chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/23/20 - I received my first dose.  Following that dose I had mild soreness in my arm and was just tired, for the next day.  1/21/21 I received my second dose.  This time I had a very sore arm, very sore neck muscles and back, generalized achy body, and tiredness.  Until yesterday 1/28/21 - I woke up early morning 0200 with a severe headache, I took some pain medicine and fell back to sleep, I woke up in the AM unable to function.  I could not keep anything down all day (food or drink).  I had the headache all day.  I emailed my PCP who called me in some medication that helped get rid of the headache and ease the vomiting.
A week after the first vaccine, she was breaking out in hives that were very itchy on her back. Her primary care doctor told her it would be okay to go in for the second dose. After the second dose, her hives on her back moved to her arms, hands, legs, and feet. Her hives than turned to blisters and her dermatologist did a skin test and it came back as Bullous Pemphigoid. We were advised to put steroid cream and wrap the area with gauze. A week and a half after the second vaccine, she was admitted to the ER with an estimated 30 blisters. She stayed for 7 days as her healthcare team got her infection under control. She needed a home health nurse for 3 weeks, once home, and discharged once
Feb.22,2021--March.28.2021 Pimples out-broken on chest, small area red on shoulder and waist. Self-treated several days with Advil around Mar.3,2021.Possible Food Allergy from some brand of milk which I drunk almost daily from August.2020 to March.3 2021 when I realized it maybe the problem. And some wild caught fishes whcih I had them so many times from Jan.31, 2021 to March.31,2021.  March.28.2021 1st Dose COVID Vaccine Moderna  Only sore arm. No fever, headache or other abnormal signs. April.6.2021 Saw Dermatologist. Who diagnosed that I was having some allergic reaction. She didn't link the rashes situation to my Moderna Vaccination. Did skin biopsy on my waist, had skin Allergic reaction as result a week later. Dr. Prescribed 16days Steroid treatment and Triamcinolone cream for rashes. But I decided to take antihistamine Claritin twice a day instead of Steroid. Following my primary physician Dr.'s suggestion that I shouldn't take any steroid after being vaccinated in 14days.   April.12.2021 Over another week,Claritin and cream were not much helping. Rashes aggressively expanded to almost full body. I was too itchy to sleep. By checking FDA vaccine Fact Sheet, I came to realized this maybe caused by Moderna Vaccine. There were big red lumps on my waist, rashes on arms and legs, from fingers to toes. But my upper body and head had only a few pimples on the neck and mouth roof. Had anal bleeding twice in two days, it's rare to me. Don't know if it's related. Saw PCP. Because it was over 14days after vaccination, the rashes were so bad, that She Started steroid Treatment(prednisone) for me right away, with an extra muscle injection of steroid. Prescribed antihistamine hydyoxyzine and Triamcinolone cream.   April 22, 2021 This is the 11th day of steroid treatment. Most of big lumps Rashes were calmed down to brown scars. But some fresh ones are still coming out of my buttocks,belly, legs and arms. Had vaginal yeast for several days, with fluconazole tablet one dose became better. Plus my eyes were discomfort during these days.  The treatment  continues.
A spontaneous report from a Regulatory Authority (VAERS) concerns a neonate of unknown gender. Concomitant medications and concomitant diseases were not reported. On an unknown date the patient's mother received FLUMIST QUADRIVALENT (intranasal). The patient experienced pulmonary hypertension as a neonate. The outcome of the pulmonary hypertension was unknown. The reporter considered the pulmonary hypertension serious as an important medical event. In the absence of reporter's causality the company physician considered the pulmonary hypertension to be related to the suspect drug FLUMIST QUADRIVALENT. Corrected report 17-Oct-2014: company causality changed from no to yes, route changed from nasal to transplacental, parental route (nasal) added, pregnancy page filled in.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender wit multiple myeloma. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 04-OCT-2017, the patient was administered with properly stored VARIVAX, lot # N017700 with expiration date 09-JUN-2019(strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not provided) which was stored appropriately. No adverse reaction reported. No further information was provided. There was no product quality complaint (PQC) involved.
hives; severe rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and RASH (severe rash) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (hives) and RASH (severe rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and RASH (severe rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications included 2 IM steroids injection, oral steroids.
