chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt chills (first 24 hours), itchy at injection site (first 24 hours),  Continuous muscle aches, fatigue,  headaches, neck aches, sore at injection site.  Took acetaminophen 500 mg, 2 tablets every 4-6 hours for at least 2 days. Took Benadryl 2 tablets once first night.
Apparent fever of unknown degree during night of 12/22/14 with episodes of vomiting and Ibuprofen given every 6 hours. About 8:30 AM 12/23/14 child had an episode of blank staring and not moving of unknown length of time. Took to ER where fever was 100.5, one episode of vomiting and benign exam according to nurse.
Pulmonary hypertension; Cold sweats; Chills; Bones and back ache; Bones and back ache; Sweating; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, solution for injection, batch/lot number: not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing COVID-19 from 2020. She was a long term COVID patient for the last year and a few months. She was still on medication. Concomitant medications were not reported. The patient experienced pulmonary hypertension on an unspecified date, cold sweats, chills, bones and back ache, sweating on an unspecified date in 2021. The patient stated that, I was okay for 14 days. On the 15 day of my first dose which was last night I started to experience cold sweats, chills, bones and back ache. It just woke me up. I was sweating and I had chills. I had a horrible aching around my back. I had to sit for quite a lot of time maybe until 3 in the morning. It started to feel better, but It was horrible last night. I have the long term COVID. I am still on medication. Caller wants to know if the second dose is required for people with previous COVID-19 history. She was really concerned with getting the second. The patient underwent lab tests and procedures which included investigation: pulmonary hypertension on an unspecified date, SARS-COV-2 test: positive on an unknown date in 2020. Therapeutic measures taken as a result of pulmonary hypertension included blood thinners. The outcome of pulmonary hypertension was unknown. The outcome of the rest of the events was recovering at the time of this report.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time/6 months later received a 2nd dose) in a 31-year-old male 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, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time/6 months later received a 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving 2nd dose on proper time/6 months later received a 2nd dose) outcome was unknown. No concomitant medication information were given. It was reported that patient might received a false vaccination card "a phony card that is on the news" so discarded it and wanted to check the vaccination records over the phone. After receiving 1st dose of the Moderna COVID19 vaccine 6 months later patient received a 2nd dose. No treatment information were given. This case was linked to MOD-2022-589930 (Patient Link). Reporter did not allow further contact
Information has been received from a certified medical assistant, via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. The patient's pregnancy was confirmed by an ultrasound (date not reported). She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, irregular spotting and bleeding was ongoing; the outcome of vomiting was not specified. The patient was seen at the physician's office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2009. Initial and follow up information has been received from a certified medical assistant and a registered nurse, certified. Via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. There were no previous pregnancies. In February 2008, the pregnancy was confirmed by a pregnancy test, and on 11-MAR-2008, the patient had and ultrasound that was "normal for dates, placenta, amniotic fluid good." She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, the outcome of irregular spotting and bleeding and the outcome of vomiting was not specified. The patient was seen at the physician's office, and was currently living in a treatment shelter. Additional information has been requested.
Mother reports Right leg pain beginning the night of 11/19/19. Woke up on 11/20/19 with Right knee, thigh pain and edema. Mom reports unable to straighten right knee. Refused to weight bear on right extremity. Pt and mother reported to office on 11/20/19 for evaluation at approx. 10:30am. It was noted that Patient had pain of right knee with mild edema, difficulty bending, refused to walk on extremity. Also with right thigh pain and mild edema. She had pain with passive ROM of right knee and right hip. Tenderness with palpation of entire right knee and thigh, and noted tenderness with palpation of right hip. Limp was noted when she attempted to take 1 step. There was no redness noted to hip, thigh, or knee. No tenderness noted with palpation of right tib/fib, ankle or foot. Full active and passive ROM of ankle without tenderness. She was afebrile. Denied any chills, nausea, vomiting.
Patient stated the day after vaccination she has shortness of breath and irregular heart beat.  She is still feeling difficulty breathing and heart rate irregularity as of today.
I have had mild tinnitus since 2004.  I never had a problem with it interfering with falling asleep.  Since March 2021 it has become sever to the point I need to take Valium or Ambien to sleep 3-4 times a week.  Prior to March 2021 I only need to take one or 2 of those medications once a month.  The sever tinnitus not only causes me to difficulty falling asleep it is with me all day.
day after: dizziness, tiredness, headache, nausea, sore arm  (one day in bed then lingered but improved over next two days ) 1 week/5 days later: dizziness, nausea, light sensitive -- requiring staying in bed in dark room (lasted one day) soon after that: tinnitus (has not remitted -- currently some days better/some worse -- in process of getting audiology assessment and ENT consult)
Initial report received on 24 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3588AA received on 01 June 2010, lot number C3615AA received on 30 July 2010 and lot number C3615AA received on 30 September 2010 and 1 dose of TRIHIBIT; lot number U3497BA received on 01 July 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, approximately one year after the last dose. On 11 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of amoxicillin/penicillin starting on 19 July 2012 for 7 days. The subject was not hospitalized. At the time of final contact on 27 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Error by vaccine administration nurse, 0.2 mL given by nurse on 3/2/21 at VAX Clinic. Client was called at 6:00 pm on 3/2/21 and did not answer. Voicemail explaining situation with call back number was left.
