chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching all over her body after the 2nd dose; Hives all over her body after the 2nd dose; Injection site soreness after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her body after the 2nd dose), URTICARIA (Hives all over her body after the 2nd dose) and VACCINATION SITE PAIN (Injection site soreness after the 2nd dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, CHLORTHALIDONE and CLONIDINE for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Injection site soreness after the 2nd dose). On 16-May-2021, the patient experienced PRURITUS (Itching all over her body after the 2nd dose) and URTICARIA (Hives all over her body after the 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 16-May-2021, VACCINATION SITE PAIN (Injection site soreness after the 2nd dose) had resolved. At the time of the report, PRURITUS (Itching all over her body after the 2nd dose) and URTICARIA (Hives all over her body after the 2nd dose) outcome was unknown.
red, raised rash to arms, legs & chest w/severe itching; rash was treated w/Pred therapy; rash last approx 6 wks w/gradual improvement in sx;
Two days after receiving the vaccination, she started having lip swelling and oral ulcerations to her lips and inside of her mouth
Pfizer monovalent vaccine given as a booster dose instead of pfizer bivalent vaccine. No adverse events.
he hasn't eaten because he can't pass the food, he can't swallow; he hasn't eaten because he can't pass the food, he can't swallow; This is a spontaneous report from a contactable consumer (Patient's mother). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0183), via an unspecified route of administration on arm left on 09Aug2021 (Age at Vaccination: 12 Years) as dose 2, single for COVID-19 immunization. The reported verbatim indication was reported included to protect from Covid since they are going back to school. Patients Medical History (including any illness at time of vaccination) was reported as none. Family Medical History Relevant to Adverse events was reported as not applicable. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported as none. The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0175), via an unspecified route of administration on arm left on 19Jul2021 (at the age of 12 Years) as dose 1, single for COVID-19 immunization. On 10Aug2021, the patient experienced he hasn't eaten because he can't pass the food, he can't swallow. On 12Aug2021, the patient experienced that he hasn't eaten. It was reported that patient received the second dose of the Pfizer Covid-19 vaccine on Monday, 09Aug. Now he feels his throat closed and he hasn't eaten because he can't pass the food, he can't swallow. The reporter reported that her son hadn't told her but he felt something like this with the first dose. With the 2nd dose he feels like food won't go through. Before, he was able to swallow but now he can't swallow. It has got-ten worse. On Tuesday he could swallow food but that night he felt it didn't go through. Yesterday he didn't eat. Today he has had only a little piece of donut with milk. The events has not resulted in Emergency Room or Physician Office visit. Relevant Tests was reported as none. The outcome of the events was not resolved.
Blood Clots found after a Cat Scan and trip to emergency for a series of TIA's.
Immediately after the injection, my arm hurt badly. The next day it was getting worse and it's now over two months and the throbbing and achy feeling in my arm and shoulder is still there.  There is also a burning feeling
Soldier had large hives on the left side of the chest, neck and left arms, that were itchy.
patient had miscarriage after vaccination; This is a spontaneous report from a non-contactable consumer via a Pfizer Sponsored Program. This consumer reported for two female patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had miscarriage after vaccination on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101154129 different  patient, same reporter/product/event
Blood pressure reduced substantially 30 points and it is 106/63; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure reduced substantially 30 points and it is 106/63) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020. Concurrent medical conditions included Hypertension and Chronic kidney disease. Concomitant products included LOSARTAN from 04-Jan-2021 to an unknown date for Hypertension.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HYPOTENSION (Blood pressure reduced substantially 30 points and it is 106/63). At the time of the report, HYPOTENSION (Blood pressure reduced substantially 30 points and it is 106/63) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure measurement: 106/63 Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 69-year-old male, with PMH of COVID-19, hypertension on losartan, and CKD, who experienced NS unexpected event of "blood pressure reduced 30 points to 106/63."  Event onset occurred 4 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported adverse event via click to chat forum. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional reported that they had a patient with previous reaction to SHINGRIX and would not classify as severe but described as a significant rash at injection site. No further information was reported regarding the event.
BODY ACHES IN LEGS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 01:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 08:00, the subject experienced body aches in legs. On 06-MAR-2021 08:00, the subject experienced chills. On 06-MAR-2021 08:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches in legs, and chills on 07-MAR-2021, and had not recovered from headache. This report was non-serious.
Ears started ringing same evening as shot received. Ears have been ringing constantly ever since. (3 weeks so far).
Developed numerous eye floater associated with sparks of light similar to that of retinal tear. PT sought care with ophthalmologist and found no adverse eye conditions aside from reported symptoms.
