chrisvoncsefalvay/vaers-outcomes huggingface dataset:
syringes actually broke at the neck/syringe leaked when put the needle on; The initial case was missing the following minimum criteria: reportable event. Upon receipt of follow-up information on 23Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A child patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EY0433, Expiration Date: Nov2023) for immunisation, Device Lot Number: EY0433, Device Expiration Date: Nov2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "syringes actually broke at the neck/syringe leaked when put the needle on ". Additional information: NDC number of Prevnar 13: 0005197101. Three damaged Prevnar 13 syringes: Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on and went to administer, or when just had gotten air out. Fortunately, was not in kids leg, leaked straight out of middle neck part. The reporter clarified there were three separate patients involved, all prior to administration when preparing drawing up and never really got in room with the patients. The sample of the product was available to be returned.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300129342 same reporter, suspect drug and event; different patient;US-PFIZER INC-202300129299 same reporter, suspect drug and event; different patient;
I started to feel unwell, and I had chills and fever. I had a dry cough. Five days later I went to the ER and I tested positive for Covid-19. I was given monoclonal antibodies. I had home health and when I returned home my blood pressure was high. My Amlodipine was increased. I still had a runny nose and a slight cough and extreme fatigue with headaches. The symptoms lasted for about two weeks. I did not have any loss of taste or smell. It has been over two months and I am still a little fatigued.
Redness surrounding injection site of about 4 cm noted the evening of the injection, pruritis and rash on the chest and upper back 2 days following and continued for several days.
If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series; Product administration interrupted; No Adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT AVAILABILITY ISSUE (If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) 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 assessments were provided for PRODUCT AVAILABILITY ISSUE (If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series) and PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted).    No concomitant medications were reported. Patient was not able to complete the 2nd dose from primary series of vaccination and was asking if can get a Pfizer Monovalent adult dose instead. It had been more than 36 days after the first dose was received. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2023: follow up received, contains non significant information.
I had the shot and came home. That day I started to feel fatigue. The next 2 days after the shot. I was exhausted, queasy nauseated and the pain in my shoulder and in my armpit. this was two days later and felt under my armpit and looked in the mirror and cupped a large ball of swelling. after a few hours and days, it continued to get larger. I still was nauseated and couldn't sit. I took a photo of it. It took about three weeks to go down some.  It is still not normal. I showed the photo to my doctor, and he was shocked. Now it puffy and I can cup it in my hand.  I got the shot from the guy at pharmacy.  My friend thinks I got in the bone.  It still is not normal.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer regarding a female patient who experienced autism. The patient received the fifth dose on an unspecified date. Relevant medical history was not provided. The indication for Prevnar was immunization. Product was administered on an unspecified date. The dose regimen was 1 dose. Concomitant medications were not reported. A mother reported that her daughter was administered a fifth dose of Prevnar (overdose) on an unspecified date. Sometime in September 2005, the mother states that her child was diagnosed with autism. No additional information was available at the time of this report.
Urticarial rash of arms, legs and trunk which occurred the next day, no anaphylaxis
Pt received vax on 08/18. In the evening of the following day, he became very drowsy, lethargic, no reaction at site and no fever. 08/21 he was still drowsy so parents consulted physician. He was active and no problems were noted.
Motrin taken at 7AM Two shots administered 9AM Drowsy and sluggish 2PM Armpit temperature 101.5F 5PM Motrin taken at 6PM Ear temperature 102.2F 6PM Fever continued into the next morning
fever; 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 PYREXIA (fever) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications not provided. Treatment information was not provided.
Reports increased temperature 99 Sat-Sun. 1/24-1/25/04 Wed AM 1/28/04 developed rash- hive like. Has been given Benadryl. 1/30/04 rash continues and appears hive like in nature wheals- erythema etc. Continue with rash.
Very sore arm starting a few hours after the vaccination on October 13. Then, the next day (Oct 14) I started getting chills and felt fatigued. Then came severe nausea, vomiting, and dizziness.  I feel almost 100%  better today (Oct15), but still have a small headache and a slightly sore arm.
