chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflammation syndrome; back ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation syndrome) and BACK PAIN (back ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation syndrome) and BACK PAIN (back ache). At the time of the report, INFLAMMATION (Inflammation syndrome) and BACK PAIN (back ache) outcome was unknown.            No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD21-051697, MOD21-051726 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-051697: MOD21-051726:
Pt woke up Wed am 3/17/04 with left arm swollen, reddened and harden to the touch, child has complaints of pain and itching at site, child is without fever per mother, or other problems. Mother has applied ice to area without improvement. Child came to clinic today 3/18/04 to have TB test read & mother showed left arm to staff, pt referred to clinic in AM. No doctor there today. Mother advised if condition worsens to to go ER.
Bumps at site of injection; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Bumps at site of injection) and VACCINATION SITE PAIN (Soreness of arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Bumps at site of injection) and VACCINATION SITE PAIN (Soreness of arm). At the time of the report, VACCINATION SITE SWELLING (Bumps at site of injection) and VACCINATION SITE PAIN (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant information was not provided.   Reporter did not allow further contact
he tasted something that reminded him of nickels after both of his Pfizer shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 52 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "he tasted something that reminded him of nickels after both of his Pfizer shots".  Additional information: The sensation came on within minutes of receiving his first dose of the Pfizer Covid-19 vaccination this past week. He tried to get rid of it with coffee, then mouthwash. Twenty-four hours later, the metal taste remained. He tasted something that reminded him of nickels after both of his Pfizer shots. The metallic taste went away after a few days . The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200169518 Same reporter, different drugs/patients/events;US-PFIZER INC-202200169566 Same reporter, different drugs/patients/events
Severe burning of skin over entire body; Hypersensitive to touch including fabric; Swollen neck and hands; Swollen neck and hands; Pain in pelvic area and anus; Pain in pelvic area and anus; Severe lower back pain accompanied with chills; Severe lower back pain accompanied with chills; Headache; Fever; Nausea; Fatigue; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EW0202), via an unspecified route in the right arm on 04Jun2021 at 11:00, as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included topiramate 50mg and norethrindrone 35mg (medications the patient received within 2 weeks of vaccination). Patient previously received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EW0202), via on an unspecified route in the right arm on 14May2021 at 11:00, as a single dose for covid-19 immunization. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 04Jun2021 at 22:00, patient experienced severe burning of skin over entire body, hypersensitive to touch including fabric, swollen neck and hands, pain in pelvic area and anus, severe lower back pain accompanied with chills, headache, fever, nausea and fatigue. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist referring to 2 newborns (numbered 96 and 97). Background: Since June 2915, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 14-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter.
suspected vaccination failure; shingles five times; they hurt bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles five times in one year. The patient reported that, it was not fun to get shingles, they hurt bad. The patient finally stayed clear enough to get the shot. The patient suggested that, if you had not got the shot, it was a lot better to get it than to get the shingles. The patient again stated that, shingles hurt like crazy. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.
It was reported that a 34 year old female patient, who is also a doctor,  received a Typhim VI vaccination on 06/23/00. Reportedly on 06/26/00, the patient developed joint pain. The patient was not evaluated by a rheumatologist however, was advised by another physician to take Ibuprofen. The Ibuprofen was effective for the joint pain. Further info requested.
Received vaccine 07/26/2021 Right arm . The next day my upper right side of Chest felt almost swollen/ stiff, no physical pain. On  roughly 08/02/2021, I noticed that the feeling of my upper right side of chest felt almost swollen/stiff again, but this time, above my collarbone the area was sensitive to the touch. In addition, upon feeling around the area, I noticed a small bump were my vein/ tendon is.  I researched and found that others experienced similar cases with the Pfizer shot. I did not seek medical attention as the  tenderness and swollen feeling went away after about 5 days. I have received my second dose today, 8/20/2021 and was told to report my Adverse reaction to the first dose.
mom reports pt t103 & jerking movements; has red swollen legs where DTP was given; MD treated w/ATB to prevent abscess possibility;
Development of fever to 101 degrees 48 hours after administration.  Urticarial type rash to lower extremities 48 - 72 hours following administration of vaccinations.  No treatment other than close observation and administration of Infant Tylenol or Ibuprofen for fever.
