chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received HAVRIX. Co-suspect products included PEDIARIX and ENGERIX B. On an unknown date, the patient received HAVRIX at an unknown dose, PEDIARIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, PEDIARIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Up to 45 patients may have been vaccinated with vaccine stored outside data limits.
On April 7 left upper arm at injection site began to itch. At that time she noticed a lump in the area and that the skin was hot. Same night approximately 6:30 PM noticed redness approximately size 1 1/2 inches diameter. 7 AM ON April 8 3 1/2 inches diameter, red, hot to touch
JE 3# 1 in February with no problems. JE vaccine # 2 received on 26 Apr.  She stated the following day she noticed a fine rash on her upper torso to include neck and few areas on face. Later that PM she had several episodes of diarrhea.  She reported fatigue but denied nausea, vomiting, and fever. No respiratory symptoms or angioedema. Rash described as bumps with minimal itching, and does not come and go. Never had anything like this before or problems with previous immunizations. No one else at home with rash or diarrhea. Was able to return to normal diet on 28th, and rash is going away. Currently is feeling well but skin is still bumpy.
The patient received 0.5 ml of the vaccine instead of 0.25 ml as the Second Booster requires
Headache, Arthralgia, Fever, sleepy, site pain Narrative:  Other Relevant History:
Patient started shivering very badly around 7:00 PM 6/6/18, then decided to check her temperature. Her temp was 102F. She felt like she had flu-like symptoms, with achiness in her bones, and literally all over her body. She took 800 mg Ibuprofen and rechecked her temp around 8:00 PM and it was still 102F. The Ibuprofen did not help her at all. She felt bad all night and continued Ibuprofen when appropriate. The fever finally went down this morning 6/7/18, but was at 99.7F. As of this afternoon around 3:15 PM, she was starting to feel better, but still had some aches in her hips and legs. I called her around 6:00 PM and she was feeling better.
Pt presented with rash and lump in arm pit. Amoxicillin-Pot Clavulante 875-125 mg was started.
No other AE reported; has been administered since the temperature excursion; This spontaneous report was received from an agency referring to a patient of unknown age and gender. Information on pertinent medical history, concomitant medication and drug allergies/reactions was not reported.  On 23-DEC-2020 the patient was vaccinated with a temperature excursion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S010729 with expiration date 01-DEC-2021; lot# 1637648 with expiration date 19-JUN-2022; dose and route were not reported) for prophylaxis (product storage error).     The administered doses of the vaccine experienced a temperature excursion 32.9 Fahrenheit (F) and 34 F for 24 minutes and 16 hours time frame. Whether there was previous temperature excursion was not applicable. The digital data logger was involved. No product to retrieve. Device was not available for evaluation (obtain was false). No other AE was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Initial information received from another manufacturer (service request number 1-5744669503) on 19 November 2012. The information was originally provided to the other manufacturer by a non-healthcare professional. A female patient of unspecified demographics, whose concurrent conditions and concomitant medications were not reported, had exposed to rabid animal and received Rabies vaccine (Manufacturer, lot number, route, dose and anatomical site of vaccination were not reported) on unspecified date in 1945 or 1946. The patient was barely able to walk after vaccination. The patient had not recovered. Corrective treatment and laboratory tests were not reported. List of documents held by the reported. None.
Complaint of hair loss (patch) following administration of 2nd dose of GARDASIL.
Presented to ED with fatigue, sore throat, gen weakness & cough: + Covid in ED: CXR: opacity in RL base, concerning for PNA; initially on room air; TX: startedon maxipime, rocephin, 12/19 Vit C, Zithromax, decadron, lovenox,   zinc added 12/21 pt worsened overnight with increasing O2 requirements and elevated temp; CRP up to 5.17; remdesivir added; O2 @ 2 LPM via NC 12/22 O2 @ 4 LPM; discussed Toci tx but pt declined; prone positioning ad lib; 12/24 O2 @ 5 LPM; CRP trending down (peaked as 12.81) 12/27 afib with RVR; Cardizem started; O2 @ 6 LPM; 12/28 NSR, 4 lpm O2 12/31 off supplemental O2; remains on room air; doing well
Patient reports having moderate erythema (14cm wide, 7 cm long, oval shaped) 1 day following PPSV23 vaccination. Inflammation made mobility of L arm difficult and patient reports that adverse event lasted for 5-6 days. Patient reported pain 3/10 when at rest, but higher when trying to move L extremity. Patient was seen by a provider on 12/16/19 after calling the Triage nurse on 12/13/2019 and being referred. Erythema was treated with a course of oral antibiotics and resolved in 5-6 days.
