chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The pharmacist accidentally gave a group of people the wrong dosage of the Moderna booster at a dose of 0.5ml. They wanted the bivalent booster, but they gave the one intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The pharmacist accidentally gave a group of people the wrong dosage of the Moderna booster at a dose of 0.5ml. They wanted the bivalent booster, but they gave the one intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The pharmacist accidentally gave a group of people the wrong dosage of the Moderna booster at a dose of 0.5ml. They wanted the bivalent booster, but they gave the one intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The pharmacist accidentally gave a group of people the wrong dosage of the Moderna booster at a dose of 0.5ml. They wanted the bivalent booster, but they gave the one intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The pharmacist accidentally gave a group of people the wrong dosage of the Moderna booster at a dose of 0.5ml. They wanted the bivalent booster, but they gave the one intended for ages 6-11).    No concomitant information was reported.  No treatment information was provided.
The patient noted the next day she had a rash come up around the injection site. She did not report it, and it continued to grow throughout the week. Her daughter came to visit her today and she told her daughter about the rash. The daughter called the pharmacy and was advised to bring her to the pharmacy or urgent care clinic across from us. The daughter brought her mom into the pharmacy to see if it was something I thought could be treated topically or if she needed to take her to the Dr. I told her after seeing her definitely the doctor. They came back later with a prescription for an oral antibiotic.
2 weeks post varicella vaccination developed 1-2 mm pox lesions; mild prodrome with mild cough, coryza.
After 2nd vaccination, client felt throat itchiness and swelling, and tongue swelling 15 minutes after. Client and guardian verbalized same adverse effects after 1st dose, and risks explained prior to 2nd dose vaccination. Client had difficultly swallowing and guardian gave client oral Benadryl which decreased some symptoms. No s/sx of resp distress, no SOB. client and guardian verbalized they did not need to be transferred to ER for further evaluation. Client and guardian left clinic @ 2:45 PM
Breakthrough COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID 19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (Breakthrough COVID 19). At the time of the report, COVID-19 (Breakthrough COVID 19) outcome was unknown.            No treatment medication was reported. No Concomitant medication was reported.  This is a spontaneous case concerning a 75-year-old male patient with no relevant medical history reported, who experienced AESI, non-serious, unexpected event of COVID-19. The event occurred on an unknown date after receiving two doses of mRNA-1273. Rechallenge is not applicable since it cannot be assessed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-360264 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 75-year-old male patient with no relevant medical history reported, who experienced AESI, non-serious, unexpected event of COVID-19. The event occurred on an unknown date after receiving two doses of mRNA-1273. Rechallenge is not applicable since it cannot be assessed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer.  Medical history was none.  There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimers disease; This is one of 30 cases reported from this site; No adverse effects noted;
Bruise on injection sight and my pulse has been above 90 even when resting.  Anxiety symptoms, headache, chills.
The day after my first dose of the vaccine I started to feel sick and tested positive for COVID-19 on 04/20/2021 after receiving the vaccine.
itching; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and URTICARIA (hives). At the time of the report, PRURITUS (itching) and URTICARIA (hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (13May2022) Negative with antigen; (15May2022) Positive on antigen test. Therapeutic measures were taken as a result of covid-19. Clinical course: No other medication in 2weeks. COVID 19 Treatment: Paxlovid. Treatment start date: 05May2022 and stop date: 10May2022. Finished 5 day course of Paxlovid, felt fine and tested negative with an antigen test on Day 8. On Day 10 (on 14May2022), tested positive on antigen test. Have a mild cough and minor congestion like mild allergy symptoms.  No follow-up attempts are possible. No further information is expected.
Second Covid 19 shot 4/23/2021, swelled when she got home and it was pink/red and felt hot. 4/24/2021 "felt crummy." 4/25/2021: Temp up to 103- fever, blood pressure low (101/41), short of breath and coarse breathing, puffy around both eyes. She felt bad (headache and stomach pain- middle to left side). Went to urgent care on 4/25 and was directed to go to emergency room. Labs and scan done. Frequent diarrhea 4/25. Sweats and chills, shakes, runny nose and diarrhea, nausea, sore throat. Last couple days (reported 4/27/2021 at appointment with PCP for follow up on reaction
SARS-COV-19 Infection. Cough, fever, loss of taste, headache, sore throat, myalgia.
