chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleeding intermenstrual; Inappropriate age at vaccine administration; This is a spontaneous report from a contactable pharmacist. A 13-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 23May2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bleeding intermenstrual on 24May2021 with outcome of unknown. It was reported that the patient had her monthly period earlier in month so this was very early, after about 18 days since last period.  The information on the lot/batch number has been requested.
Patient received 5 doses of the Janssen vaccine instead of one dose. This is an administration error. Patient had no side effect or long term effects.
Cellulitis around site of injection noticed redness developing in the area where she had vaccine the day of.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included IRON, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), PROBIOTIC 10 and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication, FAMOTIDINE (PEPCID AC) for an unknown indication and an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm, red). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for P, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 10-Mar-2021, PAIN IN EXTREMITY (sore arm, red) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-083722, MOD21-079818, MOD21-079820 (E2B Linked Report).; Sender's Comments: MOD-202 083722:DOSE 2 MOD21-079818: MOD21-079820:
On the 16th of May, I got an itchy throat. I thought it was allergies. The next day, on the 17th, I started with a cough. The cough went on until the 31st. During that time, on the 20th, I had a temp of 99 and, on the 22nd, it went up to 101. I had an asthma prepared pack because, as of April, my doctor diagnosed me with asthma. She prescribed a pack that included MEDROL. I started the MEDROL and my laryngitis started on the 19th. I had a video visit with my doctor on the 24th. She told me to switch off the MEDROL to prednisone. I took prednisone from the 24th to the 30th. She also told me to start a Z-PAK on the 24th and that was 5 days. It ended on the 28th. She also had me start a medication that included guaifenesin and codeine. I wheezed worse. During this time, I was also talking albuterol in a nebulizer. I ran out of albuterol so the next batch of albuterol solution was DUONEB - ipratropium bromide and albuterol sulfate inhalation solution. During this time, I couldn't blow more than 220 or 230 so we were doing more of the inhalation therapy. I wasn't getting better so she prescribed another Z-PAK. I took that from June 1st to the 5th. On June 6th, I thought I had a sinus infection. It was intense. Within a day, I ended up with a huge blister on my gum over one of my teeth. It ended up being a dental abscess. That was 3 days of pain. It deflated on the 8th. I had to see an oral surgeon and will be having it removed on Tuesday.
I received flu vaccination 10/11/13 1000 and by the even I had an ache in my arm which led to shoulder/neck/ear pain during the night. I have lots of pain shoulder/neck area still and was seen by a provider.
Hives, red blistered skin, warm, fluid and swollen. Hives moved from shoulder to wrist covering all of arm within five days time. Required treatment.
Felt nauseated, sleepy and light-headed after 1/2 an hour, post vax. No wheezing, sore throat or hives.
Day 11 post vaccine fever and irritability. Day 12 typical measles like rash and fever. Day 13 increase rash, fever, irritability. Day 14 rash and ataxia and hyperextension of head intermittently. Hospitalized. Ataxia confirmed. Labs showed neutropenia. Day 15 ataxia began to subside.
Information has been received from a physician concerning a 4 and 1/2 week old patient who was vaccinated PO with one dose of ROTATEQ at another location. The baby was fine when seen at 11 months old. There was no product quality complaint. No other details. Additional information has been requested.
Initial unsolicited report received from consumer (patients sister) via social media on 22 August 2016. This case is linked with case 2016SA157332, 2016SA157340, 2016SA158504 and 2016SA157319 (same social media report). This case involves female patient (age was not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DTwP) (dose, batch number, expiration date, dose in series, site and route of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced whooping cough. Laboratory data and corrective treatment were not reported. Patient's outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: whooping cough. List of documents held by sender: none. Sender's Comments: This poorly documented case concerns of unknown age female developed Whooping Cough after vaccination with DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) of unknown manufacturer. Hence Details regarding date of vaccination, onset of event, relevant medical history, prior history of vaccination and its tolerance are needed to further assess the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experienced anxiety and palpitations post vaccination. Patient was transferred to the emergency department. She was in the ED from 10:25 AM to 11:26 AM.