[Tuesday 11:35 AM]      09:45 Second dose Moderna vaccine lot number 007M20A exp 7/2021 given at vaccine clinic.  10:00 Pt reports feeling light headed, dizzy, pt walked a few steps with supervision to stretcher. Vitals remain stable though hypertensive at 148/90.  10:20 BP 128/97 HR 92 Reports tingling to roof of mouth. Observed baseline oral exam due to pt past report of anaphylaxis in the setting of allergy shot, oral exam appears normal, pink mucosa, no swelling. Will continue to monitor on stretcher. Pt drinking water without any problems and does not appear in distress.  10:35 Noted hoarse voice, re-examined oral mucosa and patient's tongue, palate and, uvula now appears flushed, red and slightly but noticeably swollen, face is also now flushed. Lips appear same size and not swollen. Called RRT immediately. Advised transfer to ED. Pt remains in no distress.  10:40 RRT arrives to vaccine clinic in auditorium, gave report to RRT, reexamined oral mucosa which appears the same as 10:35 assessment (lightly but noticeably red, swollen tongue, palate and uvula). Face remains flushed as documented at 10:35. BP 128/90 HR 89.  10:45 Pt en route to ED with RT at bedside in no apparent distress.
On 10-17-19 patient came in to report vaccine injury associated with injection given on 9-28-19.  She said she experienced much more pain and a "crackling" sound at the time of the injection.  She reported a much larger red and swollen area than after her first dose of Shingrix.  She also complains of numbness or tingling down her arm and into her hand. Her MD told her the needle likely hit a nerve but recommended no further treatment.
Dec 16 around 3:00 began running low grade fever. Over the next couple days it got up to 102.5 without meds. Spoke with PCP and was told to keep an eye on him and give him TYLENOL to keep him comfortable. Fever resolved on it's own by 12/20/2022. Received pneumococcal, MMR, and Varicella vaccines on 12/08 and we were told it could possibly cause rash and fever.
Pt experience respiratory distress approximately 5 minutes after receiving the vaccine. She self administered her prescription ProAir 5 times without relief. She then self-administered her own Epi pen.  She began to show some signs of improvement but at about 5 min post-administration her respirations began to be more distressed. Benedryl, deep IM was administered. Again, after about 3 minutes there was some improvement but after 5 minutes a second dose of  Epi was administered. By this time EMS had arrived and assumed care.  Pt was taken to hospital.
Pt presented to on site clinic approx. 3 1/2 hours after receiving Typhim Vi (0.5cc given IM to Left Deltoid). Upon exam, pt shivering, pale, non diaphoretic but awake, alert and oriented. T=99.6, B/P 84-90/60 (hypotension) IV started.
Menstrual cramping beginning about 4 days after vaccination at a time when normally would not cramp. Spotting about 10 days after vaccination. On birth control pills, takes regularly, has never had bleeding or cramping outside of normal period time.
Macular/papular rash-diffuse entire body, + blanching-temp. 100, day 12 following vaccines.
SOB, WEAKNESS, ABNORMAL VITAL SIGNS, UNRESPONSIVE VERBALLY
Patient received second dose of covid, developed shortness of breath, hives and throat swelling.  Patient had minor urticaria with first dose.  Patient in severe distress, intubated for airway protection.  Treated with benadryl and epi by EMS.
I received my second vaccination Moderna COVID-19 Vaccine EUA on 2/26/21 at 4:00, and started feeling ill around 11:00 p.m.  During the night I developed fever, chills, tremors, rapid heart rate, nausea, body aches, headaches, and fatigue. This lasted about 36 hours. These symptoms were similar to those I experienced when I had Covid-19 in early December of 2020.
