chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given an undiluted Pfizer vaccine (concentrated) explained to patient may have more side effects.
Pt recv Comvax SC instead of IM on 10/14/98 ; on 10/16/98 pt exp hard lump at vax site
1st dose 02Oct2019, 2nd 18Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number HE4P7, expiry date 25th January 2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2 October 2019).   On 18th November 2022, the patient received the 2nd dose of Shingrix. On 18th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 01-DEC-2022 Reporter's comment: This case was reported by pharmacist. The pharmacist reported that patient received first dose of Shingrix on 2 October 2022 and then did not get the second dose until 18th November 2022. The first dose was administered at a different facility so the reporter did not have the lot number, expiration date. The second dose was administered from lot number HE4P7 expiration date 25th January 2024. Additional supportive information: As patient received first dose of Shingrix on did not get the second dose until 18th November 2022 which led to drug dose administration interval too long. Reporter consented to follow.
On 12/13/2021 about 3 after the shot I had severe inflammation in my back, pain in my ribcage, it was worse in my left side. It continued for about 10 days. Mostly burning in my back around the top front of my chest. I tried resting but it came back. I didn't go initially but I called my doctor this week and had to go to my urgent care where they prescribed prednisone. I am going to schedule a follow-up with my doctor.
Fever: 3/17 at 5:00 pm to 3/18 at 4:00 pm Headache: 3/17 at 4:00 to 3/18 at 10:00 pm
Pt received immunizations 3-30-16. Mom noticed immunization site, red, swollen in AM before sending child to school. After returning from school ice applied, swelling increased (L) arm pain noted. Warmth to site.
Denied having received a Covid vaccine prior, after giving Moderna 1st dose, indicated had received Pfizer 1st dose on 2/27/2021
pt had febrile sz 2-3 days p/vax;pt hosp over night;hosp records reveal sz 1OCT96;dx febrile sx & viral illness;pt acting sluggish;T103.9;BP 110/60;P140;pt stared;neutrophils 78.3;lymphs 13.2;MPV 7.0;co2 19.2;
Acute pain in shoulder. Flu vaccine administered high on shoulder. pain after 1 week in lifting up arm. Pain not subsiding.
This spontaneous report as received from a pharmacist refers to a 63 years old female patient with no drug reaction/allergies and no pertinent medical history, who on approximately 28-JUN-2012 ("a week before last week") was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On the same date of administration of ZOSTAVAX the patient complained of pain and developed a red welt at injection site. No treatment was given for an AE. The patient sought medical attention via contacting pharmacist. At the time of the report the outcome of the events was unknown. Additional information is not expected.
Arm was also very sore; body aches; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was also very sore), PAIN (body aches), CHILLS (chills) and NAUSEA (nausea) in a 32-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Nov-2023, the patient experienced PAIN IN EXTREMITY (Arm was also very sore), PAIN (body aches), CHILLS (chills) and NAUSEA (nausea). On 08-Nov-2023, PAIN (body aches), CHILLS (chills) and NAUSEA (nausea) had resolved. On 09-Nov-2023, PAIN IN EXTREMITY (Arm was also very sore) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's nausea started about 10 hours after vaccination, followed by chills and body aches that lasted for about a day. The patient's arm was also very sore for 2 days.  No treatment medications were reported.
Red whelps on face and Right arm 24 hours later; contacted PCP who advised to take OTC ZYRTEC. Some swelling of upper lip also.
Patient received flu shot on Saturday 9/19/20, reported to have mild fever on sunday 9/20/20 which she took ibuprofen and was able to alleviate the symptoms.  On Monday 9/21/20, patient reported to have rash on face and rash on both hands and swollen on fingers.  Will follow up with PCP to seek medical advice
temp 104 x 12hr broke out in rash & full blown case of chicken pox by 2MAY97;
My arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 84 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm is sore". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He got his vaccine, he felt fine after it for the rest of the day.  The next morning he woke up with dizziness, headache and vision/near sighedness was impaired.  He has some emotional issues that have been corrected but they seemed to have returned.  Also had fatigue that was fairly  mild at first, and over the next 3 days got worse, and has remained the same since that time to present.   About a week some of the dizziness and headaches are not as often, but the headaches have become more severe.  Before it was a low grade migraine that was constant, but other times it is horrific and others not too bad.  No predictability.  No fever, no chills, no sore injection site.  He has notified his doctor who tested his electrolytes which came back normal.  He ended up falling getting out of the shower and hurt his back and shoulder and prescribed him Hydrocodone which did not help the headache.
