chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Expired vaccine was administered to total 24 patients including 15 males and 9 females. It was reported that administrations were mostly for booster shots. No side effects were reported for the patient. No treatment medications were reported.
Pfizer Pediatric dose given was for a 5-11 vaccine, patient at the time was 4 years old
At 3 am the night of the vaccine, I woke up with flu like symptoms, including a headache and shortness of breath. Two days later, I had a severe manic episode that lasted for three days (bipolar was well managed with medication at this point and I had not had a manic episode in months). Along with the manic episode, I developed chest pressure and shortness of breath, along with dizziness and a pounding sensation in my chest.  Any physical activity or even a sip of coffee sets my heart off. I am still experiencing these symptoms to this day and caused me to lose my job because I am not able to perform the required tasks. I had a premature atrial contraction prior to the COVID vaccine, but it had cleared up and I had been off of the medication for months with no problems.  I have been to the doctor's office (primary care physician-4/15/21 and 4/20/21) twice, the emergency room once (4/26/21), urgent care (4/14/21), and now am seeing a cardiologist for this condition (first visit 4/29/21).
throat swelling shut, called ambulance, took Benadryl. Currently nausea, burning lower stomach, severe lethargy, hot skin,
Continuing severe left shoulder and arm pain with left arm weakness. It has been 4 months and the pain is getting worse, as is the weakness.
This spontaneous report as received from a pharmacist via a company representative refers to 2 unspecified patients of unknown gender and age. On unknown dates the patients were vaccinated with ZOSTAVAX 19400 PFU, dosage not reported. On unknown dates after vaccination the patients developed a rash. It was reported that on unknown dates the patients came to the pharmacy with a prescription from unspecified physicians for VALTREX. The outcome of developed rash is unknown. Additional information has been requested.
1st dose of the vaccine given 17Apr2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given 17Apr2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 205A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given 17Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given 17Apr2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided
PNEUMOVAX 23 administered in (R) deltoid 9/23/16. Site on 9/24/16 red, warm to touch, tender and swollen. Instructed to go to urgent care clinic for evaluation.
Pt developed a rash on chest and arms and up. Rash is maculopapular with erythematous base with white pustular area. Chicken Pox
PATIENT REFERS ITCH IN MOUTH, ARMS AND LEGS. ITCH IN THROAT. WAS TREATED WITH BENADRYL AND EPIPEN 0.3 MG.
Patient presented for the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine, reporting arm soreness after 1st dose of Pfizer vaccine. Patient received 2nd dose and was asked to remain for observation for 30 minutes given history of severe allergies. Twenty minutes after administration, patient reported sensation of throat and chest tightness. Within 2-3 minutes, patient became more hoarse, began coughing, had audible wheezing. No swelling noted in mouth or around lips or at vaccination site. Patient denied nausea. Epinephrine 0.3 mg (EpiPen) IM and diphenhydramine 50 mg IM were administered to patient and emergency response team was called to site for further evaluation. Vital signs normal except for tachycardia to HR 107. No audible wheezing on lung ausculation on reassessment after 5-10 minutes.  Patient was transferred to ED for further assessment, but left prior to evaluation by an ED provider. Patient was unable to be reached by telephone for follow-up at number provided.
5/15 TC from mom reporting child diagnosed with cellulitis (L) thigh @ Urgent Care on 5-14. Has an approx. 5 inch in diameter area of redness & hardness. MD ordered an antibiotic. 5/19/09 F/U TC, redness & hardness are resolving - ambulating without difficulty, cont. antibiotic.
Chills - teeth chattering, body shakes (these stopped after taking Tylenol) Body aches Headache Tired - stayed in bed all day Very mild waves of nausea Sore arm for 3 days All symptoms stopped around 11pm the same day.
