chrisvoncsefalvay/vaers-outcomes huggingface dataset:
April 15th my husband and I had our old folks' Covid booster shots. We took our shots at store. I did not want to use this store but we had much difficulty finding a place where the old folks' booster was provided. The lady stuck a round patch on my arm then needled the shot through the patch. Seemed the patch was rubber or latex. All the other vaccinations I received were just a simple prick after an alcohol wipe - no patch - almost no pain - but this shot hurt. I was surprised that it hurt. It hurt more than a shot should hurt when I was pricked. I had asked why the round rubber patch. I thought it odd that a needle would go through a rubber patch then into my arm. Now - over a month later - my arm at the location of the shot has developed a lingering soreness. It is too much soreness to ignore and seems to be increasing rather than decreasing. That is not right. I had little reaction to the prior three shots for covid. I think that a tiny dab of the plastic or latex of the patch was shoved into my arm. I think that is why my arm is sore where the needle went in. From the internet: The bandage is circular, with an adhesive membrane. A nurse cleans the patient?s arm, applies the Barrier Bandage, and then administers the shot right through the bandage. It then acts immediately as a band-aid to catch and conceal any fluids from the broken skin. ?The Barrier Bandage is constructed of a self-sealing, non-coring, elastomeric membrane. which is another way of saying once the needle passes through the barrier, it reseals preventing any fluid from coming out,? person said. Person is with Inject-Safe? Barrier Bandages. Overall person said the product is a safer, quicker, and more affordable way to administer a vaccine. I VERY STRONGLY DISAGREE AND BELIEVE THAT ALTHOUGH MOST WILL NOT HAVE PLASTIC STUCK Into THEIR ARM - THIS IS NOT GOOD AND NOT RIGHT AND MY ARM STILL HURTS 05/27/22
I went to the ER 5/25/2021 for headaches, nausea and calves, ankles, and feet swollen badly. Dr, prescribed a fluid pills and the swelling was gone after a couple of days.
Walking on level surface (concrete sidewalk) for 1 mile total. My knees began to hurt, again. 1st round of knee/joint/muscle pain had begun after 60 days on Pravastatin. June 1, 2016 thru July 31, 2016. Stopped statin on August 22, 2016. Pain in legs began to subside. However, 7 days after receiving High Dose Flu shot, pain began again. Intense. Pain subsided after 880 mg. of naproxen. But stopped naproxen due to possible long term side effects. Pain continues as of this writing, ~ 30 days.
Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant products were not provided. Treatment medication were not reported. It was reported that there was a mistake given during phone call regarding lot 012H21B. That lot was not affected, but lot 042J21A should have been reported with a BUD of Feb 17, 2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
worried they didn't get enough of the first dose; the dose came out the side of the syringe; Most of the dose ran down patient's arm; A spontaneous report was received from a pharmacist concerning a 61 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the dose came out side of the syringe.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 16 Feb 2021, the patient received their first  planned dose of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the deltoid muscle for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the pharmacist was injecting the Moderna vaccine and the dose came out of the syringe. Most of the dose ran down the patient's arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events outcome was recovered.; Reporter's Comments: This report refers to a case of Product administration error  Underdose ,Device connection issue,Exposure via skin contact  for mRNA-1273, lot # 031M20A with no associated AEs.
Five days post vax the pt developed a rash that look like measles all over body. Onset 5 days post vax, reported 7 days post vax.
After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, and shedding an excessive amount when brushing. She started noticing this about 1-2 weeks after her first vaccine, and it got worse after the second vaccine on 1/7/21 (Pfizer Lot#EK9231). It is an even thinning, no patches of hair loss. She was diagnosed with COVID on 10/7/20 which resulted in hospitalization. Reporting fatigue, continued loss of sense of taste and smell, decreased appetite, and hair loss. Experiencing fatigue and decreased energy, worse in the evening, falls asleep easily when she gets home after work, started when she got COVID.
Arthralgias, pruritic lesions x3, scalp, finger, temporal region left side, Tylenol for discomfort. Other symptoms, crying, achy, diarrhea, no temperature.
BODY ACHES; CHILLS; SORE ARM; HEADACHES; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination (series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-DEC-2021, the patient experienced body aches. On 09-DEC-2021, the patient experienced chills. On 09-DEC-2021, the patient experienced sore arm. On 09-DEC-2021, the patient experienced headaches. On 09-DEC-2021, the patient experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, headaches, sore arm, and tiredness. This report was non-serious.
Swelling, redness and itching at shot site 9 days after getting 1st moderna vaccine. Face is flushed. Headache. No reactions aside from a slightly sore arm at injection site Day1-Day3. No reactions to vaccine Day 4-Day 8. Have taken no medications or Benadryl type OTC drugs  on Day 9 to mitigate the swelling, redness, pain, etc.