Fever; Nausea; Vertigo; The initial case was missing the following minimum criteria: Unidentifiable Patient. Upon receipt of follow-up information on (28Sep2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 5 patients. This is the 1st of 5 patients.  A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CN8296), intramuscular on 26Aug2020 14:04 at a single dose (also reported as 1-1-1/2) for Men B/ immunisation, and 2nd dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, lot number: U6596AA), intramuscular on right arm on 26Aug2020 14:04 at unknown dose for immunisation. The patient previously took 1st dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) on unspecified date. The patient's concomitant medications were not reported. The patient experienced fever 27Aug2020, nausea and vertigo on 27Aug2020. The events did not cause hospitalization. The patient took Benadryl and Advil on 27Aug2020 as treatment for the events. The outcome of the event fever was recovered on 30Aug2020 while unknown for other events. The physician reported that the suspect product had a causal effect to the adverse events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020375958 Same reporter, similar drugs and events, different patient; -PFIZER INC-2020375956 Same reporter, similar drugs and events, different patient;US-PFIZER INC-2020375957 Same reporter, similar drugs and events, different patient; -PFIZER INC-2020375959 Same reporter, similar drugs and events, different patient
Starting the next morning and continuing for a total of 3 days /72 hours: chills and shaking with no relief. No amount antiinflammatories helped, no ammount of layered clothing assisted with the feeling of freezing. This also occurred in mid 80s-low 90 degree weather.
Fever 103-104 Blood pressure 180/110 Pulse 120 Blurred vision Nausea  Vomiting Severe headache Debilitating fatigue/exhaustion
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 27Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 18Aug2021 as dose 3 (booster), single (Lot number: EA6780) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Feb2022 as dose 4 (booster), single (Lot number: 026L21B) for covid-19 immunisation. The patient's relevant medical history included: "Selective IgA Deficiency" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Mod to Severe Asthma" (unspecified if ongoing); "Sjogrens Syndrome" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: ZEGRID, start date: Jan2014, stop date: Sep2022; MONTELUKAST, start date: Jan2016, stop date: 28Aug2022; ESTRADIOL, start date: Jan2020 (ongoing). Past drug history included: Cephalosporins, reaction(s): "known allergies: Cephalosporins", notes: known allergies: Cephalosporins; Codeine for known allergies: Codeine, notes: known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Finished Paxlovid on Sept 3 am dose. Reoccurrence of headache and stuffy nose started on Sept 6 pm evening; Positive, notes: Prior negative covid test on Sept 5 pm, current covid positive test as of Sept 7 am; Negative, notes: Prior negative covid test on Sept 5 pm, current covid positive test as of Sept 7 am. Therapeutic measures were taken as a result of vaccination failure.
pt recvd vax 18OCT95 & devel an inj site rxn characterized by redness, warmth, swelling & hardness;the above rxn lasted for 1 day & subsided;this is one of three patients from this site who exp these sx p/flu vax;
None at all issues with first dose, very mild soreness and that was it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 01Mar2021 12:45 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "vitamin d deficiency" (ongoing). Concomitant medication(s) included: VITAMIN D2 taken for vitamin d deficiency, start date: 2019 (ongoing). The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "None at all issues with first dose, very mild soreness and that was it".  Additional information: The patient had no relevant family medical history. The patient had no prior vaccinations within 4 weeks. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The event did not result to emergency/physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness and nausea followed by low blood pressure/heart rate and vomiting within 10 minutes of receiving the vaccine. Symptoms resolved 10-15 minutes after vomiting (20-30 minutes after vaccination  Sore arm and body aches lasted apx 36 hours after vaccination
Despite having been vaccinated twice (on 3/25/2021 and 4/22/2022) and boosted (11/22/2022) all Moderna and being exposed to covid-19 positive individual 1/7/2022, I tested positive 1/13/2022. Very mild symptoms. One night had a very runny nose. Also had a fever which had I not checked, would have gone undetected. Tested negative on 1/24/2022. Around that same time, started developing symptoms of fatigue, low stamina, brain fog, whole body aches, and excessive daytime sleepiness. On 2/11/2022, I requested crisis sick time from my manager as I felt unable to safely drive for more than 30 minutes without feeling the lead veil of sleepiness begin to pull on my eyelids. Also, I had noticed I was falling asleep while working from home and in the middle of meetings or customer support sessions. Dr. Prescribed prednisone. issue persist.
