chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL, ALLOPURINOL, EZETIMIBE (ZETIA), ROSUVASTATIN CALCIUM (CRESTOR), TERIZIDONE, CALCITONIN, SALMON and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment information was provided by the reporter.  Patient wanted to get the Moderna COVID-19 booster vaccine but ended up testing positive again for COVID.; Sender's Comments: This case concerns a 80-year-old male patient with no relevant medical history, who experienced the unexpected events of COVID-19 and Drug Ineffective. The events occurred approximately 8 months after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) in not affected by this report.
pt recvd flu shot & devel itching on back 345PM; no allergies, no prior flu shot; nor recent illness or known egg allergy; mild small patches of erythema & upper & lower back in areas of itching &  scratching;
At 4AM I had severe cold/chills to the point of shaking. Around 7AM I got up to use rest room and went to my knees, then rolled onto my back to prevent passing out.
pt states that he has pain in the right arm and had developed fatigue, headache, chills and fever reaching 103.2. He woke up with pain in the right side of his neck.  Today 3/12/2021 his symptoms have subsided with exception of a head ache fatigue.
Patient received a fluad shot on 12/1/21 and came to the pharmacy on 12/4/21 with a small bruise, a little dried blood, and a red area that looked like cellulitis.
Suspected Vaccination failure; have the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she had received the Shingles shot and still had the shingles.  So the patient stated that the shot did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
knot in the injection site / lump at injection site; sore the first day; yesterday the site became painful; small red circle in the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (knot in the injection site / lump at injection site), PAIN (sore the first day), VACCINATION SITE INDURATION (yesterday the site became painful) and VACCINATION SITE ERYTHEMA (small red circle in the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION SITE MASS (knot in the injection site / lump at injection site), PAIN (sore the first day), VACCINATION SITE INDURATION (yesterday the site became painful) and VACCINATION SITE ERYTHEMA (small red circle in the injection site). At the time of the report, VACCINATION SITE MASS (knot in the injection site / lump at injection site), VACCINATION SITE INDURATION (yesterday the site became painful) and VACCINATION SITE ERYTHEMA (small red circle in the injection site) outcome was unknown and PAIN (sore the first day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided
My partner and I came down with a cold with sinus drainage, which ended up being COVID-19 a little bit of a fever and lasted 5 or 6 days. I tested positive on 12/13/2022. I had a telehealth visit on 12/14/2022 and was prescribed Molnupiravir.
hives covering entire body, starting at neck and back; swelling and redness in face and lips; itching; throat tingling.  11/06/09 and 11/09/09 Medical records received for DOS 11/04/09. Final DX: Acute allergic reaction. Hives and swollen lip approx 1hr s/p H1N1 vaccine. H/O multiple allergies and hypertrophic cardiomyopathy. O2 sat 98%. Resolved with antihistamine and steroid tx. D/C to home.   11/9/09:  ED Records received for date of service 11/4/09. Dx:  Acute allergic reaction.  No new information.
Patient states he felt some diffuse palpitation did not feel right and wanted to get himself checked. On arrival patient is somewhat anxious has some diffuse skin erythema over the chest wife is not sure if that is at baseline or if its new. Patient denies any shortness of breath states his chest felt funny earlier but has no symptoms at this time.  Reported SOB earlier.  Patient is having hiccups. Patient has no emesis has no respiratory difficulty denies shortness of breath saturations are 98% on room air with respiratory rate of 20. Patient has no abdominal pain no other rash to the abdomen torso extremities etc. Patient had first vaccination with no allergic reaction. Patient denies any history of allergies to medication. Patient is symptom free and is able to give good history no change in voice no neurological symptoms.  Patient treated with diphenhydramine 25mg IV x1, Famotidine 20mg IV x1, Lorazepam 0.5mg IV x1, Methylprednisolone 125mg IV x1; Discharged to home with prescriptions/ OTC  for Epinephrine 0.3mg/0.3ml IM, Famotidine 20mg po , Benadryl 25mg po
pt recv vax 14NOV95&15JAN96 pt devel an erythematous rash form T5 through T10,including the lt axilla&lt upper flank;had a low-grade fever from 16JAN96 to 17JAN96;seen by MD who dx pt as having devel herpes zoster;seen by MD
COVID arm; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm) and PRURITUS (Itchy). At the time of the report, VACCINATION SITE REACTION (COVID arm) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Possible
Janssen COVID-19 Vaccine EUA Patient complained of dizziness and lightheadedness followed by lip swelling with tingling and "tight throat".  Patient evaluated  and placed on 2L of oxygen via N/C.  At 1619 Benadryl 50 mg was administered orally. At 1623 epinephrine 0.3 mg was administered. Patient transported to ER for observation. Patient observed until 1823 with a final diagnosis of allergic reaction, and discharged with resolution of symptoms and prednisone 40 mg daily x 3.
