chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pains in her chest like a heart attack like her chest was tightening; sick to stomach; throwing up; stomach was hard as a rock; weak; chest was tightening; This is a spontaneous report from a contactable consumer (who is also the patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included influenza vaccine (reported as "flu shot") on an unspecified date for immunization which made the patient sick. The patient reported that she woke up early on 14Apr2021 at 03:00 sick to her stomach, throwing up, her stomach was hard as a rock and weak. She had pains in her chest like a heart attack like her chest was tightening. She felt like she was dying. The patient wanted to know how long this sickness from the shot lasts. She stated that she will probably not take the second shot and mentioned that she should go to the emergency room. She wanted to know what they will give her in the emergency room. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
10 month after receiving VARIVAX in right thigh, shingles erupted in the same location - L - distribution. No history of prior varicella.
The day after I was sick with flu like symptoms. For 3 weeks following I had severe fatigue and brain fog to the point I could not work.  I was very slow to process when someone spoke to me. I could not think clearly. I needed to take naps daily, sometimes twice per day.
101.4 fever, low grade fever for four days Headache, severe for three days Nausea Vomiting Diarrhea Muscle pain at injection site Swollen lymph nodes under arm (size of large grape) Swollen gums Lethargy, four days
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 03-OCT-2014 the patient was vaccinated with improperly stored VARIVAX (Merck) (dose/frequency: 0.5 ml, route: subcutaneous). VARIVAX (Merck) was exposed to -7 Celsius for eight hours. No adverse effects were reported. No product quality complaint (PQC) was filed for VARIVAX (Merck). This case is linked to 1410USA004928 (same reporter link). Additional information has been requested.
Back side of Left shoulder, then pain proceeded to arm. Pain also started from mid left side of neck down shoulder blade, after a couple days pain moves down arm to elbow, a couple days pain moves down to wrist. The tingling started. My left arm and shoulder was a Level 10+ for 4 months. Emergency room tried to call it arthritis, MRI showed minor tear in rotator cuff. Another cat scan on neck showed minor arthritic. Now it has been 7 months since the shot and all that pain has been going away. Plus there is still inflammation from where they gave me shot.
Patient had gotton really sick in Dec. 2004 with 2 E.R. visits and he has been sick every since his vaccine shots. Any questions please call.
arm still sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-JUL-2023, the patient received Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm still sore). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine last Wednesday.  The patient's arm still hurt.
Slight rash on face and neck with itchiness and soreness to touch. Took Benedryl and Tylenol to relieve symptoms. At 2 a.m. 11/16, awoke to severe pain throughout body (including just touching skin) and fever/chills. Took hot bath, Vicodin and Benadryl for relief of pain. 11/17 at approximately 5 p.m., onset of pain began to occur again. Took Vicodin and Benadryl to relieve symptoms.
Active full body raised red rash, steroid resolved but returned after treatment. Itchy and warm to touch, more prevalent in morning.
Pt exp muscle cramps in the hands & feet 24 hrs p/vax; these cramps resolved but the pt now has cramps in head (behind the ears & in the middle of the head);
This case was reported by a pharmacist and described the occurrence of muscle pain in a female subject of unspecified age (30's - 40's) who was vaccinated with Flu vaccine (manufacturer unspecified0. Concurrent medical conditions included lymphoma. The subject was reportedly undergoing chemotherapy on a protocol called ABVD and was receiving multiple unspecified concurrent medications. On 12 November 2008 the subject received unspecified dose of Flu vaccine (unknown). On 13 November 2008, 1 day after vaccination with Flu vaccine, the subject developed pain in her arm. Muscle pain was reported with onset of 13 November 2008. Pain progressed to her shoulders and neck. Leg pain was also documented. The subject reported that she was experiencing weakness and as a result was unable to open jars. She had shortness of breath on climbing stairs. Additionally, she reported that it hurt to lift her arms above her head. At the time of reporting, muscle pain was unresolved and the outcome of the other events was unspecified.
patient was administered a pediatric dose of VAQTA; the patient had received his first dose of VAQTA as a child, but did not receive the second dose within the time frame recommended within the prescribing information; No additional AE reported; This spontaneous report was received from a pharmacist, via a company representative, referring to a 19-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter for prophylaxis. (strength, route of administration, lot # and expiration date were not reported). Caller stated the health care professional (HCP) did not provide the date the pediatric dose of hepatitis a vaccine, inactivated(VAQTA) was administered. Caller stated the patient was following the "catch up" vaccination schedule as the patient had received his first dose of hepatitis a vaccine, inactivated(VAQTA) as a child, but did not receive the second dose within the time frame recommended within the prescribing information. Caller did not have any information about the dates of administration. No additional adverse event (AE) was reported.