1st dose in APR-2019, received 2nd dose 7/6/2022  due to the pandemic; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (as received 1st dose of Shingrix in April 2019).   On 6th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the pain in arm and social problem were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comments: The patient had received the 2nd dose one day before the reporting date (yesterday), however, the 2nd dose was received late due to the pandemic. The patient also reported that she had experienced a sore arm. The patient had asked if could take Tylenol. The patient also wanted to know if they need to take the 3rd dose. Spoken as per the content and provided medical disclaimer and was referred to Healthcare professional (HCP). The reporter consented to follow-up. As it was not clearly after which dose patient had experienced sore arm, therefore as per processing convention it was considered that the event was occurred after the latest dose.
Patient had shingles show up over her back and her belly area with pustules and painful areas. Was prescribed a pain med to take twice a day, for a month (daughter not sure of name).
The patient was given vaccination at 0828 and remained in clinic for 15 minutes before departing. Approximately 1 hour later the error was discovered that the vial had been diluted incorrectly. It was diluted with only 0.22 mL instead of the intended amount of 2.2 mL.  The parents were notified and the child returned to clinic at approximately 1052 same day and met with a pediatrician of the clinic. The child had complaint of some aching in his left upper extremity, otherwise no other complaints. Patient is to take acetaminophen 5ml every 6 hours for 24 hours and a follow-up virtual call is scheduled for next day.
Pt describes she got massive/severe headaches. Different that what she usually got as far as location of the headache. Also reported weight loss, without trying to lose weight, lost 35 lbs, currently 107 lbs, (height = 5'7). Pt has recovered on the headache (does not happen anymore), have never regained her weight. Has talked to her MD about it, but they just attribute it to her COPD.
missed 2 days of work-got fever 101-103 all upper trunk muscles ached, clear to waist & trouble getting to sitting position; lasted 2 1/2 days-no local react
Began with papular rash on 3/6/06 now has about 30 macular spots on back, neck and legs. To use Aveeno for bathing and Benadryl for itching.
screaming constantly following vax dx inconsolable screaming p/vax;episode lasted for 2 days;
not feeling well; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DCBOH) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-102905 (Patient Link).
Pt recvd vax & 1 wk later had pain in legs inc to numbness & tingling also involved lips;
Pt states itching rash on chest beneath bilateral breasts, behind bilateral knees, inside wrist, but none at knees or breasts.
Gastrointestinal symptoms, nausea, vomiting, diarrhea, fatigue.
On Friday morning 5/7/2021 I woke up with a sore left arm from my COVID Vaccine given on Thursday 5/6/2021. I went to work and at 10:00 am I started experiencing bad body aches, chills, and pain under my left arm. I was able to continue to work all day but the body aches and pain began to get worse with pain under the bottom of my feet, left arm, pain in the palm of my hands, and severe chills with being cold and hot. After work I went home and became very weak and nausea on the stomach. During the night I woke up often feeling very weak and had to take pain meds to help with the body aches 400 mg Ibuprofen. in the morning I was very weak and had body aches and chills. I was at the bathroom sink and fainted which I dont remember much because I was very weak standing at the sink. I was told by my son I was on the floor in the bathroom passed out and my mom called 911. my son tried to help me up off the floor but I was too heavy to lift up so I told him I would turn over on my knees and hold on to the bathroom sink to get up off the floor to get back in bed until the EMT came inside. I was then tranported to the hospital. I was told by the doctor I had a bad side effect from the COVID Vaccine and was dehydrated so they gave me an IV along with pain meds because I had severe back and neck pain due to the fall of passing out on the floor in the bathroom. I was unable to turn my head or neck to the right side and have a bruise on my right side of my back. Also I have severe pain from the top of my neck in the back of my head to the middle of my back.
Red around neck; Bad rash all over the body like in the back, in the neck, in the leg; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red around neck) and RASH (Bad rash all over the body like in the back, in the neck, in the leg) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ERYTHEMA (Red around neck) and RASH (Bad rash all over the body like in the back, in the neck, in the leg). At the time of the report, ERYTHEMA (Red around neck) and RASH (Bad rash all over the body like in the back, in the neck, in the leg) was resolving.            Patient was taking other concomitant medications. Treatment medications were unknown.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
No medical treatment sought by patient. She reported experiencing some blurry vision but she was able to sit down and it then passed after approximately 1 hour.
flu like; Fever; Pounding headache; Ache joints; This is a spontaneous report received from a contactable non-health care professional (parent) reporting on behalf of a patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 24Mar2021 at 15:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient has not received any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 at 18:00, the patient experienced fever, pounding headache, ache joints and flu like. It was reported as the patient had called doctor to let them know that had received the first dose and doctor gave her instructions to stay at home to let it pass unless worsening. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever, pounding headache, ache joints and flu like were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Systemic: Bell's Palsy-Medium, Additional Details: The patient called us to report that about 4 hours after she received her first dose, she noticed that her jaw felt heavy/tight, similar to lockjaw but not as severe. It was more difficult for her to talk/chew, although still possible. That evening she felt that it was already subsiding, but she took Benadryl in case. She felt fine by the following morning.