Patient presented for Moderna Bivalent Booster at mobile vaccination clinic. Patient was registered, injected, and placed into observation per SOP. Patient did report an allergy to eggs, so patient was cleared for vaccination with observation of 30 minutes.  Approximately 10 minutes into observation period, patient approached Lead RN and asked "Is it normal to feel cold in my throat?". Lead RN & Auxiliary RN began assessments. No obstruction was visualized in airway. Patient continued to feel sensation of cold and and additionally some tightness in throat. Lead RN activated BLS protocol. Lead RN attempted to obtain BP using manual cuff & stethoscope supplied in anaphylaxis kit. However, BP was not auscultatable. Auxiliary RN then attempted and also could not auscultate. Auxiliary RN asked Team LVN to obtain a wrist cuff from the facility. Initial were hypertensive & tachypneic. Additionally, Auxiliary RN was auscultating lungs and assessed diminished upper lobes with anterior/posterior wheezing sounds. Auxiliary RN recommended to Lead RN that assessments are consistent with anaphylactic reaction and that epinephrine should be administered. Lead RN then immediately administered epinephrine 0.3mg via autoinjector to right thigh. Concurrently, one Team LVN was on telephone with Duty Officer and another Team LVN called 911 for EMS. After administration of epinephrine, patient continued to be AOX4, continued to have sensation of difficult breathing, and cold extremities. RNs taught patient to deep breathe and perform vagal maneuver on self.  EMS arrived approximately 15 minutes later at approximately 11:00. Lead RN gave report to Paramedics. Paramedic commented that pulse ox showed "low SPO2". During Paramedic interview, patient newly disclosed that she has Hx of asthma and uses an inhaler but does not have it with her. Crucially, staff member reveals at this point that patient ate eggs in the morning and continues to enjoy eggs despite her allergy. Paramedic instructed patient to walk to the gurney, but patient stated "I don't think I can". On 2nd request, patient walks to gurney.  Paramedic told Lead RN that patient will be taken to Hospital.  VS: 1040: BP 151/99 & HR 94 & RR 26 & Capillary Refill Greater 3 Seconds. 1046: BP 112/66 & HR 61 & RR 22 & Capillary Refill Under 3 Seconds (epinephrine had been administered) 1051: BP 173/145 & HR 109 & RR 25 & Capillary Refill Greater 3 Seconds.  NAx: 1040: Lung sounds upper lobes diminished. Lungs sounds anterior/posterior wheezing. Patient outwardly nervous but otherwise AOX4 and compliant with instructions to perform vagal maneuvers on self. 1051: Lungs sounds wheezing improved but continues. Patient reports continued sensation of breathing difficulty. Extremities cool to touch. Patient outwardly nervous but otherwise AOX4 and compliant with instructions to perform vagal maneuvers on self.  I called patient's cellphone the day after on 01/13/2023. She answered and stated that she was still at hospital. She sounded lethargic but fully conversational and AOX4. She stated that she still has SOB when walking to the bathroom.
Pt  c/o anxious, dizziness, and nausea 5 minutes after his second dose of COVID vaccine. He became pale, diaphoretic with clammy skin. assisted patient lay down on yoga met with legs elevated. His vital signs are: BP 125/84; P 87; R 18; O2 saturation 100%. patient felt better 2 to 3 minutes after lay supine. Assisted patient back to chair. Continue to monitor patient until all symptom subsided. Patient left observation area with wife at 07:45pm.
Swelling noticed 6/3/15. By 6/4/15 almost entire upper arm hot and swollen. Patient states it felt like a bee sting. Went to MD 6/4; MD diagnosed local rxn and told pt to take BENADRYL. Improved over week as of 6/9, still itchy but swelling gone.
