chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stiff fingers on both of her hands; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff fingers on both of her hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULOSKELETAL STIFFNESS (stiff fingers on both of her hands). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff fingers on both of her hands) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received updated event onset date.
This child had 5.5 x 4.5 cm warmth, red, and tender area of right deltoid; cellulitis. Treated with Cephalexin for 10 days.
3 hours and 45 min after getting the injection, I had a series of symptoms:  -Feeling as if head in a vise, crushing pain on all sides. -Blood pressure started rapidly rising to the highest blood pressure I have ever felt.  This felt much worse than 250 blood pressure which I have had before.    Blood pressure went from normal to 250+ in less than 10 minutes. -Shock symptoms started and I became freezing cold and felt like I would pass out.   -I got into bed under many blankets, and I took Benadryl and my blood pressure medicine 3 hours early.  I was ready to call an ambulance since I felt I would pass out.  The cold sensation lasted all night; each time I got out of bed I started shaking cold. -This morning the symptoms are mainly elevated blood pressure by about 50 points.  No one has been able to advise me if I should take the second shot, and that is really bad.
Pt had swelling at injection site that was very painful, and lasted for about 5 days post vaccination. No treatment was given. Pt has recovered fully.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (occurred 2 years ago on Thanksgiving 2019). Concomitant products included SIMVASTATIN for Cholesterol blood excessive, IBANDRONATE SODIUM (IBANDRONATE) for Disorder bone (NOS), CENTRUM FOR WOMEN for Nutritional supplementation, LEVOTHYROXINE for Thyroid therapy, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 02-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-345046 (Patient Link).
A tingling in the face; This is a spontaneous report from a non-contactable consumer (patient). An elderly (65+ years) non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 12Feb2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient received any other vaccine within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for covid-19 post vaccination. On 12Feb2021, the patient experienced a tingling in the face (similar to a dental novocaine injection) that started 2 hours after dosing and has now subsided. No treatment was received for the event. Outcome of event was recovered on Feb2021.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient reported chronic dry cough and shortness of breath approximately 1.5 days after vaccine administration that persisted up to two months before resolving completely
Information has been received from a physician concerning a 22 year old female patient with asthma and anxiety and no drug reactions or allergies who on an unspecified date in the past was vaccinated with a dose of MMR II (Lot# unknown) and a dose of VARIVAX (Lot# unknown). Concomitant therapy included LEXAPRO, ATIVAN and albuterol. The physician reported that when recently tested, the patient did not have a positive titer for measles or varicella. On an unspecified date, she was administered a dose of MMR II (Lot# unknown) and a dose of VARIVAX (Lot# unknown) and then 4 weeks later a booster of MMR II (Lot# unknown) and then 2 weeks later a booster of VARIVAX (Lot# unknown). As it standed now the patient had low rubeola, low rubella and negative varicella titer. The patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow-up information was received from the physician who reported that there was not adverse event. No further information is available.
3-27-07: Parent called dr's office to report patient had the following symptoms for 2 days: "wakign with really, bad headache", "numbness and tingling down one arm, then the other arm, intermittently", "neck hurts, constantly tired, sometimes dizzy", soreness at injection site
About a week after getting the flu shot, I ended up getting AIDP (Acute Inflammatory Demyelinating Polyneuropathy)-AKA GBS.
Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Additional Details: within 2 minutes of vaccine and sitting in our observation area, pt felt very ill. she was radiating heat and felt very hot. she was pale and knelt over like she was about to faint. her bp was slightly low at 87/26 but her temperature was normal around 97. she said she felt very nauseous and her hands, arms, feet and legs were very numb. we called the ambulance and emt helped to assess her and she seemed fine. did not go to hospital.  called to check on patient a couple hours later and she is ok
This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in a male patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine. Additional details were reported as follows: The reporter stated that her next door neighbor's nephew received an flu vaccine (unknown brand) several years ago. No further details were reported. This was the 3rd case out of the three cases reported by the same reporter.