Injection site soreness 8 hours later, development of flu like symptoms. Next day full flu like symptoms, muscle aches, headaches, chills, weakness. Lasted for 4 days. On day 5 lungs really became sore and O2 began dropping into the mid to upper 80s again. Patient is a previous Covid pnuemonia patient with ground glass nodules from Covid 5 months ago. The lung pains and 02 swings felt as bad as Covid pnuemonia back in October and lasted for about 2 weeks. During this time the patient started Symbicort and Abuterol inhalers again for treatment of the lung issues.
The patient has warm swelling in the left arm. The swelling is associated with generalized weakness, skin discoloration and warmth. The patient denies any bleeding. Following PPV23 injection in left deltoid. Warmth, erythema, swelling, pain pt states. Assessment Local reaction to pneumococcal vaccine, Initial encounter (TS0.A95A). Patient Plan start KEFLEX. Stop HIPREX while on KEFLEX then restart after completing KEFLEX.
Right arm pain at site of injection on 6/6/14- 6/9/14.  Discovered swollen right supraclavicular lymph node and swollen right axillary lymph node on 6/9/2014.  Right side of back near shoulder blade started hurting 6/14/14.  Icepick headaches on top right side of head here and there for 2 weeks.  On and off ear ache.  Rear right neck pain.  Tired ever since the day of the injection.  Random body aches.  Lots of anxiety because now we have to screen for cancer.
Information has been received from a medical assistant referring to a 21 year old female patient. The patient had no pertinent medical history or drug allergies. On unknown dates, the patient was vaccinated with RECOMBIVAX HB series (dose, route and lot # were not reported). There was no concomitant therapy. On 11-APR-2014 the patient had negative titers so she received a booster dose of RECOMBIVAX HB on an unknown date in April 2014. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Localized rash developed at right thigh injection site on 11/20/18. Rash grew in size over three day period but remained on leg only. As of 11/24/18, local rash primarily disappeared, however a diffusely raised and erythematous rash developed to bilateral buttocks, thighs, and calves. Benadryl was given, response currently unknown. Will be seeking follow up in medical clinic/ER if adverse reaction persists despite treatment.
developed rash over neck, chest back and top of head.  Eventually it mostly disappeared but some spots still remain.  Recommended to see dermatologist if does not totally disappear.  Also developed chest pain and just completed routine of wearing a Zio patch to see if there is any cardiac issues developed or just pain.  No results have been returned yet.
Shortly after vaccine was administered patient complained of Tingling in arms and shakiness in hands. He stated his head felt warm (99.4) and had a slight headache. After sitting in store for a while (20-30 minutes) patient felt better and went home with a slightly sore arm.
Child woke with a widespread rash covering her whole body and fever. Rash and fever worsened and persisted for 7 days.
Having 100 degree fever, 101 degree fever at night every night since I got it and I got in on Thursday; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown), via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown), via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient stated that she had a question about the second Covid vaccine which she received from Pfizer. The patient was having 100-degree fever, 101-degree fever at night every night since she got it and got on Thursday (further clarification not provided) on an unspecified date and she just wanted to know if that was normal or that something to worried about. The patient underwent lab test which included Body Temperature (Fever): 100-101 degrees on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested.
This spontaneous case reported by a consumer, describes the occurrence of taste disorder (changes in taste) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for an unknown indication. The patient's past medical history included no adverse event. On Jan 1, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On Jan 3, 2021, patient experienced taste disorder (changes in taste). At the time of the report, taste disorder (changes in taste) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Reporter did not allow further contact.
This non-serious initial spontaneous case, was received from other health professional (nurse) on 27-Sep-2017, concerning a 55-year-old adult male patient. The patient's medical history and concomiant medications were not reported. On 20-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number 18703 (as reported), expiry date: Apr-2018, route of administration: intramuscular and anatomical location: right deltoid). The patient received the vaccine under 65 years of age, which was considered as inappropriate age at vaccine administration it was reported that, no adverse event was experienced by the patient. The reporter assessed the report as non-serious. Follow-up recieved on 13-Oct-2017: The vaccine administration details were updated (route of administration: intramuscular and anatomical location: right deltoid). New event no adverse event was coded. Narrative amended accordingling.