Patient tested positive to Covid-19 on 02/27/2022 and admitted to hospital on 02/28/2022 for acute kidney failure, acute respiratory failure with hypoxia.  Patient expired on 03/16/2022.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "migraines" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; XELJANZ, start date: 07May2022. Past drug history included: Augmentin, reaction(s): "Known allergies:augmentin", notes: known allergies: yes - augmentin; Demerol, reaction(s): "Known allergies:demerol", notes: known allergies: yes - demerol; Imitrex, reaction(s): "known allergies:imitrex", notes: known allergies: yes -  imitrex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 30Apr2022 to 04May2022 taken orally.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Initial and follow-up information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated with MUMPSVAX instead of with MMR II. There were no adverse effects reported. The nurse said the error was not due to product label confusion. It was reported that the first nurse pulled a vial from the MUMPSVAX box without verifying it. After dose administration, the nurse put the vial into the MMR II box. Subsequently, another nurse pulled the same MUMPSVAX and administered it. It was noted that neither nurse caught the error at the time of administration. The error was noticed at the end of the day. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information requested.
pt recv vax 18JAN96 & began crying inconsolably for 4-5 hr;this is 1 of 4 pt from this site to report adverse exp;
Fever - 103 F; Urine Infection; This is a spontaneous report from a contactable consumer, the patient. A 30-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 in the left arm on 26Apr2021 at 10:30 (at the age of 30-years-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 in the left arm on 05Apr2021 at 10:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced fever-103 F and urine infection. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of fever-103 F and urine infection and included treatment with unspecified antibiotics. The outcomes of the fever-103 F and urine infection were recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
soreness on his right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on his right arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on his right arm). At the time of the report, PAIN IN EXTREMITY (soreness on his right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      No treatment information was provided. No relevant concomitant medications reported.
A little soreness in our arms.; Had complained of his lower back hurting; Fever was 102.9; Husband woke up with diarrhea; Running a temperature.; Low grade fever/low temperature 100 or so; This is a spontaneous report received from a contactable consumer or patients wife. A 80-years-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as Dose 1,single for an unspecified indication .Medical history included road traffic accident from an unknown date and unknown if ongoing ,When patient was young he was injured in an automobile accident; and had to remove his spleen.The patient's concomitant medications were not reported.The patient experienced a little soreness in his arms on an unspecified date, husband woke up with diarrhea, running a temperature, low grade fever/low temperature 100 or so on Feb2021, had complained of his lower back hurting on an unspecified date, fever was 102.9 on Feb2021.The patient underwent lab tests and procedures which included body temperature: low temperature 100 or so on Feb2021,body temperature: fever was 102.9 on Feb2021 ,body temperature: 102.4 on Feb2021 last night that it was 102.9 and this morning it was 102.4. Therapeutic measures were taken as a result of running a temperature,low grade fever/low temperature 100 or so and fever was 102.9.The outcome of the events was unknown.The batch or lot number was not available because the Caller was unwilling to complete the report.The caller Wanted to know if one can get side effects after two weeks. Clarified that it was the right arm and it is for Pfizer Covid vaccine.The caller also reported that her husband was on blood thinner,So will it effect him.  Follow-up (09Feb2021): This is a follow-up spontaneous report received from a contactable consumer (patient's wife). This consumer (patient's wife) reported for a 80-year-old patient that her husband reported of his back hurting and dates for adverse events like right arm was a little sore,for Low grade fever,Diarrhea was unspecified.Ndc,expiry date and lot number was not provided by the caller.Reporter details: Email address was captured as provided.  Information about batch/lot number has been requested. Follow-up (07MAY2021): Follow-up attempts completed. No further information is expected.
We do not know of any adverse events, however the patient received 0.3 mL of undiluted Covid vaccine.
all over body aches and inflammation since that vaccination. I still have inflammation in my back, nerve pain, and it radiates to my leg and  knee on my left side only.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a male patient of unknown age referring to himself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 29-AUG-2012, the approximately 78-year-old patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at an emergency room (ER) at a hospital for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, and economic losses. The outcome of the shingles was unknown. Causality related. Additional information has been requested.
