chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 11 year old female who on 01-Nov-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot #653938/0954F). On 09 Nov 2006 the patient developed cellulitis in the arm where vaccine was administered. Unspecified medical attention was sought. At the time of the report, the patient was recovering from the cellulitis. Additional information has been requested. This is in follow-up to report9s0 previously submitted on 12/14/2006. Entitle and follow-up information has been received from a physician concerning a 11 year old female student with a cephalosporin allergy who on 01-NOV-2006 was vaccinated with a 0.5 ml first dose of GRDASIL (lot # 653938/0954F). On 09-NOV-2006 the patient developed cellulites in the arm where vaccine was administrated. The patient's arm was red, hot, swollen, painful and tender. The patient sought medical attention. A complete blood cell count and x-ray were performed (results in reported). It was reported that the patient had an allergic reaction to cephalexin "once started." Subsequently, the patient recovered from cellulites. Follow-up information reported the physician considered cellulites to be disabling event. Additional information has been requested.
10 cm erythema and swelling and pruritus at site of injection (L deltoid).
2" red circle on rt leg where shot was given;pt has been crying cont since receiving immun on 16DEC96;
Pt arrived at health unit asking to receive a Yellow Fever vaccine as he was going to another country.  He had just left the Clinic 15 minutes prior and had received a Typhoid vaccine.  After researching interactions between getting both vaccines in one day, the yellow fever vaccine was administered.  Approximately 1 hour after receiving the Typhoid Vaccine we administrated the Yellow Fever vaccine.  Allergies were reviewed.  Asked specifically if patient was allergic to Eggs, Chicken or Gelatin.  Patient verbalized he was not allergic to any of those items.  Pt states 15 minutes after leaving the Unit, his throat started swelling, felt pressure in his ears, eyes were swollen and lips were swelling.  Patient reports he went home and took a nebulizer treatment. Patient reports he then drove himself to ER.  Patient reports he was given Benadryl IM, a steroid IM and Pepcid.  He was given a prescription of oral steroids and Pepcid.  Patient called at 3:00 pm to report VAERS and stated he was feeling better.
This spontaneous report as received from a registered nurse refers to patients of unknown age and gender. It was reported that 13 doses of ROTATEQ (doses and units were not reported) were improperly stored and administered to unspecified number of patients since 11-SEP-2014. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Left upper arm with 13cm x 13cm area of erythema and induration with swelling expanding from injection site. Tx plan: Ice, elevate, BENADRYL.
Narrative:  COVID infection following COVID vaccine series 03/31, Pfizer, dose #1 04/21, Pfizer, dose #2 11/10, Pfizer #3 12/27 COVID swab, result: detected 12/25 pt cc: cough, diarrhea, headache, rhinorrhea, sore throat exposure: unknown 12/30 clinically resolved
Information has been received from a nurse concerning a 39 year old male with diabetes, hyperlipidaemia, penicillin allergy and iron deficiency anaemia who on 12-OCT-2010 was vaccinated IM with PNEUMOVAX 23 0.5 ml (lot # 667082/0466Z). Concomitant therapy included ACTOS, simvastatin (manufacturer unknown), lisinopril (manufacturer unknown), NOVOLOG, aspirin and VICTOZA. Nurse reported that the patient experienced adverse reactions after receiving PNEMUNOVAX 23 on 12-OCT-2010. Patient called the office complaining of muscle aches, fever and redness around injection site on 13-OCT-2010. Patient was seen by the doctor on 14-OCT-2010. In the office, he complained of worsening of fever, generalized muscle ache, nausea and feeling of "hit by truck". The patient also complained his arm was very hot and tender to touch and had decreased appetite. Physician diagnosed cellulitis and abscess and prescribed BACTRIM DS. On 16-OCT-2010, patient came beck into the office. No fever was present but his arm was very sore and redness was spreading despite taking BACTRIM DS as prescribed for 2 days. Physician advised patient to go to emergency room (ER) on 16-OCT-2010 and patient received IV antibiotic in the ER and subsequently admitted to hospital. Patient received several courses of IV vancomycin in the hospital prior to discharge. On 19-OCT-2010, patient's wife called the office to inform them of patient's discharge. Physician requested follow up visit with the patient on 20-OCT-2010 but he did not show for the appointment. Additional information has been requested.
