chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed eye tearing and itchiness of lower left eyelid that evening. The next morning, a painful erosion appeared on lower lid with swelling and erythema and mild conjunctival injection. It looked like a fixed drug eruption type reaction.
heart issues Atrial tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the parent.  A 21-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL TACHYCARDIA (non-serious), outcome "unknown".  Clinical information: Patient was having heart issues, Atrial tachycardia, after research this can lead to cardiomyopathy. Reporter, as a mother knew it was the vaccine and this was push on us that it was completely safe there was disregard for the potential side effects and it was all about the money. It should not have been shoved down people's throats. They should acknowledge that the vaccine was bad and we never should've gotten it. Reporter said there was nothing else that would've caused this heart issue in reporters daughter. It was forced on them and people were forced to get it for their job and people would not have gotten the vaccine if they knew all the side effects that could happen.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt had large 6cm in diameter lesion around site with shoulder pain and decrease ROM of right shoulder was given Benadryl and antibiotic.
Pt vaccinated with OPV had aseptic meningitis & CSF culture positive for Poliovirus after recent ORIMUNE.
4/11/21  (evening)  - Headache.  Called doctor on Monday. Took 1 aspirin with doctor's approval and was fine.  5/4/21 (approximately 1 a.m.)  Awoke feeling nauseous. Went to bathroom and proceeded to vomit four times over the next 90 minutes. Last episode was just vomiting water that I'd sipped and could not hold down.  No sore throat, fever, chills or diarrhea. Just vomiting.  Able to handle crackers, ginger tea & ginger beer. Plan to try soup today. Still more tired than normal (though 16-18 hour workdays don't help here), and stomach still feels a little unsettled.  5/4/21 - Present - Headache. Afraid to take aspirin as it might upset stomach that has already had a tough time.   NOTE: Regarding question on next page about adverse reactions to vaccines, I haven't had a vaccine since childhood. My parents, who were typically never sick, became terribly ill for months after receiving their first and only flu vaccine. One of my sister's had a similar reaction. For that reason, my other sister and I have never opted for vaccines in adulthood, until now. I just took it now because I don't want to die, my employer is pushing for us to return to campus, and I know my high school students will not vaccinate or wear masks if they can avoid it.
patient had no symptoms of adverse effects, however patient was given expired vaccine-vaccine expired on 3/2/23, rcvd the injection on 3/14/23.  Mother and Case Manager were notified, once discovered (3/29/23) during chart review
mom states 7 days p/vax were given pt devel fever & broke out w/a rash;pt was seen by ARNP & dx w/hives;ARNP impression was not vax related but could not rule it out;
Fever, Rash, Diarrhea, rash at vaccine site Narrative:  Other Relevant History:
had a severe reaction to PNEUMOVAX 23; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concurrent condition and concomitant medication were not provided.       On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.         On an unknown date, the patient had a severe reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) previously and was hospitalized. No additional adverse event details provided due to consumer being unable to be transferred to agent. The outcome of vaccination complication was unknown. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.
Nausea, vomiting, fever to 101, headache, myalgias--treated with ibuprofen.
half or might be less than of the dose administered; might be due to equipment failure that the needle/hub got separated and some fell on the arm; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (half or might be less than of the dose administered) and DEVICE CONNECTION ISSUE (might be due to equipment failure that the needle/hub got separated and some fell on the arm) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced UNDERDOSE (half or might be less than of the dose administered) and DEVICE CONNECTION ISSUE (might be due to equipment failure that the needle/hub got separated and some fell on the arm). On 07-Mar-2021, UNDERDOSE (half or might be less than of the dose administered) and DEVICE CONNECTION ISSUE (might be due to equipment failure that the needle/hub got separated and some fell on the arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. The patient had no adverse reactions. The patient received both doses of mRNA-1273 (Moderna COVID-19 Vaccine); therefore, the action in response to the events was not applicable.; Sender's Comments: This report refers to a case of underdose, and device connection team for mRNA-1273, lot # 029A21A with no associated AEs.
No adverse effects reported; Nurse reports one dose of improperly stored pneumovax was administered to patient on 9/23/2019; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 23-SEP-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection; lot # R009163, expiration date: 06-JAN-2020 (strength, dose, schedule, anatomical location, and route of administration were not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit: 34.9 Fahrenheit (reported as "lowest temperature") for a duration of 119 minutes. There was no previous temperature excursion. There was an involvement of data logger. No adverse effects reported. No product quality complaints (PQC) were involved.
Information has been received from a pharmacist referring to a patent of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 01-SEP-2018, the patient was inadvertently administered a dose of PREVNAR 13 ((Lot# S58702, expiration date 31-AUG-2019; strength, dose, frequency, route and indication were not reported). On 30-SEP-2018, the patient was inadvertently administered a dose of PNEUMOVAX 23 (lot # R002085, expiration date 31-OCT-2018; strength, dose, frequency and route were not reported) for prophylaxis. No adverse effect reported.
