chrisvoncsefalvay/vaers-outcomes huggingface dataset:
coughing; sneezing; runny nose; Throat scratchy too; Initial information was received on 26-Nov-2022 regarding an unsolicited valid non-serious case received from a patient.  This case involves a patient with unknown gender who had coughing, sneezing, runny nose and throat scratchy too after being vaccinated with Moderna COVID-19 vaccine and Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) and Moderna COVID-19 vaccine (not produced) (with unknown strength, dose, route, administration site, lot number and expiration date) for Prophylactic vaccination.  On an unknown date the patient had coughing (cough), sneezing, runny nose (rhinorrhoea) and throat scratchy too (throat irritation) (unknown latency) Crazy no fever thou following the administration of Influenza vaccine and Moderna COVID-19 vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported for all the events.   Outcome: Unknown for all the events.; Sender's Comments:
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information was concurrent condition and historical medication. On an 20-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902/ expiration date- 18-JUL-2017. Temperature was 6.7 F (Fahrenheit), temperature was 30 minutes and call was not because of the data logger. Previous temperature excursion was 12 F for 2 hours. No concurrent medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Her husband hurt his leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her husband hurt his leg) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Her husband hurt his leg). At the time of the report, PAIN IN EXTREMITY (Her husband hurt his leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient needs to take Tylenol Extra Strength for leg hurt. The 2nd dose of the Moderna COVID-19 vaccine scheduled on 06 Mar 2021.  No concomitant product information was provided.
allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The patient developed allergic reactions in which her lip and chin filler got swollen on fourth day post vaccination. Patient was informed that she was not eligible for second Moderna vaccine and she should wait and get Pfizer vaccine.  The treatment medication was not provided.
Sudden onset shaking chills , headache , body aches , joints pains , weakness. Chills relieved 30 minute after taking 500 mg Tylenal .  No relief of headache , body aches and joint pains . IN pain , weak and losing balance at 7 am , temp 99 , mild nausea . Took 5/325 hydrocodone , paetial relief joint pains , headache persists .
pt recv vax 16APR97 & 23JUN97 pt devel a mild lymphadenopathy;25JUN97 pt recovered;the reporter felt that the lymphadenopathy was not related to therapy w/measles vax;
Covid19 breakthrough.  1st Vaccine on 03/03/2021.  Pt presents with nasal congestion, sore throat, fatigue, fever and increased confusion.  Had recent exposure by caregiver.  Given IV steroids.
Developed rash to chest, abdomen and arms approximately 1 hour after injection. Went away after taking Claritin. Rash returned approximately 24 hours after taking 1 st dose of Claritin.  Took a second Claritin, rash went away and returned the next morning. Rash noted to abdomen, chest, arms and legs at the time this report is being completed.
Rebound case of Covid 19; Rebound case of Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), on 02May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound case of Covid 19". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were not taken as a result of covid-19.  Clinical course: The anti-viral details were product COVID 19 Treatment, with Paxlovid, treatment start date was16Jun2022 and treatment stop date: 21Jun2022. For the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Child complained of aching in left arm. Mother gave child one spoonful of liquid Tylenol. Redness on left arm occurred 9/22/00 evening. On 9/23/00, the pain in the left arm decreased. No pain in arm today.
On March 18-slept all day. On March 19 woke up with red, swollen, hot arm (injection side).  Contacted doctor and sent picture which did not make it to vaccine coordinator completing this form.  Pt states improved.  2 weeks later, April 2 pt was traveling and woke with right wrist swelling.  Went to MD while traveling and diagnosed covid arm. Pt also put on course of cephalexin orally.  Pt also instructed to go to ER in 2 days if not improved-pt reports arm significantly improved and did not follow up, but did finish antibiotics.  Pt was doing well until 5/1 and woke with right foot swelling and pain. Went to PCP and they took xrays which were negative. Pt prescribed prednisone and another course of cephalexin.  Advised to contact vaccine clinic over concern these reactions to right side of body were from Moderna.  Pt had not problems with first vaccine on 2/17/21.  Symptoms only started after second dose.
Around 5 to 7 months after administration pharmacy team members saw patient about to faint in the waiting area. EMS called checked visitor. Patient confronted feeling better, but was taken to local ED where to low blood pressure.