This spontaneous report was received from a social media user, as part of a marketing research program and refers to an unspecified number of male patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients (reported as "boys") were presenting new physical and physiological problems (details were unspecified). Some of these males could not perform sexually and they were hesitant to discuss their problems with parents. The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
tachycardia, palpitations lasting all morning; 2 extra doses of metoprolol
3:00 PM - felt dizzy 5:00 PM - Wheezing and coughing, hard to breathe 7:00 PM - Fever, Headache 6:00 AM - Fever broke, headache remains, fatigued.
Received vaccine on Monday 3/1.  Symptoms of hypersensitivity on L shoulder blade around to underarm began in 24-48hrs.  Pain increased. On Monday 3/8 a shingles lesions was noted in this area.  Was seen by PA in PCP office on 3/8. Treated with valtrex.
This spontaneous report as received from a health professional refers to a 66 year old female patient with generalized anxiety disorder, diabetes mellitus without mention of complication, type 2 or unspecified type, uncontrolled, overactive/hypertonicity of bladder, mixed hyperlipidemia, Gastrooesophageal reflux disease (GERD), allergic rhinitis due to pollen, other specified peripheral neuropathy, benign hypertensive heart disease without heart failure, tinea cruris, dermatophytosis of groin and perianal area, other non specified abnormal serum enzyme level-left, localized osteoarthritis not specified whether primary or secondary hand-l thumb, carpal tunnel syndrome bilateral, unspecified vitamin d deficiency, generalized osteoarthritis involving multiple sites, cervical spondylosis with myelopathy and lumbosacral spondylosis without myelopathy. The patient is allergic to AUGMENTIN, BACTRIM DS, CIPRO and Lisinopril (cough). The patient's medical history included palpitations and hives. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown) (lot number, expiry date, route and dose were not reported). Concomitant therapies included LANTUS and NOVOLOG. On an unknown date, the patient experienced arm swelling. The outcome of arm swelling was unknown. Additional information has been requested.
Received vaccine while pregnant; Mild soreness at injection site; This is a spontaneous report from a contactable nurse (patient, self-reporting). A 31-year-old pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 04May2021 at 16:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Patient has no medical and past drug history. Concomitant medications included pre-natal and acetylsalicylic acid (BABY ASPIRIN) from unknown dates for unknown indication. The patient was in her eighteen weeks of gestation period at the time of vaccination. Delivery date was provided as 28Sep2021. 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 04May2021 the patient experienced mild soreness at injection site. No treatment was received. The clinical outcome of the event mild soreness at injection site was not recovered and the event Received vaccine while pregnant was unknown at the time of this report.
44-year-old male client  presents to Covid Vaccination and requests to see a nurse. Lead nurse reported to client. Client reports he got vaccinated yesterday 10/26/2022 with a Pfizer Bivalent booster Lot#GJ6665 on left arm. Client reports that 2 to 3 hours after vaccination he experienced numbness and sweating on left hand, on going muscle spams by tricep area, and feeling of tightness on forearm. Today he reports muscle spasms by tricep area and tightness on forearm area. Muscle spasms come and go every 15 to 20 minutes and last a few seconds. Client has full range of motion on left arm and left hand. Client reports no other symptoms. NKA, no medical conditions, and no medication currently taking. Client reports no adverse reactions to previous Covid vaccines. Client educated on possible side effects and adverse reactions after a Covid Vaccine. Client educated to seek medical care if symptoms do not go away or progress and to follow up with PCP as soon as possible. Client verbalized understanding. Client left the facility with steady gait. Client was contacted via phone call by lead nurse to offer a list of clinics in case client does not have a PCP. Client verbalized he has a PCP. At 1317 a medical consult was sent to Dr.  via text message to advise for any further recommendations. At 1321 Dr. advised to complete a VAERS.
Pt was given 1st dose of pfizer vaccine on 5/14. She reported a history of allergic reactions and has the epi pen at home. Pt was asked to wait by pharmacy for at least 30 min due to hx. Pt reported feeling a little weird and tingly after the shot and benadryl was offered and accepted by the pt. I requested she stay for observation and she recovered and felt well within another 30 minutes. I requested the patient call to check in on 5/15 and go to er or urgent care if experiencing signs of an allergic reaction. Pt called to check in and was feeling some tingling and numbness on the left side of her bottom lip. I advised that she go to get evaluated for potential allergic reaction and follow up with us once she has. She agreed to seek treatment. She did not feel the need for emergency services to be called. Pt called back to report visit to ER on 5/15 and they suspect a reaction from the shot. The patient is still experiencing some numbness in her face and arm. Pt was evaluated at the er and reports only receiving some pain medicine prior to discharge.
