chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was given by (RN), Client didn't seem sick or overly nervous.  She sat on moms lap while mom answered questions about previous vaccinations.  Pfizers 6mo-4 yr covid shot was given 0.2 mL in RD. Client did not appear to be in distress after vaccination and walked out of room for 15 min wait.  During wait, mother states Patient begin to show symptoms of wanting to vomit.  Mother states client never vomited and was showing signs of feeling better when we arrived to the car.  Vital signs were taken, and snacks and orange juice were given.  Mom stated client may have just been upset that father was unable to go with them to get vaccinated.
A pediatrician reported that a 12 month old female received her 4th dose of Prevnar vaccine, in the left arm, on 4/5/01. She also received Prevnar vaccine on 8/8/00 at 4 months of age, 10/13/00 at 6 months of age and 1/5/01 at 9 months of age. On 5/23/01, at 13 months of age, the child developed an injection site reaction characterized by tenderness, induration and warmth.
first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021; Cold Chills; Shakes; Low grade fever; Headache; Fatigue/ Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021). In February 2021, the patient experienced FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021) had resolved. In February 2021, FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-430596.
Redness itching at site of administration during first 5 to 10 minutes after injection.  Progress to itching to back and left elbow - about 20 minutes after injection - 50 mg of Benadryl by mouth. C/o itching numbness to mouth, nose, and tip of tongue; also occasional cough - 30 minutes. Presented to personal physician's office for additional care: Benadryl 50 mg, IM times 2, Kenalog IM, epinephrine subcutaneuous.  Also received ProHair inhaler and adminstered several puffs.  Monitored and released after being watched for several hours.  Patient sent home with Benadryl and Prednisone prescriptions.
Headache, Myalgia, Fever, NauseaVomiting, fatigue, chills, swelling, pain and bumps under left arm pit
Developed painful swelling upper arm about 4 inches below injection site day following Moderna booster. Swelling  spread to larger area upper right arm, developed red rash, arm felt hot and very tender. Still present today (day 5 since injection). No other symptoms! NO FEVER, NO CHILLS, NO MUSCLE ACHES, just painful swollen "COVID ARM".
This spontaneous report as received from a consumer. The consumer stated she knows of others that had side effects regarding flu shotsand being vaccinated with shingles vaccinations such as ZOSTAVAX. The call was ended before further information was obtained. Additional information is not expected.
I've been a well controlled type 1 diabetic for over 32 years. After this shot, my blood sugars were randomly high for about a week. They have since resolved, but with my experience as a diabetic, I believe the random highs were related to getting the shot.
- Rash Bilat thighs & bilat hands - Severe dry skin + dry / cracked lips.  - Sore painful arm.
This case was reported by a consumer and described the occurrence of swelling arm in a male patient who received SHINGRIX. On 31st January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling arm, bruising of arm and erythematous rash. On an unknown date, the outcome of the swelling arm, bruising of arm and erythematous rash were unknown. It was unknown if the reporter considered the swelling arm, bruising of arm and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 4th February 2018, the reporter stated that, he received his SHINGRIX shot on Wednesday evening and he had some swelling and bruising on the arm that he had the shot and a red rash. The reporter wanted to know if that was normal. On 5th February 2018, an attempt was made to contact the patient, however he did not answer.
This spontaneous report as received from a nurse refers to an 13 years old male patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 31-MAR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Pt recvd 2nd dose of vax & exp joint pain, swelling of both feet, ankles & face; parotitis & fever; herpes simplex was noted about the month; pt was seen in MD office; poss serum sickness; arthralgia, sjorgen,s synd, dry eyes,  iritis, n/v;
She had not had all of the doses of Prevnar/The child had dose on 02Sep2009. She had another dose 17Nov2011; Child is ill with pneumonia; Child is ill with pneumonia; The child had dose on 02Sep2009. She had another dose 17Nov2011; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse reported that 2-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: F25578) as the second dose, via an unspecified route of administration into thigh on 17Nov2011 at single dose for immunization, received pneumococcal 7-val conj vac (dipht crm197 protein) (PREVNAR) as the first dose, via an unspecified route of administration into thigh on 02Sep2009 at single dose for immunization. There were no medical history and concomitant medications. The child had first dose on 02Sep2009, she had another dose on 17Nov2011. It was reported that previously were using paper charts. The product was documented as Prevnar. They were unsure if it was Prevnar 7 or Prevnar 13. She had not had all of the doses of Prevnar. She was not a regular check up kid. On 03Dec2019, the child was ill with pneumonia. The child went to the immediate care on 03Dec2019. Then she was admitted to the hospital on 03Dec2019 due to pneumonia. The doctor was concerned because the child had pneumonia. If she was properly vaccinated with Prevnar 13, she might not be sick right now. She had not had any recent shots. The organism she was ill with would have been covered if fully immunized. There was no record of recent vaccines. The outcome of pneumonia was not resolved.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal conjugate vaccines  in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
Had his vaccine, he had some reaction but not aware of what it was.  On 3/20/21 they found him slumped over the toilet where he had died.  His brother had spoken with him the day before and was supposed to see him on Saturday.  Brother is not aware if he had taken anything for his symptoms, probably just took some Tylenol.
