chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cognitive -- severe symptoms began ~3 days after Pfizer 2nd dose.  Extreme disorientation and confusion (transient), memory loss (longterm), extreme lethargy - unable to move, intermittant psychosis (mild, esp. when going to sleep), and anxiety (transient but very extreme, unlike anything I've felt before, not improved by diazepam)  (continued for 10 days then began to improve dramatically followed by alternating relapse on a daily basis for 4 weeks, up to present -- dramatically and stably improved by steroid treatment, returned after discontinuing)   Nerve pain --  began ~1 week after Pfizer second dose. -- tingling, burning throughout extremities, especially fingertips, toes, hips; transient (usually 5 seconds or less). Progressively became more frequent (20+ / day), longer lasting (up to 20 seconds) and more severe (like stabbing or electric shock). Gradually resolved after course of dexamethasone beginning 3 weeks after vaccination.   Sharp inner ear pain -- (both ears) began ~1 week after Pfizer second dose. Rare events (~5x / day), very transient (1-2 seconds) but extremely painful. Continues up to present,  (4 weeks after Pfizer second dose). Also constant popping of both ears beginning week 2 to present, feels like fluid inside.   Adenopathy -- On 4/28/21 noticed massive swelling on left pectoral muscle (contralateral to vaccine injection site), diagnosed as lymphadenopathy, moderately painful. Continued to get worse for 1 week, began dexamethasone on 5/7/21. Dramatically improved, however swelling returned after discontinuing steroid and spread to all lymph nodes, including neck and others. Became extremely painful on 5/14/21, unable to walk due to swelling in inguinal lymph nodes.  Again dramatically improved after steroid injection on 5/16/21.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site inflammation in a 79-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 11th June 2018 11:38, the patient received SHINGRIX (intramuscular). In June 2018, several hours after receiving SHINGRIX, the patient experienced injection site inflammation, facial puffiness and injection site pain. On an unknown date, the outcome of the injection site inflammation, facial puffiness and injection site pain were recovering/resolving. The reporter considered the injection site inflammation and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the facial puffiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine in left deltoid. The health care professional reported that the patient experienced inflammation and soreness in the arm where the injection was given. The patient also experienced puffy feeling in the face. The reporter did not provide patient information.
Information has been received from a certified medical assistant concerning an adult female patient who on an unknown date was vaccinated with a dose of (Lot #660717/0224). Subsequently, the patient experienced a sore shoulder which lasted over one week, the patient had no swelling and redness noted. At the time of reporting the patient was recovering. The certified medical assistant reported that the last year they never received any adverse reaction complaints and this year they had already received five complaints. The reporter has requested a lot check. In follow up the medical assistant reported that the patient was vaccinated on 13-OCT-2008. In October 2008, the patient experienced a sore, stiff arm. Subsequently, the patient recovered from the sore, stiff arm. The medical assistant still administered additional patients using lot # 660717/0224X. However, she now administered it in the patients' hips instead of arms. No adverse events have been reported after she changed injection sites. A standard lot check investigation was performed. All in process quality checks for the lot number 660717/0224X was satisfactory. The lot number 660717/0224X met the requirements of the Agency and was released. This is one of several reports provided by the same source. Additional information has been requested.
Patient described swelling and heat at injection site that started as a 4"x4"  area the day following vaccination. On Day 2 following  the vaccination, the patient stated that the redness and swelling had doubled in size, but her arm did not seem as hot as the day before.
eyes "feel funny"; Sore Throat; sprayed out onto his face and eyes; sprayed out onto his face and eyes; sprayed out onto his face and eyes; This case was reported by a pharmacist via call center representative and described the occurrence of abnormal sensation in eye in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st May 2022, the patient received Shingrix. On 31st May 2022, less than a day after receiving Shingrix, the patient experienced abnormal sensation in eye, sore throat, occupational exposure while administering product, exposure via skin contact and exposure via eye contact. On an unknown date, the outcome of the abnormal sensation in eye, sore throat, occupational exposure while administering product, exposure via skin contact and exposure via eye contact were unknown.   It was unknown if the reporter considered the abnormal sensation in eye and sore throat to be related to Shingrix.     Additional Information: GSK receipt date 1 June 2022: Reporter's comment: The pharmacist reported that he was going to give a Shingrix vaccine and the reconstituted vaccine sprayed out onto his face and eyes. He did flush with water.  He tried to go to the ER but the wait was too long. The planned to go back to ER on the day of reporting. He stated his eyes feel funny and throat was sore. The reporter did not have vaccine lot number/expiration date information available at the time of reporting. The reporter Consented to follow up.  Additional Supportive Information: While pharmacist was going to give a Shingrix vaccine and the reconstituted vaccine sprayed out onto his face and eyes, which led to exposure while administering product, exposure via skin contact and exposure via eye contact.
