chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had severe Vitamin D deficiency; Chills; Fainted; Total and complete exhaustion/soo tired; confusion; cried; could barely function, weak; flashes in eyes; i think i am going to die/ horrid / never felt so horrible in my life; headache immediately; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030V21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (headache immediately). On 08-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), CRYING (cried), ASTHENIA (could barely function, weak), VITREOUS FLOATERS (flashes in eyes), FEELING ABNORMAL (i think i am going to die/ horrid / never felt so horrible in my life) and FATIGUE (Total and complete exhaustion/soo tired). On an unknown date, the patient experienced VITAMIN D DEFICIENCY (had severe Vitamin D deficiency) and CHILLS (Chills). At the time of the report, SYNCOPE (Fainted), VITAMIN D DEFICIENCY (had severe Vitamin D deficiency), CONFUSIONAL STATE (confusion), CRYING (cried), ASTHENIA (could barely function, weak), VITREOUS FLOATERS (flashes in eyes), FEELING ABNORMAL (i think i am going to die/ horrid / never felt so horrible in my life) and CHILLS (Chills) outcome was unknown and HEADACHE (headache immediately) and FATIGUE (Total and complete exhaustion/soo tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood test: vitamin d normal (normal) Vitamin D normal. In 2021, Blood test: severe vitamin d deficiency (abnormal) severe Vitamin D deficiency.         The treatment reported was patient was prescribed Vitamin D 50,000 units once weekly and Tylenol. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-109872 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Pt was fed a bottle of formula before being put to bed. When Mom laid her down she noticed she didn't move like normal. Tried to wake her up but couldn't. Father had to give CPR to get baby to breathe. Called 911. Baby was seen in ER put in hospital x2 days.
03/11/2021- 'hypertensive  crisis, post 1st Pfizer, approx 1.5hrs later had pounding HA, went to UC, elevated BP, went back to work, 'massive' HA, feeling unwell, fluttering in chest, flushed feeing, went back to UC but ct decided to go to ER, BP 187/126, low Na/K levels, hx HTN, ER changed  BP meds, hrt monitor on x 48hrs. Night before getting  C-vaccine, flushed, feeling unwell. PCP ok'ed 2nd dose at hospital.
In my left armpit I experienced soreness and swelling. I first experienced this on Sunday, April 19, 2021 around 8am. As of April 22, 2021 I still have the swelling. My lymph node in my left armpit is still tender to the touch.
a few hrs p/DTP/HIB/OPV mom reports that pt devel orange-like little pimples on back of the legs w/carrot-orange circles; pt is very fair-skinned;
pt recv vax 3JUL96 & exp redness & soreness @ the inj site;
PAIN ON THE BACK; RASH (LOCATED ALL OVER THE BREAST); TINGLING ON LEGS AND ARMS; PAIN ON THE LEFT SIDE UNDERNEATH THE SHOULDER; WEAKNESS ON LEGS AND ARMS; INJECTION SITE PAIN (LEFT ARM); This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: amoxicillin allergy, penicillin allergy, sulfur allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was not a drug abuse or illicit drug user. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced pain on the back. On 21-AUG-2021, the patient experienced rash (located all over the breast). On 21-AUG-2021, the patient experienced tingling on legs and arms. On 21-AUG-2021, the patient experienced pain on the left side underneath the shoulder. On 21-AUG-2021, the patient experienced weakness on legs and arms. On 21-AUG-2021, the patient experienced injection site pain (left arm). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash (located all over the breast), tingling on legs and arms, pain on the back, pain on the left side underneath the shoulder, weakness on legs and arms, and injection site pain (left arm). This report was non-serious.
chills; This is a spontaneous report from two contactable consumers.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced chills on 23Dec2020. The patient outcome of the events was recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
inc temp shortly p/vax 7JUN96;temp cont & on 9JUN96 inc temp 105+ ? sz;adm to hosp by MD;
Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patient was notified and reported she had no symptoms.
Shortness of breath, cough, wheezing and chest tightness. Positive COVID-19 test.
Patient reports brief syncopal episodes within minutes after receipt of anthrax vaccine (most recent episode after anthrax vaccine #6 on 9 Jul 2011, but had 3 other episodes following 3 previous doses of anthrax vaccine). Patient describes as "blacking out within a minute of getting vaccine".  All episodes witnessed and patient experienced "convulsions" or what he was told were "seizures".  (No documentation) Per evaluating Allergist, Nov 2018, seizures likely to be myoclonic jerks associated with syncope. Denies syncopal episodes with receipt of other vaccines. No injuries associated with syncopal episodes. Due to reproducibility of episodes, medically exempted from future anthrax vaccines in pre-event setting.
