chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little numb around the area; Pain over her eyebrow/has the pain very frequently/at nighttime she rolls over other side/pain towards temporal area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain over her eyebrow/has the pain very frequently/at nighttime she rolls over other side/pain towards temporal area) and HYPOAESTHESIA (Little numb around the area) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Pain over her eyebrow/has the pain very frequently/at nighttime she rolls over other side/pain towards temporal area). On an unknown date, the patient experienced HYPOAESTHESIA (Little numb around the area). At the time of the report, PAIN (Pain over her eyebrow/has the pain very frequently/at nighttime she rolls over other side/pain towards temporal area) and HYPOAESTHESIA (Little numb around the area) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not have concomitant medication.  No treatment was reported by the reporter.  Second dose was administered on 26 Mar 2021 with a batch number of 044A21A.
I am prone to tinnitus but now it seems to be constant ringing in both ears and it doesn't stop. It seems to have gotten worse.
Local rxn round approximately 7.5 cm lesion c/w local rxn; possible early cellulitis will follow closely.
fever; headache; chills; body aches, especially in my back; body aches, especially in my back; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation and experienced painful, swollen axillary lymph node. It was reported that after the second dose, the patient had a rougher go of it with fever, headache, chills, body aches, especially in back. Clinical outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Took Paxlovid on day 1 of being positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Took Paxlovid on day 1 of being positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (No, unknown historical drug.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 25-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced COVID-19 (Took Paxlovid on day 1 of being positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (Took Paxlovid on day 1 of being positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         It was reported that patient symptoms returned on Day 12. Patient thought they were allergies. Patient tested positive again for COVID 19 on day 16.  The patient had received any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously receive a COVID-19 Vaccine. Device Date reported as 26-May-2022  Company comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred approximately 9 months after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 15-May. Patient tested negative 7 days after testing positive. Symptoms returned on day 12 and patient tested positive again for COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected non serious  of COVID 19 which occurred approximately 9 months after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 15-May. Patient tested negative 7 days after testing positive. Symptoms returned on day 12 and patient tested positive again for COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient reports getting vaccine 4-5 months ago, unsure of exact date of vaccination. Wife reports in last 3 months patient has had memory issues and behavior disturbances, of note no diagnosis of PTSD or mood disorders. Has apparently had psychological stressors, unclear if alcohol or drugs involved.   Per wife on 7/29, patient acted restless in bed then fell from bed with difficulty breathing. She started CPR, when EMS arrived he was found to be in Vfib - he subsequently received 7 shocks, multiple rounds of epi and amio finally reaching ROSC. Troponin found to be 2723, so patient was taken emergently to cath lab. No blockages were found, but EF was <15%. Since then, patient has been inpatient, went through targeted temperature management, extubated 7/30. EF from 8/2 is now 60-65% - planning to pursue further cardiac workup at outside hospital or get ICD. Neurologically intact with no signs of anoxic brain injury.
Injection given at 2PM I had neck pain and headache at 9PM that evening. At 3am woke up with chills, full muscle aches, headache and felt flu like. At 9am following morning still a very bad headache along with chills and extreme fatigue. By noon headache gone but fatigue an chills continued for several hours. Exactly 3 days later I developed an awful rash started on hands. This rash is extremely itchy an painful at times. The rash is on hands, arms, legs, belly, neck an back pretty much everywhere. My legs started swelling on day 6.
pt says on the first day after taking the vax she had a sore arm and muscles aches in her back.  Later that night she had a 103.2 fever so she took 2 Advil and went to back to bed.  Next morning her temp was normal.  She still had the achy muscles in her back, she started getting pain at the injection site and she developed a headache.  By night time her fever was 99 so she took more medicine and went to bed.  Next morning she was very nauseated and she had to go to the bathroom.  She started getting heart palpations.  At this time all of her symptoms have subsided except the heart palpitations which she is going to schedule an appt w/ her PCP.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # L011846, expiry date: 16-JUN-2017 (dosing details were not reported). It was reported that GARDASIL 9 went to a temperature of 8.4 C for 1 minute and then went to 0.6 C for 1 minute. No data logger was used. No previous temperature excursion was reported. The vaccine was back in range. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
4 hours after vaccine was administered pt. experienced hives all over body, dizziness, itchiness, dry and itchy eyes and has developed a cough.
Grandmother reported low grade fever, poor appetite at time of filing report. Reporting d/t administration error. Administered 3 days past expiration date.