Information has been received from a physician concerning a 58 year old male pt who, post vax, on the following day, presented to a physician with "right injection arm painful, irritated, and red. The pt's temperaure was normal. The following day, the pt presented to an ER room with cellulitis and swelling, twice the normal size from the injection site to below the elbow. The pt was treated with ceftriaxone disodium salt hemiheptahydrat (Rocephin). On 5/8/2000, the pt was seen in the physician's office and was still red, swollen and itchy". Additional information has been requested.
Possibly administering less than recommended doses of M-M-R II; no adverse events; This spontaneous report was received from a pharmacist, refers to unspecified number of patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, previous drug reactions/allergies were not reported. The patients' concomitant medications included sterile diluent.  On an unknown date, a nurse had been possibly administering less than recommended doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to an unspecified number of patients. Pharmacist reported that although the nurse was reconstituting with the entire 0.7 ml of the supplied sterile diluent, rather than administering the entire contents of the reconstituted vaccine, the nurse was administering 0.5mL (incorrect dose administered). This was possibly causing less than recommended dosing. No adverse effects reported.
Patient was sitting in observation area and complained of vision changes. Patient states mild blurred vision. Escorted back to EMS room. Patient laid down on cot to rest eyes and relax. SaO2 100%, HR: 86. Patient denies improvement or worsening of symptoms after 15 minutes. Discussed situation and options with patient and father further. Options of staying in EMS room, going home, or calling PCP were discussed. Father believed patient will feel better after resting at home. Patient did have increased anxiety in clinic setting and I agreed that they would be more comfortable at home. @1615: Discussed follow up care if symptoms change. Dad verbalized understanding. Patient states they are "ok" but still have mild blurred vision. Dad was ready to take patient home. Patient walked out and appeared to be managing activity without any problem., RN was notified of interaction with this patient and agreed to treatment recommendation.
tingling in my tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in my tongue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (tetanus).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling in my tongue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 26-Feb-2021 at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Feb-2021 at an unspecified dose and frequency and IBUPROFEN on 26-Feb-2021 at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (tingling in my tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided.
C/O rash x 1 day. On Augmentin x 3 doses.
Donor reports waking up with a sore arm on 02/09/2023, Donor also states she was exhausted on 02/09/2023, donor also has redness and warmth around vaccination site. Donor reports pain when contact is made with vaccination site. Donor states she still has all of the above symptoms at this time.
Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST and METHYLPHENIDATE HYDROCHLORIDE (CONCERTA) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.   This case was linked to MOD-2021-030559 (Patient Link).
As writer is giving the Gardisil patient becomes pale and diaphoretic. Patient slouches down on exam table. Head of the exam table down and patient hoisted further up on table. Call light for help pushed.  Patient not talking and squirming on table. Mask removed from patient's face. Patient sits up on own. Writer asks patient her name. Patient responds. Writer lays patient back down. Help arrives and vital signs taken: Blood pressure 124/73, pulse 93, respirations 20. Patient begins weeping stating she felt weird and didn't know what was happening. Ice pack placed on forehead. Patient states it is too cold. Ice pack removed. Patient offered juice. Sits up on own and is given apple juice. Ice water given as well. Patient states she has a little bit of nausea and a slight headache. Patient remained for 20 minutes after incident. Explained to patient and mother fainting reaction is not unusual. Both verbalize understanding. Patient states she is feeling fine. Writer walks patient and mother to lobby. Letter for school provided. Patient left with mother without further incident.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 02/17/2021 and 03/10/2021. They presented to emergency dept on 08/28/2021 for shortness of breath and were admitted to hospital the same day. They also tested positive for COVID-19 via PCR test on 08/28/2021. After several days of treatment, the individual was placed on comfort care due to poor prognosis, due to the significant underlying medical conditions. They remained hospitalized until their death on 09/01/2021.
