chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started about 14 hours later. (around 10 pm) Chills and then terrible shaking and trembling. That lasted about 3 hours when it slowed down and finally stopped. I slept. in the morning I awoke, with a terrible headache and was completely exhausted. I slept all day. (taking Advil and Tylenol for the headache. Nothing helped. I finally took an Imitrex, when I went to bed again. During the day, when I woke I had about a bottle of water during the entire day and all night . Didn't feel like eating anything. Today I was still tired and the headache was back, but not as bad. I had breakfast and supper and slept in between. Tonight I feel much better.
Developed sensation of head/body jerking/vibrating.  Similar to having seizure but not physically moving.  Vision problem, where when i look at something, it moved sideways before becoming still.  Severe burning in my head as if my head was on fire.  Twitching in my eye lids, cheek, lips.  Had some numbness and tingling first day after about 8 hours.  But the other symptoms started day 2.  Also had some jerking of head, shoulders, hand/fingers off and on after  7 days and am still experiencing that.  Symptoms intermittent, but can last off and on all day sometimes.  Othertimes only about 5-6 times/day and last from a few seconds to several minutes.
Reports L arm with swelling at site that progressed to under the arm nodes swelling. Lasted for 3 days. Fever spiked to 103 at home. Resolved by 5 days.
Pt recv vax on 3/15/99; 24 hr post vax pt exp local erythema on left thigh
pt recvd 3 doses of Engerix-B on 27NOV90, 3JAN91 & 30MAY91; 26JUL91 lab tests indicated did not convert; recvd a booster dose of Engerix-B on 30JUL91; 3SEP91 lab tests indicate pt converted;
extreme, severe, sudden onset headache six hours after shot extreme muscle soreness at injection site starting overnight
Patient with increasing erythema (now 2 days post vaccine), itching, and warmth on R thigh. Per patient's mom area of redness has increased markedly since yesterday. 13 cm x 14cm Erythema plus induration at R thigh.
Fever 8/1/02-8/7/02(103F-105F) Rash 8/5/02 Ataxia developed 8/5/02.  Follow up:  child had trouble with balance 08/07/2002.  Parents to bring child back to office if problem worsens.
Patient received 2nd dose of COVID-19 Pfizer vaccine on 2FEB and tested positive for COVID-19 via nasal swab on 24May.
Headache/ Feels like headache is double today from yesterday; Fatigue/ Feels like Fatigue is double today from yesterday; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache/ Feels like headache is double today from yesterday) and FATIGUE (Fatigue/ Feels like Fatigue is double today from yesterday) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced HEADACHE (Headache/ Feels like headache is double today from yesterday) and FATIGUE (Fatigue/ Feels like Fatigue is double today from yesterday).   At the time of the report, HEADACHE (Headache/ Feels like headache is double today from yesterday) and FATIGUE (Fatigue/ Feels like Fatigue is double today from yesterday) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No adverse reactions were reported by patient.
I had to go pee and I noticed in the toilet it was lightly tinted green; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Dec2022 as dose nomber unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHROMATURIA (non-serious), outcome "unknown", described as "I had to go pee and I noticed in the toilet it was lightly tinted green". Additional information: patient that states the following: "I just got my shot [PREVNAR 20] about 20 minutes ago at (institute name withheld) I came home because I had to go pee and I noticed in the toilet it was lightly tinted green and I was like, what is that? Has this been reported as a side effect of PREVNAR 20?  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
15 cm x 5 cm red raised warm skin below vaccination site with light erythema of the whole upper arm. PEPCID 40 mg x 7. Loratadine 10 mg x 7. KELFEX 500 TID x 7.
pt  inadvertently recv acel immune which is not recommended for immunizing persons on or after their seventh birthday  & devel redness @ the inj site;
This patient states she had a flu shot 12/07 and took Benadryl 12/07 for a rash to her face and redness to the injection site of the left upper arm. Complains of headache onset last night, diarrhea "x 32" today, some nausea, 2 cm area of induration / erythema at left brachium. The patient was discharged.
