chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna arm; Redness goes down all the way around to elbow; hard; itching; red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION COMPLICATION (Moderna arm), ERYTHEMA (Redness goes down all the way around to elbow), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Pt was given DTaP, IPV, HBV, HAV and MMRV, Father denied reason re: not to give vaccine. After MMRV administered within 5 minutes a 10 mm raised area developed 2" above mentioned site. Ice applied-Client observed for approx. 30 min. No further swelling, no shortness of breath. ER plan reviewed.
"Increased skeletal pain, Shinbone, back, muscle tightening swelling in back, sharp pains throughout knees and shinbones.      These are ongoing medical issues but over the pat week they increased to the point where I stayed in bed with warm compresses and analgesic topic creams  from Christmas through Monday the 28th. Currently working and taking 3 advils every six hours to deal with back pain."
Information has been received from a physician concerning an 8 year old female who on 09-JUL-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#657943/0726U). There was no concomitant medication. Subsequently, the patient developed swelling of the right arm. The patient had two separate office visits and the swelling was diagnosed as cellulitis. There were no ER visits. The patient was treated with an unspecified antibiotic. The patient recovered. No other information was provided. Additional information has been requested.
Patient reported she woke up the day after the flu shot with swollen face and tongue and tearing from the left eye. She didn't looked for medical attention. She waited and called us on 10/20/17. She said is better but not completely gone.
At about 11:00 am  which was about 22 hours after receiving 2nd dose of Moderna patient exhibited difficulty breathing and soon breathing became more difficult to point where her shoulders were lifting to breathe. At 6:45 pm she passed away.
Arthralgia, HYPERtension,  Chills & fatigue Narrative:
patient on day 3 experience swelling, redness in her left arm at the injection site. very itchy and felt like a knot in her arm. it got slightly better on day 5 but on day 8, swelling came back and it was extremely itchy.
LEG CRAMPS IN BOTH LEGS WHEN SITTING/LAYING IN BED; CHILLS; FEVER; SKIN LESION POPPED UP ON ANKLE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's disease, and other pre-existing medical conditions included: Patient has a skin condition called something like annular granular .Patient was unsure of the name. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the patient experienced skin lesion popped up on ankle. On an unspecified date, the patient experienced leg cramps in both legs when sitting/laying in bed, chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99-101 degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps in both legs when sitting/laying in bed, chills, and fever, and was recovering from skin lesion popped up on ankle. This report was non-serious.
Patient was given flu shot and ppd skin test on 12/17/19 for her CNA program. Patient came in 12/19/19 to have her ppd skin test read and c/o of injection site of the flu was hurting. This writer looked at the injection site and noted it to be red, swollen, raised and hard. This writer then put pt. on the schedule to be further examined by provider.
Chills and low energy at 1am. Even with electric blanket set to high, it was difficult to not feel chills and fall asleep. Woke up run down and with a headache.
2cm tender lymph node,  axillary, on the same side where she got the vaccine
Rash on the 16th.  Worsened on the 18th. Fever spiked the 18th.  Fever worsened, rash worsened on the 19th.  Rash got better, but still present on the 21st, fever still present.
Patient complained of pressure behind left eye, small headache. Rates pain 3/10  on 0-10 pain scale.  Gradual onset. Patient reports she is not in much discomfort. Intends to continue with her errands after she is released.  Monitored, discussed seeking additional medical assistance if headache did not subside or got worse. Patient expressed understanding.  Released from post-vaccination area at 12:45pm
I experienced a continuous chronic sinus infection, I have to flush my sinuses everyday and take a nasal spray. I can't seem to get rid of this sinus infection, I've been experiencing this since vaccination.
Pt had 1st seizure, 2 days, post vax, at 13:00; 2nd seizure was at 19:00 on the same day and a 3rd seizure at 11:00 on 7/1/01. Pt had continued vomiting and diarrhea from early morning (before vaccination) up to 1 week after. Pt is now required to take Tegretol "anti-epileptic" drug for 1 year. Pt seems to have returned to a healthy state. As he is only 18 months, who knows if and when any other symptoms/seizures will occur again.  Nurse follow up on 07/27/04 states: "gastroenteritis."
lip is swelling; big sore on the top of her lip; oral herpes / cold sores; tongue swelling; shortness of breath; difficulty swallowing; sores/herpes zoster on her lips; sore where the shot was administered; This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included denosumab (Prolia Injection) for an unknown indication.   Concurrent medical conditions included the patient stated she has bad allergies. Illness at time of vaccination included the patient had a prolia injection several months ago..   On 9th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Prolia Injection at an unknown dose and frequency. In September 2020, less than a week after receiving Shingrix, the patient experienced lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain. The action taken with Prolia Injection was unknown. On an unknown date, the outcome of the lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain were unknown.   It was unknown if the reporter considered the lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the first dose of Shingrix last Wednesday. She took some Benadryl before getting the shot. She now stated her lip is swelling and she had a big sore on the top of her lip. The patient had never had oral herpes before and was wondering whether it could be because of the shot.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 07-DEC-2015 at time- 21:31, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 1.7 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
For approximately 24 hours I had a severe head ache and very tired.  Left arm was very sore for several days.
