chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication was reported. No treatment medication was reported.  This case pertains to the 101 patient of the total 190 patients.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335:Master case
pt recv vax 12MAY98 & 13MAY98 devel migratory arthralgia & arthritis w/a low grade fever;27MAY to MD w/joint aches;T100.7;gen rash;during exam acute pharyngitis w/tonsillar hypertrophy;sx attributed to serum sickness secondary to vax
Profuse bleeding from injection site. Sore stiff neck muscles for 4 days Fever after 2 days for 8 hours 100F
Feb 8 states she had a cold. Feb 9 added stomach ache and nausea.  Feb 9 visited urgent care facility for exam and Covid-19 test. Rapid test results were negative. Appeared tired but fine.  Told to go home and rest. Feb 10 at 9:00 am found dead on the floor  in pool of blood and aspirated. Excessive blood in toilet, pooled on floor and hallway rug.
After receiving the Pentacel Vaccination, the patient began experiencing stomach upsets, constipation and vomiting, mucous and blood in stool, and extreme crying. The patient could no longer sleep on his back or lying down, and would wake up frequently crying in pain. The patient started nursing more frequently, sleeping sporadically and wheezing frequently.  The patient also appeared to have a case of whooping cough, and was brought in at around 3 months of age but the doctor refused to believe it, and instead gave patient a test for rsv which came out negative.  The patient was breastfed and an elimination diet was started by the patient's mother, after the symptoms did not go away.  Some relief was experienced after several potential allergens were eliminated but the patient at 15 months is still suffering from gastrointestinal distress, and having difficulty sleeping.
Palpitations, dizziness, feeling hot - about 4.5 hours after the vaccination
This case was reported by a healthcare professional and described the occurrence of exacerbation of pain in muscles in a 14-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject's medical history included leg weakness and sore muscle. Subject participated in baseball, basketball and weight training. Concurrent medications included cold and sinus medication. On 19 November 2007 at 19:42 the subject inadvertently received unspecified dose of Fluarix (.5 ml, unknown, right arm) and experienced a vaccination error. He was supposed to receive an influenza vaccine that was approved for  14 year old subjects. At an unspecified time after vaccination with Fluarix, on or before 30 November 2007, the subject experienced exacerbation of pain in muscles and muscle weakness aggravated. At the time of reporting the exacerbation of pain in muscles and muscle weakness aggravated were unresolved. The healthcare professional considered that the exacerbation of pain in muscles and muscle weakness aggravated were possibly related to vaccination with Fluarix. Follow-up received on 09 January 2008 via the healthcare professional. She reported that two days following vaccination with FLUARIX (intramuscular), on 21 November 2007, the subject experienced exacerbation of pain in muscles and muscle weakness aggravated. It was also reported that the events had improved by 10 December 2007. In the relevant medical history section of the adverse event form, it was noted that leg weakness and sore muscle started on 21 November 2007 and resolved on 10 December 2007. The reporter considered that the events were not serious and possibly related to the use of FLUARIX. The healthcare professional also considered that the events could have been associated with the subject's participation in weight training, baseball and basketball practices.
Shots were given 0900 Friday Feb 1, 2008. The day after the shots were administered, there was a 2 inch area around the injection site that was raised, red, very warm to the touch, and VERY painful to the point that my daughter could not walk or put pressure on her leg whatsoever. The entire area was very hard, it felt almost as if there was a rock under her skin. This lasted for 3.5 days. Monday February 4th, we took her to see the doctor to be seen and by that point the symptoms and side effects were going away. During the time she was experiencing symptoms, we were giving her Tylenol and Motrin to help with pain and trying our best to keep swelling down by giving her baths and applying cold compresses. 12 days following the shots (Feb 13th) she then had another reaction where she had a fever of 103.2 and ws very cranky. Again, she was given Tylenol and Motrin to help with the fever. These symptoms lasted approx 3 days and she was not seen by the doctor.
Next day presented with localized reaction: red, swollen, warm to touch. Denied SOB or wheezing. Advised Benadryl and ice, and ER precautions if worsens or difficulty breathing.
