chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    Concomitant medication not reported. Treatment medication not reported. Dose 1, dose 2, dose 3 were administered on unknown date by route intramuscular and on deltoid. Dose 4 administered by 3:05 PM with dose 0.5.
LEFT LEG PAIN, SWELLING, ERTHEMA, WARM TO TOUCH. WAS GIVEN ANTIBOTICS IF SWELLING INCREASES.
pt recvd vax; pt devel headache & blurred vision in am; on pm, pt devel itching all over;
Patient had routine booster on 08/13/2004.  On 08/14/2004 the patient's arm was hot with some swelling.  She had a fever in the 100s with a headache and she felt dizzy and some muscle achiness.  On 08/17/2004 the patient came back into see the doctor and her arm was still a little swollen and sore but was much better.  Her other symptoms had gone also.
Having nausea, vomiting and unable to have bowel movement for 12 days. Symptoms for 12 days so far. having myalgias and fatigue. Excessive coughing
At 3AM 5/24, patient woke up feeling "bad". She went to work, had temp by 11A and by 4P it was 103 degrees F. She went home and discovered arm swollen. She went to urgent care.
Pt vaccinated around 1:00pm. No adverse reaction in office. Wife reports around 1/2 hour after receiving vaccine he began experiencing "throat closing up " + hoarseness. Also "uneasy stomach". Reports he was very restless during night Mon/Tues. Didn't feel well yesterday. Still not well today though going about activities. Has not seen doctor. Encouraged strongly to do so. Pt called. Stated he's feeling much better. I don't think it's form the shot. States he's heard there's a lot of "crud' going around and he thinks that is what he's had. States his initial symptoms was "itching" in throat then "bad cold ' symptoms: cough, feeling of congestion. Nurse stated Doctor has not returned call. We will contact him again and ask that he call pt to help determine if he feels symptoms were from flu vaccine. states, "I'll get another flu shot next year because I get them all the time." Informed we would want to know if any future shots are contraindicated.
After receving the Polio and MMR shot my son's leg (Polio Injection Location) swelled to the size of a softball. He is complaining of pain and difficulty walking the day after. 48 hours after receiving the shot he still complains of pain. The site is hot to the touch, swollen, and hard. He is not running a fever but was lethargic for the first 24 hours.
Erythema, swelling, tenderness to palpation at site, hypotension, lightheadedness, fever.
Redness & swelling both injection sites, shortness of breath.  Difficulty taking deep breath.
Patient received the Moderna full dose 0.5ml instead of 0.25 ml on 10/25. I looked through the company email to see if it was approved to give but did not see the change in dose. I called Moderna on 10/26 to get more information sent to me. I called patient on 10/29 and he stated that he experienced the same side effect as with the other shot. he had 100.5 fever and felt achy starting from 11pm till morning.
Painful Lymph node under arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events painful lymph node under arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Painful Lymph node under arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), painful lymph node under arm was unknown.