Adult dose given to 12MO patient; Adult dose given to 12MO patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received HAV (Havrix adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 03-APR-2023, the patient received Havrix adult. On 03-APR-2023, an unknown time after receiving Havrix adult, the patient experienced inappropriate age at vaccine administration (Verbatim: Adult dose given to 12MO patient) and overdose (Verbatim: Adult dose given to 12MO patient). The outcome of the inappropriate age at vaccine administration and overdose were unknown.   Additional Information: GSK receipt date: 04-APR-2023 The reporter asked for safety information regarding such situation.  The reporter consented to follow up. The patient administered the Havrix adult vaccine to infant which led to inappropriate age at vaccine administration and overdose.
Administered with the vaccine which has been stored in the refrigerator for more than 30 days; Administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.   This case was linked to MOD-2021-265450 (Patient Link).
J96.00 ACUTE RESPIRATORY FAILURE 12/30/2021 COVID-19 DISEASE
Severe arm pain; Fatigue similar to when he had COVID; Arm started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started to hurt), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue similar to when he had COVID) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue similar to when he had COVID). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm started to hurt), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue similar to when he had COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
No adverse events from the above vaccination, other than a sore arm that last approximately 24 hours.  However the reason for this report is, this individual who is 17 yo was given a Moderna Covid vaccination which has an Emergency Use Authorization for those 18 years old and older.
VACCINE MISADMINISTRATION - CLIENT SHOULD NOT HAVE RECEIVED NASAL DUE TO AGE
p/vax pt devel large egg size lump @ inj site;warm & tender;had subsided by the time wife notified the clinic;
peticial outbreak on lower extremities; had eczematous rash on upper chest when given vax; recent course of ATB for URI; poss assoc of URI & Henock-Scholein purpura;
1. Emesis 5 days consecutively right after injection and then 3 days consecutively multiple times with additional sharp abdominal pain: No treatment for emesis, but took Hyoscyamine for abdominal/intestinal pain 2. Nausea everyday: Prescribed Ondansetron 3a. Bruising and unknown, painful lumps in legs causing painful/limited mobility; suspected blood clotting: Sent to have bloodwork done on 5/14/2021, for: Testosterone/Free/Bioavailable and Total MS, CBC (including DIFF/PLT), Comprehensive Metabolic Panel, Prothrombin W/Inr + Partial Thromboplastin Times, SED Rate by Modified Westergren, D-Dimer Quantitative, Estradiol. 3b. Results of bloodwork: High Testosterone (1035 H), High Testosterone Free (235.7 H), High Testosterone Bioavailable (464.3 H), High Red Blood Cell Count (6.13 H), High Hemoglobin (16.6 H), High Hematocrit (50.9 H), SED Rate by Modified Westergren (2), D-Dimer Quantitative (0.19), Estradiol (83): No treatment, but repeated labs ordered
W/in 24 hrs post vax developed a fine papular rash on her face, arms & legs; rash remitted in a few days but recurred one wk later;
8/16/2022: 1:19pm Resident is S/P covid booster, day# 2/3 to left deltoid, but more so the outer aspect of left forearm and not deltoid area. Area is red and swollen. No drainage noted to site. There is also some bruising noted to area.  1:30pm Left mid upper arm laterally/posterior redness noted with slightly raised area. 9:14pm injection site red and warm to touch. Client rates pain on the site 4/10;prn Tylenol offered, resident refused, afebrile. 9:37pm Dr. advised of reddened area to patient's left deltoid approximately 2 inches in diameter, patient rates pain in the area as 4/10 but is refusing PRN tylenol. 8/17/2022: Reddened area observed on left upper arm. Resident states that there is pain at reddened site. Site is warm to touch. 8/18/2022: Covid booster LD, 8cm x 11cm redness/swelling with c/o soreness. 8/19/2022: Covid-19 booster to LD. Red raised area is diminishing. Resident now c/o "itchiness" to LUE.