Unexplained urticaria, angioedema of face and hands 11 days post injection Sore arm, fever of 100. 8 F, severe headache body aches within 2- 12 hours of administration
pt recvd vax 5JAN96 & took longer nap-mom woke pt up-pt was limp & lost color; to ER-responded p/stimulation 312PM T99.9, P175, BP 90/52;observed in ER x 2hrs;550PM T100.8;dx hyporesponsive episode
Itching; hives; have allergies; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), URTICARIA (hives) and ALLERGY TO VACCINE (have allergies) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), URTICARIA (hives) and ALLERGY TO VACCINE (have allergies). At the time of the report, PRURITUS (Itching), URTICARIA (hives) and ALLERGY TO VACCINE (have allergies) outcome was unknown.     Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
left quadricept pain post rabies vaccine x4 and IgG administration. pain with ambulation and running. No sx of local infection or site reaction
3:35 pm V/S: BP 133/75 HR 85 Pulse ox 96%. Patient c/o abdomen feeling "hot", queasiness and feeling warm all over. C/O throat tightness. No stridor. COR RRR without murmur. 8:40-4:19 pm: Rec'd epinephrine, albuterol, BENADRYL, prednisone. V/S remained stable. 5:00 pm - Throat felt tickly. Epi given and pt transported to ER 5:02 pm.
Head pain, chest pain, chills, fever, bitter taste in mouth, nausea, pain when breathing and suffocation, huge pain of the head to the point of having red eyes.
Small-Fiber Neuropathy; This literature-non-study case was reported in a literature article and describes the occurrence of SMALL FIBRE NEUROPATHY (Small-Fiber Neuropathy) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SMALL FIBRE NEUROPATHY (Small-Fiber Neuropathy) (seriousness criterion medically significant). At the time of the report, SMALL FIBRE NEUROPATHY (Small-Fiber Neuropathy) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient had the small-fiber neuropathy after second dose of vaccination with mRNA-1273 SARS-CoV-2 vaccine.  Company comment: This is a literature non-study case concerning a 43-year-old, female patient with no reported medical history, who experienced the unexpected, serious (due to medically significant) event of small fiber neuropathy. The event occurred after the second dose of mRNA-1273 received on an unknown date. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
tender, swollen lt arm, abd non tender gastroenteritis-enteritis, painful arm secondary to MMR shot;
Severe Ice-pick Headaches which responded to Advil for 1-2 hours  Went to the ER 4/12/2021: CT Scan administered. No abnormality evidenced Steroid, Tylenol 3, plus other medication by IV  Received Methylprednisolone Rx, Extra Strength Tylenol 650mg
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Severe, Systemic: Shakiness-Severe, Additional Details: patient described an uncontrollable shaking for approximately 1/2 hours
Dose was administered outside of the recommended time window after first vial puncture. Dose deemed Invalid.
Information has been received from a licensed practical nurse concerning 1 female (age not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with GARDASIL (lot # unknown). There was no concomitant medication. The nurse reported that on an unspecified date post-vaccination the patient felt light headed after vaccination with GARDASIL. Medical attention was sought. At the time of reporting it was unknown if the patient had recovered. Follow-up information was received. It was unknown to the reporter. The patient never reported to the office that she had an advers effect. Additional information is not expected.
One patient developed the regular mild flu-like symptoms; Patient received vaccine that may not have an extended expiration date; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.  vial was removed from the freezer 40 minutes before administration.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: The follow up received on 25Oct2021 contains new event of flu-like symptoms
On the second dose I had a slight headache and stomach issues with diarrhea. Towards the end of February I had bad pain in my right thumb with a cyst that prompted me to go to the Doctor because it has changed my nail bed. My PCP set up visit for orthopedics, and the orthopedic appointment was 04/16/2021. At this appointment the orthopedist diagnosed me with a cyst in my thumb joint that is tunneling up under my nail bed that is distorting my nail bed. He said he could go in and drain out the fluid but it could come back. He stated a massage could help. I've also experienced tendonitis in my Achilles, and I went to another orthopedics Doctor on 04/07/2021 and he did x-rays of my feet. I have been doing heel inserts and stretching exercises for that. Sometimes I can't wear tennis shoes. The heel bone is swollen and it is still ongoing. For my thumb and my heel I take Tylenol.
By 6PM that evening I had a rash (small red bumps w/ white center) from face to waist, including arms. I had a severe sore throat and slept 16 hours straight barely  able to use the bathroom when I awoke, was extremely nauseous and eyes were swollen. I could not go to work, I was bed ridden for 3 days. My eyes remained swollen during this time. On Tues, I called the doc because the rash went away except now I had a larger spot on the sole of my foot that looked like smaller ones. She explained it as a bug bit and nothing more. I explained the intense reaction to the shot and she said that's strange and told me to call if it continued. Over the next 2 weeks, I was having severe joint pain in my hips, knees and ankles. It progressed to the point that I could not stand. Doing dishes, folding wash, bagging groceries, caused excruciating pain. I returned to the doc on 1/19/05. No explanation was given for my health problems since the shot. Over the next 2 weeks, pain continued and onset of nausea when lying down began. A subtle sore throat persisted. By 2/8/04 I could not stand the pain, nor nausea, I returned to the doc. I explained that I was also noticing low grade fevers and an aversion to sunlight. I begged for tests to be performed because I was losing sleep, not working and feeling terrible since the MMR shot. I was given medications for the pain (Naproxen) and nausea. I was sleeping 16-18 hours a day by this point. When I did walk. I had to slide my  legs as if on skis. The doc called on 2/10/05 to tell me that chronic fatigue syndrome was suspected as being triggered by the MMR shot. I have no idea if this is true or accurate information. What I do know is my symptoms continue. When I take my medications. I walk easier but it is still painful, it is now 2/19/05 and I am not sleeping 16 hours each day, but close to it. I get exhausted easily and my hip pain is the worst it has ever been. I am upset for several reasons: I was healthy until I received this vaccine. My doc mentioned nothing about a reporting system, I found this out on my own by doing research about vaccines. I was never counseled on the possible adverse reactions. Thank you for your time.