caller's high blood pressure shot up really high; rash all over her neck; severe allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TALWIN [PENTAZOCINE]. Vaccination history included: Bnt162b2 (Dose number: 1, Manufacturer: Pfizer), for COVID-19 Immunization, reaction(s): "she had scaly rash all over her neck for 4 or 5 months", "severe allergies", "they were not sure if her throat would close"; Bnt162b2 (Dose number: 2, Manufacturer: Pfizer), for COVID-19 Immunization, reaction(s): "severe allergies", "had hives for another 4 months". The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "caller's high blood pressure shot up really high"; RASH (non-serious), outcome "unknown", described as "rash all over her neck"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergies".  Additional Information: It was reported that the patient was calling about the Pfizer COVID-19 Vaccine and had questions about if it interacts with a medication that she takes called Talwin. The caller stated that she had severe allergies with the first dose of the Pfizer COVID-19 Vaccine.She went to the allergy department for four hours and they were not sure if her throat would close up. Then for 4-5 months after that she had a scaly rash all over her neck. With the second dose of the Pfizer COVID-19 Vaccine the caller stated that she had hives for another 4 months. With her first booster dose of the Pfizer COVID-19 Vaccine, the caller stated that her blood pressure shot up really high and she also had a rash all over her neck. With her second booster dose of the Pfizer COVID-19 Vaccine, the caller stated that she didn't have any of the other problems; but she felt very drugged for about a week and was completely out of it. The caller stated that this occurred three weeks ago. The caller also mentioned that this vaccine is very new to her since she has never had any other vaccines since she was 08 years old.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On the 5th day after receiving the vaccine I became dizzy.  The next morning I became very dizzy and went to the hospital.  They admitted me to Emergency because my blood pressure was extremely high-they said later it was about 187/ ?.  While I was there the blood pressure went up over 200 to 214/81.  I was dizzy and nausious and shaking because I became very cold even though the nurse covered me with 3 blankets.  After I left the hospital it took until after I got a prescription for meclizine filled and took one at 7PM before I was able to get the blood pressure down to a normal range - 130/64.  Today I am still taking meclizine as prescribed and am still slightly dizzy.  I do not know if this was related to the vaccine or not.
This spontaneous report as received from a pharmacist refers to some patient of unknown age. The reporter reported that sometimes, he does not get enough diluent volume to produce total volume of 0.65 ml for live ZOSTAVAX when reconstituted and some patients might have less than 0.65 ml live ZOSTAVAX. Specific number of patients unspecified. No adverse effects reported. PQC was filed. Additional information is not expected.
Pain in her breast; cyst in her breast; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST PAIN (Pain in her breast) and BREAST CYST (cyst in her breast) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Pain in her breast) and BREAST CYST (cyst in her breast). On 15-Apr-2021, BREAST PAIN (Pain in her breast) and BREAST CYST (cyst in her breast) had 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.   No concomitant medications were reported Treatment information was not provided
FEVER,HEADACHE,BODY ACHES,NIGHT SWEATS,DIZZINESS,SORE THROAT,RUNNY NOSE,STIFFNESS IN HANDS AND  FEET- UNABLE TO TWIST OPEN A BOTTLE TOP.
felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient).  A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour.  The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
Dizziness; Headaches; This is a spontaneous report from a contactable consumer (patient's father) through a Pfizer-sponsored program.. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 2, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had dizziness and headaches. The events were assessed as serious (medically significant). The patient had been to specialists (physician office visit), and was unable to work because of the reported events. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
This infant had a 2 inch diameter reaction around the area of DTaP. Warm to touch. Giving him Motrin and cool compresses to the area, left thigh. On Augmentin for 2 weeks for Serous Otitis Media. Started 04/18/01.
Headache, Sedation, Myalgia, Fever, Chills; Pain,redness,swelling,itching at injection site Narrative:
24 hrs later, sore throat. It has gone away. Went to nurse today - red throat, vomiting, diarrhea. Has been sleeping since home from school.
Thrombosed Hemorrhoids.  Extreme pain, bleeding.  Went in to urgent care after 3 days and they cut them open to remove blood clots. There was no clear event that triggered these to appear.
Starting last week I had cold symptoms, massive headaches, and this week I no longer can smell or taste. I got a covid test to ensure i did not get sick in the meantime but it came back negative..