I received the flu vaccine at the same time as the booster shot.  I had fever in the injection site, body aches, swollen left arm at injection site, swollen lymph node under left arm, headache, fatigue
April 8, 2021 had Janssen shot.  April 9 to today date I have been Nausea , severe muscle aches, chill, fever, very tired.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure under control" (unspecified if ongoing); "High cholesterol treated" (unspecified if ongoing); "Lung surgery as a child" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing), notes: \. The patient's concomitant medications were not reported. Past drug history included: Vioxx, reaction(s): "Known allergies: Vioxx"; Lisinopril, reaction(s): "Known allergies: lisinopril"; Antibiotics, reaction(s): "Known allergies: Some antibiotics.".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. it was reported that the patient received treatment of Paxlovid from 12Jul2023 to 16Jul2023 for COVID-19 infection.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer. This 53-year-old non-pregnant female consumer reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 17Feb2021 at 12:45 (at the age of 53 years) as dose 2, single for covid-19 immunization. Medical history included cancer diagnosis 28Dec2020. Lumpectomy for successful removal of breast cancer left side 01Feb2021. No known allergies. Concomitant medication(s) in two weeks included levothyroxine sodium (LEVOXYL) 137mcg; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) 100-25 mg; colecalciferol (D3) 2000IU. No Covid prior vaccination and post vaccination. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 26Jan2021 at 12:45 (at the age of 53 years) as dose 1, single for covid-19 immunization. Severe pain and heavy feeling in my right arm at and around the site of injection on 17Feb2021 at 15:00. Her second dose was on 17Feb, that day she had symptoms of soreness and heaviness in the arm that received the injection. She did not submit her adverse event right away because she didn't have the full story until she recovered from the soreness and heaviness. She did not remember exactly what day, she submitted the adverse event form. She waited until she was fully recovered. According to the information, she did submit on 23Feb2021. AE treatment: Tylenol for pain. The outcome of events was recovered on an unspecified date of 2021. Follow-up attempts completed. No further information expected.
When I woke up at 12:30AM on the 12/22. I had a very sharp pain in my left shoulder and my left side causing shortness of breath. I ended up moving around and got it to lessen and went to work the next morning. I called the clinic in town when I described what happened and the nurse said to go to the ER. This was 11 hours after the initial onset. They did a CT scan and found pulmonary embolisms in both lower lungs, mostly in the left. I was put on XARELTO and there is no family history of this. It took about until Christmas Eve in the evening before the symptoms subsided. I took TYLENOL and ibuprofen and rotated those every 3 hours for a week to control the pain. They gave me oxycodone and I took that once and couldn't see a difference so I stayed with the TYLENOL and ibuprofen. I went  through the course of XARELTO. I had some side effects from the medication that included blood in the urine and constipation. That finally let up when I reduced the medication from 30mg to 20mg. I've also had a CT scan on my legs trying to figure out where these clots are coming from and they couldn't find anything. I have an appointment on Feb 10 for a CT urogram. On Feb 17, I have my annual physical and I'll follow up with a colonoscopy. This looks like I have 3 to 6 months of being on a blood thinner to make sure these clots go away.
Patient received COVID vaccination during hospital stay on 11/29, patient deceased 1/7/22
pain in his neck; pain in his neck and shoulder on the right side; 3-4 days later a rash presented on the right side of his chest; This case was reported by a consumer and described the occurrence of neck pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced neck pain, shoulder pain and rash. On an unknown date, the outcome of the neck pain, shoulder pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, shoulder pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm. After receiving 1st dose of Shingrix, the patient experienced rash presented on the right side of his chest as well as pain in his neck and shoulder on the right side. The reporter did not consent to follow up.
A pharmacist reported that a pediatric pt received a tetanus toxoid vaccine and subsequently developed a grand mal seizure. No further information was available at the date of this report. This event is considered medically important.
I got little sick but this one is bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 (Lot number: EN6198) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; KLONOPIN; TOPAMAX. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got little sick but this one is bad".  Additional information: Reaction/event as reported by primary source : she got little sick but this one was bad. Consumer stated, "Okay, she really did not know where to start so, may be we jump in and ask questions that will be great because she was not feeling well. Okay, so on 1Apr she had her second Covid vaccination Pfizer one, her first one she got little sick but this one was bad and she had a partner that she was living with and she and patient have been together for 25 years and both got their shots on the same days and she was in the shape reporter was in, which was not good. When requested for probing, Consumer stated, she also had Lupus so she was in autoimmune lupus and prone disease and all kind of stuff though. When probed for as she was suffering from any other medical condition, consumer stated, "It had been since she received her first shot; you mean high blood pressure." (Further not clarified hence not captured in tab).   No follow-up attempts are possible. No further information is expected.