The patient's medical history and concomitant medications were reported as None. The patient previously received the first dose of BNT162B2 (lot EW0158) on 08Apr2021 at the age in left arm for covid-19 immunization. The patient stated after the 2nd dose she had around 11:00am was mostly related to menstruation and she had her period that was supposed to be coming after 7 days but suddenly after the 2nd dose of the vaccine she began bleeding with clots 1-2 hours after the 2nd dose of the Pfizer COVID Vaccine; Patient stated this was unusual for her to bleed and have blood clots in her menses that started right away and the other thing she had were body aches and fever which are normal, the fever and body aches began in the evening around 9:00pm on 30Apr2021 and then the next day she had fever and body aches the whole day and the fever and body aches are not there now and resolved the third day. Stated the bleeding was still there and is now better. She wanted to report this and got worried that one thing was unusual regarding the menstrual bleeding and will visit the healthcare professional (HCP) to make sure everything was ok in terms of bleeding and because she needs to visit her GYN doctor just to check that this was ok. The outcome of the events fever and body aches 02May2021, the outcome of the other events was unknown.
Hot, swollen, painful joints in hands; painful lumbar and sacrum/lower back--incapacitating. Saw primary care physician March 29, 2021 when OTC anti-inflammatories were ineffective.
This spontaneous report as received from a consumer refers to a 59 year old female patient with hypertension who was reporting on herself. The subject's pertinent medical history included high blood pressure. Concomitant therapies included unspecified high blood pressure medications. The patient had no drug reactions or allergies. On 27-JUN-2016, the patient was vaccinated with the first dose of ZOSTAVAX (dose, lot # and expiration date were not provided) administered via unknown route. On 29-JUN-2016, the patient experienced joint pain, X-ray was performed, no result was reported. The patient sought medical attention through office visit. No treatment was given for this adverse event. The action taken was not applicable. The outcome of joint pain was reported as not recovered/not resolved. The relatedness between the suspect vaccine and the event of joint pain was not provided. Additional information has been requested.
Pt developed a fever of 103,  he did have a heart cath done the morning of 11/14/19. Arm of the injection site where the PPSV 23 and flu vaccine was given is red, swollen and tender.  He was seen at Hospital ER the evening of 11/14/19, was diagnosed with fever and injection site reaction, possible cellulitis. Placed on Keflex 500mg .  Pt seen in the office 11/18/19 still had some redness and swelling, advised to finish course of Keflex and return if symptoms failed to improve or worsened.
Administered vaccine in subq space of pt's left arm, but mistakenly used a 1 inch needle instead of 5/8" needle when administering MMR-II which is supposed to be given subq. Pt did not have a reaction to this and this vaccine does not need to be re-administered if inadvertently given IM.
Not able to tolerate Vivotif; Abdominal pain; A spontaneous report was received from a pharmacist on 26SEP2022. It described a 25-year-old male patient who had "abdominal pain" (PT: Abdominal pain) and was "not able to tolerate Vivotif" (PT: Drug intolerance). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported that the patient took his first dose of Vivotif on 21SEP2022. On 25SEP2022, following the third dose of Vivotif the patient had abdominal pain. Reportedly, the patient was not able to tolerate the vaccine and did not want to continue with the fourth dose of Vivotif. The outcome of the reported events was unknown.  Action taken with Vivotif with respect to the event "not able to tolerate Vivotif" was not applicable and for the event "abdominal pain" it was unknown.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif for immunization, and he had abdominal pain and was not able to tolerate Vivotif (drug intolerance). Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain and drug intolerance is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took Vivotif for immunization, and he had abdominal pain and was not able to tolerate Vivotif (drug intolerance). Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal pain and drug intolerance is assessed as possible. The case is considered non serious as per medical assessment.