Bleeding; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 12Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included haven't had the period in 4 years. The patient's concomitant medications were not reported. The patient got the vaccine 3 days ago and the patient was feeling sick for the last two days (13Apr2021) but today (15Apr2021), the patient went to go to bathroom and she was bleeding (patient haven't had the period in 4 years). The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
On 2/14/2000, the pt experienced a rash on the left shoulder blade and on the back. The rash scabbed over the night. The pt recovered on 2/17/00. No further information is available.
pt presented with SOB; tested positive for COVID; hx of multiple myeloma, currently taking chemotherapy; HSV encephalitis; pt's condition declined, need for oxygen requirement increased and pt died in the hospital
SHINGRIX administration site became red, warm to touch, area is about 5 inches across. Pt self admin ibuprofen to control symptoms. Pt reported that she had similar reactions for the first dose of her SHINGRIX on May 2, 2018. Pt also remembers having similar reactions when she had her Dtap shot many years ago.
Fever of 101, aches, erythema at injection site, and tachycardia.
Patient believed she received an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient believed she received an expired vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048f, 044b21a and 008b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient believed she received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient believed she received an expired vaccine) had resolved.            No treatment drug was reported. No concomitant drug was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Non-Significant Follow up received
4/19/21 920am S/P RECIEVING COVID 19 VACCINE (MODERNA) #1 THE PATIENT BECAME UNRESPONSIVE, PALE & DIAPHROTIC BP 82/40 P 47. PO 100%. THE EPISODE LASTED ONE MINUTE & THE PATINET BECAME ALERT BUT DISORIENTED, JUICE & PRETZLES WERE GIVEN
Seen for laceration needed updates d'T  *dipheria toxin)but inadvertently given DTP (dipheria pertussis toxin). Developed allergic reaction at injection site. Painful but resolved.
UrticariaPruritus Mild throat constriction, peri-orbital swelling
fever to 105.8 x 3 days started on 27JUL96 exudate on tonsils on 30JUL96;
several hr p/vax pt noticed a numbness/tingling sensation in rt arm;rt hand was swollen;later that day states rt side of body face, arm, leg was swollen;this episode last 12hr then swelling diminished & pt was fine;
CHIEF COMPLAINT:   Coughing up blood x4 days. SOB/Chest tightness, diarrhea, sore throat and HA. Fully vaccinated.   HISTORY OF PRESENT ILLNESS:     62-year-old female past medical history of hypertension, hyperlipidemia, diabetes, COPD presenting the hospital due to worsening shortness of breath. She reports that she has been having shortness of breath for the past 6 days. She also has an associated cough that is productive of green and at times bloody sputum. She is vaccinated for COVID-19 but received her vaccine more than 6 months ago. Her husband was also found to have Covid and exhibited symptoms before her. She reported to the hospital initially for antibody infusion for COVID-19. At the infusion center she was found to be hypoxic and with elevated blood pressure so she was sent to the emergency room. In the ER, she was afebrile and hypertensive up to the 200s systolic and requiring 5 L nasal cannula to maintain saturation above 90%. Lab work is notable for elevated D-dimer to 24,000. CT angio was negative for pulmonary embolism but did reveal patchy opacities consistent with Covid pneumonia. Covid PCR was positive.
Pt recv vax on 11/17/98; on 11/18/98 pt exp red vax site
15 min after 2nd dose given on 07Nov90 pt exp dizziness which resolved w/out tx.  03Apr91 vax 3rd dose; 07Apr exp fever 102F, edema face, hands, feet & ankles, fatigue & malaise.
Patient was given a booster shot for COVID-19 too early. She received her 2nd dose on 5/10/2021; however, she received her booster dose on 10/27/2021 which is less than 6 months than the recommended time period for the COVID-19 vaccine.
5:00 PM mother reports that child would not take bottle then felt warm and started vomiting. no vomiting through the night.  vomiting started again in this AM. 11-12-03 talked to mother, she related that infant recovered from illness from shots.  But became ill last evening with fever 102 and was seen in ER.
hands and wrists tingly about two minutes after injection.  30 minutes after injection, hands ice cold.  Hands remained ice cold for two days.  Had to wear gloves indoors.  Arm very hot and sore for two days.   third day just a little sore.  Fourth day I got dizzy and fluttering in chest after light exertion.  Still  slightly dizzy on occasion after standing up.