chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 18Nov2021 as dose 3 (booster), single (Lot number: FH3080) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing). No Known allergies. Concomitant medication(s) in 2 weeks product included: LOSARTAN; CITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Experiencing mild cold like symptoms and a positive covid test after taking Paxlovid and previously testing negative. The patient received COVID 19 Treatment: Paxlovid from 21Jun2022 to 26Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My daughter, who lives next door, informed me that she tested positive for COVID-19 on 12/18/2022. I hadn't noticed anything wrong at that point, but 6 or 7 hours later, I got a strange sensation in my throat and nose. I haven't been sick in 30 years, so I was aware something was wrong. I took an at home COVID-19 test and it was negative. I took another 24 hours later, and it was positive. I emailed my nurse practitioner to inform her of my positive results and to request PAZLOVID. Around 10:00AM, I was notified that the prescription was filled. My symptoms were about the same just with nose and throat irritation. Everything just felt like a bad cold, and I was very tired. Every time I sat down, I wanted to go to sleep. After beginning the PAXLOVID, I felt a little better every day and on day six, I'd say I was completely normal. Today though, I woke up with my sinus cavity entirely clogged.
The first symptom to appear was a change in patient's speech.  This was noticed in May 2021, about a month after her 2nd Modena Vaccine.  On June 20th, 2021  several extended family members urged patient to be evaluated for a stroke.  Her general practitioner referred her to a neurologist.  The neurologist did several tests and suspected ALS, but he referred her to a specialist for the diagnosis.  The specialist neurologist diagnosed patient with PLS in October 2021.  At this time her speech was a more difficult to understand and some food was becoming difficult to swallow.  On March 4, 2022 patient was re-diagnosed  as having Bulbar Onset ALS, by this time her speech was worse and swallowing was becoming more and more difficult.   Due to swallowing becoming more difficult, in July 2022 patient was given radiation to her saliva glands to cut their production and a feeding tube was surgically placed.  Patient was still able to eat some food, but was relying more and more on the feeding tube as the year progressed. She was able to feed herself with a syringe.    By January 2023 patient exclusively uses the feeding tube for nutrition and her hands became weaker so she began to have to use feeding bags with a pump.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA. 15 minutes after receiving  vaccine, patient stated her throat started to feel "tingly and itchy". Patient stated that her tongue began to also feel the same way. Epi Pen was administered. 10 minutes following EpiPen, patient began to have a headache. Patient then took ibuprofen. No other signs/symptoms developed. Patient observed for several hours. Patient had full recovery.
1/19-5pm headache and knees ache. 8 pm 102 fever, headache. Cough. Body aches. Chills. Tremors.fatigue  Thru 1-20.   1-21  tremors stopped.  1-22   Everything but fatigue  knee aches. Headache  stopped. 1-25  only fatigue and knee ache.   2-2 knees still ache
This spontaneous report was received from a office manager referring to a 10 week old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 27-MAR-2018, the patient was vaccinated with an improperly stored ROTATEQ, lot # N013884, expiration date on 05-DEC-2018 (anatomical location and administration route were not reported) for prophylaxis (Incorrect product storage). Concomitant medications included properly stored Sterile Diluent. No adverse effects were reported. The vaccine was stored at 47 degrees Fahrenheit to 77degrees F (61.7 degrees F) for 2 hours 30 minutes and 32 degrees F to 35 degrees F (33F) for 6 hours 51 minutes. The  previous temperature excursion was reported as 47 degrees F to 77 degrees F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116; US-009507513-1808USA007352; US-009507513-1808USA007355; US-009507513-1808USA007354; US-009507513-1808USA007353.
Had expected sore arm with a rash and some of the other common side affects. 7 days after injection, site of injection swelled again, became tender and is covered in hives.
itching of arm within first 24 hours and then pain, swelling  and redness of left mid arm  below deltoid muscle.
