chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation concerning a female child who, for the first two years of her life, was vaccinated with injections containing the "dangerous and highly toxic" mercury based preservative thimerosal. The alleged result of these vaccinations is that the pt now suffers from, and in the future will continue to suffer from, the toxic neurological effects of mercury poisoning. Immunization records were received as follow-up info. Per the records, on 08/06/97, the pt was vaccinated in the right thigh with varicella virus vaccine live (lot 05363 reported, invalid for the product) and in the right thigh with MMR vaccine (lot 620805/0239E). Concomitant vaccinatiions included ActHib/DTP (lot 0776040 given IM in the left upper outer gluteal on 09/19/96; lot 0795420 given IM in the right upper outer gluteal on 11/20/96; lot 0795470 given IM in the left thigh on 01/22/97), Orimune (lot 0745K given on 09/19/96; lot 0744H given 11/20/96; lot 0749M given 01/22/97), hep b vaccine recomb (Engerix B unreported lot given 07/20/96; lot 2129A2 given IM in the right thigh on 09/19/96; lot 2201A2 given IM in the right thigh on 01/22/97) and PPD test (lot 250311) given in the right arm on 09/30/99. Upon internal review toxic neurological effect and mercury poisoning were determined to be other important medical events. No further info is available.  Reported on 03/14/2003: "This is an amended report.  The primary suspect therapy was changed from varicella virus vaccine live to hepatitis B vaccine recombinant (yeast)(manufacturer unknown).  This report was corrected as amended.  Reported on 05/14/2003: "Follow up information received on 05/01/2003 reported that the patient received injections of vaccines allegedly containing thimerosal on the following dates: 07/20/1996, 09/19/1996, 11/20/1996, 01/22/1997, 08/16/1997, 09/30/1999, and 11/23/1999.  Upon internal review toxic neurological effect and mercury poisoning were determined to be other important medical events.  No further information is available.
Pt was extremely apprehensive about receiving the shot, but cooperative. When pt received her shot she appeared fine so she was sent back to class. 15-20 min after she returned to class the RN was called to go see her at her classroom because she was unwell, per RN pt was "light headed" and "Dizzy". Pt admitted being "super nervous" vitals were normal. RN had pt elevate her feet, take deep breath and drink water and within 10 min pt felt "fine".
Left armpit pain, possible swollen lymph nodes. Arm pain at injection site, and arm pain outside of arm on the elbow side.  Body aches, back pain, flu like symptoms,  weakness, fatigue, dizziness.
She started feeling nauseated 1/19/21, had three episodes of emesis and a headache.  She also began to feel itchy and then later that evening, developed large red welts on the upper body.  1/20/21 was seen again for rash spreading from her head to thighs
THROWING UP; LOW BLOOD PRESSURE 98/68; This spontaneous report received from a consumer concerned a 97 year old female. 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced throwing up. On 21-JUN-2021, the subject experienced low blood pressure 98/68. Laboratory data included: Blood pressure (NR: not provided) low blood pressure 98/68. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up, and low blood pressure 98/68. This report was non-serious.
could not lift the arm and that had no use of left arm; Sweats; pain went from elbow up to the neck , front chest; pain in the arm where the vaccine was given; lymph node was the size of an egg; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain in the arm where the vaccine was given), PAIN (pain went from elbow up to the neck , front chest), LYMPHADENOPATHY (lymph node was the size of an egg), INJECTED LIMB MOBILITY DECREASED (could not lift the arm and that had no use of left arm) and HYPERHIDROSIS (Sweats) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included Allopyranol, Hydroclorizide, LISINOPRIL and METOPROLOL for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain in the arm where the vaccine was given), PAIN (pain went from elbow up to the neck , front chest) and LYMPHADENOPATHY (lymph node was the size of an egg). On 17-Jan-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (could not lift the arm and that had no use of left arm) and HYPERHIDROSIS (Sweats). At the time of the report, VACCINATION SITE PAIN (pain in the arm where the vaccine was given), PAIN (pain went from elbow up to the neck , front chest), INJECTED LIMB MOBILITY DECREASED (could not lift the arm and that had no use of left arm) and HYPERHIDROSIS (Sweats) was resolving and LYMPHADENOPATHY (lymph node was the size of an egg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included none.
Pain, swelling, redness at injection site, noted 1 day after injection. Progressed to approximately 12 cm x 5 cm area of erythema and edema by day 3.
