chrisvoncsefalvay/vaers-outcomes huggingface dataset:
digestive problems; I feel bad; i cant eat; I've been sick for 9 months; can't even stand up anymore; I can't work anymore; the tongue became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (the tongue became numb), DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat) and ILLNESS (I've been sick for 9 months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced HYPOAESTHESIA ORAL (the tongue became numb). On an unknown date, the patient experienced DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat), ILLNESS (I've been sick for 9 months), DYSSTASIA (can't even stand up anymore) and IMPAIRED WORK ABILITY (I can't work anymore). At the time of the report, HYPOAESTHESIA ORAL (the tongue became numb), DYSPEPSIA (digestive problems), FEELING ABNORMAL (I feel bad), FEEDING DISORDER (i cant eat), ILLNESS (I've been sick for 9 months), DYSSTASIA (can't even stand up anymore) and IMPAIRED WORK ABILITY (I can't work anymore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood pressure measurement: increased (High) increased. On 21-May-2021, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient took the first dose of Moderna on 21-May-2021 and after 20 minutes, the tongue became numb, the heart rate increased, and the blood pressure rose. Two months after the vaccine, the patient felt bad. The patient couldn't eat. Digestive problems.  The reporter stated that after the Moderna vaccine, the patient had been sick for 9 months. But very badly, the patient could not even stand up anymore. The patient stated they couldn't live this way anymore and couldn't work anymore.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow-up information included no new information On 01-Feb-2022: Translation document was received on 04-Feb-2022 which contains significant information. Added new events.
Redness around shot site that migrated distally. Also had induration and T change with erythema. Also pain, follow by ecchymosis. Started Augmentin BID 3/16/07 and cold compresses from onset.
acute optic neuritis; A spontaneous report was received from a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced acute optic neuritis.       The patient's medical history was not provided. No relevant concomitant medications were provided.   On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011L20A) in the left arm intramuscularly for prophylaxis of COVID-19.  On 08 Jan 2021, the day after administration, the patient stated he started to develop an adverse reaction that eventually culminated in acute optic neuritis. He mentioned that he was unsure if the vaccine caused it. He had a CT scan, MRI scan and lumbar puncture with results pending. He also stated that every diagnosis that could cause optic neuritis came back negative. The only change was receiving the vaccine before his symptoms started.   On 22 Jan 2021, the patient reported his eye was getting better, but his vision was still not fully repaired.  Treatment for the event included prednisone.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, acute optic neuritis, was unknown.  Follow-up received on 22 Jan 2021 included: update the reporter address, lot number, treatment and status of event.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot 011L20A), and who experienced the serious unlisted event of acute optic neuritis.  Based on the current available information and temporal association between the use of the product and the onset of event on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Low grade fever during day; parents described episode of jerking "all over" for approx 1 min about 6-8 hrs p/DTP; sleepy p/episode & for most of evening;
Pt received their 1st dose of Moderna on May 19, 2021 Pt came to clinic to receive the 2nd dose of Moderna. Vaccinator inadvertently administer a dose of Pfizer. Pt had no symptoms and is aware of the inadvertent dose.
Pt walked in and stated he wanted his "second shot." I asked if he wanted Shingrix and he said yes. Confirmed in the room he was getting his Shingrix shot and he confirmed yes. So, received a 3rd dose of Shingrix. No adverse effects as of yet.
pt started crying & turned blood red in the face; stopped breathing for approx 15 seconds; had 4 episodes of apnea on the way to hosp; while in hosp eyes were fixed-wild looking some stiffness; t101+
Shortly after vaccines administered, within 20 seconds, baby became very pale, gray around mouth. Noted by mother and nurse. Physician called; O2 administered. Baby perked up; heart rate and pulse oximetry started. Few minutes later, again very pale, gray around mouth. Transferred to hospital and observed for 24 hours. Medical records received on 12/22/2004 states pt experienced vomiting.
sore arm for a few days after first dose of Moderna COVID-19 Vaccine; tired for a few days after first dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a few days after first dose of Moderna COVID-19 Vaccine) and FATIGUE (tired for a few days after first dose of Moderna COVID-19 Vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a few days after first dose of Moderna COVID-19 Vaccine) and FATIGUE (tired for a few days after first dose of Moderna COVID-19 Vaccine). On 26-Mar-2021, PAIN IN EXTREMITY (sore arm for a few days after first dose of Moderna COVID-19 Vaccine) and FATIGUE (tired for a few days after first dose of Moderna COVID-19 Vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.
No adverse rxn. Pt received one xtra MMR she did not need. Pt record indicated need for #2 MMR & NP didn't check other site in EMR that had record of all previous immunizations that is clearly read only scanned the flow sheet in order to interpret # 2 MMR had been given 6/20/2003.