Follow-up information from the physician revealed that the child received no other vaccines within 4 weeks of Flumist administration. Information regarding Flumist (2003-2004 Formula) (Influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 8-year-old son who experienced vomiting, diarrhea and nausea. The patient received a dose on 18-Dec-2003. Medical History: The child had no medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Dec-2003. Dose regimen was 0.25 mL in each nostril. Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, 5 hours after receiving Flumist, the child developed nausea, vomiting and diarrhea. The nausea continued through the night until 5:00 am on 19-Dec-2003. As of 19-Dec-2003, the diarrhea was subsiding and the child was "experiencing very loose stools".  No medications were taken for the diarrhea or vomiting. Of note, the child's mother developed severe joint pain after receiving a dose of Flumist (2003-2004 formula) on 18-Dec-2003 (see MCN: HQWYE893323DEC03).
I was given the flu and PPV vaccine on same arm and same sight. Severe arm discomfort for 2 days. It was so much that it would wake me up when sleeping. Area was warm and on I had body aches, headache and on the 2nd day large red hives developed on the injection sight and the area was very warm to touch. I have gotten the flu shot for the past 7 years and never had this type of reaction. This is first time for PPV shot.
Vaccinator inserted the needle into the client's left deltoid muscle. Upon activation of the plunger the vaccinator noted fluid dripping on the client's arm. Once the vaccinator noted the liquid on the client's arm she stopped administering the vaccine and removed the needle from the client's arm. Lead RN noted the plunger had been depressed approximately 0.03 milliliters. Per CDC guidance, the client received a repeat dose of 0.3 mL of Pfizer COVID vaccine (Lot#FL3209 exp: 06/30/2022) in the left deltoid muscle at 3:07PM. The client also received the Flucelvax Quadrivalent vaccine (Lot#308497 exp: 06/30/2022) in the right deltoid muscle at 3:07PM. The client did not report any symptoms during the 15 minute observation period. Lead RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site ambulating unassisted with a steady gait.
Patient passed out during her observation period after vaccination. She hit her head on a wall and was unresponsive. She quickly regained consciousness. Patient was given water and an ice pack. she was observed for an addition 20 minutes and left on her own accord with her parents.
SLEPT WHOLE DAY UNTIL 5PM; DIZZY; HEADACHE; COULDNT SLEEP; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced couldnt sleep. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced slept whole day until 5pm. On 06-APR-2021, the subject experienced dizzy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, was recovering from fatigue, and the outcome of dizzy, couldnt sleep and slept whole day until 5pm was not reported. This report was non-serious.
Red, raised bumps located in the antecubital area of both arms and the lower extremities that appeared around 7 days after the vaccine.
101 fever, severe body aches, nausea, loss of appetite, shaking and chills for 2 days.
Broke out in hives the same day she took the first dosage. She broke out all over her chest and around her hips. She did not finish the pills.
Three and one half years subsequent to receiving one dose of varicella virus vaccine live the pt experienced varicella with greater than 18-20 lesions. The pt was afebrile.
Vaccine was administered using diluent that was not included in original packaging. Sterile diluent was used to reconstitute not diluent included and intended.
Seizure and fever started 5th day after vaccine administration. Patient was taken to the emergency room twice within the same day for febrile seizures - once at 2:00 AM and again at 10:30 PM.  Child given acetaminophen and motrin and discharged after both visits.  RX given for Diastat.  Recommended follow up with neurology for evaluation and EEG/MRI. Follow up with PCP.
hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient did not have a history of allergies to any food or medications or other products. The patient received unspecified medications within two weeks prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 01Apr2021 at 10:30 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, the patient experienced hot flashes. No therapeutic measures were taken for the events. The clinical outcome of the event hot flashes was unknown at the time of report.   No follow up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
I received the injection at 08:15 arm after hung around upon me getting ready to go elevated heart rate and  pulse started to race. Then I stayed there lips started to tingle after 10 mins heart rate came down. I went back to work 1 1/2 hrs tongue was till numb and tingling. I went back to facility where I first received my vaccine. I was told to go to the ED checked blood pressure and I was offered Benadryl I declined. I dint miss any days of work.
Swelling and rash development at the injection site.  Site was hot and stiff.  Medics treated with anti-histamine and ice.
Intermittent fevers between 100.0 - 101.0 degrees persisting for 24 hours.
Collar Bone Pain; Shoulder Pain; Inflammation; Swelling; Able to raise arm, but hurts to move it at all.
