chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of facial asymmetry in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced facial asymmetry (serious criteria GSK medically significant), shingles and red face. The patient was treated with famciclovir (Famvir) and ophthalmologicals (Eye Drop Medication {Nos}). On an unknown date, the outcome of the facial asymmetry and red face were unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the facial asymmetry, shingles and red face to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX on another location. The patient's age at vaccination was not reported but it could be 76 years or 77 years. The patient was started on Famvir and steroidal eye drops in February 2019 due to the shingles being close to their eye. The patient had almost like a bells palsy to one side of face from the shingles, which was chronically red. In 2019, the patient was recovered from shingles bout.
Patient developed pain in lower half of left upper arm and left elbow joint the day after receiving the vaccine.  Now one month later, there is still pain in the left elbow, but it is less than it was before.  No swelling noted in left elbow.
headache, nausea and vomiting, pain (tingling at times) in the shoulders, legs, and buttocks
Patient became dizzy, pale, diaphoretic and clammy after vaccines given.  Patient placed flat on floor and then vomited twice.  Cool compress applied to neck and allowed to remain in a recovery position for 20 minutes.
Rash on trunk , back and Neck 2 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on trunk , back and Neck 2 days after first shot) in a 58-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on trunk , back and Neck 2 days after first shot). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on trunk , back and Neck 2 days after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  It was reported that it was like the first dose of Moderna COVID-19 vaccine on a Wednesday, and had a Rash on Friday on trunk , back and Neck. She took Benadryl and the rash disappeared within 24 hours.   This case was linked to MOD-2021-378159 (Patient Link).
Patient came to vaccination site to recieve her 2nd primary Moderna vaccine. 1st Primary Moderna administered on 1/19/2022 at same vaccination site. She did recieve her 2nd Primary on date stated above, which is 7 days too early for this vaccine. She did not report any adverse effects in her observation time period and safetly left the site. Troubleshooting: reviewed dates between Moderna shots specificially with scribe, vaccinator and scribes at registration. Was not reported, found in data mining.
Event happened after 2nd dose. This is a 56-year-old gentleman who presents to the emergency room for evaluation. e states that he has had an ongoing cough and shortness of breath. Treatment: Tylenol, zinc sulphate
Information has been received from a physician concerning a 74 year old female patient who "1 week ago" on approximately 18-MAR-2009 was vaccinated with ZOSTAVAX (Merck) subcutaneously. Subsequently the patient experienced an exacerbation of chronic obstructive pulmonary disease (COPD) after receiving ZOSTAVAX (Merck). The patient had sought unspecified medical attention via a phone call. No lab tests were performed. At the time of reporting the patient's exacerbation of chronic obstructive pulmonary disease (COPD) persisted. Additional information has been requested.
Fever (103) for several hours, chills, dizziness, vomited once (prob from dizziness), extremely achy muscles entire body. Next day, drained, and a bit achy, but able to go to work.
Received 0.25ml Moderna booster 3 months after J&J vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml Moderna booster 3 months after J&J vaccine) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine in August 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concurrent medical conditions included Immunocompromised.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml Moderna booster 3 months after J&J vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml Moderna booster 3 months after J&J vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient was immunocompromised and the pharmacist was wanted to know when it would be possible for the patient to received the second booster dose from Moderna.  Treatment information was not reported.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 26-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J0006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Pericarditis - sharp pains in the chest; CVT - intense headache in top right of skull, went to emergency room; lower leg and thigh pains for months awakening late at night; Tinnitus.  None of these conditions was present prior to vaccination.