Received extra dose of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 21-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date 26th October 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (had already finished the scheme of Pediarix).   On 1st March 2023, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comment: The nurse called to report  that earlier that day (on the day of reporting) a patient that had already finished the scheme of Pediarix received an extra dose of such vaccine.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient had received the 4th dose of Pediarix, which had led to extra dose administered.
Anaphylaxis. Tx- EPI, KENALOG, monitoring symptoms resolved with treatment.
Was in good health. Received 2nd dose of COVID19 vaccine on 4/7 with progressive weakness and confusion following vaccination. Admitted to hospital on 4/18 with confusion, fevers, thrombocytopenia, mediastinal adenopathy and elevated LFTS and inflammatory markers. Workup has been negative but ongoing fevers and confusion. Labs have improved without treatment.
Presented with cough, congestion, SOB; + covid PTA on 10/27; rec'd monoclonal antibodies PTA but continued to have cough/nausea; admitted wtih hypozemic resp failure due to covid 19 PNA; Oxygen initially 2 LPM, down to room air by d/c; inflammatory markers down by d/c.  Tx: Decadron, Lovenox, Vit C, Pulmicort, Vit D3, Singulair, Zinc
Information has been received from a nurse via a company rep regarding the female nurse who on an unspecified date received the pneumococcal 23v polysaccharide vaccine (lot not provided). Subsequently, she experienced a 4 day localized erythema and painful swelling. The reporter felt that the nurse's experience was related to vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Pt received Janssen vaccine, pt waited 30 minutes post vaccine administration due to his allergies.  Pt reported throat pressure and difficulty swallowing approx  30 minutes post vaccine.  Pt alert and no difficulty with speaking.  EMS activated and patient transported to ER for evaluation
rt arm red circle larger than fifty cent piece given med & ATB;muscles tight, swelling, difficult to move arm;
Information has been received from the nursing staff of a pediatric practice concerning patients who were vaccinated with a dose of Gardasil (lot number unknown) and experienced pain at the injection site after receiving Gardasil. The pain was worse than the pain with other vaccines. The outcome was unknown. Additional information was received from a registered nurse via phone call who reported that there were too many patients to quantify who complained about the pain of the injection. Additional information has been requested.
Severe body aches chills and temp of 100.3. Symptoms lasted about 12 hours.   Estimated due date 9/23/21
A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows; It feels like hives on the top of my head; I couldn't sleep because of the itching; Rash in both shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head), INSOMNIA (I couldn't sleep because of the itching) and RASH (Rash in both shoulder) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for Pain: Cortisone shot (Patient got cortisone shot between the two shots. It was on the opposite arm and in his right shoulder) on 03-Mar-2021. Concurrent medical conditions included Pain (Patient had pain from another injury (fell)), Vitamin D low, Leukemia and Hypokalaemia. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head), INSOMNIA (I couldn't sleep because of the itching) and RASH (Rash in both shoulder). At the time of the report, PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head) and INSOMNIA (I couldn't sleep because of the itching) outcome was unknown and RASH (Rash in both shoulder) had not resolved.      Concomitant medications included medications for leukemia, low potassium, low vitamin D and pain. The patient stated 4 medications a day, 6-7 pills per day.   The patient's HCP recommended diphenhydramine and hydrocortisone cream to apply to the arm and shoulder. The patient had not started treatment at the time of this report.
Presented with SOB x 2 weeks, hx COPD on oxygen at home.  Dx with COPD exacerbation.  Treated with breathing tx, steroids, abx, vit c &d, and oxygen.  D/C to facility.
There was no adverse reaction. This was an administration error as the patient was underage for this vaccine.
Fever 12/24/20 @12:30 am woke up with severe chills (rigors) lasted 3 hours max was 103.7 f, extremely tiredness. 12/25/20 @ 12:00 midnight all symptoms resolved, fever gone. 12/25/20- much better just a little tired. Narrative:
Patient describes nausea, fatigue and headache. Also has arm soreness, but very mild
Question: Any new symptoms of fever, cough, shortness of breath? Answer:   Yes   Question: Have you been exposed to anyone with COVID or a person under investigation for COVID in the last 10 days? Answer:   Yes
5PM20JAN99 devel redness & itching on face;530PM 20JAN99 devel wheals face, neck & back;550PM seen in ER for rash;macules papules & wheals;acute allerg rxn;
Client complaint: neck pain, leg pain, spasms to left side of her body, tingling sensation on left side near knee and calf, electric shock type feeling. The symptoms started several weeks after the second of the 2 dose series.  Client also reported receiving 2 doses of chicken pox vaccines in 2003 with no adverse reaction. However protective antibodies were not reported and the series was repeated in 2005.
