chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via other manufacturer and described the occurrence of impending doom in a adult female patient who received DTaP (Reduced antigen). On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced impending doom. On an unknown date, the outcome of the impending doom was unknown. It was unknown if the reporter considered the impending doom to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that 2 years ago she got a PNEUMOVAX and recently PREVNAR 13, reported headache at night after vaccination, however was not sure if that was related to the vaccination because she gets frequent headaches. In the past years, the patient received TDaP and she thought that she was going to die. The reporter declined to provide additional information to document that. The reporter called to inquire about if PREVNAR 13 also indicated for children. The reporter wanted to make sure that she got the right vaccine that, she was wondering if there is more than one formulation of PREVNAR 13.
Developed soreness in left shoulder and chest area. On Mar 2, 2021 I measured my blood pressure at 5:00AM to be 163 over 99.  My normal blood pressure is 130-135 over 71-75.  Went to the emergency room where an EKG. chest ex-ray and blood work were performed.  Doctor reported that all test were normal but blood pressure was still high at 146 over 89.  I have continually monitored my blood pressure as follows: 3/2 @ 10:00 PM 144/73;  3/3 @ 7:00 AM 147/77;  3/3 @ 10:00PM; 165/83:  3/4 @ 7:00AM 165/83:  3/5 @8:00AM 157/77.   The ER doctor Dr. indicated that the vaccine could have caused inflamation which caused the change in blood pressure
Pt states she noticed swelling over injection site around 1600. Pt iced site throughout the evening and morning, but swelling/erythema increased. No fever/chills or body aches, denies muscle soreness, not tender to the touch. Swelling 125 mm x 120 mm. Pt began antibiotics last night for cough.
Delayed skin reaction. Severe itching at injection site. Small white blister. Hardened area.
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that no adverse reactions have been reported by patient from the 3rd dose. Reporter stated that 2 vials of the Moderna COVID-19 vaccine were left in the refrigerator past their use by date. Patient was given full 3rd dose of the Moderna COVID-19 vaccine.   This case was linked to MOD-2021-364220, MOD-2021-364234  , MOD-2021-364264  , MOD-2021-364651  , MOD-2021-364672  , MOD-2021-364689  , MOD-2021-364712  , MOD-2021-364761  , MOD-2021-364787, MOD-2021-364818  , MOD-2021-365038  , MOD-2021-364953  , MOD-2021-364958  , MOD-2021-364993  , MOD-2021-365049  , MOD-2021-365054  , MOD-2021-365065  , MOD-2021-365098  , MOD-2021-365191 (Patient Link).
A patient received only liquid DTaP-IPV portion without mixing the powder HIB portion, no AE; Initial information regarding an unsolicited valid non-serious case was received from nurse via Medical Information (Reference number- 00599798) and transmitted to Sanofi on 13-May-2021.  This case involves a three-month-old female patient who received 0.5 mL 2nd dose which was only liquid dtap-ipv portion without mixing the powder hib portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ389AB and expiry date: 09-Oct-2021) via an unknown  route in the left thigh for prophylactic vaccination on 13-May-2021 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination.  The caller would like to know if this will be considered a full vaccine for polio or not.  This was a case of actual medication error case due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  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.
Left thigh erythematous, warm to touch, edema, vaccine reaction vs. insect bite.
12 hours after vaccination I had swelling and severe pain upper left arm, severe muscle and joint aches and headache, loss of appetite. Woke me around 3:00 AM, lasted 2 days. 3rd day felt washed out and hollow, head still feels swollen.  Unable to move out of bed for 2 days due to pain. Drank lots and lots of water to flush out of system. Am in between doctors right now  and was to out of things to call anybody.  Don't really want the 2nd vaccination due to the more severe effects 2nd doses are having on others. COVID symptoms twice in my life is more then enough.
stroke like symptoms lasting 30-60 seconds; garbled speech x 2 episodes approx 5 hours apart.; significant ataxic gait; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm right, administration date 21Mar2021 (Lot number: ER2613) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizure" (unspecified if ongoing). The patient did not have COVID prior to vaccination. The patient did not receive any other vaccines within 4 weeks of the COVID vaccine. There were no concomitant medications. Past drug history included: Dilantin, reaction(s): "known allergies: Dilantin"; Lamictal, reaction(s): "known allergies: Lamictal". Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right), administration date: 27Feb2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "stroke like symptoms lasting 30-60 seconds"; SPEECH DISORDER (medically significant) with onset 22Mar2021, outcome "recovered", described as "garbled speech x 2 episodes approx 5 hours apart."; ATAXIA (medically significant) with onset 22Mar2021, outcome "recovered", described as "significant ataxic gait". Therapeutic measures were not taken as a result of cerebrovascular accident, speech disorder, ataxia. The patient was not COVID tested post vaccination.