Very fussy; prolonged screaming x 8-10 hrs-inconsolable; tx APAP drops;
On 01/30/2021 at 08:00 had an extreme headache.  Then having extreme difficulty keeping my eyes open, like I was trying to drift off to sleep.  Immediately there after, I started vomiting.  These symptoms lasted 4 days extremely fast and hard. Tylenol was take for the headache and helped very little. I slept a lot and I couldn?t eat or drink anything witching vomiting it back up. Even my regular meds with a little water came back up.  The evening of the 4th day, I was able to keep clear broth down and crackers helped with the nausea some.  The following week, I still didn?t feel quite right and kept fighting off sleep. Today is the 10th of February and toe nausea has returned. Getting out of bed, I dry heaved for an hour.  I feel if I eat anything it?s going to come back up.  My theory is that the side effects didn?t go away the week I felt somewhat better and had resurfaced, starting out slowly like before. I called my primary at the VA and we discussed what I was already doing i.e. a bland diet until I feel better.
COVID-19; Side effects; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION COMPLICATION (Side effects) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (COVID-19). In January 2021, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, COVID-19 (COVID-19) and VACCINATION COMPLICATION (Side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: (Positive) Test result positive was on 14 Jan 2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant product use was not provided by the reporter.  Treatment for the event included none.; Sender's Comments: Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the event Vaccination complication, a causal relationship cannot be excluded.
Patient was admitted to hospital from 08/2018-09/18/2018 for rehab due to Guillain Barre Syndrome. Was initial seen at ER on 08/16/2018 with vomiting, and elevated B/S in 500's, 1 week after receiving vaccines, and was transferred to community hospital 08/16/2018 where he spent 4 days, he then went to another hospital due to progressive weakness, and was admitted for 2 weeks, and started on IVIG which improved symptoms. Had pain all over with numbness.
Inconsolable  crying for 3 hours after injection. Happened @ 2 mo vaccination also, same Injection with Lot # K7TF9 7/20/2020
Patient states symptoms began the same day he got the covid vaccine (9/24) lasted approx, 48 hours --he reports he lost complete control of bowel and bladder, was vomiting, was unable to use  legs due to feeling of paralysis, and was very fatigued --he states N/V/D were resolved last night (9/26), was able to use his legs, able to walk this am (9/27), fatigue has improved
He seemed fine as soon as he get out, he mentioned the site was painful. 30 mins later, he started having a severe headache. As soon as he said that, his body started trembling, from foot all the way up. We were heading to town, so I started driving straight to the hospital there. His body went limp as he was trembling. Trembling was nonstop, he said his body was in full pain. He was saying stuff that didn't make sense. His sentences did not make any sense. That lasted a whole 30-45 mins. As soon as I got there, his trembling body stopped. I asked him if he still have a headache, he said his head felt better, so we just waited in the parking lot of the hospital. Within an hour the trembles and headache was gone, but he just didn't feel good. When we came back home, he wanted to lay down. I took his temp, cause he was hot, and his temp was at 104. So I stripped him down. The high temp lasted more that about 10 mins, then it dropped back down to 103 and then it begin to normalize. He then slept  like all day. When he woke up, he had an appetite, he was acting normal.
No adverse affects reported; an improperly stored dose of PEDVAX HIB administered to patient on 8/20/2019; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 20-AUG-2019, the patient was administered a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(PEDVAXHIB) ( Lot No. R027326 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 10-JUL-2021; strength and dose were not reported), intramuscularly for prophylaxis. No adverse events were reported. The temperature of storage was below 36 degrees Fahrenheit/ 2 degrees centigrade (35.4 F) for 27 minutes. There was no previous temperature excursion. Data logger was involved.
pt recv vax 26AUG97 & that same day pt devel inj site redness & swelling;27AUG97 pt recovered;
Initial unsolicited misuse report received from a consumer (patient's mother) on 09-May-2017. This case involves a 31-month-old male patient (reported as 2 and half year) who was vaccinated with second dose of DAPTACEL (Batch number, expiry date and dose were not reported) intramuscularly in left leg on 13-May-2016. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included allergies: no known drug allergies, seasonal allergies for pollen, trees, and grasses. Concomitant medications were not reported. On 13-May-2016, one hour following the vaccination, the patient had experienced 2 hives on chest and seven hours following the vaccination, the patient had developed rash that looked like a "heat rash" on right leg which was the opposite leg in which the patient had received vaccination. It was also reported that no other symptoms had seen. It was a case of inappropriate schedule of vaccine administered. Laboratory investigations and corrective treatments were not reported. On an unknown date, within days, the patient recovered from the events. 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. 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. List of documents held by sender: none.
