chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingles in her left arm,tingling is spreading It has moved to her left shoulder, between neck & shoulder, and down her left side to her waist. It's also in her left shoulder blade and is now moving down her left leg.tingling is constant; severe pain comes in waves; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingles in her left arm,tingling is spreading It has moved to her left shoulder, between neck & shoulder, and down her left side to her waist. It's also in her left shoulder blade and is now moving down her left leg.tingling is constant) and PAIN (severe pain comes in waves) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-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 PARAESTHESIA (Tingles in her left arm,tingling is spreading It has moved to her left shoulder, between neck & shoulder, and down her left side to her waist. It's also in her left shoulder blade and is now moving down her left leg.tingling is constant) and PAIN (severe pain comes in waves). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and GABAPENTIN (NEURONTIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingles in her left arm,tingling is spreading It has moved to her left shoulder, between neck & shoulder, and down her left side to her waist. It's also in her left shoulder blade and is now moving down her left leg.tingling is constant) and PAIN (severe pain comes in waves) had not resolved.            Patient has been scheduled for an EMG & is going to see a neurologist.   Concomitant medications were not reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-351265.
No further AEs reported; patient missed a 3rd dose of GARDASIL 9; This spontaneous report has been received from a pharmacist, concerning a 40 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, frequency, route, lot number and expiration date were not provided) for prophylaxis. On 15-JAN-2021, the patient missed the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9). No further adverse events reported.
never received the second dose; Ringing in the ear became much louder after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear became much louder after first vaccine) and PRODUCT DOSE OMISSION ISSUE (never received the second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Ringing in ears.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced TINNITUS (Ringing in the ear became much louder after first vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never received the second dose). At the time of the report, TINNITUS (Ringing in the ear became much louder after first vaccine) had not resolved and PRODUCT DOSE OMISSION ISSUE (never received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported
After second shot behind left ear had a sharp pain for weeks. Then loosing control of left side of face and seeing my doctor. Still having sharp pain in ear. Then immediately seeing neurologist and being diagnosed with Bells Palsy. Not being able to work my full time job. Taking medication.
She had a severe reaction; all her joints are aching like a bad case of arthritis; Her arm where the shot was given is so very sore and achy. It is more than just a typical ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had a severe reaction), ARTHRALGIA (all her joints are aching like a bad case of arthritis) and VACCINATION SITE PAIN (Her arm where the shot was given is so very sore and achy. It is more than just a typical ache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 065E21A (026A21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had a severe reaction), ARTHRALGIA (all her joints are aching like a bad case of arthritis) and VACCINATION SITE PAIN (Her arm where the shot was given is so very sore and achy. It is more than just a typical ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She had a severe reaction), ARTHRALGIA (all her joints are aching like a bad case of arthritis) and VACCINATION SITE PAIN (Her arm where the shot was given is so very sore and achy. It is more than just a typical ache) outcome was unknown.            Patient was concerned because by now she shouldn't be feeling anything.  Reporter stated that patient has concomitant medications, but her daughter (primary reporter) did not have the list.
w/in 5min began to exp laryngospasm & dyspnea (no evidence of panic disorder) P88, BP 110/60, R16;pt relieved w/epi & DPH;
Burning sensation of my inner foot and palm; Body ache; Fever; This is a spontaneous report from a contactable consumer (Patient itself). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0182 and expiration date: not reported), via an unspecified route of administration on 05May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was experiencing side effects of COVID Vaccine. The patient had fever and body ache on 06May2021. The patient had vaccine on last Wednesday and had 'fever' on Thursday, was okay on Friday and Saturday and on Sunday had fever and along with that also had burning sensation of inner foot and palm on 09May2021. The patient took Tylenol 500mg (dose) for fever and pain. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a 56 year old female patient who on Oct 19 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0514P). Within 24 hours, the patient developed a site reaction which included swelling, soreness, redness and local heat extending from the site down to her wrist, The patient treated the symptoms with ice and diphenhydramine HCL (Benadryl). At the time of this report, the patient was recovering. Unspecified medical attention was sought. Additional information has been requested.
pt began tx for OM w/Cefzil 5/18/9;pt recv vax 5/22/99;pt broke out w/rash on abd on 5/23/99 which worsened;pt presented to ER w/full body hives including facial swelling & a large swollen red area @ site of IPV;
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  This case contains information for patient 43 out of 100 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
developed a rash all over my midsection, sides of my breasts. and up around my ears and scalp. It was solid, very red and itchy.  There was NO rash at the site of the injection
Started with headache, muscle aches and feeling feverish.  Truly bad event in middle of night with sweating, stomach craps, diarrhea and vomiting lasting over one hour.  After two hours, felt normal again.  Could be bad timing, but if related thought you guys would want to know.
