chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 12 or 13 years old female patient. No pertinent medical history or drug reactions were provided. Concomitant therapies included Tdap (manufacturer unknown) or Td Absorbed. The physician reported that, on an unknown date over 20 years ago, he had an unspecified female patient who received her 1st dose of VARIVAX (Merck) injection (dose, route, lot#, expiry date unspecified) as she required vaccination at that time. It was reported that 2 weeks later she developed an immune thrombocytopenic purpura, ITP and a bleeding disorder. The patient sought medical attention, she contacted physician. The reporter stated that the patient made a full recovery (date unspecified) and was a normal adult at the time of report. Physician also stated that he reported one of the two cases that were documented years ago, concerning this ITP condition after subsequent administration of VARIVAX (Merck) (date not provided). No other information was provided for the other case. Physician stated that he reported this incident over 20 years ago, but he was unable to find documentation. Upon internal review the immune thrombocytopenic purpura was considered to be medically significant. The relatedness between event and VARIVAX (Merck) was unknown. This is the one of several report received from the same reporter. Additional information has been requested.
Have experienced lots of headaches, back pain, muscle pain such as arms biceps, elbows, knees, foot, heels, weakness, itchy skin, hands, fingers, very tired all the time. Lack of sexual interest and pimples on my legs.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (7-8 days after getting 2nd dose got hives, since then coming and going, splotchy raised ones, on face, goes around perimeter, eyelid and side of face like eyebrows,  look like mosquito bites, big, not like pimples, never had hives like this before) and HEADACHE (that evening I had really bad headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy (she was allergic to oysters and she gets hives when she eats oysters). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control. On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced HEADACHE (that evening I had really bad headache). On 29-May-2021, the patient experienced URTICARIA (7-8 days after getting 2nd dose got hives, since then coming and going, splotchy raised ones, on face, goes around perimeter, eyelid and side of face like eyebrows,  look like mosquito bites, big, not like pimples, never had hives like this before). The patient was treated with IBUPROFEN 23-May-2021 for Headache, at a dose of 1 dosage form. On 23-May-2021, HEADACHE (that evening I had really bad headache) had resolved. At the time of the report, URTICARIA (7-8 days after getting 2nd dose got hives, since then coming and going, splotchy raised ones, on face, goes around perimeter, eyelid and side of face like eyebrows,  look like mosquito bites, big, not like pimples, never had hives like this before) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient went outside in the heat and hives became bad. Treatment medication include Ibuprofen just 1 tablet OTC on 23MAY2021 and Benadryl on 04JUN2021 at night. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable. This case was linked to MOD-2021-209192.
Chills; aches; pain; feverish; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Lot number: ER8737) for covid-19 immunisation. The patient's relevant medical history included: "Other medical History: Chron's disease" (unspecified if ongoing), notes: Other medical History: Chron's disease; "Other medical History: autoimmune liver disease" (unspecified if ongoing), notes: Other medical History: autoimmune liver disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6198), administration date: Mar2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "recovered"; PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "aches"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered", described as "feverish"; PAIN (non-serious) with onset Mar2021, outcome "recovered"; HYPERHIDROSIS (non-serious) with onset Mar2021, outcome "recovered", described as "sweating". It was unknown if therapeutic measures were taken as a result of chills, pain, pain, pyrexia, hyperhidrosis.  Additional Information: It was unknown if patient had known allergies. It was unknown if patient received other vaccine in four weeks. It was unknown if patient had covid prior vaccination and covid tested post vaccination.  Follow-Up (13Oct2022): Follow-up attempts are completed. No further information is expected.
The person administering the vaccine did not go deep enough into the muscle and the vaccine accumulated in the subcutaneous fat layer. I had a hard, red, hot spot under the skin that night and continued to spread out very slowly over the next day being hot to touch and very red. I massaged the area with my hand for the next two days and the hard spot where the vaccine was got a little softer but is still there. I haven't had any other reactions except the redness and hot to touch. I'm concerned that since the vaccine was not administered correctly that I will not get the full immunity expected by the second dose. I do have pictures I took of my arm if needed.
Pt states rash around sight, and bilateral elbows. Pt described fevers, chills, and joint pain following day.