2/20/21- ?Vaso/vagal vs anaphylaxis, approx 1:20 PM, 10-15 min post vaccine, HA, approx 1:30PM nausea, dizzy, unable to stand on own BP 120/78, low for ct, O2 8L/simple mask, 911 called, throat felt dry, anxious, denied airway prob, no wheezing or stridor, epi not indicated, FIRE/EMS arrived, after a few minutes client able to stand on own, declined going to hospital, felt well enough to drive 20" home.  2 hrs post vaccine, throat scratchy, back became itchy, took Benadryl x 2 with resolution after 2nd dose, At 3:45, spoke County Manager, ct kept feeling the need to clearher  throat, ct referred to PCP.  02/25-Client feeling fine now,spoke w/PCP, cleared to get 2nd dose at hospital. Ct has hx asthma/smg
took my first shot the JJ; Sore arm; Felt bloated that evening but didn''t think much of it.  Started spotting Sunday. Received my period today. I keep track of my cycles; Felt bloated that evening but didn''t think much of it.  Started spotting Sunday. Received my period today. I keep track of my cycles; Started spotting Sunday; Received Pfizer booster shot on Saturday at noon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 12:15 (Lot number: FF2588) at the age of 43 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulphur, reaction(s): "Drug Allergy". Vaccination history included: J&j (Dose 1, I took my first shot w the JJ on 13Mar.), administration date: 13Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 12:15, outcome "unknown", described as "Received Pfizer booster shot on Saturday at noon"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "took my first shot the JJ"; MENSTRUATION IRREGULAR (non-serious), ABDOMINAL DISTENSION (non-serious) all with onset 15Nov2021 14:00, outcome "unknown" and all described as "Felt bloated that evening but didn''t think much of it. Started spotting Sunday. Received my period today. I keep track of my cycles"; INTERMENSTRUAL BLEEDING (non-serious) with onset 15Nov2021 14:00, outcome "unknown", described as "Started spotting Sunday"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of menstruation irregular, abdominal distension, intermenstrual bleeding.  Additional Information: No other vaccine in four weeks. Patient had covid prior vaccination. No covid tested post vaccination. Facility type vaccine was Pharmacy or Drug Store. It was reported that patient was not due for a period for another 11 days, thought maybe it was due to ovulation but this was much heavier than spotting. So much more that had to insert a menstrual cup. Patient was not stressed. Haven't changed physical activities, nor diet. It was reported that she could only chock it up to receiving the Pfizer booster shot. Patient did not have any symptoms or side effects when took first shot with JJ on 13Mar.  Follow-up attempts are completed. No further information is expected.
Presented with 4 days of fatigue, nausea, HA, cough, SOB, and low grade temp; Covid +; admit with Covid PNA; TX with doxycycline, remdesivir, Symbicort, Maxipime, steroid, zinc, and supplemental O2.
1414: Patient had c/o "heart flutters" fell faint(fainted) and assisted safely to the ground. Patient was monitored and released. No further intervention
This spontaneous report as received from an office's vaccine coordinator via field representative refers to a patient of unknown demographics. On an unknown date in November 2013 the patient was vaccinated with ROTATEQ vial standard  second dose orally. Dose, lot number and expiry date were known. On an unknown date in November 2013, the patient developed vomiting after vaccination. The field representative had made an attempt to report these events within the 24 hour reporting period on Wednesday 27-NOV-2013 however was unable to connect with the after-hours reporting system to leave a message. The outcome of vomiting was unknown. The field representative mentioned that the events described in this report and the linked case (1312USA001450) occurred with patients who were administered ROTATEQ from the same unspecified lot number and expiry date. This is 2 of 2 reports from the same reporter. additional information has been requested.
Soreness, Redness, and Swelling from the upper left arm down to the elbow by 9/4/12. Arm feels stiff. Mild fever at 99.5 by evening on 9/3/12.
Patient had just had her blood drawn and then felt light headed and nauseated, felt like she was goint to faint.  She was taken to an exam room to lie down.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 24-Sep-2021.
Fell two weeks after immunization. Developed blood clot after procedure. Husband concerned immunization is cause of clot and not the surgery or down-time after the procedure. Transfered to new hospital from previous hospital and had significant stroke due to clot
Painful solid lumps developed in both breasts. I can not decide whether this has to be qualified as permanent damage or none of the above in Item 21, but out of precaution I prefer to have it referred to as a permanent damage as we are trying to understand what's going on.
muscle pain & weakness devel evening of 14NOV; seen by MD 17NOV92 w/marked weakness; referred to neurologist dx myelopathy secondary to Hep B vax on oral Pred;
Started to have a localized rash/warm and swellingto touch on injection site about 5 minutes after receiving vaccine. Cold compress and Diphenhydramine 25mg PO @ 0928. Rash spread to upper back and a couple spots on forehead. No shortness of breath, any trouble breathing. Medication helped with reduction of rash and swelling.
Deltoid swelled to size of a softball, redness, coughing, wheezing.