Pt developed fever up to 103, red, swollen tender area around the vaccine spot that then spreaded to the elbow with mild movement limitation, Pt developed possible cellulitis, required antibiotic treatment.
Left posterior thigh with group of red edematous papules with central 1 mm vesicles, not painful to patient, although he has some neuropathy from his diabetes. Patient also didn't feel much pain during the biopsy process, so he either has a very high pain tolerance or doesn't have good sensation in his legs. Best fit is shingles. Bacterial infection felt to be less likely.
Patient received the 3rd dose of Pfizer COVID19 vaccine on 10/29/21. A couple of hours following this vaccine administration, it was determined that she had received the 1st dose of Pfizer COVID19 vaccine on 8/29/21 & 2nd dose on 9/20/21. The 3rd dose she received on 10/29/21 was administered 5 months too early. Patient was made aware of the error on 10/29/21. Spoke to her on 10/29/21 @ 6 hours after vaccine was given and she said she was feeling well. Made her aware she may experience typical vaccine side effects (sore arm, fever, chills, headache, fatigue, body aches), but these should resolved within 2 days. Told patient to notify employee health if she has worse side effects or if side effects persist. She verbalized understanding of this. Told patient she should NOT receive any more doses of any COVID19 vaccine. She verbalized understanding. Patient is aware this vaccine administration error is being reported to VAERS.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 26-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included Hep A vaccine (manufacturer unknown) on an unknown date (intramuscular in the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Never had a reaction, other than tenderness at injection site nothing real significant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: FL9265 or maybe EL9265, NDC, Expiry date: Unknown), administration date: 26Jan2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "Never had a reaction, other than tenderness at injection site nothing real significant"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EL9267 or might be EI9267 , NDC, Expiry date: Unknown), administration date: 16Feb2021, when the patient was 80-year-old, for COVID-19 immunization, reaction(s): "Never had a reaction, other than tenderness at injection site nothing real significant". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Never had a reaction, other than tenderness at injection site nothing real significant".  Additional information: No prior vaccinations (within 4 weeks) was administered. AE(s) following prior vaccinations was none. Patient's medical history (including any illness at time of vaccination) was none. Patient reported he did not think so of any family medical history relevant to AE(s). Relevant tests were reported as none. No additional vaccines were administered on same date of the Pfizer Suspect. Patient took first booster shot on 27Sep2021. The Lot was FE2588 or FI2588. NDC and expiry date was unknown. Never had a reaction, other than tenderness at injection site nothing real significant. There was a product complaint to report. Patient was diagnosed with Covid-19 after receiving Covid-19 vaccine and booster shots. Product strength and count size dispensed was not provided. Additional lot numbers: First Dose: FL9265 or maybe EL9265, second Dose: EL9267 or might be EI9267, first Booster: FE2588 or FI2588. It was not provided if a sample of the product available to be returned. The packaging sealed and intact was not provided. Report was not related to a study or programme. Other conditions and investigations were reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received dose from vial more than 12 hours punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial more than 12 hours punctured) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial more than 12 hours punctured). On 17-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial more than 12 hours punctured) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2021: Significant follow up received on 17-OCT-2021 and  Patient information updated, dose number and dose details updated.
Felt tired first on 12/08/2021. Next day tired, needles sensations around heart, fever, breathing issues, (asthma) body aches, headaches and nausea. Today (12 days later) abdominal pain and nausea, strong headaches and great tiredness.
The patient reported that she experienced a: Fever, Sore Throat, Headache, Muscle Aches, Chills, Runny nose, Shortness of Breath Abdominal Pains, Cough, Nausea, Vomiting, Diarrhea, and Fatigue. Symptoms started on 7/30. The patient stated that she lives with her husband who tested positive. Reported Chronic Kidney Disease, Hypertension, PROBABLE MYOCARDIAL INFARCTION> DEATH ON 8/28/2021