Initial report received on 16 December 2009 from a healthcare professional. A 5 year old male received an intramuscular left thigh injection of FLUZONE (Lot number U3366AA) on 12 December 2009. On 13 December 2009 the patient was seen in the emergency room for left thigh leg pain and swelling. The left thigh measured 33 inches and the right thigh measured 31.5 inches. The left leg was described as a warm erythematous, maculo-papular rash. Lyme test performed on 13 December 2009 was negative. The patient was seen in the doctor's office on 14 December 2009. Treatment medications included BENADRYL and MOTRIN. At the time of vaccination the patient had an ear infection, which was being treated with an unspecified antibiotic until 12 December 2009. The outcome was unknown. Follow up information received on 01 February 2010 from a health care professional. On 09 November 2009 the patient received a first dose of H1N1 (lot UP003AA) intramuscularly in the left leg. The patient recovered on 14 December 2009. The patient did not have any other symptoms nor did he receive additional treatment. The reporter also noted that the patient had a red, swollen leg after the first dose of FLUZONE at the age of three years and six months. Follow-up information was received 01 March 2010 from a health care professional. The patient had not experienced any adverse events following H1N1 vaccination on 09 November 2009. Follow-up information was received 09 April and 15 April 2010 from a health care professional. Laboratory findings included mild increased ESR and increased CRP. A chest x-ray was negative. During the patient's follow-up visit on 14 December 2009, leg swelling was still present (previously reported as recovered); however, the patient was noted to be feeling better that day and walking. Office notes from that visit also noted, "?Toxic Syndrome" and "(illegible) cellulitis"; however, the reporter stated that no additional treatments were prescribed other than what was previously reported; BENADRYL two tsp by mouth and MOTRIN. The reporter could not confirm that the patient recovered, but did state that the patient had been seen in follow-up on 12 January 2010 and 03 February 2010 for other unrelated issues, and there was no mention of ongoing leg swelling noted during those visits. At the time of the report, the reporter had no additional information to provide. The patient experienced another event at three years of age which is captured in case 2010-00824. Documents held by sender: None.
Immediately had pain my my arm upon injection, which turned to an overall soreness for the rest of the day on the 29th. On the 30th had continued pain in my arm and at times ranged from mild to moderate (e.g., if I reached to pick something from a shelf, rolled onto it while sleeping). The morning of the 30th I woke up with a 99.1 fever, which subsided over time. I also have been experiencing a headache, nausea, and body aches. I tried to go to work, but ended up going home early because the symptoms continued. I am taking Tylenol to attempt to manage the fever, headache, and body ache.
C/O runny nose. Continued after injection for a few days. 11/25/2002   Is doing fine. No more runny nose. Case closed.
On 03/04/2021 I started getting pains in my right arm. When I went to the doctor they thought it was tendinitis. The pain was getting better but on 05/02/2021 I started getting a fever. I went to get a covid test and it was negative. All of a sudden, my arm had red rashes all over. I went to the ER. They diagnosed it as shingles. They did blood work, my potassium was low so they had me stay for the night so they could give me some medications for that and for shingles. I had a lot of pain with it. I still have occasional pain in there but the redness is gone, there is only one red spot left.
High Pitch screams for 3 days and for 10 days: lethargy (limp) - Non reactive - lack eye contact avoid communication - stopped feeding - stopped laughing / smiling - stopped sleeping.
Employee states that she had a 3-4 inch size oblong redness and warmth to right deltoid.  In previous years, it was only a quarter size.  Denies nausea, vomiting, body aches, chills, or fever.  She reported to Occupational Health on 10/4/13 her symptoms.  Counseled on different forms of flu vaccines for future purposes.  She acknowledged understanding and will monitor any potential symptoms in the future from the flu vaccine.
Acute toxic metabolic encephalopathy secondary to polypharmacy, Counseled.  Resolved on discharge. ED visit and hospital admission within 6 weeks of receiving the CVOID vaccine.
JUN97 family noted starring spells & twitching of mouth & arms;seen by MD 1JUL97 & sz dx;mom called clinic to report;had meningitis as infant;
Patient received five vaccination 03/05/01. Starting 03/17/01 her hair started to fall out and in a period of 2 months she lost 50% of her hair. The back of her head is completely bald.
Fatigue, lethargy, confusion, started on day 8 after the vaccine.  The confusion got worse on day 9.  All symptoms present but subsiding on day 10 after the vaccine.
No symptoms reported.; HCP called to report an expired dose of PROQUAD was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; PROQUAD adminitrated at 70 F for a time frame of: 0 Hours 9 Minutes 0 Seconds; This spontaneous report has been received from a pharmacist referring to a 4-year-old. The patient's medical history, concurrent condition, and concomitant therapies were not reported.  On 14-JUN-2023, the patient was vaccinated with an expired (conflicting information as upon internal review the vaccine was not expired) and improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, first dose, administered for prophylaxis (strength, dose and route of administration were not provided; lot number W024971 was considered as a valid number and expiration date reported as 02-JUN-2023 but upon internal reviewestablished as 05-FEB-2024) (expired product administered) (product storage error).  The excursion occurred with a temperature of 70 Farenheit (F) for 0 hours and 9 minutes and 0 seconds. There was no previous temperature excursion reported. No symptoms or adverse events reported.
