chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; tinnitus; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 2022NVX-US-000003868.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 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: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; TINNITUS (non-serious), outcome "unknown". Clinical course: On 14Oct2022, it was reported that a patient started treatment on 11Oct2021 with Pfizer BioNTech COVID-19 vaccine for COVID-19 immunization. It was reported that the patient had tinnitus and hearing loss.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received lower than authorized dose. Patient received Moderna COVID-19 vaccine, Bivalent for 6 months to 4 years of age. After error was identified, patient received Moderna COVID-19 vaccine, Bivalent for 12 years and older.
This spontaneous report was received from a physician, via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml,  lot # L007720 with expiration date of 08-JUL-2016, (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperatures of -1 F (also reported as -1 Celsius degree) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Malaise, no treatment, resolved after 48 hours Chills, resolved by next morning Warm skin, resolved by following evening Cough with mucus ongoing Mild headache, resolved after 48 hours Lots of tears produced from eyes, resolved morning after vaccine
Erythematous from site of injection around arm - mid section of bicep/arm is 1.5 cm larger than opposite arm. Warm to touch. Pt instructed to use ice, Tylenol for any discomfort.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 27-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
This spontaneous report received from a health care professional via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: obesity, depression, and allergy (Drug not specified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received non-company suspect vaccine Pfizer BioNTech covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, administered on 10-DEC-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. The patient received non-company suspect drug nirmatrelvir/ritonavir (Paxlovid) (Form of admin, oral, batch number was not reported, expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2022 to 03-SEP-2022 for covid-19 treatment. On 01-SEP-2022, the patient experienced bradycardia, dizziness and suspected covid-19 infection (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable, action taken with Paxlovid was treatment withdrawn on 03-SEP-2022. The outcome of the bradycardia, dizziness, revaccination with different covid-19 vaccine and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220925638-covid-19 vaccine ad26.cov2.s-bradycardia.The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Swollen arm; Hardness; Swelling; Hotness; Feeling crabby; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), INDURATION (Hardness), SWELLING (Swelling), FEELING HOT (Hotness) and IRRITABILITY (Feeling crabby) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included IBUPROFEN, PARACETAMOL (TYLENOL) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), INDURATION (Hardness), SWELLING (Swelling), FEELING HOT (Hotness) and IRRITABILITY (Feeling crabby). At the time of the report, PERIPHERAL SWELLING (Swollen arm), INDURATION (Hardness), SWELLING (Swelling), FEELING HOT (Hotness) and IRRITABILITY (Feeling crabby) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information reported
it was rpt fr pharmD concerning pt who was vax & approx july98 pt exp a varicella like rash. addl info requested
gave with the wrong sized needle, so it ended up being injected to the SQ area instead of IM with no reported adverse event; Initial information was received on 19-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 40 years old adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone QIV] was given with the wrong sized needle, so it ended up being injected to the sq area instead of im with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose (once) of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot number, expiry date: unknown) (Strength: standard) via subcutaneous route in unknown administration site for Immunization and was given wrong sized needle, so it ended up being injected to the sq area instead of im with no reported adverse event (incorrect route of product administration) (Latency: same day). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Minor body aches, along with weakness and exhaustion. Left-sided facial numbness. No fever.
4 x 3 inch red, hot, firm swelling right arm.  Resolved in3 days.
Sometime in 1968, she received 1/2 dose influenza vaccine due to "mother reporting allergy to everything" while in school. That night c/o fever, hot red face, site swelling and tenderness, pain with moving shoulder. Denied cp, sob, angioedema, wheezing, dysphagia, rashes, n/v/d, or any other discomfort. Treated with steroids and antibiotics and told allergic to influenza. No influenza vaccine since 1968.
Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient; No adverse event; Patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever tested or diagnosed for COVID-19.     On 21-Sep-2022 at 1:59 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 1:59 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient).    Concomitant medication was not provided.  The patient received previous 3 dose of vaccine intramuscular in deltoid.  Anatomical location of bivalent vaccine was reported as deltoid.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any patient at the time of report. Date vials moved from freezer to refrigerator was 07-Sep-2022 both monovalent vaccines  Treatment information was not provided.
Numbness; Tingling; swelling in right arm and leg; Headache; Fatigue; Pain and soreness; These symptoms were worse with vaccine #2 and lasted longer; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in right arm on 20Feb2021 (at the age of 56-year-old) as dose 2, single dose for COVID-19 immunisation. Medical history included, type 2 diabetes, depression, anxiety and had sulfa allergies from unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); methylphenidate hydrochloride (CONCERTA); metformin; lisinopril; alprazolam (XANAX). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in right arm on 02Feb2021 (at the age of 56-year-old) as single dose for COVID-19 immunisation was in clinic. Patient previously took sulfur and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On 20Feb2021 15:00, patient experienced numbness, tingling, swelling in right arm and leg, headache, fatigue, pain and soreness. These symptoms were worse with vaccine 2 and lasted longer. Patient did not receive treatment in response to the events. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. stated (R) arm was hot, Red, had a big knot that was hard like a rock, swollen & painful. Also had chills. Used ice & took Aspirin & Allertec. Started soon after vaccines & said she felt terrible the next day but today (12/9) is much better - Arm still red & has bruise but not painful or knot.