Fever of 102.5 for six hours until Aleve was given and severe nausea (no vomiting).
Immense pain in the arm including swelling at the injection site.  Over the counter pills did not help. After several days, the intense pain subsided but pain still remained. I could not sleep on my left side because my arm still hurt. I could not lift my left arm without pain. I could not lift things like a school backpack or my cat without pain. Any slight touch on the arm in the vicinity of the injection site caused sharp pain.  The problems with my arm still exist - pain and limited use - even seven months later.  I've been told the shot was given in the wrong spot on my arm and will have to go and pay for physical therapy.
a patient who received one dose of shingrix in the fall of 2021 but has not received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received in fall of 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: a patient who received one dose of shingrix in the fall of 2021 but has not received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-JUL-2023 The patient had not received the second dose of Shingrix.  He wanted to know if he had to start the two dose series over again or if he only needs the second shot.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
04/06/2021 11:30 soreness in left arm    13:00 tingling in left fingers    18:00   99.9 degrees F       20:00    101.1 F      21:00  102.1 F    22:30 101.7 F   04/07/2021    12;26   101.8 degrees F      1:34   101.5 F         9:00    99.0 F          11:00  99.0 F         soreness, cramping in left calf   04/08/2021     soreness in right shoulder
I had a BVT in my leg and a PE in my lungs and I was treated with a clot blocker. I was sent home and was told that I would be on blood thinners the rest of my life.
Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a physician via phone. This case seven month old patient (gender not reported) who was vaccinated with an expired one dose of PENTACEL (batch number not reported, expiry date 24-JUN-2018, route and site of administration were not reported) on 09 July 2018. It was a case of actual medication error due to expired vaccine used as PENTACEL was administered to a 7-month old patient on 09Jul2018 and the product was out of date with an expiration date of 24Jun2018. It was unknown if any adverse event was occurred. 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 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 sender: none.
involuntary muscle contractions involving many muscle groups intermittently present following few days of restlessness p/inj & cont from day post inj to present time;
Recvd Hep B vax AUG88 immediately p/muscle ache, weakness, fatigue;
Pt recv vax on 1/22/99; on 2/3/99 pt exp rash on face to trunk, fever x 24 hr
4:40pm pt. woke from nap mom states her stomach and eyes look red and I am afraid "she is having another reaction to immunizations she got today" advised to take child.
6 days, post vax, the pt developed large area of redness and edema at the injection site. Very warm to touch. Pt was treated with Augmentin for 10 days.
swelling; arm pain; itch; developed a rash at injection site; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site) and PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-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 SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site), PYREXIA (fever) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site), PYREXIA (fever) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given by the reporter.
Headaches, nausea, red spots over body. Itching. Saw Doctor was given steroids. Took 2 wks. to recover.
After the Pfizer Covid-19 booster shot (administered November 19, 2021), I experienced a severe headache in the left rear of my head (including behind the ear), an increasing unbalanced/foggy feeling and vision impairment. These symptoms began November 20, 2021 and are increasing in severity, and new symptoms are occurring. On November 25, 2021, my headache was so severe that I became nauseated and had to lie down to try to alleviate the pain. I am currently experiencing the following increasing symptoms: headache, vision issues, imbalance, feeling like I'm "in a fog" and weakness/numbness in my left arm and leg.
Woke early next morning (approximately 4am on 4/14/21) with injection site pain, extreme fatigue and muscle aches. Later in the day developed low grade fever (around 98.8 degrees), chills, and headache.  Spent most of the day in bed. Next day, 4/15/21 was still fatigued and weak with dull headache but functioning. Also developed very sore right  armpit pain in same arm as injection (lymph node swollen). On 4/16/21 still had some fatigue, armpit pain, and dull headache (coupled with PMS so unclear if related to vaccine). On 4/17/21 and 4/18/21 still have right armpit pain and started what appears to be normal menstrual cycle on 4/18/21 (I understand there have been reports about the Covid 19 vaccines impacting menstrual cycles). Treated symptoms with extra strength Tylenol, rest, and drinking plenty of fluids. Made full recovery.
pt cried for 7 days day & noc, nearly nonstop; pt refused to take breast & bottle; unable to comfort pt; pt did not eat or drink; pt devel a bad cold-bronchitis-pneumonia;
Red bumps around injection site within one hour post injection.  Swelling, redness, quarter size lump over injection site, pain and muscle spasming x 22 days post injection.