Pt states immediately post vaccine "throat began to feel tighter" & states dizziness p/t arrival & @ time of arrival, & informed RN of experiencing dizziness p/t &  at time of vaccination & received TDAP 6/14/21. Pt states only dizziness & tightened throat at this time 1635. Pt vitals: 122/62 HR 78, 98% RA, RR 16, No swelling, inflammation, redness to throat & inside mouth, appeared WNL. No dysphagia, no dysphasia. Pt & family informed medical professional of vaccine & what to expect over post vaccine & when to call DR, EMS, & go to ER. Pt & family verbalized understanding & states no needs at time at 1720 &
After getting the shot patient started getting sweaty, we asked if he is ok he said yea he is fine just feeling little off. After minute or so he got up to grab a drink.  We told him to take off the mask to make it easier to breath.  After getting water from cooler he just fell down.  Got him up he was responding saying he was dizzy.  Just got him seated back after 30 minutes he walked out on his own.  Offered to call ambulance he declined it.  When he left he said he felt fine
Upper lip spasm; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 04Mar2021 at 08:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indications from unspecified dates. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient had tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 14Mar2021, the patient experienced lip spasm which started about two weeks after having had received the vaccine. Therapeutic measures and treatment were not taken for the adverse event lip spasm. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event lip spasm was unknown.   No follow-up attempts are needed. No further information is expected.
Hoarseness, swelling of throat, diff breathing, panicky reaction, all lasting approx 2 hours until arrival in ER, treated with nebulizer and benadryl and zantac through iv saline drip.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unspecified age and gender.  No medical history and concurrent conditions were reported. On an unspecified dates, the patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ (lot # K011952 and expiry date: 17-JUN-2016) (dose, route and site of administration was not reported). No concomitant medications were reported. No adverse effect were reported. The outcome of incorrect product storage was not reported. No product quality complaint (PQC) was filed. Additional information has been requested.
When patient woke up on 9-3-14, left arm was red and swollen and painful. Patient went to doctor and received an antibiotic. Dr. felt patient got skin infection from vaccination.
pt recv vax & 5min later pressure in chest & nausea, Bp 152/70 down 10min later to 124/64; heart rate 72 & regular adm for cardiac work-up
BOOSTER; passed out; Sickness; Dizzy; Tiredness; General body appearance abnormal/bad shape; Confused; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4220680-00 (AbbVie).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (cf (40 mg,1 in 2 week). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Drug :PFIZER BIONTECH COVID-19 VACCINE, Route of Admin: Intramuscular, Indication for use : COVID-19 VACCINATION), for covid-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "BOOSTER"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; GENERAL PHYSICAL CONDITION ABNORMAL (non-serious), outcome "unknown", described as "General body appearance abnormal/bad shape"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confused". The action taken for adalimumab was unknown. The patient had been in bad shape, she got really really sick with her covid booster shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of passing out, patient had been in bad shape/got sick with covid booster shot unknown onset, dizzy, tired, patient had been in bad shape/got sick with covid booster shot unknown onset and confused was not provided. The events of passing out, patient had been in bad shape/got sick with covid booster shot unknown onset, dizzy, tired, patient had been in bad shape/got sick with covid booster shot unknown onset and confused are not assessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunisation, Booster, Loss of consciousness, Illness, dizziness, Fatigue, General physical condition abnormal, confusional state and the suspect drug BNT162B2.
Varifax given in error.  No adverse effects known.  The correct vaccine (gardasil) was also given.
PATIENT HAVING REDNESS ABOUT THE SIZE OF A SOFTBALL ON LEFT ARM RIGHT BELOW INJECTION SITE OF SHINGRIX VACCINATION SHE RECEIVED 2 DAYS PRIOR. MILD SORENESS THAT HAS IMPROVED FROM INITIAL VACCINATION DATE AND WARM TO TOUCH BUT NO SWELLING/MALAISE/FEVER REPORTED.
No additional AE; Patient was administered improperly stored VARlVAX on 03/15/2021.; This spontaneous report was received from a healthcare professional referring to a 4-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T010315 with an expiration date on 24-MAR-2022) for prophylaxis (strength, dose, anatomical location, and route of administration were not reported).        Administered dose of vaccine experienced a temperature excursion of -13 degrees Celcius (°C) for 2 hours and 19 minutes on unspecified dates. A data logger was involved. There were no previous excursions reported.  No adverse events were reported.