8/30/23 after waking up, 7:30 am tingling on the entire sole of left foot, tingling on left leg from foot to the knee, muscle weakness, lower right leg up to the knee felt weak.  Symptoms maintained during the entire day, slightly swaying gait, did do a 2-mile hike anyway as that is my routine, symptoms persisted throughout the day; same symptoms to a lesser degree the next morning 8/31; symptoms were fading; 9/1, this morning, the symptoms were almost completely gone; as of this moment ~7pm I feel completely normal; since it was improving over time and is fine now, I did not consult a physician nor medical facility.
terrible stomachache, loss of appetite, cough, flu like sx, aches & pain, dryness of mouth, loss strength;bad taste in mouth;
10 days after her first dose of Pfizer SARS-CoV-2 vaccine she developed AKI; AIN; This is a literature report.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; ipilimumab (IPILIMUMAB), (Batch/Lot number: unknown) for metastatic malignant melanoma. The patient's relevant medical history included: "Metastatic melanoma" (ongoing), notes: was on Ipilimumab for Metastatic melanoma. The patient's concomitant medications were not reported. The following information was reported: ACUTE KIDNEY INJURY (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "10 days after her first dose of Pfizer SARS-CoV-2 vaccine she developed AKI"; TUBULOINTERSTITIAL NEPHRITIS (medically significant), outcome "unknown", described as "AIN". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed AIN; Blood creatinine: 3.4 mg/dl, notes: (b/1 1.3 mg/dL); 1.6 mg/dl, notes: At 5 months; SARS-CoV-2 test: Negative. The action taken for ipilimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of acute kidney injury, tubulointerstitial nephritis. The following death information was reported, despite no fatal outcome. The patient date of death was unknown. Reported cause of death: "Sepsis", "Multiorgan failure". It was not reported if an autopsy was performed.  Clinical Course: A 68 year old female was on ipilimumab for metastatic melanoma. 10 days after her first dose of Pfizer SARS-CoV-2 vaccine, she developed AKI, SCr 3.4 mg/dL (b/1 1.3 mg/dL). COVID-19 PCR was negative. Kidney biopsy showed AIN. ICPi was stopped and oral prednisone (1mg/kg) was started. At 5 months her SCr was 1.6 mg/dL on prednisone 5 mg qd, however she died from sepsis and multiorgan failure.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new 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.,Linked Report(s) : US-PFIZER INC-202201326257 Same article/drug/event different patient;US-PFIZER INC-PV202200110499 Same article/drug/event different patient;; Reported Cause(s) of Death: Sepsis; Multiorgan failure
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored ZOSTAVAX (lot # 671075/1197AA, exp date 25-OCT-2012) on 23-JUL-2012. No adverse event reported. Additional information has been requested.
Information has been received from a certified medical assistant concerning a 75 year old female who on 05-FEB-2007 was vaccinated with a dose of Varivax instead of a dose of Zostavax. It was not known how the mistake was made. There was no report of any adverse reaction. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
CHILLS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and headache. This report was non-serious.
Patient described cellulitis after immunizatons. Both IMZ were given in the same arm so unsure which may have caused the cellulitis. Patient sought treatment and received an oral steroid and antibiotic.
pleurisy; This case was reported by a other health professional via call center representative and described the occurrence of pleurisy in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix. On 14th June 2019, 2 days after receiving Shingrix, the patient experienced pleurisy. On an unknown date, the outcome of the pleurisy was unknown.   It was unknown if the reporter considered the pleurisy to be related to Shingrix.  Additional details were reported as follows: This case was reported by the pharmacy intern. Forty-eight hours after vaccination, the patient experienced pleurisy. The emergency room visit required. The reporter consented to follow up.
Hypersensitivity reaction localized to the injection site on the same arm of the injection; She says that the rash got very big but went away on its own after 2 to 3 days; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (She says that the rash got very big but went away on its own after 2 to 3 days) and VACCINATION SITE HYPERSENSITIVITY (Hypersensitivity reaction localized to the injection site on the same arm of the injection) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026Z20A) for COVID-19 vaccination.     Concomitant products included COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HYPERSENSITIVITY (Hypersensitivity reaction localized to the injection site on the same arm of the injection). In January 2021, the patient experienced RASH (She says that the rash got very big but went away on its own after 2 to 3 days). On 11-Jan-2021, VACCINATION SITE HYPERSENSITIVITY (Hypersensitivity reaction localized to the injection site on the same arm of the injection) had resolved. In January 2021, RASH (She says that the rash got very big but went away on its own after 2 to 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Other concomitant medications included birth control pills Treatment medication included unspecified topical cream.  The patient stated that the rash got very big but went away on its own after 2 to 3 days and also she has no known allergies.   This case was linked to MOD-2022-461882 (Patient Link).
Injection site swelling. Advised to ice & watch for signs of infection. If not resolved by next day, maybe check w/MD.
