccinated the patient (R006221 and expiration date 29-FEB-2020 or R029517 and expiration date 14-OCT-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA006332: US-009507513-1909USA006331: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328:
The excursion expiration date of 7 days thawed in refrigerator was followed  because of the Pfizer email approving the 7 days.  policy was to follow the expiration of 5 days.
Annual exam 3/8/13 received shingles vaccine left deltoid on 3/17/13 she presented to urgent care for severe pain (L) shoulder radiating to fingers, symptoms started 5 days after vaccine. Treated with PERCOCET, NSAID's, ice, LIDODERM, gabapentin. US and X-ray done, OK. Pain finally started improving 1st week of April.
Fever 100.4 with NSAID; Severe body aches; Fatigue headache; Loss of appetite.