I developed 3 blood clots in lungs (2 right and 1 left lung)
12 hours after receiving the vaccine I developed a fever, severe chills, uncontrollable shivering, and I could not get warm. I also had horrible body aches and pains, in my lower extremities, and extreme fatigue.  These symptoms lasted about 30 hours and then they just were gone.
cold symptoms; My arm is sore; feel congested like when I get sick; This is a spontaneous report from a non-contactable consumer (patient) via Medical information team. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 19May2021 (at the age of 29-years-old) at first dose, single for COVID-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that he had cold symptoms. He thought he had allergies before the shot because he would usually get them about this time of year and it would start to act up. The patient's arm was also sore and felt that it was something he had before the shot because they were kind of similar and he just felt congested like when gets sick. Additionally, the patient wanted to know how long he has to wait to take medications like Nyquil or Dayquil. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
received her first dose of Pfizer vaccine of the series.  On her way to the observation area she began feeling weak, lightheaded, nauseas and dizzy.  This was about 5 minutes post vaccination.  She made it to an observation chair and an RN was notified  She was given an ice pack and water.  VItals were initially read at BP 69/42, SPO2 99%, and HR between 90 and 100.   BP was then taken manually and was 98/62. Despite SPO2 level steady of >95% , patient state she was having trouble breathing and speaking.  She also stated that her throat felt sore.  She also felt "shaky" and was visibly shaking.  She continued to appear and feel worse.  Her mother was with her and agreed with the move to call an ambulance and she was transported to the ER.
Herpes zoster ophthalmicus (left); The vaccine did not prevent shingles, but rather caused a persistent strain of herpes zoster accompanied by pain; The vaccine did not prevent shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for prevention of shingles. The vaccine did not prevent shingles (vaccination failure), but rather caused a persistent strain of herpes zoster accompanied by pain to the patient, then on unknown date, the patient suffered an outbreak of shingles, which was accompanied by sharp pain in his left eye. Therefore, he presented to a physician and was diagnosed with herpes zoster and herpes zoster ophthalmicus (left). As a result, he had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Ophthalmic herpes zoster was considered a medically significant event.
after 2nd dose, severe flu like symptoms for 24-48 hours. After that long lasting issue of knee inflammation and temple region vain inflammation.  CRP level is was high in recent blood work.
Syringe malfunctioned & less than 1/2 of the dose was given. Vaccine repeated in L arm.
The patient experienced extreme swelling at injection site, heat, even 8 days later arm was red but no longer swollen or hot, redness almost wrapped around arm . Patient's first shot. Symptoms were present 4hours after receiving shot, not immediate . Patient was instructed
This spontaneous report as received from a healthcare worker refers to a "child" patient of unknown age with no pertinent medical history/drug allergies or drug reactions reported. On 06-MAY-2015, the patient was accidentally vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot# and expiration date were not reported) instead of (Merck) PROQUAD. There was not concomitant therapy reported. No adverse event reported. Additional information has been requested.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
20NOV96 pt noted a black bruise @ inj site which persists;pt notified MD & no treatment was prescribed;half dollar sized & purplish w/induration @ inj site;diff breathing;queasy & v, serum sickness w/hepatic involvement, resp infect;
2:45 PM 11/8/07 FLUZONE VACCINE WAS GIVEN IN LEFT DELTOID, CLIENT FELT TINGLING ENTIRE INNER LEFT ARM FROM IM SITE TO ALL 5 FINGERS OF LEFT HAND.
Tinnitus started in both ears the next morning.  A low level buzzing sound which is constant.  I decided to get the second booster shot of Moderna on 05/31/2022.  This resulted in increased volume of the buzzing sound, like bugs on a warm summer night is the best way to describe it.  The tinnitus has been constant since.
Covid Arm ( itching/red/swollen) after one week. Headache for three days and nausea after shot. Fatigue. Bizarre dreams
Fever 38.5°C (101.3°F) 24 hours; This is a spontaneous report from a contactable other HCP. This 49-year-old male other HCP reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) at Left Arm at single dose for COVID-19 immunization on 07Jan2021.  Relevant history and concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) Intramuscularly at Left arm at single dose on 16Dec2020, 12:00 PM for COVID-19 immunization. The patient experienced Fever 38.5°C (101.3°F) for 24 hours since 07Jan2021, 04:00 AM. Treatment was received for the event (unspecified), outcome of event was resolved on unknown date in Jan2021.  The patient was not COVID infected prior vaccination. The patient had not COVID tested post vaccination.