chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 15-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse practitioner by phone. This case involves a 3 years old (reported as 3 year and 11 months) female patient who was vaccinated with a 0.25 ml first dose once injection of FLUZONE QUADRIVALENT (Batch number: UT6262NA and expiry date: 30-Jun-2019) in right thigh (route of administration not reported) on 14-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine. It was a case of actual medication error due to vaccine under dose because the nurse practitioner prescribed a dose of 0.5 mL, but the medical assistant who administered the dose grabbed a 0.25 mL syringe in error. It was unknown if any adverse event occurred or not following the vaccination. It was reported that PTC template was not completed because it was not realized until after the call that this would be reported also as a PTC since it is a combination drug/device product and there was a mix-up. 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. Documents held by the sender: none.
Dry cough; Shortness of breath; Fever-I don't remember how high; Body aches all over; Nausea; Headaches; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Dry cough), DYSPNOEA (Shortness of breath), PYREXIA (Fever-I don't remember how high) and MYALGIA (Body aches all over) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] and BECLOMETASONE DIPROPIONATE (QVAR) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever-I don't remember how high), MYALGIA (Body aches all over), NAUSEA (Nausea) and HEADACHE (Headaches). On 07-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced COUGH (Dry cough). On 05-Mar-2021, NAUSEA (Nausea) had resolved. On 06-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever-I don't remember how high) and HEADACHE (Headaches) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) and MYALGIA (Body aches all over) outcome was unknown.            Treatment information were not provided.   This case was linked to MOD-2021-111314, MOD-2021-040985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNI case, no new information was added
Redness, swelling at injection site. Pain in arm muscle not allowing movement passed shoulder. General tiredness, overall feeling blah. Headache that wouldn't go away even when ibuprofen taken 200 mg twice during the day.
Pt exp non-response p/a series of 3 doses of Engerix-B given 27AUG90, 26SEP90 & 05APR91; 2 additional doses will be given;
About 1 week after dose 1 I experienced pain in the right shoulder joint and surrounding muscle; About 1 week after dose 1 I experienced pain in the right shoulder joint and surrounding muscle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "About 1 week after dose 1 I experienced pain in the right shoulder joint and surrounding muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, myalgia.  Additional information: No other vaccine in four weeks, other medications in two weeks: Multivitamins. All 3 injections were administered in the right arm at each visit. About 1 week after dose #1 I experienced pain in the right shoulder joint and surrounding muscle. A few days after dose #2 I experienced increased pain in the right shoulder joint adverse event increased pain in the right shoulder joint and surrounding muscle. The symptoms reduced slightly but after dose #3 I again experienced increased pain in the right shoulder joint and surrounding muscle. These symptoms still continue. There is also pain when raising the arm overhead, lifting items overhead and performing any activity requiring rotation of the right shoulder. The left (did not have any injections) remains without any similar symptoms. Adverse event treatment includes that heating pad & used analgesics. No covid prior vaccination, covid tested post vaccination. Known allergies includes that NKDA. Other medical history none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1) Menstruation began and continued for FOUR WEEKS with accompanying painful abdominal cramping, strange sensations within my uterus.   With IUD I have had very light (needing no more than a panty liner/day) and regular (3-5 days every 28 days) periods for the last 3 years. Prior to the IUD my periods were heavy, but always regular (28 days).   My OBGYN, prescribed 10 days of projesterone (i am on day 5) and the bleeding is lessoning (still pink and present but no longer needing a tampon). Abdominal cramping continues and hasn't lessoned.   2) Muscular and Bone pain  in extremeties/limbs: it feels like someone has a fishing hook or meat hook attached deep within my muscle/bone on the upper part (below shoulder, above elbow) of my arms and the upper part  of both inner thighs (midway between knee and vaginal opening) and PULLING it (it is in a very localized location but DEEP within the muscles on all 4 limbs). This symptoms has occurred daily for  4 weeks post shot. Though I am still  mobile and have full use of my limbs.   3) increased autoimmune inflammation (joints hurt again similar to when I had COVID- daily for  4 weeks post shot)   4). I have ongoing lung symptoms from COVID itself and am worried that the above symptoms caused from the vaccine will also continue as it's been over a month.
Patient presented w/ loss of consciousness on 4/26. Initial workup negative. Pt then had a witnessed seizure requiring intubation for airway protection. After extubation on 4/29, patient was noted to have profound leg weakness out of proportion to brief intubation. Infectious and neurologic workup negative for transverse myelitis. Thought to be possibly auto-immune Guillain-Barre like peripheral neuropathy. Started on plasma exchange with immediate good response.