pt recv vax MAY98 & devel an inj site rxn (edema, hard raised 2.5inch area, itching);
It was reported that a female patient received a Rabies Imovax IM vaccination. Reportedly 24-36 hours post vaccination the patient developed a burning sensation in all mucous membranes of her body, ringing in her ears with hearing deficit, increased urinary output, mood swings and memory impairment, fever. Patient also developed numbness and tingling of her extremities resulting in muscle spasms and low back pain, nausea, diarrhea, chest pain and palpitations. Patient stated "most these resolved in 3 days". No indication of physician evaluation.
Son stated he got dizzy, closed his eyes and fainted, 911 was called and EMT arrived, son woke approximately 45 seconds later, lips and face were flushed, EMT checked vitals (blood pressure, oxygen saturation, glucose, and heart rate) all vitals were normal, refused Emergency transport to local ED.
Patient started feeling very dizzy and nauseous and warm upon receipt of the vaccine. He denied any shortness of breath or swelling. There was no rash or redness present. After 30 minutes and a glass of water he felt fine.
uncontrollable and untreatable (imodium AD did not help) diarrhea started day after vaccination on 10/28/21 and started to dissipate on 11/07/21
Patient not properly screened for eligibility to receive 2nd dose - received vaccine 2 days too early.
pain in the administration site; tired; feeling dehydrated; had a low degree fever; nostrils were stuffed or clogged; pain in the arm; went to sleep 3 hours earlier than usually did, waking up five hour later; feeling like that was about to had flu; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients (Herself and Her friend).This is the Friend report. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date at single dose for covid-19 immunization. It was the second dose. The patient's medical history and concomitant medications were not reported. The Consumer reported that the same symptoms were experienced by a friend of her after the administration of the second dose of the Pfizer's COVID-19 vaccine. The same symptoms included felt only pain in the administration site, at night felt really tired, went to sleep 3 hours earlier than usually did, waking up five hour later with pain in the arm and feeling dehydrated, also feeling like that was about to had flu, had a lowdegree fever, and nostrils were stuffed or clogged. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518390 Same Reporter and Drug and event, different Patient.
Swelling, and discomfort at site. Few days later, started itching in neck area on same side of vax. Traveled down to the shoulder area. Applied lotion to help with the itching etc. Took a few days to subside. Could feel the bumpy rash area on neck. Then daughter started having same symptoms.
Moderna COVID-19 Vaccine EUA Around the injection site I started to itch and I noticed a couple of knots. Soon after I had swollen, red, rash on my arm. This was on Day 8.  I took Benadryl twice on Day 9 and by evening only a bit of redness was left. Day 10 was back to normal.
severe anaphylaxis; Initial information received on 09-Feb-2021 regarding an unsolicited valid serious case received from a physician.  This case involves female patient who experienced anaphylaxis (anaphylactic reaction), while she received vaccine RABIES VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect RABIES VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  The patient developed a serious severe anaphylaxis (anaphylactic reaction) (unknown latency) following the administration of RABIES VACCINE. This event was assessed as medically significant.  The reaction happened in the mid-90's (patient believes it may have been 1996 but is unsure the exact year), and now presented to see if we could determine the component of the vaccine that may have caused the reaction. Patient had contacted multiple people at the university and involved with Rabies Vaccination program, and they are unsure which rabies vaccine would have been given. Patient feels, it was likely Imovax, but this is not certain. If she able to determine which vaccine the patient received, only can test the relevant components. This is particularly relevant for her now as she is interested in COVID vaccination, and want to confirm that the rabies vaccine she received in the past did not contain polyethylene glycol (PEG)/polysorbates [what are thought to be the allergenic components in the messenger ribonucleic acid (mRNA) COVID vaccines]. None of the current Rabies vaccines contains these ingredients to my knowledge, but she want to confirm with the manufacturer that prior formulations did not include them either.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for anaphylactic reaction.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a female patient presented with anaphylactic reaction after vaccination with RABIES VACCINE (unknown manufacturer). The time to onset is unknown. Medical history, concomitant medication, lab data ruling out alternative etiologies would be needed for complete assessment. Based upon the reported information role of an vaccine cannot be assessed.
