chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening after I got the first dose I experienced painful muscle aches starting in my legs and progressing to the rest of my body, around 7pm. My left shoulder was a little achy, but no different than any other shot. About 30 minutes later I felt chills and felt really cold. I went to bed and tried to sleep. I woke up several times in pain. I did not take any pain meds. At 1am I went to the bathroom and felt nauseous and lightheaded. My vision got blurry and it felt like I was going to pass out, so I grabbed the towel rack and closed my eyes.  I must have blacked out for a second and lowered myself down to the floor. I came to, and I was sitting on the ground, sweating a lot. I stayed on the floor for at least 10 minutes cooling down. (I had dressed warmly and turned on my heater after the chills started). I heard ringing in my ears while I was sitting on the floor. It went away after 5 minutes. I got up and went back to bed. I woke up at 9am and felt a lot better. Some minimal soreness. No more chills.
I am sick and I have a lot of symptoms. Well, I have got a lot of health problems.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Lot number: EW0158) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (its ER8727 was the 1st dose), administration date: 22Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I am sick and I have a lot of symptoms. Well, I have got a lot of health problems.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness.  Additional Information: It was reported that, the patient had no medical history. Dates for I am sick and I have a lot of symptoms. Well, I have got a lot of health problems (From: Unspecified To: Unspecified). NDC number of COVID19 Vaccine: Unknown, UPC number of COVID19 Vaccine: Unknown. Consumer stated, I would like to sign up for, I have had the two Pfizer shots and that was back to on April 12 of 21 and I was wondering, I had doctors note because I am sick and I have a lot of symptoms. Well, I have got a lot of health problems. event captured as per verbatim. She had the blood test done recently. The patient was not received Treatment. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The 2nd was done on 12Apr2021.  Follow-up attempts are completed. No further information is expected.
Thursday, Oct 13th  - I began noticing medium joint pain in knees - elbow. Took ADVIL to cope. In the middle of the night appx 2 am - woke w/swollen tongue - lips - nasal passages - face - throat.
Not positive on the exact Influenza shot I received so I selected the first option. Yesterday I received the flu shot in my right arm and had the typical sore arm for the night.  This morning it feels like a pulled muscle under the right arm going from my armpit down the side of my chest. Starting late this morning, my whole body aches and I have the chills. My head has also been pounding since I woke up feeling almost like a migraine and feeling nauseous.
Refrigeration excursions identified/undergone several temperature excursions; No adverse event; Vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Aug-2022 at 10:37 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Aug-2022 at 10:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions).    No concomitant medication was provided. Patient had received vaccine on deltoid body site. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. Storage condition at the time of the excursion-Refrigerator. There were 2 unbroken cartons and 20 vials.Two different lot numbers AS1412B and 057A22A were reported. The vial(s) moved from freezer to refrigerator on 7-SEP-2022.  Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients. It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19. Treatment medication was not provided by the reporter.
Cold; Then it affected her joints; Chills; On her upper arm, she felt something warm; Very red around the area and lower and across; Felt a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), ARTHRALGIA (Then it affected her joints), VACCINATION SITE WARMTH (On her upper arm, she felt something warm), ERYTHEMA (Very red around the area and lower and across) and VACCINATION SITE PRURITUS (Felt a little itchy) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE WARMTH (On her upper arm, she felt something warm), ERYTHEMA (Very red around the area and lower and across) and VACCINATION SITE PRURITUS (Felt a little itchy). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), ARTHRALGIA (Then it affected her joints) and CHILLS (Chills). At the time of the report, NASOPHARYNGITIS (Cold), ARTHRALGIA (Then it affected her joints), VACCINATION SITE WARMTH (On her upper arm, she felt something warm), ERYTHEMA (Very red around the area and lower and across), VACCINATION SITE PRURITUS (Felt a little itchy) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported No treatment information was reported.
On 4/3/00, the pt experienced a 4-5 cm circular nodule at site of injection, area is tender to even light palpation. Area is erythematous and warm to touch. This extends an additional 2-3 cm beyond nodule. Pt complained of feeling flushed, pt is afebrile. Pt saw MD on 4/5/00 treated with Augmentin and Motrin. Nodule is decreasing in size.
