chrisvoncsefalvay/vaers-outcomes huggingface dataset:
can barely walk; balance is off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can barely walk"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance is off".  Additional information: Reporter was calling about "Super COVID-19 vaccine".  Reporter had the vaccine and can barely walk and a lot of people she knows had the same thing. Her balance was off and she has to use a walker. There was one lady at church and they were the only 2 that got vaccinated and both have some problem. She was really pissed off. Reporter has been to Physical Therapy and everything and done a lot of testing. She knows the vaccine caused this. She has seen her primary care doctor and neurologist. She states hang on she has to take this call.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): PFIZER INC-202300051026 same product and event, different patient;
After getting the gardasil vaccine three weeks ago, my daughter has severe back pain, general muscle aches, fatigue and terrible headaches. She also had swelling of her mouth and lips. I am very concerned about her back problem because it is very unusual and the doctor really doesn't know what is wrong. These symptoms didn't occur until after her first dose of gardasil. SHE WILL NOT BE RECEIVING THE LAST TWO DOSES OF THE DRUG! 4/1/09-records received-office visit 2/2/09-C/O hives rash on body since 2/7/09, itchy and red-seen in ED started on prednisone. assessment:dermatitis secondary to PCN. 2/17/09 office visit C/O bad headaches every couple of days. Not eating for one week but drinking soda and caffeine. Fatigue. Assessment possible eating diorder possible cause of headaches suspect underlying mood disorder. Received Gardasil/Adacel Menactra. Referred to eating disorder clinic. Office visit 3/2/09-C/O inflammation in upper back with pain began day before and is a recurrent porblem however first time seen for the problem. Assessment muscle sprain likely secondary to month of coughing. 3/10/09-requests referral to specialist. Office visit 3/17/09 C/O hives and persistent back pain.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL as first dose of HPV series (dose, route, lot # and expiry date not reported) and on an unknown date, the patient received second dose of HPV series GARDASIL 9 (dose, route, lot # and expiry date not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Pulsatile Tinnitus on and off from day 4-11 Severe Pulsatile Tinnitus day 12 to present
Pfizer vaccine given 6 days after expiration date. (3/31/2022)  Pfizer notified.  Case # 00622567 They stated the stability of the Pfizer vaccine is good for 9 months and 1 week. This vaccine was given on day 6 and therefore  considered a good dose.
Stabbing abdominal pain, extreme lower and upper extremity fatigue and weakness so much so that I couldn?t use a computer mouse to work. I got tested twice to make sure I didn?t have COVID.  All of this started 3 days after receiving the vaccine and is still ongoing, although is slowly getting better.
Resident received plasma while hospitalized before both doses of vaccine were given. No adverse events after administration of vaccine. Facility wanted to inform of medication error.
Sharp pain in chest when taking deep breaths beginning about 24 hours after injection lasting approximately 3-4 days after injection; Moderate soreness in arm where injection was received and tenderness in underarm beginning a few hours after injection and lasting approximately 2 days after injection
Tested positive at hospital during outbreak on 4/27, hospital reporting cold-like symptoms until 05/06 when patient was noted to be hypoxic (70% O2 saturation on RA). Patient presented to ED with tachypnea and dyspnea.  O2 saturations in ED were in the low 90% and patient did require oxygen supplementation after admission. Received dexamethasone, no remdesivir given time course. Has required HFNC up to 40L/80%. Currently weaning oxygen but still admitted.
Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had extreme difficulty swallowing as if I had a ball in my throat.  Nurses recognized and immediately gave me Benadryl.  Today I feel a lot of pressure in my head, fatigue, tingling in lips and right hand.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date: 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
headache, pain under left cheek bone, slight earache in left ear, body aches and pains in lower extremities - thighs, behind knee caps, calves and ankles.
Extreme tenderness at injection site beginning about 8-10 hours following administration into left deltoid 1 1/2 - 2" area of pale erythema at site.
presented to ED one day after bleeding with petechiae and swollen tongue/lip. Ongoing lethargy to -family elected short term care versus further workup/repeat labs. platelet count 44,000 from prior 113,000 in oct. Hgb without changes-13.1  CT of head revealed no acute changes. Hx of afib and was also treated for a UTI.  Called nursing at the facilty 11/19 for follow up and she remains comfortable with no other changes to mouth. She is on short term care.
Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.; no adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.) and NO ADVERSE EVENT (no adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022.).    No concomitant medications were reported.  The Moderna suspect vaccine indications were also reported as Hypersensitivity symptom, Hypersensitivity reactions NOS, Reaction hypersensitivity (NOS), Allergy NOS, Hypersensitivity NOS, Hypersensitivity reaction, Allergy.  It was reported that the patient was made aware that he received a 0.25 mL of Moderna Bivalent Booster dose. Patient denies to had distress at this time. Patient denied to had to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in eight weeks from  15-Sep-2022. Patient stated would like to be re vaccinated. Patient made aware that they will reach out to patient regarding to receive full vaccination.   It was reported that reporter reviewed side effects and serve allergic reactions with parent and encouraged patient to seek emergency services for severe allergic reactions by calling 911 or going to the nearest hospital.   No treatment medications were reported.