Headache Congestion  Sore throat Sore ear Nausea Diarrhea Shortness of breath/big deep breaths Body aches Night sweats/wake up every 30 min Coughing Light head/dizzy Fever
FEVER; HEADACHE; CHILLS; BODY ACHE; MUSCLE ACHES; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced muscle aches. Laboratory data included: Body temperature (NR: not provided) 103.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and muscle aches, and the outcome of fever, chills and body ache was not reported. This report was non-serious.
Started 03-23-2021, throwing up, freezing & hot. Severe night sweats had to change to 4 different beds a night. Clammy, headachs, did not eat for 6 days. Iching red welt on left arm the size of a pear. Very weak, balance issues. No taste and no smell.   Telemed call on 04-01-2021. Medication prescribed was Promethazine 25 MG tablets and Flucinolone 0.025% ointment. Per Dr., because of the severe reactions to the first dose of the vaccine, I was advised not to have the second dose. I received a note from the doctor that I should not have the second dose. I am still having some symptoms.  I am being treated by businesses like someone who has not been vaccinated. I am being threatened Quarantine.
Bump at injection site noticed the day after. Today at the pharmacy she has a red, irregular shaped rash at injection site. Patient denies pain or discomfort. The initial bump has disappeared
Patient received the vaccine and had generalized itchiness at 1pm. At 1:30 pm, the patient received one tablet of Benadryl 25 mg and itchiness symptoms improved.
hard time sleeping; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time sleeping) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (hard time sleeping) and FATIGUE (fatigue). At the time of the report, INSOMNIA (hard time sleeping) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Vomiting; little bit of a sore arm; had no appetite; diarrhea; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea), FATIGUE (exhausted) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Hypersensitive syndrome and Blood pressure high.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea) and FATIGUE (exhausted). On an unknown date, the patient experienced VOMITING (Vomiting). The patient was treated with DOMPERIDONE (MOTILIUM [DOMPERIDONE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea), FATIGUE (exhausted) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were low dose high blood pressure medication.
Headache for 3 days, arm pain at injection site for 3 days, fever 24hrs, chills for 2 days, general not feeling well, soar throat on 2nd day.
Sore throat/terrible sore throat; Sweats; Fatigue; This is a spontaneous case from initially received from other non-health professional (consumer) on 10-Jan-2019, concerning a male patient of unknown age.  The patient's medical history included skin cancer for 10 years. The patient did not receive any concomitant medications.  On an unknown date in Sep-2018 (reported as 4 months ago), the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 and expiration date: 31-May-2019) for influenza prophylaxis.   On the same day, within 20 minutes of receiving the vaccine, the patient experienced sore throat. Over the next several days, it became a terrible sore throat. On an unknown date, after vaccination the patient experienced fatigue and sweats but did not know if he had a fever. He did not take a temperature. The patient did not see his MD or in any after-hours clinic. As a treatment, the patient took bedrest and homecare. It was reported that, the patient was not hospitalized. It took him 2 months to recover from the events.   The outcome of the event (sore throat) was recovered on an unspecified date in Nov-2018 (reported as 2 months afterwards) and the events (fatigue and sweaty) as recovered on an unspecified date in 2018.  The reporter assessed this case as non-serious.  Non-significant follow-up received on 18-Mar-2019. Med Info Number (SEQ19-00694) was added in additional information tab. It was reported that attempt was made on 11-Feb-2019 in order to obtain further follow-up information with no success. Hence this case is considered as lost to follow-up.; Reporter's Comments: A male patient of unknown age experienced sore throat within 20 minutes after administration and fatigue and sweaty after an unspecified period of time after administration of Flucelvax QIVc. The company assessed the causality of the event (sore throat) as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events. The company assessed the causality of the events (fatigue and sweaty) as unassessable due to lack of information regarding the vaccination date and onset latency of the events.