Fluzone QIV NP PFS reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; product was administered to patient post excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA069463 (CLUSTER), 2023SA057733(CLUSTER) and 2023SA069771(CLUSTER).  This case involves Adult and unknown gender patient and other health professional reported that Influenza quadrival A-B vaccine [Fluzone QIV] (fluzone qiv np pfs) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with and product was administered to patient post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date fluzone qiv np pfs reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event (product storage error) and the patient received a  dose of suspect Influenza quadrival A-B vaccine suspension for injection (lot: UT7683NA, expiry date: 30-Jun-2023) with unknown strength, dose via unknown route in unknown administration site for prophylactic vaccination, post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 recieved Rotavirus Vaccine on 04/16/2007 and returned to office on 04/18/2007 with complaints of vomiting and diarrhea that started in AM Mom tried giving pedialyte and she could not keep that as well. No fever at home. Patient also recieved other 2 months vaccines as well on 04/16/2007. Dr.  admitted her in the hospital on 04/18/2007 and discharged on 04/20/2007. While admitted Rotovirus test was done and came back positive.Child was placed on IV Fluids for dehydration and recovered good. Discharged returned to office  for follow up and doing good.  4/27/07 Received vax records from PCP which confirms RO lot number on VAERS report & also corrected patient name. 4/27/07 Received medical records from hospital which reveal patient experienced vomiting & diarrhea for 1 day prior to admit.  Seen by PCP & found to be dehydrated.  Admitted to hospital 4/18-4/20/07 for IFV.  Progressed well & d/c to home on oral feedings w/o further vomiting or diarrhea. FINAL DX: Rotavirus positive gastroenteritis and mild dehydration.
Case previously recorded as MA2009-3335. Initial case report received from a physician via Med Com, on 26 OCT 2009. A 7-month-old child was vaccinated with 0.5 ml S-OIV FLUVIRIN (batch no. 100813-7P) i.m. on 24 OCT 2009. No adverse event was reported. Reference no. NA09-07008.
About 12 hours after receiving the SHINGRIX, pt began to feel aching in the whole body with chills and fever and was not able to sleep. He had more pain and swelling at the site of the injection. He had an outbreak of shingles in 9/2016. Now about 28 hours after vaccine and have recommended that the patient put ice on the local reaction and that he take tylenol for the systemic symptoms.
Patient states he received vaccine at 11 AM and by 3 PM he was burning up with fever and hot chills, dizzy, body aches and pains - were "on fire".  Went to bed and awoke at 9 PM - temp was 101F; took Tylenol and Advil.  Feels better 10/17 - went to work but still achy joints.
Patient received the Pfizer-BioNTech COVID- 19 Vaccine EUA at 13:43. She then reported facial soreness, flushing, and swelling on the right side of her face. Benadryl 25 mg. p.o. was administered and patient was monitored for additional observation (30 minutes). After the first 30 minutes patient still felt swelling and warmth on the right side of her face. Later on, patient noted improvement in symptoms and went home.
CHILLS; TEMP 102.6; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, temp 102.6, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp 102.6, headache and chills was not reported. This report was non-serious.
Injection site, warm to touch, red, about 1 1/2-2 inch diameter, hard lump beneath. Painful to touch.
8:50 AM Pt received Tdap, PPD screen, MCV4, HPV#1.  Pt then stated that she felt light headed.  Pt then had stiffening of of upper body for 1-2 second.  Pt aware after incident.  Pt able to follow commands, gives name of sibling to call and #.  Pt aware of where she is at.  No breakfast ingestion taken prior to vaccination.  Blood glucose post vaccination 141, BP 100/60, HR 64, RR 16.  Pt being observed.  No recourse at this time.
