chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health care professional concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. Since the beginning of November 2016 through 17-NOV-2016, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035510, Expiration date: 13-MAY-2017, orally for prophylaxis. The vaccine doses were exposed to a temperature of 48.1F for 20 minutes. The reporter stated that the vaccine doses had previous temperature excursions of 35.6F for 1 hour, 35.5 (units not provided) for 40 minutes and 35 (units not provided) for 30 minutes. The temperature excursion was detected by a data logger. There were no adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003501: US-009507513-1612USA014191: US-009507513-1612USA014189.
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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) (unknown route) 1 dosage form. On 30-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
A Merck employee called to report an AE that was reported to her by a HCP. The HCP said her friend called her, who's daughter sees another pediatrician, and told the HCP that her daughter inadvertently received a dose of GARDASIL 9 at her four month; her daughter inadvertently received a dose of GARDASIL 9 at her four month well check up, rather than receiving her scheduled PREVNAR 20; No additional AE reported; This spontaneous report was received from a physician and refers to a 4-month-old female patient. No information on patient's medical history, current conditions and concomitant medication was provided.  On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) instead of scheduled pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (product administered to patient of inappropriate age, no adverse event and wrong product administered).
Right arm had 5cm red, induration when seen by Dr. No treatment was given. The red/induration area went away within 48 hrs. of seeing the doctor. Patient was seen by Dr. on 11-4-10.
pt recvd vax 16OCT89 & on 24OCT89 devel a fever of 10 4.2, rash & vomiting & was irritable for 48 hrs; pt recovered; pt recvd 2nd dose of vax 22JUL93 w/no problems; No further details were provided;
It was discovered on 8/23 that the dose delivered to this patient may not have been diluted.  Patitents mother was contacted 8/25 and the patient is currently without symptoms/side effects.
Possibly be giving me the diarrhea; Medicine is giving me diarrhea which is possible because lots of time antibiotics does do they; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiry date not reported) via unspecified route of administration on 10Jun2021 as dose 1, single for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. Patient enquired that possibly be giving me the diarrhea; Medicine is giving me diarrhea which is possible because lots of time antibiotics does  they do, on unspecified date in Jun2021. Consumer stated, "Yes, I was reading over the paper that they gave me when I took the shots today the first one at (withheld) and I was looking at the paper it doesn't say anything about diarrhea. Now I am on an Antibiotic and 'Microbial' (further not clarified hence captured as Unspecified medication) is the Generic for 'Microbial' and I have to got after tonight, I have to take the other one tonight, I have two more day. So, would that possibly be giving me the diarrhea. In response to patient, they informed role of Medical Information and Drug Safety for further information. Patient received treatment for the event. The outcome of event was unknown.   Information on Lot/Batch number was available. Additional information has been requested.   .
day 9 post vaccine: left arm, shoulder, and left side of neck pain and headache. Treated with Neurontin and continue darvocet prn.  Symptomatic treatment thru day 21 post vaccine.  Follow up on 12/09/03: "This civilian RN experienced a progressive polyneuropathy after receiving smallpox vaccine on 02/10/03.  EMG/NCV/MRI and physical exam are all w/in normal limits.  Although diminished from that initially experienced, she continues to have pain in the left arm and leg.  Pt has had to reduce work hrs and takes multiple daily medications to control symptoms.  Quality of life has been significantly altered.  Present medications: Celebrex, skelexin, pamelor, trileptal, zantac, prozac."
Information has been received from a physician concerning an 8-week-old patient who on 03-AUG-2006 was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (unspecified), a dose of Hib conj vaccine (manufacturer unknown) and a dose of pneumococcal 4 6B 9V 14 18C 23F conj vaccine (CRM197) (PREVNAR).  The physician reported that on 05-AUG-2006, the patient experienced rash.  It was unknown if medical attention was sought.  It was noted that the patient had no other known exposure to a rash or illness at home and there were no new foods or soaps introduced due to the patient's age.  As of 11-AUG-2006, the patient's rash persisted.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/8/2006.  Information has been received from a physician concerning an 8-week-old female with no medical history who on 03-AUG-2006, at 1130, was vaccinated PO with the first dose of ROTATEQ (Lot #653754/0139F).  Concomitant vaccinations administered on that same day included the first IM dose in the left lower thigh of TRIPEDIA (Lot #U1615AA), the first IM dose in the left upper thigh of ACTHIB (Lot #UE902AA), the first IM dose in the right lower thigh of PREVNAR (Lot #B02657B) and the first IM dose in the right upper thigh of IPOL (Lot #Y0991).  There was no illness at the time of vaccination.  Vaccinations given within four weeks of ROTATEQ included the second IM dose in the right thigh of hepatitis B virus vaccine (Lot #652093) at 0930 on 10-JUL-2006.  The physician reported that on 05-AUG-2006, the patient developed a rash.  On 11-AUG-2006, the patient presented to the office with 2mm red macules scattered on her arms, legs and torso.  By 12-AUG-2006, the patient had developed erythema multiforms minor.  It was noted that the patient had no other known exposure to a rash or illnesses at home and there were no new foods or soaps introduced due to the patient's age.  On 15-AUG-2006, the patient was changed from ENFAMIL to soy (PROSOBEE).  The patient's rash gradually faded and by approximately 18-AUG-2006 or 19-AUG-2006 the erythema multiforme minor had resolved.  Follow-up information contained the following adverse experience: upper respiratory infection (URI) (12-AUG-2006).  Additional information is not expected.