Rash; blurred vision; loss of balance; headache; nausea; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 27Jan2021 08:30 at single dose for Covid-19 immunization. The patient was not pregnant at time of vaccination. The Patient's medical history included Hbp (Blood pressure high). The Patient's concomitant medication included lisinopril, famotidine, and ferrous sulfate. The patient previously took Procardia and Amoxicillin; both experienced allergies. On 28Jan2021, the patient experienced rash, blurred vision, loss of balance, headache, and nausea. The patient did not received treatment for the events. The outcome of the events was recovering.  The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not tested for covid since vaccination.
p/vax pt c/o arm feeling numb like when you to to dentis;observed in clinc x 30min & numbness resolved;no resp s/s;
no adverse effects reported; improperly store PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On 16-DEC-2019, the patient was vaccinated with improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (dose and dosing schedule were unknown) (lot # S017430 with Expiration date: 18-MAY-2021) via subcutaneous route for prophylaxis. It was reported that the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was stored at a temperature of 30.78F with a time frame of 15 minutes. The previous temperature of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was lowest temperature below 36 degree Fahrenheit (30.78 F) 311 cycles. No digital data logger was involved. No adverse effects were reported. No product quality complaints were reported.
This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02347, 2012-02348, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 10-year-old male patient had received a 0.5 ml dose 5 injection of DTaP, lot number 0151F (manufacturer, route and site not reported) on 14 June 2006. The patient was 5-years-old at the time. On the same date, the patient had received a 0.5 ml dose 4 injection of IPV, a 0.5ml dose 2 injection of MMR, and a 0.5ml dose 2 injection of Hep A (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 19 January 2012 with complaints of a cough for a couple of weeks, shortness of breath (SOB), hard to breathe, headache and vomiting once after coughing. Upon examination, the patient's lungs pre-nebulizer treatment had moderate air movement and right sided coarse wheeze while post-nebulizer had good air movement and no wheeze or crackle. The physician's assessment was cough and reactive airways disease (RAD). A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 23 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was seen again on 26 January 2012 with diagnosis of cough, pertussis and RAD. The patient was treated with Albuterol nebulizer, FLOVENT HFA, Albuterol aerosol, azithromycin and prednisone. The patient had an allergy to AUGMENTIN and CEFTIN (stomach upset) and took no concomitant medications. The patient had a past medical history of bloody noses, febrile seizures, reactive airways disease (RAD), non-displaced right tibial fracture, bedwetting, croup, headache, sinusitis, pharyngitis, cholelithiasis, abdominal pain, otalgia, eustachian tube disorder, rhinitis, syncope and collapse, asthma and upper respiratory infection (URI). The patient's vaccine history included 4 previous doses of TRIPEDIA (sanofi pasteur Inc): lot number U0503AA on 11 July 2001, lot number U0513BA on 14 September 2001, lot number U0536BA on 16 November 2001 and lot number U0582AA on 28 August 2002 (routes and sites not reported). The patient was also up-to-date on HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father passed away from a myocardial infarction (MI) in August 2006, paternal grandfather passed away of an MI and maternal grandfather had an MI. The patient's mother had a history of RAD, allergies, sinus infections and weight problems. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
This spontaneous report was received from a medical assistant and refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-MAR-2016, the patient received improperly stored GARDASIL 9 (lot  number L037339 and expiration date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
CHILLS,  SEVERE HEADAKE, UPSET STOMACH, ACHING ALL OVER, DIZINESS
Approx 20 minutes after receiving vaccine pt felt the injection site was warm.  Pt came back to the Clinic and upon exam the injection site was red and was warm to the touch.  A 2 inch rash surrounded the injection site and the pt was breaking out in a rash down both arms and on her back.   RN WHNP gave the pt one Diphenhydramine HCI 50mg with a glass of water.  Pt remained at the clinic for approx 30 minutes at which time she stated she felt better and the injection site was not as warm.  Pt left the clinic to go home.  She was instructed to call her OB/GYN due to the pt being 35 weeks pregnant.  Pt was also instructed to take an additional Diphenhydramine HCI at bedtime.
Approximately two hours after receiving the Td vaccine, my daughter complained of extreme numbness and inability to move her entire left arm.  Additionally, she felt pain into her lower Trapezius muscle, and also could not feel the sensation of strokes and pressure touches to her skin along her arm, or left hand.  This occurred for over four more hours.  She was monitored continually to see if any improvement  in moving her arm, but there was none. She was given Tylenol to mediate the pain in her upper shoulder, and used an ice pack. She finally fell asleep around 11 p.m., or so.