Feel like a have shingles in eye; feels like have sty; Swelled feels like have sty; Eye started to hurt; Forehead had bumpy rash; feel like I am having and allergy tingling; tingling; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 26th November 2019, the patient received the 1st dose of Shingrix. On 1st December 2019, 5 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), stye, eye swelling, eye pain, papular rash, allergic reaction and tingling. On an unknown date, the outcome of the ophthalmic herpes zoster, stye, eye swelling, eye pain, allergic reaction and tingling were unknown and the outcome of the papular rash was recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, stye, eye swelling, eye pain, papular rash, allergic reaction and tingling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left arm. In the night of 1st December 2019, the patient started having problem with the eye the patient had shingles in. There was swelling felt like the patient had stye. The patient's forehead had bumpy rash that came and went and the patient almost felt like he or she was having and allergy tingling etc. The patient felt fine on Saturday and most of Sunday till the patient's eye started to hurt. The patient felt like he or she had shingles in eye and other symptoms that went with it. The patient was wondering how long reactions occur after getting vaccinated.
Patient received 2nd dose of the high dose flu vaccine.  1st dose received on 9/9/2021.  Day after received, she is reporting no adverse reactions .
Fever of 101.2 Fahrenheit for the first night, shivering, then for the next two days muscle aches, headaches, weakness, and nausea.
I received the flu vaccine - Oct. 31 - no adverse effects. I received the Pneumonia vaccine - Nov. 10: Nov 11 arm swelled in armpit; stiff neck and congestion. Nov 15 sudden severe hearing loss. Nov 19 - visited PCP - 10 day course Prednisone. Dec 17 - visited Dr (ENT) who ordered Brain MRI and intratympanic dexamethasone injections.
My daughter who has never had any nosebleeds woke up with a nosebleed 2 hours after the vaccine.
HIGH FEVER, CHILLS, SINUS CONGESTION, SINUS DRAINAGE, PAIN IN ARM THAT MOVED DOWN THE ARM AS TIME PASSED.
Had DTP 19MAR91 did not walk 20MAR91 7 x 11 cm, blotchy, indurated, warm patch medial to site of inject rt thigh 24MAR91;
Fever; Chills; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 23Dec2020 at 17:45, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. On 24Dec2020 at 6 AM, the patient experienced fever, chills, and fatigue lasting 36 hours. No treatment was received for the events. Post vaccination on an unspecified date, the patient underwent COVID-19 nasal swab test that was negative. The patient recovered from the events on 25Dec2020 (18:00).
pt recvd vax & exp syncopal episode, falling backwards & striking occiput of head LOC lasted less than 10 sec but was disoriented exp some slurred speech & rt sided weakness w/in 30 mins had returned to nl & was transported to hosp;
given a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MY5G5, expiry date 31st January 2023) for prophylaxis.   On 24th February 2023, the patient received Boostrix. On 24th February 2023, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-Feb-2023  Reporter's comment: The healthcare professional reported that earlier on the day of reporting, a patient was given a dose of Boostrix that had expired.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient was administered with expired Boostrix vaccine, which led to expired vaccine used.
185 doses, incorrectly stored vaccines that have not been injected; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient did not receive FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced intercepted product storage error (Verbatim: 185 doses, incorrectly stored vaccines that have not been injected). The outcome of the intercepted product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2023 The pharmacist reported that he had some FluLaval that was in a cooler with the temp log reading minus 1.6 Celsius. The vaccine was injected and the reporter wonder if need to revaccinate those individuals. 64 patients received the vaccine from the cooler reading minus 1.6 Celsius. The pharmacists reported that he had 185 doses, that had not been injected which led to intercepted product storage error. The reporter consented to follow up via postal.    The vaccine administration facility is the same as primary reporter. The Healthcare professional stated she would rather provide patient demographics at follow up. This case is linked with US2023144281, same reporter.; Sender's Comments:  US-GSK-US2023144281:Original Case : US2023144281
Moderna- initial arm pain, headache, flushing for first few hours but resolved However, today, 1 full week later, now have new onset redness, swelling and pain to site of injection Have also had neck pain, feeling of neck strain the last few days on same side as infection, but am not sure it is attributed,  started 2 days after vaccine .
