chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states several have had the same thing even a women who hadn't bleed in 15-20 years she; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient in her 60's received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (1ST BOOSTER DOSE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Caller states several have had the same thing even a women who hadn't bleed in 15-20 years she".  Clinical information: Agent stated that the caller was reporting that after the 2nd booster Pfizer shot it caused her to start menstruating. Caller stated several have had the same thing even a women who hadn't bleed in 15-20 years she was in her 60s. Caller declined to complete report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201140024 same reporter/drug/event, different patient;
pt recvd vax & exp myalgia in back, severe burning sensation down lt side of neck; numbness; devel hives on face, neck & chest; pain in shoulder persisted; dec strength;
Mild muscle pain on 15th, on 16th moderate muscle pain, and on 17th and 18th severe muscle pain. Tylenol did not help. 3 200mg ibuprofen helped about 50%.
change in voice. Patient does not have new pets. Patient does not have a history of asthma. Patient does have a history of environmental allergens. Patient did not have recent travel. Patient does not have a history of smoking. Patient  did not have previous Chest X-ray. Patient did not have had a PPD done. Ambulatory referral to ENT.  Treated with Prilosec 20 mg 20 mg 1 tab bid, Dymista 137-50 mcg/spray 1 spray by Nasal rout BID.
Stopped in clinic 8/28/09, no office visit. Employee looked at arm (sm red, warm area at inj site). Advised cool pack and antihistamine and follow up if worsening sx's occur.
Patient presented with redness, swelling, and pain at injection site. Red circle is the size of large grapefruit/small cantaloupe. He has also had a fever and chills last 2 nights. Pt has been applying ice pack at injection site and treating fever/ pain with APAP.
Patient presented to clinic on 11/02/23. Patient was symptomatic with severe flu-like symptoms the next day. PCP Dr. referred patient to hospital on 11/03/23 from senior living facility. Patient was discharged from hospital later that evening and recovered from dehydration and flu-like symptoms.
severe nasal congestion that lasted for a week and a half to two weeks; took Sudafed cough and cold capsules, tylenol extra strength, Robitussin CF. mild but noticeable headache
Fever (up to 100.1) off and on  which lasted for at least 3 days, chills, joint pain, diarrhea, fatigue, wheezing in my lungs and a very large red lump at the injection site about the size of a small orange.
Resident stated she woke up the next morning after receiving vaccines feeling exhausted. Slept approximately 8 hours during he day, in 4 hours intervals, feeling "extreme lethargy". Also C/O slight redness and warmth at injection site of the left arm where Pneumococcal vaccine administered. Felt better the following day, not quite herself. Was never given high dose flu shot in the past. Stated she is a woman of small stature. Fully recovered.
received the pfizer vaccine the 2 doses only had diarrhea for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 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: DIARRHOEA (non-serious), outcome "recovered", described as "received the pfizer vaccine the 2 doses only had diarrhea for 2 days". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a lawyer and described the occurrence of balance problems in a 54 year old male patient who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced balance problems, heat intolerance, migratory arthralgias, and fatigue with lupus like syndrome. Time to onset, treatment, and outcome were not reported. Comment: Lupus-like syndrome is considered medically serious. Legal case no follow-up available.
eye turned red immediately, both feet swollen, next day fatigue. rash, knee swollen, fever, headache
states he had his third booster yesterday and is on aspirin therapy 81mg and forgot to not take it before the vaccination 3 and a half hours before he received it; received BNT162B2 dose 3; received BNT162B2 dose 3; This is a spontaneous report from a Pfizer-sponsored program by contactable consumer (patient) reported himself. A male patient of an unknown age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on an unknown date as dose 3, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included acetylsalicylic acid [ASPIRIN (E.C.)]. The patient received BNT162B2 on an unknown date as historical vaccine as dose 1 and dose 2, single for COVID-19 immunization. The patient stated that he just got his booster vaccine and was on 81 mg of aspirin therapy and forgot to not take it before the vaccination 3 and a half hours before he received it. He stated when he got his first two doses, he read something not to take it. He stated it was routine aspirin that he has been taking for a long time. The outcome of event was unknown.  No further information obtained. offered to email the information but the patient declined. Information about lot/batch number cannot be obtained. No further information expected.