Dizziness, Myalgia, Arthralgia,  chills Narrative:
Approximately five to ten minutes after receiving the DTap vaccine, patient started to complain that his chest hurt. This progressively got worse, he turned very pale and weak. We left the doctors office and within five minutes went back. Patient never lost consciousness but continued to complain of chest pains, asking to go back to the doctor's office and was very weak. I carried him into the doctor's office, the doctor checked patient's pulse and heart rate and said they were normal. After lying down at the doctor's office, patient had color back in his face, said his chest no longer hurt and seemed to be himself. This was very frightening for me. He has never had a reaction to a vaccination prior to this.
Post vax, the pt developed chills, sweats, body aches, fever of 103.5, head and heart pounding pain, shaking, teeth chattering, throat tightness, nausea, diarrhea, anxiety, and restlessness.
Fever; chills; body aches; vomiting; diarrhea; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This Nurse reported similar events for 3 patients. This is 1st of 3 reports. 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 was not reported. The patient's concomitant medications were not reported. The patient experienced fever, chills, body aches, vomiting and diarrhea. Symptoms began almost immediately after receiving shot and lasted for about 12 hours. Event took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021072646 same reporter/drug/event, different patient;US-PFIZER INC-2021072647 same reporter/drug/event, different patient
The pt was covered in large bruises all over her body. She had a nose bleed and petechia all over her body including eye area and bleeding gums. She was treated in ER and then transferred to the hospital for an overnight stay and treated with IV and Renrho. Diagnosed with thrombocytopenia
Pt  at 1000 am, reported to staff that he had a history of passing out after getting shots.  Pt was put on the Gurney prior to receiving the vaccine.  After receiving the vaccine Pt became light headed and diaphoretic with n/v. After an hour of symptoms not improving an ambulance was called and Pt was sent to the ED.
Given to patient under 18 years older. Per manufacturer, no dose is needed to be repeated however VAERS needs to be filled out.
NEUROPATHY; ENCEPHALOPATHY; DYSTONIA; DISABLED; DYSAUTONOMIA; ANXIETY; UNABLE TO WORK; BLURRED VISION; COULD NOT STAND UP; COULD NOT LIFT HER ARMS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number unknown, expiry unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unknown date, within 24 hours of receiving vaccination, patient experienced numbness and tingling, headache, blurred vision, and could not stand up. The patient went to emergency room and was told that it was a vaccine adverse reaction. The patient could not able to lift arms, had twitches and tremors. Despite all of the severe symptoms, the patient was dismissed and informed that she had anxiety. The patient was advised to have a neurologist, but that examination would take two months. The patient had visited physician's office. Eventually the patient was diagnosed with neuropathy, encephalopathy, dystonia and dysautonomia. It was reported that after two months, the patient was disabled and unable to work.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, neuropathy, encephalopathy, dystonia, dysautonomia, disabled, unable to work, headache, blurred vision, could not stand up, and could not lift her arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211225584-covid-19 vaccine ad26.cov2.s- neuropathy, encephalopathy, dystonia, disabled. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt began having sz 9 days p/vax;arms straight out, knees pulling up to chest eyes looking to the lt;was hosp for 2 days started the phenobarb;taken for 1wk then started taking another med;dx infantile spasms;
Red rash appeared near the injection site on my left arm. It's a bit sore when touched.
Feels terrible; raised with bumps and blisters; it is really hot; hands are ice cubes/hands are freezing; throat is sore; rash that is about 4-5 inches long on the arm at the injection site; arm is swollen/is double the size and under the arm in the armpit area too; Chills/Chills are bad; Fever/had fever; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing) and OROPHARYNGEAL PAIN (throat is sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Complex regional pain syndrome (7-8 years), Adrenal insufficiency, Asthma and Migraine. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, OXYCODONE, CELECOXIB (CELEBREX), OMEPRAZOLE, MONTELUKAST, SUCRALFATE (CARAFATE), ZOLPIDEM TARTRATE (AMBIEN), SIMVASTATIN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE RASH (rash that is about 4-5 inches long on the arm at the injection site), VACCINATION SITE SWELLING (arm is swollen/is double the size and under the arm in the armpit area too), CHILLS (Chills/Chills are bad), PYREXIA (Fever/had fever), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (Feels terrible), VACCINATION SITE VESICLES (raised with bumps and blisters), VACCINATION SITE WARMTH (it is really hot), PERIPHERAL COLDNESS (hands are ice cubes/hands are freezing), OROPHARYNGEAL PAIN (throat is sore), VACCINATION SITE RASH (rash that is about 4-5 inches long on the arm at the injection site), VACCINATION SITE SWELLING (arm is swollen/is double the size and under the arm in the armpit area too), CHILLS (Chills/Chills are bad), PYREXIA (Fever/had fever), HEADACHE (headache) and NAUSEA (nausea) had not resolved.            It was reported that patient had lot of health problems.  No treatment medication information was given.   This case was linked to MOD-2021-407234 (Patient Link).