Information has been received from a registered nurse concerning her 6 year old son who in May 1999 was vaccinated with varicella vaccine. On 10/14/2001, the pt developed a mild case of chicken pox. There were approximately 60 lesions mostly on his trunk and three lesions on his face. The RN reported that her other two children had the same experiences. Additional info has been requested.
Vaccinated with Pfizer on 4/1/21 and 4/23/21.  Symptom onset on 7/20/21 with cough, sore throat, nasal congestion, headache and fatigue,  Tested positive for Covid-19 on 7/20/21
Cellulitis surrounding vaccine site in left deltoid began 1 1/2 days after vaccine. 10cm x 9 1/2 cm erythema and central induration.
Started 24 hours after vaccine, began to recede 72 hours after vaccine. No systemic complaints. Warm, tender, 8 x 8.5 cm localized reaction at site of KINRIX.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patients' were vaccinated with improperly stored ROTATEQ (lot # L008057, expiry date 01-DEC-2016). No adverse events were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pain in right leg that started the same day she received the immunization. She describes the pain as "shooting". Also complained of tingling of her right leg. Pain lasted for several days.
Child began throwing up and vomit continues until today, 4/24/15.  Child also suffered from bouts of constipation followed by diarrhea. Child was taken back to Dr's office but Dr. dismissed symptoms as "normal" and nothing to be concerned about.  However, child is still vomiting and has not been normal self.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Rash on the injection arm (below the injection site) with a short period of shooting/tingling pain in arm. Patient had a latent reaction, started 2 days after injection. Rash is still there about but patient states a lot better than the previous day.
Case number PHEH2014US022425, is an initial spontaneous report received from a pharmacist on 06 Nov 2014l. This report refers to a 69 year old female patient. Her medical history and concomitant medication was not reported. Pharmacist reported that she was vaccinated with FLUVIRIN (batch number: unknown) twice during the 2014-2015 flu season in error. She received the second dose of FLUVIRIN (batch number: 1413301) on 06 Nov 2014. No adverse event was reported. No further information was provided.
Given vaccine 12 hours after vial was punctured; Sore arm; A spontaneous report was received from a healthcare professional who was also a 37-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced product storage error and sore arm.  The patient's medical history was not provided.  Concomitant products included alprazolam.  On 31 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced product storage error when she received a dose of vaccine taken from a vial that had been punctured 12 hours before. She also experienced a sore arm.  Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the event, product storage error, was resolved on 31 Dec 2020.  The outcome of the event, sore arm, was unknown.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273 and concerns a 37 year-old, female patient, who experienced the event of pain in extremity. The event occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Patient and wife were at vaccine clinic to receive both flu and covid vaccines. Nurse had four vaccine's in front of her, two flu and two covid. When administering vaccine, patient accidently received two covid vaccines, instead of one covid and one flu. Patient is aware two pfizer covid vaccines were administered to him and will watch for symptoms.
Patient received ZOSTAVAX vaccination and 2 days later came in with redness and swelling at the injection site.
Fever (Tmax - 101.8). Nausea & vomiting. Lightheadedness. Treated with p.o. Ibuprofen.
Pt called 5 days post vaccine to report c/o shoulder pain, wrist pain, then ankle pain which started 2 days post vaccine.
Patient became light-headed and pale. Patient was placed in shock postition on exam table, ice-pack to base of neck. Patient stated no breakfast and no liquid intake yet this AM. Given approx 300cc's water and piece hard candy. After 15 to 20 minutes symptoms resolved.
Left arm cellulitis 2/5/16 treated by MD with doxycycline 100mg BID.
MA administered 0.3ml of undiluted pediatric Covid vaccine in place of the bivalent booster.  No adverse reaction reported.
WHOLE LEFT THIGH SWELLED UP THE SIZE OF A SOFTBALL AND WAS SEVERELY INFLAMED AND ITCHY.
This is a 67-year-old female patient that presents to the ER with generalized weakness.  The patient has a history of diabetes hypertension and uterine cancer.  Patient states that she was seen in the ER last week for COVID.  She was put on what sounds like Paxlovid sometime last week.  She states that about 1900 hrs. last night her legs became weak and gave out on her and she fell to the floor facedown on a linoleum flooring.  She did hit the top of her head.  There is no laceration.  She did not get knocked out.  No loss of consciousness.  Her brother found her sometime this morning.  She is soiled with both feces and urine.  She has chills and rigors on ER presentation. Associated Symptoms: chills, cough, URI symptoms, weakness
Shingles vaccine. Floaters in left eye and eye pain in eyeball. Going to specialist today
Patient reported severe muscle pain at injection site that spread to her left arm/down to finger, and across chest beginning approx. 2 hours after receiving vaccine. Patient has been applying cold compresses and taking ibuprofen. Client states she has improved a lot today. Now rates pain 2/10.  Patient states she saw a physician yesterday afternoon and was prescribed Keflex, which she has just picked up and plans to start taking.
pt described severe edema & erythema from groin to ankle rt leg; lasting until following AM; accompanied by prolonged period of crying; no sz acitivty;
Have sore arm about an hour after injection, Have had a headache upon waking the day after receiving the vaccine. I have taken Aleve or Advil to lessen the pain.