BRAIN FOG; WANT TO SLEEP DUE TO RESTLESSNESS; FEVERISH LIKE FLUSHED/HOT FLASH; TIREDNESS; LITTLE NAUSEATED AS LIKE A FLU BUG; HEADACHE; RESTLESS; LEFT ARM THROBBING/ACHY; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 165 pounds, and height was 62 inches. The patient's past medical history included cough, fever, and penicillin allergy, and concurrent conditions included low thyroid, alcoholic, non smoker, and seasonal allergy. The patient had no drug abuse or illicit drug usage at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included thyroid for low thyroid. On FEB-2020, Laboratory data included: Body temperature (NR: not provided) 103 temperature.  On 21-JUL-2021, the subject experienced restless. On 21-JUL-2021, the subject experienced left arm throbbing/achy. On 21-JUL-2021, the subject experienced did not sleep well. On 21-JUL-2021, the subject experienced headache. On 22-JUL-2021, the subject experienced brain fog. On 22-JUL-2021, the subject experienced want to sleep due to restlessness. On 22-JUL-2021, the subject experienced feverish like flushed/hot flash. On 22-JUL-2021, the subject experienced tiredness. On 22-JUL-2021, the subject experienced little nauseated as like a flu bug. Laboratory data included: Body temperature (NR: not provided) 101.5 or 101.9 degrees Fahrenheit, 99 F, 99.8 F. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish like flushed/hot flash on 22-JUL-2021, was recovering from restless, headache, tiredness, brain fog, and little nauseated as like a flu bug, had not recovered from left arm throbbing/achy, and want to sleep due to restlessness, and the outcome of did not sleep well was not reported. This report was non-serious.
no adverse event; M-M-R II that underwent temperature excursion was administered; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 06-AUG-2021, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live albumin status rHA (recombinant Human albumin) (M-M-R II) lot# T007235, expiraction date 27-FEB-2022, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion/time frame was of 47 Fahrenheit degrees (°F) (53°F) for 5 hours 0 minutes 0 seconds on 09-AUG-2021. However, a previous temperature excursion above 47°F (48°F) was reported in different dates: on 03-AUG-2021 for 11 hours 0 minutes and 0 seconds was reported, on 05-AUG-2021 for 8 hours 0 minutes and 0 seconds, on 06-AUG-2021 for 8 hours 30 minutes and 0 seconds and on 07-AUG-2021 for 29 hours 0 minutes and 0 seconds. A digital data logger was involved. No adverse effects were reported.
Moderna COVID?19 Vaccine EUA - Metalic taste - Lump in her throat- felt like swelling - Nausea and then vomiting - Shaking and started to become unresponsive.
Severe and sudden vertigo, nausea, and dissyness. Rotating between hot flashes and chills, unable to keep food/water down.
Mom called the clinic stating that he is being taken to ED w/ difficulty breathing.  No cough.  No rash.  No fever.  No other sx.
Guillain-Barre Syndrome. Symptoms began 9/20/18. Patient seen in office 9/21/18 and hospitalized at Hospital. He had ataxic gait, weakness of extremities, and areflexia. He was treated with IVIG. He developed swallowing difficulty and G-tube placed. Transferred to another hospital 9/30/18 and undergoing plasmaphoresis.
administered an expired ACTHIB to a patient with no reported adverse event; Initial information received  on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 year old female patient who experienced administered an expired acthib to a patient with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Dec-2022, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE for Powder and solvent for solution for injection (frequency: 1 day) (lot: UJ600AA, expiry date: 30-Nov-2022, strength: unknown) via intramuscular route in the left thigh for immunization.  On 28-DEC-2022 (latency: 1 day) the patient developed a non-serious administered an expired acthib to a patient with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  No lab test available. Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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.
