chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I wasn't feeling right; After second dose, whole arm swollen and painful, lasted 3 weeks; After second dose, whole arm swollen and painful, lasted 3 weeks; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (I wasn't feeling right), VACCINATION SITE PAIN (After second dose, whole arm swollen and painful, lasted 3 weeks) and VACCINATION SITE SWELLING (After second dose, whole arm swollen and painful, lasted 3 weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included PRAVASTATIN and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (After second dose, whole arm swollen and painful, lasted 3 weeks) and VACCINATION SITE SWELLING (After second dose, whole arm swollen and painful, lasted 3 weeks). On an unknown date, the patient experienced MALAISE (I wasn't feeling right). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In 2021, VACCINATION SITE PAIN (After second dose, whole arm swollen and painful, lasted 3 weeks) and VACCINATION SITE SWELLING (After second dose, whole arm swollen and painful, lasted 3 weeks) had resolved. At the time of the report, MALAISE (I wasn't feeling right) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
inc temp of 102-104.6 ax x 48 hrs; excessive crying x 3-4 hrs; MD r/o any infect, no treatment; no other s/s;
Pt immunization card was checked. Child was given immunizations. When mom was given immunization information sheets (VIS) mom said her child should not have gotten Hep-B as she got 1st one at birth and 2nd one on 6/29/01 and the nurse failed to write it into the Pink Immunization. So the 3rd Hep-B given in Hib/Hep (Comvax) at 15:45. Discovered this at 17:50 on 8/29/01. The child had no apparent reaction from this and no evidence seen of reaction after 15 minutes.
Redness and bums around the midriff area; Itching around midriff area, stomach, lower back; Burns around midriff area; Itching on injecction site arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness and bums around the midriff area), PRURITUS (Itching around midriff area, stomach, lower back), ABDOMINAL DISCOMFORT (Burns around midriff area) and VACCINATION SITE PRURITUS (Itching on injecction site arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (Redness and bums around the midriff area), PRURITUS (Itching around midriff area, stomach, lower back), ABDOMINAL DISCOMFORT (Burns around midriff area) and VACCINATION SITE PRURITUS (Itching on injecction site arm). At the time of the report, ERYTHEMA (Redness and bums around the midriff area), PRURITUS (Itching around midriff area, stomach, lower back), ABDOMINAL DISCOMFORT (Burns around midriff area) and VACCINATION SITE PRURITUS (Itching on injecction site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  This case was linked to MOD-2021-132958 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: follow-up was received on 14-MAY-2021 and patient initial, new event were updated
Vaccine leaked from luer-lok, unk amount given; Vaccine went down the patient's arm; Vaccine went down the patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 2A54M, expiry date 21-MAY-2024) for prophylaxis.   On 19-APR-2023, the patient received the 2nd dose of Shingrix. On 19-APR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Vaccine leaked from luer-lok, unk amount given), exposure via skin contact (Verbatim: Vaccine went down the patient's arm) and inadvertent exposure to vaccine (Verbatim: Vaccine went down the patient's arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 24-APR-2023 The pharmacist administered Shingrix vaccine to a patient, and some of the vaccine leaked from the luer-lok so that the patient did not receive the full dose.  The pharmacist was unable to determine how much of the dose the patient received.  The pharmacist asked that what is the recommendation in this case, should the dose be repeated?  The pharmacist added that some of the vaccine went down the patient's arm. No product quality complaint (PQC) as leaking was from the syringe. The reporter did not consent to follow-up. The patient did not received full dose of Shingrix as some of the vaccine leaked from the luer-lok to the patient's arm, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Severe axillary lymphadenopathy in the arm of the injection. Swelling and pain preventing full upright extension of arm.  Pain is more than just tenderness In the area. Treating with ibuprofen 800mg every 6 hours.
This spontaneous report was received from a male consumer of an unknown age, reporting on himself, with rash, a line bumps from the top of his neck to the midpoint in his back and no drug reactions or allergies, who 3 1/2 weeks ago in approximately December 2012, was vaccinated underneath in his left arm with a dose of live ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that one week later after vaccination, in approximately December 2012, he developed a rash under his arm at the site of injection. Soon after the area around the injection site became hard, he experienced chills, shortness of breath and vomited. This lasted 24 to 48 hours. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the consumer reported that he felt better, but the injection site was still hardened. The consumer had scheduled a visit with his physician next week. The relatedness for rash under his arm at the injection site, patient experienced vomited, shortness of breath, chills and the area around the injection site became hard was unknown for live ZOSTAVAX. Additional information has been requested.