Patient was given a Dtap vaccine instead of a Tdap vaccine. The Medical Assistant pulled and gave the wrong vaccine.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash all around injection site) and RASH (Rash down arm to elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     Concomitant products included TOPIRAMATE (TOPAMAX) and SIMVASTATIN (ZOCOR) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash all around injection site) and RASH (Rash down arm to elbow). At the time of the report, VACCINATION SITE RASH (Rash all around injection site) and RASH (Rash down arm to elbow) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant Product: Antidepressant.  Patient stated she received the first Moderna vaccine on 2-2-2021. Patient stated after first Moderna vaccine she had a rash on day 9,all around the injection site down arm above elbow.
Pt recvd vax 24JUN92 & the next day woke w/lightheadedness, h/a & tingling;
Sore arm; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-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 PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were provided. Treatment medications were unknown.   This case was linked to MOD-2021-219870 (Patient Link).
At 1 am I woke up shivering but had no fever, terrible body aches and a headache My arm was beat red, sore and warm to the touch
After about a month, I started having severe pain in my spinal column. Couldn't raise my leg when in bed. Had a hard time walking. I had to have a special 'magnetic' type of therapy in my lower back that help me significantly. I was in another country then. I also started having problems with the macula in my left eye.  When I got my second dose in the states, I started having hip joint problems that I had never had before.
09:32- Patient reported feeling short of breath, dizzy, when standing.  MD consult requested - BP 119/88, p-88, O2 sats- 99%,  09:55- complains of continued shortness of breath, no worse.  No trouble swallowing, no throat tightening.  10:00-  cleared to leave,  While waiting for shuttle, felt dizzy and light headed.  Returned to triage area.   Orthostatic vitals-  sitting: 119/88, p88,   standing- 128/83, p- 72,  Given apple juice and reported feeling better.  Patient cleared to leave 10:27 am.
Sunday after injection, had a low-grade fever and slept half the day.  A couple days later I noticed a bump on my neck which I thought was an ingrown hair or bug bite. One week later I had the same low grade fever and the 'bump had expanded across my neck and shoulders. Made it in to the doctor a couple days later and was diagnosed with Shingles.  There were no other life stressors that could have caused it, life was good. Now, three weeks later, the pain has diminished but still present. Nerve sensitivity remains.
Pt recv vax on 6/3/97; on 11/15/98 pt exp rash on LA w/ pain, vesicles, crusted & papules; tx=Acyclovic
Redness/mild swelling in left upper arm.  2 days after shot was received.
3APR92 recvd 2nd dose of vax & 17APR92 devel elevated liver enzymes, muscle aches, joint swelling, elevated ESR, a blistering-type rash, chills, fever, post nasal drip, arthritic pain, pharyngitis, tachycardia, fainting, & photosensitivity;
COVID-19 vaccine dose was not diluted, resulting in patient receiving twice the recommended dose. The patient had a sore arm for 2 weeks. No other significant side effects or adverse events have been noted by the parent. The patient received the 2nd dose on 6/24/2022.
Itchy watery blister on right leg size of pea hard knot and bruise looking, tender to touch per mom. Tx: MOTRIN for pain; BENADRYL for itchy. Alternate hot/cold compress. No longer 20 mins/nor direct skin.
hasnt had period; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (hasnt had period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (hasnt had period). At the time of the report, AMENORRHOEA (hasnt had period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were given
This spontaneous report was received from a professional nurse referring to unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ Lot # L010844 - Expiration date: 16-NOV-2016 (strength, dose and route were not provided). No symptoms were reported. The reporter stated that duration of the event of incorrect product storage was about a time frame of 3 hours, and reported temperature was 58 degrees F. The vaccines did not undergo a previous temperature excursion. There was no data logger issue reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, Arthralgia, Rash, NauseaVomiting, Pain at site, chills, fever Narrative:   Other Relevant History:
Breakthrough case admission after 2 vaccines Pfizer 5/3/21 lot# Ew0172; Pfizer 5/24/21 lot# Ew0183
This is a spontaneous report from a Pfizer-sponsored program, from a contactable pharmacist. A 67-year-old female patient received PREVNAR 13 (Lot R75238, Expiration Date May2018, NDC# 0005197102), intramuscular in right arm on 13Sep2017 11:20 at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness around the area and it is warm to the touch 19Sep2017. Both events were reported as worsened on unspecified date. The patient visited physician office. The events were considered medically significant and related to pneumococcal 13-val conjugate vaccine (dipht crm197 protein). The outcome of the events was not recovered. Sender's Comments: Based on the information currently available, the reported events with pneumococcal 13-valent conjugate vaccine in this patient cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.