Initial unsolicited report received from a Nurse on 15-Dec-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (DID NOT SPECIFY WHICH BRAND) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced aches and pain. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
pt recv vax 25FEB97 & 11MAR97 pt devel t104 which lasted for 3 days when it dec to 101-102 for a total of about 5 days;pt also had a fine pinkish rash on tops on hand & feet & few petechiae on face;aching & cranky did not eat for couple day
Pt had well visit & received DTaP #4, HIB #4, PCV13 #4 was fine after. At 2am pt whining - mom checked on her & pt was stiff w/head & eyes rolled back, shaking, foaming at mouth & unresponsive 911 came, temp was 104, hr 200 brought to ER.
Patient had received 1 dose of the Moderna vaccine on 1/10/2021, lot number 025L20A, and was informed , according to the patient, by a health care provider that since he caught COVID-19 between the date of his first dose to around 2/7/2021 to start the series over with Pfizer. He was administered the Pfizer vaccine on 04/22/2021 however told the pharmacy that it was his first covid vaccine and did not disclose that he had previously had a moderna vaccine. We did not become aware of the error until the patient came back for his second dose of Pfizer and we saw that he had received Moderna at an earlier time and questioned why he came in for a pfizer vaccine, The patient was not given an additional dose of pfizer and stated that they did not have any adverse reactions to receiving both manufacturers.
Itching developed on right arm, initially then spread to left arm. Itching progressed to flaking skin to a rash and onto irregular bumps on arms and shoulders developing over the course of 12 hours. No fever but does have itching of entire body.
Information has been received from a physician concerning a 2 month old pt with no medical history who in Jul 2006, was vaccinated PO with the first 2.0mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The physician reported that in Jul 2006, 14 days after vaccination, the pt developed very slight diarrhea. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. In Jul 2006, the pt's diarrhea resolved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 8/10/2006.  Information has been received from a physician concerning a 2-month-old patient with no medical history who on July 2006, was vaccinated PO with the first 2.0 mL dose of ROTATEQ.  The physician reported that in July 2006, 14 days after vaccination, the patient developed very slight diarrhea.  Unspecified medical attention was sought, but no laboratory / diagnostic tests were performed.  In July 2006, 1-2 days after onset, the patient's diarrhea resolved.  Additional information is not expected.
pt recvd vax; at about 18 hrs of age devel intractable focal rt sided sz;dilantin & phenobarb given;subsequent eval has shown focal EEG,a nonspecific MRI,both on the rt w/ sz on lt;tx w/ atb's & acyclovir for full courses;
Sore arm; Chills; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). On 09-Mar-2021, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Consumer does not have an email or fax number to provide, stated Is feeling fine' and has no additional information to report.
first dose of the Moderna Covid-19 vaccine on 15PAR2021 and got scared to receive the second dose; Felt tired; Got scared/kind of scared him; It made him sick, put him down for a day kind of scared him; Put him down for a day kind of scared him; This spontaneous case was reported by a consumer and describes the occurrence of FEAR OF INJECTION (Got scared/kind of scared him), ILLNESS (It made him sick, put him down for a day kind of scared him), MOBILITY DECREASED (Put him down for a day kind of scared him), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna Covid-19 vaccine on 15PAR2021 and got scared to receive the second dose) and FATIGUE (Felt tired) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, FINASTERIDE, GABAPENTIN and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced FEAR OF INJECTION (Got scared/kind of scared him), ILLNESS (It made him sick, put him down for a day kind of scared him) and MOBILITY DECREASED (Put him down for a day kind of scared him). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna Covid-19 vaccine on 15PAR2021 and got scared to receive the second dose) and FATIGUE (Felt tired). At the time of the report, FEAR OF INJECTION (Got scared/kind of scared him), ILLNESS (It made him sick, put him down for a day kind of scared him), MOBILITY DECREASED (Put him down for a day kind of scared him) and FATIGUE (Felt tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna Covid-19 vaccine on 15PAR2021 and got scared to receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient got scared to receive the second dose. Caller states that a couple of hours after receiving the first dose of the vaccine, it made him sick, put him down for a day and kind of scared him, felt tired and the feeling lasted a day. Patient did not take any medication because he is diabetic and has high blood pressure. No treatment information was provided.
Covid arm. Swollen in the area of shot and red circle about 6 inches across. It?s warm and hard to the touch
Lymphadenopathy most significantly in left axilla lasted for about a week. Fever and body aches for seven days.
Malignant melanoma previously in remission, now stage 4 metastatic after Covid vaxes.