Patient received the Gardasil vaccine (#K005083) on June 25, 2014 at approximately 2:30 pm administered by a nurse. Approximately 10-15 minutes later, as her mother was completing check out formalities in the lobby, patient complained of dizziness, nausea and said she could not hear too well (as though her ears were filled with fluid). She felt limp against me so I made her sit on the floor while the nurses came to her. They took her to a room and asked her to lie down. Patient asked for water and they gave her a box of juice. They put wet towel on her forehead and a dry ice pack wrapped in ice on her chest. They also took her blood pressure. After about 10-15 minutes of lying down, patient said she felt better and returned home. She went to bed in the afternoon and
Information has been received from a registered pharmacist concerning a 71 year old female patient who on 01-SEP-2010 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). On 03-SEP-2010, the patient got redness in the injection site. The outcome of the patient was not reported. Patient did not seek medical attention. Redness in the injection site were considered to be an other important medical event by the reporter. Additional information has been requested.
SYNCOPE; MIGRAINE; WHOLE BODY TREMORS; VOMITING; NUMBNESS IN HAND AND FEET; WHOLE BODY ACHES; 105.0 F TEMPERATURE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 120 pounds, and height was 60 inches. Obstetrics history included gravida 1 para 1 (gave birth to a daughter 8 weeks ago). Concurrent conditions included penicillin allergy, non-alcohol user and non-smoker. The patient was not pregnant at the time of vaccination and had no history of drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on left arm on 03-APR-2021 for prophylactic vaccination. The product was stored properly from receipt to administration. No concomitant medications were reported.  On 03-APR-2021, the patient experienced migraine, whole body tremors, vomiting, had a temperature of 105.0 F (required emergency room visit/urgent care), numbness in hand and feet, and whole body aches. On the same day, she recovered from whole body tremors. On 04-APR-2021, the patient experienced syncope. On the same day, she recovered from syncope, vomiting, and numbness in hand and feet. On 05-APR-2021, she recovered from whole body aches and 'temperature 105.0 F'. The patient was breastfeeding her child at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, vomiting, numbness in hand and feet, 105.0 F temperature, whole body aches and whole body tremors, and was recovering from migraine. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210412341.; Sender's Comments: V0:20210411086-covid-19 vaccine ad26.cov2.s-Syncope. 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).
This is a spontaneous report from a contactable pharmacist who reported similar events for two patients. This is the 2nd of 2 reports. An 80 years old male patient received PREVENAR 13; (lot W51924, expiry date Jul2020; NDC number 0005-1971-02) on 01Oct2018, at single dose, for immunization. Medical history included ongoing arthritis pain, high blood pressure, ongoing erectile dysfunction and ongoing pain. Concomitant medications included oral ELIQUIS from 2017 and ongoing, 5 mg tablet, twice a day, oral flecainide from 2017 and ongoing, 100 mg tablet, twice a day, nasal fluticasone from 2017 and ongoing, 50 mcg nasal, 2 spray each nostril daily, oral gabapentin from 2017 and ongoing, 600 mg tablet, twice a day, lidocaine 5% ointment twice a day, from 02Oct2018 and ongoing, for arthritis pain, oral lorazepam from 28Sep2018 and ongoing, 0.5 mg tablet, 1 time/day at bedtime, oral hydrochlorothiazide, losartan potassium from 2017 and ongoing, 100/25 mg tablet, once a day, oral VIAGRA from 2017 and ongoing, 100 mg, as needed (up to every other day, only took 4 a month), for erectile dysfunction, oral tramadol from Sep2018 and ongoing, 50 mg tablet, 3x/day, for pain. On 06Oct2018, the patient had a delayed reaction and experienced arm turned red, hot and swollen with little red bumps on arm. The reaction was local where the vaccine was given, though it did spread down his arm from 07Oct2018 until 08Oct2018. The patient went to the Doctor. Treatment for the reaction included sulfamethoxazole-trimethoprim from 08Oct2018 at 800-160 mg tablet, one tablet twice a day for 7 days by mouth. The doctor prescribed this medication for cellulitis (no further clarification was provided about this statement). The events delayed reaction, arm turned red, hot and swollen started getting better on 08Oct2018 and were resolving at the time of report. Little red bumps on arm outcome was unknown. The reporting pharmacist added that she had a box of 10 vaccines and she only administered 3 of the vaccines. Two out of the three patients had delayed reactions where their arm turned red, hot, swollen with little red bumps/dots throughout the arm at the same spot that the vaccine was given. The reporter considered the events arm turned red, hot, and swollen with little red bumps on arm serious as medically significant. The reporter considered all the events related to the vaccination. Sender's Comments: Based on the information currently available, a contributory role of PREVENAR 13 towards the occurrence of "vaccination site swelling/erythema/warmth and red bumps" cannot be fully excluded considering the known adverse event profile of PREVENAR 13. Linked Report(s): US-PFIZER INC-2018421081 same reporter/drug, similar events, different patient.
Costochondritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COSTOCHONDRITIS (non-serious) with onset 2022, outcome "not recovered".  Additional information: It was reported that after the third dose of the Pfizer Covid 19 Vaccine she was diagnosed with costochondritis. That had been going on since 3rd vaccine dose. It's been such a long time, but she came such a long way. Transfer agent provided information to her that it's uncertain if vaccine caused this diagnosis. Caller noted she had been battling since then (after 3rd dose), "such a long time hate to get it and here we go again, but if it's unrelated" then she stated she would want to get it. Caller noted that was where she had concerns about getting the booster dose as she noted she had come a long way from then, it's been a long time, patient did not want to get the vaccine if that was what triggered it. Never been prone to anything in the past and that was where HCP was not sure.  Follow-up attempts are completed. No further information is expected.
felt dehydrated; pain in the arm; but it was still hard; arm swelling where she got the injection; Dizziness; This is a spontaneous report from a contactable consumer reporting for herself.  A 26-year-old female patient received first dose BNT162B2 (Pfizer product, lot number EH9899), via an unspecified route of administration on 17Dec2020 06:00 at single dose on left arm for COVID-19 immunization. There were no medical history and concomitant medications. No prior vaccinations (within 4 weeks); no adverse events following prior vaccinations. The patient reported that she was the unit secretary in the hospital. She got the first dose COVID vaccine yesterday (17Dec2020 06:00). Vaccination facility type was hospital; vaccine was not administered at military facility. She was reading the paper they gave her at work. She had arm swelling where she got the injection, it had gone down a little, but it was still hard. She also felt dizziness and dehydrated. The dizziness started about an hour ago (on 18Dec2020). Since laying down it had improved a little. She has felt dehydrated since around 11am (18Dec2020 11:00). She was sipping on Gatorade, but still felt dehydrated. She took a Tylenol today (18Dec2020) for the pain in the arm and swelling. She had gone to the website and it didn't say what to do about the side effects besides call #.  She didn't think she needs to call # for a swollen arm. Therapeutic measures were taken as a result of arm swelling where she got the injection, pain in the arm and felt dehydrated. The adverse events did not require a visit to emergency room or physician office. The outcome for events arm swelling where she got the injection and Dizziness was resolving while for other events was unknown.
After the injection was given, the mother, sibling and I discussed the patient's family and baseball team. Other small talk took approx 10 minutes and then the family started toward the checkout area as they then visited with other staff members - usual for them as they are long standing patients. After approx 15 minutes, the patient became pale and started to fall - his mother caught him by the arm and they sat on a nearby bench by the reception/check out area. The patient reclined on the bench with his feet elevated. The MD was called and examined the patient. A cold pack was placed on his head and sips of gatoraide were taken. The patient started to slowly feel better and MD discharged him. approx 20.