Vomitting, Wretching, Dry Heaving, Diahrrea, Mild Fever, Beet Red Face,  Body Aches, Cough, Lethargy starting the evening of the vaccination 4/10/21 9PM.  Continued until 4/11/21 Midday.
pt recv vax 11AM 8MAY97;mom reports star-like & shaking approx 2-3PM same day;crying 1 1/2hr-no solace;t102 ax;mom states APAP given PMD advised to go to ER;appetite poor x2day;r/o hypoglycemia;
Patient 's left arm was warm to touch, erythematous, edematous, pruritic and painful. Dr. ordered DURICEF 500mg x 5 days.
This spontaneous report was received from a other health professional refers to a patient of unknown age. On 09-SEP-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 09-SEP-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Patient reported shoulder pain when moving the arm above chest level starting 2-3 days after vaccination.  They have been going to physical therapy since then.
Information has been received from a physician concerning a 14 year old female, with no pertinent medical history, who on 14-JUN-2007 was vaccinated IM, with a first dose of Gardasil (lot # "02630"). There was no concomitant medication. Approximately, on 14-JUN-2007 it was reported the patient was "light-headed", "out of it", and lethargic. On 15-JUN-2007 the patient had to be carried into the physicians office. Her sugar level was at 176 (hyperglycemic). She was tested for diabetes but it came back "negative". It was reported that by 16-JUN-2007 the patient "was feeling much better." The physician considered "light-headed", "out of it", lethargic, and a sugar level at 176 to be disabling. Additional information has been requested.
Itching all over my body and feels like a rash with no signs on the skin, started hour after shot given
reconstituted with a sterile diluent instead of the supplied AS01b diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent).  The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 Clinical Operations Manager reported that a nurse administered a dose of Shingrix that was reconstituted with a sterile diluent instead of the supplied AS01b diluent, which led to wrong solution used in drug reconstitution.  They were not sure which patient it was that received this dose, they had it narrowed down to 4 patients.   The dose was given sometime between 05-Aug-2023 to 22-Aug-2023. At the time of reporting, no repeat doses have been administered. The reporter consented to follow up. This case was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR116984:same reporter US-GSK-US2023AMR116985:same reporter US-GSK-US2023116324:same reporter
fatigue; Joint pain/The joint and muscle pain I experience were primarily in my neck, shoulder elbows, wrist and fingers.; sore musles/The joint and muscle pain I experience were primarily in my neck, shoulder elbows, wrist and fingers.; headache; This is a spontaneous report from a contactable consumer. A 75-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 14Jan2021 16:45 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, and had 2 surgeries 1) was a discectomy in the lower back and 2) in 2019, right rotator cuff surgery. Prior to the surgeries, the patient suffered from arthritis that subsided following the surgeries and no longer take medications for the second surgery in 2017 was a cervical fusion of C2-3. Family's medical history includes: Mother- heart disease, Father- Cancer, Sister- COPD- cancer, and Brother- Diabetes type 2. Concomitant medications included amlodipine besylate; and metoprolol tartrate; taken for hypertension from unspecified start dates and ongoing. On 14Jan2021 21:00, the patient experienced sore muscles/joint pain, and headache (extreme). The joint and muscle pain the patient experienced were primarily in the patient's neck, shoulders, elbow, wrist and fingers. On 15Jan2021, the patient experienced fatigue. The events were assessed as serious (disability). The patient did not receive treatment for the events. The outcome of the events was recovered on 16Jan2021. It was reported that the patient received second dose of bnt162b2 on 04Feb2021 12:45 (lot number: EL9265) in right arm via intramuscular.
Injection Site soreness, by bedtime, slight fever, chills (all night), overall aches (like the Flu), terrible headache upon waking.  No appetite, symptoms continued for 3 days.  Back to somewhat normal on day #4.