This spontaneous report was received from a health care professional refers to a 7 week old patient of unknown gender. On 16-OCT-2014 the patient was 7 weeks old and was vaccinated with first dose of LIQUID PEDVAXHIB injection (dose, route, frequency unspecified). On 26-JAN-2015 the patient was 4 months old and was vaccinated with second dose of LIQUID PEDVAXHIB injection (dose, route, frequency unspecified). No adverse experience reported. No further information provided. Additional information has been requested.
1/6/15 1100 administered 6 mo immunizations. 5 minutes after noted red blotchy areas on R/side of head. L/side of nose, neck (anterior) lt red raised area at injection site. No difficulty with breathing. Appt. with allergist set up.
Heart palpitations for 3 days; Muscle weakness; Shooting pain along whole right side; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Aug2021 at 17:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 08:00, the patient experienced heart palpations for 3 days, muscle weakness and shooting pain along the whole right side which was ongoing at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event heart palpations was resolved on 06Aug2021 and muscle weakness and shooting pain along whole right side were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Received H1N1 LAIV and injectable seasonal flu vaccine-same day-healthcare worker-onset of headache 24-36 hrs post vaccination, ongoing as of report date with no relief.
3-5 minutes following administration of vaccine patient experienced itching and swelling of upper lip, swelling of mouth, rash bilateral arms. Benadryl 50mg intramuscular was administered and additional 30 minutes of observation conducted. ER referral was offered to the patient, she declined.  B/P 135/82 and HR 85 at time of check out.
Left hand swollen and painful in morning following flu shot.  Then right hand next day, continuing and included shoulders and still have symptoms as of 3-5-08.  Been seen by doctor's on 4 occasions.  Diagnosis of R.A. - meds - Prednisone and Methotrexate.  Not able to work.  No previous RA.  Vaccine given in left shoulder or upper arm.
This spontaneous report as received from a 44 year old female patient regarding herself via a market research agency. On an unknown date in 2012 the patient was vaccinated with GARDASIL (lot number and frequency unknown) dose 3 (dosing regimen and frequency unknown). On an unknown date in 2012 the patient threw up after last shot. It was reported that the event diminished after stopping suspect therapy. The outcome of threw up after last shot was unknown. The reporter considered the events to be related to the therapy with GARDASIL. Additional information has been requested.
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient age reported as 23 Year 9 Month.  No concomitant medication information was reported. patients at facility that received moderna vaccine between 08-Apr-2022 and 15-Dec-2022. No treatment information was reported. Order Date and Completion Date reported as 10-Feb-2022. NDC ID reported as 80777027398 and Person Nbr reported as Unknown.
Shingles; Not completed the schedule yet; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report for 2nd dose. The age at vaccination was not reported for 1st dose. The patient received Shingrix and had Shingles. All patient identifiers were reported.  The patient had a recent episode of Shingles and did not completed the schedule yet, which led to incomplete course of vaccination. The reporter consented to follow up. No further details were reported.
Wheals on face and trunk about 15 minutes after vaccine administered, no dyspnea, wheezing, no grunting, flaring, retracting. Given Benadryl 18mg and observed until hives resolved about 10 minutes.
Received 2009 H1N1 FLUMIST. Consent form indicates person has asthma. Vaccinator gave wrong type of vaccine.
Patient reports having intermittent/persistent mild-moderate shoulder pain since receiving the vaccine on 7/21/2021.. the patient reports it does not interfere with their daily activities but it is uncomfortable
Diarrhea, acid burn, pimples, exposed wound, pain under scar tissue
Pt lost consciousness - went pale, limp, eyes rolled for 1 minute. Not himself for 1 hour. To ER, to private MD x2.
Since 20 December she has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body and typically occur at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. Her symptoms led her to be seen in the ER on 24 Dec where she was treated with oral antihistamines and oral corticosteroid with transient relief of symptoms. Since that time she has been treated with two courses of oral corticosteroids. She denies generalized cutaneous, laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 9 December, 11 days prior to onset of symptoms. She has used oral antihistamines with control of symptoms. She denies constitutional symptoms. UCT score today is 16 (2, 4, 3, 2, 1, 1, 1, 2).
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with asthma who received a dose of PNEUMOVAX 23 "two years ago" (in approximately 2012) received a second dose of PNEUMOVAX 23 on 22-MAY-2014. The patient had a chronic pulmonary condition, and the pharmacist did not know if the patient was on any medication for her asthma. No adverse effect is currently known. The pharmacist did not have the patient's identifying information at the time of this call; he was inquiring about when the plan to revaccinate this patient of behalf of doctor. The outcome of chronic pulmonary condition was unknown. Additional information has been requested.
pt recvd vax & 7 days p/vax exp coughing & border bronchospasm;
Patient received 1 dose of Moderna vaccine on April 19th,2021 and received the second dose on May 7th, 2021 Janssen vaccine used.  Administrator informed. Increased observation of patient initiated.
Jannen COVID-19 Vaccine EUA - Fever 99.7, deep body aches, severe headache, nausea - Contacted vaccine provider approx 3:00 pm(15 hours after symptoms started)  and was advised that tylenol could be taken, which subdued severity. Headache and back ache lasted into the following day 48 hours post vaccine.