Described redness to site immediately after injection which resolved. The next day he c/o neck and shoulder feeling tight and hot. Seen by ER MD who noted no particular warmth erythema rash who asked that he stop series due to possible hypersensitivity and use Benadryl 25 mg tid x 2 days.
pt recvd vax; pt devel metallic taste & dizziness; exp headache; neck pain; sore throat, fatigue, chills & low grade fever; pt tx intravenous fluids in ER;
Next morning I had a severe headache upon waking.  Dizziness and general feeling of unwell.  Fever and gasto symptoms.  Stayed in bed the entire day with headache that would not go away
Injection site red; Injection site / "heated"; Can still feel a small bump at injection site; Tired; Chills; Vaccine stung when going in / soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number T7GA9, expiry date 11th November 2022) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and chills. On 2nd June 2021, the patient experienced injection site erythema, injection site warmth and injection site swelling. In June 2021, the outcome of the injection site erythema, injection site warmth, fatigue and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site swelling, fatigue and chills to be related to Shingrix.  Additional details were provided as follows: The case reported by patient herself. The patient received 1st dose of Shingrix in right arm muscle and on the same day experienced soreness at injection site, tired and chills. The next day, patient also experienced injection site small bump, injection site redness and injection site heat. The reporter mentioned that, the vaccine stung while going in. The Pharmacist told to patient, some of the newly trained staff was giving one vial (adjuvant) instead of reconstituting. The patient was inquiring if Shingrix dose equal to two vials, also inquiring if Shingrix needs to be 2 doses only or if she may need another dose in the future. The patient was concerned but with further questioning, she feels she did get both because she saw the pharmacy reconstituting two vials with different colored caps.  Educated on when to receive second dose.  The consent with Healthcare professional was given. The case has been linked with the case US2021AMR121361, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR121361:Same reporter
pt fainted and fell out of chair around 10 minutes after receiving Pfizer covid vaccine rx# 487548. rph on duty immediately went out and cradled pt's head as pt regained consciousness and talked to her until she was fully conscious and could sit up. pt asked for water, got for her and rph sat with pt talking to her until she felt well enough to leave on her own. She was asked several times if she wanted an ambulance and pt declined. pt waited around for another 10 minutes and left without incident.
The evening after I got the shot I started feeling so tired and then developed a splitting headache and low grade fever. I also had a very hard time sleeping and was up and down all night.
Dizziness, Headache, Tiredness, Lightheaded, Very Sore Arm, Very Nausea's, Painful Bruising(Left Leg), Blurry Vision.
Fever 102.9, chills, body aches, mild headache- started 10:30pm. on 7/28/2009. Called Dr. at 11:15pm. Gave motrin and tylenol overnight.  Hives -started 9:00pm on 7/29/2009. Gave Benadryl. Will call Doctor in morning of 7/30/2009.
Hepatitis B Vaccine that was administered was expired. Vaccine was given on 12/8/2017, which the vaccine's expiration date is 15SEP2017. No treatment needed.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 9:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:42 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 40.70 as per the dose received on 13-Feb-2021 and 40.80 as per the dose received on 20-Mar-2021.  Concomitant medication of the patient was not reported.  The patient had poor quality vaccine administration on 13-Feb-2021 09:34 and 20-Mar-2021 09:42.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021. The vaccines moved to clinic on 13-Feb-2021. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. These vials were moved to fridge on 09-Mar-2021 and beyond use date for the vials was reported as 08-Apr-2021. The vaccines moved to clinic on 20-Mar-2021.Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and  traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
First day after vaccine: aches, chills, fever 101.4, fatigue.  Second day after vaccine: fever 100.4, fatigue.  Days3-9(today) after the vaccine fever has been between 99.1 and 99.5.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion was 8 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was previously discharged on 3/1/21 for a heart failure exacerbation with edema. He came back to the ED on 4/10/21 with general weakness, dehydration, and shortness of breath. His admission consisted of persistent hypotension which limited the ability for diuresis for his edema. His mental status declined and he was transition to hospice care before passing on 4/17/21. PMH significant for CAD/atherosclerosis, STEMI, hypertension, diabetes, hyperlipidemia, AAA s/p open repair 2008, aortic arch aneurysm has declined surgical repair, COPD, tobacco abuse, alcohol abuse, CVA, cerebral aneurysm.
Sore arm reports felt as if someone punched her in the arm. Area red and raised. Dec 10, 2021 still has 2 CM raised lesion
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
Child developed chickenpox on 03/10/2003. Lesions on trunk (front and back) neck, forehead, back of knee, upper arms, no hands or privates. At least 20 lesions noted and mom says he continues to break out. (child has hypogammaglobulinemia(diag before injection)