chrisvoncsefalvay/vaers-outcomes huggingface dataset:
only the diluent portion of Pentacel was given to a 9 month old male, no adverse event; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a nine months old male patient who was vaccinated with diluent portion of a 0.5 ml third dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL (lot number: UJ018ABA and Exp. Date: 09-Oct-2020) via unknown route in the left vastus lateralis on 27-Jun-2019. (Liquid: lot # U6215AA, exp date: 10/9/2020, Lypholized Powder: UJ018AB, exp: 10/9/2020).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique as only the diluent portion of Pentacel was administered to the patient.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
congested; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious) with onset Mar2021, outcome "unknown", described as "congested".  Additional information: The patient got first dose 2 days ago. She was congested and wanted to know if it is okay to take a decongestant.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinated with a dose of PEDVAXHIB (lot# was unspecified, 0.5 ml, intramuscular) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated that she went to the observation area and started to have difficulty breathing, the emergency squad went to the patient and advised her to get out of car and go into the squad to get evaluated and the patient refused because did not want to go to the local hospital here.  They observed the patient for 30 more minutes and determined that she needed her inhaler. but, she had forgotten it they advised again to go to hospital and patient refused.  she stated that she was fine and decided to drive to the hospital in her home town.  when she arrived they gave her a nebulizer treatment as she had wheezing and high blood pressure when arrived at hospital.    The patient stated that the physician told her that she was fine and that she just had a histamine reaction.  He stated that the blood pressure that was 179/99 prior to her leaving would go down as she was not relaxed and over excited.  Patient stated that she did take her blood pressure when she got home and it was normal. and she felt better.  she stated that if she was by herself that day, she would have never reported it, because she has had worst Asthma attack's In the past. The patient also stated that her doctor advised her to get the second shot in the series and to make sure she carries her inhaler with her when she goes.
pt recv vax 8AUG96 & 17SEP96 pt had not seroconverted;pt also indicated had a positive test for varicella antibodies in JAN94, but MD believed this was a lab error;
Muscle Pain; Headache; Nausea; Diarrhea; Sore Arm; Rash around injection site with 4 inches in DIAMETER; Tired; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th October 2019, 12 hrs after receiving Shingrix, the patient experienced muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue. On an unknown date, the outcome of the muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, nausea, diarrhea, pain in arm, injection site rash and fatigue to be related to Shingrix.  Additional details were received as follows: The patient stated that about 12 hours after getting the Shingrix vaccine, she experienced muscle pain, headache, nausea, diarrhea, sore arm, rash around injection site with 4 inches in diameter, and fatigue.  She recovered within 4 days. No further details were provided. The patient did not consent to follow up.
Left arm had significant soreness and limited movement still 1.5 weeks after injection.  After reading a couple articles online, determined it could be caused by an incorrect injection into shoulder tendon instead of deltoid muscle, causing inflammation of the tendon.  Took Aleve and it felt significantly better.  Still a little soreness almost 3 weeks later without Aleve.  Went to see worksite nurse practitioner yesterday.
The patient was administered the Pediatric Pfizer vaccine with a dose of (0.2ml).  Patient should have been vaccinated with the adult Pfizer dose  of (0.3ml).  The patient did not show any signs or symptoms of any issues with this dose.
pt recv vax 25NOV98 & 6DEC98 devel diarrhea;the diarrhea contained mucus & blood;stool cult were negative;guaiac was positive;MD changed the formula fed tot he infant & sx resolved;
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (005570). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed inflammation (chronic inflammation throughout entire body after receiving both of the vaccines), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
report a side effect/ did have side effects with these two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report a side effect/ did have side effects with these two) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Thyroid disorder NOS. Concomitant products included LEVOCETIRIZINE for Allergy NOS, MULTIVITAMIN [VITAMINS NOS] for Elderly, LEVOTHYROXINE SODIUM for Thyroid disorder NOS.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report a side effect/ did have side effects with these two). At the time of the report, VACCINATION COMPLICATION (report a side effect/ did have side effects with these two) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-391830, MOD-2021-391838 (Patient Link).
3/3/21 4:30pm: left arm soreness 3/4/21 about 1:00am: Chills/Sweats and body aches 3/4/21 6:45am: fatigue, body soreness (barely could move without pain), 99.3 fever, arm soreness, chills 3/4/21 all day: fatigue, extreme tiredness, chills, body soreness, headache, sweats, arm soreness 3/4/21 8:30pm: took 500mg of Tylenol outcome: slept through the night 3/5/21 3:00pm: moderate-severe headache and neck pain/stiffness, left arm soreness 3/5/21 6:30pm: 500mg Tylenol outcome: nothing 3/6/21 7:15am: severe headache and neck stiffness/soreness (could not move neck) 3/6/21 10:00am: 30min hot shower, head pounding when looking down then up
lost his smell; fever; lost his taste; dry skin; dry mouth; This is a spontaneous report from a contactable consumer. The reporter reported for two patients. This is first case out of 2 cases.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as unknown dose number, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lost his smell, fever and lost his taste and experienced the dry skin and dry mouth on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
I received the Pneumovax vaccine in my left arm from my private physician's nurse on Wednesday, May 28. The physician recommended the vaccine because of my HIV status. At bedtime on May 28, I began experiencing significant chills and over the course of the night was unable to sleep. By the next morning, I was soaked in sweat and had difficulty lifting my left arm without experiencing moderate to severe pain. The following afternoon, I noticed substantial inflammation and reddness around the injection site extending up my upper arm and down past my elbow. My skin was also warm and painful to the touch. At the advise of my physician, I took Benadryl on the evening of May 29. The pain and inflammation subsided by the morning of Friday, May 30, but my arm remains sore and its range of motion limited.