Redness, swelling and tenderness at injection site of Proquad vaccine in right thigh. Suspect large local reaction, but bacterial cellulitis is possible.
Fever, chills, aches, headache; treated with Tylenol; fever broke in the evening of day 2 after the shot; felt mostly all better by day 3 just a bit achy and tired
Information has been received from a physician concerning a patient who "2 months ago" (approximately on 06-NOV-2010) was vaccinated with GARDASIL and developed a sore shoulder following the vaccination in approximately November 2010 (reported as about 2 months ago). When the information was reporting, the patient recovered from sore shoulder. It was unknown if the patient sought medical attention. No further information was available.
Clammy hands/feet early  5am  on  2/13/21, went to ER 2/13/21 due to numbness on R side of face with tingling on R side of head and tightness of  neck.  2/14 thrush in mouth 2/15 - achiness L arm 2/16- pain swollen lymph r side, clammy hands persist with foul smell Ongoing tingling in my Whole Back, Fluctuating BP , tachycardia
mild discomfort; had received a dose of the pediatric presentation of the vaccine as a booster/ mild dose/younger dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DISCOMFORT (mild discomfort) and INCORRECT DOSE ADMINISTERED (had received a dose of the pediatric presentation of the vaccine as a booster/ mild dose/younger dose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (had received a dose of the pediatric presentation of the vaccine as a booster/ mild dose/younger dose). On an unknown date, the patient experienced DISCOMFORT (mild discomfort). At the time of the report, DISCOMFORT (mild discomfort) and INCORRECT DOSE ADMINISTERED (had received a dose of the pediatric presentation of the vaccine as a booster/ mild dose/younger dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient was told to wait 60 days before receiving an  dose of the Bivalent vaccine.  No treatment was given to the patient.
Metallic taste; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 16:30 (Batch/Lot Number: EK9231) as single dose for an Covid-19 immunization.The patient had none medical his-tory There were no concomitant medications.Calling about the Covid-19 Vaccine she states that she got her 1st dose yesterday, 28Jan2021. About 15 minutes after, she got an odd metallic taste in her mouth that she still has. she enquired that this is not a side effect that was listed.Vaccination Facility type is Hospital.The outcome was not recovered.
Patients received some Moderna COVID19 doses that were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 31 Aug 2021 vials were initially stored in refrigerator, it mentioned that the vials didn't undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-534284.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Non-significant follow up appended.
1 hr 15min after flu inj. given, c/o "burning around mouth and nose." Reports "like fever blister but very intense". Also itching at injection site. S/S persisted through Fri. (Oct 25). Sat. morning broke out with fever blister. Has been allergy tested. No egg allergy though. I advised her to contact allergy MD to see if needs to receive flu shot in future.
THREE DAYS AFTER RECEIVING THE SECOND DOSE OF THE VACCINE, I WOKE UP WITH SEVERE HIVES ON MY INNER THIGHS,  BOTH LEGS, MY FOREARM,  THE BACK OF MY HANDS, FINGERS AND WRIST.   THE SWELLING CONTINUED AND I NOW HAVE HIVES ALL OVER MY ENTIRE BODY.  I ALSO EXPERIENCED SEVER LOWER,  RIGHTSIDE ABDOMINAL PAIN, AS WELL AS SEVERE LOWER BACK PAIN.   I WAS TREATED IN THE ER, PRESCRIBED A  CORTOSONE CREAM AND WAS GIVEN A BENADRYL.  MY SYMPTOMS CONTINUED, THE WELTS ON MY BODY ARE VERY PAINFUL AND I CURRENTLY, I AN UNABLE TO MAKE A FIST WITH MY RIGHT HAND, DUE TO THE SWELLING.
After shot, waited 30min to be observed.  Home, both jaws 'tight', arm soar but not painful; next day very tired and just layed around at home; slight soar throat but quickly ok same day, headache at temples for 24 hours or so, slight nausea but not enough to vomit, drinking and eating to keep stomach calmer, lasted few days; gland swollen high on collar bone area left side, soar but not painful.  On 4/19/21 (10 days later) awoke to bright red and hot  area under that initial swolen gland (that gland not red), and painful, about 6 mm long and half as wide, with swelling well beyond that red zone.  Applying antibiotic ointment.  Next day 4/20/21, went to urgent care regarding back ach, and showed that red spot to the doc.  Doc said many people having same reaction to the Moderna shot, all days after the shot and that it is not an 'infection'.  Next day, bright red area larger at 7mm long, now also stinging.  Now concerned about 2nd dose to be given 5/14/21 (more than 28 days away as 'soonest' per Kaiser). Maybe have shot in right arm instead of left arm again, but everyone I know got really sick and glands all swollen up (as i usually get with flu shot and doctors said NO more flu shots for me due to bad reactions)!  I am right handed and need to do a lot daily with that arm, but want to try to eliminate a sever 2nd reaction (always worse than 1st shots given to me).  Let me know please.