Moderna Covid 19 Vaccine EUA.   Shooting pains in arms, legs, wrists, and feet.  Extreme fatigue, chills, lethargy.   Symptoms began about 10 hours after injection and lasted throughout the night and the entire next day until I took two Alleve and went to sleep.
11JUL92 not eating; 12JUL92 vomiting, not eating; 13JUL92 vomiting & diarrhea-no fever; referred to MD;
Patient called to report she had gone to the ER on 11/25 due to her arm being red and hot. She also reported nausea ER gave her Amoxicillin she said and told her to take BENADRYL. I told her to follow up with her PCP as well and use ice on her arm. It was her left arm.
Red oval rash on upper arm at injection site appeared about 2 weeks after 1st dose of Moderna.  Overall body warmth but no temperature and slight fatigue lasting for about a day or two. No itch at current time, just red.
ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED
Chest pain 4 hours after 1st shot of Moderna covid19 vaccination, followed by irregular heart rate and palpitations for 6 weeks. In addition, memory problems, profound fatigue, foggy thinking.
patient lied on intake form and said he had never received any moderna doses. after administration and checking cairs it shows she received in jan and feb 2021. no reaction at this time and wasn't eligible for 3rd dose when administered.
DIARRHEA; This spontaneous report received from a parent concerned a 34 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Delayed Injection site reaction- started with redness, itching, warm to touch and swelling about 8 days after vaccination. Still red no longer swollen or warm to touch at 2 weeks post vaccination.
12AUG93 pt administered 10AM mom called 240PM pt w/non-stop grunting, looks pale, t100.6 R; no resp distress per mom; pt won't nurse, sounds like hurting;
04sep90 pt vax 2nd hepta B.  06sep90 pt ex swelling and numerous tender lumps in left axilla w/ pain in arm.  pt tx w/ dicloxacillin.  left axillary tenderness improved and pt devel right axxill tenderness w/ lumps. see worm
Patient reported she felt "tingling of the throat" a "few minutes" after her vaccination. Patient reported she did not  report it while in observation. Patient reported the tingling went away on its own.
hypotension, diaphoretic  I received high dose flu( shot FLUZONE 2021/2022) 8/31. That evening, I experienced malaise, low back pain, neck pain. The next morning, I felt dizzy, lightheaded, became diaphoretic when I attempted to get out of bed. I lay in bed an hour and a half before I was able to get up and walk 5ft to get BP monitor and go back to bed. I felt very ill. I was not initially able to get BP reading. After a couple attempts and several minutes later, I had irreg HR 63 BP 69/57, Irreg HR 83 BP 67/45, Irreg HR 81, BP 97/69. I stayed in bed several hours before I began to feel better. VS a couple hours later Irreg 86 108/77. I rested most of the day. Today, I feel fine.
Cellulitis around the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; came back bigger redder/darker; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; A spontaneous/solicited report was received from a consumer who is 67 year female who experienced a reaction to the vaccine, developed cellulitis around the injection site, with a red spot the size of a quarter that was sore, warm and had a lump which became bigger, redder, and darker (rash macular).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in an unspecified arm for prophylaxis of COVID-19 infection.     On 02-MAR2-021, the patient initially reported her AE, see previous report MOD21-043017/MOD-2021-032495. She stated that it began to fade between 02-MAR-MAR-2021 through 05-MAR-2021. On 06-MAR-2021 patient states "it came back bigger and redder/darker". She went to a walk in clinic at pharmacy because it was bothering her. She was diagnosed with cellulitis and was told it was either an allergic reaction to the needle or something in vaccine. She stated that when she went to the clinic it wasn't quite 3 inches in diameter. She was prescribed antibiotics, and told to put an ice pack on the injection site as well as take acetaminophen(Tylenol).  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, reaction to the vaccine, developed cellulitis around the injection site, with a red spot the size of a quarter that was sore, warm and had a lump which became bigger, redder, and darker (rash macular) is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (Lot # M040004, expiration date 20-MAY-2018, dose and route were unknown) for prophylaxis. The temperature excursion was at 47.2 Fahrenheit for 45 minutes. Previous temperature excursion was at 47.8 Fahrenheit for 1 hour and 16 minutes. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001211: US-009507513-1708USA003660: US-009507513-1708USA003658:
Sore arm after 1st shot. Body aches after 2nd dose that lasted half a day. Second dose was 1/8/2021. Also developed episcleritis a couple of weeks later that wouldn't go away. This was new an unusual for me so I wondered if it might be because of the vaccine. Currently being treated with prednisolone eye drops.