Area of injection became red, swollen, warm to touch and very sore. Seen in ER 07/07/02- 10:45, Given Keflex  2 gram qid x 1 day; 500 mg qid x 6 days.
On 08/03/2022 I didn't feel well when I went to sleep. Then, when I woke up the next day I was sick. I had a fever, body aches, running nose, and sneezing. I took an COVID-19 test and tested positive Then, the next day my throat started hurting additional to the other symptoms. I spoke to the doctor because I wasn't getting better and she prescribed me Paxlovid.
Within an hour of the vaccine, I started to feel a fever blister under my nose and it was very painful. I woke up the next day and I had fever blisters all around my nose and inside my nose. They were very painful, and my nose was a little swollen. I also had a big fever blister on my lip which was really big. I went to the doctor and she gave me some antibiotic cream and they went down within four days of using the cream. Several of my coworkers had similar fever blisters.
Patient was about to receive vaccination, feeling anxious (per spouse), spouse wanted us to speed it up so he can get home. After receiving vaccination, about 5 minutes later, notified by spouse, had a seizure, told to call ambulance, intern/flu administrator called ambulance, during the call patient had another seizure.
Pfizer COVID19 Vaccine in 04Jul2021 and a dose (lot 052E21A) of Moderna COVID19 Vaccine today 25Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID19 Vaccine in 04Jul2021 and a dose (lot # 052E21A) of Moderna COVID19 Vaccine today 25Aug2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized with COVID) on 06-Jul-2021 and Organ transplant. Previously administered products included for COVID-19 vaccination: Pfizer Biotech vaccine on 04-Jul-2021.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID19 Vaccine in 04Jul2021 and a dose (lot # 052E21A) of Moderna COVID19 Vaccine today 25Aug2021) (seriousness criterion hospitalization). The patient was hospitalized from 06-Jul-2021 to 13-Jul-2021 due to INTERCHANGE OF VACCINE PRODUCTS. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID19 Vaccine in 04Jul2021 and a dose (lot # 052E21A) of Moderna COVID19 Vaccine today 25Aug2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was reported.  company comment: This report refers to a case of Interchange of vaccine products for mRNA-1273 (lot # 052E21A).  with no associated adverse events. Further information has been requested.; Sender's Comments: This report refers to a case of Interchange of vaccine products for mRNA-1273 (lot # 052E21A).  with no associated adverse events. Further information has been requested.
She feels horrible like she has the flu; She feels horrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (She feels horrible like she has the flu) and FEELING ABNORMAL (She feels horrible) in a 62-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (She feels horrible like she has the flu) and FEELING ABNORMAL (She feels horrible). At the time of the report, INFLUENZA (She feels horrible like she has the flu) and FEELING ABNORMAL (She feels horrible) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant and treatment information was reported.
PNEUMOVAX given on 4/1/09 - had pain that day. Rash developed on 4/2/09 - Seen in our office 4/3/09 txd with MEDROL dose pack (5 day tx) and BENADRYL - Per Pt symptoms  totally resolved by 4/5/09.
I was woken up by severe chest pain, which continued for the next few hours. I felt the pain above my stomach, below my sternum, and above my heart, and it was a sharp, stabbing pain. My heart was also beating faster than normal.  The stabbing chest pain continued for the next few hours before eventually subsiding. However, for the next few days I occasionally felt a fleeting, stabbing chest pain. After a few days, it went away completely. I had never had such a sustained chest pain before.
No adverse responses to vaccine at this time. First vaccine was received on 08/30/21. The second  vaccine was received 09/23/2021 by RN. Currently this person in not exhibiting any adverse effects, no necessary treatment at this time, but will continue to monitor for a positive patient outcome.
pt recvd vax;shaking of extremities;T 101.6 R;jitteryness;f/u,mom states pt had v,d & hives;to MD,said pt had otitis media,acute gastroenteritis,an allergic rxn to a cough med mom was giving pt which has been prescribed for older sibling;
fever blisters on her lip; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Not re-ported), via an unspecified route of administration on 26Feb2021 as 2nd dose, single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: unknown) on an unspecified date for COVID-19 immunization. On 04Mar2021, after second dose the patient experienced fever blisters. Consumer stated that she had her second Pfizer vaccine last Friday (26Feb2021), and this morning she woke and had a couple of fever blisters on her lip. She took her fever blister medicine. She took an antiviral medication. She asked that did she negate her second dose. She was wondering if it will affect the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash developed on abdomen, back, arms,  neck. Started approximately 4/12/2021, worsened on 4/17/2021. Exam is more consistent with Pityriasis rosea vs strep vs non-specific dermatitis.
