chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she is having a problem with balance and dragging her right leg/balance was off; felt foggy; She has to walk very slowly; her arm started to feel funny. Patient stated it was not painful but felt numb; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: 31May2021), via an unspecified route of administration (anatomical location: Arm left) on 18Jan2021 at 14:30 at 0.3 mg, SINGLE DOSE for COVID-19 immunisation. Patient's medical history included 'hyperthyroid' from an unknown date and unknown if ongoing. Patient has no prior vaccinations within 4 weeks. There were no additional vaccines administered on the same date of Pfizer suspect. Patient has no history of previous immunizations with the Pfizer vaccine considered as suspect as this was the first dose. Concomitant medications included levothyroxine sodium (L-THYROXINE [LEVOTHYROXINE SODIUM]) for 'hyperthyroid'.  The patient reported that she received her first dose of COVID vaccine yesterday (18Jan2021) afternoon at 2:30. Patient stated that at 09:00 pm last night (18Jan2021), her arm started to feel funny. Patient mentioned that it was not painful but felt numb. Patient stated that today (19Jan2021), when she woke up, she is having a problem with balance and dragging her right leg. Patient also mentioned that she also felt foggy. Patient would like to know if these are common side effects. Patient would also like to know how long the symptoms will last. Patient also stated that she has an appointment tomorrow with her HCP and she will be unable to drive in the current state she is in and will have someone else drive her to the appointment. It was also reported that patient was calling on the line calling about the Corona shot and clarified it to be the Pfizer COVID Vaccine. Patient initially stated she received her first dose around 2'oclock yesterday (18Jan2021). Patient mentioned that she is having a reaction that she does not see on the list. Patient received the injection in her left arm and her left arm feels funny which is to be expected, but her right leg is dragging. Patient also reported that her balance was off which it never was. Patient added that she also felt foggy. Patient was calling to see if this was a side effect and if it is, when will it go away. She started to notice her right leg dragging this morning around 7:30 am on 19Jan2021. She thought it would go away. Around this same time she noticed her balance was off. She has to walk very slowly. As she walks by she has to touch the wall and that is not like her at all. She is normally very active. Normally she walks for an hour as an active person. This feeling is not like her. She started to feel foggy this morning when she woke up. Patient clarified that time of vaccination was 2:30 pm. Vaccination facility type was reported as hospital. The events were assessed as non-serious. Outcome of the event 'her arm started to feel funny. Patient stated it was not painful but felt numb' was unknown, outcome of the remaining events was not recovered.
She started have swelling and weight gain starting 2 days after immunization.  She has a history of DVT and had more swelling and redness in one leg leading to ultrasound to rule out a DVT and labs significant for an elevated D-dimer which then led to a CTA of her chest because of additional complaints of breathlessness.  The ultrasound and CTA were negative for any clots.  She was prescribed furosemide for the swelling.  D-dimer was 2.26 micrograms/mL.  Due to the temporal nature of events, I felt filing a report was necessary.
shingles after each jab; Initial information  received on 23-Feb-2022 regarding an unsolicited valid Social media non-serious case received from a consumer.  This case involves a patient of unknown demographics who developed shingles each time after administration of vaccine Influenza vaccine.  The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength, batch number, expiration date: unknown) via unknown route in unknown administration site for immunization. Information on batch number was requested.  On an unknown date, the reporter reported that his/her friend developed shingles (herpes zoster) (unknown latency) following the administration of Influenza vaccine.  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (herpes zoster).  At time of reporting, the outcome was Unknown for the event (herpes zoster).
HCP said that 606 doses were given after expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were reported. Vials were placed in refrigerator on 03-Nov-2021 No temperature excursion was reported.
Redness, swelling, hard, and tender at injection site. Also reports dizziness, fever, and nausea.
I am unable to work.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), on 15May2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "I am unable to work.". Additional information: the patient after received vaccine, was unable to work.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Pt reports redness at (L) deltoid within 24 hours which progressed to 70 x 120 mm red, hot area with induration and itching.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Facial swelling, hoarseness in throat, swelling of the tongue reported approx. 6 hours after admin.