Fever today Tmax-101 degrees F with neck pain + muscle aches "sunburn" like feeling on her face + posterior trunk areas, (L) arm swollen with redness + tenderness to touch
Noticed pain to my L axilla ~4 days after vaccine administration and then palpated a mass under my armpit.
generalized sz w/fever followed by postictal drowsiness 24 hrs p/vax;
Received third dose, unknown immunological status; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received third dose, unknown immunological status) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ACCIDENTAL OVERDOSE (Received third dose, unknown immunological status). In December 2021, ACCIDENTAL OVERDOSE (Received third dose, unknown immunological status) had resolved.            No concomitant medication was provided. The patient had third dose last week and it looks like it was a full 100 mcg/0.5 mL. No treatment information was provided.
Pfizer vaccine # 2 - severe arm pain, trapezius pain, Headache, fever began within 24 hours of vaccine #2.  improving - still some HA now improving
So at first I was just sleepy, fever, and Thursday/Friday of that week my fever was so bad I could not even get out of bed. I was shuffling to get to the bathroom. I was doing all I could do just to get water into me so I would not dehydrate. I was trying to move so I wouldn't get stiff but it was not good. I did not take Tylenol as it does not work for me. My roommate suggested Advil but I just felt like if this was the shot, that I needed to push through it because my immune system was working for me. The headache that I was having was the worst headache I have ever had, my eyeballs were popping out it felt like a mountain of headaches on my head. I felt like I was in serious trouble. I called my sons wife and told all my children that I love them, because I felt something was seriously wrong. When I came back downstairs Friday evening, after a birthday party for my older son, I was sitting on the couch and asked for some apple juice. I drank some apple juice and my friend got a phone call. One of the children at the phone call had been exposed to COVID positive person. I was not directly exposed to that person but I was down there right after, and he was all over the couch (that I was on). My immune system was obviously working hard already and weakened. SO my friend got us tests and we were both negative. But the DR said do to my symptons she kept me out of work. The fever, I did just pushing through and drinking water. I started taking Advil after five days, but I just kept pushing fluids. I was so weak and my joint pain was bad, I could not get up. I tried to walk as much as I could but it was not much. The joint pain was very bad. The main issues were, no appetite, extreme exhaustion, fever of 102.7 and muscle aches and headache. I took one Ubrelvy at the beginning so I knew it wasn't a migraine, I knew it was from the shot. I took off two jobs, I work for two agencies and one paid me and the other did not.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Within a couple hours of receiving the Tdap booster (following a routine physical in which my daughter received an excellent bill of health), she developed a large, red hive at the site of the injection, that encompassed her shoulder/upper arm area and was excruciating to the touch. I gave her Benadryl and she wanted to ice the arm on and off constantly, but by the next day, she was also experiencing muscle weakness and some paralysis in the left arm.  The weakness/paralysis worsened then moved down her left side into her left hip making it difficult to weight bear.  She was taken to urgent care where a physician checked strength and reflexes in extremities telling me there was a "marked" difference between the left and right sides of her body and noting the hive which had receded somewhat but was still visible to the doctor.  Patient was also starting to experience headaches, fatigue and muscle/joint pain and weakness in additional areas of the body and would complain of feeling "hot on the inside" though she did not feel like she had a fever when I checked her.  The urgent care doctor suggested Tylenol and to see a neurologist if the symptoms did not resolve.  By late afternoon on 1/15/09, the muscle weakness was beginning to recede, but patient is still not feeling herself.
Patient complained about increase in heart rate. I called paramedics. (911). Vital signs were normal.
One month after the vaccine, I started spotting. Every month thereafter, I had a pink discharge on a monthly basis. On January 18th and then on the 28th, I had a pap test and ultrasound. On March 3rd, I had spotting again. They tried Endometrial biopsy but was unsuccessful because they couldn't enter the uterus. April 29th, I had a D&C and Hysteroscopy. On May 2nd I was diagnosed with Grade 1 Uterine Cancer.
Red itchy rash appeared on my arm on day 8.  There is a knot under the skin.  It started small but now is 3"across.
Information has been received from an office manager concerning a female baby who on an unspecified date in 2007 was vaccinated with the second dose of ROTATEQ.  The office manager reported that in 2007 the patient was seen in the office for severe vomiting and was sent to the emergency room.  An x-ray was taken and the patient was diagnosed with intussusception.  The patient had surgery.  The outcome was reported as recovered (date not reported).  Upon internal review intussusception was considered to be an other important medical event.  This is one of two reports from the same source.  Additional information has been requested.