10 minutes after receiving shot, tingling both arms and brief moment of feeling like falling. Headache started quickly and remained for next 3 days. That evening more tired than usual. Next day, fever 100.2, body aches/skin, headaches, nauseated, redness on injection site with pain; toward evening SOB and Heartrate 140?s with minimal exertion ( problem I had after covid in March 2020, still have issues with it but not that high and when resting it is normal however that night resting was 120). Symptoms continued for next 2 days. Then fever broke, still tired and nauseated and large painful red bump on arm at injection site.
Patient is a new resident who was admitted to our facility on 8/11/21 after a hospitalization for a stroke.  Per her records, she received the first dose of the Pfizer COVID vaccine on 7/5/21 and had a CVA on 7/6/21 (she has a prior history of CVA's also)
This spontaneous case, was received from other-health professional (nurse) on 05-Oct-2017, concerning a 14-year-old adolescent male patient. The patient concomitant medication included Acetylsalicylic acid for an unknown indication. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195221 and expiry date: Apr-2018). The patient received vaccine that underwent temperature excursion (less than 32.54-degree F for about 25 hours). The reporter assessed the events as non-serious. Follow-up received on 24-Oct-2017: Route of administration and anatomical location was updated to intramuscular and right deltoid. As per reporter, there were no any adverse events reported after vaccination. Narrative amended accordingly.
I had a fever of 101.8F, body aches and some sniffles. I took a home COVID-19 Test that came back positive. I called the COVID-19 chat, they asked all the questions that I answered and then asked if I wanted the Paxlovid and let them know that I did want it. I started taking it immediately.
hotness, going to pass out, vomit, stomach issues, afib, swollen lymph nodes, naseau
3 hours later, 5:30 pm Heaviness in legs  9 hours later, 11:30pm low fever, chills, aches for 2 hours. Took acetaminophen for relief. Symptoms did not return.  12-27 hours later, until 5pm the next day, sheer fatigue and exhaustion. Mind seemed sharp.  No symptoms again until 3 days later, (72 hours), fatigue and heaviness feeling in head and body, headache, thirsty Sleep helped headache go. Drank water.  3 1/2 days later, in morning, woke with dizziness and vertigo like feelings. Stumbled and head fog. Dull feeling still on this 4th day. Muscles weakness in limbs, feeling faint, tightness in head, dehydrated feeling, congested.   Drinking water. Sitting. Still working desk job, teacher.
My husbands cousin had a major heart attack and is in a coma.; My husbands cousin had a major heart attack and is in a coma.; This is a spontaneous report from a non-contactable consumer. This consumer reported for a patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported husband's cousin had a major heart attack and is in a coma. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
That evening of the day of injection, L arm got sore, warm, continued getting painful to move. No soreness or other symptoms 24hrs after shot.  6 days after shot L arm site itchy, then extremely itchy. Topical hydrocortisone eased itch. Then saw red raised large patch around site, stinging/itching intermittently, is now 9 days after shot, 4 days after itching started my injection still red, raised patch and very itchy every few hours.
After 8 days a 6x 3 cm area in the area of the injection site became red, swollen  and very primitive.  It has continued for these 3 days.  No other symptoms
Rash on chest after 1st dose; Rash all over back after 2nd dose; Itchy rash on legs and chest after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on chest after 1st dose), RASH (Rash all over back after 2nd dose) and RASH (Itchy rash on legs and chest after 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m20 and 007b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash on chest after 1st dose), RASH (Rash all over back after 2nd dose) and RASH (Itchy rash on legs and chest after 2nd dose). The patient was treated with TRIAMCINOLONE ACETONIDE for Itch, at an unspecified dose and frequency and HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) for Itch, at an unspecified dose and frequency. At the time of the report, RASH (Rash on chest after 1st dose), RASH (Rash all over back after 2nd dose) and RASH (Itchy rash on legs and chest after 2nd dose) outcome was unknown. Not Provided
Several days after receiving the first Covid vaccine dose,  developed a rash.  The rash presented on both of his upper arms and both thighs.  The rash was more pronounced near the injection site on his left arm.  The bumps looked like small raised pimples without pus.  They itched.
I had headache and fever.  I feel like I am run down.  These symptoms has lasted about a 2 weeks.  I went to  the doctor about this.  I got a Covid-19 test, which came back negative.  On Friday, I started having achiness and fever.  I went back to the doctor.  She did another Covid-19 test, unknown result at this time.