Information has received from a licensed practical nurse concerning her 8 year old daughter with no pertinent medical history or drug allergies who on 05-SEP-2000 and 25-JUL-2007 at 14:30 was vaccinated with her first (Lot # 632716/1690J) and second (Lot# 656823/0305U) 0.5mL SC does of varicella virus vaccine live (Oka/Merck) in the left thigh. There was no illness at the time of vaccination. There was no concomitant medication. On 31-JUL-2007, the student developed a 2 cm circular lesion on her left thigh area at the injection site which was also red and swollen. Unspecified medical attention was sought. No lab diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Child woke with non-traumatic R knee pain & effusion on the morning of 7/29. He was seen in the ED, joint was aspirated and work-up initiated. He still has pain and swelling as of 7/13/21 and is unable to bear weight.
Patient was given a dose of MMR that had already expired.  MMR expired on 10/18/23 A call was placed to Merck and they recommended the dose of MMR be repeated in 4 weeks.   Parent was notified by Dr. They agreed to come back in 4 weeks for repeat dose
FEELING DIZZY; NECK PAIN; EARS PAIN; CHEST PAIN; LEFT ARM PAIN; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: UNKNOWN) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced feeling dizzy, neck pain, ears pain, chest pain, left arm pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feeling dizzy, neck pain, ears pain, chest pain and left arm pain was not reported. This report was non-serious.
Fatigue 8PM. Fell asleep 8:30 PM. Awakened at 9:30PM by severe, uncontrolled chills, neck and shoulder pain, biting of tongue, could not speak well.
stressed out and have hives; stressed out and have hives; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (stressed out and have hives) and URTICARIA CHOLINERGIC (stressed out and have hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA CHOLINERGIC (stressed out and have hives). On an unknown date, the patient experienced STRESS (stressed out and have hives). At the time of the report, STRESS (stressed out and have hives) and URTICARIA CHOLINERGIC (stressed out and have hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
hurt both times; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received shingle shot in 2019 and stated that it really hurt. This case had been linked with US2021AMR024828 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024828:same patient
Delayed allergic reaction Erythemathous, sweling rash en elbows, knees area and legs. Urticarial, intense itching, she didn't improve with benadryl. Treatment with Prednisolone and ceterizine for 5 days
She received her Moderna COVID vaccine on 02/26/201 which was a Friday, then on Monday and Tuesday patient had decreased appetite and felt miserable. Then on 03/08/2021 she started having chest pain that made her go to the ER. She was then found to have a multisegmental pulmonary embolism
This vaccination was received as a reaction to a scratch received while shaving. Swelling, sore, red, lasting several days.
Loss of all verbal skills for 1.5 months, some loss of motor skills in legs for 1 month, internal blood blister towards right eye still present at 2 years of age, and shook head back and forth while sleeping for 1 month.  Loss of verbal skills transitioned into severe speech delay (only 2-3 words spoken at 18 months old).  Continued speech delay at 2 years of age.  02/19/2006 MR received from PCP.  WCC on 4/5/2006 showing normal growth and development and PE with resolving AGE.  WCC 6/7/06 with normal growth and dev.  Parental concern over vaccine ingredients. Several sick visits for mild head trauma, choking, cold sx. 9 mon WCC with normal growth and dev and PE. AGE in 11/06.  12 mon WCC noting behavior and sleep problems and lack of interest in solid food. Normal growth and dev noted. 03/10/2008 Records received from current PCP  beginning with WCC 7/17/07(Age 1 yr 7 mon) through 10/31/07.  Speech delay noted on 1st exam.  Sent for speech eval 7/31/07 showing moderate/severe expressive language skills. Receptive language-no concerns. 1/20/2009 Continued negative symptoms from mercury poisioning (behavior issues, bacterial infection) in gut, food intolerances.  Follow-up: Speech delay and sleep issues continue to this day.
Vaccine was administered after the FDA removed the authorization of the Pfizer BioNTech COVID-19 Vaccine, Bivalent on 09/11/2023.
Pain began hours after receiving the injection. The next day (1/13/19) she wore a long sleeve shirt and did not notice the rash. Rash and pain is below the injection site, into the muscle and up into the armpit. Feels like she pulled the entire muscle.
Patient was fully vaccinated and tested positive for covid. She was vaccinated on 12/18/20 with Pfizer BioNTech lot EJ1685 and then on 1/8/21 with Pfizer BioNTech lot EJ1685. She tested positive for covid on 4/8/21. Her husband was positive prior to her testing positive.
Patient received pediatric 5-11 dose instead of 12+ dose. NO symptoms or adverse event during course of vaccine administration or observation period.