chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She's having she doesn't know if it is cold or allergies; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (She's having she doesn't know if it is cold or allergies) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (She's having she doesn't know if it is cold or allergies). At the time of the report, HYPERSENSITIVITY (She's having she doesn't know if it is cold or allergies) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient does not know if it was cold or allergies, she was due for her second dose tomorrow(at a time of report), both work at school in the medical field.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter details and suspect drug dosage details for second dose were updated.
Arm only hurt a little; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm only hurt a little) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm only hurt a little). At the time of the report, PAIN IN EXTREMITY (Arm only hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported   This case was linked to MOD-2021-141281.
Fever 103.8 24 hours after immunization persisting 24 hours. Pt very fussy, tired, acts like in pain.
Chills and fever first night, red and blotchy day 2. Day 3 injection site red and warm. Day 5 area clear no redness at site.
3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.; 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: reported a positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After a family gathering at them renaissance festival, 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test. The two family members over the age of 50 have been prescribed Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201333384 same product and event, different patient;US-PFIZER INC-PV202200112164 same product and event, different patient;
Hospitalized for cough, dyspnea and diarrhea currently on treatment for multiple myeloma.
Body ache; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    Previously administered products included for Drug use for unknown indication: Iron and Erythromycin. Past adverse reactions to the above products included Drug hypersensitivity with Erythromycin and Iron. Concurrent medical conditions included Psoriatic arthritis.   On 28-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for Injection, Single Dose Pen. On 28-Sep-2022, the patient experienced MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (fatigue). On 29-Sep-2022, MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (fatigue) had resolved.            No concomitant medication information was provided.  The reporter's causality for body aches, chills and fatigue with Adalimumab Solution for Injection, single dose pen was not provided.  Agency's opinion was that the causality for the event(s) of body aches, chills and fatigue with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.  Agency's opinion was that the causality for the event(s) of body aches, chills and fatigue with Adalimumab Solution for Injection was Not Provided.  number was reported as 4782590.  It was unknown if patient was enrolled in COVID-19 vaccine trial or not.  No treatment information was provided.
From initial information received on 06Aug04 from a health care professional regarding an adverse event occurring, it was reported that a six month old female pt received her third dose of Acthib, lot number UE203AA, administered in the right thigh; a third dose of Daptacel lot number C1697AA administered in the left thigh and a dose of Prevnar, lot A57559D, administered in the left thigh on 05Aug04. The routes of vaccination were not reported. That same day, the pt developed local redness measuring the size of a dime on her right thigh with heat at the site. The site was also described as warm to the touch. Tylenol and warm compresses were recommended. The pt's recovery status was reported as unk. From  additional information received on 10Sep04 from the initial reporter, additional pt, responsible physician, vaccine and adverse event information was provided. The adverse event onset date was corrected to 06Aug04 (previously reported as 05Aug04). None of the other information provided changes any of the previously reported medical information. From additional information received on 15Nov04 from the initial reporter, it was reported that the pt recovered from these events. No further information is anticipated. This case is considered closed.
Patient presented with redness, warmth, itching and pain to L deltoid a couple hrs after PPSV 23 on 11/1/19. Redness increased in size over weekend. She treated with ASA, naproxen and ice which did not relieve pain. Triaged situation 11/4/19, appt 11/5/19, patient states seems to be getting better this morning. Provider assessed reaction and felt this was an  allergic response to immunization. Will monitor and f/u in two days for re-evaluation. No medications prescribed.
After vaccine administration, the patient lost consciousness/fainted for about 10 seconds. Pharmacy staff elevated patient's legs and applied cold compress to patient's neck and face and he regained consciousness. He was in a chair with armrests and didn't fall from chair or injure himself. Pharmacy team provided water and monitored patient  for a further 15 minutes and allowed him to go home with caregiver at that time.
BRUISING/BLOOD SPOTS ON SKIN AND HAD BUMPS ON IT; CHILLS; BAD HEADACHE; REAL TIRED/FATIGUE; BURNING SENSATION AT INJECTION SITE; BODY ACHES; ARM BURNED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: antibiotic allergy, no alcohol use, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-DEC-2021, the patient experienced body aches, arm burned, and burning sensation at injection site. On 11-DEC-2021, the patient experienced chills, bad headache, and real tired/fatigue. On 18-DEC-2021, the patient experienced bruising/blood spots on skin and had bumps on it. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, burning sensation at injection site, bad headache, and real tired/fatigue on 12-DEC-2021, and arm burned, and had not recovered from bruising/blood spots on skin and had bumps on it. This report was non-serious.
Swelling in left leg. Ankle is still swollen now, but leg has gone down.