felt pain on injection site; headache; very achy; cold; This is a spontaneous report from a contactable healthcare professional reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 24Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced drug allergy. Patient stated that she got the Covid vaccine last 24Dec2020 and felt fantastic for 12 hours and after that she felt pain on injection site, headache, very achy and cold for 2 days in Dec2020 and then it went away. Then last Friday, she experienced the same signs and symptoms and had herself swabbed yesterday and got a negative result. She wanted to know if this is a delayed reaction to the vaccine or if she could be having Covid since she is an HCP is usually exposed to patients. Patient also mentioned that she is allergic to Thimerosal. She mentioned that she is allergic to Thimerosal and wants to know if the Covid vaccine contains any derivatives which may be similar to it. Escalating to inquiry to Second line. Offered to provide list of ingredients which she could check with local pharmacist if it does contain Thimerosal derivatives but insisted that there may be scientists or pharmacists from Pfizer who can check on this information. The outcome of the events was unknown.  Information about lot/batch number has been requested.
He had uncontrollable hyperactivity. Blurting nonsensible statements and thoughts. Very loud, amped up, rough, abrasive behavior. This behavior is extremely atypical for my child who is mild mannered and a calm person. I have never seen him behave this way, ever in all of his existence.  He was this way the entire next day following vaccine.  2nd day post vaccine, he had mellowed some with sporadic moments throughout day of this erratic behavior. By third day, he had calmed to his normal personality.
Patient came in today 10/28/23 and stated that 3 days after receiving vaccines on 10/21/23, he started having neck pain/stiffness in neck area and area between shoulder and neck, also soreness when moving arm. Asked patient if he had soreness in muscle where vaccine was given in the time following vaccines. Asked him to show me where soreness was to assess proper placement of injections, he pointed directly to proper area of deltoid muscle where vaccines were administered. Recommended that he follow up with primary care physician.
had a rebound; had a rebound; This is a spontaneous report received from a contactable reporter (Consumer), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had a rebound".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ACHES; CHILLS; EXHAUSTION; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) 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 aches, chills, exhaustion, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from aches, chills, exhaustion, and fever. This report was non-serious.
patient was in tremendous pain from neck all the way down my arm to wrist and the top of thumb; patient could not raise his/her arm above waist; it frightened patient considerably; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious Social Media case received from a consumer.  This case involves unknown demographics patient who was in tremendous pain from neck all the way down my arm to wrist and the top of thumb (pain), could not raise his/her arm above waist (hypokinesia), it frightened patient considerably (fear), while he/she received vaccine INFLUENZA VACCINE.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was in tremendous pain from neck all the way down my arm to wrist and the top of thumb (pain), could not raise his/her arm above waist (hypokinesia), it frightened patient considerably (fear) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for all events.  There will be no information available on the batch number for this case.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included Albuterol Inhaler, AMBIEN and tramadol. On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injected mobility decreased was unknown. The reporter considered the injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated that patient reported that her left arm was so painful that she could not raise her left arm. The pain lasted approximately 3 to 4 days.
"Bumps" noted on 1/13/06, became vesicular.  No other symptoms.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Severe
Headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headaches). The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     It was unknown if the company considered the headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAY-2023 The patient enquired that how long does the headache last after receiving Shingrix in terms of days, weeks and months.
Soreness at injection site.; Cold; Allergy symptoms; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 11:15 as dose 4 (booster), single (Lot number: GH9693) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if COVID prior vaccination: Yes" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 30155BA, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 05Nov2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Mar2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 21Sep2022 at 19:00, outcome "recovering", described as "Allergy symptoms"; NASOPHARYNGITIS (non-serious) with onset 21Sep2022 at 19:00, outcome "recovering", described as "Cold"; VACCINATION SITE PAIN (non-serious) with onset 21Sep2022 at 19:00, outcome "recovering", described as "Soreness at injection site."; FATIGUE (non-serious) with onset 21Sep2022 at 19:00, outcome "recovering", described as "Tiredness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination site pain, nasopharyngitis, hypersensitivity, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications patient had received within 2 weeks of vaccination.  Follow-up attempts are completed. No further information is expected.
Client reports that on 9/18/14 in the evening she started to not feel well. She reports loss of appetite accompanied by 5 pound weight loss between 9/18 and 9/24. Client also reports a "horrible headache" mostly on left side of head. She reports neck pain and stiffness that "comes and goes". The headache is also accompanied by nausea that makes her "unable to even brush teeth". Client also reports that she feels very cold but her body temp. to touch feels warm/normal. She has been taking 4 Advil pills per day and it has not helped with the pain. She is not sure if she has a fever as she has not checked her temp. Client did report that on 9/23 the symptoms had all stopped but then reappeared on 9/24 at 2:30 a.m.
Shingles / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023 This case was reported by the patient via interactive digital media. The got shingles from the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient was given .25cc of Novartis H1N1 shot, which is only reccommended for patients 4 years and older.