chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came for her 2nd dose of Pfizer COVID  vaccine and was vaccinated with Pfizer(Bivalent Booster) . Patient was stable, with no adverse reaction noted. Team leads notified and Dr. was notified about the incident and instructed that patient is ok to come back in two months for her booster with Pfizer (Bivalent Booster).
Initial and follow-up information has been received from a registered nurse and a certified medical assistant concerning a 73 year old, female patient, whose reported weight was 144 pounds and whose reported height was 64 inches, who in January 1999 was vaccinated with a first dose of Pneumovax 23. In February, 2007, the patient was vaccinated intramuscularly into the left arm with the second dose of Pneumovax 23, (lot # 655586/0881F). Subsequently the patient's arm became swollen, red and painful. The patient developed a local reaction to the vaccine. Unspecified medical attention was sought. At the time of the report, the patient had recovered. Additional information has been requested.
varicella exposure 23APR97;varicella vax 29APR97;pupils unequal 30APR97;seen in clinic 1MAY97;rt pupil w/adhesions;seen ophtholmology 2MAY97 uveitis rx steroid gtts;varicella 1st day 7MAY97 rx Acyclovir;
experienced blurry vision after receiving Bexsero and Menveo on the same day; This case was reported by a physician via call center representative and described the occurrence of blurred vision in a 6-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Bexsero and the 1st dose of Menveo. On 26th September 2020, 1 days after receiving Bexsero and Menveo, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was recovered/resolved.   It was unknown if the reporter considered the blurred vision to be related to Bexsero and Menveo.  Additional details were reported as follows: The patient received Bexsero and Menveo vaccines on the same day and experienced blurry vision. Physician stated that the symptom started the following day and the last week the vision improved, and the patient was recovering. The reporter consented to follow up.
Angioedema of lips, left hand and soles of bilateral feet. Rash to face, full body itching
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine administered to total 24 patients including 15 males and 9 females, mostly for booster shots. No side effects was reported. No concomitant medications was reported. No treatment medications was reported.
Vaccine was not diluted before drawing. Patient received twice the recommended dose. No significant side effects or adverse events noted as of 6/28/2022.
facial drooping; chills; nauseated; tired; stomach cramping; a little wheezy; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), dose 1st via an unspecified route of administration, administered in Left arm on 23Mar2021 14:00 as single dose for covid-19 immunisation. Medical history included Immunocompromised. Concomitant medications included levothyroxine sodium (SYNTHROID), amlodipine, eszopiclone (LUNESTA), rabeprazole. The patient previously took hydrocodone, oxycodone, augmentin and experienced Known allergies. On 24Mar2021 13:00, patient experienced facial drooping, chills, nauseated, stomach cramping, tired, a little wheezy. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and nasal swab was tested post vaccination. The outcome of the event was recovering.
swollen lymph nodes; A spontaneous report was received from a  Consumer husband concerning a who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event Swollen lymph nodes.  The patient's medical history was not provided. No relevant concomitant medications were reported.    The vaccination details are not provided.  The event details are not provided  Laboratory details was not  provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event outcomes are not reported.  The reporter assessed the event, Swollen lymph nodes related to study drug.
Varicella outbreak 3/18/2004. Had varivax administered 6/26/1998. Chickenpox noted left arm
Patient has not reported any adverse reactions at this point however patient received two Pfizer booster shots separated by  2 months (10/5 and 12/2/21)
INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site soreness was not reported. This report was non-serious.
Low grade fevers (99.9 - 100.2), cough, & sore throat.
Numbness lt shoulder to finger tips- neck boil-like rt eye hot & like "hot oil".