Patient received moderna covid vaccine (spikevax)when looking for RSV vaccine (arexvy)
Expired vaccine given; pregnant patient administered expired booster shot; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A, 002C21A and 033C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TDAP (Manufacturer: Boostrix, Lot number : J3946, Route: IM deltoid left and dose number 1.) on 16-Nov-2021. Concurrent medical conditions included Allergy to antibiotic, Allergy to antibiotic and Allergy to antibiotic.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021 at 10:40 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Feb-2022. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Pregnancy test: positive (Positive) positive. On 16-Jul-2021, Ultrasound scan: no abnormal findings no abnormal findings. On 23-Jul-2021, Ultrasound scan: no abnormal findings no abnormal findings. On 04-Dec-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, Gene mutation identification test: no abnormal findings no abnormal findings.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: Follow-up received on 08-DEC-2021, contains significant information includes: reporter details,patient height, weight, race, pregnancy information, medical history, laboratory details and product dose details were added.
On a flight home from a trip abroad, I began having severe sinus drainage. At that point, I was taking OTC medicine in the hope it would dry it up. Later that night, I had drainage and coughing. On 3/2/2023 or 3/3/2023, I went to the ER and was diagnosed with COVID-19. I underwent a chest X-ray, and my lungs were clear. I was prescribed a steroid, but not antibiotic or antiviral. I took the steroid twice a day for seven days. At the time of this writing, I still don't feel well. I'm coughing a lot, though I haven't had a fever. I haven't been able to sleep well, though I have found that I rest better sitting up rather than lying down. I have been drinking lots of water and taking lots of cough syrup. I was also prescribed some cough pills, though they don't help much. I took a home antigen test earlier today, and the result was positive.
Headache; Mild fever; Mild sore throat; Tiredness; Body rash; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 17:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included prozac (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if ongoing. Patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not pregnant. The patient had not tested positive for COVID-19 since the vaccination. On 17Mar2021 at 17:00, the patient experienced headache, mild fever, mild sore throat, tiredness and body rash more than 24 hours after injections. Patient did not receive any treatment for the events. The clinical outcomes of the events headache, mild fever, mild sore throat, tiredness, body rash were recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
loss of taste and smell; loss of taste and smell; Purple , red circle on the injection site; swelling on the injection site; developed a lump underneath her arm that lasted for one week; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell), LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site) 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.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell), LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site). At the time of the report, ANOSMIA (loss of taste and smell) and AGEUSIA (loss of taste and smell) had not resolved and LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test negative: negative (Negative) negative. On an unknown date, SARS-CoV-2 test negative: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided. Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Follow up received on 18-FEB-2021 contain significant information about additional events after first dose, and outcome of previous events unknown to not recovered. Added lab data information. On 14-Jun-2021: Follow-up received on 14-Jun-2021 and does not contain any new information.
Rash diffuse over chest, abdomen, upper & lower extremities. All observed one week after administration in the medical office. No other adverse noted & mom had not observed any other symptoms.
Guillain-Barre syndrome; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a patient of unknown age and gender received a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient had Guillain-Barre syndrome (GBS). Outcome was unknown. It was not clear if the event was resulting from the administration of pneumococcal 13-val conj vac (dipht crm197 protein) or due to another vaccine or a medication since the pharmacist had no information on that. Information on the batch number has been requested.; Sender's Comments: Current information is very limited and does not allow a full medically meaningful assessment, especially lack of complete medical history, concomitant medications, concurrent medical conditions and event details including time lag between the onset of the event and administration date of PREVENAR 13 and etiological workups. The event Guillain-Barre syndrome more likely represents an intercurrent medical condition unrelated to the use of  PREVENAR 13.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
About 42 hours after her first dose, Patient woke up in the night and vomited and had diarrhea. She went back to sleep and felt fine in the morning. She did not have any further episodes.