chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced the same side effects; achiness; flu like; slightly elevated temperature/feels feverish; joint pain; headache; lymph nodes feel sore all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish), ARTHRALGIA (joint pain), HEADACHE (headache) and LYMPH NODE PAIN (lymph nodes feel sore all over). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish), ARTHRALGIA (joint pain), HEADACHE (headache) and LYMPH NODE PAIN (lymph nodes feel sore all over) was resolving.            After taking Excedrin, the patient felt some better.   This case was linked to MOD-2021-364147, MOD-2021-365066 (Patient Link).
15 year old patient received Flublok, no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA314663 (same reporter).  This case involves a 15 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1952, expiry date: 30-Jun-2020) via intramuscular route in the right deltoid, on 07-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age of vaccine administration.  At the time of reporting the patient had no adverse 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 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.
Developed sore arm, redness increased, malaise for 48 hours. Decreased pain, but redness continues; after receiving TDAP & FLUZONE in (L) arm.
Rash on my whole upper torso/ rash from groin to up under her arms and entire upper torso; Sick; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 71-years-old female patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) single dose via an unspecified route of administration on 27Apr2021 for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included Escitalopram (LEXAPRO), captopril, hydrochlorothiazide (Hydrochlorothiazide), Losartan (LOSARTAN), Metoprolol (METOPROLOL) and Vitamins: (Consumer stated, Vitamins and something like that). Historical vaccine included first dose (Lot number: ER8730). The patient reported she had her second COVID shot on Tuesday morning on 27Apr2021 and she had many symptoms and sick and also she had rash from groin to up under her arms and entire upper torso. She did not have any rash on the injection site. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Headache; body aches; fever; chills; sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 17:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. 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 01Apr2021 at 05:00, the patient experienced headache, body aches, fever, chills and sore at injection site. No therapeutic measures were taken as a result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body aches, fever, chills and sore at injection site was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Patient experienced severe soreness to arm with redness/swelling. Unable to sleep b/c of discomfort.
patient developed sore throat, headache, and new loss of taste / smell on 07/14/21.  He tested positive for COVID on 07/18/21.
After second dose I had a bad period with huge bleeding.; Menstruation stopped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 17:00 (Lot number: EW0173) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot unknown: EW0157, Administrator route: Intramuscular, Administration time: 14:30, Vaccine location: Left arm), administration date: 13Apr2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "not recovered", described as "After second dose I had a bad period with huge bleeding."; AMENORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Menstruation stopped". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heavy menstrual bleeding, amenorrhoea.  Additional information: Patient medical history and concomitant medications reported as none. Patient had no known allergies. The patient did not take other vaccine in four weeks and did not administer other medications in two weeks. After second dose she had a bad period with huge bleeding. And then her menstruation stopped. She did not have any problem before and she went on period on time on each month. The patient was not diagnosed with covid-19 prior vaccination. The patient has been tested with covid-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
My side effects after taking the 3rd dose included achiness, chills, and a sore arm. I also contracted Covid-19. My symptoms included a high fever, chills, headache, cough, congestion, and a lack of energy.
pins and needles on the left side of the face; tingling sensation on face; burning sensation on face; A spontaneous report was received from a health care professional (nurse) concerning a 54 years old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, peripheral neuropathy, tingling, burning sensation.  The patient's medical history provided was chronic interstitial cystitis.  Concomitant medication reported was gabapentin.  On 26 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient received the second dose of the Moderna vaccine on 23Jan2021 (Lot number: 032L20A).  On 23/Jan/2021 the patient experienced peripheral neuropathy, tingling, burning sensation.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient lost consciousness about 2 minutes after administration of vaccine. Patient gained consciousness and was alert and feeling better after sitting down for 30 minutes.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2014 (conflicting information: prior to date of vaccination), the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
headache; stiffness in the back of my neck; lower back pain; nausea when I eat; A spontaneous report (United States) was received from a consumer concerning a 57-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, stiffness in the back of my neck(musculoskeletal stiffness), lower back pain(pain), nausea when i eat(nausea).  The patient's medical history was not provided. Concomitant medications reported were estradiol, losartan, mirtazapine, Vitamin C, Calcium, Vitamin D, Multi vitamin, omeprazole, albuterol inhaler(salbutamol) for drug use for unknown indication.  On 12 Feb 2021, approximately 2 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) headache , stiffness in the back of my neck , lower back pain and nausea when eat.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, stiffness in the back of my neck , lower back pain and nausea when i eat was unknown.
A few hours following vaccination, I got a headache followed by total body joint pain. I left work to go home and go to bed. The pain resided the following day but fatigue lasted over a week from the vaccine dose. I started my menstrual cycle the following Saturday evening, 8/28/20201, which is abnormal for me since I always get them in the mornings. The following morning I woke up with severe menstrual cramping to where I could not get out of bed the entire day of 8/29/20201. The bleeding was very heavy which is also abnormal for me, I have had regular cycles since having my child almost 3 years ago, without the use of hormonal birth control. I was dizzy and very drained the whole day with an unusual amount of blood clots in my menstrual blood. I went to the doctor on the following Thursday for a follow up of these symptoms and testing.