RASH ON RIGHT SIDE OF TRUNK, DX: SHINGLES. TX: ACYCLOVIR
Significant, on-going pain in the muscles of lower and upper right arm near the elbow (not the shoulder where the shot was given).  This pain started about a month after receiving the shot and is not diminishing or going away even now 5 months after receiving the shot. Also had the same side effects in the left arm where the first shot was given but right after the shot was given and not as severe. It has mostly subsided in the left arm over about a 4 week period but occasionally still have some mild pain.
Sore arm; Fever of 100.9; Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.9), PAIN (Body aches), CHILLS (Chills) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.9), PAIN (Body aches), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.9), PAIN (Body aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
The first series of the Covid shot given 3-15-21 lot 031A21A about 3 weeks after the shot I woke up Saturday morning with swollen lips they stayed like this until Monday so I called and went to see Dr. he thought it was nerves or stress causing it so he prescribe MethyIPREDNISolone tablets, USP 4 mg 1 pack. Once I started taking them the following day my lips began to go back down to normal but they were very dry and pealing for a few more days. On April 13 I was given my second Covid shot and on  Thursday about 1 pm my lips began to itch really bad around the edges by Friday morning April 16th I woke up  with swollen lips again. I called Dr. office and let them know my lips had swelled up again and that I had just gotten the second Covid shot on Tuesday. so Dr. called in the prescription MethyIPREDNISolone tablets, USP 4 mg 1 pack. I began taking them Saturday morning and by Sunday my lips had gone back down to normal and again very dry and pealing but much worst than last time.
DIZZINESS; WOBBLY; OVERALL FEELING TERRIBLE; FOOT ACHE; This spontaneous report received from a patient concerned a 91 year old female. 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced dizziness. On 17-MAY-2021, the subject experienced wobbly. On 17-MAY-2021, the subject experienced overall feeling terrible. On 17-MAY-2021, the subject experienced foot ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, foot ache, wobbly, and overall feeling terrible. This report was non-serious. This case, from the same reporter is linked to 20210622893.
patient received dose from vial that experience temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose from vial that experience temperature excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose from vial that experience temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose from vial that experience temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication was reported  no treatment medication was reported
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand Other: Moderna, Vaccine administration date: 07Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 20Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 15Dec2022; TADALAFIL, stop date: 15Dec2022. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "unknown", described as "Vaccine brand Other: Moderna, Vaccine administration date: 07Sep2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2022) Positive, notes: Positive test five days after completing treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    Reporter did not allow further contact
fast heart beat; shortness of breath on and off; Difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment information does not provided.   Reporter did not allow further contact
Patient completed the 4 dose series of Hiberix but received a 5th dose on 16May2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received Hib (Hiberix) (batch number 2977H, expiry date 16th May 2023) for prophylaxis.   Previously administered products included Hiberix (the patient completed the 4 doses series).   On 16th May 2022, the patient received the 5th dose of Hiberix. On 16th May 2022, unknown after receiving Hiberix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: Reporter's Comments: The nurse reported that the patient received a 5th dose of Hiberix. The reporter consented to follow up. Additional Supportive Information: The patient received 5th dose of Hiberix, which led to extra dose administered.
What I went thought after the shot I got real sore and then so sore that I couldn't touch it. I started having headaches and pains across my shoulders this went on about 1 1/2 months.