Patient received FLUZONE HIGH DOSE in the AM at the office. She called on the way to the ER stating she was having symptoms of shaking and body severe pain.
Headache, sensation of hot and cold, depression, fatigue, mood disorder, brain fog. Most noticeable and reason I am writing is due to heart palpitations felt on and off for almost 3 weeks. These were accompanied by sense of pre panic attack type tightness around solar plexus area and need to take deep breaths almost to try to calm my nervous system and reset my irregular heart Rythm.
PENTACEL and PCV-13 administered in right thigh muscle area on 11/23/10. On 11/26/10 patient returns to clinic with 7cm x 6cm area of very light erythema of tissue on right upper thigh. Non-tender to touch and soft to palpation. Instructed to apply warm compresses to site and BENADRYL as needed.
Immediately after vaccne arm swollen hard not. 10/2/14: c/o of HA all night.
adult dose administered to a 17 yeras old patient; no adverse effects; This spontaneous report was received from a nurse regarding to a 17-year-old adolescent patient of unknown gender. Information on patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (dose, strength, frequency were not reported, lot # S001832 with expiration date 12-MAY-2020) via unknown route for prophylaxis. On an unknown date the 17-year-old patient was administered an adult dose of hepatitis a vaccine, inactivated (VAQTA) (product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). There was not involvement of product quality complaint (PQC).
Arm turned bright red and swelled to twice normal size with red lines going down arm. PNEUMOVAX injection.
Admitted for hypoxic respiratory failure from covid19 pneumonia, despite vaccination with J&J April 2021.
This is an instance of breakthrough COVID-19 disease after which death occurred.  The individual was vaccinated with the   Pfizer product on 03/16/2021 and 04/06/2021. They became symptomatic on 12/07/2021 and tested positive on 12/10/2021. They were admitted to hospital on 12/09/2021 with a primary complaint of CVA evaluation. They were discharged on 12/11/2021 but then re-admitted on 12/15/2021. They remained hospitalized until their death on 12/20/2021. Death Certificate details are as follows:  Part I Cause of Death A: Hypoxemic Respiratory Failure B: Pulmonary Edema C: COVID 19 Part II Other Significant Conditions: Severe Coronary Artery Disease, Severe Peripheral Vascular Disease
Dark red, square  painless spot on deltoid near injection site. Also itching welps (hives) on back, hands, feet. This is my third day. Hives have gotten worse on my back.
c/o left arm soreness morning of 10/06/2010. States 10/05/2010 no problems. Face flushed earlier in morning. Injection site red, warm and firm to touch. Temp: 97.7, neuro/vas intact. ROM wnl. redness area approx 1 and 1/2 inch long x 2 inches wide. rx: Tylenol and cold packs. states she feels fine other than the sore left arm. rx: Tylenol and cold packs. rechecked 10/07/2010: redness greatly decreased to a faint pink, warm to touch, states decrease in soreness.
This spontaneous report as received from a pharmacist refers multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies/reactions or concomitant medications. On an unknown date, the patients were inadvertently vaccinated with improperly stored VARIVAX lot # M033907 with expiration date of 20-JUL-2018 and lot # M033214 with expiration date of 13-JUL-2018, subcutaneously, for prophylaxis (dose and route of administration were not reported); diluted in sterile water diluent, for prophylaxis (lot number and expiration date were not reported). No adverse effects reported. No additional information was provided. Administered doses of vaccines experienced the temperature excursion of 15-46 degrees Fahrenheit (27.6°F) for 2.5 hours. Data logger was not involved. There were previous excursions of 6-14 degrees Fahrenheit (12.8°F) for 1.5 hours. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA000321.
This spontaneous report was received from a medical assistant reporting a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-AUG-2016, the patient was vaccinated with M-M-R Ii injection, lot # K011317, expiration date 14-AUG-2016 (strength, dose and route of administration were not provided). There were no concomitant medications reported. No adverse events were reported and no product quality complaint was involved. Additional information is not expected as the reporter did not consent for new follow up attempts.
Initial misuse report received from a healthcare professional on 24 September 2013 and on 20 March 2014 at GPV. A 03-year-old patient of unknown gender had received FLUZONE 0.25 ml instead of 0.5 ml. No adverse event was reported. The list of documents held by sender: none