Patient called me saying that we gave him Pfizer vaccine on the 4/6th and he got JNJ on the 2nd. I called him tom confirm he said he said I made wrong decision of getting JNJ so his wife told him to get Pfizer and he come to our pharmacy to get pfizer. He apologized when I asked him why he did not tell us or why he wrongly answer the consent form  .I called again to ask if he had any side effects but he did not answer
screamed most of day p/vax w/high pitched cry; knot on leg size of golf ball w/reddness; warm compresses; redness & heat left p/4 hrs & knot remained 1-1 1/2mo;
The patient received the oral RotaTeq vaccine on 7/31/09.  She returned on 8/2/09 and had 1 day of hematochezia from stoma area, but this symptom resolved in approx. 24 hours.  This was thought to be possibly related to vaccine administration.  Fecal occult blood test was not performed as stools were thrown away and symptoms resolved prior to being able to test sample.  [Patient did require admission to the hospital for Gram-Negative Blood stream infection by her central line which was thought to be unrelated to the vaccine administation.]  10/27/09:  Hospital records and discharge summary received for dates of service  8/2/09 to 8/14/09  and 8/31/09 to 9/16/09 Dx:  Short bowel syndrome, resolved line sepsis.   Assessment:  Received rotavirus on 8/1/09 and spiked a temperature on 8/2/09 of 104.5.  Admitted to surgical service tachycardic with a P of 172 and tachypnic with a RR of 60.  Liver was palpable 1-2 cm below the right costal margin and jaundice was noted.  Completed 14 days of IV Cefepime.  On TPN via Broviac 2/2 short bowel syndrome at birth and subsequent bowel resection with ostomy.  Oral feeds of 10 ml. Q 3 hrs. were started during this hospitalization.  Currently on nystatin for diaper rash.  Discharged home on 8/14/09 to follow up in pediatric clinic on 9/1/09.   Readmitted on 8/31/09 for short gut syndrome. Given bowel prep and IV fluids.  Underwent iliostomy reversal and placement of R facial vein Broviac as previous one had been damaged.   Fed by NG tube until day 8, then advanced to oral feeds of 30 ml. Q 3 hrs.  Developed TPN cholestasis and started on Actigall.  Discharged to home on TPN and oral feeds.   1/6/2010:  Discharge summary and hospital records received for dates of service 12/14/09 to 12/19/09.  Dx:  Line sepsis.  Presented to ED with fever, broviac catheter in place for TPN.  Also has cold and cough.  Started on IV antibiotics for presumed line infection.  No fevers throughout admission, tolerated feedings well.  Discharged to home.
Shingles sores occured and diagnosed by physician on 11/03/2010.  Treated by antibiotic.
Many days after shot, woke up with bad vertigo that lasted 12 hours. Consistently dizzy thereafter for two weeks. Dizzy after waking up and bouts of vertigo initiated by lifting or moving head too quickly ever since those first two weeks.
Wife tested positive as well; Wife tested positive as well; This is a spontaneous report from a non contactable consumer.  A female patient of unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications was not reported. On 09Apr2021, the patient tested positive. The lab tests included PCR (Nasal swab), result: Positive on 09Apr2021. The outcome of the events was unknown.   Follow-Up (14Apr2021): Upon follow up, new information included that the patient was vaccinated (first and second dose of vaccine was unknown.)  No follow-up attempts are possible. No further information is expected.
Around 9pm 4/5/21 (night of J&J Covid vaccine administration), patient had difficulty finding words--had never experienced this before. She also had minor/expected symptoms like low grade subjective fever, body aches, fatigue. Then within 2-3 weeks she also started having right sided chest and right breast pain, discomfort, and prominent breast tissue on right.  She had positional pain in anterior right/center chest when bending forward past 45 degrees, and which would go away when she was positioned upright or supine. This pain/pressure persisted for weeks to months. She also experienced a feeling pf pressure in right chest and difficulty getting a full breath into right side of her chest/lungs. These symptoms persist to this day, 12/7/2021.
FELT A LITTLE BIT IF SOMETHING; RECEIVED AN EXPIRED VACCINE; FATIGUE; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: high blood pressure, arthritis, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-SEP-2021, the patient experienced felt a little bit if something. On 22-SEP-2021, the patient experienced received an expired vaccine. On 22-SEP-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received an expired vaccine, fatigue and felt a little bit if something was not reported. This report was non-serious.
Detached retina; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: RETINAL DETACHMENT (medically significant), outcome "unknown", described as "Detached retina". Therapeutic measures were taken as a result of retinal detachment. Clinical course: on 05Jan, patient had emergency surgery for a detached retina. Patient had no other injury or medical indicator, it happened suddenly. Patient have had the Pfizer vaccine for COVID. Patient just wanted to report in case this is data that the company is collecting of a common theme.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient notices hives on upper body and arms on 6/30/13 (Sunday). Called our pharmacy on 7/1/13 to report hives: the hives are improving. Patient has not taken anything for hives. Recommended BENADRYL 25mg up to QID. Pt also said he was out of town over the weekend and said he had spent time in the hotel's pool.
Experiencing a buzzing in my head. It's a high pitched "E" sound that doesn't go away.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose Moderna,Lot#012L20A 2nd dose Moderna,lot#012M20A Diagnosed covid positive:08/04/21 Symptom onset:07/31/21 Exposure:community Symptoms:Fatigue, congestion,runny nose,sinus congestion.