The symptoms started in early Feb 2022, about 2 months after receiving the booster dose of COVID-19 vaccine (Moderna) on 11/24/21.  I started feeling occasional chest discomfort (tightness, pressure) when I was walking up and down stairs or on flat ground.  It could happen more than 10 times a day, each less than 1-2 min without pain. I discussed with my health provider and did a stress test at Cardiology department on 4/29/22.  PVC was noticed at Stage I and resolved later. I was then given a Zio monitor to assess PVC frequency for three days. Detailed results are listed at the Continuation page. No treatment has been provided so far.
My son was sick 3 full days after his second vaccination. He was nauseated and dry heaving for days, fever and fatigue. I had no idea that a vaccine could cause a child to be so sick. I had one sick little boy.
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Fatigue, confusion including disorientation and perceptual disturbances that fluctuated throughout the day. Two episodes of orthostasis and severe tinnitus lasting about 5 minutes each.
One inch diameter, subcutaneous fibroma (L) mid-deltoid at site of Anthrax vaccination.
Headache began the evening after injection; felt feverish for the next 2 nights and had nausea and vomiting for 24 hours.  Got prescription for Zofran which helped reduce nausea and stopped the vomiting.  Also took Tylenol Arthritis 2 tabs every 8 hours for headache and arm pain.  Arm did not show any redness or swelling at injection site, but pain radiated from the area.
This report describes arthritis in a female of unspecified age who received Lyme disease vaccine recombinant  OspA (Lymerix). Medical history, concurrent conditions and concurrent medications were not specified. On an unspecified date, the vaccinee received her second injection of Lymerix. At an unspecified time, post-vaccination, she experienced arthritis. As of 04/17/02, the event persisted. The adverse event 'arthritis' does not meet ICH serious critertria but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
patient dad registered on line the wrong date of birth on patient. patient born 05/25/2005 and dad did his paper work as 5/25/2002 which qualified him for moderna vaccine. So patient was only 16 when he got moderna vaccine.
Profuse itchy rash over entire body, except top of shoulders, neck and face, which had spread over several days.  Rash started on fourth day following second dose of vaccine after low-grade fever the day/night before of 100.3.  No  other symptoms associated with rash.
Right side of body went numb  Slurred speech  Confusion  Anger  Vomiting  Fever
The pt developed a 7cm x 8cm area of redness and swelling on left arm.
Headache, flu-like symptoms (aches, weakness, lethargy) that subsided within 12 hours of onset
Day 4 or 6 post vaccination, person states substernal chest pain. Did not report it until 3/13/03 during take check. Checked over by the doctor at that time. Later called the doctor and the lead person for the smallpox vaccination program. Patient went to his PCP and was informed he had a slight case of pericarditis.
Patient fainted  approximately 3 minutes after receiving dose, she regained consciousness shortly after. Patient noted abdominal pain when she became conscious.  EMS was called to ensure patient was ok.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 17-SEP-2018, the patient was vaccinated with improperly stored GARDASIL 9 lot # R011628, expiration date 11-DEC-2020, for prophylaxis (dosage information and route were not reported). No adverse effects reported. The temperature/time frame was below 0 degree C (-1.64 degree C) for 24 hours. There was no previous temperature excursion. A data logger was involved.
Moderna COVID-19 Vaccine EUA Woke up at around 4am feeling very nauseous and light headed. Sat and tried to stand up from toilet several times but felt like passing out. Had cold sweats. After third attempt found myself lying on bathroom floor. As my  showed 15 minute gap, I figure I was passed out for about that length of time. I was very tired and SOB trying to get back to bed. Spent rest of day asleep; very tired and nauseous . Following day still tired but about 75% back to normal.
Information has been received from a nurse prescriber referring to more than 23 children of unknown age and gender. Information about concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates, multiple doses of improperly stored M-M-R II (lot # L32044, expiry date 24-AUG-2017, dose, frequency and route were not provided) were administered to the patients over two month period. The vaccines were stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. Additional information has been requested.