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
administered an ACT HIB however instead of using the provided and recommended diluent they used a different diluent which is sterile water for live virus vaccine with no preservatives with no reported adverse event; Initial information received on 17-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old male patient who was administered a haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] however instead of using the provided and recommended diluent, reporter used a different diluent which is sterile water for live virus vaccine with no preservatives with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 14-Apr-2023, the patient was administered a Standard dose of 0.5 ml suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ739ABA, expiry date-10-AUG-2023) via intramuscular route in the left thigh for Immunization, however, instead of using the provided and recommended diluent, used a different diluent which is sterile water for live virus vaccine with no preservatives with no reported adverse event (product preparation error) (latency- same day). Caller wants to know if they need to revaccinate the patient.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received vaccine without incident. As patient was walking to the observation area, he felt a little dizzy. He ambulated to the observation  room without difficulty.  As he was sitting in  the chair in observation he passed out in the chair with observer present who caught him and  then the patient was placed in a wheelchair to take him to private observation area. By the time he was wheeled to  the private area he was semi-alert.   Vital signs were taken, EMS was called.  Patient became fully alert within 5 minutes. He was diaphretic. VS were within normal limits. Patient did state he had a very light lunch.  He had something to eat in the ambulance and felt better. EMS returned him to the clinic after about 30 minutes and patient stated he felt fine.
had a 101 degrees fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection, (Batch/Lot number was not reported)), dose 1 via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a 101 degrees fever on 16Mar2021. The patient would like to know if she can take Tylenol. The outcome of event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Patient reported dizziness, lightheadedness, and "fuzzy" sensation.  BP monitored frequently over 60 minutes, average 137/86.  Patient left with caregiver to go to doctor at 6 PM.
Felt hot, diaphoretic, lightheaded, pale. BP 99/61 (pulse 68), O2 sat 100%.
In February, Severpain on right ankle to the point of no movement of the foot, though lasted a few seconds; Went to see a Podiatrist, diabetic neuropathy was ruled out: Consulted with my PCP two days ago, 5/31/2022; seeing neurologist was recommended.  During the two clinic visits, the intensity and frequency  of prickly pains became less, but mosquito sting like pain, itchiness and hives occur here and there, all over my body, including feet, legs, chest, face, scalp.  Again, every incident  lasts a few seconds.
Patient received wrong vaccination but did not experience any adverse events. Patient was not treated and outcome was positive.
Some of these effects have gotten worse or developed over time; Swelling of the right arm, right side of neck, right shoulder, right side into breast; Swelling of the right arm, right side of neck, right shoulder, right side into breast; Swelling of the right arm, right side of neck, right shoulder, right side into breast; movement decrease; trouble swallowing; pain; This is a spontaneous report from a contactable other hcp/nurse (patient). A 45-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1285 and expiry date: unknown) intramuscularly, administered in the right arm on 12Jan2021 15:15, as a single dose for COVID-19 immunization. Medical history included Asthma, Hyperinsulinemia, Hypertension, Obesity and Tachycardia. Known allergies: Lortab and penicillin. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), metoprolol (METOPROLOL) and amlodipine (AMLODIPINE). The patient experienced Swelling of the right arm, right side of neck, right shoulder, right side into breast, movement decrease, trouble swallowing at times and pain on 13Jan2021 at 03:00 PM. Some of these effects have gotten worse or developed over time. The patient went to the hospital and got put on a steroid pack (Medrol dose pack) and was told to take Benadryl as well. That was after a week of swelling. However, the patients arm was still swollen and was stiff and hurts to move and lay on. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jan2021, sars-cov-2 test: negative on 21Jan2021, sars-cov-2 test: negative on 26Jan2021, sars-cov-2 test: negative on 28Jan2021, sars-cov-2 test: negative on 02Feb2021. The clinical outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 2:22 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 2:22 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient was given dose from vial that was stored in an ultracold freezer which was colder than they should have been. The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
approx 48 minutes after injection, pt left after a 30 minute observation, went to restroom and had c/o facial swelling, flushing and redness. bp 172/85, hr 83, rr 18, RA sat 100%. epi 0.3mg im given at 1644.
Said vaccine drove her completely crazy; This is a spontaneous report received from a contactable reporter (Consumer) for a sponsored program (159558). The reporter is the patient.  A 82 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Bach/Lot number: unknown), for covid-19 immunization, reaction: "drove her completely crazy". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Said vaccine drove her completely crazy".  Additional information: Patient had both doses of covid vaccine and had reaction both times after vaccine. She said that vaccine drove her completely crazy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.