chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed visiting nurse concerning a 1 year old male with no pertinent medical history or drug allergies who on 24-SEP-2007 was vaccinated SC with a 0.5 ml dose of MMR (LOT# 655486/0426U). Suspect vaccination administered on that same day included a dose of Varivax. The patient developed a rash and was diagnosed with Henoch Schonlein purpura during an emergency room visit on 03-OCT-2007. Lab diagnostic studies performed included a urinalysis. The patient was not admitted to the hospital. Subsequently, the patient recovered. There was no product quality complaint. Upon internal review, Henoch Schonlein purpura was determined to be an other important medical event. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced limbs stiffness and injection site bruising. On an unknown date, the outcome of the pain in arm, limbs stiffness and injection site bruising were recovered/resolved. It was unknown if the reporter considered the pain in arm, limbs stiffness and injection site bruising to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. After vaccination, the patient experienced pain on her entire left arm which lasted the entire day and then resolved. The patient also experienced a bruise at the injection site but that did not resolve for 2 to 3 months. The bruise was black in color and the patient described, it was the worse bruise she had ever. The patient could not recall the onset of the bruise. The patient also had stiffness to her arm after the injection. At the time of reporting, all the symptoms were resolved. The contact details of the physician was provided. The reporter gave consent to follow up.
Numbness, originally, started below  his elbow and upper arm, and now it has affected his shoulder, neck and around his shoulder blade on his back/cannot feel his upper lower back; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness, originally, started below  his elbow and upper arm, and now it has affected his shoulder, neck and around his shoulder blade on his back/cannot feel his upper lower back) and PAIN IN EXTREMITY (Sore arm) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LURASIDONE HYDROCHLORIDE (LATUDA), ATOMOXETINE HYDROCHLORIDE (STRATTERA), GUANFACINE HYDROCHLORIDE (TENEX), MOMETASONE FUROATE (ASMANEX) and DUPILUMAB (DUPIXENT) for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced HYPOAESTHESIA (Numbness, originally, started below  his elbow and upper arm, and now it has affected his shoulder, neck and around his shoulder blade on his back/cannot feel his upper lower back) and PAIN IN EXTREMITY (Sore arm). At the time of the report, HYPOAESTHESIA (Numbness, originally, started below  his elbow and upper arm, and now it has affected his shoulder, neck and around his shoulder blade on his back/cannot feel his upper lower back) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was  provided.
anaphylactic reaction to DPT vaccine made with horse serum; Initial information regarding an unsolicited valid serious case received from non-healthcare professional (consumer) from Pfizer (Reference number: 2021013116) on 11-Jan-2021.  This case involved a female patient aged an approximately 3 to 4 year at around years 1964 or 1966 who experienced anaphylactic reaction (Anaphylactic reaction) to DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE made with horse serum.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the patient developed a serious anaphylactic reaction to DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE made with horse serum (Anaphylactic reaction).  No relevant laboratory details were provided.  The event of anaphylactic reaction was assessed as medically significant as per important medical event list.  It was not reported if the patient received a corrective treatment.  Outcome of the event of anaphylactic reaction was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves an approximately 3 to 4 year old female patient who presented with anaphylactic reaction after receiving DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer. Time to onset is unknown. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient had complaints of lightheadedness/dizziness approx. 5-10 minutes after injection. Lasted for approx. 5 minutes. Patient was seated, cold cloth applied to neck and wrists, given water to drink. s/s resolved with intervention and seating. Patient with no other complaints.
Date:3/13/21  820am Patient c/o feeling nauseous, vomited x1 small amount of yellow color emesis. Patient stated  that she feels dizzy and lightheaded. VS 97.3,20,81,176/86 O2 sat @ 96% on Room air. Patient stated that she ate breakfast and took blood pressure medication this morning. Son stated that patient was nauseous while en route to  get vaccination. patient awake, alert and verbally responsive. Resting in w/c. Close monitoring in progress. 835am Patient states that she feels a little better VS 97.6,18,70, 134/79. patient stated that she usually gets nervous when getting vaccinations. Encouraged to rest for 15 more minutes. 8:50 am patient stable. VS 97.5, 18, 131/80,72. Patient verbalize relief. left facility with son at side.