My upper arm developed a rash, swelling, pain I also had a headache, stomach ache and fatigue for 3 days.
pt was nervous and within 5 minutes or receiving vaccine while standing next to mother at cash register passed out and fell.
Arm still hurts at injection site after second Moderna Covid Shot in series after a little over 2 months. Hurts to move arm backwards (opposite of lift). SJe mentioned this to PCP at recent visit. He said sometimes people require steroid injection due to that
Diarrhea; fever of 101.1 deg F; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (fever of 101.1 deg F) and VOMITING (Vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Concurrent medical conditions included AFib and Type 2 diabetes mellitus. Concomitant products included INSULIN, LIRAGLUTIDE (VICTOZA) and METFORMIN for an unknown indication.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (fever of 101.1 deg F) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved and PYREXIA (fever of 101.1 deg F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Blood glucose: 177 (High) blood sugar lever went up to 177 units from its usual 120 units.. On 30-Oct-2021, Body temperature: 101.1 (High) 101.1 degree F. On 30-Oct-2021, Heart rate: 101-103 breaths per minute (High) it only ranges from 70-90BPM prior to vaccination.
Pt inadvertently received an extra dose of Twinrix (Hep A and B). Denies any symptoms.
Allergic skin reaction (generalized). Treated with Benadryl in ER.
10/27/99: 3 1/2 cm x 2 1/2 cm reddened raised area.10/28/99: 3 1/2 cm x 3 1/2 cm slightly hard underneath reddened area with itching.11/6/99: 2 cm x 2 cm hard area.
23MAR94 onset of fever, rash on trunk, arms face; saw MD; strep  culture done; ATB given that PM t104, knot under rt ear; APAP given; MD not sure vax react vs viral rec culture;
Initially chills and fever. Woke with diffuse, severe myalgia--most severe in quadriceps bilaterally.
10 21/08 Pt called to report  that on 9/09/08 she was given Menomune and Hep B #2 vaccine - 2 days later she experienced myalgia, arthralgia, headache, lethargy, slow thought process and stiff neck. Took two days off from work. Better 6 days later. 15 days later (9/24/08) had Flu shot with PCP and then reported transient visual loss in both eyes. Seen by eye Md - no report of optic neuritis. She now reports she is significantly better.
Pt recvd vax @ 145PM on 20APR92 had grand mal sz 7AM 21APR92 last 45 mins was hosp until 8PM on 22APR92;t102; pt has cold w/purulent rhinorrhea, febrile seizure, short sz, stiffened up, problems w/resp, sl post-ictal;
Client started with chest tightening she believed was due to COPD, took her personal inhaler, c/o hand tingling, quickly progressed to wheezing, difficulty breathing, Epi pen administered, O2 started and 911 called
Patient was 4 years old when she received the vaccine. This age has not been approved for vaccination. Parents lied about patients age on vaccination form and before vaccination was given.
Confusion, slurred speech, ptosis of the right eyelid, lightheadedness, right facial droop and trouble with memory with associated soreness in right arm post Moderna vaccination second dose for COVID-19 on 23 March 2021.   TIA vs vaccine reaction (symptom onset roughly 45 minutes post injection)   CT of the head without contrast, CTA head and neck and MRI of brain without contrast, CTA head and neck showed mild beaded appearance of the distal cervical segment of the left vertebral artery consistent with fibromuscular dysplasia. There is no stenosis. MRI brain showed chronic microvascular ischemia  DC with Plavix and neurology referral, symptoms resolved
Expired dose of Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-Jul-2022 Reporter's Comments: The reporter stated that on 01st July 2022, the patient received a dose of Bexsero that had expired on 30th June 2022. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Mother called the clinic approx 2 hours after vaccination reporting a fever of 102.  I recommended Children's Tylenol or Children's Ibuprofen.  Begin cooling measures ie: warm water bath, liquids and to call PMD and notify.  At about 3pm Mom called again and reported a Temp of 104.and child is "listless" (she had not done the cooling measures).  Call PMD and begin cooling measures...she did.  In AM of 9-19-06 mother reports child continued with fever as high as 104 but is at 101 at the time (9am)of the call.  She plans on calling PMD again.  I told here to continue cooling measures as needed and to contine Tylenol or Motrin.
Injection site pain, headache, muscle pain, chills, joint pain, nausea.