On 08/29/20 at 10:45 AM I felt dizziness and nausea when I attempted to get out of bed.  I had to hold onto things to keep my balance.  I felt so nauseous that I didn't want to eat.  I drank 1/4 cup of Kefir and milk, some orange juice and some milk mixed with Carnation Breakfast Essentials.  I fed my two pets and laid down to rest from 12:30 PM  until 2:00 PM.  I had three (3) bowel movements between 11:00 AM and 2:30 PM.  At 2:02 PM I still felt some dizziness and nausea but decided to eat a little or the dizziness and nausea might never go away.  So I ate a small bowl of cereal, a slice of bread with peanut butter plus a few grapes.  At 6:15 PM I fed the birds and did from chores and had low energy but the dizziness and nausea was gone.  The reason I am reporting this is that I check the information with my flu shot and it listed dizziness at least as a side effect.
postherpetic neuralgia; shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 19-MAR-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and postherpetic neuralgia. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events of shingles and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Rash no redness around the area of vaccine about 2 cm diameter. As per pt felt itchy and warm.
Increase pain and severity of menstrual cycle. Exceptionally heavier flow, menstrual cramps, ance  etc
Loss of taste began the morning after vaccine and I?m now on day two of loss of taste.
HPV vaccine dose 2 was administered 3 weeks and 3 days after the HPV vaccine dose 1, 5 days before the minimum recommendation of 4 weeks. No adverse reaction was noted. Patient was given HPV vaccine dose 2 on 01/17/2023 and HPV vaccine dose 3 is scheduled 12 weeks apart on April 11th 2023
Patient given pediatric Pfizer COVID19 vaccine instead of adult Pfizer COVID19 vaccine.
Pain in the middle of the back on both sides. Pain increased when attempting to take a deep breath.
I have been  having left leg pain, rashes that are like shingles on my right arm, left leg with pain.  I have had issues with the nerves in my bladder, heart, ovary and uterus affected.  I went to urgent care, my pcm, had labs, had mri, a couple ultrasounds and now need to see a cardiologist.  Also fatigue.
Vomiting/ nausea  103 fever Diarrhea  Chills  Inability to sleep  Sweating    Pain in muscles
Headache, Myalgia, Athralgia, NauseaVomiting, fatigue and hot flashes/sweating Narrative  Other Relevant History:
About 1 to 2 minutes after she got her shot she got dizzy and fainted, falling off the table at the office
Started feeling warm and had aches in joints. Don't think temperature went over 100. Stopped early Saturday afternoon (less than 24 hours).
Based on additional information received on 05 October 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 26 August 2015. This case involves a five-year-old female patient who was vaccinated with a fourth dose of DAPTACEL (batch number: C4630AA, expiration date: 28 October 2016, dose and dose number were not reported) intramuscularly in left deltoid on 09 July 2015. The patient had a medical history of milk, dust mites, tree pollen, chalk allergies and possible asthma. The patient had history of prior reaction to MMR vaccine (reaction not specified). Concomitant medication was not reported. On 09 July 2015, within 24 hours following the vaccination, the patient had swelling and redness of left arm due to which it was hard to get a shirt on. Since 09 July 2015, the patient had behavior meltdowns. On an unspecified date, the patient had seen physician for cough and cold after DAPTACEL vaccination, but not for behavior issues or local reaction. The patient required ER or doctor visit. It was reported that reporter did not know if DAPTACEL was the DTaP given for prior doses of DTaP. Laboratory investigation and corrective treatment were not reported. On an unspecified date, four days later onset, the patient was recovered from event left arm swollen, redness which was hard to get a shirt on. The patient was not recovered from event behavior meltdowns, cough and cold. Follow up report received from a physician on 05 October 2015. Patient address details updated. No other information reported. List of documents held by sender: none.
limited medical information received on patient; pt to ED with a positive COVID test and hypoxic; hx of renal transplant on systemic immunosuppression; COVID pneumonia; required intubation; pt's condition worsened and he died in the hospital
temperature spiked to 101F; cills and tremors; headache; sore arm; tremors; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "temperature spiked to 101F"; CHILLS (non-serious), outcome "unknown", described as "cills and tremors"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm"; TREMOR (non-serious), outcome "unknown", described as "tremors". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, chills, headache, pain in extremity, tremor.  Additional information: Patient got the Pfizer COVID-19 vaccine yesterday (15Mar2021) and felt fine after vaccination. Seven hours later, her temperature spiked to 101F and had chills and tremors. she also developed headache and sore arm. She took Tylenol for her symptoms Today (16Mar2021), she feels fine but still has a sore arm. She wanted to know if those are normal with the vaccine and if the adverse event worsen after the second dose of the vaccine. She mentioned that she might not get the second dose of the vaccine because of her experience with the first.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 9 year old male with no pertinent medical history and no drug allergies, who on 21-JAN-2002 and 28-JAN-2008 was vaccinated with 2 doses of VARIVAX (Merck), SC. There was no concomitant medication. On 08-JUL-2010 the patient broke out in chickenpox. He presented to the physician's office a week later with no fever. He had multiple scabs and areas were excoriated. He was given BENADRYL. There were no labs or diagnostics tests performed. At the time of the reporting, the patient was recovering. Additional information has been requested.