Stiff neck; Headache; Shooting pains; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EC9263, Expiration date: unknown), via an unspecified route of administration in arm right on 19Feb2021 (at the age of 80-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EC3247, Expiration date was not reported), via an unspecified route of administration in arm left on 29Jan2021 (at the age of 80-years-old) as a dose 1, single for COVID-19 immunization and experienced COVID-19 and sore arm. Enquired, the reporter, who was a female patient, aged 80, received second dose of Pfizer vaccine on 19Feb2021. Stated that, starting Saturday morning on 20Feb2021 and continuing into today, the patient was experiencing a stiff neck, shooting pains and a bad headache. Enquired, was this a side effect of the vaccine. Stated that, she has a very stiff neck that gives her headache and shooting pains when she moves her head at all. Stated that, with her first shot all she had was a sore arm. Stated that, the reporter wanted to know whether this was something they have heard of, related to the vaccine. The events stiff neck, headache and shooting pains when moving head were reported as worsened. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
expired tenivac was given to a patient with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jul-2023, the patient received expired dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult suspension for injection (lot: U6922AA, Expiry date: 22-Jan-2023) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation) with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial unsolicited report received from nurse on 29-Aug-2018. This case involves a seven years old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH DOSE (Batch number: UI981AB, expiration date: 16-Mar-2019, route: Intramuscular and site of administration was Left Arm) on 29-Aug-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration (FLUZONE HD given to pediatric patients). No adverse event symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
devel sz 8 or 9 mon p/vax-before this event began exp numbness in lt hand tested for MS & other problems all negative;
Injection site soreness and headache within 1 hour after shot. Fever, chills, headache, body aches, nausea, chest pain, joint pain, stomach cramps and diarrhea. These symptoms started once I woke up at noon and became progressively worse throughout the day.
T104-105;TEMPRA GIVEN;MOM TOLD KIDNEY AND BLADDER INFECT;
Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-APR-2012 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-DEC-2016 the patient was treated by a physician for blistering vesicular outbreak which had spread to the eyes and was then diagnosed as herpes zoster, or shingles with ophthalmic interference. The patient was treated again by the physician for ongoing and worsening symptoms of blisters forming on the eyes and forehead. The patient was prescribed acyclovir to help manage his recurrent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Patient accidently received fluzone hd. She said she already received the flu vaccine last week.
Patient presents to the ED with shortness of breath. Patient admitted for further evaluation and treated with remdesivir.
Information has been received from a medical assistant concerning a female medical assistant. On 12-AUG-2008 the medical assistant was preparing to attach a needle to prefilled GARDASIL syringe (Lot # 0250X) when the vaccine splashed into her left eye. She was going administer the injection, so before she attached the needle, she was trying to take off the gray colored syringe tip cap, when the plunger popped out through the back end and the vaccine splashed into her eyes. The safety device did not activate. The needle was not attached. The syringe was empty and there in no vaccine left. the syringe was the first one on the right side of the tray, when they took it out for use. There was no damage to the package or the tray. The medical assistant has been administered GARASIL vaccine for a long time. When the vaccine splashed into her left eye, she immediately flushed her eye. The eye was irrigated but still "Burns a little." There was no redness or pain. There was slight burning sensation and irritation in her sinuses. No visual problems are noted. At the time or the report the patient had not recovered. Information has been received from a medical assistant regarding GARDASIL in a prefilled syringe (lot number: 0250X). It was reported that the plunger of the vaccine prefilled syringe "came out the wrong way" as the tip cap was being removed. SR Number: 1-3088949518. Additional information has been requested.
pt recvd measles vax on 24JAN92 & 31JAN92 devel t102 & sunburn like rash on face; pt presented to MD's office on 3FEB92 & the rash had petecchial character;
5/23/07 Zostavax. 5/24 hair dyed. developed rash past neck. Saw derm, given triamcinolone and Benadryl. About 2 wk later developed itchy rash lower 1/2 of back. 7/3/07 I called VAERS and was referred to CDC, was told no rashes of this type reported with Zostavax
H & P states m, 2 weeks after second vaccine, developed myalgias, arthralgias, swelling and generalized weakness, seen in clinic and started on oral corticosteriods,  9/19 to ER and admitted , given IV,,,,,,,, fluids, steriods. co of increased joint pain, and swelling of upper extremities
No adverse effects or symptoms reported; patient received ROTATEQ intramuscularly rather than orally; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  08-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742463, expiration date was reported as 20-AUG-2022, but upon internal validation established as 20-SEP-2022) intramuscularly rather than orally (Product use issue) for prophylaxis. The patient received full 2 ml dose in one leg as two separate injections of 1 ml each. No adverse effects or symptoms reported (No adverse event).
5 days p/vax pt c/o rash, urticaria, nausea & dark (orange-brown) urine;
Patient was admitted to the critical care unit with severe sepsis secondary to proteus UTI and possible septicemia, bilateral hydronephrosis secondary to renal calculi. Patient was placed on palliative care and discharged to a hospice facility.