Passed out; Feeling funny, that his insides were cold; Heart rate low; A spontaneous report was received from a 32-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported felt funny, his insides were cold, low heart rate, and passed out.  The patient's medical history was not provided. Concomitant medications were not reported.  The patient received their first of two planned doses of mRNA-1273 on an undisclosed date.  On 08 Jan 2021, prior to the onset of events, the patient received their second dose of mRNA-1273 (Batch number: unknown) intramuscularly in his left arm for prophylaxis of COVID-19 infection. Afterwards, he felt funny, his insides were cold, and he passed out. His smartwatch reported that his heart rate was low. He said now he was feeling better.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, felt funny, his insides were cold, low heart rate, and passed out, were recovered on 08 Jan 2021.; Reporter's Comments: This case concerns a 32 year old male patient who experienced serious events of Loss of consciousness and Chills and a non-serious event of Heart rate decreased following their second dose of mRNA-1273 (Batch number: unknown). Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
No symptoms reported; Patient received second dose in PEDVAXHIN immunization series that was improperly stored. Temperature 15C. Time frame: 2 hours 56 minutes. Previous temperature excursion? Y. 10 C 1 hour 1 minute and 12.5 C 1 hour 22 minutes.; This spontaneous report as received from a other health professional refers to a patient of unknown age. On 15-JAN-2020, the patient was vaccinated with  improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot# S000355 has been verified to be a valid lot number, expiration date 10-OCT-2021) (second dose) for prophylaxis. On 15-JAN-2020, the vaccine was improperly stored temperature 15 Celsius degree (C), time frame 2 hours 56 minutes, previously there were temperature excursion: 10 C for 1 hour 1 minute and 12.5C for 1 hour 22 minutes. No symptoms reported.  Digital data logger was involved.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2020 as dose 1, single (Batch/Lot number: unknown), in 2020 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, in 2022.  Patient has had 4 total Covid-19 shots and had a flu shot about 4 weeks ago. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2022, outcome "unknown" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Positive, notes: Unit: Not Provided. Home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201378688 same reporter/patient/drug, different doses/AE;
Had not received the 2nd dose yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th May 2018).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Had not received the 2nd dose yet.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
mom presented to immunization clinic on 10/13/99 to show nurses area of dimpling/retraction on child's rt thigh;mom states area devel 1mo p/child recv vax; A 15-day follow up report received 10/28/2002 adds: The pt was hospitalized on 04/07/1999. The pt received an Aristacort injection at that time. It is unknown if the 'dimpling and retraction' is from the immunization or the Aristacort. The pt has been seen by a plastic surgeon.  Follow-up #2 (08/23/2002): During internal review of all files, it was deemed necessary to amend the report by upgrading the seriousness of this case to a 15-Day Alert report. This case is closed.
Healthy young women of 25 years of age with spontaneous pregnancy. Regular period prior to becoming pregnant. Patient had miscarriage on 04/29/21 with anembryonic pregnancy. Anembryonic pregnancy confirmed by ultrasound on 4/23/21. Covid vaccine received on 4/8/21. Patient roughly 4 wks pregnancy at time of vaccine dose.
Case previously recorded as MA2009-5698. We received the following information via a health care provided from Novartis Pharma on the 24 NOV 2009. This 3-year child was vaccinated with FLUVIRIN (batch number 10073801AN) on 24-Nov-2009 for off label use. There was no event associated with this use. Novartis Vaccines ref no. NA09-008786.
pt recv vax & devel a large area of cellulitis (area of rxn spread 3x the initial size), tx w/keflex po; rxn resolved p/approx 1 wk;this is one of 8 patients from this site who exp above rxn;
Following administration of #2 DTP that evening pt had approx 2 hrs when pt was quite irritable, crying w/some calming; Episodes also when pt would just sit & look @ mom; irritability continued for 2 days;
Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark; Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark). At the time of the report, PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: The completed Form includes an update to patient's race and additional event details, the patient had not received 2nd dose at the time of the FU report
Patient returned to clinic today for PPD reading and complaint of an itchy red rash on face which started on 2/20/2019 after returning home from work. Patient reports using an over the counter oral anti-histamine or allergy pill (could not recall name, however she was certain that it was not BENADRYL). No relief offered according to patient. Assessment today shows pruritic erythematous rash (hives) on facial cheeks, around mouth and chin. Referred to Primary Care Provider or ER.
This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. On 10-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Circumstances surrounding his death are not evident in chart. Patient missed his second COVID shot due to hospitalization at a facility sometime before his death on 3/12/21. Comorbidities include CAD, Afib, AAA, obesity, prostate cancer, advanced age, HTN.