Tiny bit of soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Tiny bit of soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for Macular degeneration, APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL), METOPROLOL, TORSEMIDE, POTASSIUM CHLORIDE, BUPROPION, LEVOCETIRIZINE, FLUTICASONE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), SALBUTAMOL (ALBUTEROL HFA), MULTIVITAMINS [VITAMINS NOS] and L-ARGININE [ARGININE] for an unknown indication.   On 04-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. In February 2021, the patient experienced PAIN (Tiny bit of soreness). At the time of the report, PAIN (Tiny bit of soreness) outcome was unknown.            Concomitant medication included l-glulisine. No treatment information was provided.   This case was linked to MOD-2021-035078, MOD-2021-035078 (Patient Link).
had given an expired IPOL injection with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Media Information (under the reference 00814501).  This case involves a 4 years old male patient who had given an expired IPV (VERO) [IPOL] injection (expired product administered).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.   On 15-Oct-2021, the patient received a dose of suspect IPOL (0.5 ml, total, lot R1F972M and expiration date: 3-Oct-2021) via intramuscular route in the deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  At time of reporting, the outcome was unknown for the reported 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.
Patient came to pharmacy only for moderna booster vaccination. Patient received flu vaccination intended for another patient. Patient confirmed their name multiple times before entering and after entering immunization booth. Patient was well informed in the booth prior to receiving vaccination that two vaccinations were prepared, flu and moderna booster, and confirmed with patient if they wanted both shots in one arm  or one shot in each arm. Pt confirmed to have both shots in one arm. When patient was presented with their immunization card, they stated that that was not their name. Patient received an apology. The patient then stated they were sorry, that they were OK and did not appear to be upset. The patient only wanted their COVID vaccination card and left upon receipt of their card. Patient was not charged cost of flu HD vaccination
Vaccinated neighbors that got covid-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Vaccinated neighbors that got covid-19) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Vaccinated neighbors that got covid-19). At the time of the report, COVID-19 (Vaccinated neighbors that got covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided.  No treatment medications was provided.   This case was linked to MOD-2021-294379 (Patient Link).
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 47-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Atropine, reaction(s): "Known allergies: Atropine". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive; (Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 07Nov2023 to 12Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384553 same patient, different event/ drug;
Woke up with neck pain on R side (vaccine administration side)  Pain got worse and patient went to urgent care - was prescribed steroid and NSAID and topical ice.
Patient had urinary retention within 24 hours of the first injection. This required emergency room visit. Foley catheter was attempted to be placed but it was found that he had urethral stricture. This could not be dilated. Suprapubic tube had to be placed. Time course: within five hours of injection patient had decreased force of stream after his second dose. He was seen in urgent care facility and catheter could not be placed. Then transferred to another hospital emergency room where catheter could not be placed. Suprapubic tube was then placed in the early morning of 23 April. He was then found to have a urethral stricture which required open surgical repair on June 11, 2021. He is now fully recovered.
About 24 hours after the first dose, I began developing rashes on various points of my body. Right leg ankle, right forearm, and chest area. It is not painful, just very itchy.
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L001325, expiration date 13-JAN-2017; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Very sore arm at the injection site; She had to lay down and sleep for a hour because of being very tired; Achy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. This patient received the Pfizer COVID-19 Vaccine 18 days ago, yesterday was day 18 or day 19 she guessed; and she had a very sore arm at the injection site again, which she had for about 1.5 days when she got the Pfizer COVID-19 Vaccine. She got very tired and achy. She had to lay down and sleep for an hour because of being very tired. Information on the lot/batch number has been requested.
Vaccine given before it was due. Dose #1 given 7/9/18. Dose #2 given 8/7/18. Dose #3 given 9/20/18.
Had chills, Headache, itching. Got home and itched for 45min, coughing. took 50mg of Benadryl. Stopped itching/coughing went to sleep.
Breakthrough case admission after 4 vaccines Moderna 2/18/21 Lot# 031M20A;  Moderna 3/18/21 Lot# 045A21A Moderna 1/17/21 Lot# 939903;  Moderna 8/17/22 Lot# 051B22A
Soreness Sunday and small red spot noticed to right of injection site. Monday- spot grew and became warm, size of a dime. By Tuesday, 11/7- red patch turned purple and was very hot to the touch. It was the size of the palm of my hand.  I went the ER as my  Primary Care nor the Urgent Care could see me. I was prescribed Bactrim for 7 days. As of today, 11/11/23 there is still some redness, not hot to the touch. Red are the size of a half dollar.
Mother brought child in for a covid vaccation, and technician mistakenly administer the moderna updated booster  instead of the moderna pediatric immunization...... upon review of sheet, pharmacist noticed error and alerted parent.... was told as of today, patient has not experienced any side effects from incorrect immunization yet, but will continue to monitor