complained of chest pain after having the vaccine; very fatigued; very sluggish; Sore arm; This is a spontaneous report received from a contactable consumer (parent). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Lot Number: EW0177, at the age of 16-year-old) as single dose for covid-19 immunisation. Medical history included heart murmur. The patient's concomitant medications were not reported. Historical Vaccine included 2 vaccines in Mar2021 (Caller said that her son had 2 vaccines in Mar2021 on his annual doctor visit, she did not have the names of the vaccines and then had a booster for the vaccine 4 weeks later. The booster was 14 days prior to receiving the Covid vaccine), and meningococcal vaccine on 01May2021 (at the age of 16-year-old, Caller said that it was a meningococcal vaccine. She thought there were 2 different meningococcal vaccines). Caller was a consumer that was calling on behalf of her son that received his first dose of the Covid-19 Vaccine. She said that she saw on the news recently that Pfizer was looking into reports that teenagers were developing heart issues after receiving the vaccine. The caller said that her son was 16 years old and received his first dose on 15May2021. The caller said that her son had a really small heart murmur. When they got home later that day after he received the vaccine on 15May2021, he said that he had chest pain. She said that he did not have a fever, but was very fatigued and very sluggish for a couple of days. She said that this had been on her mind since she saw it on the news. She was concerned if he should get the second dose on 05Jun2021 with his pediatrician. The caller also said that because he turned 16 in Mar2021, he recently had 2 other vaccines and he had a booster. So he had 3 shots prior to having the Covid-19 Vaccine. The caller said that he received the Covid-19 Vaccine after 14 days of receiving the booster. The caller said that the fatigue and feeling sluggish lasted a couple of days, but stated that he was still tired a lot. The caller said that her son also reported that he had a sore arm. She said that he noticed it a couple of hours after his vaccination and lasted about 3 days. He had completely recovered from the sore arm. The outcome of the event chest pain was unknown, of event fatigue was not recovered, of event sluggish was recovering, of the event sore arm was recovered on 18May2021.
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 an 85-year-old female 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 medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported.  No treatment information was reported.
Patient received immunizations 8/10/2018 in the afternoon. On the evening of 8/11/2018 began to develop progressive erythema and swelling around the injection site on the left thigh (where the KINRIX had been administered). Starting the evening of 8/13/2018 began to develop intermittent hives throughout trunk and arms, as well as rash on torso and flank. Patient seen in the office for evaluation on 8/14/2018 and physical examination was consistent with erythema and warmth on the left thigh measuring 10.5 cm x 13.cm, as well as scattered rash on torso.
Patient was given oral vaccine that expired 10 days ago. Merck was called Case #. The potency is still viable and manufacture does not recommend re vaccination but leaves that up to the medical provider.
Mom reports swelling and tautness of entire upper right arm 48 hrs after injections. At 60 hrs there is still mild swelling of right upper arm compared to the left one. No erythema.
Patient got the DTP vaccine on 2/12/13 and coughed a dry cough for 2 weeks after.  When it turned into gagging and fever, he was finally diagnosed with whooping cough.  The P in DTP is Pertussis, otherwise known as whooping cough... which he got FROM the vaccine.
ventral tongue and lip tingling, beginning 20 min after vaccination,  improving over hours beginning prior to and continuing after Diphenhydramine, 50-75% resolved after 2 hrs and fully resolved on awakening this am, no SOB, no lip swelling, no rash, no nausea, no throat fullness, no fever
Moderna COVID-19 Vaccine EUA Feeling aches at point of injection; chills in the evening after about 12 hours and all through the night into the morning; joint pain' muscle tension in legs
Numbness in right arm, right and left legs. Started about 2 hours after getting the 1st dose  of Pfizer vaccine (06/30/21) and no numbness when I woke up the next morning.   Fast heartbeat, intermittent  pounding heartbeat at 3am 07/03/21 and was normal when I woke up the next morning   I never went to the doctor
psoriasis came back and got even worse than before; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis came back and got even worse than before) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Psoriasis.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (psoriasis came back and got even worse than before). At the time of the report, PSORIASIS (psoriasis came back and got even worse than before) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
urticarial rash on upper arms, elbows, back, buttocks, upper posterior thighs.  Symptoms were noticed 24 hours after immunization, patient was seen 2 days after immunization and treated with benadryl 50mg im then 50mg po tid prn.  Rash resolved when re-evaluated in 24 hours.