The patient received first dose on 5MAR2021, second dose on 12APR2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 5MAR2021, second dose on 12APR2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 5MAR2021, second dose on 12APR2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 5MAR2021, second dose on 12APR2021) outcome was unknown.            No concomitant drug was reported. The patient received 4 doses of the Moderna covid-19 vaccine by intramuscular injection. No treatment drug was reported.   This case was linked to MOD-2022-569444 (Patient Link).
My heart started pounding irregularly and rapidly and I felt like I was going to faint/except for tachycardia and irregular heartbeat- a sinus rhythm; I felt like I was going to faint; My heart started pounding irregularly and rapidly and I felt like I was going to faint/except for tachycardia and irregular heartbeat- a sinus rhythm; they feel tired; They had an "immediate allergic reaction, or what I feel was an allergic reaction"; This spontaneous report has been received from a 72-year-old female patient, referring to herself. The patient's medical history and concomitant medications were not provided. The patient's concurrent conditions included an allergy to penicillin and sulfa. The patient did not receive any other vaccine or begun a new medication in the last fourteen days.  On 01-OCT-2020 (in the afternoon), the patient was vaccinated with pneumococcal vaccine PNEUMOVAX23 0.5 milliliter once a year, subcutaneously (lot number and expiration date were not provided) for prevention of pneumococcal disease caused by 23 serotypes contained in the vaccine.  On 01-OCT-2020, the patient stated that had an immediate allergic reaction or what she felt that was an allergic reaction. The reporter stated that her heart started pounding irregularly and rapidly and felt like she was going to faint (dizziness). Due to the patient was in the doctor's office (also reported that the patient was hospitalized), the physician performed a blood pressure check which was normal and an electrocardiogram (EKG) which was normal except for tachycardia and irregular heartbeat related with sinus rhythm. The reporter stated that she was fully recovered, but she felt tired.  The patient did not receive any treatment for the adverse events.  The outcome of tachycardia, sinus rhythm, dizziness and allergic reaction was recovering. The outcome of felt tired was not recovered. The reporter did not provide a relationship between the adverse events and the therapy.
RUNNY NOSE; LIKE GOING THROUGH NIGHTMARE; FEELING VERY BAD; ANSWERING QUESTIONS/RESPONDING WITH A LONG DELAY; TIRED JOINTS; SICK; SLIGHT HEADACHE; FEELING TIRED; RECEIVED JANSSEN VACCINE AS A BOOSTER SHOT AFTER TWO DOSES OF PFIZER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EW0179, expiry: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 07-OCT-2021, the patient experienced sick, tired joints, slight headache, feeling tired, and received janssen vaccine as a booster shot after two doses of pfizer. On 08-OCT-2021, the patient experienced answering questions/responding with a long delay, like going through nightmare, and feeling very bad. On 10-OCT-2021, the patient experienced runny nose. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, feeling tired, slight headache, tired joints, and runny nose, and the outcome of answering questions/responding with a long delay, like going through nightmare, received janssen vaccine as a booster shot after two doses of pfizer and feeling very bad was not reported. This report was non-serious.
Varicella (wild type) diagnosed on 5/23/05.  Treated with acyclovir.
I received a routine flu shot in my right shoulder. A few days after receiving the flu shot I contacted by healthcare provider to inform them my right shoulder was sore and that I was experiencing pain and had a lack of movement. Since receiving the vaccine and becoming aware of the problem I have underwent 2 cortisone injections (November 30th and February 14th), physical therapy (January 18, 23, 26 and 30th, February 1 and 13), acupuncture (March 22) and just recently an MRI (March 20) was completed. The MRI results show no physical or structural damage. I have essentially been told to deal with it. Currently, I have difficulty and pain associated with getting dressed, picking up anything over a few pounds, throwing, etc... I cannot sleep well and wake up at all hours of the night with shoulder pain. I have had a tremendous decline in the quality of my life. I stopped taking my anti-inflammatory after 4 months of continuous use because I am concerned about the potential for internal damage from the NSAID.