medical assistant inadvertently gave a BOOSTRIX vaccine instead of a Flu vaccine; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Tdap vaccine (In 2015 received).   On an unknown date, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 19th October 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:  20-OCT-2022 Reporters comment: The reporter reported that medical assistant inadvertently given a boostrix vaccine instead of a flu vaccine in left deltoid age was unknown. No other information provided The reporter did not consent to follow-up. Additional Supportive information: Till the time of reporting, medical assistant inadvertently given a boostrix vaccine instead of a flu vaccine , which led to Wrong vaccine administered.
I experienced symptoms of bronchitis on 06/13/2022 with wheezing, congestion, head congestion, and runny nose. I was prescribed amoxycillin clavulanate potassium tablets after I was diagnosed with an Upper Respiratory Tract infection with acute Sinusitis. I was ill for 14 days.
This is a spontaneous report received from a contactable Physician via Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received the 3rd dose of TRUMENBA at single dose on 12Apr2017 for immunisation. Medical history included seizure history of seizures but had been seizure free for years prior to receiving TRUMENBA. She was not on any medications at the time she received TRUMENBA. The patient previously took trileptal. The patient previously received the 1st and 2nd doses of TRUMENBA at single dose on an unspecified date for immunisation. On 12Apr17, the patient had had a seizure later that night.  Her exam returned to baseline the next day and she has been seizure free since. The outcome of the events was unknown; Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
First dose 6/1/21, second dose 6/22/21 Chest pain and elevated troponin, treated with ibuprofen, echo with normal function and no effusion
ON 3/19/2021 AT 11:13 A.M., THIS 28 Y/O FEMALE RECEIVED HER 2ND COVID (MODERNA) VACCINE.  APPROXIMATELY 35 MINUTES LATER HAD ONSET NAUSEA, VOMITING, AND ABDOMINAL PAIN. SHE CAME FROM THE MONITORING AREA AND WAS ASSESSED AND GIVEN 25MG BENADRYL LIQUID PO.  ALSO GIVEN SOME SPRITE.  SHE WAS MONITORED FOR ABOUT ANOTHER 15 MINUTES AND STATED SHE WAS FEELING BETTER SO RELEASED TO GO HOME.  WITHIN ABOUT 10 MINUTES, SHE CALLED BACK TO OUR VACCINATION SITE AND SAID THAT SHE HAD BEGAN TO HAVE SOME CHEST TIGHTNESS AND USED HER EPIPEN BUT WONDERED IF SHE NEEDED TO COME BACK TO THE VACCINATION SITE OR GO TO THE HOSPITAL.  PATIENT WAS ADVISED TO GO TO THE NEAREST HOSPITAL.
Rash from neck to thighs. Symmetrical rash.  Extreme redness, itching, skin warm to touch.
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 13-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
swelling & redness @ site of inj rt arm;large plum size hard area w/in swollen area;pain lasting 4 days;hardness reducing in size over time, @ present *6-12) pea size;
He has his second Pfizer vaccine on Friday 7th, his tonsil are swollen again, very swollen; almost touching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 07May2021 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Single), administration date: 09Apr2021, for covid-19 immunization, reaction(s): "Tonsillitis streptococcal", "Swollen tonsils". The following information was reported: TONSILLAR HYPERTROPHY (non-serious) with onset May2021, outcome "not recovered", described as "He has his second Pfizer vaccine on Friday 7th, his tonsil are swollen again, very swollen; almost touching". The event "he has his second pfizer vaccine on friday 7th, his tonsil are swollen again, very swollen; almost touching" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tonsillar hypertrophy.  Additional information: The reporter calling for his son, he stated on (09Apr2021) his receives the Pfizer vaccine and on next day 10Apr(Confirmed as 10Apr2021) his lymph node swollen, tonsil were swollen and by that evening at about 10 O'clock, It was so badly swollen, so took him to emergency care and they did a strep test on him and the strep test came back positive, so they prescribed him amoxicillin, So he finished the course of amoxicillin then on 04May2021 (Confirmed as 07May2021) his tonsil were swollen again then he goes back to the doctor and they did another strep test but did not find strep and they gave him Methylprednisolone and Azithromycin. So he just finish his last course yesterday. Treatment for Adverse Effect were received Amoxicillin, Methylprednisolone (4mg, orally), Azithromycin (250mg, orally tablet). Date for first shot: 09Apr2021. Start date of adverse effect 10Apr2021 Date for second shot: 07May2021. Further probing could not be done as reporter don't want to share further information. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
About 20 days after being vaccinated with my first Moderna shot in my left arm, I developed a chicken-pox-like rash on the skin of my chest, on my left clavicle, under my left arm, on my left wrist.  About 40 itchy blisters that became very sore, weak skinned and bled in the shower when I brushed over them with a wash cloth.  I also noticed a 2? circular red rash under my armpit. After about a week they are mostly healing except for under my arm which appears like I have a poison oak rash (but it's not poison oak)... I have never experienced  anything like this before and think it is a vaccine side effect.