A report was received from a health care professional on 12/17/03 concerning a 6 year old male vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and he later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.
The shot mildly burned when it went in; normally no sensation registered in past. Within minutes, extreme fatigue, weakness, heart palpitations, breathing labored, and feeling general illness began and lasted several hours.  Have not had this reaction to any previous flu shots in preceding years.
received a dose which expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HBV (Engerix B) (batch number YL2L3, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Engerix-B, a day before reporting date which expired a week ago, which led to expired vaccine used. The reporter consented to follow up via email.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. Initial information was processed along with additional information received on 10-DEC-2021 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2. s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose and start therapy date were not reported for prophylactic vaccination. On an unspecified date, the patient experienced runny nose, headache, congestion (previous event subsumed within suspected COVID-19 infection), and tested positive for covid-19 which indicates patient had suspected Covid-19 infection and suspected clinical vaccination failure (dose number in series 1). Laboratory test type for COVID-19 was not specified. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch/lot number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for prophylactic vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000206508.; Sender's Comments: V0: 20211225687-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
PT RECEIVED COVID VACCINE AT 15:38 PT C/O AFTER 1 MIN OF CHEST PAIN AND SHORTNESS OF BREATH.  PT REPORTS H/O ANAPHYLAXIS REACTION TO FISH AND NO OTHER ALLERGIES WERE REPORTED,PT STATES  FEELINMG SAME SYMPTOMS AT THIS TIME. VITALS WERE TAKEN 169/89 p. 104 PULSE OX% 95. PT WAS SPEAKING  IN FULL SENTANCES AND DID NOT APPEAR IN RESPIRATORY DISTRESS ,PT REPORTED CONTINUED TO FEEL CHEST PRESSURE AND TIGHTNESS IN THROAT, AT THIS POINT EPINEPHRINE 0.3 ML WAS ADMINISTERED BY RN ON LEFT THIGH AND 911 WAS CALLED.  ON ARRIVAL OD PARAMEDICS AND EVALUATION OF PT REPORTED FEELING BETTER AFTER EPINEPHRINE AND DECLINED TO GO TO ER. PT LEFT THE CLINICON HER OWN IN STABLE CONDITION.
Administered past expiration. Moved from freezer to fridge 10/7/21 with 30 expiration on 11/6/21. Verified no repeat dose needed with manufacturer.
Changes in my menstrual cycle- I have had an IUD since 2017 and haven't had a period since insertion in April 2017. Once I received the vaccine my periods started again and have become increasingly worse; my period has become painful and heavy. I have had migraines on/off for the past 10 years, but once I received the vaccine I developed a constant baseline headache (2/3 in pain), and my migraines have become worse and last longer than normal.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 01-NOV-2012 at 10:28, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hours time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I started getting symptoms of sinus issues. I also had achiness, fatigue, low grade fever, headache, and, congestion. I took PCR COVID-19 with positive results. I was prescribed PAXLOVID. I feel like the PAXLOVID helped. My symptoms lasted for 4 days.
This spontaneous report was received from a certified nurse practitioner concerning a patient of unknown age and gender. On 08-MAR-2013, the patient who was intended to received ZOSTAVAX, was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously due to human error (this is not a product quality complaint). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
A non-serious spontaneous report of FLUMIST given to a 22 month old child was received from a health professional concerning a one-year-old female. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 07-Oct-2011 and did not have any adverse events. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
I notice a different feeling in my arm-it seems to be a itching burning sensation.  After a few minutes I pulled up my sleeve and noticed small red spots forming, It  was splotchy  over a  little over an  inch wide and long.  I watched this and it continued but was more annoying than anything.  Later in afternoon it was spreading to a wider area and was showing a brighter redness.  By 11 p.m. the coloring had spread and my upper arm felt warm to the touch and had swollen some.  I slept fairly well, woke up and it had increased in size .  Wednesday  morning  the redness was bright red and much of the upper arm was affected.  I called Dr. office and saw Dr. not my usual doctor..
A non-serious spontaneous report of H1N1 administered to 9 month old male was received from a consumer.  The patient was not having any relevant medical history and concomitant medication.  The patient received H1N1, Intranasal on 03-Nov-2009.  There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.  Additional information was received on 17-Nov-2009 and incorporated into the narrative: Age of the patient and information on medical history, concomitant medications was included.