Joint pain in knees. After about 3 hours took 800mg of Ibuprofen and pain subsided. Arm pain, redness, and swelling at injection site. Arm pain began 12/01/2018 (within 1 day), redness and swelling noticed 12/02/2018 (day 2). All continue as of reporting 12/03/2018.
We were sitting in the after-shot waiting area for the mandatory 15 minute wait period. Patient was getting restless and started asking to leave ~13 minutes after shot. I said ?no, we need to wait the full 15 minutes they recommend?. About on minute later, or ~14 minutes after shot, Patient said he felt like he was going to pass out. As I turned my head to look at him to began to slump towards me unconscious and I held him up by his shoulder and waved the paramedics over. He was unconscious with eyes closed for about 5 seconds and by the time the paramedics got there his eyes were fluttering, but he remained unresponsive for another ~10-15 seconds as they were calling his name, tapping his shoulder, and asking him questions. Then he finally came around and, while groggy, he was able to answer questions. He sat there a couple minutes talking to paramedics and they had wheelchair, but he said he could walk and got up slowly to walk slowly back to clinic area.
3" redness, swelling, lumpy, painful diameter;+hives, whole arm swollen;
Loose, frequent, fart smelling stools  5 days post vaccine. No bld in a stool. No vomiting no fever.
congestion, rhinorrhea, sore throat, myalgias, headaches, adenopathy
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    This case contains information about patient 06 out of 42 patients. Concomitant product use was not provided by the reporter. Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.  Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50 % or more. Vaccine was given within current guidelines except seven were under 65.  Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved.  No adverse reactions occurred. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Itching / the itch is where she got the shot on Saturday, at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 (Batch/Lot number: unknown, Expiration Date: 01Nov2021) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Tremors" (unspecified if ongoing), notes: Verbatim: Tremors; "A-fib" (unspecified if ongoing), notes: Verbatim: A-fib. Concomitant medication(s) included: FLU VACCINE VII, administration date 11Oct2021. Vaccination history included: Bnt162b2 (Dose:1, SINGLE, Lot: EL3302 , Anatomical location : left arm, Expiry: Unknown.), administration date: 23Jan2021, when the patient was 84 years old, for Covid-19 immunization; Bnt162b2 (Dose:2, SINGLE, Lot: EL9264, Expiry: Unknown.), administration date: 10Feb2021, when the patient was 84 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 31Oct2021, outcome "not recovered", described as "Itching / the itch is where she got the shot on Saturday, at the injection site". Therapeutic measures were taken as a result of vaccination site pruritus.  Additional Information: It was stated that patient had the booster shot for the Pfizer Covid 19 Vaccine on Saturday at noon. The first 2 doses she sailed right through. She sailed through this dose until yesterday evening, then it started to itch. That's the only problem she had. She tried itch creams and it works for a little while. She also tried an ice pack and that stopped the itch. That morning she woke up and it started itching again, it's not bad, just annoying. She wanted to know if she was doing the right thing by putting cortisone itch medicine on it or using the ice pack. She stated that the ice seems to work the best, but it's hard to do things with an ice pack on it. Clarified that the itch was where she got the shot on Saturday, at the injection site. She did not have any hives or anything there. She thought she would call Pfizer first because she thought that it might be faster than trying to get through to the doctor's office or the pharmacy. Stated that the itch came and gone. It's just annoying, but she can live with it. The first 2 doses were done at a hospital. States that maybe the booster injection wasn't as good from because nurses did it at the hospital. Stated that her grandson did all her shopping, and he bought the cheapest stuff. She thought it's a brand Cortaid. She wanted the real stuff, and he bought the generic brand. No further details provided. Patient relevant tests wee none.  The lot/batch number is not available despite the follow-up attempts made. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diffuse paresthesia initially including the gums but then arms and legs with weakness in the arms.  Enhancing lesion at C2-3 on the MRI consistent with demyelination. Initial dose was the Johnson and Johnson. This was a booster dose
Five minutes after vaccination, pt started having tongue and throat tingling, itchy and scratchy sensation. Denies chest pain, swelling, rash or sob.
This spontaneous report has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions, concomitant therapies or allergies were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX, (route of administration, dose and anatomical location were not provided) lot # L026415, expiration date 15-OCT-2016. No adverse event was reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
HEAVY; FELT REALLY COLD; FEVER; GENERALLY TIRED; SLIGHT PAIN IN THE INJECTION SITE; This spontaneous report received from a consumer via a company representative concerned a male 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced heavy, felt really cold, fever, generally tired, and slight pain in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy, felt really cold, fever, and generally tired, and had not recovered from slight pain in the injection site. This report was non-serious. This case, from the same reporter is linked to 20210755580.
Flu shot received in (L) arm on Monday 10/24/16. On Tuesday morning above individual had severe pain in left hip area. Pain has lessened each day but still exists on day 5. Recovered by day 7.