3 doses of PNEUMOV AX-23 were given yesterday which had expired; This spontaneous report was received from an administrator who was reporting on patient of unknown age and gender. No information concerning patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-OCT-2020, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location and strength were not provided; lot number S026366 was confirmed to be valid, expiration date 17-SEP-2020) for prophylaxis. The vaccine has not undergone temperature excursion, and was supported up to one month after expiration. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA002452: US-009507513-2010USA002548:
Arm pain (painful 5/10 to move arm at all), chills, low grade fever, body aches, muscle cramping, headache, low back pain, nausea, difficulty sleeping- onset 2000 after 1400 shot and ongoing next day at 0640
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), SWELLING FACE (cheeks felt swollen/puffy), PRURITUS (itchy everywhere (arms, torso, legs,)), CHILLS (chills) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore right arm), SWELLING FACE (cheeks felt swollen/puffy), PRURITUS (itchy everywhere (arms, torso, legs,)), CHILLS (chills), HEADACHE (headache) and PRURITUS (itchy legs). On 25-Mar-2021, PAIN IN EXTREMITY (sore right arm), SWELLING FACE (cheeks felt swollen/puffy), PRURITUS (itchy everywhere (arms, torso, legs,)), CHILLS (chills), HEADACHE (headache) and PRURITUS (itchy legs) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication history was not provided by reporter. Treatment information included Ibuprofen. This case was linked to MOD-2021-083248. Reporter did not allow further contact.
This spontaneous report has been received from a licensed practical  nurse referring to an unspecified number of patients. On unspecified dates an the patients were vaccinated with VARIVAX (lot # L021215, expiration date 10-JUN-2017, dose and route were not reported) which was improperly stored. The vaccine has been stored under temperature of 40 Fahrenheit temperature for 2.5 hours. No adverse effects were reported. This is one of several reports of the same source. Additional information has been requested.
PATIENT WAS GIVEN PFIZER-BIONTECH VACCINE WHEN IT SHOULD OF BEEN THE PFIZER-BIONTECH BIVALENT VACCINE. PATIENT REPORTED NO ADVERSE EFFECTS
Head fogginess; tiredness; feeling unwell; Nausea; light vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERB727), via unspecified route of administration, at left arm on 25Mar2021 at 9:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient medical history included anxiety, depression, asthma. Concomitant therapy included venlafaxine hydrochloride (EFFEXOR), doxycycline (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) for unknown indication. The patient was not allergic to medications, foods or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 11:00 (within 2 hours of vaccine), the patient experienced head fogginess, tiredness and feeling unwell whereas, she experienced nausea and vomiting later on (as reported). No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events head fogginess, tiredness, feeling unwell, nausea and vomiting were resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information expected.
Intractable nausea and vomiting. Treated with zofran, Phenergan, nexium. Symptoms continue to persist daily from January 9, 2021 to present day. Tests ordered include EGD, gastric emptying study, HIDA scan, ultrasound of right upper abdominal quadrant and abdominal CT with contrast. Optical nerve checked to rule out pseudotumor cerebri. All test results normal thus far. Labs drawn to check for auto immune disorders and celiac disease.  Awaiting these results. Colonoscopy ordered. Awaiting appointment. Elavil added to medication list. Breath tests ordered to check for bacteria and glucose deficiency. Awaiting test kits. Intractable nausea and vomiting continue.  Thus far doctors can find no cause.
At 3:00 pm the following day(03/24/21) after covid-19 vaccine #2 was administered (03/23/21), patient was at grocery store and experienced severe entire back pain that lasted until around 8:00pm, patient was then in bed at 8:00pm, tried to get out of bed, legs went numb and weak and gave out, arms started feeling numb as well. Patient reports his son helped him back to bed and patient fell asleep, slept through the night and the next day 03/25/21 all of patient's reported symptoms were gone.
15 minutes after getting the injection my vision became as if looking through wavy glass.  My vision was not blurry, but it was difficult to interpret what I was seeing.  Transparent shapes drifted across my visual field.  There was occasionally a flickering sensation to my vision.  Both eyes were involved.  I have never had this effect before or since.  The effect lasted 25 minutes, and then resolved to normal vision.
Seizure activity for approx 5-10 secs about 2 mins after injection.
Tinnitus in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 12:00 (Lot number: ER2613) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "drug allergy", notes: known allergies: Augmentin. The following information was reported: TINNITUS (non-serious) with onset 20Mar2021 12:15, outcome "not recovered", described as "Tinnitus in ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.