This is a 25 year old female who presented to the ED with a possible allergic reaction from her 1st dose Pfizer vaccine.  The patient received her vaccine on 1/23/21.  Within 12 hours of vaccination, the patient developed a rash (no reported symptoms of breathing difficulty).  The rash did not resolve, so the patient went to an urgent care on 1/25 and she was prescribed 6 days of prednisone, benadryl and famotidine.  She reports that the rash continued, but waxed/waned.  She presented to the ED on 1/27/21 with ongoing rash as well as an episode of throat tightness (which developed after she took her prednisone, benadryl, and a zyrtec).    On presentation to ED, the patient's BP=123/72, HR=65, RR=16, SpO2=99%.  The provider described the rash as "warm, dry, erythematous wheal-like rash over central chest around perimeter of her face and scattered across extremities."  No other symptoms observed on physical exam. Throat tightness had resolved. Rash was considered mild and the patient was felt to be stable for discharge to home with a new prescription for Epi-pen.  Patient did not respond to post-discharge phone call follow-up.  Does not appear to be anaphylaxis,
MA inserted vaccine needle in pt left thigh. needle entered thigh and when plugger was pushed to administer vaccine syringe detached from needle all medication spilling out. MA could verify any medication was administered.
Awoke in the night with very heavy sweating, soaked pajamas and bedding. Only one episode. Gone the next day. No abiding fever or other symptoms.
Breakthrough case after Covid vaccination.  C/O feeling feverish, chills, muscle aches, runny nose, loss of taste/smell, headache, fatigue, and cough
Mother of child called to state developed a red rash over entire body 11/19/09, was seen by PCP.  States was diagnosed by PCP as a reaction to the H1N1 vaccine.  Patient not feeling well and is not eating as much as normal per described by mother.  Mother notes no environmental changes other than received H1N1 vaccine 11/16/09.
had a period for approx. 10 days after both vaccines. She was post menopausal; This is a spontaneous report from a contactable consumer (reported for herself). A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:30 (at the age of 57 years old) (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 11:15 (at the age of 57 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Hypothyroidism, post menopausal. No known allergies. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (TIROSINT). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a period for approx. 10 days after both vaccines. She was post menopausal. The event started in Mar2021. No treatment for the event. The reporter considered as the event was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
powder reconstituted with another diluent; powder reconstituted with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 424JG, expiry date 28th July 2023) and (batch number FA95N, expiry date unknown) for prophylaxis.   In August 2022, the patient received Shingrix. On an unknown date, the dose was an unknown dose. In August 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 21-Sep-2022 Reporter's comment: The clinical coordinator called for enquiry.  The reporter asked was there any safety information or any harm to patient.  The reporter asked what should they do.  The call center reported that they found 3 vials of Shingrix diluent and were doing an investigation, was unsure if three patients were given the powder reconstituted with another diluent.  The call center was unsure and did not had a specific person/patient involved at that moment due to Healthcare professional investigating back from 15th August 2022 to 29th August 2022.  The permission for consent to follow-up was denied. Additional Supportive Information: The patient was given the powder reconstituted with another diluent, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with US2022135797 and US2022135798 reported by same reporter. Two different batch numbers were reported were 424JG and FA95N.; Sender's Comments:  US-GSK-US2022135797:Same reporter US-GSK-US2022135798:Same reporter
My first menstrual cycle after the my second dose of the COVID-19 dose was immediately afterward and normal. The second menstrual cycle was late and much more intense than it normally is. I vomited from the pain and had to take the day off from work. I am now experiencing my third period since my second COVID-19 dose and my period is once again very painful, although I have not vomited from the pain this time.   The first day of my period is the worst now and I am able to manage the remaining days with extra strength ibuprofen.  Since my first period after the COVID-19 vaccine dose was normal, I am wondering if the way I am feeling is not related to the vaccine. I am also wondering if my first period was more normal because it was so close to the vaccine that my body didn?t have as strong of an immune response.  I suppose it is all good news because it means the vaccine is working! I am disappointed to undergo such severe pain (I?ve never vomited from pain before) and miss work, though.