Patient reported to her doctor due to swelling and redness at injection site in arm. Her doctor prescribed an antibiotic (patient unsure of name) at this time as he felt there was infection present.
a patient was administered a expired Tenivac vaccine; Initial information received on 28-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient (gender not reported and age at onset not reported) who was administered a expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot U5525AA, expiration date: Jan-2019 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Dr. grabbed KINRIX instead of Hep B. We are unaware of any adverse reactions just to report wrong vaccine given.
on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; tingling; bruising; rash; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration in the left arm, on 01Feb2021 08:30, at a single dose, for covid-19 immunization. Medical history included kidney stones, BPD2 (bipolar II disorder), and anxiety; there were no known allergies. Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; and imipramine taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The vaccine was given at the hospital. The patient experienced left side: sharp shooting pains, constant pain; fatigue; numbness; tingling; bruising; rash and; on the legs, hands: nerve damage. All the adverse events happened on 02Feb2021 which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had not recovered from all the adverse events at the time of the report despite having an unspecified medication and ongoing treatment received for them. The patient also had imaging and labs on Feb2021 for these adverse events with unknown results. The patient has not been Covid-tested post vaccination.
Information has been received from a physician concerning male patient who at two months old, on 12-NOV-2007, was vaccinated with the first dose of ROTATEQ (lot #657045/1053U), then at 4 months old, on 21-JAN-2008, the patient received the second dose of ROTATEQ (lot #657988/1193U), and the third dose of ROTATEQ (lot #659682/1733U) was given at 6 months old on 17-MAR-2008. The physician reported on 04-NOV-2008, the patient went to the office, had a stool test done and was diagnosed with rotavirus. The physician reported that the patient was given I.V. fluids, and subsequently, the patient recovered from rotavirus. Additional information has been requested.
Patient notes previous COVID infection in November of 2020.  Patient received first dose of Moderna Vaccine at 1:30P.  At about 7PM, patient noted fever/chils and took acetimonophen with some improvement.  The following the morning, the patient complained of severe chills and fevers which prevented her from leaving the bed for 48 hours except for food and bathroom.  Upon the advice of her personal physician, patient request to defer 2nd dose due to the severity of symptoms.
Severe shivering and chills that came on very suddenly. I was lucky I was at home and I am in good physical condition. I was able to get into my pajamas and get into bed. As soon as I got warm (in about 10-15 minutes), I was fine. If I was in a less fit condition or was driving at the time, I have no idea what kind of outcome there would have been. I think everyone should be advised to go straight home after this shot and if disabled in any way, should have someone stay with them for 24 hours.
Patient was vaccinated on 12/5/6.  She noticed rash on back of upper left arm on 12/8.  Prior to 12/8 she was aware of tenderness and itching in the same area.
No adverse event; Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    Concomitant product use was not provided by the reporter. lot 053C21A should have been reported with a BUD of 1-Jul-2021. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Follow up consists of Non significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
99.9 fever. body aches. Joint pain. Headache, nausea, fatigue
pt recv vax OCT94; JAN 1995 pt began to complain of arthritis in the shoulder area;
Client had 4 yo. vaccines done and parent reports major swelling to arm (L) of the following day. Client took child to doctors - the f/day broke out with hives arms and legs.
PT described feeling sick x3days including shivers/chills, fever. Then felt off the next 2 weeks including fatigue. It went away after that.
c/o dizziness few minutes after taking the vaccine.  pt has no past medical history.  no history of allergic reaction voiced.   First set V/S:  BP 149/112 on the left arm, 190/112 on the right arm.  BS 140, O2Sat 98%., R 20. P=85.   pt. offered to go to the ER for evaluation and she eclined.  Pt. monitored for another 30 minutes with BP rechecked.  BP was 199/98.  Pt. stated that she feels ok to drive self home.   Adviced pt. to f/u with PCP.  Pt. verbalized understanding.
Afternoon of day patient was vaccinated, began with tactile fever. At night, when laying in bed she developed clonic tonic movement of limbs, with eyes fixed upward gaze. Also developed a rash that same night. Temp @ hospital T = 100.1, SZ lasted 1 minute.
After receiving the Covid19 Pfizer-BioNTech noticed pain near collarbone.  Area was tender to the touch and after massaging the area noticed a ball of mass, maybe 1 cm or less in diamater.  PCP diagnosed as a swollen lymph node and believes this was a side effect to the booster shot received on 12/22/2021.
Patient with cellulitis of injection site. Swelling, redness and warm to touch noted-treated with antibiotic.
30min p/vax c/o bilat hip & thigh pain;90min p/vax crying w/h/a;sx improve w/Ibuprofen but were present for 2 days p/vax;nl neuro exam;anterior thighs legs feel cold & numb;
screamed uncontrollably for 7 hrs, & cried for another 6 hrs;