Pt recvd vax 17JUN92 & 10-14 days following vax devel one centimeter hyperpigmented raised nodule @ inject site; nodule devel a central dimple that did not ulcerate; nodule was biopsied & inflammatory cells were present;
Weird stabbing pain in my lower left abdomen. The pain pulsates randomly and goes away within seconds of its start.; Continually having dizziness and headaches.; Continually having dizziness and headaches.; 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: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, obesity, depression and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 04:00, the patient experienced weird stabbing pain in lower left abdomen. The pain pulsated randomly and goes away within seconds of its start. The patient continually had dizziness and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weird stabbing pain in lower left abdomen, pain pulsates randomly and goes away within seconds of its start, dizziness and headaches were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Lot number: Ew0181) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Feb2022 as dose 4 (booster), single (Lot number: Dd7j21-2a), in left arm. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Known allergy: cipro, reaction(s): "Allergy"; Known allergy: flagyl, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Manufacture by- Pfizer, Vaccine lot number- Em9810, Vaccine dose number- 1, Vaccine location- Left arm), administration date: 15Feb2021, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "Drug ineffective", "covid-19"; BNT162b2 (Manufacture by- Pfizer, Vaccine lot number- En6202, Vaccine dose number- 2, Vaccine location- Left arm), administration date: 08Mar2021, when the patient was 37-year-old, for Covid-19 immunization, reaction(s): "covid-19", "covid-19"; BNT162b2 (Manufacture by- Pfizer, Vaccine lot number- En6202, Vaccine dose number- 2, Vaccine location- Left arm), administration date: 08Mar2021, when the patient was 37-year-old, for Covid-19 Immunization, reaction(s): "Drug ineffective". The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "tired". Additional information: Patient also on Humira. got covid and started Pax and delayed Humira until symptoms subsided. took the Humira on day 4 of Pax.  finished Pax,  felt a lot better,  tests went to negative. continued to feel tired, though. But then I developed cold like symptoms and retested positive in a rapid test again (day 14). .
headache and fever within 5 hours after injection followed by congestion, loss of appetite and extreme malaise. Fever ranged between 99.0 and 101 degrees and broke after 36 hours. Headache lasted 24 hours, congestion for 48 hours. Fatigue for 48 hours
01/23/22 presents to ED by EMS for "unresponsive". PMHx of "DM 2, HTN, HLD, dementia"
Upon arising noted some facial and neck swelling and rash at site of pneumonia vaccine.  As AM progressed, complained of single episode of SOB and scratchy throat which responded without treatment.  Had taken a Zyrtec on 10/21/10 and took another late AM on 10/22/10.  Reported this happened x2 before following Mexican food. Had been seen by allergist for testing in past and no allergies noted upon testing. Reports no history of allergy to eggs, latex or other ingredients in either vaccine.  BP 106/78, HR 80 and regular, chest clear, no wheezing or congestion noted.  Called primary physician and was referred to her allergist.  Seen by allergist on 10/22/10.
(+) erythema 5 x 3 cm with area of induration and tenderness left deltoid (inject site). Pain and redness x 1 day. No treatment at home.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient 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. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Moderna (elasomeran) (Dose number in series 2). The patient received non-company suspect vaccine Pfizer Biontech (tozinameran) (Dose number in series 3) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 07-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included Zoloft (sertraline hydrochloride) for drug used for unknown indication.  On unspecified date in AUG-2023, the patient experienced covid-19 infection (confirmed covid-19 infection) (Dose number in series 3) which led to confirmed clinical vaccination failure (Dose number in series 1).  Patient was treated with paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 30-AUG-2023 to 04-SEP-2023 for treatment of covid-19.  Patient tested positive for covid again after 3 negative tests over 5 days. Last dose of Paxlovid was on 04-SEP-2023. The patient had negative rapid antigen tests on 04-SEP-2023, 06-SEP-2023, and 08-SEP-2023. On 10-SEP-2023, patient had a bad cough, so took a rapid antigen test again. It was positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000296996.; Sender's Comments: V0: 20230927820-Confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.