Patient began to feel "hot all over" approximately 5 minutes after vaccine administration. Symptoms were almost completely resolved after about 10 more minutes.
Our patient had a reaction to recent immunizations given in her left arm.  The patient presented to the pharmacy on 10.02.2020, which was 3 days post immunizations given on 09.29.2020, with a significant raised red area.  The patient stated that the area was not present until 10.02.2020, possibly starting late evening on 10.01.2020.  The area felt warm and was itchy and sensitive.  The patient had taken over-the-counter Benadryl which had reduced the size of the area by about half.  Upon presentation, the red area was visually estimated at 4.5 inches wide and 2 inches high.  The patient had received both the  Fluzone HD Quad 2020-21 and Pneumovax23 in the left arm.  The patient stated that she had received a flu shot in the past without incident.
It is still really red, I actually had couple more red spots where the shot was; I was just surprised to see it is still  pretty large bruised about 2 weeks after the shot; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: INJECTION SITE ERYTHEMA (non-serious) with onset Nov2021, outcome "unknown", described as "It is still really red, I actually had couple more red spots where the shot was"; INJECTION SITE BRUISING (non-serious) with onset Nov2021, outcome "unknown", described as "I was just surprised to see it is still pretty large bruised about 2 weeks after the shot"; IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received dose of Boostrix on 11/9/22 and a second dose on 3/29/23. Parent notified and monitoring for adverse effects. None reported at this time.
Lethargy within 2 hours. Antisocial behavior next day with anger, and hostility. Withdrawn and rebellious activity. Slight fever next day. Insomnia x1 week. Sx lasted 2 weeks.
recurrent high fever >103, lethargy, malaise, joint pains, insomnia;
intense screaming x 20 minutes; approx 4 hrs p/vax mom picked up pt ?jerking of head w/crying; approx once every 8 sec; no color change; on exam occ gasp w/crying & shaking of body but no sz;
At Apx 3:30PM, patient began having redness and extreme itching at the site of the injection.  She also had redness and mild swelling across her forehead, nose, cheeks and chin, but no itching on the face.  At Apx 3:45PM, patient began to complain of an extreme sore throat.  Patient also felt very hot to the touch, but a temperature was not taken.  At Apx 4:00PM, patient was attempting to eat and had a very difficult time swallowing.  Patient stated that she felt her throat was swelling.  At Apx 4:15PM, patient took 50mg of Diphenhydramine.
Increase in patients RNR levels; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ENZYME LEVEL INCREASED (Increase in patients RNR levels) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ENZYME LEVEL INCREASED (Increase in patients RNR levels). At the time of the report, ENZYME LEVEL INCREASED (Increase in patients RNR levels) 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.   No concomitant medications were provided. No lab data regarding RNR levels were provided. Treatment medications were not provided.
pt recv flu vax & pneumococcal vax combined & given in one inj;pt exp sore arm only;
Fever 100-101 F; Chills; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 02May2021 at 13:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 11Apr2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. 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 03May2021 at 07:00, the patient woke up with chills and severe muscle aches after receiving second dose. On 03May2021 at 09:30, the patient experienced fever 100-101 F which lasted at least until the patient went to sleep that night at 21:00. The clinical outcomes of chills, muscle aches and fever 100-101 F were recovering.  No follow-up attempts are needed. No further information is expected.
3 inch diameter rash around the original injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (3 inch diameter rash around the original injection site) in an 80-year-old female patient 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 UNK. On 05-Feb-2021, the patient experienced VACCINATION SITE RASH (3 inch diameter rash around the original injection site). At the time of the report, VACCINATION SITE RASH (3 inch diameter rash around the original injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up received on 05-MAY-2021, No new information
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that on approximately 05-OCT-2012 the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. No laboratory diagnostic test were performed. The patient sought medical attention by notifying the physician. The physician was inquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of several reports from the same reporter. Additional information has been requested.