One day after I got vaccine, I felt severe fatigue and nausea in the morning. After that, I got high fever (38.6C) and all body aches. Because of sever nausea, I could not eat or drink except small amount of water, but every time I felt stomachache after I drink water. I could not move from bed. The symptom did not change by the end of the day. 2 days after vaccination, fever was gone in the morning. However, I still felt severe fatigue, nausea, and muscle pain in the morning. I could not eat or drink except small amount of water by 5:00 pm. After 5:00 pm, I could drink and eat, and gradually recovered. 3 days after vaccination, I felt slight headache and muscleache, but it was manageable by painkiller.   I took pain killer 2nd day around noon and 3rd day in the morning. Other than painkiller, I didn't take any treatment.
No AE; Nurse reported that a 37 years old male patient received PROQUAD instead of MMR II and VARIVAX due to a human error.; Nurse reported that a 37 years old male patient received PROQUAD instead of MMR II and VARIVAX due to a human error.; This spontaneous report was received from a nurse and refers to a 37-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, 1 dose, valid lot #X009731, expiration date: 30-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product use issue)  instead of varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, due to a human error (Wrong product administered). No additional adverse events were reported (No adverse event).
Miscarriage at 8 weeks pregnant (est. due date April 5, 2022)
received expired dose; 11 YO received infanrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 11-year-old patient who received DTPa (Infanrix) (batch number unknown, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-JUN-2022 Reporter's comment:  The patient received the Infanrix vaccine, which was expired on 28th May 2022 The reporter consented to follow up. Additional supportive information: The patient received Infanrix vaccine at 11 years of age, which led to inappropriate age at vaccine administration and expired vaccine used. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093050:Same reporter
other side effects; Chills; fever; rash on legs,arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (other side effects), CHILLS (Chills), PYREXIA (fever) and RASH (rash on legs,arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (other side effects), CHILLS (Chills), PYREXIA (fever) and RASH (rash on legs,arm). At the time of the report, VACCINATION COMPLICATION (other side effects), CHILLS (Chills), PYREXIA (fever) and RASH (rash on legs,arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: follow-up was received on 27-APR-2021, contain no significant information.
No other AE reported; pediatric patient received an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a pediatric patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not provided.   On 11-DEC-2020, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S017630, expiration date 06-DEC-2020, administered orally (dose and strength were not provided) for prophylaxis. No other adverse event was reported. The outcome was unknown.
48 hrs after vaccination, patient had just finished breast feeding. Mother was burping him and he went still and turned blue. It lasted for approx. 1 min. Mother hit his back several times and he returned to himself. This occurred on a weekend. Mother did not call until 2 days later and he was seen then. Has had back arching fussiness since. Mother also insists eczema due to vaccines.
Syncope occurred within 5 minutes of vaccine. LOC lasted about 60 seconds with return to baseline after 5 minutes. Vital signs remained within expected range for 40 minutes with 5 separate checks. Discharged home.
I had a scratch in my throat and already or understood I had been exposed to COVID-19 and had mainly upper respiratory issues with some difficulty breathing. I had symptoms for three months and I saw a pulmonary specialist that prescribed which symptoms have now resolved.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patient were vaccinated with a dose of GARDASIL (Lot number J002641, expiration date 10-DEC-2015, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shortness of Breath      onset for "awhile" per family. on exertion and when sleeping     Pt is a 67y.o. male presenting to the ED with chief complaint "shortness of breath." Patient states that for the past week he's been experiencing gradually worsening shortness of breath. He states that symptoms are especially worse with exertion and while lying flat. He denies any history of MI/stent placement, asthma, COPD or heart failure. He reports he is a former smoker and quit approximately 2 years ago. He admits to a nonproductive cough. He denies any fevers, chills, sick contacts, chest pain, abdominal pain, nausea, vomiting, diarrhea, lower extremity edema. He reports that he is fully vaccinated for COVID. He has no other complaints at this time.         Review of Systems  Constitutional: Negative for chills and fever.  HENT: Negative for rhinorrhea and sore throat.   Eyes: Negative for pain and redness.  Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Genitourinary: Negative for frequency and urgency.  Musculoskeletal: Negative for back pain and neck pain.  Skin: Negative for rash and wound.  Neurological: Negative for weakness and headaches.