Extreme menstrual cycle change - very, very heavy bleeding with large clots and period lasting much longer in general. Painful cramping in stomach.  Severe fatigue - worst I have ever experienced. Still ongoing, day 6 of abnormal symptoms.  The last two days I have woken up with a bad headache. I track my menstrual cycles very meticulously and know that this is extremely out of the ordinary.
This spontaneous report as received from a 63 years old female patient with no pertinent medical history and no drug reactions/allergies, reporting on herself, who was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported) subcutaneous, on her left arm, on 18-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-OCT-2012 the patient experienced that "it had been about 3 inches x 2.5 inches down on arm, itchy, and swollen, hard lump, on back side of her arm where she had had a red area". The patient did not seek medical attention and no treatment was given. No lab diagnostics studies were performed. At the time of report the status of patient was unknown. The relatedness for adverse events were not reported for ZOSTAVAX. Additional information has been requested.
1st day: Low fever 99.7, swollen glands.  Afternoon stomach ache.  2nd day: high fever 102.9, swollen glands.  3rd day: low fever in morning, afternoon broke.
sever arm pain (injection arm), severe dizziness, sever tiredness,  moderate body ache, mild nausea, metallic taste in mouth. All starting about 2.5 hours after injection and starting to vane after 48 hours clearing up 72 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day and as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "hyperlipidaemia" (unspecified if ongoing); "extrinsic asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril", notes: Known allergies: Lisinopril; Hctz, reaction(s): "Known allergies: HCTZ", notes: Known allergies: HCTZ; Spironloactone, reaction(s): "Known allergies: Spironoloactone", notes: Known allergies: Spironoloactone. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) negative; (17Jun2022) positive, notes: developed symptoms 16Jun2022, retested 17Jun2022 and positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid; Treatment start date: 03Jun2022, Treatment stop date: 08Jun2022; Indication: Treatment of COVID-19; Administrator route: Oral. It was unknown if the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Event: Retested for COVID 10Jun2022 negative, and developed symptoms 16Jun2022, retested 17Jun2022 and positive. Adverse event start date: 15Jun2022  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 known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
About an hour afterwards I had flu like symptoms and a sore throat. However at about 9:00 pm that night, my whole body was itching and I was coughing . I woke up the next day still feeling a little weak, and had I hives on my face under my eyes and on my cheeks. These grew larger so I applied Cortisone cream.  These hives eventually became smaller after 2 weeks, and went away. Then they came back, went away, came back etc. for about a 2 months.
A 2 year old received DTAP on 6/22/01. Mom states she noticed redness and swelling on 6/24/01. The left deltoid area was red, hard, swollen and hot to touch. Approx. size of a coke can. Encouraged mom to apply cool cloths and continue Tylenol for discomfort.
He developed wheezing, congestion, runny nose, cough, and fever by the following morning.  Was seen in office on 2/17/13 (9 days after vaccine for the above mentioned symptoms). On 3/6/13 I took him back because he'd remained congested for a month. On 3/14/13 we were seen again for congestion.
PT RECEIVED SEVERAL VACCINES TODAY, QUICKLY BECAME PALE ASKED FOR WATER AND GIVEN, TOOK A FEW SIPS THEN LOST CONSCIOUSNESS AND BODY SHOOK AND SEMI SLID DOWN ON THE CHAIR X 30 SECONDS, REGAINED CONSCIOUSNESS SAT UP IN CHAIR AND B/P TAKEN, PTS KNEES WERE ELEVATED AND DR CHECKED PTS HEARTBEAT, PT STATES HE DID NOT EAT TODAY, PT TOOK IN SMALL AMT OF WATER AND GIVEN SPRITE AND A SMALL AMT OF CEREAL, AND SAT IN CLINIC UNTIL HE FELT BETTER, PT LEFT AMBULATORY HOME WITH HIS FEMALE COMPANION WHO WAS DRIVING FOR HIM.
Itching, brief shortness of breath.  No wheezing.  No hives or rash.  Shortness of breath immediately subsided.  Itching subsided after 40 min.