TEMPERATURE  EXCURSION OF 51.5 DEGREES FAHRENHEIT TO 52.4 DEGREES FAHRENHEIT FOR 2 DAYS (OUT OF ACCEPTABLE LIMIT); VACCINE WITH TEMPERATURE EXCURSION WAS ADMINISTERED TO PATIENTS (10 DOSES USED); This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, 203A21A and expiry: 05-AUG-2021) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced temperature excursion of 51.5 degrees fahrenheit to 52.4 degrees fahrenheit for 2 days (out of acceptable limit), and vaccine with temperature excursion was administered to subjects (10 doses used). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion of 51.5 degrees fahrenheit to 52.4 degrees fahrenheit for 2 days (out of acceptable limit) and vaccine with temperature excursion was administered to patients (10 doses used) was not reported. This report was non-serious.
gave a shot today to a lady and called us later to inform that there's a leakage to her injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (gave a shot today to a lady and called us later to inform that there's a leakage to her injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced UNDERDOSE (gave a shot today to a lady and called us later to inform that there's a leakage to her injection site). On 30-Jul-2021, UNDERDOSE (gave a shot today to a lady and called us later to inform that there's a leakage to her injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 30-JUL-2021, the patient received the first dose of Moderna vaccine and informed that there was a leakage to injection site 20 to 30 minutes after vaccination.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Blurry vision; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration on 24Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient experienced blurry vision on 27Jun2021. When probed for the concern, patient stated patient got 2nd shot of Pfizer Covid Vaccine on Thursday on 24Jun2021 and today on 27Jun2021 patient was just experiencing blurry vision. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
A few minutes after administering the shot, patient stated she was having visual changes, auditory changes, her limbs felt very heavy, and she was very pale.  An ice pack was placed on the back of her neck and she was given a bottle of water.  After about 10 minutes she said her vision was improving and her limbs felt better.  She also stated that she had a metallic taste in her mouth and she felt pressure in her head, mainly around her ears.   I continued to fan her to try and cool her down.  She stated that she was feeling better but still had slight pressure in her ears after about  25 minutes after shot was given.  After 35 to 40 minutes she said her vision was good, her limbs felt ok (except  for some heaviness at injection site on arm), the pressure in her head was better, but she still had the metallic taste (but it had gotten much better).  Patient's mother was with her and we talked to her the whole time she was having the event.  After about 45 minutes, she was able to stand up and stated that she felt good.  I followed up about 2 hours later with her mother and she stated that patient was feeling much better.
Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients received doses of PEDVAXHIB (lot#, dose, route not reported) stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 12-OCT-2014 the patient was vaccinated with improperly stored ZOSTAVAX (lot number unknown), which exposed to 15 F for six hours, 0.65 ml, subcutaneous. No adverse effects were reported. The outcome was unknown.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-DEC-2016, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 2017, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Patient states 2-19-21 at night had flu-like symptoms and 2-20-2021 had 102.0 fever and chills all day. Sunday am 2-21-21 pt. states she woke up with a red rash and blisters on her face and her face was swollen.  She called and notified her specialist doctor and was told to take Tylenol 500mg 3x a day and to take Benadryl. Pt. states on 2-22-21 she continued to have fever and the left side of her neck was swollen from the middle of her face back to her ear. 2-23-21 Pt. states she stayed in bed feeling bad and the swelling remained. 2-24-21 Pt. states she was feeling better and swollen resolved. Pt. states she did not go to the hospital or see a doctor.
Fever, chills, body aches, arm pain and pain in the rib cage area, especially on the day after the shot.  The arm pain, fever, chills and general body aches went away but occasionally feel like pain in the rib cage area.