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HAV (Havrix) (batch number D94MK, expiry date 5th July 2021) for prophylaxis.   On 24th August 2021, the patient received Havrix. On 24th August 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: Medical Assistant reported that, the patient received an expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Bilateral arm pain and stiffness, bilateral clavical pain, neck pain started a day after vaccine and remains to this day 7/5/2022, I have not been the same after the 3rd vaccine and have yet to get a solid diagnosis aside from some sort of cross between polymyalgia rheumatica/fibromyalgia prompted by an overreactive immune response to the booster
On 7/7/14 HCW reported redness to injection site. On 7-8-14 the redness and firmness measured 5ins by 5 ins and was painful. Evaluated by MD on site.
A report has been received from a Health Professional concerning a 9 year old, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on 13-Jan-2014. Office manager reported that on 13-Jan-2014, the administered some expired FLUMIST QUARDIVALENT. Not reporting any symptoms. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by reporter.
chills; slight fever; arm  started to ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  started to ache ), CHILLS (chills) and PYREXIA (slight fever) in a female 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.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm  started to ache ). On 19-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (slight fever). At the time of the report, PAIN IN EXTREMITY (arm  started to ache ), CHILLS (chills) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
3 hrs p/vax to mid anterior thigh  pt exp pain & dec motion; rx Ibuprofen
headache, injection site muscle cramps, squeezing sensation where she received injection, muscle spasms in stomach and back, intense chills, upset stomach, nausea, intense smell of boiled eggs,
Information has been received from a nurse concerning her medical assistant colleague, who is a female in her thirties.  The medical assistant was vaccinating a patient with Gardasil on 06-NOV-2007.  Subsequently, the needle popped off the pre-filled syringe and the medical assistant was splashed in her eye.  The reporter did not know which eye was splashed.  The medical assistant went to the eye station and washed the splashed eye with water.  The reporter stated that this was staff error and not a product quality complaint.  The medical assistant is fine, but her eye feels irritated, which the caller says may be due to the washing and rubbing of it.  The medical assistant is recovering.  Additional information has been requested.
Pt recvd 3 doses of Engerix-B 19FEB91, 19MAR91 5SEP91 & it was determined that pt did not convert p/vax series;
Information has been received from a physician, via a company representative, concerning a 42 year old male, with type I diabetes mellitus, blood pressure and cholesterol, who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown). Concomitant therapy included blood pressure (therapy unspecified) and cholesterol (therapy unspecified) medications, and insulin.  Subsequently, the day after the vaccinations and for the whole week, on an unspecified date, the patient experienced lost total control of his sugars and had to take twice the amount of insulin to maintain proper levels.  The physician noted that he is a reliable patient that maintains good control of his glucose levels normally.  The patient also suffered arm soreness the day after this vaccination.  Subsequently, 1 and a half weeks post vaccination the patient's glucose levels were back under control and the patient recovered from arm soreness.  No product quality complaint was involved.  Additional information has been requested.
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter
Delayed Anaplyactic Shock. Patient awoke with swollen face and trouble breathing. She went to Urgent Care. She was given an IV steroid that helped. Further details of treatment are unknown to me.  She was still experiencing swelling of the lips the day after (03/24/21) that was self treated at home with oral Benadryl.
Dose 1 (box 11) Pain injection site, reaction to previous exposure to vaccine Dose 2 sleep excessive, nausea, headache, feeling unwell, injection site induration, injection site pain
Information has been received from a physician, via a company representative, concerning a 7 year old male, with unknown medical history and unknown drug reactions allergies, who on 19-OCT-2001 was vaccinated (route unknown) with a dose of Varivax (Lot # unknown). On 05-MAY-2006 the patient developed chickenpox. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
The needle injected into the patient's arm became loose when pulling the syringe to administer the vaccination. All the medication spilled onto patient's arm.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M022086, expiration date 09-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 47 and 77 degrees Fahrenheit (51F) for 30 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. Additional information has been requested.
Fever, abdominal pain, nausea, vomiting and diarrhea.