C/O pain at sight, followed by 2 days of achiness and chills, developed axillary lymphandeopathy on the third day
swelling in the lower part of the arm pits/this side effect of swollen lymph nodes; side effect of swollen lymph nodes/when it gets hot and swollen it really hurts; sometimes it was swollen and hard/it gets hard so fast; it gets hot /the warmth under her arm continues; Fever; Headaches; Chills; can barely move her arm; swelling underarms are painful; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some considerable swelling in the lower part of the armpits. She had fever, chills, and headaches that had already gone away. The swelling underarms were painful about the size around a baseball, sometimes it was swollen and hard. Pain was always there. The patient asked what recommendations could be made about this side effect of swollen lymph nodes. When it got hot and swollen it really hurt so she might not be able to work tomorrow. The patient was treated with paracetamol (TYLENOL) on Saturday (24Apr2021) around 14:30 because she had a fever and it helped a little. It got swollen so fast and it got so hard and hot that she could barely move her arm and it happened all of a sudden. She also took paracetamol on Sunday (25Apr2021) when the pain was intense and constant. The warmth under her arm continued and the pain was always there and it was intense. The outcomes of hot and pain were not recovered. The outcomes of fever, chills, and headaches were recovered. The outcomes of swollen lymph nodes, hard, and could barely move her arm were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Medium, Additional Details: Pt received 2nd dose Covid19(pfizer-biontech) on 9/25/2021 at 10:30AM. Pt was with mom, appeared nervous. Pharmacy Intern sat with pt for several minutes prior to vaccine administration. Vaccine given and pt felt lightheaded, had full conversation with intern. After 3-4 minutes, pt appeared to have a seizure, body tensed up, possibly loss of consciousness for about 1 min. Pt recovered, was fully alert for remainder of time at pharmacy.
Dx - shingles - painful (R) leg (R) hip. Not bearing wt. x2d then zoster like rash noted only on (R) leg.
Grew very pale after injection on 2/15/2008. 4/14/2008 grew very pale again without seizure. ? related to pertussis.
7 days after vaccination developed a large round circle in area underneath injections site in left arm.   It was very itchy and at first i thought it was a bug bite.    The circle was approximately 3x3 inches and was red, itchy and painful.   The next day it was still present so I called for medical advice and spoke to a nurse on 4/3.   She advised me it was a reaction to the Moderna vaccine I had received a week ago called "covid arm" or a delayed cutaneous hypersensitivity.  She advised me to use hydrocortisone cream and benadryl for the itching and tylenol for pain.  I did that and it improved.  The rash disappeared completely 6 days later, improving everyday.  She told me to let the person giving me my second vaccine know that this had occurred, and to receive the 2nd injection in my other arm.
fever 101;h/a, muscle aches, vertigo, rash on forehead 4 days no tx;
3/13/2023 I had flu like symptoms. I had congestion, a bit of a cough and was achy. I went to bed and stayed there for two days. On 3/14/23 I took an at home COVID test which was positive. I had a telehealth with my PA and was prescribed PAXLOVID. I started taking the PAXLOVID on 3/14/23. I was feeling much better the next day. I had a funny metallic taste in my mouth and did not have much of an appetite. I was very thirsty. My symptoms got much better, a dramatic improvement. I was up and around on the third day. I have recovered. I have not retested.
On 12/25/2022 I had flu-like symptoms, postnasal drip, cough, fatigue. I slept most of the day. I tested positive on 12/26/2022 and contacted my provider via telehealth and she prescribed PAXLOVID. I finished the 5-day course of medication for treatment. Also my wife and son contacted COVID-19 48 hours after my positive test. My wife and son are both negative as of now. I am still testing positive for COVID-19. I also still have a postnasal drip and sneezing.
Diarrhea everyday since vaccinated in Feb,  but slowed down to just a little prior to 2nd dose. He didn't report the diarrhea to CDC or to family MD
HAND AND FOUR FINGERS NUMB; This spontaneous report received from a patient concerned a 51 year old male. 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 and expiry: 07-AUG-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced hand and four fingers numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hand and four fingers numb was not reported. This report was non-serious.
Fever, chills, body aches, headache, muscle soreness at injection site, approximately 6 hours after vaccine was administered. Lasted about 15 hours.
p/ pt recv vax approx 2mo later pt devel erythema, itching & herpes zoster, 1st devel approx 14 lesions. treated w/acyclovir
fatigue; injection site pain/ Soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and INJECTION SITE PAIN (injection site pain/ Soreness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and INJECTION SITE PAIN (injection site pain/ Soreness). At the time of the report, FATIGUE (fatigue) and INJECTION SITE PAIN (injection site pain/ Soreness) outcome was unknown. Not Provided          No concomitant medication reported  No treatment information was provided  Action taken with mRNA-1273 in response to the event was not applicable.