Clotting and breakthrough bleeding for 4 weeks following 1st vaccination, then swelling of lymph nodes 48 hrs. following 2nd vaccination.
Strep throat; Spontaneous report received on 06DEC2019.  A caregiver (consumer's mother) reported that her 12-year-old daughter developed "strep throat" (PT: Pharyngitis streptococcal), while being on oral Vivotif for typhoid fever prophylaxis. On 30NOV2019, she started taking Vivotif. It was reported that after taking the second dose, she developed the symptoms of strep throat. She underwent for test culture and the result was positive for strep, which was confirmed on 05DEC2019. On 06DEC2019, she took the last dose of Vivotif. Treatment medication included antibiotic (unspecified name starting with cef)), which she started taking after three days of her last dose of Vivotif on 09DEC2019. At the time of report, the reported event was not resolved.  Medical history included allergy to amoxicillin, allergy NOS and had strep throat previously.  Concomitant medication included cetirizine (over the counter) for allergies.  Company Comment: A consumer developed streptococcal sore throat after taking the second dose of Vivotif. In response to the event, the consumer started taking antibiotic after three days of her last dose of Vivotif. Considering the infectious nature of the event, and consumer's medical history of strep throat, the causality of the event is assessed as not related.; Sender's Comments: A consumer developed streptococcal sore throat after taking the second dose of Vivotif. In response to the event, the consumer started taking antibiotic after three days of her last dose of Vivotif. Considering the infectious nature of the event, and consumer's medical history of strep throat, the causality of the event is assessed as not related.
Patient presented to ED about 5 hours after vaccine with shortness of breath and temperature 100.4
For the first week I had moderate or mild reactions the second week ( I am currently on day 10) my reactions have gotten much worse. Day 7 night was met by extreme fatigue not being able to get out of bed and extreme migraine headache. Day 8 extreme fatigue and couldn?t get out of bed. Day 9 extreme abdominal pain. Now on day 10 extreme diarrhea. This is complete crap. No one said that reactions would last a week or more. You all lied to us to get us to take this shot without knowing if it was safe for everyone.
blood bleed in his right eye; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0164), dose 2 via an unspecified route of administration on 19Apr2021 at 11:30 (57 years age at the time of vaccination) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection,  Lot#ER8732), dose 1 via an unspecified route of administration in Left arm on 29Mar2021 (57 year age at the time of vaccination) for COVID-19 immunisation. On 20Apr2021 at 09:30, this morning, consumer has a blood bleed in his eye and consumer did not see anything online that indicates a connection, is there a connection? Consumer stated consumer took a shower and when consumer got out of shower, consumer noticed it. Consumer took Eye Drops on a normal basis; Moisturizing Eye Drops. Consumer also mentioned his daughter roommate(s) sister had to go to the emergency as she developed shingles and other issues related to the vaccine. The shingles started in the eye. The outcome of event was not resolved.  Follow-up (26May2021): Follow-up attempts completed. No further information expected.
Shoulder pain lasting 2+ weeks. Patient treated with acetaminophen and ibuprofen. Suspect vaccine administered too high in arm.
Allergies: Codeine, Adhesive Bandage, Pneumococcal Vaccines; This is a spontaneous report from a Pfizer-sponsored program from two contactable physicians. A 72-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name unknown), via an unspecified route of administration on an unknown date at single dose for immunization;  codeine (trade name unknown), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced allergies: codeine, adhesive bandage, pneumococcal vaccines on an unspecified date. The action taken in response to the event for codeine was unknown. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Found on floor in office at approx 0900. Was responsive and assisted to chair, minimally responsive. SM did not appear to have fallen, but to have laid down on purpose while feeling weak. Paramedics were notified and arrived at approx 0950. He complained of dizziness and tingling hands. CBG was checked on arrival and pt's blood glucose was 40, then 30 and 29 on rechecks. Was given sugary snack/drinks and iv fluids. Medics reported weak pulse and low BP. After initial treatment, pt was able to stand with minimal assist and transfer to stretcher for transport to ER at Hospital. Upon arrival to hospital CBG was still under 50, but was alert and conversational. However hand tingling
pt recv vax 13MAY97 & devel alopecia circumscripta on the face & scalp;this hair loss shape was presented as round;pt was not hosp
Covid-19 Treatment; Covid-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Apr2022 as dose 4 (booster), single (Lot number: 057M21H), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Elevated Cholesterol" (unspecified if ongoing), notes: Elevated Cholesterol; "acid reflux" (unspecified if ongoing); "elevated A1c" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.
One hour after vaccines administered pt developed rash with erythematous wheals. Rash on trunk, arms, legs. Denied tongue swelling, denies breathing difficulties. PE: lungs clear to auscultation without wheezing. Diphenhydramine 50mg Kb IM (15mg given in L thigh at 4:55pm). Pt referred to hospital ER for further evaluation.