3/10/21 - right arm (injection site) pain 3/11/21 - right arm(injection site) pain/soreness 3/11/21 - under right armpit swelling; injection site mild soreness 3/12/21 - under right armpit swelling
No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender 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.    In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 09th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case (Patient 1)
Lymphedema; swelling; her arm looks like it's a foot thick; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included breast cancer (no chemo but radiation). The patient's concomitant medications were not reported. Reporter states 30% of the patients had cancer and radiation. They get the same side effect she has, some in the arms, she got hers in her leg, says she has intense swelling, called lymphedema, says her legs belong on an elephant. arm started 3-4 days after her vaccine, her arm looks like it's a foot thick, and her other arm is perfectly normal. states the only thing we have in common was no chemo but radiation. The outcome of the event lymphedema was reported as not recovered and rest of the events was unknown.  Information on lot/batch number has been requested
PATIENT RECEIVED MODERNA BOOSTER AT AGE 16. NO ADVERSE REACTIONS AT TIME OF VACCINATION. ATTEMPTED TO CONTACT PARENTS BUT NO ANSWER.
Patient reports no pain at time of administration. At approximately 10:30 pm the same evening as the vaccine was administered, patient reports noticing a painful red (not raised) rash developing underneath the arm near the left armpit. Patient also reports fever (temperature unknown), severe throbbing pain at and around injection site, and tingling sensation from left shoulder to left wrist. Timeframe of fever/pain development is unclear from patient report. Patient reports rash had spread from underneath arm to left breast. Rash was not causing pain today (5/16/19) and fever no longer present per patient report. Patient denied shortness of breath and throat/lip swelling/tingling. No treatment given, patient advised to follow up with primary care physician.
Really bad arm pain. Ibuprofen does not cut it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 14:30 (Lot number: EW0162) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration time: 06:30 PM, Vaccine location: Right arm, Brand: ER8730, Lot number: EW0162), administration date: 26Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Apr2021 18:00, outcome "not recovered", described as "Really bad arm pain. Ibuprofen does not cut it.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility type vaccine was reported as Pharmacy or Drug Store. No known allergies were reported. No other medical history reported. The patient had neither received any other vaccine in four weeks nor received other medications in two weeks. The patient was neither diagnosed with Covid prior vaccination nor tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Started shivering, then developed a fever that eventually rose to 105.5 about midnight. Continued to have fever off and on at least 3 days (today). Not sure how long this will continue.
Cannot remember exact date of vaccination or onset of symptoms.  Has had severe headaches, depression, symptoms of Raynauds, general malaise.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "gastroesophageal reflux" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with paxlovid from 17May2023 to 21May2023.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300206865 same patient, different drug, different event.;
01/24/2021 - Dose 1 Moderna vaccine 02/04/2021 - Tested positive for Covid 19 04/10/2021 - Zero antibodies detected
Patient fails to develop immunity after 2 rounds of Hep B; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of therapy non-responder in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder (Verbatim: Patient fails to develop immunity after 2 rounds of Hep B). The outcome of the therapy non-responder was unknown.   Additional Information: GSK receipt date: 15-May-2023 The reporter called to discuss the appropriate steps to take when a current patient fails to develop immunity after 2 rounds of Hepatitis B vaccinations prior to starting Kesimpta.
Per patients mother: May 4, 2016 patient stated she had a significant increase of vocal ticks (approx. 50) which started that morning. May 5, 2016 mother called neurologist Dr who increased her Clonidine to 0.1mg BID. May 6 2016 Increase in vocal ticks persist despite increase in Clonidine. May 10, 2016 pt woke up with her eyes twitching and her head jerking. Later that day her mouth started jerking. Saw neurologist that day and EEG was done. He also orderd KLONOPIN 0.5mg BID. May 11, 2016 vocal ticks persist and head and mouth are still jerking.
Liver function tests were high when tested after a routine blood draw on 7/17/21 AST: 66 U/L ALT: 98 U/L - 102 U/L  They returned to normal by 8/7/21 AST: 36 U/L ALT: 53 U/L