Rash, nausea, throat feels like swelling up. Benadryl given and sent to ER.
Swelling in heart.  Went to my care provider on Tuesday had an ekg that wasn't good they took blood work that showed lots of swelling in my heart.  My heart rate was going very high then low and I had chest pain.  Went to ER on Friday and they redid tests and showed that it was heading back to normal. Still have slight chest pain a week later.  Also had fever on Friday.
On or about October 10, 2022, I started having tingling down both arms, tingling in my left cheek and a burning sensation in my back.  I also felt lightheaded and off balance.  I started taking ibuprofen for the inflammation and it helped a little bit.  I saw the doctor on October 14th and they recommended physical therapy for my back pain.  I was also referred to a pain management doctor.  I have seen him on October 20th and 26th and they will do an epidural soon.  As of today, my symptoms are still the same by my back pain is now lower towards my tail bone.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 24-JUL-2017 the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included dexamethasone sodium phosphate (DECADRON). On 28-JUL-2017, 5 days after onset of therapy the patient experienced contraindicated product administered. On an unknown date the patient experienced no adverse event. The outcome of contraindicated product administered and no adverse event is unknown. The reporter considered contraindicated product administered to be not related to M-M-R II and dexamethasone sodium phosphate (DECADRON). The reporter considered no adverse event to be not related to dexamethasone sodium phosphate (DECADRON) and M-M-R II.
area 4"x5" red, swollen, hot, no pain noted 31OCT96;1030PM ice packs applied & tavist taken;no apparent chang 31OCT96 PM p/speaking w/MD;remains same today;will have MD check on 5NOV unless worsens or becomes painful;
felt tired after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired after the second vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced FATIGUE (felt tired after the second vaccine). At the time of the report, FATIGUE (felt tired after the second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-323752.
No adverse effect reported; patient may have only received a partial dose of M-M-R II; some of the vaccine went on the patient's skin; patient was "moving a lot" during administration of a dose of M-M-R II which made administration difficult. As a result, patient may have only received a partial dose of M-M-R II; This spontaneous report was received from a nurse and refers to a 15-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-MAR-2019, the patient was moving a lot (which was clarified as a normal movement for a 15-month-old child who did not want an injection) during administration of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot # R002049, expiration date 22-JAN-2020 (exact dose and site of administration were not reported) for prophylaxis. As a result, the patient may have only received a partial dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), as some of the vaccine went on the patient's skin.  No adverse effects were reported.
I started the heaviest and most painful menstrual cycle I?ve ever had. Heavy bleeding for five days and no sign of stopping. Cramping so badly that I was shaking with pain at one point
Patient was mistakenly given an expired dose of vaccine (expired 12/2020, administered 1/2021). No known adverse events at this time.
Case number PHEH2012US004482 is a combined initial and follow-up spontaneous report received from a nurse on 14 Feb 2012 and 16 Feb 2012: This report refers to a patient of unknown age group and gender. This patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: M10129) intramuscularly on an unknown date. No adverse event was reported following this administration error.
Severe rash on both arms, chest, both thighs one week after the 2nd COVID vaccination. Strong constipation. Significant worsening of migraine with new symptoms in the following weeks and months, including dizziness, brain fog, trouble concentrating, headaches, and visual migraines. Significant worsening of tinnitus. Eventually I was put on two new migraine medication (Emgality and Ubrelvy) to keep the symptoms under control, but I am still struggling frequently with migraine symptoms and tinnitus.
p/vax areas noted over entire body, including trunk, extremities, face;areas vary in size from 1cm to large blotches, some raised & red, some brown & not raised;red raised areas over entire body;probably DTAP rxn;
Initially (approximately 12 hours) after injection had a low grade fever and general aches. That got better in less than a day. Then three days later fever started back up (100.5) and the general sore throat I?d had for two weeks prior to the shot became intense. Cough. Headache. Left eyelid  swelling started 6 days after injection. Diarrhea since the day after injection- ongoing.
Patient reported on 9/21/15 4:00 pm that she was shaky and did not feel well. She called a neighbor and she was taken to the hospital. She also reported having an injection in her eye at the doctor's office in her 9/21 report (informed post vaccination).
Loss of hearing (low muffled sound) initially in the right ear but now (as of 22:26)  in both ears, along with a slightly stiff neck on the upper right side.  No ringing sound with the loss of hearing.  First initial sign was around 17:40 and continues.
Itchy patches of rash on forearms, chest, legs, and abdomen.  Rash resolving on 6/5/21
Erythema and swelling in right arm from injection site to elbow. Child complained of headache.