Thoracic myelopathy, likely transverse myelitis, poss. first presentation mult. sclerosis, recent covid vaccine
Patient received COVID vaccine (dose 1) at local Pharmacy on afternoon of 3-12-2021. She says early the next morning she began itching and proceeded to break out into hives. Since that time, the hives have spread diffusely over most of her body and are still present at the visit today in the clinic on 3-18-2021.
sick; Initial information was received on 13-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got sick while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength, form, dosage, frequency, expiry date: unknown) for Immunization.  On an unknown date the patient developed a non-serious event of sick (illness) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Received first dose of COVID 19 vaccine on 03/12/21. Pt reports after leaving facility she developed hives to face and neck and throat became itchy. On 3/15/21, pt denies s/s at this time. Reports she took Benadryl Q6H for symptoms and took an early dose on Saturday (3/13/21)  due to difficulty swallowing. Pt reports the Benadryl worked and is no longer having hives or difficulty swallowing or itchy throat.
Fever blister; This case was reported by a pharmacist via other manufacturer and described the occurrence of fever blister in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and broken out with a fever blister. The pharmacist asked, if the patient could take Valtrex or would it compromise the efficacy of the vaccine.
Patient bled at injection site (upper right arm) and was swabbed. By time Band-Aid was applied 15-20 seconds a grape sized raised area appeared at inj. site and site and surrounding area appeared red and Pt became light headed. 911 was called, but patient did not want this & called friends to come pick her up. I walked her over to waiting area where she sat and then Police arrived who subsequently called EMT who arrive 5 minutes later. Pt mentioned tingly hands and EMT check vitals which were normal. She refused to be brought to Hospital and signed out against medical advise. She left with friends who assisted her (she was a bit dizzy) about 30-40 minutes following the injection. We all cautioned her and I called her later in the day where she was doing fine. She was given Benadryl 25mg while at the pharmacy.
Patient complained of feeling hot, sweaty, flushed, dizzy, headache within 5 minutes of receiving flu shot. Epinephrine 0.3ml SQ given as instructed per Dr. Symptoms resolved.
My problems begin on 03-Apr-2021 just after my second Moderna vaccine shot on April the first; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (My problems begin on 03-Apr-2021 just after my second Moderna vaccine shot on April the first) in a 76-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2022, the patient experienced IMMUNISATION REACTION (My problems begin on 03-Apr-2021 just after my second Moderna vaccine shot on April the first). At the time of the report, IMMUNISATION REACTION (My problems begin on 03-Apr-2021 just after my second Moderna vaccine shot on April the first) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Symptoms began as sore throat and Burning tongue about 30 minutes after administration. By two hours post Vaccine I was vomiting. I lost sense of taste and smell, had an enlarged red tongue, fever Up to 104°, never below 100° on Tylenol,, nausea, and vomiting continuously. I was told by my physician I should expect to be sick after the vaccine as I had a reaction to the shingles vaccine. I was told the risks of The Covid vaccine were less than the benefit. I was extremely ill continuously until I showed up at the emergency room on April 16. I was severely dehydrated and in kidney failure. The staff believed I had active Covid, but I tested negative twice. I was hospitalized for three nights receiving IV fluids, anabiotic?s, and medication. It was four more weeks until I completely Recovered and stopped having fevers to 103° and frequent  episodes of chills and sweating. My tongue was red and raw for about six weeks post vaccine.
Noted that patient received 2 doses of annual flu vaccine (different formulations) within a 10 week period. This was due to documentation of first vaccination for annual flu not being placed into medical record nor into Vaccination System.  By the time documentation was verified for receipt of first flu vaccine dose, a second one had already been administered.
On 5/10/06, pt reported left arm has been hurting every since had Tetanus Diphtheria Booster on 1/06/2006. On 5/10/06, reported sharp pain in left arm. L arm aches when moving it.
Allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The patient has an unspecified allergy to a flu vaccine. No additional details provided.  It was unknown whether non-gsk or verifiable vaccine.
Fever of 102 degree F, Shaky, Body Aches, Diarrhea, Not drinking
Pt presented to urge center - received shingles vaccine Saturday 2/8/14 left arm has large lump c/o achy, fever headache and discharge at injection site. Assessed - Left posterior forearm draining vesicle, warm, edema, erythema, fever.
On April 16, after one 6oz mixed drink of sake, gin and lime my left arm began to feel a numb/tingling feeling which started at the vaccination point and traveled down my arm into my fingers. The feeling was not painful, but a dull soreness/numb/tingling in the whole left arm. I had received my first Moderna vaccine on April 11 and had not consumed any alcoholic drinks since receiving the shot before April 16. No abnormal sensations in the right arm. In the morning of April 17, the soreness/tingling remained in the left arm. I took one ibuprofen and the feeling went away. In the evening of April 17, I had one glass of red wine and the soreness/numb/tingling feeling returned to my left arm. I took one ibuprofen and the feeling went away. I have not had any alcohol since, and have not had any soreness/numb/tingling in my left arm since. I have not experienced this feeling in my arm at any other time, including after annual flu shots. At the vaccination point, there is still a small pink bump.