A spontaneous report was received from a 30-year-old, female healthcare facility staff member who received Moderna's COVID-19 vaccine (mRNA-1273) and developed nausea, lightheadedness, headaches, numbness of injection arm and loss of sense of taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31-Dec-2020, after receiving vaccine, patient reported nausea, lightheadedness, headaches, numbness of injection arm that lasted for a few hours. On 01-Jan-2021, patient lost her sense of taste and was tested for COVID-19. Patient's rapid COVID-19 test was negative and she is waiting results from a PCR test she took 04-Jan-2021.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, nausea, lightheadedness, headaches, numbness of injection arm and loss of sense of taste, were considered recovered/resolved.; Reporter's Comments: This case concerns a 29-year-old female who had nonserious events of unexpected ageusia, hypoaesthesia, dizziness and expected headache, nausea.  Event onset occurred the same day as the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
None- vaccine given 11 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 11 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported   This case was linked to MOD-2021-395985 (Patient Link).
Body aches, joint pain, ringing in ear, earache, shortness of breath, headache.
Pt recvd 2nd dose of vax on 7OCT91 & w/in 3 mins exp SOB, chest tightness, syncope, palpitations & hypertension;
1am day after vaccination pt awoke and could not move her L arm.  Around 5am went to parents and entire L upper arm spreading to axilla, shoulder and upper back with significant swelling.  Due to swelling and pain went to ER, had eval to r/o DVT which was negative, felt swelling 2/2 vaccine reaction.
contracted COVID and a week later he died; contracted COVID and a week later he died.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), outcome "fatal", described as "contracted COVID and a week later he died"; COVID-19 (death, medically significant), outcome "fatal", described as "contracted COVID and a week later he died.". The patient date of death was unknown. The reported cause of death was covid-19, drug ineffective. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: contracted COVID and a week later he died.; contracted COVID and a week later he died
pt presented 10/3/22 stating that she had been having pain in her arm since her vaccination on 8/16/22 and that she was going to give it a little more time to see if it would resolve then she would seek medical treatment
"Painful" arm. Denies redness, swelling.  Has tried warm/cold compresses-no help.
My wife got COVID-19. I had symptoms. I was almost unconscious with symptoms. I had fatigue, I felt I had global transient amnesia. I could not remember anything, not even my children's birthday. I was not with fever. I was just unable to respond properly. I was totally out of it. We both took PAXLOVID, and the within 4 to 5 days we had rebound. I saw a doctor for the rebound and I went to the emergency room at the hospital. I was given fluids and a chest x-ray. I was just diagnosed with rebound COVID-19. I stayed about three hours. I lost my sense of smell and taste. It is not totally back. Other than that, I am fine.
pt recv vax 4JUN97 & 6JUN97 pt devel a rash that resembled mosquito bites on arm & neck;approx 2 days later pt recovered;
2 days p/vax MOC reported pt thigh was red, swollen & hot to touch;also was irritable & cried w/a high pitch;had a fever & small amount of pus exuded from inj site;went to clinic given APAP;indentation & scar like appearance @ site
Pfizer COVID-19 Vaccine EUA  Patient became dizzy after receiving COVID-19 vaccination. RN took blood pressure and it was with in normal limits. Staff took employee to for examination.  Employee was examined and released by  provider. She stated that she was in a hurry to get to clinic and wanted to make sure that she did not miss her appointment. She is a diabetic and she has not eaten since noon and usually eats supper somewhere between 6 and 8:00 p.m (received vaccine at 5:50 PM). Pt also states she takes her evening dose of her blood pressure medication 6 PM and had not taken it prior to her vaccination. Pt also started oxybutynin 2 days ago.  1/29/21: Pt received Dose 2 of the vaccine with no issue.
Intestinal Pain; Chills; fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Intestinal Pain), PYREXIA (fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN (Intestinal Pain) and CHILLS (Chills). On 20-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, ABDOMINAL PAIN (Intestinal Pain) and CHILLS (Chills) outcome was unknown.            No Concomitant and treatment medications information was reported.
Rec'd Boostrix on 7/17/09; reports vomiting, hives, arms feel heavy, wheezing, back burning, swelling at site on 7/20/09 Advised benedryl
Arm was red at the injection site; Arm was swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm was red at the injection site) and VACCINATION SITE SWELLING (Arm was swollen at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm was red at the injection site) and VACCINATION SITE SWELLING (Arm was swollen at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Arm was red at the injection site) and VACCINATION SITE SWELLING (Arm was swollen at the injection site) outcome was unknown. Not Provided          Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 24-OCT-2012 at 17:24, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
After receiving the vaccine my whole upper part of my arm was sore, but that didn't last long. I have been having headaches before ever getting the vaccine, and I have been taking medications for my headaches. After receiving the vaccine my headaches have gotten worse. Also the medications have not been helping with my headaches anymore either.