Burning sensation of lips at 14 min post vaccine folliwed by mildly swollen upper lip. Then started feeling ill and lightheaded so reportedto site nurse/ems. Bp 190/100 which I have never experienced before.  Bp on diovan 80 mg typically 110/60; without diovan is 140/80 -90.  Given 2 benadryl and monitored and given 2 more.  About 60-90 min bp 155/90 and I went home. Took more benadryl and bp 134/80 this morning and have not taken ot for 10 hrs but feel ok. No local rx.
Red swollen itchy bumps, similar to a flea or mosquito bite.  Appears on torso, neck, back, legs and arms.
When going to bed- fever, chills, intense headache. Intense dreams. Took 400mg Ibuprofen at 5am, went back to fitful sleep.  Saturday- Woke up around 9am, still feverish, bad headache, no hunger, no thirst. Nausea. Took 400 mg Ibuprofen. Drank some water, went back to bed. Intense sense of smell. Midday took a kaopectate pill, tried to eat a cracker, drank some gingerale and water. Threw up at 3pm and 5pm. Severe nausea, could not drink a lot.  Sunday- Slept through the night (still had fever). Woke up drenched, headache gone, still not hungry, throat sore. Drank tea. Slept more. 5pm started to feel better, felt hunger. ate 6 saltines and a bowl of brothy soup (water based veggie). Lower fever, took 500mg Acetaminophen. Monday- Slept through the night, woke up, still have a sore throat, very sore shoulder and arm pain (injection arm). Still very drowsy, but feeling better.
Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy). At the time of the report, RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was unknown by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash on arm (upper and lower) in which FLUVIRIN PF vaccine administered. Persisted several days to my knowledge.
10 minutes after vaccine administration the patient started feeling faint and vomiting repeatedly. The patient remained conscious the whole time. no other symptoms were observed. the parents called 911 after 10 minutes of vomiting. The patient was taken out the store by the paramedics.
Case number PHEH2013US023706 is an initial spontaneous report received from a physician on 12 NOV 2013. This report refers to a 64-years-old male patient. On an unknown date, he was vaccinated with FLUVIRIIN 2013-2014 (batch number: 1309201) intramuscularly. But the vaccine had been exposed to temperatures up to 51 Fahrenheit overnight on 11 NOV 2013. No adverse reaction was reported following this administration error (incorrect storage of drug).
pt screaming couldn't be consoled, ?stopped breathing 2X;mom called by babysitter to come to get child; this happened @ about 1PM;mom took child to ER @ 730PM;pt is fine;
Had WCE 1/7, developed temp 102 at 2 PM 1/7, increased to 104, irritable.
Left Distal Deep Vein Thrombosis Prescribed Eliquis for 3-6 mo.
A physician told the representative that he used Vaxelis to vaccinate a patient at two months of age. Physician used Pentacel to vaccinate the same patient at 4 months of age.; A physician told the representative that he used Vaxelis to vaccinate a patient at two months of age. Physician used Pentacel to vaccinate the same patient at 4 months of age.; This non-serious spontaneous safety report, case ID 02294724 (Interaction number 02294722), was received by partner, on 30Nov2022 and forwarded on 01Dec2022 from a physician.  Due to the nature of the event, he causal relationship between Vaxelis and the reported event "A physician told the representative that he used Vaxelis to vaccinate a patient at two months of age. Physician used Pentacel to vaccinate the same patient at 4 months of age" was not applicable.  Further information is expected.
Received 2 doses of Moderna 12/27/20 and 1/24/21.  She had a positive Covid test on 4/7/21.  Her 3yr  daughter tested positive on 4/5/21. Patient felt sxs of fatigue and muscle aches.  She attributed these to working many hours.  No further sxs reported
10 x 10 cm well demarcated lesion left upper arm with central circular lesion 3 cm diameter warm to touch. Treated with.
approx 2-3 hrs p/vax given pt devel fever of 102 R 12JAN93; fever up to 106 R; mom gave APAP & bathed in tepid water; pt began to eat better;
Right arm site of injection red, warm to touch, mild bruised.  Vomiting and diarrhea
mom said pt was having fever, vomiting, & rash; took to MD; not eating; pos strep throat; mom took pt to ER & md said it could be reaction to Hep B vax;