chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The adverse event that took place was that the second dose in the COVID-19 Pfizer monovalent two-dose series was given to the patient too soon after his first dose. According to CAIR, the patient received a first dose of Pfizer on 3/30/2023. This early administration occurred during a pop-up clinic that our Covid Team held on 4/6/2023 at Harm Reduction Services (2800 Stockton Blvd, Sacramento, CA 95817). I am reporting this event as I discovered this error while performing quality assurance checks on our past clinics, but was not present in the vaccination area while this patient was vaccinated. There were no report of any patients having any adverse effects at this clinic, and no patients showed any signs or symptoms after being vaccinated.
Red bumps on lower legs (possibly Poiser Oak)-- itchy, noticed when I awoke day after vaccine vaginal yeast infection (noticed 2 days after vaccine and still have) irritated stomach/colon
Information has been received from a certified medical assistant referring to a 61 year old female patient. Concurrent condition and medical history was not reported. On 09-FEB-2016 the patient was vaccinated with a dose of expired ZOSTAVAX (0.65 ml, subcutaneous, lot # K012921, expired date: 29-NOV-2015) in the left arm (expired vaccine used). No adverse effects reported. Additional information is not expected as there is no consent for follow up.
Have had ocular migraines  that started 1 week after 1st dose and increased in frequency after second dose.  Have been seeing my PCP and Ophthalmologist.  I have been referred to a neurologist.
Site: Pain at Injection Site-Medium, Additional Details: patient reported having sore shoulder up to neck 5 minutes after getting vaccine. at 15 minutes she stated nothing was worse or better. no signs of allergic reaction.
The patient was getting this flu shot in his left arm. When I tried to press the plunger on the syringe it was stuck. I had to take it out of the left arm but the syringe was full.  I gave him another shot on the right arm and it worked.  A few minutes later, dad said he was not feeling well.   He had dizziness and tinnitus, vision problems.  He drank some water and sprite and waited at the pharmacy for 30 minutes. He started feeling better and then left.
I got hives for about 1 week after shot #1/ intermittent hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced intermittent hives for a week after first shot. The reporter consented to follow up.
Redness and swelling upper arm-red streaks down arm-quite painful and hot to the touch.  Went to local urgent care facility after speaking with nurse.  Was given antibiotic to take for ten days and asked not to leave on planned trip.  Was cautioned to receive immediate care if symptoms did not subside or worsened. Responded positively to treatment within approximately 6 days.
patients were administered with an expired pentacel with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who were administered with an expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 10-Oct-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ785AA, expiry date: 09-Oct-2023 with unknown strength) via intramuscular route in the left thigh as prophylactic vaccination.  On 10-Oct-2023 the patient was administered with an expired /Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache, Sedation, Fever, NauseaVomiting, Decreased Appetite Narrative:  About 6-8 hours after first dose on 1/5/21 noted nausea and decreased appetite. The next morning 1/6/21 noted vomiting, headache and fatigue. Fever up to 101.3. Missed work x 1 day. No known prior COVID infection.    Other Relevant History:
Vaccine recipient received the vaccine on 12/18/2020. On 12/19/2020 reported that the injection site had prominent redness and swelling. On 12/22/2020, the site was warm to the touch and the pain was mild, but bothersome. Over these 5 days the injection site became swollen with increased redness and pain. On 12/23/2020, the vaccine recipient reported that they were feeling better and has followed-up with occupational health with no further issues.
Screamed after shots for 2 days per parents, was not consolable. Acted different after vaccines. Less eye contact for a while. Still doesn't seem to have as much eye contact as before shots (per parents). No fever reaction per parents.
feeling sick; Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.; fever; chills; Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), MALAISE (feeling sick), VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), PYREXIA (fever) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Sentinel node biopsy (Sentinel node dissection in the left arm.). Concurrent medical conditions included Diverticulitis (worsening for the last 5 years.). Concomitant products included CALCIUM for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.), PYREXIA (fever) and CHILLS (chills). On 25-Feb-2021, the patient experienced MALAISE (feeling sick). On 25-Feb-2021, MALAISE (feeling sick), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE REACTION (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.) and VACCINATION SITE ERYTHEMA (Ended up getting another injection site reaction on the hip which was 6 inches across and was red in color.) outcome was unknown.            It was reported that the 2nd dose of the Moderna vaccine on 24-Feb-2021 was given in the hip.  The patient said that patient did not want to receive it in the left arm  as patient had a sentinel node dissection on that side.  Patient reported that the injection site reaction on the hip which was 6 inches across and was red in color had not hurt so much. Fever and chills only lasted overnight. The next morning when patient woke up, patient was feeling sick, but started feeling better with movement. AE had not caused patient to seek medical care. Patient had not experienced a similar event in the past. Patient received Tylenol for side effects related to the vaccine.   This case was linked to MOD-2022-628835, MOD-2022-628840 (Patient Link).