Pt reports 41/2cm times 33/4cm of erythema, induration and heat to left deltoid muscle on 2/22/01, mild pain, redness. Treatment  - local heat, massage, Benadryl, Ibuprofen.
After receiving 2 month vaccines (patient was 60 days old) mother an aunt returned to the house.  A few hours later they were giving him a bath and he turned red "from head to toe" and stopped breathing and moving x about 30 seconds.  No physical stimulation or rescue breathing given.  They called his name and he started to respond.  Had a separate episode with similar symptoms and time course.  One dose of Acetaminophen 2.5 ml (80mg) had been given prior.  Family called virtual care and were told to observe. Did well overnight with no further episodes and drinking well.  Never had fever or abnormal movements.
Pt received full dose Moderna for booster after completing Janssen primary series 3/19/21.  No reaction noted during observation.
pt recv vax 2-3 days post & exp abd cramping & gen gastrointestinal upset;ER or MD visit was required;
pt recv vax 13JUN96 & devel gen urticaria 6hr later, ince to 15JUN;gone by 18JUN assoc w/low grade fever (100);
Patient had what we believe to be allergic reaction - pain, very red swollen at injection site.
Pt was accidentally vaccinated and did not meet the minimum age requirement of 16 years old for Pfizer vaccine. No other adverse events other than that.
more than usual bowel movements and body tingling all over at random.  Body tingling would occur more during strenuous movements and would occur with presyncope sensations without having a syncope episode
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given by the reporter. No treatment information were provided by the reporter.
Case number PHEH2013US023738 is an initial spontaneous report received from a consumer on 11 Nov 2013. This report refers to a 54-year-old female patient. Her medical history included latex allergy. Her concomitant medications were not reported. She had well tolerated the vaccines which she administered in the past. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in her left arm from a MDV on 09 Nov 2013 at 6:30 pm. She experienced localized redness (one inch in diameter) and swelling at the injection site at an unknown date, after vaccination. She had completely recovered from the events after two days. The seriousness and causality of the events were not assessed. Significant follow up received from the consumer on 17 Dec 2013: Vaccination date and time, vaccination site and event duration were updated.
Generalized malaise,  neck pain, shortness of breath (mild), lymph nodes swollen in neck, non productive cough, no fever or chills.
Rash and itching for 2 days. Rx BENADRYL and antibiotic.
Pfizer 1st dose: 3/11/2021(Lot #EN6208).  Pfizer 2nd dose: 4/23/2021 (Lot # EW0171).  Patient reported having syncopal episode after the first dose and second dose of COVID vaccine.  Patient presented to ED on 4/24/21 and complained about prolonged syncopal episode.  Per report, patient developed syncope within hours after receiving 2nd dose.  EKG showed no evidence of arrhythmia.  ECHO showed an EF of 60-65 %, small LV, chamber that was hyper dynamic and proximal septal thinning and akinesis.
hard nodule (dime size) to right deltoid w/ purplish bruise. Evaluated by EMS-Cleared
1330: Rec'd first Covid vaccine 1342: Pt c/o itchy, red chest, rash on back; Benadryl 25 mg IM rt deltoid given 1351: BP 121/82  HR 72 SpO2 100% 1357: Benadryl 25 mg IM rt deltoid repeated 1418: Pt left facilty in her own car, self-driven
Adverse Event: patient fainted after receiving third vaccination. She received adacel and fluzone quad in left arm and then pfizer bivalent in right arm.  Treatment: Caught patient when she was falling out of chair and gently laid her on the floor. She came back to consciousness within about 5-10 seconds. We provided her with water and orange juice and also gave her an ice pack. We had her remain at the pharmacy until she was feeling better.  Outcome: patient recovered and said she was feeling ok within about 15 minutes.
mom reports fever of 104 ax during noc of 3NOV93 p/vax MD notified; ran fever 3 noc in a row then fine red rash on abdo & back; MD notified by mom;