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: This cazse case was reported by the patient's wife. The age at vaccination was not reported. The patient experienced sore arm. The reporter did not consent to follow up. No additional information was provided. This case has been linked with US2019125959, reported by the same reporter.
Parent states that child began to develop a pustule/papular rash on the left side of his face about 3 hours after receiving his vaccines. He does complain of slight itching but denies any other symptoms. he does have a few papules on his neck today, as well.
Information has been received from a physician and licensed practical nurse concerning an 11 year old white female with no known allergies or past medical history who on 22-SEP1998 was vaccinated in the right arm with a 0.5 ml dose of Varivax (lot # "08404"). There was no concomitant medication or illness at the time of vaccination. On 27-JUL-2006, two weeks after her unvaccinated sibling had a case of shingles, the patient developed a breakthrough case of chickenpox, with between 50 and 100 lesions, "she was covered in bumps". The patient also had fevers and back pain. Medical attention was sought, a varicella zoster DNA PCR was performed and varicella zoster was detected. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for adrenal insufficiency. Vaccination took place on 3/19/09. According to the physician the relationship is 'None'.
Bad Flu like symptons without fever for 2 -3 days. Started evening of shot. Arm swollen Red hot, swelleng redness continues for 4 days. Went to the Dr and was put on Keflex for Cellulitis.
2 days after applying the vaccine I felt body pain, then a week later I began to have pressure in my chest that reached my throat so I was for a full week the third week I decided to go to the hospital and they discovered that I had blood clots in an artery in my heart. Then they installed 2 stents in my heart 2 days later they sent me home and 1 week later I had to return to the hospital after the studies they detected that I had blood clots in both legs, I had no problem before the vaccine and I'm almost 100 percent sure this is what caused these problems.
Felt very Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt very Fatigued) in an 89-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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Felt very Fatigued). On 27-Mar-2021, FATIGUE (Felt very Fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information includes Blood Pressure medication,Vitamins and supplements were reported by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-125329 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter information was updated.Dose 2 information was updated.Concomitant product information was updated.
A lot of fever, nosebleeds in several occasions, headache every day, diarrhea, dizziness, dilated pupils and cannot catch my breath and I lost my appetite.
joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); Swelling of left arm and left armpit (possibly lymph node swelling); Swelling of left arm and left armpit (possibly lymph node swelling); Unable to lift left arm past shoulder; mild fever; full body ache/pain; slight disorientation when standing; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 27Jan2021 17:45 at a single dose for COVID-19 immunization. Medical history included latex allergy. Concomitant medication included influenza vaccine (TRIVALENT INFLUENZA VACCINE) on 11Jan2021. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunisation (first dose at 05:45 PM, left arm). First symptom: headache/fatigue at 3:30 pm on 28Jan2021, sleep at 11 pm. Woke up at 8 am 29Jan2021, symptoms include mild fever (temperature not taken), severe headache, full body ache/pain, slight disorientation when standing. Symptoms alleviated by taking 1 acetaminophen (TYLENOL) pill (extra strength). Symptoms returned at 4 pm, another Tylenol pill taken to relieve symptoms. On 30Jan2021, mild symptoms in the morning including headache, joint/muscle ache on left arm (site of injection). Treated with Tylenol. Swelling of left arm and left armpit (possibly lymph node swelling). Unable to lift left arm past shoulder. On 31Jan2021, persisting mild headache and left arm aches, now able to lift left arm past shoulder, but with some discomfort. Treat with Tylenol. On 01Feb2021, mild headache still persisting, significantly reduced swelling of left arm/armpit. Full motion with left arm without discomfort. Treat with Tylenol. Events were reported as non-serious; did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event swelling arm was unknown while recovering for the other events.   Information on the lot/batch number has been requested.
After getting the Covid imz (Janssen) pt felt like fainting, she layed on the floor for a few minutes, since she was feeling light headed. then she sat for several minutes, pt was conscoius at all times, she drank a little bit of water. Pt stayed for additional 15 min for observation.
Itching and redness at the vaccine site on arm.  Over 2 days (currently), has developed into a large red patch, aprox 2 inches x 3 inches, with less itching.  General soreness in the same area.