Patient received 2nd dose on 1/29/21.  Was treated for symptoms of Guillian Barre syndrome requiring inpatient rehabilitation.
booster; do COVID-19 test and I was positive; do COVID-19 test and I was positive; little pain over the belt; the area and after that the back, like over the kidney area little bit higher, lungs; I could not sleep two nights, waking trying to sit, trying to bed; I got sick; temperature lift little bit over the red line; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "tested positive for virus"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "tested positive for virus".  The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "do COVID-19 test and I was positive"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "little pain over the belt; the area and after that the back, like over the kidney area little bit higher, lungs"; INSOMNIA (non-serious) with onset Nov2021, outcome "unknown", described as "I could not sleep two nights, waking trying to sit, trying to bed"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "I got sick"; BODY TEMPERATURE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "temperature lift little bit over the red line". The patient underwent the following laboratory tests and procedures: body temperature: (Nov2021) lift little bit over the red line; sars-cov-2 test: (Nov2021) negative; (Nov2021) negative; (Nov2021) positive, notes: they might be wrong but they said they will send me within 3 days they will send me the correct result.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I experienced a breakthrough case of COVID-19 and it felt like I had a cold at first, my nose was very runny but I knew it was more than a cold when I lost my sense of taste/smell. I tested positive for COVID-19 with slight fever, fatigue, loss of smell and taste, runny nose, upset stomach and heartburn. It seemed like COVID-19 made my heartburn even worse.
Vaccine reconstituted with sterile water; Received vaccine reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 29EY3, expiry date 28-JUN-2024) for prophylaxis.   On 15-MAR-2023, the patient received the 2nd dose of Shingrix. On 15-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Vaccine reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Received vaccine reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter reported that the patient received Shingrix vaccine which was reconstituted with sterile water. The reporter did consent to follow up via email. Shingrix vaccine reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 "arm soreness". Additional information: The patient had arm soreness. It was bad for about 3 days. The patient couldn't even lay on side.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient said the same night of the vax she had 104 fever, body aches, shakes and she couldn't walk. Joints and muscles were aching. Went to ER 3 days later due to not being able to walk after testing at ER, they said her diagnosis was an adverse reaction to COVID-19 vaccine. 10 days after, she went to ER she was able to walk.
Constant cough, wheezing, severe headache, muscle aches, light headed, cold sweats, brain fogs, itching on wrist,
Pediatric patient was administered 0.2mL of  Adult BioNTech Pfizer COVID vaccine. While patient was in observation patient showed no adverse reactions. Consulted with provider who informed the patients that per the CDC there were no contraindications.
During night after receiving the shot  I woke up  at about 2)) AM to go to the bathroom.  When I got into the bathroom I suddenly had very strong chills and immediately passed out.  While passed out I uninated .  I woke up and have not had any problems since.
Moderna Covid19 vaccine administered to a patient younger than 18 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid19 vaccine administered to a patient younger than 18 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H2113) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid19 vaccine administered to a patient younger than 18 years old). On 27-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid19 vaccine administered to a patient younger than 18 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller reported she had a patient of 16 years who received the first dose of vaccine . The patient did not experience any symptoms after the vaccine and is not on concomitant medication. Concomitant medications was not reported.  Treatment medications was not reported.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated totally 9 doses of improperly stored RECOMBIVAX HB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 74-year-old male patient who received SHINGRIX. Concomitant products included Atorvastatin, omeprazole and metoprolol. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort, fever and injection site pain. On an unknown date, the outcome of the injection site discomfort, fever and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site discomfort, fever and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he experienced discomfort and soreness at his injection site.
0935 vaccine given. 35 minutes after vaccine pt. became hot, nauseated & developed a headache on the left temple. Pt. dry heaved but did not vomit. Pt. was escorted to the nurses office where an  ice pack was applied to pt.'s neck, water given, 1000mg tylenol given for headache, T 98.4,  154/104 76.  denies pain to injection site. Pt. states she still feels warm, & about the same.  Pt stated she has preexisting stomach issues & she is use to being mildly nauseated.  Pt. did not eat today. 1040  Pt. said she is feeling less warm, headache is about the same.  Supervisors with pt.   1050  Pt. is going to remain in her vehicle for a while, call & tell supervisor how she is feeling then drive home (she lives about 20 minutes away)  Pt. verbalized understanding if she does not continue to feel better she will come back inside for assistance.
