chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When patient came in for their second dose of Pfizer toddler primary dose series, I was filling out the CDC for the patient. I noticed that the lot number for the first dose was a pediatric Pfizer lot number. Initially I was not sure if it was a clerical error or an incorrect vaccine was given. I notified the parent that the child received Pediatric Pfizer vaccine instead of toddler upon speaking to the pharmacist on duty on 6/26/22. The pharmacist was not aware that there was a separate vial for toddler Pfizer vaccine (maroon color). The parent stated that the patient did not experience any side effects as a result of the first dose (pediatric dose- orange cap). Error was discovered on 7/17/22.
This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: WE0158) via an unspecified route of administration in the left arm on 16Apr2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 23Apr2021, the patient experienced severely delayed menses. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severely delayed menses was not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: WE0172) via an unspecified route of administration in the left arm on 07May2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports severe arm pain and lack of mobility at injection which increased over the rest of the day. She used over the counter products and we advised her seek medical help instead of self help. She went to the doctor, but pain medication did not relieve her pain. She was referred to the ER, where Xray was performed. Patient was not clear about what was revealed in the Xray, if anything. She reported to us on 11/11/20 the events of the last few weeks since the initial conversation. It is now 6 weeks later, she is feeling some improvement, but still can not sleep or fully lift the arm without pain.
these hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said that after received 1st shot of Shingrix it hurt. No contact details were reported. For tolerance in 2nd dose refer case US2021AMR175027.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175027:Same reporter
Left upper outter arm red, hard and swollen, itchy seen by PCP 11/27/07 TX: Tylenol and Benadryl, Follow-up visit in 1 week.
Vaccine local reaction. No need to further deter DTaP. Lt anterior thigh with flat macula rash. Swelling injection site. If worsen or develop further s+s RTC.
An itchy rash that started at the injection site the morning after injection. It is raised, and red, warm to the touch. After calling the pharmacy which gave the shot they advised to use BENADRYL cream and or ibuprofen. Advised if the rash got worse to go to my campus health center which will be done in the morning.
Pt recvd Engerix-B & on the following dates; 9JUL91, 9AUG91, 9JAN92 pt is reported as being a non-converter booster dose of Engerix-B given 30APR92; also in AUG91 pt underwent a thyroidectomy;
Administered with the vaccine from vial which has been punctured for more than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that 12 patients received vaccine punctured more than 12 hrs.
Swollen lymph nodes.  Still swollen to this date.  Severe body aches, headache, dry cough.  My biggest concern is that my lymph nodes are still swollen when it was just the booster shot.  I had a bad reaction to the second shot as well.  Same side effects except my lymph nodes were only swollen for about two days.
Diagnosis - Acute myeloid luekemia   Treatment was chemo.  Symptoms- back pain, leg pains, shortness of breath, forgetfulness , red spots on arms
COVID Positive self test; COVID Positive self test; Chill; body aches; running nose; coughing; mucus build up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3247), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No known allergies. The patient was not tested positive for covid 19 prior to vaccination and had been tested positive post vaccination. Facility type vaccine reported as workplace clinic. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04May2022 at 18:00, outcome "unknown", COVID-19 (medically significant) with onset 04May2022 at 18:00, outcome "not recovered" and all described as "COVID Positive self test"; CHILLS (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "Chill"; PAIN (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "body aches"; COUGH (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "coughing"; INCREASED UPPER AIRWAY SECRETION (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "mucus build up"; RHINORRHOEA (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "running nose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2021) Negative, notes: Nasal Swab; (04May2022) Positive. Therapeutic measures were not taken as a result of covid-19, chills, pain, rhinorrhoea, cough, increased upper airway secretion.
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 73-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergies: amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: very positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received vaccine. No other medication in 2 weeks. Patient received treatment with Anti-viral for COVID 19 from 08Jul2022 to 12Jul2022. Rebound 4 days after completing course of Paxlovid, developed heavy sinus congestion, sneezing, runny nose and very positive antigen test.
pt  received the  third dose of Pfizer COVID that had expired. This vial was prepared more than 12 hrs prior to injection, and its window of stability haf already passed when pt received this vaccine. When contacted pt once this error was identified, she did not experience any side effect from the dose. Pt will come back to pharmacy to get re-vaccinated.