This spontaneous report was received from a doctor of pharmacy refers to a 49 years old male patient who on an unknown date, was vaccinated intramuscularly in his left arm with a 0.5 ml dose of PNEUMOVAX 23 (lot # 669776/0614AA) that was expired. The vaccine expired on 27-SEP-2012. No adverse effects were reported. Additional information has been requested.
pt recvd vax & exp fever,body aching,anorexia,weariness,fatigue,lethargy,myalgias,arthralgias;seen by MD 5AUG94 EBV VCA IgG came back positive;dx epstein barre virus synd despite neg IgM;exp joint & muscle pain,swollen rt ankle;
positive for COVID-19; positive for COVID-19; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was scheduled to receive the second dose this 27Mar2021. She is positive for COVID-19 and would have to postpone her vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Reportedly, the individual experienced "side effects",; Reportedly, the individual experienced "side effects", and therefore did not get her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Reportedly, the individual experienced "side effects",) and PRODUCT DOSE OMISSION ISSUE (Reportedly, the individual experienced "side effects", and therefore did not get her second dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     No Medical History information was reported.    In June 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Reportedly, the individual experienced "side effects",) and PRODUCT DOSE OMISSION ISSUE (Reportedly, the individual experienced "side effects", and therefore did not get her second dose). At the time of the report, IMMUNISATION REACTION (Reportedly, the individual experienced "side effects",) and PRODUCT DOSE OMISSION ISSUE (Reportedly, the individual experienced "side effects", and therefore did not get her second dose) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Stabbing pain at sight of injection, intense pain running up to neck and down to fingers. Burning sensation on back of left hand, Thumb and fore finger on left hand number and tingly. The pain is constant sometimes milder then others. The pain runs from neck to fingers and is most prominent in elbow, forearm and sight of injection. Arm shakes and is weak when the pain is at peak.
He got a shot Thursday, late that evening I noticed a quarter sized welt on his arm where he got the shot. The next morning, he had a sore arm and intense nausea, very faint, was unable to walk, lost color in his lips. I sat him down and wheeled him into the bathroom. Called the pediatric clinic. They told me to call the PCP. He was shivering but not cold, that lasted 5 minutes. They said TYLENOL and cold compress. We did that and the next day he was a little sick to his stomach and sore, swollen lymph node under the arm. He had a low grade fever. By Sunday, the place on his arm had grown to two inches and itchy and warm to the touch. He took BENADRYL, as per the pediatrician. On Monday, the spot was three inches and still pink. It was warm and painful to the touch. We did a virtual telehealth. She put him on an antibiotic three times a day for seven days. She mentioned the injection site may be too low.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's concurrent conditions included haemophilia. Patient's drug reaction/allergies or concomitant information was not reported. On an unknown date, the patient was vaccinated with ROTATEQ orally (strength, dosage schedule, lot # and expiration date were not reported). On an unknown date, the patient developed significant bloating and was admitted to a hospital for an unspecified time length. While in the hospital the patient received unspecified treatment. At the reporting time the patient's outcome of bloating was unknown, as well the causality assessment between the event and therapy with ROTATEQ. No product quality complaint (PQC) was involved. Additional information has been requested.
Immediately: left arm pain at injection site lasting a couple of days and went away next day: left side headache continuously for 2 days then on and off runny nose left ear pain started 3/14/18 left earlobe very red, hot to touch 3/15/18 am left jaw pain, left eye pain patient called doctor and sent picture he told patient to go to urgent care 3/15/18, because he may have mastoiditis.
The morning after injection with DTaP right thigh bruise markedly swollen erythematous and tender, No fever, Child otherwise well; Ambulating, Ibuprofen given, Observe for now.
The patient's wife asked me if any mental health type side effects had been reported with SHINGRIX, and I looked it up and said I couldn't find anything. She stated that her husband had been diagnosed with being bipolar for a long time, but that a few days after receiving his 1st SHINGRIX dose he went into a very scary manic episode. She did not provide me with any details besides that he was hospitalized. She wasn't sure if this was necessarily the cause but found the timing peculiar. She did not state whether this was the worse episode he has ever had, but I have known them for 3 and 1/2 years and I haven't heard of any other episodes prior to this. She said it seemed that he was on a steady but slow upward slide with his manic state and a few days after receiving the shot it appeared to be more precipitated. I stated I would at least report the information.
Several minutes after the vaccine she became light headed, EMT evaluated her and stated she was tachycardic (did not give a pulse) and was initially unable to find a BP.  She appeared pale and was crying and hyperventilating.  She stated she had a funny feeling in her throat and numbness in her fingers.  We prepared to administer an epi-pen but she was increasingly anxious so we had to place her in a supine position first.  Immediately she started to feel better, her color was normal and her blood pressure was 110/70 with a pulse of 67.  Her throat no longer felt ?funny.?  We continued to monitor her and did NOT administer epinephrine.  An ambulance arrived and she was ambulatory and feeling normal so declined transport. Follow-up with patient 1/18/21, she states she is feeling good. She said she and her mother both have a history of passing out with any procedure involving needles and she does not feel her symptoms were caused by the vaccine itself. She plans to receive her scheduled 2nd dose from us.
c/o severe h/a & fever approx 7hr p/vax;temp was reportedly 101.8 (o);h/a was severe;pt crying;@ 9PM PHN made HV T99.4 R used APAP;severe h/a approx 24hr;no n/v;all sx resolved;no neck pain/rigidity) photosensitivity);