About 2 to 3 weeks after my second vaccination, I began to become fatigued, lost my appetite, cognitive function began to decline and I became weak. I am slowly getting better. Cognitive function has increased. I have a little more energy and appetite is back.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with initial dose of ZOSTAVAX (dosage and indication were not reported). On an unknown date, two years after first dose, patient possibly received a second dose of ZOSTAVAX. No symptoms reported. Additional information has been requested.
Slept for 12 hours straight 2 nights in a row; Large covid arm 3 inches across and 4 inches deep; Hot arm; Sore arm; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 12 hours straight 2 nights in a row), PERIPHERAL SWELLING (Large covid arm 3 inches across and 4 inches deep), FEELING HOT (Hot arm), MYALGIA (Sore arm) and FATIGUE (Very tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included HYDROCHLOROTHIAZIDE for Glaucoma, OMEPRAZOLE, LEVOTHYROXINE, PHENYTOIN (DILANTIN [PHENYTOIN]), SPIRONOLACTONE, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CITRATE;COLECALCIFEROL]), SIMVASTATIN, WARFARIN and METOPROLOL for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept for 12 hours straight 2 nights in a row), PERIPHERAL SWELLING (Large covid arm 3 inches across and 4 inches deep), FEELING HOT (Hot arm), MYALGIA (Sore arm) and FATIGUE (Very tired). At the time of the report, HYPERSOMNIA (Slept for 12 hours straight 2 nights in a row), PERIPHERAL SWELLING (Large covid arm 3 inches across and 4 inches deep), FEELING HOT (Hot arm), MYALGIA (Sore arm) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient took Tylenol for symptoms.   This case was linked to MOD-2021-311066 (Patient Link).
Pt recvd 3 doses of hep B vax,recving 3rd vax 08AUG90 & tested negative for HBSAB.
Acute urticaria with dermatographism x 21 days and ongoing, onset 12 days after receiving Moderna bivalent booster. Took ceterizine 2x daily for two weeks, then took ceterizine 2x plus famotidine 1x for one week.  Plan is to add hydroxyzine 4x daily, plus ceterizine, plus famotidine. If urticaria and dermatographism does not resolve, will take presnisone in addition to antihistamines as described.
One hour after injection had generalized sudden onset edema, noticed especially in face.  Started to have scratchy throat but that dissipated after taking 50 mg Benadryl which I always carry and it subsided fairly quickly.  Got a welt at site of injection on the next day that now about 47 hours later is still large and inflamed.  Maximum size of welt on day after vaccine was 11 cm x 7 cm and 1.5 cm high.
Soreness and sharp pains in the muscle around the injection site a few hours after injection until 48 hours after injection.  Acheness through out the entire body after 12 hours after injection until 48 hours after injection.  Felt hot and feverish 12 hours after injection until 36 hours after injection
Made sick for 2 weeks; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported made sick for 2 weeks while receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date, strength, form, frequency not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "made sick for 2 weeks" (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (Made sick for 2 weeks).  At time of reporting, the outcome was Unknown for the event made sick for 2 weeks.
19OCT92 @ 8PM lt leg swollen below knee to top of hip area;
Initial unsolicited report received from a consumer on 25 March 2016. This case is linked with 2016SA062160. This case involves a male patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number, expiry date, dose number, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient was diagnosed with having the elevated fever of 104 Fahrenheit, flu and had a positive flu test for A strain of Flu. It was reported that the patient required doctor visit. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none. Sender's Comments: This is a non-medically confirmed case. Reportedly, the patient was tested for Influenza type A approximately 4-5 months after vaccination. As with any vaccine, INFLUENZA QUADRIVAL A-B VACCINE may not protect 100% of vaccinated individuals. Further information including but not limited to patient's medical history, details of symptoms, test results confirming the diagnosis and the strain identified and immune status at the time of vaccination would be needed for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Pharmacist said that a nurse only injected the DTap-IPV component of the PENTACEL to a patient before mixing it, with no reported adverse event; Initial information received on 08-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 4 years old male patient who was only injected the dtap-ipv component of the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] before mixing it, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Aug-2023, the patient received 0.5 mL last dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine, suspension for injection (batch number, expiry date unknown) via intramuscular route in unknown administration site for immunization, only the dtap-ipv component of the pentacel was injected before mixing it, with no reported adverse event (single component of a two-component product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event pharmacist said that a nurse only injected the dtap-ipv component of the pentacel to a patient before mixing it, with no reported adverse event.  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.