left side aches; Swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number=1, date=05Apr2021), administration date: 05Apr2021, when the patient was 27 years old, for Covid-19 Immunisation, reaction(s): "Ovulation delayed". The following information was reported: PAIN (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "left side aches"; LYMPHADENOPATHY (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of pain, lymphadenopathy.  Additional information: Swollen lymph nodes and left side aches 12 hours after 2 nd dose. After 1st dose, delayed ovulation and period by 1 week. No change to daily routine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient had no known allergies. There were no other vaccines administered in four weeks and no other medications taken in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt arm was tingling, painful, with mark one week after vaccination. advised pt to take bennadryl and use ice/heat. And seek medical attention if no improvement
Anaphylactic shock; This is a spontaneous report from a contactable retired nurse (mother) reported on behalf of the patient. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history included COVID-19 and drug induced coma and forgetfulness. The caller stated that his son had the long haul symptoms of COVID-19. The caller stated that her son used to be a multitasker, used to do two or three things at a time, a couple of conversations at once and he could no longer do this. The caller stated that her son was also very forgetful. The patient concomitant medications were not reported. The patient experienced an anaphylactic shock and had a same rash on arms (rash as the caller experienced) after receiving the first dose of the vaccine. The caller son showed his arms to his mother and had the same kind of distribution of those little round rashes which the caller also experienced. The caller son arms looked like the callers. The caller stated that after her son received the first dose Pfizer Covid Vaccine, he could not breathe. The caller stated that her son was definitely lucky and he was still at the vaccination facility and the persons at the facility handled it. The caller stated that her son will not take the second dose Pfizer Covid Vaccine. The case was considered as serious due to the event (anaphylactic shock). The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The event anaphylactic shock was considered related to suspect drug based on strong temporal association and known safety profile of the drug.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Light-headed, fuzzy  0 HA, vision changes, 0 chest pressure, 0 SOB 0 wheezing 0 urtucaria
No Adverse event; Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.).    No concomitant medications were reported. It was reported that there were no temperature excursions involved, and the vaccine was not expired. No treatment information was provided.
Medical Assistant gave the wrong vaccine to patient. Meningitis B was given to patient instead of Meningitis (Menveo). Manager, Provider,  Team Lead and Health Department were all informed once discovered.  Parent has since be informed.
Six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The researchers found that on an unspecifies date, six of the patients developed shingles within several days of receiving the vaccine. All of the patients were women, and five of the reactions happened after the first vaccine dose. The National Institute of Neurological Disorders and Stroke also said that it's triggered by the same virus that causes chickenpox. Caller was asking if she should take a Shingles shot before getting the vaccine. Caller was surprised that we did not have any data on shingles or herpes since the Pfizer-BioNTech COVID-19 Vaccine was linked in the article and people have reported these. Outcome of the event was unknown.  Information about lot/both number has been requested.
Mom reports 1st lesions mon 1/16/06 pm few red bumps on neck extending to arms. Increase in # today.
1 day after Flumist developed mild fever, then vomiting. 2 days later, developed hive-like rash which initially stayed about the same until about day 6 when it flared into a full Stevens-Johnson's Syndrome and she was admitted to the hospital.  10/19/09:  Medical records and discharge summary received for dates of hospitalization 10/15/09 to 10/16/09.  Dx:  Stevens Johnson Syndrome/Toxic Epidermal Necrolysis. Assessment:  Presented with a 2 day hx. of macular and vesiculobullous rash with mucosal and ophthalmologic involvement consistent with SJS/TEN.  4 days prior to admission pt. had malaise, fever, vomiting and headache which resolved after taking one dose of APAP.  Rash began on face and medial thighs persisting for one day then progressing on the day of admission to trunk, arms and hands with blisters on the original sites.  Medicated with Tylenol and Benadryl with no improvement.  Also developed watery eyes which progressed to yellow drainage, pain and photophobia.  Ophthalmology consult done. Also had a sore throat, dysphasia and a nonproductive cough x 1 day.  IV fluids initiated.  IVIG therapy initiated.  Transferred to a local burn unit for supportive care.
pt recvd 2nd vax 2JUL92 & exp 5-10 mins BP 140/90, P80, resp 22, nausea, dizziness, flushed feeling SOB, h/a & DPH;
Right arm red, warm, pruritic and painful to touch with raised red area approximately 4 x 5cm with larger area 7 x 8cm not raised but red. Could not go to school. Had decreased appetite and headache. On exam, appeared to feel badly.
about 8 days after receiving my shot, i noticed muscle cramping in my hands, legs and feet. As of today, I still have some cramping but not as bad.