This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation and FLU VACCINE, via an unspecified route of administration, on an unspecified date, at an unspecified dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced not feeling well, feeling lightheaded and increased blood pressure all on unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: increased.  No follow-up attempts possible. No further information expected.
one day after my first vaccine, I started to feel muscular pain in my legs, it felt as if they were extremely sore. At first I though t it was due to a personal training session but then it would not go away (also I have been swimming for 7 month almost every day, so I should not get sore.  Then about a day before the second vaccine everything went back to normal, now after the second vaccine I had the same symptoms (2/3/21 was the second dose) and they are still persisting.  If I take Aleve Muscular Pain, they symptoms go away completely but come back as soom as the medication wears off.  It feels like I am constantly sore, if I am active it is fine but once I sit or lay for extended periods of time I have a problem getting up.
Patient presented with SOB, wheezing after vaccine. Epi Pen given, along with 50mg Bendadryl.Lungs clear, Pulse Ox 99%, BP 170/90 EMS called and transported patient to ED for further treatment and evaluation. Patient symptoms were resolved when dc from clinic to ED.
Low Blood Pressure; Site soreness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low Blood Pressure), VACCINATION SITE PAIN (Site soreness) and FATIGUE (Tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Exercise induced asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] and BECLOMETASONE DIPROPIONATE (QVAR) for Exercise induced asthma.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPOTENSION (Low Blood Pressure), VACCINATION SITE PAIN (Site soreness) and FATIGUE (Tired). On 04-Feb-2021, VACCINATION SITE PAIN (Site soreness) and FATIGUE (Tired) had resolved. At the time of the report, HYPOTENSION (Low Blood Pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: low (Low) Low.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient has increased salt intake to increase the blood pressure.   This case was linked to MOD21-050566 (E2B Linked Report). This case was linked to MOD-2021-116640.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up document received on 07-MAY-2021. Patient's date of birth was verified. It contains no new information.; Sender's Comments:  MOD21-050566.
None. Package insert had expiration date, unknown to us, this was not correct. Moderna found with proper storage, vaccine maintained the activity necessary to protect against the SARS-COV-2 virus at the time of administration. Viability check done by Moderna found vaccine to be viable and effective.
Arthralgia, NauseaVomiting & HYPOtension Narrative:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-JAN-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician/MD as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-AUG-2016, the patient was treated by the physician/MD (same one who administered the ZOSTAVAX) for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the herpes zoster was unknown. Causality assessment was related. Additional information has been requested.
mom called several hrs p/vax eyes pink & puffy;rapid noisy resp;medicated tx on Breathing machine in ER
Fever, fatigue and muscle pain the night of the vaccination day.  Next day was back to normal
Pt reported site of injection to be "swollen" and area red from "shoulder to elbow" and "knot" under skin at site of injection.
Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens when I move around and change position; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on the left arm on 06Jan2021 (15:00) at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included ibuprofen. On 07Jan2021 (12:30 AM), the patient had felt bad; bad headache; nausea; and was dizzy which happened when she moved around and changed position. The patient had received paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as treatment for the reported adverse events. The outcome of the events, 'felt bad', 'bad headache', 'nausea' and 'dizzy which happened when she moved around and changed position', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested since the vaccination. The patient had COVID-19 test which was negative on 08Jan2021.
Patient came into clinic on 9/07/17 and stated she had a mild reaction to the vaccines she received on 6/15/17. She received MMR and Varicella on that date. She stated that when she got home, she had a rash on her face. That was the only symptom, no breathing difficulty, tongue swelling, no lips swelling. She stated the rash went away on its own and it was not a cause for concern for her but she wanted to let me know. I advised the patient, next time she has symptoms and she is having breathing difficulty to call 911.