Patient had a reaction after her first shot because it was given subcutaneously; Patient had a reaction after her first shot because it was given subcutaneously; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had a reaction after her first shot because it was given subcutaneously) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had a reaction after her first shot because it was given subcutaneously) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a reaction after her first shot because it was given subcutaneously) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had a reaction after her first shot because it was given subcutaneously). At the time of the report, IMMUNISATION REACTION (Patient had a reaction after her first shot because it was given subcutaneously) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had a reaction after her first shot because it was given subcutaneously) outcome was unknown.   The action taken with mRNA-1273 (Spikevax) (Subcutaneous) was unknown.   No concomitant medications were provided.  The patient stated that her second shot was better because it was not subcutaneous. The patient also stated that she called Moderna two years ago but did not have a case number.   No treatment medications were reported.
Client was given 2nd dose of Novavax from a lot number that expired on 2/28/23.
not doing well; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (not doing well) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not doing well). At the time of the report, MALAISE (not doing well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
pt recvd flu vax & exp intense itching; 28OCT92 devel redness, rash & swelling of the arm of inject from the shoulder to elbow;
Menstrual cycle - heavier and multiple cycles. Started menstrual cycle 4 days after receiving vaccine (irregular timing and irregular bleeding). 4 weeks of periods to follow. Started progesterone and it eased but has not completely resolved.
his son developed myocarditis after Covid shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown ,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "his son developed myocarditis after Covid shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
48 hours MENACTRA 1st developed tingling of right foot. area also felt cold. No weakness, denies numbness. Few hours after onset of right arm symptoms patient also described same in right arm. Completely normal neurologic exam within 5 hours of symptom onset. Patient reports symptoms completely resolved by 9/19/07 (5 days after onset).
Nothing major, just Constant Itchy Palms in both hands  Have taken Benadryl twice and that stops for a day or do Then it starts up again .  My question is will it eventually stop? Or will it get worse after my second dose?
5 year old child who received a booster dose of the Moderna COVID-19 vaccine by accident; some soreness in left arm, at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some soreness in left arm, at the injection site) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old child who received a booster dose of the Moderna COVID-19 vaccine by accident) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93909) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In November 2021, the patient experienced VACCINATION SITE PAIN (some soreness in left arm, at the injection site). On 21-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old child who received a booster dose of the Moderna COVID-19 vaccine by accident). On 21-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old child who received a booster dose of the Moderna COVID-19 vaccine by accident) had resolved. At the time of the report, VACCINATION SITE PAIN (some soreness in left arm, at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the five years old patient received a booster dose of the Moderna COVID-19 vaccine by accident on 21-Nov-2021. The patient was supposed to get the Pfizer pediatric vaccine first dose, but the HCP gave the patient, the Moderna COVID-19 booster dose of 0.25 ml as the patient's first dose.  No concomitant medications were reported.  No treatment information were reported.
Note that date/time are approximate. Initially had some shortness of breath, then noticed right arm tender and red on 12/2012. Called on call doctor on 12/12 and was advised to use Benadryl and ice over her arm. Benadryl resolved the shortness of breath that she had experienced. Seen in office 12/14 and still has an erythematous area on right upper arm12 cm x 5 cm in size.
This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. On 15-MAY-2017, the patients were vaccinated with VARIVAX lot # M046005, expiration date 18-NOV-2018 that might have underwent temperature excursions of -14 to -10 degrees Celsius for 1 hour and -9 to 8 degrees Celsius for 2 hours reconstituted in sterile diluent. No adverse experience was reported. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA015663:
Information has been received from a certified medical assistant (C.M.A.) concerning a pediatric patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-MAR-2016, the patient was vaccinated with an expired dose of VARIVAX (Merck), the second dose in series, 0.5 ml expiration date 06-MAR-2016 (lot # unspecified), subcutaneously. No adverse effects were reported. It was also reported that therapy with VARIVAX (Merck) was continued. Additional information has been requested.