Patient reports swelling and redness (heat). Also, states that his arm hurt when moving. Informed patient to use Benadryl, Motrin, and Cold compresses for 15 min per day, several times a day.
Warm to touch yesterday not so today. Red small circle around it. Lump underneath it. Vaccine given not in the deltoid given lower in the arm.
Information has been received from a registered nurse concerning a female patient who in approximately 1999 (reported as ten year ago) was vaccinated with two dose of VARIVAX (Lot not reported). Subsequently the patient was found to have negative antibody titers. The patient's have negative antibody titers persisted. No further information is available.
No other AE; MMRll did experience a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      Between 29-JUN-2021 and 30-JUN-2021, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number S039310, expiration date 04-DEC-2021 had a temperature excursion of 72 degrees Farhrenheit (°F) for 17 hours and 15 minutes, and was administered on 06-JUL-2021 (dosage regimen and route of administration were not reported) for prophylaxis (Product storage error). No adverse events were reported.; Sender's Comments:  US-009507513-2107USA007742:
Noticed that the injection site was near the joint and a couple of inches above the deltoid. Began to experience excruciating posterior shoulder pain several hours after the injection.
CHEST PRESSURE; FEVER; MUSCLE ACHES; HEADACHE; CHILLS; This spontaneous report received from a parent concerned a 19 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, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced muscle aches. On 07-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99-100.5 F. On 08-MAR-2021, the subject experienced chest pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, fever, and muscle aches, had not recovered from chest pressure, and the outcome of headache was not reported. This report was non-serious.
This spontaneous report as received from a licensed visiting nurse refers to an unspecified number of babies of unknown age. The patients were vaccinated with lot # (670243/0921AA, exp date 15-DEC-2012) dose of ROTATEQ on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that when the medical assistants were giving ROTATEQ with lot number 0921AA, the babies cried like it did not taste good spitting it out. The nurse reported that babies seem to cry more and spit the product out more with the lot number in description above. No treatment information was reported. The outcome of crying like it did not taste good was unknown. The nurse felt that the events were related to ROTATEQ lot number 0921AA. Additional information has been requested.
This spontaneous report as received from a pharmacist via a field employee refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date in 2015 (reported as "a couple of weeks ago"), the patient was vaccinated with the 0.65 ml dose of ZOSTAVAX (route, lot# and expiry date were not reported). Concomitant medications were not reported. On an unknown date in 2015, during the administration of ZOSTAVAX, the patient experienced an immediate stinging sensation. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Started with headache and slight fever in the evening day of injection (Wednesday), experienced slight nausea and slight sore throat during the night, next day (Thursday) overall body aches and fatigue, Fever, achiness and fatigue continued for 2 more days (Saturday).  Fever was mild 99.x, never reached 100 degrees F
Patient received dose 1 of Pfizer COVID vaccine 5-11 and experienced chest pain and left arm pain and was taken to the ED.
6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINESS-STILL HAD CHILLS. TYLENOL 2 TABS, WATER AND GATORADE.
pt devel urticarial rash on hands, face, thighs about 6 hrs p/vax;
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350 and 2020SA038352.  This case involves a 2 months old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] lot PIF541M (Expiry date 07-Dec-2020) via unknown route in the Left Thigh for Prophylactic vaccination on 20-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccinations included Dtap (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID), ActHIB (HIB VACCINE CONJ (TET TOX)), Prevnar 13 (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)), HepB (HEPATITIS B VACCINE), Rotavirus (ROTAVIRUS VACCINE)  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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.
got 2  Pfizer vaccines from pharmacy but had received a Johnon and Johnson in April at another pharmacy
Rash on chest and trunk, loss of eye contact, crying at night waking 5 times with screaming.  Fever of 105.5, was hospitalized with diarrhea and vomiting.
About a week or 2 weeks later I had ringing in my left ear. It has not resolved I still have it. I went to my doctor they sent me to a ear specialist. They did a hearing test and they seen I had some lot of hearing on my left arm.
Itches a little; pustule/shingles pox; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced itchy rash and pustular rash. On an unknown date, the outcome of the itchy rash and pustular rash were unknown.   It was unknown if the reporter considered the itchy rash and pustular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the patient who was older than 65 years of age received the 1st dose of Shingrix. On 26th August 2019, the patient called the pharmacist to report that she had one shingles pox on the palm of her hand, which itches a little. The pharmacist stated the patient sent a picture and the area looks more like a bug bite or spider bite to the pharmacist, as there was a pustule in the middle.  The patient denied fever, pain, chills, and injection site reactions.  The reporter consented to follow up but declined to provide a mailing address. She requested if safety wants to follow up that they do so via email,the pharmacist was not at work at the time of this call, so patient age and additional details were not available.