-pounding headache lasting 8 days  -swelling of the face, eyes, neck, and lymph-nodes in neck for 9+ days (ongoing)  -Swelling of the armpit and pain in the lymph-node under the armpit for 5 days
Positive COVID test result; Positive COVID test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 (Lot number: FK5168) at the age of 11 years as dose 2 (tris), single and intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: FK5168) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient received vaccine at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Patient had no known allergies. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022, outcome "recovering" and all described as "Positive COVID test result". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Hives after injection #1 Gardasil.  1 1/2 hr after given vaccine- hives developed- pt has hlo  hives and they did resolve after 2 doses of Benadryl.
pt recv vax & devel a large area of cellulitis (area of rxn spread 3x the initial size), tx Keflex po; rxn resolved p/approx 1wk;this is one of eight patients from this facility who exp the above rxn
Smallpox Vaccine received on 9 Sept 05. Area has been inflamed since shot given. Irritation to skin condition. Inflamed around vaccination area and with deep itch. Has never stopped itching.
14 year old. he got1 injection of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old. he got1 injection of Moderna) in a 14-year-old male patient 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old. he got1 injection of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old. he got1 injection of Moderna) had resolved.            Concomitant medications were not provided.  Treatment medications were not provided.  Events included I will monitor the symptoms if and will respond later
Soreness at injection site, chills, fever, fatigue,  body aches, headache. Symptoms started at 15 hours post vaccination and continued for the following 36 hours. Symptoms were relieved with OTC acetaminophen and/ibuprofen.
received Janssen J &J shot 9:15 am on April 7th approx, 24 hours later had to leave work for home because I became incredibly weak, tired and without energy. struggled at driving home had to repeatedly slap my face to stay awake. checked my temp. when arrived home, had a low fever (100.1) went to bed slept for 4 hours, checked temp (100.1) went back to sleep. woke 9 am on 4/9/2021 checked temp. (normal) fever broke on 4/9/2021 used restroom at 11:01 am 4/9/2021 large amount of bleeding from rectum LARGE AMOUNTS of blood clots in stool (shaped like Candy) Contacted medical provider. Spoke to a triage nurse, explained my concerns about bleeding from rectum and blood clots in stool... she dismissed that my restroom issues were related to the vaccine,
no adverse event, accidentally was given expired batch of vaccine (exp on 4/28/21)
Fever, chills, muscle aches, sinus congestion, cough and chest tightness, headache, fatigue, nausea all began within 36 hours of injection. It's now under 72 hours and symptoms have gotten worse.
1 Feb, 2020.  Shingrix vaccination. Swelling of approx. 2 x 2 inches at injection site within 24 hours. Around 2 to 3 days post vaccination there was a red area, approx. 0.75" h x 2" wide at the bottom of the deltoid muscle (below injection site). Approx. 2 to 5 days post vaccination, mild immune response discomfort of feeling tired, slightly feverish (temp. not taken), general aching. Deltoid stayed swollen for approx. a week.  10 Feb, 2020  - Day 9 I awoke in the middle of the night with very sharp pain along exterior of left breast (side of vaccination). At first I thought it was muscular - pectoralis major muscle, but there had been no event to cause a strained muscle. The area of pain appears to be the axilla lymph nodes extending into the breast. Noted was generalized swelling in the left axilla region. There was no sign of injury (other than the vaccination) that I believe attributed to symptoms experienced.  14 Feb, 2020 - Annual mammogram with normal results  18 Feb, 2020 - The swelling under the armpit has decreased. There is still some residual pain along the lymph node pathway radiating from the axilla and breast. Pain has been gradually decreasing though.  I thought I would report this in the event the adjuvant has been causing lymph node responses in others.
Rash on both of legs; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 30th September 2021) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix .5 ml. On 2nd November 2019, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The patient received the first dose of Shingrix on Friday. The patient developed a rash on both of his legs since receiving that. The reporter consent to follow up.
Patient up to date on COVID vaccines who admitted with hypoxia and COVID detected PCR.  Provider d/c note:  "81 YO year old female with past medical history of COPD, CAD, PVD, HTN, HLD, RA on immunosuppressed, depression presenting to Hospital with complaint of weakness and sob.  She was found to be positive for COVID-19 and treated with full course course of remdesivir and 10 days of steroids.  Her methotrexate and adalimumab were held. She required supplemental oxygen.  She was subsequently discovered to have bacterial (Pseudomonas) pneumonia and treated with 6 days of IV cefepime and discharged on 1 day of oral Cipro.  Her clinical status improved and she was deemed appropriate for placement on 12/28/2022."
Vaccine recipient inadvertently received Janssen vaccine, not approved for recipient's age. Multiple checks before administration did not catch this. The patient and parents requested Janssen as recommended by the pediatrician. Of course, if it was noticed, our clinic would not have administered this vaccine, but recommended Pfizer which was available at the event.  Parents were advised after administration and consultation with pediatrician was recommended .