PT receive Pfizer 12+ 0.3 mL dose and should have received Pfizer 5-11 0.2mL dose  No adverse reactions noted PT stayed in facility greater than 30 min
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 72-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 8th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea. On an unknown date, the outcome of the chills, fever, feeling bad, diarrhea, tiredness and lethargy were unchanged and the outcome of the nausea was unknown. It was unknown if the reporter considered the chills, fever, feeling bad, diarrhea, tiredness, lethargy and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was linked with US2018GSK150533, reported by the same reporter.
Shingles outbreak after a few days.  3 weeks late and no menstrual cycle.
lose strength/without strength/the muscle on the "rabbit" there is where lost strength; tried to lift the arm and the pain was strong; muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt; where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle; tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired). At the time of the report, ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-285679 (Patient Link).
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot number # L022261, expiration date 01-APR-2016, route and dose not provided) on multiple unspecified dates ranging from 01-SEP-2015 tot 19-NOV-2015. No adverse effects were reported. Additional information has been requested.
Red raised circle ?? at injection site; approximately 3 inches  in diameter; tender and hot to the touch.
Very weak; Unable to walk without assistance.; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 08:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included Congestive Heart Failure (CHF), Rheumatoid Arthritis (RA), fibromyalgia and Chronic Obstructive Pulmonary Disease (COPD). The patient was allergic to latex and nickel. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 08:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 08:00, two days after the second vaccine, the patient felt very weak and was unable to walk without assistance. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very weak and unable to walk were resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a consumer's son refers to his mother an 80 year old female patient with allergy (unspecified). The patient's medical history included multiple recurrences of shingles. On 10-APR-2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not provided). Concomitant therapy included unspecified allergy medication. On 10-APR-2014, the patient experienced swelling at the injection site. No treatment was given for the adverse event. The patient did not seek medical attention. The patient's son stated that his mother could skip a year of shingles but they always returned, usually in the cranial area. The patient was given a prescription for ZOSTAVAX by physician and was told to wait until her last shingles symptoms cleared, then got the ZOSTAVAX vaccine. In approximately April 2014, after a few days, the swelling went away, reported as recovered. Causality was not reported. Additional information has been requested.
STATES SHE HAS BEEN EXPERIENCING COLD SYMPTOMS SINCE BEING VACCINATED
Information has been received from a 67 year old female with latex allergy who on 28-JUN-2009 (The patient also stated she did receive the zoster vaccine live (Oka/Merck) vaccine last year.) was vaccinated with zoster vaccine live (Oka/Merck) (dose, route and site not reported). Concomitant therapy included omeprazole and oxybutynin. The patient stated that she had shingles since 28-JAN-2010. The patient's shingles persisted. It was unknown if the patient sought medical attention. Follow up information has been received from the consumer who reported that she was seen by her Doctor on 02-FEB-2010, who was aware of her shingles because the Doctor prescribed the vaccination. The patient stated that she was 8 weeks out from the outbreak of lesions. The blisters were gone, but the areas remained quite red and visible. The patient stated that she was progressing. Follow up information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-JUN-2009 (previously reported as 28-JUN-2009), a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2010, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The causality of the events is related. Additional information has been requested.
Right Arm was very painful so bad I could not lift anything for months pain is still in right arm. The pain has lasted almost a year.  I have been to physical  therapy numerous times, and chiropractors nothing is working . My dr is now taking X-ray and mri?s all of this began after the first vaccine.
28FEB91 530AM pt Mom states she had sz that lasted 2-3min, shook all over, voided on herself & had an incontinent B.M.;
t104.9-105 that noc;went to ER advised to given APAP & motrin;had fever until 1MAY96;had a complete personality change since 29APR96;won't eat or take breast much;screamed x 3 hr, irritable;
High fever of 103.6, chills and muscle aches, duration of 6-8 hours.
The patient was inadvertently given a PROQUAD instead of the MMR-II. Patient had no reaction to this event.
Information has been received from a nurse practitioner concerning a 17 year old female patient with allergies to cast and scallops who on 21-FEB-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included NYQUIL. 20 hours later, the patient developed hives. Unspecified medical attention was sought. The patient's hives persisted. The reporter indicated the patient had hives from the vaccine. Additional information has been requested.