GOT THE VIRUS; This spontaneous report received from a consumer via a representative concerned 20 patients of unspecified gender, race and ethnicity. No past medical histories or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (unspecified manufacturer) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose and start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine. Patients received booster of covid-19 vaccine (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, patients got the virus (dose number in series 2). The consumer reported, everyone is different. The action taken with covid-19 vaccine was not applicable. The outcome of got the virus was not reported. This report was non-serious. This report was associated with product quality complaint 90000209759. The suspected product quality complaint has been confirmed to be voided (this case does not qualify since the only indication was that patients had the virus but does not refer to any symptoms or lab test name/dates) based on the evaluation/investigation performed. This case, from the same reporter is linked to 20220100700.
Patient had inflammation at the injection site, as well as pruritus. On the opposite side forearm, patient had a red rash that was about 3 cm in diameter. Both of this happened the day after the vaccine was given and the rash is improving since then. Was given diphenhydramine to help with itching and rash. Was told if not improving, to return to clinic in no longer than a week. Was given ER precautions.
I woke up with a sore throat on Sunday morning 05/29/2022, that progressively got worse throughout the day. As the next day came, I started having a headache, sinus pressure, fever and chills and fatigue, I felt very exhausted. I got tested the next day, 05/30/2022, and did an at-home COVID-19 test; the test came back positive. I've been taking acetaminophen and NyQuil to help subside the symptoms gradually.
left shoulder swelled up a little bit after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (left shoulder swelled up a little bit after the 2nd dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (left shoulder swelled up a little bit after the 2nd dose). At the time of the report, SWELLING (left shoulder swelled up a little bit after the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-405240 (Patient Link).
Onset rash - itchy, burning on axilla, scapular of same arm received vaccination, 3 days later noticed 3rd area rash. On back (L) side. Onset several hours after injection. Notes rash in 3 separate areas. No other symptoms. Lesions in 3 isolated clusters (L) back and axilla - vesicular appearing patch.
Moderna COVID-19 Vaccine EUA: I received my second dose of this vaccine about 9:45am on 2/24/2021.  About 7:00pm that same day I began to feel achy.  A few hours later I began running a low-grade fever.  The worst period of side effects was about 11:30pm - 1:30pm during which I had a fever of over 100,, with aches and frequent chills (pretty much every minute during those 2 hours I would shake with chills even though I felt extremely hot).  I was taking ibuprofen at the time (at 7pm and 11pm) yet did not experience any significant relief from the chills & fever until about 1:30am.  I continued to feel achy the rest of the night with an off-and on low-grade fever (99-100), despite regular appropriate use of OTC NSAIDS (ibuprofen & tylenol).   The fever went away by about 8:00am, and the overall achiness largely went away by 10:30am.  At no time did I require any other medical attention.
Soar throat; Cough; Temperature of 100.6; Body aches; This is a spontaneous report received from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an intramuscular route of administration in the left arm on 27Jul2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Concomitant medications were not reported. On 01Aug2021 at 08:00, the patient had sore throat, cough, temperature of 100.6 (unspecified units) and body aches. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021, the patient underwent COVID test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore throat, cough, temperature of 100.6 and body aches were resolving at the time of this report.
3rd dose of the vaccine 28 days after the second one; A spontaneous report was received from a health professional concerning a male patient in his 60s who received extra dose administered.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 22 Feb 2021, prior to the onset of the symptoms, the patient received their third dose of mRNA-1273 (Batch number: Batch number not provided) for prophylaxis of COVID-19 infection.  On 22 Feb 2021, five patients received third dose of the mRNA-1273 vaccine, 28 days after the second one.  Action taken with the drug in response to the event was not applicable.  The outcome of the event was recovered/resolved.; Reporter's Comments: This case concerns a male patient of unknown gender and age who received their third dose of mRNA-1273 (Lot unknown), reporting Extra dose administered without any associated adverse events.
Developed Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. In July 2022, the patient experienced COVID-19 (Developed Covid). At the time of the report, COVID-19 (Developed Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. It was reported that patient already had original shots and two boosters. The patient developed Covid back in July of 2022 and still going through some symptoms. The patient still could not taste. No treatment medication were provided.   Reporter did not allow further contact
p/vax pt devel a severe site rxn characterized by redness, warmth & pain;tx w/NSAIDS & oral ATB;