I  had my first Pfizer dose on 3/16, I  immediately got hot and flushed with high heart rate and heart palpitations.  I  was assured by multiple doctors that this was "normal". I  was rushed to ER with sever pain my left leg and chest pain on 3/24/21. I  was instructed this was all my anxiety and it was safe to receive the second dose.  The anxiety and severe brain fog did resolve within 2 weeks. I  stupidly received the second dose 4/7/21. I  was fine for 3 days until I  got severe ear pressure, severe vertigo, low blood pressure, high heart rate, GI symptoms, severe brain fog, anxiety, neurological issues and palpitations.  9 weeks later and I  am still not recovered form the inflammation and Pfizer admitted "severe adverse reaction". I  reported this to V-Safe and heard nothing back.
A rash developed seven days after shot on chest and stomach a little on arms very itchy red bumps
Administration Error:  This patient was 17 years old and received a Moderna vaccine (approved for 18 years and older).  Patient was seen by PCP in clinic for annual wellness exam.  Covid vaccine was offered and he agreed.  PCP placed an order in chart for Moderna.  No alert generated.  Moderna was administered and no adverse effects were noted.  Patient will proceed to get Moderna for dose #2 later this month.
07Mar90 pt vax;  2 weeks later devel indurated lesion at inject site, low grade fever, fatigue, & single enlarged axillary lymph node.  WBC on 29Mar90 5700 w/ 6 atypical lymphocytes; pt was afebrile.  Sx remitted.
Friday, approximately 5:00 pm, my wife and I were leaving home to drive to grandson's baseball game.  Out of the house and on the driveway I became confused, couldn't speak, felt "clammy" and began to perspire, and couldn't drive.  My wife was asking me questions and I couldn't answer wedding date, her DOB, etc.  The symptoms disappeared after 10-15 minutes but I felt almost the same as the minimal symptoms I had with my Covid positive, January 14.  (My Covid experience resembled having a Cold).
Hives on right and left leg; off label use; other vaccine same date vaccine date 13Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Sep2021 12:00 (Lot number: FC3182) at the age of 46 years as dose 2, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 13Sep2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Generalized Anxiety" (unspecified if ongoing); "ADD" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; ADDERALL; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=FC3180, administration date=18Aug2021, administration time=10:00 AM, dose number=1, vaccine location=Left arm), administration date: 18Aug2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 13Sep2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 13Sep2021, outcome "unknown", described as "other vaccine same date vaccine date 13Sep2021"; URTICARIA (non-serious) with onset 13Sep2021 16:00, outcome "not recovered", described as "Hives on right and left leg". Therapeutic measures were not taken as a result of urticaria.  Additional information: The patient had no known allergies. The patient received other vaccine on the same day of Pfizer vaccine. Hives on right and left leg about 4 hours post injection. Facility type vaccine was Pharmacy or Drug Store. The patient took other medication in two weeks. The patient did not receive any other vaccine four weeks. The patient had no covid prior vaccination, and had not been tested for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
A nurse reported that a 3 year old male received a dose of Pnu-Imune 23 vaccine on 7/19/01. The next day, he developed an injection site reaction characterized by redness, swelling and was unable to bear weight. The child has a history of asthma and was concomitantly using inhalers. Additional information received from the reporter on 8/15/01, indicated that the pt was prescribed an oral antibiotic on approx. 7/21/01. The pt recovered.
Pain at the injection site at first, as expected. Then a round, hot, red area at the injection site...as expected. The heat/fever at the site disappeared by Sunday 10/17 but there was still some pinkness - a whole circle area around the injection site. The area has also been itchy on and off. The mark is still visible, and it's still itchy on and off, even a week after the shot.
I can't read; My back has been hurting really bad; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, , Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced i can't read, my back has been hurting really bad. After vaccination they gave me a list of side effects, but I can't read. My back has been hurting really bad since then. Is that a side effect to the shot?" The outcome of both events was not recovered.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.