Information has been received from a nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 17-FEB-2016 the patient was inadvertently vaccinated with an expired dose of VAQTA (lot # K010195, expiration date 15-JAN-2016, dose and route were unknown) (Expired product administered). No adverse effect was reported. Additional information has been requested.
I have been in menopause for over 10 years and no longer have any hot flashes. I had hot flashes during perimenopause. Shortly after the COVID vaccine I started having hot flashes. It took me a few days to realize that is what was happening. It's been 5 weeks since my vaccine and I'm still having hot flashes.
Cellulitis developed on child's upper right arm (just like her brothers with same varivax vaccine on same day). Required abx tx and resolved.
The wife of this pt reported that he received vax on 04/25/2000. One day post vax, he developed a red type of abscess on the back of neck at hairline, lymphadenopathy all through body, severe headaches, neck and joint pain, dizziness, muscles spasms and generalized weakness. He was hospitalized. The reporter stated that her husband's initial CT scan was negative. CBC and WBC - nml. However, a repeat of the the CT revealed sinus infection. ON 05/11/2000, a spinal tap was performed and found negative. Upon admission to the hospital, the pt was initially treated with IV Ancef for 5 days and experienced severe neck pain and worsening of headache for which he was treated with Vicodin. The pt was later treated with Rocephin. An MRI has been scheduled by neurologist to rule out inflammation of meninges.   Follow up information received on 5/25/00 from the pt's wife indicated that the pt was hospitalized twice of which each lasted 5 days.  60 Day FU states he still has bad head and neck pain, swollen glands, night sweats. Until the vaccine this pt was a very healthy person.
Patient Received 2 Shingrix vaccines. Had same Reaction with both vaccines. Which included Flu-like symptoms- chills, cold, weakness, body aches
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 05-OCT-2018 the patient was administered an improperly stored dose of VARIVAX (lot # N030409 and expiration date 30-OCT-2019, route, strength and frequency were not reported) with properly stored sterile diluent (MERCK) for prophylaxis. The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 9 days and -9 degrees Celsius to 8 degrees Celsius for 3 days. There were no previous excursions reported. The call was not because of a data logger. No adverse effect was reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA006946: US-009507513-1810USA004588.
had shot still had it/suspected vaccination failure; had it; worse pain imaginable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot still had it/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had it) and pain (Verbatim: worse pain imaginable). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and still had shingles. The reporter stated that worse pain imaginable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Breakthrough COVID infection. Patient fully vaccinated on 4/21/21. Patient positive lab date 8/21/2021.
difficulty breathing; left hand is sometimes heavy; red lesions on her body; This is a spontaneous report from a contactable consumer. This consumer (patient husband) reported for a female patient (reporter wife) that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Sep2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced difficulty breathing, left hand is sometimes heavy, and red lesions on her body on 2021. Customer Service states she has a consumer on the line reporting an AE for bruises after receiving the Pfizer BioNTech Covid-19 Vaccine. Customer Service unable to verify in the caller had Medical Information questions. Customer Service brought the caller on the line and MI agent took over the call. Caller states his wife received the Pfizer BioNTech Covid-19 Vaccine first dose on 14Sep2021. Caller states her second dose is due 07Oct2021. Caller states, however, that his wife is having difficulty breathing and her left hand is sometimes heavy, and she has red lesions on her body. Caller asking if his wife should get the second dose of the Pfizer BioNTech Covid-19 Vaccine, and if not, how she could get a medical waiver. Caller remote disconnected from the call prior to agent being able to provide closing remarks and offer survey. Response: Spoke from FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose (v2.0). "As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision."Referred caller to HCP and informed caller that Pfizer is unable to provide medical releases or health waivers for patients. Advised caller to speak with HCP to determine safest and most appropriate course of action for his wife. The outcome of events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Today during our morning vaccine clinic, we had seven patients here for their second Covid- 19 Moderna vaccine. After the morning was over, I went to account for the vaccine left over. I then realized my count was off and the only reason for that would be I gave one of the Moderna patients a Covid-19 Pfizer vaccine mistakenly. There is not a way for me to know which one it is, so I have listed all seven of them on the next page. I have been able to contact three of them but not the four. I will send a letter to them.   The adverse event is just that. No reaction. One patient given the wrong brand of Covid vaccine.