see in office, red, warm to touch, swelling on arm; treated with Medrol (Pak) 4 mg tablets in a dose pack 24 mg PO on day 1, then decr. by 4 mg/day x5 days per dose pack instructions; Info: dose, frequency varies by condition; dose pack = 4 mg tabs x21; give w/ food
** Uncontrollable shivering/shaking (April 21st, 7AM - 11 AM CST recovered) Body aches (April 21st, 1AM - 2 PM CST recovered) Fatigue  (April 21st, 1AM - persists) Headache  (April 21st, 1AM - persists) Pain at the injection site  (April 20th, 5PM - persists)  Took Aleve and Ibuprofen for the symptoms April 21st at 7 AM. I was not running a fever while shivering. My body temperature was 98.3.
Chills, huge injection site lump, muscle aches, dizzy, exhaustion, low grade fever
Pt complained of the sensation of bugs crawling on her back and arms which began the evening after receiving ZOSTAVAX. It is transient and intermittent. She has not sought medical attention, but will follow up if it worsens or does not resolve. She asked that it be reported.
I was looking a little drowsy or whatever and they refuse to give me my second shot; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number and Expiration: Unknown), via an unspecified route of administration on unspecified date as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient reported that on an unknown date, went to get shot yesterday at the place where patient got it in and they refused. Patient was looking a little drowsy or whatever and they refuse to give the second shot. So, patient tried to figure out how would get the second shot. Patient informed that missed second shot of COVID-19 vaccine. Patient was informed about Pfizer Medical Information and provided the number and informed about the timings as 8 AM to 8 PM from Monday to Friday and 9 AM to 3 PM Saturday and Sunday as per EST. Limited information was available over the call. Reporter did not specify about seriousness. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Medicine: Shingrix 50 mcg - second dose (approximately 8 months after first, due to pandemic) Administered 8/17, 10:00 am EST. By afternoon, very sore at injection site, mild nausea. At 2:30 am, fever of 100.7. By dawn of 8/18, fever gone, arm soreness lessened. General loginess and slight nausea. All symptoms except slight soreness at site mild to gone by 4:00 pm next day. So this is not an urgent or unexpected adverse reaction, I just thought 'd report the symptoms. They matched CDC guidance.
THE DAY FOLLOWING VACCINATION, 3/19/21, MON NOTICED SWELING AROUND INJECTION SITE AND LOW GRADE FEVER.  THE SWELLING AND REDNESS WORSENED OVER 3/20 AND 3/21.  IT EXTENDED AT ITS WORST TO TOP SHOULDER AND JUST ABOVE  ELBOW.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 1:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 79.30 for dose administered on 12-Feb-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 10:00 AM to 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of 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. Temperature recordings were taken using a brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Fever of 100° beginning 6 hours after injection and lasting for 10 hours before declining to a 99° fever. Stiff neck and headache radiating from the base of the skull. Excessive pain in the injection arm. General achiness throughout the body. Nausea and fatigue.
Fever, muscle aches, extreme fatigue, nausea.  Used Advil and rest...left work due to symptoms.  Symptoms lasted about 36 hours.  Resolved.
Per vaccinator during administration of vaccine, the needle separated from syringe. Per vaccinator about 3/4th of the dose was received by patient and a slight amount escaped from syringe when needle separated. Vaccinator did not consult pharmacist and only made pharmacist aware after letting the patient leave his station. Vaccinator described what occurred and confirmed that more than half (3/4th) of the dose was received by the patient and therefore a replacement dose was not given.
3 x 4 cm erythematous papular rash arose with 45 seconds of administration of Rotateq on the childs left flank that resolved 75% within 30 minutes and completely within 6 hours. Resolution occurred with initial central clearing and gradually fading of erythema. No other urticaria, angioedema, or discomfort/pruritis was apparent. No medical interventtion was done. Other vaccines were given after a 30 minute wait after the rash was noted---these were without complications. Child has no history of any rashes or skin conditions and no reash was present prior to Rotateq administration. No Rotateq spilled onto the dressed child during administration.