Affected the eye; white spots like glaucoma appeared 2 days after the vaccination, and has persisted. Pt also reports fatigue.
severe diarrhea; sick like nausea; pain/body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain/body aches), DIARRHOEA (severe diarrhea) and NAUSEA (sick like nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (pain/body aches) and NAUSEA (sick like nausea). On 29-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea). At the time of the report, PAIN (pain/body aches), DIARRHOEA (severe diarrhea) and NAUSEA (sick like nausea) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.  .   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received: reporter mailing address was updated
Pain in injection area, body aches, headache, fatigue.  Felt like 24 hour flu.  Took ibuprofen.  Symptoms resolved after approximately 24 hours.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided. .
Developed rash typical of Varicella Zoster, left forehead, eye and scalp with headache on 3-7/07. Treat with Acyclovir 200 MG TID x 10 day just diagnosed.
Patient came to ED feeling weak and low heart rate.  Patient admitted to the hospital with covid and bradycardia.
chest pain on the left side; neck pain also on the left side; This is a spontaneous report received from a contactable consumer, the patient. A 25 years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route on 19Mar2021 at 15:45, (at the age of 25-years-old) on the left arm as a single dose, for COVID-19 immunisation. The medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. On 19Mar2021, at 16.30, after an hour of vaccination, the patient experienced slight chest pain and neck pain on the left side. No treatment was received by the patient for the reported events and the events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chest pain on left side and neck pain on left side was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Violently sick after Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Violently sick after Moderna vaccine) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Violently sick after Moderna vaccine). At the time of the report, ILLNESS (Violently sick after Moderna vaccine) outcome was unknown.            No concomitant medication provided. No treatment information provided.
cough, chest congestion, runny nose, SOB, slight headache, startin g1/16/2022
No additional AE; Nurse reporting a temperature excursion for VARIVAX that occurred on 10/10/2022 states a dose has been administered. No additional information provided. No additional AE/PQC  Names of vaccines involved: VARIVAX: U032852 10/20/2023        ?    Tempe; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 10-OCT-2022, the varicella virus vaccine live (oka/merck)(VARIVAX) lot # U032852, expiration date 20-OCT-2023 had a temperature excursion of 6.8 degrees Fahrenheit for 30 minutes, and on 22-OCT-2022 0.5 milliliters were administrated to a patient (product storage error). No adverse event was reported.  There were no previous excursions detected.
The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; This spontaneous report was received from a nurse, referring to a child patient between 1 and 2-year-old of an unknown gender. The patient's pertinent medical history, previous drug reactions, allergies, or concomitant medications were unknown by the reporter.  On an unspecified date, the child was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose administered subcutaneously, as "routine vaccination" (lot number S027459 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) (vaccination scheme and anatomical site of injection were not reported).  On an unspecified date (also reported as "within 1-10 days of administration"), the patient experienced fever (pyrexia) and rash. According to the nurse, it could be chickenpox (varicella). The patient sought medical attention, however, no treatment was given for the events and the patient did not have any laboratory diagnostics or studies performed.   The outcome of the events pyrexia, rash and varicella was reported as recovered. The causal relationship between the abovementioned events and therapy with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) was not reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001874: US-009507513-2006USA008951: US-009507513-2007USA001873:
Patient received her Pneumovax 23 vaccination, 8+ weeks after receiving Prevnar 13.  She has a hx of breast cancer and had a bilateral mastectomy in Sept 2014.  She did not notice any immediate adverse reactions, but by the evening of 12/04/2014 she noticed increased pain and redness.  On 12/05/2014, the pain was worse and the skin around the injection site was red and swollen.  She had some limited range of monitor in her arm, due to the pain.  She denied any itching and the reaction was localized to an area about 6 inches or so around the injection area.  She did state that she reviewed her vaccination information sheet and saw that 60% of patients experience pain and 1 in 3 may have redness/swelling.  She asked me (a pharmacist at the hospital) to report her reaction.
Information has been received on 01-MAR-2019 regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-SEP-2012, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. The patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.