Information has been received from a physician, the author of the literature report, concerning a 110 days infant, gender unknown. The infant was a preterm baby and had low birth weight between 1001-1500g. This was a prospective observational cohort study in all VLBW infants who were discharged from the NICU from May 1, 2008 to April 22, 2010, when rotavirus vaccination (manufacturer unknown) with RV5 was provided at discharge to all age-eligible infants. The medical records of the infants were reviewed, and pertinent demographic , clinical, and laboratory data were recorded. The number of infants who received the rotavirus vaccine, the number of missed opportunities for vaccination, and the number of infants falling outside the recommended time period for vaccination were recorded and analyzed. There were no complications noted on follow-up. On an unknown date, the infant ws vaccinated despite being older than the recommended age limit at the time of discharge. Rotavirus vaccination (manufacturer unknown) is recommended for use in preterm infants at the time of discharge from the NICU as long as they are clinically stable and have an age range of 42 to 104 days V.10. Our study highlights the limitations of the currently recommended schedule for rotavirus vaccination, because 22% of all VLBW infants were too old at discharge to receive the vaccine, in addition, 52% of all ELBW infants discharged from the NICU were older than 104 days and also were not vaccinated.  This is one of four reports received from the same source. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
who received the booster dose of the of the Pfizer BioNtech (Comirnaty) vaccine and contracted COVID-19 infection.; who received the booster dose of the of the Pfizer BioNtech (Comirnaty) vaccine and contracted COVID-19 infection.; This is a spontaneous report from a non-contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient mentioned that he tested positive for COVID and wants to know more information on the reported lack of efficacy of the booster dose on an unspecified date. Patient added that he stayed at home, with no contact and has been very careful. He was in his senior and when the vaccine was authorized, he got his booster. He mentioned that he was quite shocked. He declined to speak with  at first and says that he is just curious where Pfizer stands on this. He was thinking about going to the media regarding the efficacy of the third dose. He does not want to keep being transferred and if it continues, he was ready to go to a lawyer. Pfizer needs to be able to talk on behalf of this and not transfer him around everything, that was typical for a large corporate company. He was giving Pfizer a chance and he does not want to but he may have to go to a lawyer who will publicize all of that. He was informed that the transferring agent had sent him to the department regarding the medical information. He states that he wants to speak with . He was not blaming this  agent he was just shocked. He thought that he has done all that he could. He has stayed inside for a year and he did not talk to anyone at all, not even for deliveries, and then he got the third shot, he is older, and then he gets COVID. He thinks that Pfizer knows more about COVID then they are disclosing is his guess. He was unable to obtain phone number because he was sick and in bed on and does not have a pen. If the call disconnects, he will have to find another way to contact them. The patient underwent lab tests and procedures which included Covid-19 test: positive on an unspecified date. Outcome of event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Patient developed a left sided ulnar neuropathy (pain, weakness) that evolved to a left sided brachial plexopathy.
BP 120/80  9:50am red splotchy area on chest, arms, stomach. Client feels hot. Pulse 68  10:15 vomited x 2. Benadryl Elixer 50mg PO given prior to vomiting. 10:45 red splotchy areas disappeared. client sleepy- co worker drove client home.
About 12 hours after the vaccine, I started having arm pain at the site and low back pain which is very unusual for me as well as a dull headache which is not uncommon for me. Around midnight I woke up with chills, and severe arthralgias in all joints down to the toes and fingers, and deep, boring pain in my long bones and neck. My skin and fingertips felt like they were burning. I was nauseated but didn?t vomit. I was up all night because I couldn?t find a position I wasn?t in pain in. Tmax 100.3 F. Took a gram of Tylenol with improvement of symptoms. Felt better in AM but when Tylenol wore off around 9 am, had another wave of the same pain all over. Tylenol improved. Felt almost completely normal by 4 pm with the exception of some lingering low back pain (central not muscular).
pain at the injection site; sweating; shivering; fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of hyperhidrosis (1st dose received in December 2019 and he had body aches, pain at the injection site, shivering and fever of 101.9 degrees,refer case US2020244465).   In March 2020, the patient received the 2nd dose of Shingrix (intramuscular). In March 2020, 6 hrs after receiving Shingrix, the patient experienced injection site pain, sweating, shivering, fever and general body pain. Rechallenge with Shingrix was positive. In March 2020, the outcome of the injection site pain, sweating, shivering, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sweating, shivering, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm. After receiving 2nd dose of Shingrix, the patient experienced fever, body aches, pain at the injection site, shivering, and sweating which lasted about 7 hours. The patient reported the events did not seem as bad with the second dose compared to the first. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244471:same reporter US-GLAXOSMITHKLINE-US2020244465:same reporter