Profound dizziness. Patient felt like she was going to fall over and had to be taken home from work.
20 year old male began experiencing chest pain about 1500 16 July 2005 while playing horseshoes. The pain decreased, pt went to sleep about 10:30 pm, then about 3am woke up with sharp pain in the center of his chest behind his chest bone. No improvement of worsening with position changes. He then went to ER, where he was treated with Morphine. In the ER bloodwork was done, finding elevated troponin. He was also found to have diffuse ST changes on his EKG, with normal sinus rhythm. After observation for 24 hours, he was discharged with no anticoagulants, indomethicin 1 tab (25 mg) by mouth three times daily, and referral to cardiology for follow-up. He reports no chest pain Monday or Tuesday, maintained bedrest for those two days, with return to work Wed on profile for no lifting for 30 days.
Initial report received from a healthcare professional on 27 February 2013. A 12-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of MENACTRA (Lot number: U4412BA, site of administratoin not reported) on 31 January 2013. The last menstrual period was on 15 November 2012. The patient's estimated date of delivery was reported as 01 July 2013. As of 27 February 2013, the patient had not experienced any adverse events. The patient health was good during pregnancy. Documents held by sender: none.
4 hours after shot was received my daughter started screaming (she had NEVER done this before).  The injection site was red and raised in a 4 inch diameter.  She had diarrea for about 16 hours after the shot was administered and a low grade fever for several hours.  Her sleep schedule was off for the next few days.
3 x 5 inch erythema area lateral and inferior to injection site.  Warm to touch.  Treated with Benadryl, Tylenol and Lidex 0.05% cream.  09/04 symptoms resolving.
I had a sinus Infection that has been going on forever. Since mid-December I have had constant sinus problems. I did not have before this 5th shot. I often feel congestion. I have runny nose drainage. I have a cough and just overall sinusitis. I contacted my Teladoc and was given antibiotics.
Heavy painful period (not due) 1 hour after vaccine and now every 2 weeks since
he can not move his left arm and when he does there is "excruciating pain; he can not move his left arm and when he does there is "excruciating pain''; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown, Route of administration: unspecified), for COVID-19 immunization, reaction(s): "normal pain and trouble using his arm because of the pain". The following information was reported: VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 09Feb2022, outcome "unknown", described as "he can not move his left arm and when he does there is "excruciating pain"; PAIN IN EXTREMITY (non-serious) with onset 09Feb2022, outcome "unknown", described as "he can not move his left arm and when he does there is "excruciating pain''".  Additional information: The reporter stated that he received his second dose of the Pfizer COIVD-19 vaccine yesterday 08Feb2022 in his left arm and this morning when he woke up, he cannot move his left arm and when he does there is "excruciating pain". The reporter further stated that when he got his first dose, he had normal pain and trouble using his arm because of the pain but this time it is so bad he cannot lift it. He would like to know if this is normal or not.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200237751 same patient/drug, different dose, similar events
COVID vaccine breakthrough case. Moderna 1/23/21 012L20A, 2/16/21 004M20A, 11/14/21 034F21A, and 8/1/22 006M21A
Red rash, not at the injection site, but down below; Arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash, not at the injection site, but down below) and PERIPHERAL SWELLING (Arm is swollen) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30L20A and 30L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash, not at the injection site, but down below) and PERIPHERAL SWELLING (Arm is swollen). At the time of the report, RASH ERYTHEMATOUS (Red rash, not at the injection site, but down below) and PERIPHERAL SWELLING (Arm is swollen) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient noticed loss of eyelashes on 12-20-19 when she tried to put mascara on for a Christmas party when she noticed her top and bottom lashes were missing.  As of 2-12-20 the top lashes have grown back but the bottom lashes are still missing.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years 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 included: "Anaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: Anti-viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: 08Jun2022,, treatment stop date: 12Jun2022,, indication: treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
heavy menses/period flow with use of sanitary pad change hourly. States started after receiving COVID vaccine.
All symptoms started around 12 hours after the vaccine and peaked at 18 hours: Fever 103f, body aches, malaise, severe headache, injection site pain, loss of appetite