6 X 8" red blanching area on (R) thigh non-tender no fluctuants - no fever (-) s/s infection heat/ice.
I had a low grade fever, cough, congestion I had been exposed to COVID-19. I took a home COVID-19 test that came back positive I went to urgent care on July 1, 2022 and had PCR COVID-19 test that also came back positive. I was prescribed PAXLOVID and albuterol nebulizer. I started taking the PAXLOVID immediately, I am still felling fatigue, nasal drainage, and a slight cough.
sick; rough shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and injection site pain. On an unknown date, the outcome of the sickness and injection site pain were recovered/resolved.   It was unknown if the reporter considered the sickness and injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient reported that, he/she got Shingles shot and they were rough shots and made him/her sick, but the patient would put up with the shots to not to get shingles. For the tolerance of 2nd dose refer case US2021AMR191930, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR191930:same reporter
Shortness of breath, temp of 103 degrees, left arm deltoid with edema, redness, warm to touch, ROCEPHIN IM in ER and KEFLEX 500 mg 1 po TID x 10 days, Naproxen DS 550 mg.
Tongue is numb like when eating spicy food; Lips are cold; Lips are swell; Swell on the eye leads; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Tongue is numb like when eating spicy food), ORAL HERPES (Lips are cold), LIP SWELLING (Lips are swell) and SWELLING OF EYELID (Swell on the eye leads) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 10-Feb-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 HYPOAESTHESIA ORAL (Tongue is numb like when eating spicy food), ORAL HERPES (Lips are cold), LIP SWELLING (Lips are swell) and SWELLING OF EYELID (Swell on the eye leads). At the time of the report, HYPOAESTHESIA ORAL (Tongue is numb like when eating spicy food), ORAL HERPES (Lips are cold), LIP SWELLING (Lips are swell) and SWELLING OF EYELID (Swell on the eye leads) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Narrative: COVID infection following COVID vaccine series 03/17, Pfizer, dose #1 04/08, Pfizer, dose #2 11/24, Pfizer, dose #3 12/27 COVID swab, result: detected 12/27 pt cc: exposure: unknown
Broke out with rash in late evening after receiving Act-Hib #4 vaccine on the same day, Seen in the health clinic for well child check-up. Rash continued to spread & seen on 01/07/03 for evaluation; Other symptoms including decreased appetite; Crankiness, but no fever or trouble breathing; Dx: urticaria second degree.
I was for positive for Covid exactly on May 15/had to cancel my appointment for my second shot because I had Covid; I was for positive for Covid exactly on May 15/had to cancel my appointment for my second shot because I had Covid; This is a spontaneous report from a contactable consumer (patient)via team. A 51-year-old female patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0158), via an unspecified route of administration on 24Apr2021 as single dose for covid-19 immunisation.  The patient medical history was none. The patient's concomitant medications were not reported. The patient stated I was for positive for covid exactly on 15May/had to cancel my appointment for my second shot because I had covid on 15May2021. The patient stated, she received the first dose of the Pfizer COVID-19 vaccine on 24Apr2021 and tested positive for COVID on 15May2021 the same day she was due to get the second dose of the Pfizer COVID-19 vaccine. She cancelled her appointment. She states she is getting conflicting information as to when to get the second dose of the vaccine. She would like to know when she can receive the second dose and if the series needs to be repeated. The events were treated with Tylenol and Robitussin. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021598751 similar report from same reporter
fever; constant diarrhea; chills; This is a spontaneous report from a sponsored program. This is a report from a contactable consumer (patient's wife).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced fever on an unspecified date with outcome of unknown, constant diarrhea on an unspecified date with outcome of unknown and chills on an unspecified date with outcome of unknown.    Information about lot/ batch number has been requested.
Severe shoulder pain; difficult to roll over in bed or lift arm over shoulder height; it is not getting any better, but is getting worse.
My toes were like in a lot of pain as if someone had like slammed a hammer on all of my toes and they were very itchy; My toes were like in a lot of pain as if someone had like slammed a hammer on all of my toes and they were very itchy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer -Biontech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 22Jan2021 at 3 o'clock (as reported) and starting that night (22Jan2021) and whole all of 23Jan2021 the patient's toes were like in a lot of pain as if someone had like slammed a hammer on all of the patient's toes and they were very itchy. The outcome of the events was unknown.   Information about batch/lot number has been requested.