Morbilliform rash, 10 X 10 cm on thigh, no induration. No past hx of problems, 4th DTP
On 9/17, client woke up with hot, red swollen arm- from shoulder to wrist. Mom gave motrin and sent child to school. After school on  9/17, symptoms persisting, Mom gave Benadryl and Motrin. Cool compresses were recommended- not sure if this was applied.  On 9/18, arm was still tight and swollen, not as red and didn't hurt as much.  Continued to attend school.  Final call on 9/23- signs and symptoms resolved fully by Saturday, 9/19. Also noted- this client has a similar reaction to a PCV 13, # 3 in series, on 4/25/12, which was administered to right leg.
VOMITING (BLACK IN COLOR); PANIC ATTACK; BODY ACHES; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stroke and concurrent conditions included: seasonal allergies, and panic attacks. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 10:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, ademetionine, fluvoxamine, and loratadine. On 10-SEP-2021, the patient experienced panic attack. On 10-SEP-2021, the patient experienced body aches. On 10-SEP-2021, the patient experienced headache. On 10-SEP-2021, the patient experienced nausea. On 10-SEP-2021, the patient experienced fever. On 11-SEP-2021, the patient experienced vomiting (black in color). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting (black in color), headache, body aches, nausea, and fever, and the outcome of panic attack was not reported. This report was non-serious.
Ribs hurt(not sure if lungs or muscles); Lost my voice; I've had all those" when agent shared common side effects; chills; body aches; Throwing Up; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Ribs hurt), VACCINATION COMPLICATION (I've had all those" when agent shared common side effects), APHONIA (Lost my voice), CHILLS (chills) and PYREXIA (Fever of 102F) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No significant historical event reported.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Fever of 102F). On 29-Mar-2021, the patient experienced VOMITING (Throwing Up). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Ribs hurt), VACCINATION COMPLICATION (I've had all those" when agent shared common side effects), APHONIA (Lost my voice), CHILLS (chills) and MYALGIA (body aches). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Ribs hurt), VACCINATION COMPLICATION (I've had all those" when agent shared common side effects), APHONIA (Lost my voice), CHILLS (chills), MYALGIA (body aches) and VOMITING (Throwing Up) outcome was unknown and PYREXIA (Fever of 102F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received 3rd dose of Moderna injections and the vial was out of use date by one day.
Brachial nerve pain radiating into arms, with weakness, burning and tingling. Symptoms continue and are exacerbated with activity. Seen in ER on 9/11/19. Given Decadron, Toradol and valium; symptoms lessened, i.e. tingling reduced, pain reduced but was not relieved. Valium and Motrin ordered until can be seen by PCP.
She came to my bed side at 2:30AM and told us that she was feeling cold. I took her to the bathroom and told her that I would go downstairs to get her medicine cup. I heard a loud crash upstairs. She had fallen. I handed her the Tylenol and she was so disoriented that she dropped the medicine all over the floor. She said her eyes felt fuzzy and she couldn't hear. She turned completely pale white and her pupils were very dilated. She was ice cold. I called 911. My husband tried to keep her talking and she said her vision was very fuzzy. She completely fainted and was shaking for about 10 minutes. The ambulance took her to the ER (UTMC Hammock) and did an IV. They took lots of blood for blood work. The doctor ran an EKG. When the doctor had her stand up, she started getting fuzzy eyes and dizziness. Then she vomited. They gave her some Zofran. The EKG came back normal. All of her blood work came back normal. They let her have the whole bag of IV fluids. We got home around 7AM. She's up to date on all her vaccinations and never had a reaction before. Today is her first day feeling back to normal. She did have chills, a headache, a slight fever, and her arm pit was sore. She had a follow up appointment yesterday at 11AM. When we saw her doctor yesterday, there were 3 viles of blood that came back kind of iffy. She is going to check to see if those are normal and let us know.
During the observation period, client started to complain of "feeling goofy," blurry vision after 24 minutes of receiving the 1st dose of the Moderna vaccine at 2:48pm.  Client stated she was very anxious regarding vaccine and missed her meds.  At 3:22pm, juice, water, meds (Xanax 1mg, lisinopril 5mg, eye med po) was given with improvement.  She denied shortness of breath, oral/airway symptoms, rash, pruritic, faintness, weakness or nausea.
1/2 of face began swelling. The same side as the vaccination was given. Noticeable amount in cheek and eyelid. Minute swelling in lips and nose.
No additional AE; Received transfer from specialist. HCP reported expired PNEUMOVAX 23 was administered to a patient on 11/07/2023. The product has been stored appropriately and has not had any TEs. The operator of the device was a healthcare professional. HCP request; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age an gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)) injection, administered for prophylaxis (lot #W007035, expiration date: 20-OCT-2023) (strength, dose description, and route of administration were not provided) (Expired product administered). No additional adverse events were reported.
Vasovagal Syncope on the 11th, severe hives to follow and fever resulting in emergency treatment via steroids, anti-inflammatories, and allergy medication.